chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: inappropriate schedule; the patient had itching at the injection site; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; This spontaneous report was received from a nurse and refers to a 30-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.    On an unspecified date in her childhood, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On 08-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On the same day, she experienced redness, swelling, and pain that radiated down her left arm to her left elbow. On an unspecified date, the patient went to an unspecified physician and the physician prescribed an unspecified antibiotic as treatment. On 16-JUL-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection in the right arm, lot # S025610, expiration date was not reported but after internal investigation was established as 18-AUG-2021 (exact dose was not reported) for varicella immunization (inappropriate schedule of product administration). On an unspecified date in July 2020 (reported as after the 16-JUL-2020 vaccination), the patient experienced itching at the injection site. The outcome of the events of redness, swelling, and pain that radiated down her left arm to her left elbow were reported as recovered. The outcome of the event of itching at the injection site was not reported.  The relatedness between the suspect therapy and the events was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: inappropriate schedule; the patient had itching at the injection site; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; redness, swelling, and pain that radiated down her left arm to her left elbow; This spontaneous report was received from a nurse and refers to a 30-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.    On an unspecified date in her childhood, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On 08-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for varicella immunization. On the same day, she experienced redness, swelling, and pain that radiated down her left arm to her left elbow. On an unspecified date, the patient went to an unspecified physician and the physician prescribed an unspecified antibiotic as treatment. On 16-JUL-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection in the right arm, lot # S025610, expiration date was not reported but after internal investigation was established as 18-AUG-2021 (exact dose was not reported) for varicella immunization (inappropriate schedule of product administration). On an unspecified date in July 2020 (reported as after the 16-JUL-2020 vaccination), the patient experienced itching at the injection site. The outcome of the events of redness, swelling, and pain that radiated down her left arm to her left elbow were reported as recovered. The outcome of the event of itching at the injection site was not reported.  The relatedness between the suspect therapy and the events was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Nurse reported administration of ROTATEQ after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  No information regarding the patient concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 23-JUL-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, lot number 1676324 has been verified to be valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date: 21-APR-2021 for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 20 hours in the temperature 8.83 degrees Celsius on unknown date prior to administration. There was no previous temperature excursion. Digital Data Logger was involved.  No additional adverse event was reported. The outcome of medication error was unknown.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; received dose of improperly stored Varivax and MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 05-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number S015464 was verified to be valid, expiration date reported and established as 20-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. On the same day, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot number S013536 was verified to be valid, expiration date reported and established as 02-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis.  The administered doses of vaccines experienced a temperature excursion of -14.3 Celsius degrees for 3 hours and 45 minutes. There was no previous temperature excursions. Digital Data Logger was involved.   The patient did not experience any additional adverse reactions.
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: Extra dose administered, Hepatitis A antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: tested antibody non-reactive; receiving Havrix on 10/28/2002, 9/13/2002, 04/04/2003; receiving Havrix on 10/28/2002, 9/13/2002 and 4/4/2003; This case was reported by a physician via other manufacturer and described the occurrence of therapy non-responder in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis and HAV (Havrix) for prophylaxis.   On 13th September 2002, the patient received the 1st dose of Havrix. On 28th October 2002, the patient received the 2nd dose of Havrix. On 4th April 2003, the patient received the 3rd dose of Havrix. In October 2002, not applicable after receiving Havrix and Havrix and unknown after receiving Havrix, the patient experienced drug dose administration interval too short. In April 2003, the patient experienced extra dose administered. On 14th July 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, extra dose administered and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received the 3rd dose of Havrix which led to extra dose administered.  The patient's tested Hepatitis A antibody test non reactive. The reporter declined consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Reactogenicity event
Clinical narrative: severe reactogenicity; day off work.; This case was reported by a other health professional via sales rep and described the occurrence of reactogenicity event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced reactogenicity event and inability to work. On an unknown date, the outcome of the reactogenicity event and inability to work were unknown.   It was unknown if the reporter considered the reactogenicity event and inability to work to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vacination with 2nd dose of Shingrix, the patient experienced severe reactogenicity and required to take the day off work. The patient did not experienced any adverse event after 1st dose of Shingrix. No additional information provided.
Sex: U
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 5 days after receiving Bexsero, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination with Bexsero, stiil had considerable muscle pain.
Sex: M
Vaccine: MEN
Symptoms: Intensive care, Meningococcal infection, Vaccination failure
Clinical narrative: he caught the disease/Suspected vaccination failure; he caught the disease; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and meningococcal infection (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that. the patient received vaccine and ended up in the ICU after he caught the disease and really had to stop endorsing faulty products. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for meningitis were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Hot flush, Insomnia
Clinical narrative: 99.2F temperature/  increased temperature; headache; tiredness; muscle pain; hot flashes; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, hot flashes and difficulty sleeping. In August 2020, the patient experienced body temperature increased, headache and tiredness. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved and the outcome of the headache, tiredness, muscle pain, hot flashes and difficulty sleeping were unknown.   It was unknown if the reporter considered the body temperature increased, headache, tiredness, muscle pain, hot flashes and difficulty sleeping to be related to Shingrix.  Additional details were received as follows: Age at vaccination was not reported. The patient received Shingrix and that night she had difficulty sleeping due to hot flashes, muscle pain, tiredness, headache, and 99.2F temperature. The patient had increased body temperature till the time of the report. The reporter refused to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 99.2F temperature/  increased temperature; headache; tiredness; muscle pain; hot flashes; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, hot flashes and difficulty sleeping. In August 2020, the patient experienced body temperature increased, headache and tiredness. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved and the outcome of the headache, tiredness, muscle pain, hot flashes and difficulty sleeping were unknown.   It was unknown if the reporter considered the body temperature increased, headache, tiredness, muscle pain, hot flashes and difficulty sleeping to be related to Shingrix.  Additional details were received as follows: Age at vaccination was not reported. The patient received Shingrix and that night she had difficulty sleeping due to hot flashes, muscle pain, tiredness, headache, and 99.2F temperature. The patient had increased body temperature till the time of the report. The reporter refused to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Faeces discoloured, Nausea, Pain
Clinical narrative: nausea; body aches; black stool; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received Shingrix. On 7th August 2020, 1 days after receiving Shingrix, the patient experienced nausea, general body pain and black stools. On an unknown date, the outcome of the nausea and general body pain were recovering/resolving and the outcome of the black stools was not recovered/not resolved.   It was unknown if the reporter considered the nausea, general body pain and black stools to be related to Shingrix.  Additional information was received as follows: The patient experienced nausea, general body pain and black stools. At the time of reporting, nausea and body aches had improved but the black stool had not. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Swelling
Clinical narrative: swelling; chills; redness; This case was reported by a consumer via call center representative and described the occurrence of swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In 2020, less than 6 months after receiving Shingrix, the patient experienced swelling, chills and redness. In 2020, the outcome of the swelling, chills and redness were recovered/resolved.   It was unknown if the reporter considered the swelling, chills and redness to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on left deltoid. The patient had a few side effects from her first dose of Shingrix in January of this year. These included chills, redness and swelling but all resolved within 2 to 3 days. The patient received second dose in July (for tolerance of second dose refer linked case US2020AMR157877). The reporter did not consent to follow up. This case was linked to case US2020AMR157877 by same patient.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Felt really tired; fever; Muscles hurt; Joints hurt in his quad muscles; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2020 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th August 2020 05:00, 4 hrs after receiving Shingrix, the patient experienced tiredness, fever, muscle pain and joint pain. On an unknown date, the outcome of the tiredness, muscle pain and joint pain were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the tiredness, fever, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 1:00 pm and around 5:00 pm felt tired and had a fever. The Fever had resolved but still feels tired, muscles hurt and joints hurt in quad muscles. The reporter consented to follow up and could follow up with the patient directly.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: was diagnosed with shingles today; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. On 21st July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th August 2020, the patient experienced shingles. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the pain in arm and shingles to be related to Shingrix.  Additional information was received as follows: The case was reported by the wife of the patient. The patient developed arm soreness after receiving her 1st dose of Shingrix. Twenty days after receiving vaccination, the patient was diagnosed with shingles on the day of reporting. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: Headache; Feeling Sick; Body Aches; Chills; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis.   On 10th August 2020, the patient received Bexsero. In August 2020, less than a day after receiving Bexsero, the patient experienced headache, malaise, general body pain and chills. On an unknown date, the outcome of the headache, malaise, general body pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the headache, malaise, general body pain and chills to be related to Bexsero.  Additional information was received as follows: The case was reported by the Clinical Supervisor. The patient experienced feeling sick, headache, body aches, and chills. Healthcare Professional noted the event began the night the vaccine was received. The events were ongoing, with no outcome at the time of this report. The reporter consented to follow up. This case was linked to case US2020158056, US2020158058 and US2020AMR159262 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020AMR159262:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Red Bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced erythropapular rash and pruritus. On an unknown date, the outcome of the erythropapular rash and pruritus were unknown.   It was unknown if the reporter considered the erythropapular rash and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient developed red bumps and itching after dose 2 of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Injection site vesicles
Clinical narrative: Blister at site of administration; This case was reported by a nurse via sales rep and described the occurrence of injection site blisters in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The nurse informed that a patient experienced blister at site of administration. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: allergic reaction Menactra vaccine; Initial information regarding an unsolicited valid non serious case was received from Pfizer (non-licensed partner) (MFR Control No: 2020290909) in the form of courtesy via a consumer or other non- healthcare professional and transmitted to Sanofi on 01-Aug-2020.  This case involves female patient (age not reported) who experienced allergic reaction to Menactra vaccine (drug hypersensitivity), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history included adverse food reaction and adverse drug reaction.  At the time of the event, the patient had ongoing milk allergy and food allergy.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction to Menactra vaccine (drug hypersensitivity), unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Laboratory details were not reported.  Final diagnosis was drug hypersensitivity.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for drug hypersensitivity.   There will be no information available on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: a patient received Hib component of the Pentacel vaccine was reconstituted with the same diluent they use for the MMR vaccine/ No AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a nurse manager.  This case involves a six-month-old male patient who was vaccinated with hib component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (Lot number on the Pentacel carton was UJ227AAA expiration date: 23-Apr-2021. Lot number on the powder component of the vaccine is UJ227AA expiration date: 23-Apr-2021. Lot number on the liquid component of the Pentacel vaccine was UJ314AA, expiration date: 23-Apr-2021) that was reconstituted with the same diluent they use for the MMR (mumps, measles and rubella) vaccine and the liquid component of the pentacel vaccine was not administered to the patient, vaccination was indicated for prophylactic vaccination on 30-Jul-2020.   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination on 30-Jul-2020.  It was a case of an actual medication error case due to wrong solution used in drug reconstitution (PT: product preparation issue).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional via phone.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA203126, 2020SA202832, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves an four year old female patient who was vaccinated with a 0.5 ml once dose of IPV (VERO) [IPOL]  (lot P1F541M expiry date 07-Dec-2020) in the left arm on 20-Jul-2020 for prophylactic vaccination after a temperature excursion. (Product storage error)  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  No other medications of vaccinations were given on that visit.  This was an actual medication error case due to product storage error temperature too low. It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Pain, Secretion discharge, Swelling
Clinical narrative: Pain, swelling, drainage, erthyema
Age: 77.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reported full body hives beginning about 8 hours post-vaccination. The hives respond to oral Benadryl 50 mg but return in 4 hours. Patient is still reporting hives 2 days following vaccination, following up w/ PCP for further treatment.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Area was bright red and warm to the touch. Patient experienced fever, chills, headache, shaking, back and neck muscle aches, and patient used Aleve to help these symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Area was bright red and warm to the touch. Patient experienced fever, chills, headache, shaking, back and neck muscle aches, and patient used Aleve to help these symptoms.
Age: 56.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: I received the vaccines on Tuesday afternoon and woke up around 11;00 p.m. with chills, fever100.7-102.5, body aches, tiredness, nausea, severe flu-like symptoms. The symptoms have continued thru Thursday at the same level not improving yet. The site of injection is red swollen and has some whelp looking places.
Age: 56.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site urticaria, Nausea, Pain, Pyrexia
Clinical narrative: I received the vaccines on Tuesday afternoon and woke up around 11;00 p.m. with chills, fever100.7-102.5, body aches, tiredness, nausea, severe flu-like symptoms. The symptoms have continued thru Thursday at the same level not improving yet. The site of injection is red swollen and has some whelp looking places.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Chills, Discomfort, Fatigue
Clinical narrative: On the 11th of August 2020 I received the shingrix vaccine at my pharmacy. By 8pm that evening I began to have fever >100 deg F along with Chills , significant myalgia and arthralgia. I took ibuprofen 400mg q 6-8 hours and supplemented with tylenol 100mg  every 6 hours or as needed.  After a very uncomfortable evening ( chills fever and joint pain ) the next morning the fever had subsided however the fatigue, weakness and arthralgia persisted. By 5 pm of day 2 the fever had returned and the arthralgia persisted through to day three. by the end of day three there was residual joint and muscle pain and persistent albeit improvement is fatugue.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: On the 11th of August 2020 I received the shingrix vaccine at my pharmacy. By 8pm that evening I began to have fever >100 deg F along with Chills , significant myalgia and arthralgia. I took ibuprofen 400mg q 6-8 hours and supplemented with tylenol 100mg  every 6 hours or as needed.  After a very uncomfortable evening ( chills fever and joint pain ) the next morning the fever had subsided however the fatigue, weakness and arthralgia persisted. By 5 pm of day 2 the fever had returned and the arthralgia persisted through to day three. by the end of day three there was residual joint and muscle pain and persistent albeit improvement is fatugue.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Vaccine recieved at 0930 am . Per nurse, patient waited 15 minutes post vaccine and left with no reported issues.  Patient called the clinic at 1000 from her car stating that the  left side of face and left arm was numb and tingly.  Patient also stated she was lightheaded and dizzy.  The nurse advised her to pull over to the side of the road and call 911.  Patient was taken to the emergency room and discharged.  Follow up call to the patient at 12:30 with no answer and at 1400.  At 1400 patient stated she was feeling much better but tingling in side of face and arm was still mildly present.  She has a roommate staying with her for the day.  Patient was advised to seek medical care if symptoms worsen or do not resolve.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Product quality issue
Clinical narrative: Patient vaccinated multiple times with HPV vaccine, had a total of 6 vaccines; Unsure which HPV vaccine the first 3 doses series was; This spontaneous report was received from a Pediatrician concerning a 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patient was vaccinated with three doses of an unspecified HPV (human papillomavirus) vaccine for prophylaxis (dose, strength, route of administration, lot number and expiration dates were not reported). After that, on unspecified dates, the patient received a second three dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, route of administration, lot number and expiration dates were not reported).  At the reporting time, the patient had received a total of 6 vaccinations. No PQC (product quality complaint) was reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient had no pertinent medical history, drug reactions or allergies and did not take any concomitant therapy.  On 04-AUG-2020, the patient was intramuscularly vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (dose was not reported, lot # S036495, expiration date 13-SEP-2021), as vaccination. On the same day, few hours after vaccination, the patient experienced unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow at the injection site. The symptoms worsened overnight. On 05-AUG-2020, he had a telecalth visit with the physician and was prescribed acetaminophen (TYLENOL) and diphenhydramine (BENADRYL). The patient did not have any laboratory test performed. The reporter requested a lot check for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S036495 with expiration date of 13-SEP-2021. At the time of the report, the patient had not recovered from the events. The relatedness between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; The patient was vaccinated with an expired PNEUMOVAX23 vaccine; This spontaneous report was received from an officer manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On 10-AUG-2020, the patient was vaccinated with an expired vaccine of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml (route of administration and anatomical location were not reported, lot number: R034249 and expiration date: 07-AUG-2020) for prophylaxis (expired vaccine used). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R034249; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt. stated she felt her arm about 5 days ago and felt a small lump where 1st vaccine was given.  She stated she did not know it was there until she touched it.  She also stated it is tender to touch only.  No redness or heat visualized by nurse today and lump is about the size of a small marble.  Instructed pt. to apply a warm compress a few times a day and to follow up with PMD if worsens.  She received second MMR today as scheduled.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: pt reported some mild pain to arm after 2 weeks of vaccination. has had symptoms of nerve pain in neck prior to vaccine and thinks there may be correlation. pt will just use selfcare overthecounter pain med or ice area but does not think necessary since pain mild
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Patient was only given diluent. Assistant did not dilute medication to inject, only gave the diluent without the medication.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at injection site began on 8/11/2020. Patient had limited movement of his left arm. He presented to the office on 8/13/2020 for evaluation. Physician evaluated the site and diagnosed him with bursitis.
Age: 67.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Insomnia, Muscle swelling, Pain, Peripheral swelling
Clinical narrative: PATIENT STATED HE FELT SEVERE PAIN AND COULDN'T SLEEP THAT SAME NIGHT OF THE VACCINE.  HIS BICEPS/TRICEPS WERE SWOLLEN.  HIS ARM WAS SWOLLEN DOWN TO THE ELBOW.  PATIENT STATED TAKING IBUPROFEN DID HELP A LITTLE BIT OF THE SWELLING BUT NOT MUCH.  PATIENT WILL CALL MD TO FOLLOW-UP.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called roughly 4-5 hours after flu shot complaining of soreness, redness and swelling around the site of injection. Patient denied any throat tingling, itchiness, Shortness of breath or other signs of allergic reaction. Patient denied have any other swelling but at the site of the injection. Patient admitted to taking over the counter "pain powder" roughly an hour after the vaccination. Patient claimed to never have any reaction to flu vaccine previously. Patient stated she had a severe Bee allergy , but did not list under allergies in the vaccine consent form. Patient was told to try a cold compress to reduce swelling and redness. She was told to contact her doctor  if she was further concerned about the reaction or if the reaction did not get better or got worse.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Time course of adverse event - 20 days; Treatment - Used Tylenol 500 - 1000mg several times per week Difficulty sleeping Body aches / Joint and muscle pain Fatigue Dizziness / Light headed / Foggy thinking Hot sweating - Face only Heart rate increased / racing - especially when lying down Increased Temperature - Highest 99.6F Oral Occasional headache  / occasional decreased appetite
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: Time course of adverse event - 20 days; Treatment - Used Tylenol 500 - 1000mg several times per week Difficulty sleeping Body aches / Joint and muscle pain Fatigue Dizziness / Light headed / Foggy thinking Hot sweating - Face only Heart rate increased / racing - especially when lying down Increased Temperature - Highest 99.6F Oral Occasional headache  / occasional decreased appetite
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Thinking abnormal
Clinical narrative: Time course of adverse event - 20 days; Treatment - Used Tylenol 500 - 1000mg several times per week Difficulty sleeping Body aches / Joint and muscle pain Fatigue Dizziness / Light headed / Foggy thinking Hot sweating - Face only Heart rate increased / racing - especially when lying down Increased Temperature - Highest 99.6F Oral Occasional headache  / occasional decreased appetite
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Malaise, Pallor
Clinical narrative: PATIENT STATED HE FELT SICK AND REQUESTED WATER, PATIENT STARTED LOOKING PALE. TRIAGE WAS CALLED, WATER AND APPLE JUICE WAS GIVEN TO THE PATIENT. PATIENT'S VITALS WERE TAKEN. AFTER ABOUT 10 MINUTES PATIENT WAS SENT HOME BY CLINIC RN.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Incredible body aches, fever, headache,  stiff left arm, nausea
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Pruritus
Clinical narrative: Left arm the patient couldnt lift it. It was red and swollen. On 8/13/2020 it was itching and a little red
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Lung disorder, Musculoskeletal disorder, Myelitis transverse, Nervous system disorder
Clinical narrative: Within days had nerve issues from neck and back of arms. emergency room October 30 when right arm lost all function. Was released three days later, but then again back in hospital Nov 26 with loss of all legs function and loss or left arm and compromised lungs. Diagnosed with transverse myelitis. Was transferred to acute and then subacute and discharged Feb 28. Am still in wheelchair now with very little leg function though my upper body has gotten better.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Wheelchair user
Clinical narrative: Within days had nerve issues from neck and back of arms. emergency room October 30 when right arm lost all function. Was released three days later, but then again back in hospital Nov 26 with loss of all legs function and loss or left arm and compromised lungs. Diagnosed with transverse myelitis. Was transferred to acute and then subacute and discharged Feb 28. Am still in wheelchair now with very little leg function though my upper body has gotten better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor, Staring
Clinical narrative: Patient was feeling dizzy, turned pale and had a blank stare for a couple minutes. Patient was kept and monitored for 45 minutes in the office. Apple juice was given before the vaccine. BP was taken 4 times before discharged. Doctor's kept monitoring the patient.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling, Vascular test normal
Clinical narrative: At almost exactly 24 hours after the shot my arm starting hurting badly on 01-08. That night I woke up with my arm swollen to about 3 times its normal size with intense pain. I called the pharmacy that gave the shot and they said to get to a doctor or ER right away. Dr got me in and said I was having a reaction. Prescribed benadryl and steroids. These initially helped the pain but the swelling never went all the way down. My arm is still swollen and painful
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Was here for his vaccines 9 days ago, that day had sore arms, still having pain on his right arm that hasn't gone away - where he received MenB. Feeling is a little numb Went to restaurant after the appointment and he ate something separate from the family, otherwise family eats the same things Next day non-bloody diarrhea started, approx 4-5 times and is happening every time after he eats Is also nauseous, and is dry heaving or vomiting with workouts - is doing some school workouts daily and is sweaty and dizzy at this time Has still been eating, but not as much and has lost some appetite Hasn't had any solid stools since the appointment, had a stool today that a little more chunks in it than the days previously  No treatment needed except PRN zofran prescribed, just supportive care (reporting due to extended symptoms >9 days long), phone call check-in 8/1 - still having diarrhea, or vomiting, but ongoing nausea
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Nausea, Pain in extremity, Retching, Vomiting
Clinical narrative: Was here for his vaccines 9 days ago, that day had sore arms, still having pain on his right arm that hasn't gone away - where he received MenB. Feeling is a little numb Went to restaurant after the appointment and he ate something separate from the family, otherwise family eats the same things Next day non-bloody diarrhea started, approx 4-5 times and is happening every time after he eats Is also nauseous, and is dry heaving or vomiting with workouts - is doing some school workouts daily and is sweaty and dizzy at this time Has still been eating, but not as much and has lost some appetite Hasn't had any solid stools since the appointment, had a stool today that a little more chunks in it than the days previously  No treatment needed except PRN zofran prescribed, just supportive care (reporting due to extended symptoms >9 days long), phone call check-in 8/1 - still having diarrhea, or vomiting, but ongoing nausea
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Arthralgia, Headache, Muscle twitching, Myalgia
Clinical narrative: About 6 hours after the injection, Patient's neck and shoulders started twitching.  Twitching lasted about 2 hours then started to slow down in frequency, until it stopped.  This symptom returned the next day, but not as severe.  She also had joint and muscle pain throughout her body the first evening. Ice and pressure on the areas seemed to help.  For the two days following, Patient had stomach pain and headaches.  All symptoms seem to have subsided.  The booster shot should be super fun!
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother reported that she noticed on 8/12/20 (the day after receiving vaccinations) redness and swelling on the patient's left leg at the site of injection. Upon examination, the area was warm and swollen, with a diameter of redness of approx. 40 mm. The patient's mother reported that the patient suffered no systemic issues; no difficulty breathing or dizziness. The patient reported that the swollen area was painful. This nurse recommended to the patient's mother that an option would be to give the patient Tylenol for discomfort and to continue monitoring the area, and to call the patient's doctor if the area got worse. This nurse advised the patient's mother that if the patient began having difficulty breathing to take her to the Emergency Room.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: this was med error , no report adverse event at this time
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: Pt lost consciousness for 15-20 seconds approx. 1 min after injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: PT REPORTED ARM SWELLING, REDNESS, TENDERNESS AFTER PNEUMOVAX. STARTED NIGHT OF VACCINE, HAS GOTTEN SOMEWHAT BETTER THE NEXT DAY, PT USING IBUPROFEN AND COLD COMPRESS. TOLD HER IF IT GETS WORSE AND NOT BETTER TO BE SEEN BY MD.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 100.4 fever, nausea, chills, vomiting early the first morning, aches/pains throughout body
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Lymphadenopathy
Clinical narrative: Client awoke morning after receiving vaccine with left swollen to the elbow and what she describes as a band around her arm just above elbow.  The lymph nodes under left arm were also swollen.  She stated this lasted for 9 days.  She went to primary doctor and was told she had an allergic reaction to vaccine and probably should not receive the second dose.  She was not given any medication for treatment.