chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: a patient received a dose of Fluzone Quadrivalent that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 / No AE; a patient received a dose of Fluzone Quadrivalent that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 / No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a six-months-old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number: UT7058MA, expiry date: 30-JUN-2021) via an unknown route in the left thigh that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 for prophylactic vaccination (product storage error and product distribution issue).  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE, ROTAVIRUS VACCINE, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  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: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A dose of FLUBLOK QUADRIVALENT was inadvertently given to a 12 year old, no AE; Initial information was received on 28-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist.  This case was linked to case 2020SA267036 (same reporter).  This case involved a 12-year-old patient who was inadvertently given a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.   On 26-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2003, expiry date: 19-May-2012) via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   Reporter wanted to know if any data available on use of Flublok quadrivalent for pediatric patients and whether the patient needed additional flu vaccines this season.   At the time of reporting, no adverse event was reported.  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: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given FLUBLOCK which is an influenza vaccine not in range for her age at the time of vaccination.  Patient's mother did not report any adverse reaction when she was contacted by our office. S
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Injection site pain, Injection site swelling
Clinical narrative: Rec'd on 9/21/2020.  Called on 9/24 with complaints of bump and tendersness at injection site.  Saw Dr. who dx cellulitis and ordered antibiotics FROM CHART Cellulitis of other specified site  (primary encounter diagnosis) Plan: sulfamethoxazole-trimethoprim (BACTRIM DS)        800-160 mg per tablet   Patient with a profound inflammatory response to her immunizations, and potentially beginning cellulitis given tracking toward axilla. She is stable and not in any distress today with normal vital signs. Will begin Bactrim x 7 days. Patient was counseled regarding proper use and potential side effects of medication. They were advised to call with any problems. Advised cool compresses. Drew line around red area. Advised with any redness that extends outside of border, worse pain, fever, rigors, she needs to go to the ER right away. Otherwise, will see back as scheduled. The patient is agreeable with the plan.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cold sweat, Pallor, Respiratory rate decreased, Syncope
Clinical narrative: 9/25/2020 6:57pm patient got immunization patient got up about 5 minutes later started to looked pale and weak, sat back down and had a fainting spell, breathing was slow and patient was clammy for about 5 minutes. patient was then lowered onto his back with legs in the air and started to become normal in color again. EMS was called and evaluated the patient he then walked out on his own with his mother
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine increased, Blood culture negative, Cellulitis, Culture urine positive, Erythema
Clinical narrative: Imm rec'd 9/23/2020.  Called office on 9/25 complaining of fever of 102.5 and vomiting. Advised to go to ED where dx with Left arm cellulitis and admitted
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Leukocytosis, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Imm rec'd 9/23/2020.  Called office on 9/25 complaining of fever of 102.5 and vomiting. Advised to go to ED where dx with Left arm cellulitis and admitted
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness, Vomiting, White blood cell count increased
Clinical narrative: Imm rec'd 9/23/2020.  Called office on 9/25 complaining of fever of 102.5 and vomiting. Advised to go to ED where dx with Left arm cellulitis and admitted
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient did not experience any other adverse events / No other AE reported; Caller was supposed to give patient MMR shot but gave them MMR Varicella shot instead; dose of PROQUAD was administered to a 27 year old patient, when the patient was supposed to receive a dose of MMRII; This spontaneous report was received from a medical assistant and refers to a 27-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-SEP-2020, the patient was supposed to be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, vaccination site, route of administration, lot # and expiration date were not provided), but instead was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S03511 (exact dose, vaccination site, route of administration and expiration date were not provided) for prophylaxis. No additional adverse events were reported.  Lot number S03511 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: the patient is not currently experiencing symptoms; patient (17 years old) accidentally received the MMRII vaccine, which she had previously in infancy/ early childhood; patient (17 years old) accidentally received the MMRII vaccine, which she had previously in infancy/ early childhood; This spontaneous report was received from a registered nurse and refers to a 17-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-SEP-2020, the patient was accidentally vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 injection, lot # S018593, expiration date 17-JUN-2021 (exact dose, vaccination site and route of administration were not provided) for prophylaxis, which she had previously received in infancy/ early childhood. The patient was not experiencing symptoms at the reporting time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Pain
Clinical narrative: redness at injection site; Body aches; headache / headache is worse.; fever of 99 degrees; muscle aches; tired; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received Shingrix. On 21st September 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, general body pain, headache, fever, muscle pain and tiredness. On an unknown date, the outcome of the injection site erythema, general body pain, headache, fever, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, general body pain, headache, fever, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient Shingrix and experienced injection site redness, headache, muscle aches, tiredness and fever of about 99 degree celsius. The reporter mentioned that the day before reporting she felt better but on the day of reporting she felt all the symptoms and headache was worse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: redness at injection site; Body aches; headache / headache is worse.; fever of 99 degrees; muscle aches; tired; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received Shingrix. On 21st September 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, general body pain, headache, fever, muscle pain and tiredness. On an unknown date, the outcome of the injection site erythema, general body pain, headache, fever, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, general body pain, headache, fever, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient Shingrix and experienced injection site redness, headache, muscle aches, tiredness and fever of about 99 degree celsius. The reporter mentioned that the day before reporting she felt better but on the day of reporting she felt all the symptoms and headache was worse.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Nausea, Pain in extremity, Pyrexia
Clinical narrative: soreness in her left arm where she received the injection; Fever; Shivering; Mild nausea; first dose of Shingrix on January 24th 2020 / second dose of Shingrix on 9/23/2020 /  due to "circumstances."; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 24th January 2020, refer case US2020AMR194760).   On 23rd September 2020, the patient received the 2nd dose of Shingrix. On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, shivering, nausea and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, shivering and nausea were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, fever, shivering and nausea to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and on the same day, experienced soreness in her left arm where she received the injection, fever, shivering, and mild nausea. Reporter stated patient was late getting the 2nd dose due to circumstances, which led to lengthening of vaccination schedule. Reporter wanted to know if Tylenol lessened the effect of Shingrix, and if there was a titer for the Shingrix injections. The reporter was provided with Medical Disclaimer, PI in content, and the number to the MI department.   The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: first dose of Shingrix subcutaneously instead of intramuscularly; redness and swelling at site of injection; swelling at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date unknown) and (batch number C7EX2, expiry date unknown) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 22nd September 2020, the 1st dose was an unknown dose. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 22nd September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated from C7ET2 to C7EX2, as per sales data sheet. The reporter stated thjat, the patient receivced 1st dose of Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. After vaccination with Shingrix, the patient experienced redness and swelling at the site of injection. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient of 15 years old was administered with a Flublok, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was vaccinated with a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination on an 26-Sep-2020PT (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  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 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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: 2 months old patient was administered with pentacel not immediately after mixing but it was kept in the refrigerator, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 2 months old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiration date not reported) not immediately after mixing but it was kept in the refrigerator, via unknown route in unknown administration site as prophylactic vaccination on 22-Sep-2020 (PT: poor quality product administered). It was his first immunization.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to deteriorated drug administered (same day latency).  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 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.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given to a patient of 17 years, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 17 years old male patient who was vaccinated with 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2028, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination either on 24-Sep-2020  or 26-Sep-2020. (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not given.   It was an actual medication error case due to due to inappropriate age at vaccine administration (same day latency).  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 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: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash occurred approximately 2 inches below injection site about 3" in size
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient stated 1 hour after receiving her vaccine she developed body tremors bilaterally.  She had tremors of hands/feet and mouth.  Subsided after several hours at home without intervention.  Claims she has no history of tremors.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUA3, MMR, UNK, VARCEL
Symptoms: Crying, Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: During receiving his shots he screamed and cried louder than any other time in the past.  He cried for about 2 hours straight afterwards.   Once home, he complained how bad it was hurting. The swelling increased about every hour on his left arm where the shots were put in.  He could not lift his arm up AT ALL. It was as red as a firetruck, tender to touch and burning hot.  His entire shoulder and upper arm swelled up 3x the normal size.  I brought him back to the Pediatrician office the very next day. The nurse gasped and put her hand over her mouth when she saw his arm. The doctor came in and said this was normal and it happens all the time . He stated to just give him benadryl and Tylenol or ibuprofen for pain. And said if his arm is not better in 2 weeks to bring him back.   He had little to no movement of his left arm for 2 weeks. It also took 2 weeks for the swelling to even START to go down.  Not only that, but he is now traumatized and petrified to go to the doctors since this happened.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUA3, MMR, UNK, VARCEL
Symptoms: Injection site warmth, Screaming
Clinical narrative: During receiving his shots he screamed and cried louder than any other time in the past.  He cried for about 2 hours straight afterwards.   Once home, he complained how bad it was hurting. The swelling increased about every hour on his left arm where the shots were put in.  He could not lift his arm up AT ALL. It was as red as a firetruck, tender to touch and burning hot.  His entire shoulder and upper arm swelled up 3x the normal size.  I brought him back to the Pediatrician office the very next day. The nurse gasped and put her hand over her mouth when she saw his arm. The doctor came in and said this was normal and it happens all the time . He stated to just give him benadryl and Tylenol or ibuprofen for pain. And said if his arm is not better in 2 weeks to bring him back.   He had little to no movement of his left arm for 2 weeks. It also took 2 weeks for the swelling to even START to go down.  Not only that, but he is now traumatized and petrified to go to the doctors since this happened.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Burning sensation, Injection site pain, Muscle spasms
Clinical narrative: Mild deep muscle pain with injection followed by full left arm pain and tenderness throughout night. Severe leg thigh cramping bilaterally at night.  Next day soreness but also upper shoulders and back muscle pain and burning. Transient joint pain, knees, fingers, elbows. Myalgias. Symptoms less today, two days after injection
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity, Tenderness
Clinical narrative: Mild deep muscle pain with injection followed by full left arm pain and tenderness throughout night. Severe leg thigh cramping bilaterally at night.  Next day soreness but also upper shoulders and back muscle pain and burning. Transient joint pain, knees, fingers, elbows. Myalgias. Symptoms less today, two days after injection
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Inflammation, Pruritus, Skin warm
Clinical narrative: Inflammation, warm to the touch, and itchy.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tinnitus
Clinical narrative: Patient notice some redness on mid upper arm and ringing in ears Friday night 10/02/2020. The redness spread to forearm on Saturday morning and Saturday night the forearm became swollen. Patient came into the Pharmacy to notify us of the reaction on Sunday afternoon. Pharmacist advised patient to take Benadryl OTC and to contact her Doctor on Monday Morning.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient reports pain at the time of injection. Following the injection the patient states she has a bruise 3" in diameter around the injection site (black and blue) with pain. No treatment sought at time of reporting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscular weakness
Clinical narrative: After the second dose on 6/14/2018 I developed mild leg weakness (hip extensors) and numbness on right calf going down foot.  Over June and July it stayed the same.  I was active however, as someone who did a lot of exercise daily (2.5 hrs) I had trouble.  On September 8th I woke up and could not walk from the waste down.  Hospitalization diagnosed transverse myelitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: After the second dose on 6/14/2018 I developed mild leg weakness (hip extensors) and numbness on right calf going down foot.  Over June and July it stayed the same.  I was active however, as someone who did a lot of exercise daily (2.5 hrs) I had trouble.  On September 8th I woke up and could not walk from the waste down.  Hospitalization diagnosed transverse myelitis.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Extra dose administered, Injection site mass
Clinical narrative: The patient had an appointment on September 29, 2020 for administration of the rotavirus vaccine and the flu vaccine. We accidentally performed a full 6-month physical exam that included the administration of the following vaccines: Pediarix, Prevnar, Influenza, and Rotavirus.  The patient, however, had already had his 6 month old physical examination on 08/04/2020 and had also received the Pediarix and Prevnar13 vaccines on that date. Rotavirus and flu vaccines were still pending at that time.  Immediately after the error was discovered (same day - 09/29/2020)  the office manager, proceeded to call the vaccine manufacturers (Pfizer and GSK) to report the incident and ask for recommendations and advice to see what steps to take following the incident. After they received the case, they called back and indicated that they had no reported cases of adverse reactions to a vaccine when an extra dose was accidentally administered. Mother and I have been in contact to discuss possible side effects of the vaccines.  MD VFC and and Health Department were also contacted to report the incident. Patient has been and is currently doing well. No high fever and patient's behavior is normal. There is only a small lump on the injection site.  A formal office incident report has been filed, as well as proactive training measures to ensure incidents such as these do not happen again in the future.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Patient reports red area with firm center that is a little larger than a quarter to injection site. Area is painful with palpation.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: On October 1, 2020, the patient reported injection site soreness from the day of the vaccination until now. She has an appointment with her primary care physician this week with this chief complaint.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Feverish Friday evening, onset 7:30 PM High fever (102) Saturday, bedridden Low grade fever Sunday (99), but active Site is still red, swollen, and painful on Monday, October 5, three days following injection.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Mass, Pain
Clinical narrative: My left arm was sore immediately after the vaccine and is still sore 3 days later. I have a raised lump that is red, hot, and itchy, as well as sore. It is limiting my range of motion.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: My left arm was sore immediately after the vaccine and is still sore 3 days later. I have a raised lump that is red, hot, and itchy, as well as sore. It is limiting my range of motion.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered
Clinical narrative: Unknowingly administered expired quadrivalent Flu vaccine given IM in the Left deltoid.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Unknowingly administered expired quadrivalent Flu vaccine given IM in the Left deltoid.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, High risk pregnancy, Joint swelling, Joint warmth, Lymphadenopathy
Clinical narrative: CERVICAL LYMPHADENOPATHY; LUPUS; ARTHRALGIA; FEVER; PREGNANCY; This case was reported by a nurse and described the occurrence of lupus in 25-year-old female patient who was vaccinated with hepatitis B vaccine (Engerix-B) for prophylaxis.   The patient's medical history included four previous pregnancies producing four normal, full-term infants.  There was no history of gout, psoriasis, Crohn's disease, or Lyme disease.  Concurrent conditions and medications were not reported.  On 25 March 2003, the patient received her first dose of Engerix-B.  Her last menstrual period began on 02 April 2003, seven days post-immunization.  On 09 April 2003, 15 days post-immunization, the patient presented to the physician with arthralgia and "high" fever.  She also developed cervical lymphadenopathy.  She was seen by a physician, who observed swollen and warm joints (affected joints not specified).  The reporter stated, "It was suspected at one point that the patient had viral meningitis, and she was treated accordingly".  However, treatment was not specified.  The patient was hospitalized twice in April 2003.  It was subsequently determined that the patient was pregnant; date of the positive pregnancy test was not provided.  The events persisted as of 09 June 2003.  The reporting nurse considered the events to be possibly related to Engerix-B administration.  On 03 July 2003, the nurse reported that it was discovered that the patient "is positive for lupus."  The most recent information was received on 11 July 2003.  The pregnancy and lupus were ongoing.  The patient's estimated date of delivery is 11 November 2003.  The reporter stated that the pregnancy is "very high risk" because of lupus.   Upon internal review following correction was performed on 28th September 2020: This case was considered as pregnancy lost to follow up.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Maternal exposure before pregnancy, Meningitis viral, Pyrexia, Systemic lupus erythematosus
Clinical narrative: CERVICAL LYMPHADENOPATHY; LUPUS; ARTHRALGIA; FEVER; PREGNANCY; This case was reported by a nurse and described the occurrence of lupus in 25-year-old female patient who was vaccinated with hepatitis B vaccine (Engerix-B) for prophylaxis.   The patient's medical history included four previous pregnancies producing four normal, full-term infants.  There was no history of gout, psoriasis, Crohn's disease, or Lyme disease.  Concurrent conditions and medications were not reported.  On 25 March 2003, the patient received her first dose of Engerix-B.  Her last menstrual period began on 02 April 2003, seven days post-immunization.  On 09 April 2003, 15 days post-immunization, the patient presented to the physician with arthralgia and "high" fever.  She also developed cervical lymphadenopathy.  She was seen by a physician, who observed swollen and warm joints (affected joints not specified).  The reporter stated, "It was suspected at one point that the patient had viral meningitis, and she was treated accordingly".  However, treatment was not specified.  The patient was hospitalized twice in April 2003.  It was subsequently determined that the patient was pregnant; date of the positive pregnancy test was not provided.  The events persisted as of 09 June 2003.  The reporting nurse considered the events to be possibly related to Engerix-B administration.  On 03 July 2003, the nurse reported that it was discovered that the patient "is positive for lupus."  The most recent information was received on 11 July 2003.  The pregnancy and lupus were ongoing.  The patient's estimated date of delivery is 11 November 2003.  The reporter stated that the pregnancy is "very high risk" because of lupus.   Upon internal review following correction was performed on 28th September 2020: This case was considered as pregnancy lost to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Flushing, Influenza like illness, Pain, Pyrexia
Clinical narrative: Feel poorly; Flush; Pain; Fever; fluish; This case was reported by a consumer via interactive digital media and described the occurrence of feels poorly in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced feels poorly, flushing, pain, fever and influenza like illness. On an unknown date, the outcome of the feels poorly, flushing, pain, fever and influenza like illness were unknown.   It was unknown if the reporter considered the feels poorly, flushing, pain, fever and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 2nd dose a day before reporting and the patient felt poorly, flush and fluish. The patient asked if it was ok to take Advil. The patient did not wanted to repress the action of the vaccine. The patient was referring to medication as pain reliever such as ibuprofen. The patient just asked if it was ok to take fever or pain reducing medication post vaccine. The patient did not wanted to repress the mode of action of the vaccine. The patient could handle it but wished to take Tylenol or Motrin. The reporter denied to provide further information
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Dizziness, Extra dose administered, Malaise
Clinical narrative: feeling sick.; feeling dizzy frequently; c-reactive protein high; second shot on February 13, 2020 / second shot a second time on September 21, 2020; This case was reported by a consumer and described the occurrence of feeling unwell in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd october 2019) and Shingrix (2nd dose received on 13th february 2020).   On 21st September 2020, the patient received Shingrix. On 21st September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 22nd September 2020, the patient experienced feeling unwell, dizziness and c-reactive protein increased. On an unknown date, the outcome of the feeling unwell, dizziness, c-reactive protein increased and extra dose administered were unknown.   It was unknown if the reporter considered the feeling unwell, dizziness and c-reactive protein increased to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on 21st september 2020 and experienced feeling sick ,feeling dizzy,c-reactive protein and extra dose administered. The patient received the first Shingrix shot on 3rd October 2019 and second shot on 13th february  2020 according to his diary but hs doctor did not kept a record. The doctor assured him there would be no problems if he got it for second time. The day afterwards patient  went for the Lab for test for creactive protein has been 1 for last 10 years and after the second dose it was 13.8. The reporter did not consented to follow up. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Bumpy rash; itchy / rash on her arms and legs; red bumpy rash on her arms and legs; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 2 days after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the patient experienced papular rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the itchy rash, red rash and papular rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist reported the patient received the 1st dose of Shingrix and developed an itchy red bumpy rash on her arms and legs that was worse in the morning of 25th September 2020. This event was ongoing. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy, Mass, Ultrasound scan abnormal
Clinical narrative: enlarged lymph node; moveable mass that was 8 mm in size right below the supraclavicular area; This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 17th September 2020, the patient received the 2nd dose of Bexsero (intramuscular). On 21st September 2020, 4 days after receiving Bexsero, the patient experienced enlargement of lymph nodes and mass. On an unknown date, the outcome of the enlargement of lymph nodes and mass were not recovered/not resolved.   It was unknown if the reporter considered the enlargement of lymph nodes and mass to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was seen at office and had a moveable mass that was 8 mm in size right below the supraclavicular area and is still there currently. On 24th September 2020, the patient had an ultrasound done and was found to have an enlarged lymph node that was still there currently. The patient was referred to an oncologist. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Burning sensation; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy.   In July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In August 2020, between 1 and 2 months after receiving Shingrix, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was recovering/resolving.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that she received 2nd dose of shingrix in july,2020 and at beginning of August she started having a Burning sensation on her right side at the waistband area. She describes it as "on fire, like a very bad sunburn.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Oral herpes
Clinical narrative: Cold sores-herpes simplex 1-fever blisters; Herpes simplex type I; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 22nd March 2022) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix. On 6th September 2020, 2 days after receiving Shingrix, the patient experienced cold sores and herpes simplex type i. On 6th September 2020, the outcome of the cold sores was not recovered/not resolved. On an unknown date, the outcome of the herpes simplex type i was recovered/resolved.   It was unknown if the reporter considered the cold sores and herpes simplex type i to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. On 25th september,2020 pharmacist reported that the female patient received 1st dose of shingrix on 4th september,2020 and experienced cold sores-herpes simplex 1-fever blisters on 6th september,2020        The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: headache; achiness; sniffles; fatigue; chills; and a sore arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2020, immediately after receiving Shingrix, the patient experienced headache, pain, sniffles, fatigue, chills and pain in arm. On 30th September 2020, the outcome of the pain, sniffles, fatigue, chills and pain in arm were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved.   The reporter considered the headache, pain, sniffles, fatigue, chills and pain in arm to be related to Shingrix.  Additional details were reported as follows: Patient received the 1st dose of Shingrix in afternoon and soon after receiving the shot she began to experience headache, achiness, sniffles, fatigue, chills and a sore arm.   Patient stated that she was still experiencing the headache and wanted to know how long side effects typically last. It was explained that symptoms usually last 2 to 3 days but could last longer for others and was advised to follow up with her physician if they become prolonged or bothersome. The reporter consented to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: headache; achiness; sniffles; fatigue; chills; and a sore arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th September 2020, immediately after receiving Shingrix, the patient experienced headache, pain, sniffles, fatigue, chills and pain in arm. On 30th September 2020, the outcome of the pain, sniffles, fatigue, chills and pain in arm were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved.   The reporter considered the headache, pain, sniffles, fatigue, chills and pain in arm to be related to Shingrix.  Additional details were reported as follows: Patient received the 1st dose of Shingrix in afternoon and soon after receiving the shot she began to experience headache, achiness, sniffles, fatigue, chills and a sore arm.   Patient stated that she was still experiencing the headache and wanted to know how long side effects typically last. It was explained that symptoms usually last 2 to 3 days but could last longer for others and was advised to follow up with her physician if they become prolonged or bothersome. The reporter consented to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Social problem
Clinical narrative: had the flu; unable to receive her second vaccine because she had the flu and shortly thereafter the Pandemic started.; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza and social problem. On an unknown date, the outcome of the influenza and social problem were unknown.   It was unknown if the reporter considered the influenza to be related to Shingrix.  Additional details were reported as follows: Patient stated that she was unable to receive her 2nd dose of Shingrix vaccine because she had the flu and shortly thereafter the Pandemic started. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at the injection site; had redness at the injection site; swelling and pain at the injection site; affected mobility of his right arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) (batch number ZX27E, expiry date 16th September 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown and the outcome of the injected limb mobility decreased was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had redness and swelling and pain at the injection site.  It has affected mobility of his right arm. The HCP stated that he reported the AE to VAERS but gave me lot and expiration date and gender of patient.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swelling in the arm; This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received the 1st dose of Shingrix a while ago and experienced swelling in the arm. The reporter did not consent to follow up. The Doctor said he could not clarify if the dose was administered IM or SQ because he did not administer it and did not know date of vaccination or when the symptoms started and did not agree to follow up and said that a pharmacist had already reported this. This case linked with US2020AMR197578, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197578:same reporter
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: 2 Oct 2020 About 09:30 PM fever (about 100 F) within a couple of hours chills and muscle aches started.  3 Oct 2020 About 02:00 AM nausea and headache started. These symptoms continued till 4 Oct 2020 about 04:00PM. 5 Oct 2020 symptoms are all gone but general fatigue remains.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: 2 Oct 2020 About 09:30 PM fever (about 100 F) within a couple of hours chills and muscle aches started.  3 Oct 2020 About 02:00 AM nausea and headache started. These symptoms continued till 4 Oct 2020 about 04:00PM. 5 Oct 2020 symptoms are all gone but general fatigue remains.