chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass, Livedo reticularis
Clinical narrative: light headed, dizzy; Tachycardia; hard welt; hypotensive; swelling in the arm-left arm 2 inches by 1 inch; swelling in the arm-left arm 2 inches by 1 inch; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female of an unknown age patient who experienced light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment( and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Patient was received the Seqirus vaccine in the past without a reaction.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that patient received a Flu shot vaccine on Friday 14Aug2020.  When she got home patient noticed her vaccine paperwork stated Seqirus, with an expiration date of May2020, patient was then told she received Flublok. The only information she had was the top of the syringe was navy and gray with the number B0170.    Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [not reported]  Details of laboratory data not reported.   The patient was treated arm with ice DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). Continued use of ice and Benadryl.  On an unknown date, the patient recovering from the all events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Pyrexia
Clinical narrative: light headed, dizzy; Tachycardia; hard welt; hypotensive; swelling in the arm-left arm 2 inches by 1 inch; swelling in the arm-left arm 2 inches by 1 inch; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female of an unknown age patient who experienced light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment( and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Patient was received the Seqirus vaccine in the past without a reaction.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that patient received a Flu shot vaccine on Friday 14Aug2020.  When she got home patient noticed her vaccine paperwork stated Seqirus, with an expiration date of May2020, patient was then told she received Flublok. The only information she had was the top of the syringe was navy and gray with the number B0170.    Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [not reported]  Details of laboratory data not reported.   The patient was treated arm with ice DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). Continued use of ice and Benadryl.  On an unknown date, the patient recovering from the all events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Dizziness, Hypotension, Peripheral swelling, Tachycardia, Urticaria
Clinical narrative: light headed, dizzy; Tachycardia; hard welt; hypotensive; swelling in the arm-left arm 2 inches by 1 inch; swelling in the arm-left arm 2 inches by 1 inch; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female of an unknown age patient who experienced light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment( and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Patient was received the Seqirus vaccine in the past without a reaction.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that patient received a Flu shot vaccine on Friday 14Aug2020.  When she got home patient noticed her vaccine paperwork stated Seqirus, with an expiration date of May2020, patient was then told she received Flublok. The only information she had was the top of the syringe was navy and gray with the number B0170.    Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [not reported]  Details of laboratory data not reported.   The patient was treated arm with ice DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). Continued use of ice and Benadryl.  On an unknown date, the patient recovering from the all events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Vaccination site reaction
Clinical narrative: light headed, dizzy; Tachycardia; hard welt; hypotensive; swelling in the arm-left arm 2 inches by 1 inch; swelling in the arm-left arm 2 inches by 1 inch; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female of an unknown age patient who experienced light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment( and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Patient was received the Seqirus vaccine in the past without a reaction.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that patient received a Flu shot vaccine on Friday 14Aug2020.  When she got home patient noticed her vaccine paperwork stated Seqirus, with an expiration date of May2020, patient was then told she received Flublok. The only information she had was the top of the syringe was navy and gray with the number B0170.    Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [not reported]  Details of laboratory data not reported.   The patient was treated arm with ice DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). Continued use of ice and Benadryl.  On an unknown date, the patient recovering from the all events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: PPV
Symptoms: Adverse event, Wrong patient received product
Clinical narrative: MA gave PNEUMOVAX 23 to the wrong patient; was actually given to another, younger patient; MA calling in an adverse event on a patient; This spontaneous report was received from a medical assistant referring to a 20 year old non-pregnant female patient. The patient's pertinent medical history included both eustachian tube dysfunction, no known drug allergies were reported and her concomitant medications included unspecified birth control.     On an unknown date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Lot # T009744, expiration date 28-JAN-2022), dosage not provided, intramuscular in the left deltoid, this vaccine was intended to be administered to a different older patient.         On an unknown date, the patient experienced an unspecified adverse event. No product quality complaint  (PQC) or additional adverse events were reported. The outcome of the unspecified adverse event was unknown. The reporter considered that the experiences were not related to the product itself.
Sex: F
Vaccine: PPV, UNK
Symptoms: Chills, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The patient called today complaining of severe soreness in her arm; She states she cannot even move her arm.; she has a fever of 100, nausea, and chills; she has a fever of 100, nausea, and chills; she has a fever of 100, nausea, and chills; This spontaneous case was received from a pharmacist referring to non-pregnant 67-year-old female patient. The patient's concurrent conditions and medical history were unknown by the reporter. Her concomitant medication included acetaminophen (+) oxycodone hydrochloride (PERCOCET), lorazepam and "AFTADATIN". The patient's allergies included cefiderocol (FETROJA) and cefiderocol.   On 16-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 milliliter once, intramuscularly as immunization against pneumococcal disease (injection site, anatomical location was not provided; lot number T007790 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) with an expiration date on 03-DEC-2021).  On the same date about an hour after vaccination, the patient experienced severe soreness in her arm (pain in extremity). She stated she could not even move her arm (movement disorder). Also, she had a fever of 100 (units not reported), nausea, and chills (pyrexia, nausea and chills). She used an ice pack on her arm to relieve the pain and acetaminophen (TYLENOL). The patient call to her primary doctor to make him aware of her symptoms, but she left a message with the nurse and had not heard back yet. She was wanting to know if these are normal side effects of the vaccine.   At the reporting time the patient had not recovered from pain in extremity, movement disorder, pyrexia, nausea and chills.  The causal relationship between the aforementioned events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T007790; expirationdate: 03-DEC-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: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: two vaccines underwent a temperature excursion and were both administered to patient; No further AE/PQC reported; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 07-JUN-2020, the patient was vaccinated with a dose of vaccines following temperature excursions. The vaccines involved are: varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, intramusculary, lot # S036636 (expiration date 14-NOV-2021) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin)(M-M-R II) 0.5 milliliter, intramusculary, lot # S018594 (expiration date 17-JUN-2021 ) for prophylaxis.  The improperly stored suspect vaccines experienced all a temperature of 28.04 degree fahrenheit (°F) for one hour and 22 minutes with no previous temperature excursion.   The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA011763:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional effects reported; Improperly stored vaccine administered; This spontaneous report was received from a nurse, concerning a 5 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   On 19-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously, for prophylaxis lot # T001187, albumin status rHa and expiration date reported as 11-JUL-2021 (strength, dose, and frequency were not reported). No adverse event was reported.   The temperature was reported as 6°F to 17°F (10.9°F) during a time frame of 2 hours and 30 minutes. There was no previous excursion.   A digital data logger was involved.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Condition aggravated, Seizure
Clinical narrative: started seizing after vaccines; This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age.  On 21-AUG-2020, the patient came to the office for vaccination. It was reported that she was pale prior to vaccines. She was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported); meningococcal vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot# and expiration date were not reported). Nurse in the office stated that this patient had a history of this type of reaction after vaccines (unspecified). Patient was "fine at discharge" from the office. Follow-up phone call few hours after discharge parent reported patient was "fine". The relatedness between the event and suspect vaccines was not provided.  Upon internal review, the event of seizure was considered to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: No adverse symptoms reported; Patient inadvertently received a dose of PROQUAD and a dose of VARIVAX during the same office visit; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 24-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S017265 with expiration date of 01-DEC-2020 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. On the same date, the patient also received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019460 with expiration date of 24-JUN-2021 (strength,  dose, route, frequency, and anatomical location were not provided) for prophylaxis (accidental overdose).      This is one of two cases from the same reporter.     ; Sender's Comments:  US-009507513-2008USA012800:
Sex: U
Vaccine: RV5
Symptoms: Product packaging issue
Clinical narrative: 3 doses given at 6, 10, and 14 weeks of age/states some of the doses had been administered; defective ROTATEQ/couple doses in their box were already opened/ dose given from opened pouch; This spontaneous report was received from a registered nurse refers to an infant of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown dates, at the age of 6, 10 and 14 weeks old, the patient was vaccinated with 3 doses rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, every 4 weeks (lot # S006159, expiration date was reported as 10-SEP-2020, but upon validation established as 10-NOV-2020, exact dose was not provided) for prophylaxis. A couple of doses (unspecified) in the current box were with the packaging already opened. None of the tubes were leaky. It appeared that the glue was not sticky enough and the packaging could be opened with minimal effort. It would stick back together if squeezed, but then would re-opened again. The box that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) came in was intact but the pouches that individual doses come in were opened. The reporter stated that 2 or 3 doses out of 10 appeared to be opened. Some doses had been administered (unspecified).
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Caller stated that on 8/11/2020 a patient was administered improperly stored PEDVAXHIB.; This spontaneous report was received from a licensed practical nurse, referring to a 9-weeks-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 11-AUG-2020, the patient was administered improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, as prophylaxis (strength, dose, vaccination scheme and anatomical site of vaccination were not reported; lot number S036823, expiration date 31-MAR-2022, which were verified to be valid). The administered vaccine experienced a temperature above 47 degrees Fahrenheit (F) or 9 degrees Celsius (8.9 C) for 33 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: on 13-AUG-2020 a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, by intramuscular route (lot number S036823 which has been verified to be valid, expiration date reported and validated as 31-MAR-2022) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of above 47 degrees Fahrenheit / 9 degrees Celsius (C) (8.9 C), during a time frame of 33 minutes, as recorded by a digital data logger. There was no previous temperature excursion.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: on an unspecified date, during the same office visit, an unspecified 4 monlh old baby was inadvertently administered MMR II, VARlVAX, and VAQTA outside the recommended age per lhe prescribing information.; No additional AE effects reported.; This spontaneous report was received from a medical assistant, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history and previous drug reactions or allergies were not reported.     On an unknown date, the medical assistan reported that, during an office visit, the patient was inadvertently vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, varicella virus vaccine live (oka/merck) (VARIVAX) injection, and hepatitis a vaccine, inactivated (VAQTA) injection (doses, dose numbers, vaccination schemes, routes of administration, lot numbers, and expiration dates were not provided), all of them as prophylaxis, outside the recommened age per the prescribign information (product administered to patient of inappropriate age). Concomitant therapies included a Merck sterile diluent (lot number and expiration date were not provided). No additional adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MMR II was given to a patient intramuscularly instead of subcutaneously; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and concomitant medications were not reported.      Nurse reported that on 24-AUG-2020, a patient was given measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA), (M-M-R II) 0.5 milliliter, administered intramuscularly instead of subcutaneously (lot number S013719, expiration date 05-MAY-2021) for prophylaxis. Nurse stated no additional adverse event (AE) details.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse called to report a patient received improperly stored ROTATEQ on 08/13/2020.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  (dosage regimen and route of administration not reported), lot # 1660981, expiration date 13-APR-2021, for prophylaxis, and was called because a digital data logger. The improper dose experienced a temperature of above 47 farenheit/ 9 celsius (average temperature was 8.9 celsius) during a time frame of 33 minutes with no previous temperature excursion. No additional adverse event was reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: soreness in the upper part of the arm; headache presented in the upper right quadrant of the brain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included automobile accident (plate in upper left arm from car accident in January).   On 14th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, headache and fatigue. On an unknown date, the outcome of the pain in arm, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache and fatigue to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient for herself. The patient received Shingrix in the right arm and had soreness in the upper part of the arm below the shoulder and fatigue. The headache presented in the upper right quadrant of the brain.  All symptoms resolved in 4 days. The reporter consented to follow up. This case has been linked with case US2020167500, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167500:same repoter
Sex: F
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: infection in her toe; This case was reported by a consumer via call center representative and described the occurrence of infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine. Previously administered products included infection. Concomitant products included galcanezumab (Emgality) and doxycycline.   On 10th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th August 2020, 161 days after receiving Shingrix, the patient experienced infection. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the infection was not recovered/not resolved.   It was unknown if the reporter considered the infection to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported an infection in her toe, requiring antibiotic treatment. The patient was concerned about reaction if she gets second Shingrix shot.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Tinnitus
Clinical narrative: Injection site pain; Tinnitus; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and tinnitus. On an unknown date, the outcome of the injection site pain and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site pain and tinnitus. HCP noted it had been several weeks since the vaccine was given, and the patient continued to experience both events.  HCP noted the patient experienced tinnitus in the right ear. The patient had an upcoming appointment with an ENT provider to evaluate the tinnitus. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness and pain at the injections site; redness and pain at the injections site; swelling at the injection site.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose Shingrix in left arm and experienced redness, pain and swelling at the injections site. The patient did not receive his second dose of Shingrix vaccine due to Covid 19 and redness, pain and swelling at the injections site. The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Headache, Injection site joint pain, Pyrexia
Clinical narrative: joint pain, left-sided shoulder, arm, back and head pain, fever, stomach pain beginning at 11PM and continuing through present time 8:15 am the next morning
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse was vaccinating at flu clinic at a school.  The only flu vaccine we had available to send was Afluria which is dosed differently for ages under 3.  She gave the full dose of 0.5 to a this child who is under 3 (she was about 11 months).  Mom was called and informed of error and was very understanding and was going to call her PCP.  No adverse affects noted.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Activated partial thromboplastin time ratio normal, Blood magnesium normal, Blood phosphorus normal, Calcium ionised normal, Computerised tomogram head normal
Clinical narrative: Patient was fussy, Dad was feeding him a bottle and his eyes were wide and rolled back in his head.  He had stiffening of his arms and legs and this lasted about 30-60 seconds.  EMS arrived and administered Versed.  He had right sided weakness after the episode.  Patient was then taken to the ER for further workup.  At the ER he had a CT scan, labs and a MRI.  Patient returned to normal functioning a couple hours later and was discharged home with the family.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Differential white blood cell count normal, Eye movement disorder, Full blood count normal, Hemiparesis, International normalised ratio normal
Clinical narrative: Patient was fussy, Dad was feeding him a bottle and his eyes were wide and rolled back in his head.  He had stiffening of his arms and legs and this lasted about 30-60 seconds.  EMS arrived and administered Versed.  He had right sided weakness after the episode.  Patient was then taken to the ER for further workup.  At the ER he had a CT scan, labs and a MRI.  Patient returned to normal functioning a couple hours later and was discharged home with the family.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Irritability, Magnetic resonance imaging brain normal, Metabolic function test normal, Musculoskeletal stiffness, Prothrombin time normal
Clinical narrative: Patient was fussy, Dad was feeding him a bottle and his eyes were wide and rolled back in his head.  He had stiffening of his arms and legs and this lasted about 30-60 seconds.  EMS arrived and administered Versed.  He had right sided weakness after the episode.  Patient was then taken to the ER for further workup.  At the ER he had a CT scan, labs and a MRI.  Patient returned to normal functioning a couple hours later and was discharged home with the family.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient was fussy, Dad was feeding him a bottle and his eyes were wide and rolled back in his head.  He had stiffening of his arms and legs and this lasted about 30-60 seconds.  EMS arrived and administered Versed.  He had right sided weakness after the episode.  Patient was then taken to the ER for further workup.  At the ER he had a CT scan, labs and a MRI.  Patient returned to normal functioning a couple hours later and was discharged home with the family.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: shivers for several hours; headache; my stomach feels strange; This case was reported by a consumer via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingles vaccine. In August 2020, less than a week after receiving Shingles vaccine, the patient experienced headache and stomach discomfort. On 20th August 2020, the patient experienced shivers. On an unknown date, the outcome of the shivers, headache and stomach discomfort were unknown.   It was unknown if the reporter considered the shivers, headache and stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had shivers for several hours during the night, the patient a headache and stomach feels strange.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pain during injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 1st dose of Shingrix. In 2019, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: The patient received the first dose of the Shingrix vaccine around Spring 2019 and second dose July 2019 (for tolerance of seocnd dose refer linked case : US2020AMR167324) both in her right arm. The reporter reported that while getting the first dose, the pharmacist jabbed the patient's arm while administering the vaccine, and she had pain during injection. The patient continued to have pain around the injection site in her right arm. The pain was not on the injection site. The pain was off and on and pain was mostly when she would wake up from her sleep. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR167324:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash below the injection; This case was reported by a pharmacist via call center representative and described the occurrence of rash 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, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash 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 adult as per the vaccine indication. The patient received Shingrix and developed rash below the injection site 3-4  days. The reporter consented to follow up.  The Pharmacist reported that she had no report information at the time of the call.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event, Product administered at inappropriate site
Clinical narrative: Tenivac vaccine was given to patient by mistake which was expired approximately past 15 days/No AE; a patient received Tenivac vaccine at left thumb/No AE; Initial information received on 12-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old male patient who was mistakenly vaccinated with 0.5 mL DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC](pre-filled syringe) which was expired approximately past 15 days batch number U6021AA and expiry date 27-Jul-2020 via unknown route at left thumb on 11-Aug-2020 for prophylactic vaccination (expired product administered).  The patient's medical treatment(s), vaccination(s) and family history were not provided.  The patient's medical history included ongoing skin laceration (cut to his thumb due to superficial laceration from a box cutter) at the time of the event.  No concomitant medication was given.   It was an actual medication error case due to expired vaccine used and vaccine administered at inappropriate site.  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: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Malaise, Fever (100.7F), Fatigue, Body Aches, Headache for approx 48 hours.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Feeling feverish (but not actually running a fever), sweaty, tired -- started day after shot, and continued through next day.  On day 3 still feeling tired, but not feverish or sweaty.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Bedridden, Paralysis
Clinical narrative: Person received flu vaccine and was paralyzed and bed-bound for 18 days and had to receive physical therapy and treatments to recover
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Oedema, Skin warm
Clinical narrative: Patient was given immunization on Monday 8/24/20 and started to develop redness, edema, warm to touch on Wednesday evening. Patient says that injection site is painful as well. Patient was seen in the office on  8/28/20 at 10:15am. Patient is being treated with Bactrim.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Swelling & of arm & face tingling
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Pallor
Clinical narrative: -8/27/2020 @11:16 am, patient received ENGERIX B .Patient alert and verbally responsive. LN advised patient to remain seated in the chair in the immunization room to be monitored.   -@11:24 AM, LN noted patient remains sitting in chair,  alert and responsive but color is pale. CODE BLUE was paged overhead. Immunization staff continued to monitor patient.   -@11:24, multiple staff came in and helped assessed the patient. Put patient on lying position with both legs elevated. -@11:25 am, patient alert and verbally responsive. VS : BP 94/64, HR 60, 02 SAT RA 98%. Staff still continued to monitor the patient. Flight Sargent, was aslo assessing patient .   @11:31 am, patient alert and verbally responsive. Color is getting better.  VS : BP 109/73, HR 60, 02 SAT RA 98%. @11:35 am, patient alert and verbally responsive. No c/o difficulty breathing. Patient is no longer pale. No c/o pain. No chest pain.  VS : BP 104/68, HR 65, 02 SAT RA 100% @11:39 am, patient alert and verbally responsive. No difficulty breathing. No lightheadedness. No c/o pain.  Patient stated she is okay now and she's able to walk to the waiting area to be continued to be monitored for another 15 minutes. RN assisted the patient going to clinic. RN clinic is aware about what happened to the patient today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Musculoskeletal disorder, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: ENTIRE LEFT ARM SWOLLEN AND PAINFUL, UNABLE TO USE FOR DAILY ACTIVITIES. BODY ACHES AND CHILLS. STARTED APPROX. 5 HOURS AFTER INJECTION, AND SYMPTOMS PERSIST. INSTRUCTED BY PCP TO USE ZYRTEC, BENADRYL, NAPROXEN, REST AND ICE/HEAT PRN.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Extreme chills at 5:30 pm, fever about 11:30 pm, chills again at 9am on 8/28, fever at 11am 8/28. Arm extremely sore. Received 2 shots same arm. Redness at the site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pallor, Presyncope, Vomiting
Clinical narrative: Patient left with mother after injections, mother came back in with child, patient was pale in color and vomited clear mucus(small amount) Child was brought into a exam room laid on the exam table with a cool compress on forehead. Patient did not completely faint and was conscious the whole time. Patient was given water as well as a lolly pop. Patient was monitored by the physician and the medical assistant. Blood pressure and pause stayed in nml range. Patient was aloud to leave after 30 minutes. His color returned to normal and patient was verbal and coherent when he left the office as well.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer regarding to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2013, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for zoster related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of both events was unknown. The both events was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of deafness was determined to be medically significant.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: lower back pain; possible swelling in her arm that received the injection; fever; Indication: "Worried about Coronavirus"; soreness in her arm; she does not feel well; light headache; This spontaneous report was received from a 50-year-old female patient, who was referring to herself. Her had seasonal allergies. She had no pertinent medical history and concomitant medications. In approximately 2015 (reported as approximately 5 years ago), she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to raise immune system and did not report any symptoms after receiving the vaccine.  On 20-AUG-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the right arm (lot# was reported as T-010293, however, after validation was established as non-valid; expiration date was reported as 30-AUG-2021) as she was worried about coronavirus. On the same day, approximately 1 hour after the vaccination, she did not feel well, had soreness in her arm and experienced light headache. On 21-AUG-2020, the patient had fever that went from 99.1 degrees Fahrenheit (F), to 100.4 F, lower back, soreness and possible swelling in her arm that received the injection. The patient reported that she thought she should get the vaccine again because of "everything going on with novel coronavirus disease of 2019 (COVID)". She reported that a doctor in the office she visited said it that revaccination would not hurt to do it again. She reached out to the physician's office and was instructed to go to the emergency room if her symptoms worsen over the weekend. No treatment was given for the events and no lab diagnostic tests were performed.  At the reporting time, the patient did not recover from the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms reported; The patient inadvertently received a dose of PROQUAD and a dose of V ARlV AX during the same office visit on 8/24/2020.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 24-AUG-2020, during the same office visit, the patient was inadvertently vaccinated with doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # S017265 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 01-DEC-2020 (exact dose, route and site of administration were not provided), and varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S019460 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 24-JUN-2021 (exact dose, route and site of administration were not provided), both for prophylaxis, which were reconstituted with sterile diluent (STERILE DILUENT) (multiple drug overdose accidental). No adverse symptoms were reported. The outcome of the multiple drug overdose accidental was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA012457:
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: pain of short duration in lower back shoulder muscle; shingles pain; stabbing pain; Lower back pain; left arm with pain; pain in shoulder / pain of short duration in lower back shoulder muscle; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a month after receiving Shingrix, the patient experienced shoulder pain. On 17th August 2020, the patient experienced pain in arm, muscle pain, shingles, pain and low back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain 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 adult as per the vaccine indication. The patient received Shingrix my left arm with pain in the shoulder for a few days. The patient had short stabbing pain of short duration in the lower back shoulder muscle.  The reporter believes this was shingles pain.