chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus
Clinical narrative: Left arm swelling of forearm, old L wrist tattoo because raised and lifted out of skin approx 3 mm, whole arm was itching with several red dots; reaction resolved within 8 hours without intervention body wide itching persisting now
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Left arm swelling of forearm, old L wrist tattoo because raised and lifted out of skin approx 3 mm, whole arm was itching with several red dots; reaction resolved within 8 hours without intervention body wide itching persisting now
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient had sudden onset of nausea .  Patient was laid flat on the floor and given and alcohol.  Symptoms resolved and patient was released home.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient has a prior anaphylaxis reaction to Doxycycline. 10minutes after immunization, she developed sweaty palms and lightheadedness. No throat swelling or difficulty breathing. Placed supine, BP 160/100, HR 60-70, O2 97% RA. After a period of monitoring the symptoms improved. No intervention given.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Fall, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: The patient called about an hour ago and stated she was experiencing severe arm pain and was unable to lift her arm last night.  She stated she fell and couldn't get back up because the injection site was so sore and painful.  She did not experience this with her first dose at all.  She stated she's taken tylenol and it has helped somewhat.  She was about to try using a warm compress on the site when I spoke to her about an hour ago.  I told her I would report the incident and then reach back out to her to follow up.  She stated she has an appointment on Monday with her doctor, so she plans to mention it then.  I also called the doctor's office to notify them of the occurrence.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; product storrage error; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # S005809 expiring on 02-NOV-2021, for prophylaxis (exact dose, frequency, route and site of administration were not reported). No adverse reactions were reported.  The hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was stored at a too low temperature of 3.0 degrees Fahrenheit (F) for the time frame of 3 hours and 30 minutes.The improper storage was recorded by Digital Data Logger. It was unknown if there was any previous temperature excursion. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005809; expirationdate: 02-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA010937: US-009507513-2011USA011543: US-009507513-2011USA010999: US-009507513-2012USA002966: US-009507513-2012USA006031: US-009507513-2011USA010974: US-009507513-2012USA002962: US-009507513-2012USA006027:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; PEDVAXHIB was administered post temperatme excursion; This spontaneous report  was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 30-NOV-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T001207, expiration date 09-JUN-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 9.3 degree Fahrenheit (°F) for 9 minutes. There was no previous temperature excursion reported. No additional adverse event reported.; Sender's Comments:  US-009507513-2012USA000834: US-009507513-2012USA000976:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: patient has an interruption in schedule administration ofGARDASIL 9; No additional AE/PQCs reported.; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced interruption in schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administration. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additonal AE reported; Improperly stored ROTATEQ was administered to patient; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 12-NOV-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1660981 and expiration date 13-APR-2021; dose and vaccination scheme were not provided) as prophylaxis. No additional adverse event was reported.  The vaccine underwent a temperature excursion below 36°F (26.2F) for a time frame of 35 hours. There was no previous temperature excursion and it was reported that a data logger was involved.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; underwent a temperature excursion and was administered; This spontaneous report was received from a medical assistant referring to a 4 year old, unknown gender patient. No information was provided regarding the patient's medical history, historical drugs, allergies and concurrent conditions. No concomitant therapies were reported.    Since 19-NOV- 2020, the vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (albumin status: rHA (recombinant human albumin) (PROQUAD) lot # T013537, expiration date 17-Oct-2021, underwent a temperature excursion (31.6 F). On 30-Nov-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (albumin status: rHA (recombinant human albumin) (PROQUAD), 0.5 milliliter, for prophylaxis (route of administration was not provided). Time frame was 22 days until 11-DEC-2020. The call was not due to data logger. There were not previous temperature excursion. No additional averse events were reported.
Sex: F
Vaccine: UNK
Symptoms: Body height decreased, Pneumonia, Reaction to previous exposure to any vaccine
Clinical narrative: she has had several cases of pneumonia; she has had several cases of pneumonia, at least two occurrences in recent years as well; shrunk a few inches for her height; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 11Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "pneumonia shot") via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunization. The patient's medical history included pneumonia when she was a child about 5 years old, ongoing obstruction COPD (patient stated this is a mild case), chronic pancreatitis (not active now), ongoing blood pressure high, different heartbeat (patient initially referred to condition as an irregular heartbeat. She later clarified and stated it is not irregular, but just different. She stated she took medication to stabilize her heartbeat). The patient's concomitant medications were not reported. The patient previously received flu vaccine (unspecified product name but stated first flu vaccine in 1956 or 1957) and experienced terrible reaction where she was unconscious for days when she was 18 years old. The patient then received smaller components; she would have to get 2 or 3 shots when newer model flu shot was introduced. Since getting the newer model flu shot vaccine the only problem she would have was an occasionally issue with redness around the site of injection and maybe a little ache. She did not even have a fever. She would just get the routine flu shot that was being given. Patient reported that she had no reactions to the pneumonia shot. However, she had several cases of pneumonia. She had one occurrence when she was a child, about 5 years old. She had at least two occurrences in recent years as well. She confirmed she did not know the name of the pneumonia shot received. She just received it as directed. She did not have exact dates of when she received the pneumonia shot. She then sated she had had one was within the last 3-5 years. The last case of pneumonia she had was in Sep2019. Patient also mentioned she had shrunk a few inches for her height. The outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a non-contactable physician.  A 39-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 14Dec2020 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unknown date in Dec2020, the patient experienced pain.  The clinical outcome of the pain was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: a sore arm/ soreness; it was very red at the area and painful; it was very red at the area and painful; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (weight (kg): 62.6, height (cm): 157) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose, one injection to her left arm for immunization. Medical history included irritable bowel syndrome with constipation (she pretty much has it under control with diet) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a sore arm/ soreness, it was very red at the area and painful on an unspecified date. She got the evolocumab (REPATHA) injection, so she is wondering if it was OK to take the COVID vaccine when it becomes available in her area. She said she took evolocumab because she has three stents and this drug lowers her cholesterol really well. She said she cannot take statins. No further details provided about statins. She said every year she got the senior flu shot, and she has also had Prevnar 13, which other than a sore arm, she had no affects from that. She received the Prevnar 13 where at that time it was a (pharmacy name) pharmacy. She had heard about it, and thought it was necessary for a person who was aging to get, it was not really prescribed to her by a provider. She had a sore arm with the Prevnar vaccine but that was not recently, it was probably like 3 years ago. She said the soreness required no treatment, it got better on its own, it was very red at the area and painful, but that gradually disappeared on its own. NDC/lot/expiry date was unknown. She said when she got injections she chooses to get them in her left arm, it's a habit she guesses. She says she got the senior double flu shot every year, and has no reaction from that, she got hers this year in September. She said she didn't get any other shots at the time she got the Prevnar vaccine 3 years ago. The outcome of events was resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: 103 temperature; Chills; Headache; Body aches; Initial information regarding this unsolicited valid non-serious courtesy case from Pfizer was received from a physician (AER No: AER 2020444724) and transmitted to Sanofi on 11-Nov-2020.   This case involves 18 year old female patient who experienced 103 temperature (pyrexia), chills, headache and body aches (pain), while she received vaccines MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included Menactra and had no adverse event.  The patient's medical history, medical treatments, concomitant medications and family history were not provided.   On 02-Jul-2020, the patient received a dose of suspect MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) lot number unknown) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number unknown expiration date: 10-Jan-2021) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient de experienced 103 temperature (pyrexia), chills, headache and body aches (pain) (Unknown latency) following the administration of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient was treated with IBUPROFEN for all events.  Event outcome was reported as Unknown for all the events.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient ever had the flu, whwn got a flu shot; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient (unknown demography) who had the flu (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious who had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This is a spontaneous case, initially received from other non-health professional (consumer) via The Agency (reference number: SEQW20-00318) on 17-Apr-2020, concerning an adult, female patient who was 64-year-old at the time of this report.   The patient's relevant medical history was not reported.  The patient's historical vaccine included an unspecified flu vaccine received on an unspecified date in 2017 after which the patient's arm hurt for 3 months.   The patient's concomitant medications were not reported.  It was reported that the patient was on unspecified antidepressants in the past (start and stop dates for antidepressants were unspecified) and none of them worked which was confirmed with a genetic test.  On an unspecified date in 2018, the patient was administered with INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient's arm hurt.  On an unspecified date, 6 months later, the patient recovered from the event of pain in arm'.  The reporter did not provide causality assessment to INN Flu Vaccine Seasonal.  This case is linked to cases 202003111 and 202003113, due to the same patient and reporter.  Follow up information received from other non-health professional (consumer) via The Agency (reference number: SEQW20-00349) on 27-Apr-2020: It was reported that the patient was on antidepressants in the past. Indication for vaccine changed from influenza prophylaxis to ASKU. Narrative amended accordingly. Additional reference number added.  Non-significant follow-up information received from other non-health professional (consumer) from The Agency [reference number: SEQW20-00404] on 15-May-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.; Sender's Comments: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Arm hurt; This is a spontaneous case initially received from other non-health professional via The Agency (reference number: SEQW20-00318) on 17-Apr-2020, concerning an adult, female patient who was 64-year-old at the time of this report.  The patient's relevant medical history and concomitant medications were not reported.  It was reported that the patient was on unspecified antidepressants in the past (start and stop dates for antidepressants were unspecified) and none of them worked.   On an unknown date, the patient had genetic test to determine the best antidepressant for her and it showed that none would work.   On an unspecified date in 2017, the patient was administered with INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient's arm hurt.  On an unspecified date, 3 months later, the patient recovered from the event of pain in arm'.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment to INN Flu Vaccine Seasonal.  This case is linked to cases 202003111 and 202003112, due to the same patient.  Follow up received from other non-health professional via The Agency (reference number: SEQW20-00349) on 27-Apr-2020: It was reported that the patient was on antidepressant in the past and that she had genetic test to determine the best antidepressant for her; indication for vaccine changed from influenza prophylaxis to ASKU, additional reference number added. Narrative was amended accordingly.   Non-significant follow-up information received from other non-health professional (consumer) from The Agency [reference number: SEQW20-00404] on 15-May-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.; Sender's Comments: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The site of the injection is red and is "as if a golf ball was cut in half"; Pain to the touch, redness and swelling around the injection; Pain to the touch, redness and swelling around the injection; Pain to the touch, redness and swelling around the injection/The site of the injection was red and as if a golf ball was cut in half; This spontaneous case  was received on 16-Sep-2020 from a consumer via the agency (reference number: SEQW20-01787) and concerned a 58-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 14-Sep-2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was not reported.   On 15-Sep-2020, one day after receiving influenza virus vaccine polyvalent, in the morning, the patient experienced pain to the touch, redness and swelling around the injection. The site of the injection was red and was "as if a golf ball had been cut in half". No corrective treatment was applied for the events.  At the time of initial reporting on 16-Sep-2020, the effects had not stopped, the patient was still experiencing the symptoms and had not recovered from the events.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Case updated on 25-Nov-2020: Correction made to information received on 16-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly.  Company comment: Vaccination site reactions (induration, pain, swelling and erythema) were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred a day after vaccination, making chronology plausible. The events have not been resolved by the time of reporting of this case. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all 4 events due to lack of confounding factors.; Sender's Comments: Vaccination site reactions (induration, pain, swelling and erythema) were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred a day after vaccination, making chronology plausible. The events have not been resolved by the time of reporting of this case. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all 4 events due to lack of confounding factors.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was received on 17-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01895) and concerned an 80-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number was not reported. The reporter stated she did not know for sure which vaccine was received, but she thinks it was the one for seniors.  On an unspecified date, unknown amount of time after receiving Influenza virus vaccine polyvalent, the patient experienced fatigue.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case updated on 25-Sep-2020: Correction made to information received on 17-Sep-2020: Company comment added.   Case updated on 27-Nov-2020: Correction made to information received on 17-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No change in the narrative.  Company comment: The event of fatigue is assessed as related to Influenza virus vaccine polyvalent.; Sender's Comments: The event of fatigue is assessed as related to Influenza virus vaccine polyvalent.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This spontaneous case was received on 18-Sep-2020, from other non-health professional (consumer) via Agency (reference number: SEQW20-01990) and concerned a female patient of unreported age.   The patient had no relevant medical history.  The patient's concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for protection against seasonal influenza. The batch number was not reported.  On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced muscle soreness. No corrective treatment was applied for the event.  On an unspecified date, the patient recovered from muscle soreness.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Case updated on 25-Nov-2020: Correction made to information received on 18-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly  Company comment: Event of muscle soreness is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: Event of muscle soreness is considered as related to influenza virus vaccine polyvalent
Sex: M
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Hurting a little bit after administration; This spontaneous case was received on 21-Sep-2020 from other non-health professional (consumer) (reference number: SEQW20-02087) and concerned an elderly male patient.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, reported as in the previous year, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, anatomical location, indication: not reported). It was unknown if the vaccine was Fluad Quadrivalent or other influenza vaccine. The batch number was not reported.  On an unspecified date in 2019, after administration, the patient had problems with the influenza vaccine hurting a little bit.  The outcome of events was not reported.  The reporter did not provide causality assessment.  This case is linked to case 202004579 (the same patient).  Case updated on 23-Nov-2020: Correction made to information received on 21-Sep-2020:  Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No change in the narrative.  Company comment: The patient was vaccinated with the suspect product, influenza virus vaccine polyvalent. Reportedly, on an unspecified date after administration, the patient had problems with the influenza vaccine hurting a little bit (coded as pain). Although onset date was not provided, reported term of the event suggested plausible chronology. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to 'related' in the safety database for reporting purposes).; Sender's Comments: The patient was vaccinated with the suspect product, influenza virus vaccine polyvalent. Reportedly, on an unspecified date after administration, the patient had problems with the influenza vaccine hurting a little bit (coded as pain). Although onset date was not provided, reported term of the event suggested plausible chronology. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to 'related' in the safety database for reporting purposes).
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Arm was a bit sore; The patient was a bit fluish; This spontaneous case was received on 12-Oct-2020, from other non-health professional (consumer) to The Agency (reference number: SEQW20-03435) and concerned a female patient of unspecified age. At the time of this report, the patient was 59-year-old.  The patient's medical history and concomitant medications were not reported.   On an unknown date, patient was vaccinated with influenza virus vaccine polyvalent [brand not specified, indication dose, route of administration, anatomical location: not reported]. The batch number was not reported.  On an unspecified date, after receiving unspecified influenza seasonal vaccine, the patient was a bit fluish and her arm was a bit sore.  The reporter did not provide a causality assessment.  The reporter assessed this case as non-serious.  This case is linked to case number 202005139 (the same reporter).  Case updated on 27-Nov-2020: Correction made to information received on 12-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No changes in narrative.  Company comment: A patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving vaccine, the patient developed pain in extremity and influenza like-illness (the patient was a bit "fluish"). Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship, diagnostic and laboratory findings, patient's medical history and concomitant medications.; Sender's Comments: A patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving vaccine, the patient developed pain in extremity and influenza like-illness (the patient was a bit "fluish"). Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship, diagnostic and laboratory findings, patient's medical history and concomitant medications.
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; This spontaneous case was received on 19-Oct-2020 from other health professional (reference number: SEQW20-03840), processed together with additional information received on 20-Oct-2020 and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed delayed hypersensitive reaction of itchy hives all over her body.  The outcome of events was not reported.  The reporter assessed events as related to influenza virus vaccine polyvalent. The patient had the exact same reaction to the 2016 flu vaccine.  The case is linked to 202005290 (the same patient).  Case updated on 27-Nov-2020: Correction made to information received on 19-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly.  Company comment: Type IV hypersensitivity reaction, urticaria and pruritus were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred on an unknown time after vaccination. Chronology is unclarified. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unlikely related due to unclarified temporality, biological plausibility and lack of other confounding factors. (unlikely related defaults to related for reporting purposes); Reporter's Comments: The reporter stated: I had the exact same reaction to the 2016 flu vaccine.; Sender's Comments: Type IV hypersensitivity reaction, urticaria and pruritus were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred on an unknown time after vaccination. Chronology is unclarified. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unlikely related due to unclarified temporality, biological plausibility and lack of other confounding factors. (unlikely related defaults to related for reporting purposes)
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in the left arm/pain was persistent and dull; Arm with limited mobility; Pain was sharp at the point of administration if pressed; This spontaneous case was received on 20-Sep-2020 from a consumer via Agency (reference number: SEQW20-03976) and concerned a 59-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Avastin (bevacizumab), synthroid (levothyroxine sodium) and pantoprazol, all used for an unreported indication.  On an unspecified date in 2020, three weeks prior the initial reporting, the patient was vaccinated with influenza virus vaccine polyvalent [brand not specified, route of administration: intramuscular, anatomical location: left arm and dose: not reported] for influenza prophylaxis. The batch number was not reported. It was reported that the vaccine was not for over 65-year-old patients.  On an unspecified date in 2020, after receiving influenza virus vaccine polyvalent, the patient experienced severe pain in the left arm, with limited mobility. The pain was persistent and dull, and it was sharp at the point of administration if pressed. It was also reported that the pain was getting worse. No corrective treatment was given for the events.  At the time of initial reporting on 20-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Case updated on 27-Nov-2020: Correction made to information received on 20-Oct-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No changes in narrative.   Company comment: A 59-year-old, male patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient developed pain in extremity, injected limb mobility decreased and vaccination site pain. With information available, causality is assessed as possibly related.; Sender's Comments: A 59-year-old, male patient was administered influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient developed pain in extremity, injected limb mobility decreased and vaccination site pain. With information available, causality is assessed as possibl
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Bp of 85/44, nauseous, body aches, chills
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This spontaneous case was received on 24-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-04206) and concerned a female patient of unreported age. At the time of initial report, the patient was 73 years old.  The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect shingles vaccine (varicella zoster vaccine rge (cho), dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving vaccines, the patient became sick.  On an unknown date, four weeks after the onset, the patient recovered from the event.  The reporter did not provide causality assessment.  This case is linked to the case 202005444 (same patient).  Company comment: The event of 'sickness' is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'sickness' is considered as related to influenza virus vaccine polyvalent.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: "After the flu shot I had trouble raising my left arm, still hurts to this date"
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: I worked overnight after getting the vaccine. I felt really tired and came home and slept until 3 pm.  When I woke up I had a dull headache and felt crummy.  Decided to sleep the remainder of the day but no fever just was fatigued and had a headache.  My arm was hurting at the injection site but the pain has sense left and the headache is gone also.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain and aching; Redness; Swelling; This spontaneous case was received on 27-Oct-2020 from other non-health professional (consumer) via Agency (reference number: SEQW20-04372) and concerned a female patient of unreported age.    The patient's medical history and concomitant medications were not reported.     On an unknown date, the patient was vaccinated with influenza virus vaccines polyvalent (brand not specified, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On an unknown date, an unknown amount of time after receiving influenza virus vaccines polyvalent, the patient experienced some pain, redness, swelling and aching. The patient stated the reactions were normal and thought that was expected.   On an unknown date, a day or two after the injection, the reactions disappeared and the patient recovered from the events.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Case updated on 26-Nov-2020: Correction made to information received on 27-Oct-2020: Suspect product recoded from 'INN Seasonal' to 'INN Flu Vaccine Seasonal'. No changes in narrative.   Company comment:The patient developed pain, erythema and swelling on an unknown date after vaccination with the suspect product, influenza virus vaccines polyvalent. Although onset date was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain, erythema and swelling on an unknown date after vaccination with the suspect product, influenza virus vaccines polyvalent. Although onset date was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever, fatigue, sore arm, nausea
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: fever, soreness, weakness
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration
Clinical narrative: On December 2, 2020, I administered MMRV vaccine to the patient. On December 4, 2020, the mother, contacted the office to report the patient having temp of 101 F, redness, swelling, and hardness at the injection site (RA). She spoke with the RN who recommended to apply a cold compress to the injection site, and to give the patient Ibuprofen or Tylenol. On December 5, the patient followed-up with the patient's mother who reported the improvement in the patient's symptoms.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Influenza vaccine given in error.  MD order was for Hepatitis B vaccine.  Infant was 4wks of age at time, well under the age limit for receiving the Influenza vaccine.   The infant received 0.5mL dose.  No adverse reactions noted.
Age: 54.0
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient out of age range for vaccine.  Over age by 5 years
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: extreme fatigue, shivering, fever,  X 24 hours pain at injection site X 72 hours
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine. The vaccine was administered on 11/17/2020 and it expired on 10/23/2020. I called the CDC on 12/15/2020 for counsel, and I was instructed to give patient the correct dose at the earliest time possible. Patient's guardian was called and notified. Guardian will take child to get her valid dose at her PCP's office.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Rash
Clinical narrative: patient came in to the pharmacy on 12/15/2020 and described an abdominal rash around her abdomen with pain that had lasted  until today and was almost completely gone when she reported to me.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: NORMAL ARM PAIN HOWEVER THE FOLLOWING WAS FELT REAL TIRED BARELY ABLE TO STAY AWAKE
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chest pain, Chills, Headache, Herpes zoster
Clinical narrative: Chest pain, headache, red dots around the knee,  sweats chills,  temp 104.4, lasted about 36 hours, Pain in sciatica,  Following Wednesday woke up with severe pain in the post op left knee. Following Sunday broke out in a rash left breast, rib cage.  Went to Dr. for the rash and was DX with Shingles.  Patient is now on Valacyclovir 1mg tab every 12 hours for the shingles. Gabapentin for pain. Had 1st vaccine 9/18/2020
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Knee operation, Rash, Rash erythematous, Sciatica
Clinical narrative: Chest pain, headache, red dots around the knee,  sweats chills,  temp 104.4, lasted about 36 hours, Pain in sciatica,  Following Wednesday woke up with severe pain in the post op left knee. Following Sunday broke out in a rash left breast, rib cage.  Went to Dr. for the rash and was DX with Shingles.  Patient is now on Valacyclovir 1mg tab every 12 hours for the shingles. Gabapentin for pain. Had 1st vaccine 9/18/2020
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: Pfizer-Bio-Tech COVID-19 Vaccine: Individual was given vaccine at 10:50 am. 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified and vitals were stable. Individual went home with husband.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Hypersomnia, Screaming
Clinical narrative: immediately after receiving the vaccinations she screamed for 5 minutes and fell asleep and was under continuous sleep all day and night after receiving the vaccine. Baby does not sleep during the day in normal circumstances longer than 1hr nap every 1.5hrs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Myalgias, Headache, Shaking chills and fever to 100.5
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I experienced a sore arm and could not lift my arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pain, redness, swelling at injection site within hours of shot (this was the booster, I had no symptoms from the first shot) and later fever (101.1), fatigue, dizziness on standing too long
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity, Skin tightness
Clinical narrative: Sore arm, tight, painful day of vaccine. Next day since early morning, headache and nausea, body aches all day; after 7:00PM projectile vomiting  5x within the hour. Nausea, body aches, headache persisting no medications have been taken.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting projectile
Clinical narrative: Sore arm, tight, painful day of vaccine. Next day since early morning, headache and nausea, body aches all day; after 7:00PM projectile vomiting  5x within the hour. Nausea, body aches, headache persisting no medications have been taken.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Swelling on arm. Placement lower than deltoid, 4 cm. treated with corticosteroids, antihistamines
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Varicella zoster virus infection
Clinical narrative: Patient received vaccine on 9/4/2020, reported development of blistery rash on right upper back on 9/6/20 that was identified as varicella-zoster virus infection on 9/7/2020
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction, Myalgia, Nausea
Clinical narrative: Pt started to have a metallic taste in her mouth immediately after administration of the Covid-19 vaccine. She started to feel nauseous and myalgias. The patient was seated, given Zofran 4mg once and Benadryl 25 mg once. After 10 min patient was eating juice + crackers. Reports she feels better. A co-worker verbalized he would drive her home, patient agreed.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Nausea
Clinical narrative: Pt started to have a metallic taste in her mouth immediately after administration of the Covid-19 vaccine. She started to feel nauseous and myalgias. The patient was seated, given Zofran 4mg once and Benadryl 25 mg once. After 10 min patient was eating juice + crackers. Reports she feels better. A co-worker verbalized he would drive her home, patient agreed.