chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site joint pain, Vaccination site pain
Clinical narrative: Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported for herself.  A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318) on 09Feb2021 at 15:00 (at 74 years) at single dose in left arm for covid-19 immunisation. Medical history included type 2 diabetes mellitus, high blood pressure.  Concomitant medication included metformin and diphenhydramine hydrochloride (LURISPAN). Patient was not pregnant.The patient previously took epinephrine and had drug allergy. The patient blood sugar level was over 400 on 10Feb2021. No treatment given for the event. The final outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Ejection fraction, Ejection fraction decreased
Clinical narrative: chest pains; Ejection fraction decreased (from 40 down to 20); This is a spontaneous report from a Pfizer-sponsored program "Covax US Support"received from a contactable consumer reporting for himself. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chest pains and ejection fraction decreased (from 40 down to 20) both on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ejection fraction: from 40 down to 20 on unknown date. The events were considered serious as caused patient's hospitalization.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Ejection fraction decreased
Clinical narrative: chest pains; Ejection fraction decreased (from 40 down to 20); This is a spontaneous report from a Pfizer-sponsored program "Covax US Support"received from a contactable consumer reporting for himself. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chest pains and ejection fraction decreased (from 40 down to 20) both on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ejection fraction: from 40 down to 20 on unknown date. The events were considered serious as caused patient's hospitalization.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: pneumonia; pneumonia; This is a spontaneous report from a contactable consumer (patient's son)  An 84-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: ok to get the 2nd dose if he tested positive after the first dose.; ok to get the 2nd dose if he tested positive after the first dose.; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for 2nd shot on 13Feb2021; asked if it is ok to get the 2nd dose if he tested positive after the first dose on an unknown date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia aspiration
Clinical narrative: Aspiration pneumonia; This is a spontaneous report from a Pfizer sponsored program  from a contactable pharmacist.   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, in Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 09Feb2021, the patient experienced aspiration pneumonia but no fever and on antibiotic. Clinical outcome was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: Event aspiration pneumonia represents a coincidental medical condition unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Seizure
Clinical narrative: 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; This is a spontaneous report from a contactable consumer.   A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at 08:00 at single dose via an unspecified route of administration on left arm  for COVID-19 immunization. Relevant medical history included Parkinson's disease, dementia, Post-traumatic stress disorder, high blood pressure and high cholesterol. Concomitant medication were not reported. It was mentioned other vaccine on 28Jan2021, but no further information provided. On 02Feb2021 at 12:00 am, 10 days after 1st dose of BNT162B2 patient experienced ischemic stroke and 4 days later the patient suffered a seizure. The events resulted in 6 days of hospitalization. At the time of the reporting the patient was recovering from events.   Information about lot/ batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient passed away after taking the vaccine. He was healthy but developed heart issue after taking vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: heart issue
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib), prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT), escitalopram oxalate (LEXAPRO), apixaban (ELIQUIS), nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 18Feb2021 with outcome of unknown. The patient asked how long should patient tolerate diarrhea? What was the next step? When offered the contact number for Pfizer Medical Information, the patient stated "I would be dead by then, you don't know?".  The information on the batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Haematochezia
Clinical narrative: his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids; his wife developed bad diarrhea; Gastrointestinal pain; This is a spontaneous report from a contactable consumer reporting for his wife.   A 69-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL9262) vaccine  , via an unspecified route of administration in the left arm, on 30Jan2021 13:30 at single dose for Covid-19 immunisation .  Medical history included clostridium difficile infection  4 or 5 years ago , haemorrhoids.  The patient's concomitant medications were not reported.  The patient  had blood in her stool, but  she thinks the blood may be from hemorrhoids  on 09Feb2021 with outcome of unknown , his wife developed bad diarrhea on 04Feb2021 with outcome of not recovered , gastrointestinal pain  on 04Feb2021 with outcome of not recovered.   Hematochetia was considered an Important Medical Event. Course of the event. The reporter said approximately 4-5 days later (Thursday, 04Feb2021), his wife developed bad diarrhea. He said his wife was tested negative for bacteria and virus in her blood. He said his wife still has the diarrhea. He said his wife provided a stool sample to her GI doctor's office yesterday, 10Feb2021, and his wife's stool is being checked for everything. He said his wife has been having 2-3 bowel movements per day. He said the day-before-yesterday (09Feb2021), his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids. He said his wife has had hemorrhoids before, and her recurring diarrhea has brought the hemorrhoids out. He said his wife has ongoing gastrointestinal pain, as well.  Follow up information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Off label use, Product use issue
Clinical narrative: her very ill after the 2nd shot; Patient had COVID-19 and received COVID-19 vaccine; Patient had COVID-19 and received COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received the second dose of (at the age of 80-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: not known), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization.  Medical history included ongoing COVID-19.  Concomitant medication included apixaban (APIXABAN) from unknown dates and indications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on an unknown date and the patient experienced COVID-19. It was stated that the patient had COVID-19 and received COVID-19 vaccine which made her very ill on an unknown date after the 2nd shot. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Deafness, Ear discomfort, Nasal congestion
Clinical narrative: hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer.  A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer.  A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Heart rate, Hypertension
Clinical narrative: She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on  25Jan2021 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient  developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure  on an unspecified date with outcome of unknown.  The patient  laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high   and  heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events.  Follow up information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She knows one person did die; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that 'she knows one person did die' on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She knows one person did die
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Oropharyngeal pain
Clinical narrative: sore throat; miserable time; Initial information was received on 16-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210219000583).  This case involves an adult patient who experienced sore throat (oropharyngeal pain) and miserable time (feeling abnormal), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 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 sore throat (oropharyngeal pain) and miserable time (feeling abnormal) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Almost lost patient due to the flu vaccine; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a child male patient who was almost lost (unevaluable event), while he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication 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 were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was almost lost (died) (unevaluable event), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It reporter said that there was no way their child will be getting the flu shot EVER again, they almost lost him due to the flu vaccine.  It was not reported if the patient received any corrective treatment or not.  The outcome for the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210217000689).  This case involves an adult patient who experienced flu, while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 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 flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death, Vaccination complication
Clinical narrative: Flu shots do kill; Initial information received on 11-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp via media.  This case involves Adult female patient (reporter's mother in-law) (age unspecified) who died (death), after she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died from flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if the patient experienced any additional symptoms/events before death.   It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done.   There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented media case which involves an adult female patient who died, after she received vaccines INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Flu shots do kill
Age: 5.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Product administration error
Clinical narrative: 5 year old male patient received dose of Daptacel after the injection they scanned the bottle and it registered as Pentacel, no AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional,  This case involves a five years old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] after the injection they scanned the bottle and it registered as DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 17-Feb-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (latency on same day).  It was also reported that Caller reports vaccine may have been administered in error. Caller they were trying Daptacel. After the injection they scanned the bottle and it registered as Pentacel. Caller reports they have contacted the manufacturer of the scanning equipment but they have not heard back yet. Caller reports this was administered on 17Feb2021. There was a call back request made and she provided the inquiry number to this case. She wanted to verify that the Daptacel was not mislabeled in anyway and that they could still use it. Additional Description of event adverse events: Reported by the She states that on Wednesday they received a new package of Daptacel and they opened it and run the bar code through a machine and it automatically runs the bar code and entered it as Pentacel and not Daptacel and it was given to a five year old child who is ok. She states that they manually loaded it in the system with the codes on the vial. She said they were questioning if it was the right codes on the vial. She said they are still waiting to hear back from the manufacturer of the scanning equipment but they have not heard back yet. This is all the information she provided at the time of her call. Reporter relationship: HCP (health care professional).  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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dyspnoea, Hypersensitivity, Injection site erythema, Neck pain
Clinical narrative: Potential anaphylactic type reaction; Difficulty breathing; Tightness in throat; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Site reaction with redness; This spontaneous case was received on 17-Feb-2021 from other health professional via Agency (reference number: SEQW21-00550) and concerned female patient of an unknown age.  The patient's medical history and concomitant medications were not provided.   On an unspecified date in Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose, route of administration and anatomical location: not reported) as influenza prophylaxis. The batch number reported was U50309.  On an unknown date in 2015, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to Afluria. She experienced site reaction with redness, pain that was shooting to neck and back. Nurse stated that the patient had potential anaphylactic type reaction as she woke in the middle of the night and had difficulty breathing and tightness in throat. Patient did not seek medical attention immediately.   On an unknown date in fall or winter, the patient was seen by medicine doctor (MD) to discuss the incident and was referred to a dermatologist. The patient had not had a flu shot since then.  The outcome of the events was not reported.   The reported assessed the events as related to Afluria Quadrivalent. Patient had an allergic reaction to Afluria in 2015.  The events of 'anaphylactic type reaction', difficulty breathing and tightness in throat were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment:The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not 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).; Reporter's Comments: Patient had an allergic reaction to Afluria in 2015.; Sender's Comments: The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not 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).
Sex: F
Vaccine: FLU4
Symptoms: Pain, Sleep disorder, Throat tightness
Clinical narrative: Potential anaphylactic type reaction; Difficulty breathing; Tightness in throat; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Pain that was shooting to neck and back; Site reaction with redness; This spontaneous case was received on 17-Feb-2021 from other health professional via Agency (reference number: SEQW21-00550) and concerned female patient of an unknown age.  The patient's medical history and concomitant medications were not provided.   On an unspecified date in Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose, route of administration and anatomical location: not reported) as influenza prophylaxis. The batch number reported was U50309.  On an unknown date in 2015, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to Afluria. She experienced site reaction with redness, pain that was shooting to neck and back. Nurse stated that the patient had potential anaphylactic type reaction as she woke in the middle of the night and had difficulty breathing and tightness in throat. Patient did not seek medical attention immediately.   On an unknown date in fall or winter, the patient was seen by medicine doctor (MD) to discuss the incident and was referred to a dermatologist. The patient had not had a flu shot since then.  The outcome of the events was not reported.   The reported assessed the events as related to Afluria Quadrivalent. Patient had an allergic reaction to Afluria in 2015.  The events of 'anaphylactic type reaction', difficulty breathing and tightness in throat were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment:The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not 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).; Reporter's Comments: Patient had an allergic reaction to Afluria in 2015.; Sender's Comments: The patient developed anaphylactoid reaction, dyspnoea, throat tightness, neck pain, pain, back pain and vaccination site erythema after vaccination with the suspect product, Afluria Quadrivalent. Although onset date for the events was not provided, narrative suggested plausible temporal relationship. The patient's medical history and concomitant medications were not 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).
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Had a more severe reaction / in terms of flu symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sinus headache (occurs generally this times of the year). Previously administered products included Flu vaccine with an associated reaction of influenza (received on an unknown date refer case US2021AMR016788).   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient got the Shingles vaccine this fall and had more severe reaction with it in term of flu symptoms. The patient think the Shingles vaccine was Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016788:Same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Mild flu symptoms for a day; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. With the Flu vaccine the patient normally had mild flu symptoms for a day. The case had been linked with US2021AMR016766 for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016766:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling face, Urticaria
Clinical narrative: Facial swelling; hives; This case was reported by a consumer and described the occurrence of facial swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling and hives. On an unknown date, the outcome of the facial swelling and hives were recovered/resolved.   It was unknown if the reporter considered the facial swelling and hives to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received dose of shingrix and experienced facial swelling and hives for over a year. The patient inquired would it be safe to have any of the Covid vaccines and were there any components of Shingrix that would be in the Covid vaccines. The information regarding consent to follow was not reported.
Sex: F
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: titers were inconclusive; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had completed a Hepatitis B vaccine series as a child had titers drawn and the titers were inconclusive, which led to therapeutic response decreased. The reporter consented to follow up. Brand name of previous HepB series was unknown.  Titers were drawn for this patient was starting nursing school.  The medical assistant stated additional patient details are not available at this time. The physician just asked the Medical Assistant to call and did not provide any further details.  The medical assistant consents to follow up from safety.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Muscular weakness
Clinical narrative: Site was red / Still bothers her / Symptoms are worse again; Site was swollen / Still bothers her / Symptoms are worse again; Arm at the injection site is still weak / muscle is weak / started after the shot / Still bothers her / Symptoms are worse again; Can't lift her arm higher than shoulder height / Still bothers her / Symptoms are worse again; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date unknown) for prophylaxis.   On 8th October 2020, the patient received Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, weakness of arms and mobility decreased. On 8th January 2021, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the weakness of arms and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, weakness of arms and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  The reported batch number JPA27 for Shingrix did not exist and was updated to JP427 as per the sales database. After receiving dose of Shingrix, the patient experienced her arm at the injection site is still weak, the muscle was weak and can't lift her arm higher than shoulder height following. The HCP reports for the first 10 days the site was red and swollen, the weakness started after the shot. The Pharmacist reports that symptoms were bad at the beginning, got a little better during November and are worse again. The patient called her doctor about it, but he couldn't see her over the holidays. The patient wants to go see him though because it still bothers her. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: she is in a lot of pain; pain is in her RIGHT arm; right upper back pain that burns and goes numb and tingly; right shoulder blade pain; back / goes numb and tingly; back / goes numb; This case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, 1 hr after receiving Shingrix, the patient experienced pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness. On an unknown date, the outcome of the pain, upper back pain, shoulder blade pain and tingling were not recovered/not resolved and the outcome of the pain in arm and numbness were unknown.   It was unknown if the reporter considered the pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 1 hour after receiving Shingrix patient experienced lots of pain. The patient received Shingrix in left arm and experienced pain in right arm and in upper back area, back pain burns and tingling and numbness. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: she is in a lot of pain; pain is in her RIGHT arm; right upper back pain that burns and goes numb and tingly; right shoulder blade pain; back / goes numb and tingly; back / goes numb; This case was reported by a consumer and described the occurrence of pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, 1 hr after receiving Shingrix, the patient experienced pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness. On an unknown date, the outcome of the pain, upper back pain, shoulder blade pain and tingling were not recovered/not resolved and the outcome of the pain in arm and numbness were unknown.   It was unknown if the reporter considered the pain, pain in arm, upper back pain, shoulder blade pain, tingling and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 1 hour after receiving Shingrix patient experienced lots of pain. The patient received Shingrix in left arm and experienced pain in right arm and in upper back area, back pain burns and tingling and numbness. The reporter did not consent to follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia, Pruritus
Clinical narrative: The right side of my face got very hot, tingly, and itchy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Diarrhoea, Heart rate increased, Injection site pain
Clinical narrative: Soreness at the point of injection; loose stool; slight rapid heartbeat/pulse but then back to normal.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: My heart beats per minute went up to 75 from 57. (I wear a fitbit fitness tracker)  It started at about 5:30 pm and lasted for less than 30 minutes and then returned to normal the fifties again
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoxia, Lethargy, Pyrexia
Clinical narrative: Patient hospitalized due to fevers, hypoxia to mid 70s, severe fatigue and lethargy which developed within hours of receiving vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache
Clinical narrative: headache and temp of 99.7
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Severe chills, headache, body aches and sweats.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Herpes zoster
Clinical narrative: Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash a week after vaccine was given.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: SDRIFE Drug Exanthem
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Got vaccine Thursday 2/18/21  Friday, a day after the vaccine: my left arm was sore.   Saturday and Sunday, 2-3 days after vaccine: my left arm was painful and very weak. I couldn't easily lift it over heart level.  Monday, four days after vaccine: Not much pain. Got back into regular exercise routine.   New weird side effect on Friday 2/26/21.  (8 days after vaccine): There is a red space around injection site about 2.5 inches in diameter. It is warm and itchy. It is also a little bit hard underneath it. Woke up with it. Doesn't hurt.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Mobility decreased
Clinical narrative: Got vaccine Thursday 2/18/21  Friday, a day after the vaccine: my left arm was sore.   Saturday and Sunday, 2-3 days after vaccine: my left arm was painful and very weak. I couldn't easily lift it over heart level.  Monday, four days after vaccine: Not much pain. Got back into regular exercise routine.   New weird side effect on Friday 2/26/21.  (8 days after vaccine): There is a red space around injection site about 2.5 inches in diameter. It is warm and itchy. It is also a little bit hard underneath it. Woke up with it. Doesn't hurt.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Palpitations
Clinical narrative: From approx 10 pm to 9:00 pm 2/24/21 I experienced the following:  Severe headache, nauseousness, vomiting, heart palptations, Chills and body ache, so much that all my teeth hurt.  All symptons left as fast as they came on.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Vomiting
Clinical narrative: From approx 10 pm to 9:00 pm 2/24/21 I experienced the following:  Severe headache, nauseousness, vomiting, heart palptations, Chills and body ache, so much that all my teeth hurt.  All symptons left as fast as they came on.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Muscle tightness, Oropharyngeal pain, Skin tightness
Clinical narrative: Over a week ago I started feeling a tightness in my right cheek and neck. I wasn't sure what it was but it went away. I received my second vaccination 3 days ago and the tightness is back. Accompanied by sore throat. I felt the area and the lymph node in front of my right ear and the one in my neck on ther right side are swollen. :
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: experienced lightheadnee and headache for 15 minutes
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: -Rash in left deltoid -10 cm in size, localized -Slight itch -Still present on 02/26/2021
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Woke up this morning with a slight fever and body aches.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early