chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: had my flu shot many weeks ago. Still I came down with the flue; Initial information was received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional(Patient).  This case involves a patient of unknown demographics who had flu shot many weeks ago. still came down with the flue while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of had my flu shot many weeks ago. still i came down with the flue (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, " I had my flu shot many weeks ago. Still I came down with the flue. Missed Christmas day and still sick although feeling better."  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Recovering.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from Patient.  This case involves an unknown age and unknown gender patient who experienced flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, expiration date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Exposure during pregnancy, Haemorrhage in pregnancy, Influenza, Malaise
Clinical narrative: spontaneous bleeding (resulting in emergency c section); sick with flu; vaccine exposure during pregnancy; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a serious spontaneous bleeding (resulting in emergency c section) (haemorrhage in pregnancy) (unknown latency) following the administration of INFLUENZA VACCINE.   On an unknown date the patient developed non-serious events of sick with flu (influenza) (unknown latency) and vaccine exposure during pregnancy (exposure during pregnancy) (latency same day) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (vaccine exposure during pregnancy, sick with flu) and emergency c section for haemorrhage in pregnancy  At time of reporting, the outcome was Unknown for all events   Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown.  Seriousness criteria- medically significant for haemorrhage in pregnancy; Sender's Comments: Sanofi company comment dated 2-JAN-2023: This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE. Additional information regarding condition at the time of vaccination, past vaccination history, lab investigation, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Spontaneous haemorrhage
Clinical narrative: spontaneous bleeding (resulting in emergency c section); sick with flu; vaccine exposure during pregnancy; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a serious spontaneous bleeding (resulting in emergency c section) (haemorrhage in pregnancy) (unknown latency) following the administration of INFLUENZA VACCINE.   On an unknown date the patient developed non-serious events of sick with flu (influenza) (unknown latency) and vaccine exposure during pregnancy (exposure during pregnancy) (latency same day) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (vaccine exposure during pregnancy, sick with flu) and emergency c section for haemorrhage in pregnancy  At time of reporting, the outcome was Unknown for all events   Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown.  Seriousness criteria- medically significant for haemorrhage in pregnancy; Sender's Comments: Sanofi company comment dated 2-JAN-2023: This case involves an unknown age female patient who experienced spontaneous bleeding (resulting in emergency c section), sick with flu and vaccine exposure during pregnancy while receiving vaccine INFLUENZA VACCINE. Additional information regarding condition at the time of vaccination, past vaccination history, lab investigation, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of suspect cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise, Pneumonia
Clinical narrative: patient was one sick cookie; at the same time also got pneumonia; 2 weeks ago got Influenza A; Initial information received on 28-Dec-2022 regarding an unsolicited valid serious social media case received from a consumer/non-hcp.   This case involves a patient of an unknown age and gender who was one sick cookie, at the same time also got pneumonia and 2 weeks ago got influenza A after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, expiry date, formulation, strength: not reported) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a serious event and was one sick cookie (illness), at the same time also got pneumonia (pneumonia), 2 weeks ago got influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event patient was one sick cookie, same time also got pneumonia and was Not Recovered / Not Resolved for the event 2 weeks ago got influenza a.  Seriousness Criteria: hospitalized for these events (illness), (pneumonia), (influenza) and medically significant for event (pneumonia).; Sender's Comments: Sanofi company comment dated 02-Jan-2023: This case involves a patient of an unknown age and gender who was one sick cookie, at the same time also got pneumonia and 2 weeks ago got influenza A after receiving vaccine INFLUENZA VACCINE. The causal role of drug cannot be excluded for the event. However,  lack of information regarding event details, vaccination history, lab data, concomitant and past medications, risk factors and medical history precludes the comprehensive assessment of the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Meningitis bacterial, Streptococcal infection
Clinical narrative: bacterial meningitis; Flu; caught strep; Initial information received on 29-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who experienced bacterial meningitis, flu and caught strep after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor The patient's medical treatment(s), vaccination(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 not reported (route, administration site, strength, formulation, expiry date and dose: unknown) for prophylactic vaccination.  On an unknown date the patient developed a serious bacterial meningitis (meningitis bacterial) and non-serious flu (influenza), caught strep (streptococcal infection) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events (bacterial meningitis, Flu, caught strep).  Outcome was Unknown for all the events  Seriousness criteria: Medically significant for bacterial meningitis; Sender's Comments: Sanofi Company Comment dated 02-Jan-2023: This case involves an unknown age and unknown gender patient who experienced bacterial meningitis, flu and caught strep after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: got sick with the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/Non-HCP.  This case involves an unknown age and unknown gender patient who got sick with the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 15-Dec-2022, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 26-DEC-2022 the patient got sick with the flu (influenza) 11 days following the administration of INFLUENZA VACCINE.  Reportedly, On December 15 I got my flu shot on December 26 I got sick with the flu ! To me the flu is worst than the Covid, I've had the Covid twice and to me the flu is worse.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick with the flu).  At time of reporting, the outcome was Unknown for the event got sick with the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: came down with the worst flu this week; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and gender patient and it was reported that he/she came down with the worst flu this week after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with unknown formulation, strength, route, lot number ,expiration and at unknown administration site) for prophylactic vaccination(immunization).  On an unknown date the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching on chest, neck started in the evening after receiving the vaccine; Initial information received on 29-Dec-2022 regarding an unsolicited valid non-serious case received from Patient.  This case involves a 68 years old female patient who experienced hives and itching on chest, neck started in the evening after receiving the vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac].  The patient's past vaccination(s) included COVID injection. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy for sulfa (Drug hypersensitivity).  On 15-Dec-2022, the patient received 0.5 ml once of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength, expiration was not reported), lot U7679AA via intramuscular route in the left arm for Immunization.  On 15-Dec-2022 the patient developed a non-serious hives (urticaria) and itching on chest, neck started in the evening after receiving the vaccine (pruritus) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  The patient was treated with steroid dose pack on 17-Dec-2022 and it has not worked, levocetirizine dihydrochloride (Allegra) was currently given for Urticaria and Pruritus.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of PENTACEL was administered with no reported adverse event; Initial information received  on 28-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient to whom expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient's concomitant medications included hepatitis A vaccine (Hepatitis A) for Immunisation.  On 28-Dec-2022, the patient received an expired 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (frequency - once, strength - standard, lot - UJ590AAA and expiry date - 18-Dec-2022), with no reported adverse event (expired product administered) (latency: same day) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Lymph node pain, Lymphadenopathy, Neuralgia, Nodule
Clinical narrative: Patient reported to pharmacy on 1/2/23 that she had been having pain about 1 month/at least 1 month prior to today.  She reports swelling of lymph nodes on back of neck/head.  On the right side, she says she has a pea size "knot" that is hard but not painful.  On the left side, lymph nodes swelling and very painful (golf ball size); she also reports nerve pain.  She says it is painful to open her mouth or touch the area.  She does report that she has a history of TMJ, but she does not believe she had done anything that would have triggered it during this time period.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Pain, Tenderness
Clinical narrative: Patient reported to pharmacy on 1/2/23 that she had been having pain about 1 month/at least 1 month prior to today.  She reports swelling of lymph nodes on back of neck/head.  On the right side, she says she has a pea size "knot" that is hard but not painful.  On the left side, lymph nodes swelling and very painful (golf ball size); she also reports nerve pain.  She says it is painful to open her mouth or touch the area.  She does report that she has a history of TMJ, but she does not believe she had done anything that would have triggered it during this time period.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Chills, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: 8:00am on 12/31/22: Nausea, cold and hot chills, major body aches, diarrhoea,  vomiting , fatigue, weakness so that I could barely shower, swollen lymph nodes in right side of neck.   Persistent nausea as of 3:20pm on 1/2/23; some diarrhoea,  itching at injection site,  break into cold sweats at slightest exertion including getting out of shower; have to change clothes several times a day.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Feeling of body temperature change, Hyperhidrosis, Injection site pruritus, Lymphadenopathy, Nausea
Clinical narrative: 8:00am on 12/31/22: Nausea, cold and hot chills, major body aches, diarrhoea,  vomiting , fatigue, weakness so that I could barely shower, swollen lymph nodes in right side of neck.   Persistent nausea as of 3:20pm on 1/2/23; some diarrhoea,  itching at injection site,  break into cold sweats at slightest exertion including getting out of shower; have to change clothes several times a day.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Vomiting
Clinical narrative: 8:00am on 12/31/22: Nausea, cold and hot chills, major body aches, diarrhoea,  vomiting , fatigue, weakness so that I could barely shower, swollen lymph nodes in right side of neck.   Persistent nausea as of 3:20pm on 1/2/23; some diarrhoea,  itching at injection site,  break into cold sweats at slightest exertion including getting out of shower; have to change clothes several times a day.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 25.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 24.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, COVID-19, Psoriasis
Clinical narrative: After my second COVID vaccine, I developed a spot that was later diagnosed as psoriasis. In July, 2022 I got COVID and the psoriasis spread very quickly throughout my groin area in an inverse psoriasis pattern. I had never had psoriasis in my life. With the next booster shots -- Moderna on 12/29/21  and Pfizer on 5/10/22, and Pfizer on 10/5/22, the psoriasis spread. When it was finally diagnosed, I tried to treat it with topical corticosteroids and light therapy but it continued to spread until it was a severe case, covering about 75% of my torso, as well as my limbs, bottom, and groin area.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test positive, Allergy to animal, Antinuclear antibody negative, Antinuclear antibody positive, Arthropod bite
Clinical narrative: Several days after receiving this second dose of the vaccine, I started getting a bumpy, itchy, red rash that looked like mosquito bites even though it was February. My doctor at the time insisted it was insect bites. After several months, many lab tests, four doctors and one biopsy later, it was determined I had hives. I still have hives after all these months. I am able to keep them in check with a quadruple dose of Zyrtek daily.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Blood immunoglobulin E, C-reactive protein normal, DNA antibody negative, Food allergy
Clinical narrative: Several days after receiving this second dose of the vaccine, I started getting a bumpy, itchy, red rash that looked like mosquito bites even though it was February. My doctor at the time insisted it was insect bites. After several months, many lab tests, four doctors and one biopsy later, it was determined I had hives. I still have hives after all these months. I am able to keep them in check with a quadruple dose of Zyrtek daily.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunology test, Laboratory test, Milk allergy, Rash erythematous, Rash pruritic
Clinical narrative: Several days after receiving this second dose of the vaccine, I started getting a bumpy, itchy, red rash that looked like mosquito bites even though it was February. My doctor at the time insisted it was insect bites. After several months, many lab tests, four doctors and one biopsy later, it was determined I had hives. I still have hives after all these months. I am able to keep them in check with a quadruple dose of Zyrtek daily.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor negative, Skin reaction, Urticaria
Clinical narrative: Several days after receiving this second dose of the vaccine, I started getting a bumpy, itchy, red rash that looked like mosquito bites even though it was February. My doctor at the time insisted it was insect bites. After several months, many lab tests, four doctors and one biopsy later, it was determined I had hives. I still have hives after all these months. I am able to keep them in check with a quadruple dose of Zyrtek daily.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: PATIENT'S SPOUSE CAME TO PHARMACY INQUIRING ABOUT LINGERING PAIN IN PATIENTS RIGHT ARM DUE TO VACCINE BEING ADMINISTERED "INTO THE BONE." PHARMACIST RECOMMENDED EXERCISING ARM, ANTI-IMFLAMMATORY MEDICATIONS, AND CONSULTING PRIMARY PROVIDER.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Sleep disorder, Tinnitus
Clinical narrative: I have experienced very minimal tinnitus for years, the audible level of which was almost impossible to detect.  Since this Covid booster, it has GREATLY increased.  I am now able to sleep only with four sleep sounds, at full volume, and still occasionally need to take a sleep aid medication in the middle of the night
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pruritus
Clinical narrative: patient reported bruising, itching at the injection site. By 10/14 she had made a full recovery
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Bivalent booster instead of Moderna (primary series) for second dose.  Called patient to notify of mix up and patient came back to get Moderna second dose.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Injection site pain, Muscle spasms, Peripheral swelling
Clinical narrative: When I got the vaccine I felt a cramp which did not go away.  Approximately minutes after 6pm my arm felt weird.  I looked at my arm and noticed the swelling.  The swelling was noticeable from my elbow down to my wrist.  The cramp was on and off.  I measured my arm and the measurement immediately below the elbow was 1.5 inch more than my right elbow and the measurement at my wrist was .75 inch more that the right wrist.  I did not experience any pain in the swollen area only at the injection site.  The next day there was no changes in the swelling. On 1/2/23  noticed the swelling is going down not has not gotten to the original size.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in to get Moderna Primary series (first dose), but technican gave Moderna Bivalent booster .
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Pt did not think that he had the pfizer bivalent booster yet- did not think he had his vaccine card with him. Said that his last vaccine was over 2 months ago and that it was Pfizer but the first 2 vaccine he got were Moderna. Vaccine given, then patient found documentation stating that he had the pfizer bivalent booster already exactly 2 months ago. Informed pt that he got an additional dose of the bivalent booster when it was not needed and gave him documentation to take home with him stating that he got that vaccine at my clinic given by me on todays date.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Depressed level of consciousness, Head injury, Immediate post-injection reaction, Incoherent, Seizure
Clinical narrative: Patient received immunizations today and immediately fainted with a brief seizure episode. He also hit the back of his head. After the episode, he was incoherent for approximately 30 minutes. The patient slowly became more alert over the next hour. His oxygen saturations have always been good.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient received immunizations today and immediately fainted with a brief seizure episode. He also hit the back of his head. After the episode, he was incoherent for approximately 30 minutes. The patient slowly became more alert over the next hour. His oxygen saturations have always been good.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction for the patient as of yet. She completed 2 doses of Shingrix back in 2019 and received a 3rd dose at this time.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PATIENT HAS A DOCUMENTED QUADRIVALENT INFLUENZA VACCINE GIVEN ON 10/19/2022 AT A DIFFERENT FACILITY. PATIENT PRESENTED TO OUR CLINIC REQUESTING INFLUENZA VACCINE, AND A QUADRIVALENT INFLUENZA VACCINE WAS ADMINISTERED ON 01/02/2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED THE ORIGINAL PFIZER MONO VALENT INSTEAD OF THE PFIZER BIVALENT DUE TO MY ERROR ,  PATIENT WILL HAVE TO RETURN TO US FOR ANOTHER VACCINE IN 2 MONTHS
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female
Clinical narrative: Breast cancer
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac flutter, Electrocardiogram normal, Palpitations
Clinical narrative: Frequent heart flutters/palpitations noted within two days after vaccine, but patient did not initially consider any connection to vaccine.    At a routine physical on 12/21/22, noted issue to doctor, who performed an in-office EKG which showed normal heart activity.    Physician  advised that heart flutters are a symptom of COVID19 but also may be a symptom of the vaccine.  Heart flutters/palpitations have lessened over time and are much less frequent as of this writing, 2.5 weeks later.
Age: 70.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administrative  error only,  the vaccine was expired. No adverse reaction occured.
Age: 10.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve replacement, Blood test abnormal, Cardiac operation, Cardiac valve disease, Echocardiogram abnormal
Clinical narrative: Myocarditis followed by deteriorated heart valves resulting in open heart surgery for aorta and mitral valve replacement.  Surgery in June 2022.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Endocarditis, Infection, Mitral valve replacement
Clinical narrative: Myocarditis followed by deteriorated heart valves resulting in open heart surgery for aorta and mitral valve replacement.  Surgery in June 2022.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Sex: U
Vaccine: COVID19
Symptoms: Aphonia, Dyspnoea, Dyspnoea exertional, Influenza like illness, Lung disorder
Clinical narrative: I approx. 3-4wks.   After my 2nd shot I started having flu type symptoms throat was affected lost voice for about 2 mths. Couldn't say a word I gradually started having difficulty breathing  something showed up in my right lung that wasnt there before was put on various meds to help me breath antibiotics  several courses and to this day I cant breath too well  just walking 12 ft leaves me out of breath
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Bursa injury
Clinical narrative: The patient is having a should pain that has persisted for several weeks after initial vaccine.    It is possible that the vaccine may have been too high and caused a bursa injury.   They have not done a follow up with a primary doctor.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 17.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 37.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 50.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 54.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 79.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 78.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 52.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 60.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 94.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Central nervous system lesion, Computerised tomogram head, Demyelination, Differential white blood cell count
Clinical narrative: On 04/19/2022, I experienced extreme fatigue and vertigo. On 04/20/2022, the vertigo continued and I began experiencing extreme double vision. I was seen in the clinic and diagnosed with vertigo and prescribed Antivert which made symptoms worse. I then went to the ER. My symptoms included double vision (diplopia), progressive paresthesia (face, tongue, arm, leg, foot). The ER referred me to a neurologist and I was scheduled for an MRI. The MRI demonstrated active demyelination with lesions in the bilateral frontal and temporal subcortical white matter, pons, medulla.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Fatigue, Full blood count, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: On 04/19/2022, I experienced extreme fatigue and vertigo. On 04/20/2022, the vertigo continued and I began experiencing extreme double vision. I was seen in the clinic and diagnosed with vertigo and prescribed Antivert which made symptoms worse. I then went to the ER. My symptoms included double vision (diplopia), progressive paresthesia (face, tongue, arm, leg, foot). The ER referred me to a neurologist and I was scheduled for an MRI. The MRI demonstrated active demyelination with lesions in the bilateral frontal and temporal subcortical white matter, pons, medulla.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pregnancy test negative, Red blood cell sedimentation rate normal, Scan with contrast
Clinical narrative: On 04/19/2022, I experienced extreme fatigue and vertigo. On 04/20/2022, the vertigo continued and I began experiencing extreme double vision. I was seen in the clinic and diagnosed with vertigo and prescribed Antivert which made symptoms worse. I then went to the ER. My symptoms included double vision (diplopia), progressive paresthesia (face, tongue, arm, leg, foot). The ER referred me to a neurologist and I was scheduled for an MRI. The MRI demonstrated active demyelination with lesions in the bilateral frontal and temporal subcortical white matter, pons, medulla.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, White matter lesion
Clinical narrative: On 04/19/2022, I experienced extreme fatigue and vertigo. On 04/20/2022, the vertigo continued and I began experiencing extreme double vision. I was seen in the clinic and diagnosed with vertigo and prescribed Antivert which made symptoms worse. I then went to the ER. My symptoms included double vision (diplopia), progressive paresthesia (face, tongue, arm, leg, foot). The ER referred me to a neurologist and I was scheduled for an MRI. The MRI demonstrated active demyelination with lesions in the bilateral frontal and temporal subcortical white matter, pons, medulla.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the 30 day BUD of December 1, 2022.