chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Baseball sized (or larger) swelling under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) for an unknown indication, from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 05:00 the patient experienced baseball sized (or larger) swelling under left armpit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event baseball sized (or larger) swelling under left armpit was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This was the second Moderna shot. Taken at 12 in the afternoon on April 16. By 5 o?clock my temperature went up to 104.0. I threw up was talking gibberish, eyes rolling back in my head. Could not stand on my own. Was incoherent. Could not dress myself. An ambulance was called I was taken to hospital.
chronic inflammatory demyelinating polyneuritis; Guillain-Barre syndrome; multiple axonal neuropathy secondary to Guillain-Barre syndrome; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute muscle weakness, subacute neuropathy and severe difficulty with mobility, difficulty with activities of daily living. The patient had been diagnosed with Guillain-Barre syndrome, multiple axonal neuropathy secondary to Guillain-Barre syndrome, and chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using it. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuritis were considered to be medically significant. All events were determined to be disabling by the reporter.
L arm 6.5cm x 7.0cm focal erythema at site of yellow fever injection with associated pruritus first noticed yesterday. Current tx: Naproxen, cold compresses, ZYRTEC and atarax as directed.
The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; This spontaneous report has been received from a medical assistant, referring to a 45-year-old female patient.  No information was provided about the patients' concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 25-AUG-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination scheme, anatomical location of administration were not reported. Lot number is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number U008600 does not match any company product as confirmed by lot verification team.) at a dose of 0.5 milliliter administered intramuscularly for immunization (prophylaxis).     On the same day, the patient reported that when she returned home, she started feeling bad (feeling abnormal) and having headache, chills, itching on the face (Pruritus), shortness of breath (Dyspnoea), and dizziness. On 26-AUG-2021, she went to the emergency room and was discharged home the same day. She was prescribed with 200mg of Excedrin. On 27-AUG-2021, she reported that the symptoms had resolved. No additional AE reported. No PQC reported. No additional information provided.  The causal relationship between therapy and the above-mentioned events was not provided.
Doctor at 12/8/2021  8:39 PM  Status: Signed    Spoke to mother she reports that child developed hives about 2 hours after receiving 2nd dose of COVID vaccine. Mother reports he had itchy hives all over his body , he had no drooling, respiratory distress, cough, swelling of lips, or vomiting. Mother reports she heard  " a wheeze" but this resolved after a few minutes She gave him 25 mg of Benadryl and she reports he is feeling better hs rash is improving Mother report she received the first dose of the pfizer vaccine (pediatric dose) and today he received the adult dose . I went over the symptoms of anaphylaxis and when to seek medical attention I recommended continuing Benadryl every 4 hours x 24 hours.      12/10/2021:  I spoke with mother today.  pt still has a raised area at injection site but benedryl discontinued.  RN
BODY ACHES; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, nausea, and chills. This report was non-serious.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Patient received both influenza and HepB vaccines around 0930 on morning of 9/12/2017. No prodromal illness or upper respiratory symptoms. Patient woke at 2230 on night of 9/12/2017 with barky cough and inspiratory stridor, ultimately presenting to Pediatric ED where she required racemic epinephrine nebulizer treatment and oral DECADRON for croup symptoms with stridor.
Sore throat; Chills; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds/ she experienced syncope; This spontaneous report was received from a nurse via company representative referring to a 13 year old female patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 12-JUN-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route not reported) lot number R032767and expiry date 31-AUG-2021 for prophylaxis. Other suspect therapies included meningococcal acyw conj vaccine (crm197) (MENVEO) (dose, route, lot number and expiry date not reported). On the same day (12-JUN-2019), after vaccination the patient was monitored for 15 minutes without symptoms, upon standing she experienced syncope. The patient was sought for the medical attention. The patient was returned to the room and monitored for 20 additional minutes. The nurse reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the most painful injection of all injections. It was also reported that patient was due for the second dose. On the same day, the patient went home and fully recovered. Causality assessment for the event was not provided by the reporter.  Upon internal review the event syncope was considered to be medically significant.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1908USA005383: US-009507513-1907USA011407:
Sore arm - resolved slowly over 48 hours Rash in armpit area underneath injection arm-  Unknown when appeared, but noticed 12 hours later, disappeared with in 24 hours Fever 48 hours after injection, low grade, lasted a few hours Chills- 48 hours after, lasted a few hours Achy and foggy brain (very flu-ish feeling)- still, 3 days later
Arm pain; Fatigue; Nausea; Insomnia; Fever; Skin sensitivity; Body aches; Light headed; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Nov2021 at 11:30(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history includes anxiety and polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR), magnesium oxide (MGO), multivitamin (MANUFACTURER UNKNOWN) and vitamin D Nos (VIT D). The patient received influenza vaccine (MANUFACTURER UNKNOWN) on 27Oct2021 within four weeks prior to the COVID vaccine. On 21Nov2021 at 13:00, the patient experienced arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
2nd shot vaccine experience: - 3:30 shot -4:30 a little groggy no big deal  -6:00 pm made/ate dinner  -9:00pm walked on treadmill for a bit and felt a little off/tired -2:30am uncontrolled chills -3:30am had to go downstairs shivering with 3 blankets, pj?s & robe on.  -6:30am uncontrolled shaking continues (3-4 hours), moaning with every breath, headache, fever 6:30am threw up and laid on random spaces of the floor throughout the house -7:30 am splitting headache, backache, etc.  -9:30 am feeling better, back aches and laying in bed.  -6:40 pm still lower back ache & mild headache. Temp is now 99.2
mom reports swelling & redness @ site of inject & screaming  which started Thurs. following inject-screaming @ least 3 hrs or longer-swelling in leg lasted 2 days-Acc to mom had fever but not checked, not seen by MD-back to nl by 3rd day
Became febrile at 4:26 pm with fever of 100.2 100.8 at 7:40  Tylenol was given on 1/5/21 at 5:31pm, 1/6/21 at 10:40am. and 1/7/21 at 5:02pm
Severe headache 3 days, nausea 3 days, weakness 5 days, pain upper part of body 5 days, unable to walk w/o assistance 2 days, red feverish arm, on 6th day could be up but only 20-30 min at a time.  9th day back to normal.
Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
This spontaneous report as received from a other health professional and refers to three patients' of unknown demographics. On unknown date(s), the patients inadvertently administered improperly stored doses of PROQUAD (lot # M042502, expiry date: 17-APR-2018) 0.5 ml for prophylaxis (incorrect product storage). The doses of PROQUAD were reconstituted with properly stored sterile diluent (details not provided). No adverse effects reported. The doses of PROQUAD were exposed to a temperature of -7 degree Centigrade for a time frame of 1 hour 10 minutes (supported). There were no previous temperature excursions. The call was due to a data logger. No Product Quality Complaint (PQC) was involved.
Information has been received from a registered nurse concerning a 65 year old white female with peripheral neuropathy who on Nov 19 2004 at 3:00 was vaccinated subcutaneously into the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646078/0257N). There were no reported illnesses at the time of vaccination. That same day, the patients arm, at and around the injection site, became tender, red, and indurated. No diagnostic studies were performed. the symptoms gradually receded over 5 days and the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. It was noted that the patient had no prior AE's following vaccination. It was also reported that a male patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA04044). The vaccine was from the same lot # but a different vial. Additional information has been requested.
This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received RECOMBIVAX HB for vaccination (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions. First excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. RECOMBIVAX HB was one of the affected products. Other products involved were GARDASIL, ROTATEQ, PNEUMOVAX 23 (single dose) and MMR II. Excursion was supported. No patients concerns or effects were reported to the office post administration of these vaccines. The patients did not seek medical attention. Product quality complaint was not reported. Outcome of events was unknown. This is one of several reports by the same reporter. Additional information has been requested.
My arms are sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arms are sore).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023  This case was reported by a patient via interactive digital media. The patient stated that they were said that he/she need another dose of vaccine, but he/she heard that getting shingles was worse. Follow-up would not possible as no contact details were available.
I began experiencing all my covid symptoms.  Chills, Fever, Cough, Nausea, Loss of Taste/Smell and Fatigue.  This lasted for approximately two days.
Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours
Pt recvd 3 doses of Engerix-B 1OCT91 found to be a non-seroconverter;
hurt as much as the Shingrix vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient information was not reported by the reporter. The patient received Shingrix vaccine in the fall and it hurt. The patient then got 2 doses of Pfizer Covid 19 vaccine and experienced local soreness at injection site.
0830pm while patient was out at a friends house started feeling dizzy, room spinning, called mom, who took her to Urgent Care (report attached) Dx:  possibly a reaction to Menveo, Hypotension with dizziness and nausea
Markedly elevated BP, left side facial and neck rash consistent with Herpes zoster.