chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 76 year old male patient. The patient's drug allergies included allergy to morphine (patient experienced nausea and headache following administration of morphine on an unspecified date). The patient's pertinent medical history was reported as none. On 03-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # K007825, exp. date: 13-JAN-2016). Concomitant therapies included PERCOCET. On an unspecified date, approximately in November 2014, the patient developed extreme tenderness, redness, and swelling after administration of PNEUMOVAX 23 which spanned from the patient's shoulder down to his elbow. The patient sought medical attention, he came back to physician's office on 05-NOV-2014 because of the reactions and received a ROCEPHIN injection (unspecified dose) for treatment. No laboratory tests were performed. The patient recovered from all the events on an unspecified date. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This case is linked to 1501USA005232 as these two cases were received from the same source. Additional information has been requested.
SPONDYLITIS ANKYLOSING AGGRAVATED; FATIGUE; This spontaneous report received from a patient concerned a 5 decade old female unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported. On an unspecified date, the patient experienced spondylitis ankylosing aggravated, and fatigue. As per the report, the reporter's stated that there was a reasonable possibility with ankylosing spondylitis flare up and adalimumab, and there was was no reasonable possibility with event fatigue and adalimumab . The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from spondylitis ankylosing aggravated, and the outcome of fatigue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021873-covid-19 vaccine ad26.cov2.s-spondylitis ankylosing aggravated. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 23-NOV-2015, patient received improperly stored VARIVAX dose 2, from batch/lot # L015045 (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired). At the time of the report, FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment details were provided. Action taken with mRNA-1273 in response to the events were not applicable.
patient passed out roughly five minutes after receiving covid dose 1, he was sitting in his chair, did not hit his head. After this, he immediately regained consciousness, vomited, and then immediately "felt a lot better" Patient stayed for 15 minutes and then left under supervision of his father
Throat feels like its closing, then he passes out. Severe headaches and muscle and joint pain. He now has seizures. He constantly tired and some days he cant get out of bed. He can't play sports he was involved in or even go to school.
Influenza vaccine given 2/3/07. At bedtime on 2/4/07 Mom noted mosquito looking bumps at at daughters hairline. Child was given Benadryl and bumps disappeared. Mom repeated Benadryl 2/5/07 do to bumps on arms. Bumps do itch. Mom denies diarrhea or fever. Mom referred to MD. This was daughters 3rd time receiving the influenza vaccine.
I got lower back pain the day after getting the second vaccine since 6 months, I literally can't do any activity. I got physiotherapy and no improvement at all. I need a solution please
4 DAYS AFTER RECIEVING VACCINE: CHILLS, FEVER, COUGH, HEADACHE, BODY ACHES, WEAKNESS
This spontaneous report has been received from a pharmacist and referring to a currently 64-year-old female patient with no drug reaction or allergies. It was reported that the patient did not have any pertinent medical history. However, it was mentioned that the patient was taken "a few medications" as concomitant therapies. Approximately on an unknown date in 2007, reported as "over 10 years ago", the patient was vaccinated with a first dose of PNEUMOVAX 23 (strength, dose, frequency, route, anatomical location, lot number and expiration date were not provided). Subsequently, on 01-FEB-2017 (also reported as on an unspecified date, yesterday), a second dose of PNEUMOVAX 23 0.5 mL, intramuscularly, Lot number: M036161, expiration date: in May 2017 (strength, frequency, and anatomical location were not provided) for prophylaxis. Other suspect vaccines administered on the same date include: a high dose of FLUZONE (Lot number: UI682AZ, Expiration date: in April 2017) (anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced joint pain and sought medical attention through a call made to her pharmacist. The patient did not undergo any laboratory tests or performed any treatment. At the reporting time, the outcome for the event of Arthralgia was unknown. The causal relationship between the adverse event and the therapy with PNEUMOVAX 23 was not provided. There was no product quality complaint involved. Additional information has been requested.
Symptoms started 1 day after injection to summarize most likely an over inflammation/ over immune response prolonged for 3 months.  Cardiovascular: Chest pain and pressure, heart rate from 40s-120s. Periods of palpitations.  Muscular: Right wrist pain, numb at times.  Neurological: Dizziness, headaches, fatigue. Brain fog, forgetful, vision poor, difficulty recalling info.  GI: Nauseated loss of appetite weight loss of 10 lbs. Bloated. Diarrhea/loose stools x 2 days.  Reproductive: Period was due the week of the injection and has never been irregular. The week of the injection started ovulating  on 10/02/21. Since then menstrual cycyles have been irregular. Bleeding started 10/09/21 and continued until 11/05/21. Bleeding varied from light to heavy saturation. Menstual cycle continues to be irregular. Also hair thinning and shedding x 1 month.
Approximately 2-3 hours after shot was administered, I had diarrhea, nausea, chills and Eustachian tube pressure.
Narrative:  Pt received influenza vaccine outside the facility per PCP ADR note, GBS occurred 2 days post-vaccine. Pt newly established care at facility - unclear exact date/time of details of influenza vaccine.
Localized redness, warmth and induration of thighs (R) 9 cm x 4.5 cm (L) 3 cm x 5 cm. Treatments cool compress, BENADRYL. By today, (R) side was still enlarging, (L) side subsiding.
This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received BOOSTRIX (batch number 5TN9R, expiry date unknown) and (batch number 3P9CL, expiry date unknown). Co-suspect products included ENGERIX B (batch number 7K5T4, expiry date unknown), (batch number 54RS5, expiry date unknown) and (batch number 797K7, expiry date unknown), HAVRIX (batch number 7K5T4, expiry date unknown) and TWINRIX (batch number 797K7, expiry date unknown).  On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received ENGERIX B. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received HAVRIX and TWINRIX. On an unknown date, an unknown time after receiving BOOSTRIX, ENGERIX B, HAVRIX and TWINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. The reporter considered the incorrect storage of drug to be unrelated to BOOSTRIX and TWINRIX. Additional information: Seven different HCP's reported to a regularly associate at a wholesale distributor that GSK vaccines were stored outside recommended temperature range. Some (or all) of the vaccines had been administered to patients. No adverse events had been reported to the wholesale distributor.
soreness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: soreness at the injection site). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: Receipt date: 02-AUG-2023 The case was received from the patient interactive digital media. The patient got the vaccine and it was a little soreness at the injection site for a couple days and take Tylenol it was a lot better than dealing with the full blown shingles pain. The follow-up could not be possible as no contact details were available.
This was my second covid vaccine, 2-3 days after receiving this dose I started experiencing chest pain, and pressure neck throbbing, blood pressure extremely high, severe headache in the back of my head and neck, short of breath, leg pain and weakness. Prescribed an additional medication for my blood pressure
Patient's Upper lip started swelling 1-3 hours after getting the Covid-19 vaccine . Patient reported that she took Benadryl and the swelling did go away
tirenedd; Body pain; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were unknown.   It was unknown if the reporter considered the tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group was selected as adult as per vaccine indication. The patient reported that the patient had the Shingrix shot yesterday and as indicated of tiredness and body pain.
Information has been received from a physician concerning an 86 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with 1 dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD) and VALTREX. Subsequently, on 17-SEP-2007 the patient developed a rash on "her lower buttocks." Medical attention was sought in the emergency room. On an unspecified date the patient recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 86 year old female with osteoporosis, increased lipids, sulfonamide and CIPRO allergies and a history of a motor vehicle accident, cerebrovascular accident, RAYNAUDS and diverticulosis who on 28-AUG-2007 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882U). The patient was recovering from a rib fracture due to a motor vehicle accident at the time of vaccination. Additional concomitant therapy included minerals (unspecified) (+) CENTRUM SILVER, LIPITOR, aspirin and folic acid. Subsequently, on 17-SEP-2007 at 2:45 PM the patient had a painful rash on her left buttocks and leg. The patient was diagnosed with shingles. The patient was given VALTREX 1 gm three times a day X 1 week and VICODIN as needed for pain. On 26-Sep-2007, the patient had an office visit and was improved (recovered). Additional information is not expected.
second GARDASIL 9 dose which she has not yet received; missed dose GARDASIL 9 vaccine; due to illness; This spontaneous report was received from a pharmacist referring to a 27-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.    On 17-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not reported).         On 17-DEC-2020, the patient experienced illness. On an unreported date, she missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On 10-MAR-2021, she was vaccinated with SARS-CoV-2 vaccine (unspecified) (reported as "COVID 19 vaccine"). At the time of reporting, the outcome of the event was unknown.   The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Received seasonal flu vaccine (IM inactivated).  Approximately 45 min after injection right deltoid area started itching.  2 hives noted at this site.  Rash at injection site radiating to neck chest area.  Resolved with BENADRYL 25 mg orally.  No adverse effects noted.
Fever, fatigue, generalized muscle soreness, loss of appetite  - treatment included tylenol, rest, and hydration.
Had Td and HBV 8/17/04: beginning 8/22/04 had general red rash with itching and was unable to lift right shoulder joint: Pop felt was R/T antibiotic taking for acne. Gave HBV @ 10/7/04: Rash began again 10/10/04: op sill feels r/t antibiotic erythromycin . Took steroids as Tx.
I had cold symptoms. I started sneezing, had congestion, and sinus pressure. Then I was tested for Covid-19 and I tested positive on the 18th of January. I received an BAM infusion and had some relief. My cold symptoms lessened. But I was still fatigued. I still lost my sense of smell and taste for a month.
Rash on left arm with swelling and tenderness (cellulitis) 4 x 6cm oral lesion.
1 wk p/vax runny nose, sore throat, cough; 23NOV92 seen by MD p/episode w/back-sensation across base of back-up spine to head; pain in back; dx fracture lumbar; 30NOV92 MD again dx pneumonia;
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 20 year old pregnant female patient. The patient had no pertinent medical history or drug reactions/allergies. On 2009 the patient received the first dose of GARDASIL (lot no. not reported). On 10-MAR-2013 the patient went to the reporter's office for second dose of GARDASIL (lot no. h015555 exp 13-APR-2013, dose 2, 0.5 ml, intramuscular). The patient was given a pregnancy test, which was positive, but the positive pregnancy test results were not given to Nurse practitioner until after GARDASIL was administered. Nurse practitioner also performed a "wet prep" test and diagnosed bacterial vaginosis, for which she was prescribed metronidazole (manufacturer unspecified). The patient became pregnant with LMP of 10-MAR-2013 and EDD of 15-DEC-2013. It was reported that the child had a gestation of 7 weeks and 5 days. The outcome of bacterial vaginosis was unknown. Additional information has been requested.
rt arm became swollen around deltoid area & about 4in below; had felt irritable & flu like sx;
Hive 2 hour after vaccine on 6-17-14. Covered trunk, face, scalp. Resolved in few hours without treatment.
Felt slightly feverish.  Woke up in middle of night, 15 hours after injection, with chills, fever.  Nausea by 11 AM 12/20/09.  Finally dug up thermometer afternoon of 12/20.  Fever spiked to 103.2.  Ice packs lowered somewhat.  Tylenol.  Vomited twice.   12/20 evening, nausea, fever to 102.8, weakness. Had to call friend to feed pets.  Fever appeared to break with ice pack to head and neck, some relief.    Fever to 102, brief by uncontrollable chills througout night of 12/20-21. Temp currently, at 7:00 AM 12/21, 99.  Headache, nausea.  Haven't eaten since early 12/20.  Drinking plenty of water when nausea reduced.  Plan to go to doctor this am (spoke with him yesterday afternoon).
Patient's arm (with the flu shot) turned bright red and slightly swollen 2 days after the vaccine, had patient take some Benadryl.
Sore arm; This is a spontaneous report from a contactable other health professional (HCP). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:00 on right arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after the first dose on 27Dec2020. There was no treatment received for the event. The outcome of the event was recovered on an unspecified date.
Previous to this I was told to stop Mesalamine and Meloxicam due to high kidney function. Thru this whole ordeal I have been in near constant arthritic pain. My thumbs are barely useable. Switching to Tylenol for Arthritis provided no relief. Prayed for morphine gods to have pity on me. This is dose #1 of 2.  Friday July 17, 2020  Shingles Vaccine #1: left arm sore at injection site  Monday July 20, 2020  Nuclear Stress Test: blood pressure became extremely low 52/46  Tuesday July 21, 2020  Woke up in the middle of the night wringing wet with sweat   Wednesday July 22, 2020  Blood Test 8am no fever. 9:15pm 99.6 and aching all over Temp 100.5 in afternoon Low grade nagging headache and low grade sore throat Can?t breath  Only relief is sleeping all day  Thursday July 23, 2020  Had diarrhea all day temp 98.6 to 99.3 still aching  Aching all over only relief is sleeping all day Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Friday July 24, 2020  Sneezed 5xs in the am temp 98.7 saw respiratory at Hospital. Got Covid test  Aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat Can?t breath  Woke up middle of night sweating still aching all over  Saturday July 25, 2020  Still aching all over only relief is sleeping all day  Low grade nagging headache and low grade sore throat  Temp 98.6-99.6  Can?t breath  Woke up middle of night sweating still aching all over  Sunday July 26, 2020  Still aching all over  Low grade nagging headache and low grade sore throat Temp 101.0 in am then 100.3 in pm & 100.0 by eve Still get winded and with minimal exertion Woke up middle of night sweating still aching all over  Monday July 26, 2020  Still sore all over. Get hot flashes. Temp in am 100.2 Covid test is NEGATIVE Still got very sweaty napping on sofa Still get winded and with minimal exertion Maybe not quite so achy and arthritis is a bit more tolerable Thumbs still very painful, still achy all over but not as severe Went to bed feeling like fever shivering was going to happen, it didn?t Injection site still sore   Tuesday July 27, 2020  Woke up in am drenched.  Still not 100% yet
Healthcare Business Professional who was in charge of vaccine storage and stability.; No additional AE reported; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot# U022320 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -11.45° Celsius (C) for 1 hour respectively.  If a digital data logger was involved was not reported.  The vaccines experience a previous temperature excursion of -14°C up to -10°C for 30 minutes.  No adverse event reported.; Sender's Comments:  US-009507513-2205USA007031: US-009507513-2205USA007284:
Exhaustion, lack of appetite, fuzzy thinking, inability to focus, lasted 25 days.  Same symptoms as from Covid in June 2020, which also caused long-term Covid.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2009, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently persistent strain of herpes zoster, also known as shingles. On or about 01-JUN-2009, the patient was treated by the same physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term  prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.