chrisvoncsefalvay/vaers-outcomes huggingface dataset:
associated with body aches and low-grade fever (99degrees F; Extreme headaches; these headaches are much worse/pain from headaches was severe; associated with body aches and low-grade fever (99degrees F; body aches decreased but then she had severe nausea for last day and half.; Received both doses in span of 20 days per the caller; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller), PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe) and PYREXIA (associated with body aches and low-grade fever (99degrees F) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller). On 31-Mar-2021, the patient experienced PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses in span of 20 days per the caller) had resolved. At the time of the report, PAIN (associated with body aches and low-grade fever (99degrees F), HEADACHE (Extreme headaches), HEADACHE (these headaches are much worse/pain from headaches was severe), PYREXIA (associated with body aches and low-grade fever (99degrees F) and NAUSEA (body aches decreased but then she had severe nausea for last day and half.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 99 degrees F- low-grade fever.         There was no concomitant list.  She received treatment this morning, 02Apr2021, at 4am patient took Tylenol with codeine as pain from headaches was severe.
Fever of 101; Haven't been feeling good all day; I have been sleeping all day; Not feeling well; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date in May2021, the patient experienced fever of 101, hadn't been feeling good all day, the patient had been sleeping all day and was not feeling well. The patient got second vaccine yesterday and hadn't been feeling good all day, but actually had a fever of 101 and didn't know it was the typical side effect and will be okay tomorrow. The patient just took and about half hour ago, and had a little fever of 101, and had been sleeping all day. The patient didn't experience it till today (17May2021). The patient just didn't know whether should just wait till tomorrow, take temperature again, whether go with the temperature again, see if it was okay or what should be done. The patient was informed about Pfizer Medical Information. The patient underwent lab test which included body temperature: 101 (fever) on an unspecified date in May2021. The outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Pt. had PREVNAR 13 on 5/24/16 - had redness and swelling with hot to touch it has continued to expand at the border. Measured 16 x 8 cm rt deltoid.
I started to get a headache after the first hour or two. Overnight my headache got much worse, I had indigestion, dizziness, body aches and was shivering off and on. The next day (Sunday) the headache was bad, but manageable with TYLENOL and shivering had stopped. I mostly had to stay in bed. Today- Monday- I still need the TYLENOL but feel more like myself. The redness/swelling at the injections site is a bit larger than a silver dollar. My husband got a shot at same time but only had a slight headache and his arm, while sore, looks nothing like mine.
BURNING AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and fibromyalgia, and other pre-existing medical conditions included the patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 2021, the subject experienced burning at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at the injection site on APR-2021. This report was non-serious.
palpitations (210 BPM); Fast heartbeat; This is a spontaneous report from a contactable other hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in arm right on 07May2021 11:30, single dose for covid-19 immunization. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153, expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 16Apr2021 01:30 PM, single dose for covid-19 immunization. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. The patient underwent lab tests and procedures which included heart rate: 210 on 12May2021 BPM. The patient's medical history was not reported. Concomitant medication that patient received within 2 weeks of vaccination included phentermine (Phentermine) taken for an unspecified indication, start and stop date were not reported; Prilosec (Omeprazole) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B 12) taken for an unspecified indication, start and stop date were not reported.  The patient experienced fast heartbeat and palpitations (210 bpm) and lasted about 10 mins. The patient was shifted to ER on 12May2021 20:30. The event fast heartbeat and palpitations (210 bpm) was found to be medically significant. The patient di not receive treatment.The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events palpitation and Heart rate increased and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
3 days of extreme fatigue then 3 days later I woke up and knee was so swollen I could not walk for 3 days. I am just now able to walk without cane but must use cane for stairs.
fever; This is a spontaneous report from a non-contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever on 13Jan2021 with outcome of recovered.  No treatment received for the adverse event. The patient did not diagnosed with COVID-19 prior to vaccination, and did not tested for COVID-19 since the vaccination.  The case is non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tenderness when she went to bed and inability to lay on the side of injection. Later noticed swelling and inflammation.
Information has been received from a physician concerning a healthy white 6 year old male (the physician's cousin) with no significant medical history including no history of immunosuppression, chickenpox or recent varicella or herpes zoster exposure who on 3/19/95 was vaccinated with a 1st dose of varicella virus vaccine live (lot 1:29B-invalid lot). There was no concomitant medication and no illnesses at the time of vaccine administration. It was noted that no rash occurred at the injection site or elsewhere within 42 days of vaccination. On 4/28/01, the pt developed herpes zoster along the right trigeminal nerve. Follow-up information received from the same physician, indicated that on 4/29/01, the pt began with a headache in the right temple. By 4/30/01, the pt developed a pustular rash over his right eyebrow, initially thought to be poison ivy, which spread over ophthalmic/right trigeminal distribution. The pt also experienced vomiting, itching and pain rated "7" on a scale of 0-10. On 5/3/01, the pt was followed-up and dx'd with shingles. The pt had a positive ophthalmic exam for herpes zoster. On 5/4/01, a vesicle specimen was obtained by the reporting physician. Seven days into the illness, the pt was reported to have what his parent thought was varicella pox on his body. On 5/24/01, the specimen was sent to the lab for identification. Follow-up information received on 6/7/01, from the lab, indicated that the preliminary polymerase chain reaction (PCR) results from this episode's specimen were VZV positive. In further follow-up from 6 20/01, PCR analysis of the vesicular specimen on 5/29/01 had identified the presence of Oka/Vaccine VZV. On 7/11/01, the physician reported that an ophthalmologist had treated the pt with valacyclovir HCI Valtrex and "several" eye drops, including vitarabine (Vira-A) and trifluridine (Viroptic). The pt's mother told the physician that the pt had developed 15-20 lesions in a generalized distribution on his body after developing the herpes zoster. The physician had not view this rash, however, the pt's mother had photographed the trigeminal nerve herpes zoster, which the physician stated was "truly a heinous picture". On 5/21/01, the pt recovered from the chickenpox. He also recovered from the herpes zoster lesions, but facial scarring remained. The reporting physician considered the chickenpox and herpes zoster to be non-serious. Additional information is not expected.
pt had sz about 2 hrs p/vax; mom @  time of sz didn't realize it was a sz; had 2 more sz @ later times; was seen in ER; had temp w/bronchitis in ER: kept for a few hrs;
Day 1, sore arm, fatigue Day 2, sore arm, fatigue, headache, chills, Day 3, fatigue, headache, diarrhea, night sweats off and on day and night, nightmares, Day 4 through the present, exhaustion, night sweats off and on day and night, nightmares, nightmares, occasional diarrhea
After receiving my 2nd dose, my right leg swelled from the knee down. I went to the ER Clinic and the found on a sonogram a DVT. I am now on blood thinners. I have multiple doctors to clear the clot.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 64 hours and 33 F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
got covid 19 12 days after receiving bivalent booster - filled out V-safe info and was contacted to submit this form
miserable/I was pretty much incapacitated for about 28 hours; excruciating pain; incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch; Scared to get the third shot; did vomit; very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot) and VOMITING (did vomit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot), VOMITING (did vomit) and NAUSEA (very nauseous). At the time of the report, FEELING ABNORMAL (miserable/I was pretty much incapacitated for about 28 hours), PAIN (excruciating pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (incapacitated for about 28 hours/had to help her get up just to use the bathroom/could not get up off the couch), FEAR (Scared to get the third shot), VOMITING (did vomit) and NAUSEA (very nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Blood test: 0.4 (Inconclusive) 0.4 non-detectable SARS-Co-V-2 antibodies IgM present..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-302102 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
my lips felt dry and my throat was scratchy.  The throat resolved within 24H, but my lips swelled.  (Not huge, not like angioedema).  But, it's been a month and they are still large and puffy.  The skin above and below my lips is numb.  Symptoms are worse in the cold (I have trouble speaking or drinking through a straw).
Information was received on 24-OCT-2017 from a consumer regarding himself as a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication are unknown. On an unknown date, reported as "about a year ago", the patient was vaccinated with ZOSTAVAX (lot number and expiration are unknown), subcutaneous for the indication to prevent shingles. On an unknown date the patient developed shingles after receiving the ZOSTAVAX. The outcome of shingles is unknown. No further adverse event information was provided. The patient requested reimbursement for ZOSTAVAX because "now he has shingles and Merck guaranteed that the vaccine would work." When the patient heard the information that he was unable to receive reimbursement, he stated that he would get a lawyer and sue Merck. The patient disconnected shortly after stating that "Merck should give him 50 grand." Additional information is not expected because the patient did not provide consent to follow up.
Child passed out and seized for 3 minutes, followed by 2 minutes of unconsciousness. When waking up he was unable to speak or move. Temp of 102.8 when EMS arrived. Appropriate Tylenol dose given in ambulance. 1 hour later at hospital temp was 102.6. Urine tox and labs drawn. All negative. Motrin given at hospital. 1 hour later temp 99.6. Pediatric neuorologist consulted. Sent home with instructions to give meds Q 3 hours until fevers subsided. *****(Child has identical twin that recieved MMR shot at the same time. Twin had fever of 103.2 with one hour of first childs seizures. Both children continue to have temps of 99 to 102 around the clock even with constant meds.)
Lymph node hurts.; felt tingling at the injection site; Arm hurting; Slept longer than she normal; Tingling in her left fingers, face and cheek on the left side; Felt very exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Optic neuritis.    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 VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted). On 12-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node hurts.). At the time of the report, VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side), FATIGUE (Felt very exhausted) and LYMPH NODE PAIN (Lymph node hurts.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As a corrective patient was laid down with feet up and was given water. Concomitant medication use was unknown Treatment information was unknown
History of present illness. Deep vein thrombophlebitis-pt states in he is still experiencing feeling of "fullness" and epriodic soreness and swelling in his left leg, especially when lying down. He occasionally takes Tylenol for pain but "tries to stay away from anything that will interfere with the Coumadin." Currently his INRs are between 2.6-2.8 on 12.5 mg f Coumadin/day. He takes no other medications. Pulmonary 6mm right upper lobe nodule and an 8mm pleural parenchymal scar. CT scan 04/12/01, 04/19/99-chest X-ray, PA and lateral-normal chest; chest PA 02/17/1998, WNL, no active disease. He is in the process of seeking follow-up care with a Pulmonologist for possible PEP scan. He has an appointment scheduled 04/24/2002. Chronic fatigue onset temporally associated with anthrax vaccination: he sleeps poorly, "I toss and turn all night-watching the clock" averaging 1-3 hrs of sleep after going to bed between 10-11pm. Feels tired all the time. Sleep studies conducted on 3/17 & 3/18/02 were positive for sleep apnea with severe daytime drowsiness. A CPAP mask was recommended with a 2nd study to assess results during napping in 4-6 weeks. Sinusitis: he has daily problems with congestion, PND and sore throat "almost every day I have a sore throat" says he has been told that he may need t have his tonsils and adenoids removed. CT scan of sinuses without IV contrast on 04/11/01 was negative.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, patients were vaccinated with (Oka/Merck) PROQUAD (dose, route and lot number were not reported). Concomitant medications were not reported. Nurse stated that an unspecified numbers of patients may had received PROQUAD (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 30-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Great experience with vaccine, but thought I should report.  On the 8th evening after shot, injection site started itching.  I scratched it and later looked in mirror.  Site was red  3 1/2" X 4 1/2"   It is now day 11 after shot and has spread 1/2 - 1  inch, but seems lighter.  Have taken picture every day to document.  I feel great otherwise and arm does not itch or bother me.  Just red.  Just wanted to make sure I can take next shot and thought I should report.
Erythematous plaque within 20 min of injection followed by 2cm Bulla developed 18-20 hrs post injection. No fever or chills. Pt felt bad. No Tx.
Muscle and bone aches, skin with burning feeling Saturday 10/17/15.  Extreme fatigue, swollen lymph nodes, low grade fever.  Sunday 10/18/15, skin started to feel itchy and burning subsided. still with aches, swollen nodes, feverish, weakness.  Monday 10/19/15,  Weakness some itchiness, aches, swollen glands and headache. 10/20/15, symptoms decreased and able to go to work, still with swollen glands, weakness, fatigue, aches.
pt recv vax 14OCT96 & 27OCT96 pt exp fever & devel a sore throat w/red spots in back of throat on the roof  & sides of mouth;29OCT96 pt exp diarrhea;
Started on 12/22 with sniffles, sore throat, low grade fever, coughing. Later fever reached 105° w/ severe cough and congestion. Went to urgent care section on 12/29. When there, was checked for flu and CoVid. CoVid came back positive. Advised some OTC and quarantine at home until 1/2. As of 1/4 still has not recovered. Is under medical supervision at home.
-itching, internal x 1 week after injection on injection site/lateral deltoid of right arm -no hives, no rash, no sign of inflammation
Narrative: 75yo male Pt w/ hx of afib, CAD, DM, HTN, depression. Pt had received covid vaccines on 3/19/21 & 4/16/21. Pt died on 12/23/21 of unknown causes, unknown place, & unknown circumstances. Not able to assess if covid vaccines were related to this death given lack of information in hospital chart  notes