chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme vomiting.; Diarrhea; Headache; Body Ache; This is a spontaneous report from a contactable consumer.   A 35-years-old female patient non pregnant received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Leg Right on 09Feb2021 13:00 (At the age of 35 years) as dose 2, single for covid-19 immunisation. The patient previously took the BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Left leg on 19Jan2021 13:00, as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was known to the allergies Penicillin, codine and iodine and experienced drug hypersensitivity. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for contraception, start and stop date were not reported. The patient received other medications within 2 weeks of vaccination Generic yaz birth control. On 13Feb2021 04:00Am, the patient had experienced Extreme vomiting, Diarrhea, headache and body aches. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 16 year old female with unknown pertinent medical history and unknown drug reactions/allergies, who was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), (lot number: 658197/0853U).  On 21-SEP-2007 the patient developed "exaggerated swelling and erythema at injection site". The date of the first vaccination is unknown. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Dull headache nagging headache starting a couple hours after vaccine that has not let up after taking headache medicine and a green bruise on my left forearm with a raised knot and hotspot down from the injection site. The knot hurts to touch and has my arm hurting to raise or use it. My arm was sore after the shot and has continued  to hurt, the knot developed 3 days after the vaccine, As of today it is still green and hot.
Vasculitis; Hearing loss- both sides; Bad cough; A lot of sinus problems; Lost almost 50 pounds in period of 6 weeks; Pain and swelling in lower extremities; Pain and swelling in lower extremities; Feet and ankle got swollen up; Off balance; Couldn't walk very well; Hair loss; Weak; Pain in legs and feet; Pain in legs and feet; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss- both sides) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myelofibrosis (In lungs). Concurrent medical conditions included Vasculitis (About 3 weeks ago.) since August 2021. Concomitant products included PREDNISONE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (Hearing loss- both sides) (seriousness criterion medically significant), COUGH (Bad cough), SINUS DISORDER (A lot of sinus problems), WEIGHT DECREASED (Lost almost 50 pounds in period of 6 weeks), PAIN IN EXTREMITY (Pain and swelling in lower extremities), SWELLING (Pain and swelling in lower extremities), JOINT SWELLING (Feet and ankle got swollen up), BALANCE DISORDER (Off balance), GAIT DISTURBANCE (Couldn't walk very well), ALOPECIA (Hair loss), ASTHENIA (Weak), the first episode of PAIN IN EXTREMITY (Pain in legs and feet), the second episode of PAIN IN EXTREMITY (Pain in legs and feet) and FATIGUE (Tired). On an unknown date, the patient experienced VASCULITIS (Vasculitis). At the time of the report, DEAFNESS (Hearing loss- both sides), COUGH (Bad cough), SINUS DISORDER (A lot of sinus problems), WEIGHT DECREASED (Lost almost 50 pounds in period of 6 weeks), PAIN IN EXTREMITY (Pain and swelling in lower extremities), SWELLING (Pain and swelling in lower extremities), JOINT SWELLING (Feet and ankle got swollen up), BALANCE DISORDER (Off balance), GAIT DISTURBANCE (Couldn't walk very well), ALOPECIA (Hair loss), ASTHENIA (Weak), the last episode of PAIN IN EXTREMITY (Pain in legs and feet), FATIGUE (Tired) and VASCULITIS (Vasculitis) outcome was unknown.            Patient was prescribed with other steroids. No treatment information was provided.  Company comment: Very limited information regarding this events has been provided at this time.  However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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 spontaneous report as received from a other health professional refers to a male patient of unknown age. Past medical history included: vaccinated with ZOSTAVAX and experienced soreness at injection site date unknown. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous. Concomitant medication were reported. On an unknown date the patient experienced soreness at the injection site. The outcome of soreness at the injection site is unknown. Action taken with ZOSTAVAX were not reported. Additional information is not expected.
No Adverse event; patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series) and NO ADVERSE EVENT (No Adverse event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 10-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series).    No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 04-Oct-2022, the patient received the 1st dose of Moderna COVID-19 vaccine (lot no: 063b22a).  No treatment medications were reported.
Approximately 2-3 hours after injection developed disequilibrium, stomach discomfort and arthralgias. Symptoms lasted 5 hours and resolved.
I had COVID-19 twice. The first I was in Sept. 16th coughing, had stuffy nose, fever, fatigue, shortness of breath, muscle ache, sore throat. They were moderate, not that bad. They lasted about 2 weeks. I got a Pulmonary embolism from this where I started feeling really dizzy and shortness of breath. I went to the ER and they found a blood clot in my lung from a CT scan. I was put on a blood thinner. My home Nov 7th I got COVID-19 again. This time I also had a Flu and double ear infection, and sinus infection. I had body ache, cough, headache, runny nose, sore throat and had these for a week and it was getting worse. I went to urgent care and was tested. And my home tests of COVID-19 the previous week was negative. I was put on antibiotics and eye drops because I was starting to get pink, and I got cough medication with codeine.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that, they had a group of 13 pharmacies and administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials had been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medication was provided.
pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
Patient received a second flu shot in the season. Patient did not report receiving a flu shot already nor did he report receiving any vaccines in the past 4 weeks even though he received a High Dose flu vaccine 1 week prior.
Patient was delirious around  3AM after vaccine was administered. Patient did take Motrin before bedtime at 11pm. Patient was up and doing better around 8am the next morning.
I started to have a runny nose. 3/25 tested with at home COVID-19 test, positive. Televisit with doctor. Prescribed PAXLOVID, ADVIL, MUCINEX, and CORICIDIN D. I had a little bit of a fever and lots of fatigue. These symptoms lasted about 2 days where I mostly slept. After that, I had just a slight, periodic cough what was productive. The cough lingered about 8 weeks.
Immediately after receiving Tdap, MCV4, and HPV 9 vaccines, the patient had a vaso-vagal reaction. Initial BP was 90/50 HR 45-50.  After 5 minutes pt was given crackers and water. Final BP 95/61 HR 73.
the patient had a folliculitis type rash, beginning about 17 Oct, day 12 after inoculation- Eruption occurred on back and chest, spreading over several days then resolving w/ recovery. NO systemic symptoms, supportive treatment provided.
No reaction to 1st dose.  Since my 2nd dose, I started to have headaches every day since the 2nd vaccine shot,  the headaches continue as of today. I called my primary care and found out that my blood pressure was higher than normal.  Readings from a low of 146/97 to a high of 184/98.  Primary care has started me on 10mg of lisinopril, once per day.  Prior to vaccine my blood pressure never exceeded 150/100 to my knowldege.  Primary care suggested I report this back to pharmacy, however, pharmcy web site suggested filling out this form.
Fever, chills, headache, blurred vision, night sweats,queasy stomach, over all body aches and pains, weakness, very sore arm at injection site. Ibuprofen, Excedrin, acetaminophen, Benadryl . So far this is day three of these events and I am trying everything to get these things done with. Heating pad helps somewhat.
Evening after receiving the 2nd COVID vaccine developed chills, body aches, fatigue temp 100.2 took Tylenol lasted for about 4-5 hours; fell 200 % better the next day.
Patient was given hepatitis A vaccine and after a couple of minutes whilst in conversation she collapsed in her seat to the floor. Call to 911 was made. Patient in this time gained consciousness and was a little dazed as to what happened. It seems she had a vasovagal syncope reaction. She later stated she has experienced such event in the past when stressed.
Patient received Pfizer dose one on 7/28/21 and Pfizer dose two on 8/9/21. There was only 12 days between doses.
Patient is a 75 yo M w/ hx of ESRD on HD MWF, OSA, DM-2, SSS s/p PPM, bladder ca on BCG Rx, CAD s/p CABG and PCI, asthma, HFrEF, HLD, OSA, recent discharge 2/14/23 for enterococcus bacteremia and MDR Ecoli UTI discharged to SNF to complete abx 2/19/23. Pt presents to ED today w/ confusion, being unable to finish a though, slurring speech, and jerking motions of both upper extremities. Currently pt recognizes he is in the hospital but is having word finding difficulties and is trying to climb out of bed. He denies any pain or trouble breathing. States he wants to go home.
Dad states that patient had temperature about 100.3 on and off for 2 weeks.
Temp 105.5 30DEC90; Ampicillin 30DEC90 begun at Hosp 30DEC90 - ER; 31DEC90 pediatrician - F/U; dx Pneumonia.
acute spinal stenosis; This is a spontaneous report from a contactable other hcp. An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 06Feb2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included prednisone acetate (PREDNISONE [PRED-NISONE ACETATE]) taken for an unspecified indication, start and stop date were not reported; cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute spinal stenosis on an unspecified date. Clinical course was reported as she has a question regarding the use of Prednisone with the COVID19 Vaccine. Her husband has been diagnosed with acute spinal stenosis. Before he was diagnosed with this, he was on Prednisone regimen. He also has gotten Cortisone injection in the hip too. He took the first dose of prednisone. He starts high and lowers it for 6 days. On the second day is when he got the COVID vaccine. her husband's first dose of Prednisone was on Friday and then on Saturday he got the vaccine. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of acute spinal stenosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child was brought back to clinic because of redness and swelling to right thigh injection site where the HIB and DTaP were given 1" apart. Patient will return for follow up tomorrow. MD advised for mother to apply ice and give Tylenol and patient will continue to follow up to clinic until all redness and swelling has gone away. A follow up report received 9/18/2002 adds: Child has completely recovered.
Per ED note: The patient is a 55-year-old male with past medical history of diabetes mellitus and end-stage renal disease on hemodialysis who presents to emergency department for complaint of nausea, vomiting, and hiccups.  The patient states that he has been having hiccups intermittently for the last week and over the last 2 to 3 days he has had vomiting.  He also admits that he has been having chills that have been going on for the last several days.  He denies any shortness of breath, chest pain, or abdominal discomfort.  The patient was febrile upon arrival in the emergency department with a temperature of 102.2 °F.  He states that he is fully vaccinated for COVID-19.  He is currently being treated for a left foot ulceration and follows with the wound clinic.
How long do the side effects from the Shingrix normally last?; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced side effects. The patient was asking, how long did the side effects from the Shingrix normally lasted.
None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found that with proper storage, the vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration.
increased heart rate around 123 beats per min usually runs 57, vomiting,headache
Flu like symptoms... lasts 3 days on the first shot and 1.5 days for the second shot.
Information has been received from a physician's assistant concerning a 7 year old female with reactive airway disease who on 08-FEB-2001, received a one time 0.5 cc dose subcutaneously in the left upper arm of varicella virus vaccine live (Oka/Merck /Lot# 631467/1682J). It was initially reported that at the time of vaccination she had an upper respiratory infection with no fever. Follow up information from the physician assistant reported no illness at the time of vaccination. There was no concomitant medication. On 01-DEC-2007, the patient developed a rash and small vesicles on the left arm and shoulder. On 03-DEC-2007, she presented to the physician's office with vesicles and no scab formation noted to be of dermatomal distribution. She was diagnosed with shingles. Treatment included acyclovir. At the time of this report the patient was recovering. The physician's assistant indicated that they had planned to send a specimen for zoster varicella identification, but the specimen was sent to a conventional laboratory facility that was unable to perform the identification test and would not forward the specimen. Therefore, no specimen would be sent for zoster varicella identification. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.