chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 87 year old female patient with rheumatoid arthritis. The patient had no pertinent drug reactions/allergies. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000434, exp. date, 10-APR-2013) 0.65 ml subcutaneous in the left arm. Concomitant therapies included methotrexate (manufacturer unknown). The pharmacist noted that the patient, experienced an injection site reaction after receiving ZOSTAVAX. On 18-JUN-2013, the patient noted that her left arm where she had the injection of ZOSTAVAX was red, swollen, warm to touch and painful. The patient was seen by her unspecified physician on an unspecified date for evaluation. The patient returned on 23-AUG-2013 to see the pharmacist and inform her that the injection site from the ZOSTAVAX was still red and "about the size of a silver dollar", but no longer was swollen, warm to touch or painful. No treatment was given for the adverse events. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
I did not have an adverse reaction to the vaccine.  I tested positive for COVID-19 on 08/07/2022 with a home test.  My symptoms where nasal blockage; coughing really bad; nauseated and a sore throat. I contacted my doctor on 08/10/2022 and due to my current medication I was advised not to take Plaxovid so they said to take Tylenol, Mucinex and throat lozenges. As of today I still have congestion, runny nose and cough. The cough is not as bad but I still have it.
Information has been received from a physician concerning a female who on approximately 15-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported).  Three minutes after vaccination the patient experienced syncope and fell down and hit her head.  An ice pack was used for treatment, after which she was awake, oriented and alert.  Subsequently, the patient recovered from syncope and falling down and hitting her head.  Additional information has been requested.
BABY WAS IN BREECH OR ABNORMAL PRESENTATION; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a neonate female. The patient was enrolled in a program:  The patient's weight was 2.98 kilograms, and height was 48 centimeters. No past medical history or concurrent conditions were reported. The patient's mother received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) one total, dose was not reported, administered on 04-JUN-2021 for covid-19 immunization and patient exposed to vaccine via transplacental route (fetal exposure during pregnancy) (dose number in series 1). The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 23-NOV-2021. The patient's mother additionally received booster non-company suspect vaccine included: BNT 162 Pfizer-BioNTech (Comirnaty) (dose number in series 2) (form of admin, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, administered on 26-OCT-2021 for covid-19 immunization and patient exposed to vaccine via transplacental route. Concomitant medications included doxylamine succinate (Unisom Sleep), famotidine (Pepcid), prenatal vitamins (4 to 6 times a week, administration route via transplacental) and paracetamol (Tylenol). On an unspecified date in NOV-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. On 02-NOV-2021, the patient experienced baby was in breech or abnormal presentation (dose number in series 2). The action taken with BNT 162 was not applicable. The patient recovered from baby was in breech or abnormal presentation on 23-NOV-2021. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation, and fetal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210801448.; Sender's Comments: V0: 20220221029-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Baby was in breech or abnormal presentation. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: CONMEDS-OTHER SUSPECT DRUGS, NATURE OF EVENT. 20220221029-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS.
-Dizziness tiredness, pain in legs, pain in left arm -Tylenol, Benadryl prn pain, local reaction, push fluids for dizziness
No additional AE details; Customer calling for TE evaluation of VARIVAX/ Temperature -14°C up to-10°C for 2 hours 5 minutes 0 seconds ; -10°C up to 8°C (-0.4C) for 1 hour 25 minutes 0 seconds; they just found out they had another TE 1 week ago/-14°C up to-10°C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from other unspecified reporter, regarding to a patient of unknown age, gender and race. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in May 2022 (also reported as "a week ago and between 11-MAY-2022 and 24-MAY-2022") they reported that varicella virus vaccine live (oka/merck) (VARIVAX) with the lot number U039949 that has been verified to be valid (expiration date: 16-DEC-2022) underwent a temperature excursion at about 14 degrees Celsius (°C) up to 10°C (-12C) for 50 minutes; 14°C up to-10°C for 2 hours and 5 minutes; and finally from-10°C up to 8°C (-0.4C) for 1 hour and 25 minutes; then on an unspecified date in May 2022 (also reported as  between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with one of this doses of varicella virus vaccine live (oka/merck) (VARIVAX)  and  sterile diluent (dose, frequency, strength, and route of administration were not provided) for prophylaxis. No further adverse event (AE) details were available.
Pt started with dizziness and lightheadedness 3 days after vaccine and that has persisted 4 days to this point
Tested 01/14/2022 COVID Had a workplace exposure Group Home Live in Care Center to COVID. Majority of residents tested positive for COVID including spouse. All vaccinated and boosted with Group home. Quarantine for 10 days. Having running nose and dry cough.
fever; chills; body aches; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got the 1st dose of Covid 19 Vaccine 20Jan2021 and got all the side effects, fever, chills and body aches on an unspecified date. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Pt began with itching at 8pm on 8-20-2020 - no rash was noted. Dad gave pt Benadryl 1 tab. Pt woke at 8 AM 8-21-2020 with hives all over body - described as raised pink spots with pale centers. Dad reports the ones on her belly and ribs are large like the size of his hand. Pt c/o itching. Dad gave Benadryl 1 tab and put pt. in Oatmeal Bath. Denied difficulty breathing/swallowing, drooling or swollen tongue. Denies fever/sx of illness. Denies redness, swelling or tenderness to injection sites. Denies prior reactions to immunizations. Denies eating any new foods. Pt. happy and active splashing in tub just itchy. Dr advised Benadryl q 6-8 hours PRN itch, monitor clinically and call back with update this afternoon
runny nose; chills; body aches; fever that ranged from 100.5 degrees to 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004AZ1A) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (abnormal) ranged from 100.5 degrees to 99 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated fever had continued to decline as well as some of the other symptoms. Some side effects were still present but were improving.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received ZOSTAVAX (lot number, dose, route and indication were not reported) in September 2012 (day unknown) and on 22-JUN-2014. No adverse symptoms requested. The action taken and outcome were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a 1 year old patient. On 10-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck), (lot number, expiry date and route was not reported) and a dose of PROQUAD, (lot number, expiry date and route was not reported) during the same visit. No symptoms were reported. Additional information has been requested.
I had a rash appear around 3 to 4 days that was raised and very itchy and grew in size.Y ou could still see the injection site. I went to my Dermatologist last week and prescribed a topical cream to put on it twice a week for 2 weeks.
Patient was weak, tired, dizzy and had no appetite.  An hour and a half later developed widespread hives.  Symptoms persisted the next day. No fever, rapid heart rate or trouble breathing.
weakness; pain in the right hip; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip). At the time of the report, ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip) had resolved.            Treatment medication was not provided.  Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information included outcome of the events.
I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45.  I was discharged Tuesday evening 2/2/21.  Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis).   My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred  and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk.  I lost motor coordination/control in hands and feet.  I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).
Patient was admitted to the hospital for fall and closed compression fracture of L3 lumbar vertebra. Patient was found to have an asymptomatic COVID infection.
This case was reported by a healthcare professional (quality assurance director for network of clinics) and described the occurrence of encephalitis influenzal in a 85-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 26 September 2013 the subject received a dose of FLULAVAL (1 ml, unknown details). On 4 October 2013, 8 days after vaccination with FLULAVAL, the subject experienced encephalitis influenzal. The reporter did not have much information to provide. The reporter was "asked by an infectious disease specialist if our [GSK's] vaccine, FLULAVAL, was an inactive vaccine." The reporter also stated that the "physician suspects the vaccine due to the diagnosis of influenza encephalitis." The subject was hospitalised and the healthcare professional considered the event was life threatening. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was related to vaccination with FLULAVAL. The reporter documented another case with FLULAVAL. See case A1046774A for details on the other case.
Large area of redness, warm in, induration involving entire anterior surface of right thigh. Till just above knee.
Moderna vaccine was out of the freezer for more than 30 days when administered.  Receipt date was 09/20/2022, administration date was 12/22/2022.
Mother states child became ill with fever, vomiting and diarrhea post shot given. After 3 days went to doctor and child was placed in hospital for dehydration.  Also diagnosed with moderate ketoacidosis.
Chest pains. Was given morphine to help subdue pain. After being discharged from hospital, I was prescribed indomethacin and colchicine to help with chest pains
Left Breast lymph node area and left lymph node below ear on neck are mildly swollen and tender
Extreme pounding in left ear. Woke me from a sound sleep. Fullness and hearing loss in left ear
diarrhea; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (chills) and VOMITING (vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills) and VOMITING (vomiting). At the time of the report, DIARRHOEA (diarrhea), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received on 22-Jul-2021 contains no new information.
His nose has been dripping; This is a spontaneous report from a contactable consumer, reporting for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history included allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had his COVID-19 vaccine three days ago and since then his nose has been dripping. He wanted to know why he was not allowed to take his allergy test. He also said that he thinks his allergy is to cortisone but was not that serious. He was going to the doctor to get a cortisone shot and he wanted to know if he was able to do that or not. He said it was an allergy shot, he guessed it was going to be cortisone, but he doesn't know for sure he just knows it was an allergy shot. He says he was supposed to get his second shot 31Jan2021, so he was trying to see if he has enough time in between to take his allergy shot. He was going to go as soon as he can to go get the allergy shot, he thinks it will be plenty of time because his second shot should be the 31Jan2021. No, he does not have time he was not sick he just doesn't want it to get worse and he just does wants to know if he can take the allergy shot. If not, it was fine, but he wants to know if it was alright to take it. He just wanted to know if he can take the allergy shot or not. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Heavy menstrual bleeding 4-5 months post vaccination. Break through bleeding throughout entire cycle.
Information has been received from a nurse concerning a 63 year old Caucasian male with no medical history who on 14-NOV-2005 at 3:30 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot#650330/0748P), in the left deltoid intramuscularly.  There were no illness at the time of vaccination.  On 15-NOV-2005 the patient developed severe left arm pain and difficulty lifting arm.  The patient came in on 15-NOV-2005 for follow up visit.  The patient's doctor diagnosed it as a localized reaction only.  Unspecified medical attention was sought.  The patient recovered.  There was no adverse following prior vaccination.  Additional information has been requested.
Achiness, fatigue, and mild nausea on 4/7/21 (day of second vaccination). Chest pain, fever, achiness, fatigue, mild nausea on 4/8/21. Symptoms mostly subsided on 4/9, so I returned to work at 3:00 pm. By about 5:00 pm, the crest pain returned and worsened until I went home, and then to the hospital around 7:00 pm. Tests were done before I was diagnosed with "acute myocarditis, elevated troponin level, coagulopathy, NSTEMI (non-ST elevated myocardial infarction)", told I likely had a heart attack, and was put on a Heparin drip and kept for additional testing and observation until 4/11/21 at approximately 5:00 pm. Official notes state
Next day body aches and fatigue.  Third day a whelp on arm 5 inches in diameter , slightly itchy, very red, swillem
Pt recvd 1 dose of Heptavax/Recombivax & 2 doses of Engerix-B & did not respond;
A few minutes after injection he started complaining of a headache and pain and aching in his hands. This slowly got worse, and we called EMS and he was taken to hospital. We are unsure of treatment at the ER, but he was released the same day with the diagnosis of "arm pain" with no mention of it being an adverse reaction from the vaccine.
On 9/11/17 the patient came in complaining of pain in her arm from vaccines she'd received on 9/7/17. I asked the patient to wait and see N.P. so that she could assess patient. The patient had a follow up appointment with N.P. on 09/15/17. After finishing her visit N.P entered the following notes:42 yr old female here today post ER visit to hospital. Patient was in the ER yesterday due to right forearm swelling, diagnosed with cellulitis to area and sent home with doxy 100 mg q 12x10 d.
This lot of Pfizer was temporarily stored in the freezer and unthawed prior to administration.  Unkown whether the stability of vaccine was compromised.  Patient did not have any adverse reactions.  Offer to revaccinate per parents discretion.
received 2nd dose of the Pfizer Vaccine, Interchangeability; A spontaneous report was received from a nurse who was also a patient, of 29-year-old, female who was administered Moderna's COVID-19 vaccine on 31-DEC-2020 and received second dose of the Pfizer vaccine (interchangeability).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31-DEC-2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) through intramuscular route at the facility for prophylaxis of COVID-19 infection. The patient was a travelling nurse.  The patient had received second dose of the Pfizer vaccine (Lot number: EL1283) on 29-JAN-2021. Patient reported no symptoms. No treatment information was provided.  The action taken for Moderna COVID-19 vaccine was not reported.  The outcome of the event, received second dose of the Pfizer vaccine (interchangeability) was considered resolved on 29-Jan-2021.; Reporter's Comments: This case concerns a 29-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot: EL1283), reporting Wrong product administered without any associated adverse events.
Soreness in arm; Headache; Chills; Painful genital herpes outbreak; Difficulty walking, uncomfortable, stayed in pajamas all weekend; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (painful genital herpes outbreak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Genital herpes (Patient states she has a history of genital herpes outbreaks.) on 26-Feb-2021.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GENITAL HERPES (painful genital herpes outbreak) (seriousness criterion medically significant) and GAIT DISTURBANCE (difficulty walking, uncomfortable, stayed in pajamas all weekend). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), HEADACHE (headache) and CHILLS (chills). The patient was treated with PROGESTERONE (PROGESTERONE ABBOTT) for Genital herpes, at an unspecified dose and frequency. At the time of the report, GENITAL HERPES (painful genital herpes outbreak), GAIT DISTURBANCE (difficulty walking, uncomfortable, stayed in pajamas all weekend), PAIN IN EXTREMITY (soreness in arm), HEADACHE (headache) and CHILLS (chills) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient tested + for covid 2-2-22 and passed 2-14-22;  had copd .  methamphetamine use??