chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just really want to know if the reaction I had to my first dose was an allergy; inflammation response; I don''t know if it was the vaccine or if it was the way the doctor injected the vaccine; not injected in the middle of my deltoid; injected on the outer side of my deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Aug2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 11Aug2021, outcome "unknown", described as "I don''t know if it was the vaccine or if it was the way the doctor injected the vaccine; not injected in the middle of my deltoid; injected on the outer side of my deltoid"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "just really want to know if the reaction I had to my first dose was an allergy"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation response".  Additional information: Consumer stated, having a hard time, patient just really want to know if the reaction  had to the first dose was an allergy, because patient have not gotten the second dose because afraid of the response from the first and doctor did not report it to VAERS and patient not getting any help around on the topic and I don't know if it was the vaccine or if it was the way the doctor injected the vaccine because it was not injected in the middle of deltoid in fact it was injected on the outer side of deltoid (further clarifications unknown hence event captured as per verbatim).
bad migraine; subtle headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: FF2593) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 25Oct2021, stop date: 25Oct2021. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2593, Location of injection: Arm Left), administration date: 25Oct2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 20Nov2021, outcome "recovered with sequelae", described as "bad migraine"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered with sequelae", described as "subtle headache". The events "bad migraine" and "subtle headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine, headache.  Additional information: other vaccine 4weeks product was Flu Shot. No other medications in two weeks. It was reported  4 days after receiving second shot, experience a very bad migraine, which lasted for 3 days before subsiding to just a subtle headache. Tylenol was taken to alleviate migraine/headache, at the recommendation of doctor office. Headache still comes and goes periodically, now 3 weeks since receiving that second Pfizer shot, taking Tylenol whenever he experience that. Unsure how long symptoms will continue. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment Tylenol (650 mg) for AE. No covid prior vaccination. covid was not tested post vaccination. No known allergies  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) in on an unknown date. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, very soon after getting vaccinated, the patient developed "shingles like blisters". No treatment information was reported. The patient sought medical attention (unspecified). The outcome of the event was not provided. This is 1 of 2 reports from the same source (other case ID 1211USA002570). Additional information has been requested.
Itching; This case was reported by a consumer via interactive digital media and described the occurrence of itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itching. On an unknown date, the outcome of the itching was unknown.   It was unknown if the reporter considered the itching to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-NOV-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient had Itching The follow up would not possible, as no contact details were available.
On the morning of 10/08/2014, We visited the pediatrician office for the first time.  My then 8 month old, received the Pediarix vaccine combination, which was prescribed by the Physician who did her exam and was administered by the nurse.  About an hour or two later, that afternoon, I noticed a swelling around patient's left eye.  She had not had any falls or other injuries during the day, and the only thing that occurred was her receiving a vaccination.  I'm a dentist, so I thought to look up the side effects of the Pediarix on drugs.com, which stated a possible side effect of "hives or hive like swelling on the face, eyelids..."  So I called the physician's office to report the findings and my concern.  I left a message, and the nurse called me back.  Upon explaining to her my observation, she immediately dismissed me, saying that patient must've hit her face and that swelling of the eye doesn't happen.  I then insisted on speaking with the physician Dr, who called me back later.  I again explained the situation to the physician, who dismissed me as well, and said that it's not a side-effect and that in all her years of practice, she's never seen or heard of it.  I told her I looked up the drug side-effects and explained what I read.  I informed that doctor that next time, I didn't want the Pediarix administered, but wanted the vaccines individually administered, because patient hadn't had any side-effects when she received her first doses individually at a previous doctor's office.  The Physician told me that she will make a note of it in patient's chart.  The swelling resolved in a few hours.  Upon returning to the office in December 2014 for patient's next round of vaccines, she was seen by different Physician.  I explained to him what happened with the Pediarix, expecting him to see/read the notes in patient's chart, which Dr said she would write.  However, he noted that there was no mention of patient's reaction to the Pediarix.  On the December visit, patient received the vaccines separately, and without incident.
DOES NOT MOVE ARM/CANNOT LIFT RIGHT ARM ABOVE SHOULDER; DAILY ACTIVITIES ARE AFFECTED DUE TO THE PAIN; SORENESS OF ARM FOR ABOUT A WEEK; SWELLING AT INJECTION SITE; POSSIBLE NERVE DAMAGE; BRUISE AT INJECTION SITE; BURNING SENSATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nerve damage in left-leg due to knee replacement, diabetes, stent in right coronary artery, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced hive like rashes when treated with levofloxacin, and ketorolac tromethamine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate. On 08-APR-2021, the subject experienced possible nerve damage. On 08-APR-2021, the subject experienced bruise at injection site. On 08-APR-2021, the subject experienced burning sensation. On 08-APR-2021, the subject experienced soreness of arm for about a week. On 08-APR-2021, the subject experienced swelling at injection site. On an unspecified date, the subject experienced does not move arm/cannot lift right arm above shoulder, and daily activities are affected due to the pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on 08-APR-2021, and swelling at injection site on 15-APR-2021, was recovering from bruise at injection site, had not recovered from soreness of arm for about a week, and possible nerve damage, and the outcome of does not move arm/cannot lift right arm above shoulder and daily activities are affected due to the pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
I got the shot and was told to stay in the store for 15 minutes and to walk the aisles.  I was walking and suddenly felt dizzy and faint like I could pass out.  I went back to the pharmacy to tell someone and sat down in a chair.  Within a minute of sitting in the chair, I had a very weird feeling in my chest.  Then for about 10 seconds I had an extremely rapid heartbeat.  Coinciding with the rapid heartbeat was the feeling of a strong pulsing/heartbeat in my stomach for the 10 seconds.  It was something I have never felt before.  My skin got a little flush and I felt off/dizzy for a while.  They monitored me for 45 minutes and gave me water, then I left.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. In June 2018, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced Shingles a few days after vaccination. No additional information was provided.
Pt received dose of J&J COVID-19 Vaccine from outside facility on 3/22/21.  He then presented at our facility's clinic on 4/16/2021 to receive his first dose of the Pfizer vaccine.  It was not noticed that the patient had previously received the J&J vaccine (unclear if the nurse administering did not notice this or if the record had not yet been filed) and the patient did not disclose this information, so the 1st dose of the Pfizer vaccine was administered.  The patient then presented on 5/7/2021 for his second dose of the pfizer vaccine.  At that time, it was noted that the patient had receive J&J as well as his first dose of Pfizer vaccine.  Following consultation with the physician on call for the clinic, the decision was made to administer the second dose.
Headache, nausea, facial hives, fatigue  All symptoms lasted well over 1 week and are still lingering in some regards
woke up morning after vaccine c/o parasthesias in bilateral lower legs came in to office for full neurologic exam which was normal. full sensation, no weakness also had the normal arm pain and swelling of left upper extremity
Within 24 hrs - significant fatigue. Then body aches developed, then significant abdominal pain, feverish, no vomiting, fatigue, symptoms lasted about a week. Missed day of work.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # M010671 and expiration date 02-JUN-2018) for prophylaxis (strength, frequency, route of administration, were not provided). No adverse events were reported. The temperature was below 32 degree Fahrenheit (F)/0 degrees Celsius (C) (31.1F), time frame was 45 minutes, there were not previous temperature excursion, and the call was not because of a data logger. Follow-up information has been received from the nurse on 26-JUN-2018 referring to a 2 year old female patient. The patient did not have pre-existing physician - diagnosed allergies, birth defects and illness at time of vaccination. On 23-JAN-2018, the patient was vaccinated with PENTACEL, M-M-R II, VARIVAX and VAQTA. On 27-FEB-2018, the patient was vaccinated with the second dose of improperly stored RECOMBIVAX HB lot # M010671, expiration date 02-JUN-2018 for prophylaxis. On 27-FEB-2018, the patient was vaccinated with improperly stored PREVNAR (dose 3, lot# R75851) and FLUZONE (lot# UT589JA) intramuscularly for prophylaxis. The vaccines were purchased with public funds. The patient was vaccinated at private doctor's office/hospital. The vaccines were improperly storage in clinical practice. There were no labs or diagnostic test. It was not sure a temperature excursion occurred as a result of a reading from a data logger.
Typical reaction at first, sore arm, body aches, fever, fatigue. Fatigue and fever lasted much longer. Fever lasted 8 weeks over 100. Fever abated, but resting body temperature now hotter than before (around 99 F).
Headache, Sedation, Myalgia, Fever, Diarrhea, Swollen lymph nodes, Sweats Narrative:  Other Relevant History:
Chronic diarrhea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Chronic diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Chronic diarrhea). At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-573721 (Patient Link).
Injection site hot to touch; Injection site itching; Left arm a little swollen; Left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Left arm a little swollen) and VACCINATION SITE PAIN (Left arm was sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.) since an unknown date.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Left arm a little swollen) and VACCINATION SITE PAIN (Left arm was sore). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (Injection site itching). On 31-Dec-2020, VACCINATION SITE PAIN (Left arm was sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Left arm a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
one month and 4 weeks after the second shot i contracted covid and pneumonia; pneumonia; one month and 4 weeks after the second shot i contracted covid and pneumonia; This is a spontaneous report from a contactable consumer (patient) from epsilon escalation team. A patient of unspecified age and gender received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Mar2021 ad dose 1 single and second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On Aug2021 (one month and 4 weeks after the second shot), patient contracted covid and pneumonia and patient wondering how it is that this happened in such a short time after the vaccinations. Patient still on oxygen. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
nearly died, being in ICU for weeks; got shingles internally/shingles; got shingles internally/suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria hospitalization, GSK medically significant and life threatening), vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the near death experience, vaccination failure and shingles were unknown.   It was unknown if the reporter considered the near death experience, vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Jul-2022 Reporter's comment: The case was reported by the patient's friend via interactive digital media. The reporter reported that one of his/her friend got shingles internally and nearly died, being in intensive care unit (ICU) for weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR105388, reported by same reporter for different patient. As per reported information, the patient was in ICU for weeks therefore hospitalization was captured for all events except vaccination failure.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105388:same report, other patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "Anxiety Medication" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 15Jan2020. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 30Aug2023 to 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 mins past administration pt became diaphoretic. Pt has history of passing out after a vaccine. Pt was lowered to a laying position as he thought he was going to pass out. EMS was called. BP was 70/40. When EMS arrived pt BP was up to 100/78 and BGC ws 106. Pt became more alert and responsive. Pt was able to drive home and did not need EMS transport.
Strange feeling to head.  Tingling running down right arm and eventually down to feet.  Tightness in throat.  Red chest and red face.  Elevated blood pressure 170/100.  elevated heart rate.  Tingling in head in first 10 minutes.  Began running down arm and then on into leg within 30 minutes.  tightening in throat and dry cough within 15 minutes.  Given 25 mg Benadryl within 10 minutes of onset of symptoms.  Given sprite and peanut butter crackers which did nothing.  Benadryl began to help.  Given another 12.5 mg 15 minutes after initial dose.  Pulse Oximeter good oxygen level 97-98 after benadryl.  Ambulance was called and I refused.  I was told to go to ER.  My husband is a registered respiratory therapist and said he would watch me and not leave me alone.  He said he would take me if symptoms got worse.  Called my dr.  Was told to take Benadryl around the clock for 48 hours.
stomach cramps; pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps ) and MYALGIA (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Headache; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Muscle soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle soreness). At the time of the report, HEADACHE (Headache) and MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Information has been received from a physician concerning a 26 month old male (also reported as female) with a history of otitis media who on 27-MAR-2003 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 641983/0291M). On 20-OCT-2003 the patient was diagnosed with shingles. It was reported that the patient never had chickenpox before. Unspecified medical attention was sought. Subsequently, on an unspecified date, the patient recovered. It was reported that the patient had not had any adverse events following prior vaccination. No additional information was reported. There was no product quality complaint involved. Additional information is not expected.