chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the covid virus in me and didn't know it didn't have any symptoms or anything; I had the covid virus in me and didn't know it didn't have any symptoms or anything; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (BioNTech COVID-19 Vaccine), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called with question regarding the BioNTech COVID-19 Vaccine. The patient had the Pfizer vaccine, covid-19 vaccine on 11Jan, Unfortunately, on an unspecified date, the patient had the covid virus in him/her and didn't know it, didn't have any symptoms or anything, ended up hospitalized. The patient was in the hospital for 8 days, put on remdesivir, got out 8 days later. The patient was getting conflicting stories as to what he/she needs to do for the second shot which was past due now. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patient's medical history and concurrent conditions were not reported. Starting on 11-JAN-2016 and after, the patients were vaccinated with an unspecified number of improperly stored PEDVAXHIB lot # K011077 and expiry date on 30-MAR-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported was 48.6 F degrees for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Administered an expired dose; Outside approved age range/ 59 year old patient received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Men B NVS (Bexsero) (batch number abxa81ez, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included splenectomy (had splenectomy).   On 7th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Administrative supervisor at MD office reported that the 59 years old patient received an expired dose of Bexsero, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow-up.
I am still feeling the effects from the shot.  I had my second on 3/30/2021. My arm has a very large red, painful area where the shot was given.  It is still very red and painful today and I feel light headed and not back to my normal. I thought the side effects only lasted a few days.  I still have a headache off and on.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ibuprofen. In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fatigue, upset stomach and activities of daily living impaired. On an unknown date, the outcome of the fatigue, upset stomach and activities of daily living impaired were unknown. It was unknown if the reporter considered the fatigue, upset stomach and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included cholesterol medication. The age at vaccination was not reported. The patient received dose of SHINGRIX about 2 to 3 weeks ago in the left arm. The patient reported that recently she had experienced fatigue and that it was getting worse. The patient was so fatigued she was almost unable to do her housework and was experiencing upset stomach. The patient had provided contact details of the physician.
Pt had redness, swelling of arm on which vaccine given as well as periorbital swelling. Fever to 102F. Self-resolved.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 09-JUL-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1013324 with expiration date 24-APR-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Breast discharge; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCHARGE (Breast discharge) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced BREAST DISCHARGE (Breast discharge). At the time of the report, BREAST DISCHARGE (Breast discharge) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 12:15 as dose 1, single (Lot number: HG4629) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose 6, Time: 10:30 AM,, lot number: GJ6743,, vaccine location: Right arm), administration date: 20Apr2023, when the patient was 78-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 5, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3 MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID Treatment).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Very irregular and long periods. The cycle went form 26 days, to 14-16 days.
Uncontrollable crying for 2 hours starting at 6:00 pm. Mother reports child cried for 3 hours uncontrollably after 1st dose of DTaP. Reports father was changing diaper, touched child's leg, and crying started. Crying stopped 30 minutes after parents gave child ibuprofen. Mother reports she gave child ibuprofen 1 hour before vaccinations were given this time, and child cried anyways for 2 hours uncontrollably starting at 6:00pm. Encouraged mother to contact child's provider to report both reactions. Mother reports infant is well after crying stopped with no other problems. Mother reports no redness, swelling, heat, or pain at injection sites, and reports child has no fever. Reports there was no redness, swelling, heat, or fever with 1st injections either.
Patient fainted and fell to floor no LOC after receiving Tdap, GARDASIL, and MENACTRA. No seizure like activity.
famous Moderna arm; I am on 5 days now it's just red and itchy; I am on 5 days now it's just red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure abnormal.Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure abnormal.On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy) outcome was unknown.    The patient was wondering if he can put a lotion on the reactions. The patient received the Moderna booster dose on left non dominant arm. The patient also put some cold cloth on the reactions.
5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. The back of my head felt heavy. I notified the nurse who measured my blood pressure which was at hypertension levels of 175/98 for 50 minutes and they called 911. They recommended that I go to the ER because my blood pressure kept rising at 45 minutes. After 1.5 hours, I measured my blood pressure at home and it was at 124/75. It took 5 hours for my blood pressure to be at 112/57. I have always been in the normal blood pressure range, so I believe the symptoms were due to the vaccine.
pt recvd vax; devel pain, swelling & redness at inject site; dx cellulitis; no cultures taken;
Right upper arm red and swollen.  Warm to touch without tenderness.  Good movement.  Placed on short course of steroids.
I had lost hearing; I couldn't hear the television and then I couldn't hear people speaking, it was real low; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Deltoid Left on 12Mar2021 (at the age of 78-years-old) as a dose 1, single for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), dose 2 via an unspecified route of administration, administered in Deltoid Left on 02Apr2021 (at the age of 78-years-old) as a dose 2, single for covid-19 immunization. The patient medical history included drug hypersensitivity- Penicillin and Sulphur and allergic to those. Concomitant medication(s) included TELMISARTAN 40 mg; ticagrelor (BRILINTA) 60 mg; FUROSEMIDE 80 mg; AMIODARONE 200 mg; LATANOPROST Dosage text: 0.005. On an unspecified date in 2021, about 2 months after the patient had the shot noticed "I could not hear the television as well and went to the ENT doctor and he said I had lost hearing but at that point he did not know what matter caused it then I could not hear people speaking, it was real low so I went to the ENT. Just a couple months after I had my last shot after that point I was hearing really well and I got hearing aid because I just had the loss in one ear. I had it in my left ear". Therapeutic measures were taken as a result of event- deafness. Outcome of the event was unknown.
PATIENT AMBULATED UP ONE FLIGHT OF STAIRS TO RETURN TO WORK FOLLOWING THE FLU VACCINE.  SHE REPORTS THAT AT THE TOP OF THE STAIRS SHE BECAME NAUSEATED, VOMITED 5 TIMES, AND BECAME SHORT OF BREATH.  SHE WAS SEEN IN THE EMERGENCY DEPT. AND GIVEN EPINEPHERINE, SOLUMEDROL, AND IV ZANTAC.  FOLLOWING THE VACCINATION SHE CONTINUES TO HAVE SEVERE MUSCLE ACHES AND FATIGUE.
Haven't had their period; This case was received via Agency Regulatory Authority(Reference number: US-irms-MOD21-112982) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Haven't had their period) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (Haven't had their period). At the time of the report, MENSTRUATION DELAYED (Haven't had their period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.  Patient got vaccine just over a month ago and still haven't had period. Patient was very regular typically and was concerned.  New information in Follow-up : Since she had the Moderna Covid vaccination my periods had been extremely irregular. This was never been a problem in the past with her.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up was received on 10-AUG-2021 and it is  Nonsignificant follow-up: Email ID added.
Diagnosed with New Daily Persistent Headache on Aug 26, 2021. Developed tension type headache early May following second Pfizer Covid-19 vaccination. Headache persists and is constant every single day since May and remains ongoing. Pain level 3-5. No prior history of headache before covid vaccine.   Over the counter medications are ineffective at relieving symptoms (tried: Advil, Tylenol, exedrine, aleve, etc.).   Migraine medication also ineffective (Rizatriptan), went through round of steroids in June as well as antibiotic in case head pain was due to sinus infection.  Visited ER on June 24, 2021 and received migraine cocktail via IV which was ineffective at reliving symptoms. On June 24  had head CT scan with no apparent issues.   Was prescribed muscle relaxer cyclobenzaprine which was not effective at relieving symptoms. Have also received 3 chiropractic appointments and 4 massages to attempt to relieve symptoms. No inner ear issue either, following visit to ENT to confirm.   Just finished a round of prednisone (5 day dose) and was prescribed amitriptyline to attempt to relieve symptoms. scheduled to obtain nerve block if headache does not go away.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: DOVATO; OLMESARTAN MEDOXOMIL. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: Known allergies: Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022 at 12:00, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: other medication details: other medication in 2weeks product: Dovato, Viiv, Olmestartan medixomil and Accord.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted while seated 3-4 minutes after immunization while in the observation area.  Pt fell out of seat and landed on the ground, may have hit head on wall during fall, claims to be ok and recovered after several seconds and was monitored for 30 minutes.
Pt's mom notified health center that pt developed fever 102.1.  Painful swelling and redness left upper arm.  Was seen in ER, pt diagnosed with allergic reaction to vaccine.  Treated with Keflex, vistaril and prednison.  Much better on 1/22/07 am.
I have been bleeding every day since right after I received the vaccine.  There has not been a day since march that I do not have to wear a tampon or pad to protect my clothing.  It is ridiculous and I just want it to stop.  How long is this going to last?
I had chills, fever and body aches for two days after receiving the vaccine. I tested positive for COVID-19 in 02/2023. I contacted my doctor and got a prescription for PAXLOVID. I had no complications taking the medication. As of today, I have no lingering COVID-19 symptoms.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 18 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA001141: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Woke up, very weak, fell in home. Wife called 911. EMT checked out pt. Did not go to the ER. Sunday 03/14/2021 was still very weak and no appetite. Monday 03/15/2021 pt was better.
This spontaneous report was received on 17-DEC-2014 from a physician (also reported as a pharmacist) via a company representative. The physician reported that he experienced shingles after being vaccinated with ZOSTAVAX. The physician reported that he got a mild case of shingles after he received the vaccine. The outcome of shingles was not reported. The physician denied seeking medical attention and denied receiving treatment for shingles. No further adverse event information was provided. Additional information has been requested.
Heart racing, blotchy face lumpy throat, itchy head. Gave benadryl po. Patient improved.
3rd booster of the Pfizer-BioNTech COVID-19 Vaccine; fluctuating Creatinine Kinase (CK) levels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 Immunization; Covid-19 vaccine (Dose 4), for Covid-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "3rd booster of the Pfizer-BioNTech COVID-19 Vaccine"; BLOOD CREATINE PHOSPHOKINASE ABNORMAL (non-serious), outcome "unknown", described as "fluctuating Creatinine Kinase (CK) levels". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller stated that the Patient just got his 3rd booster of the Pfizer-BioNTech COVID-19 Vaccine, and reported "fluctuating Creatinine Kinase (CK) levels". Caller wanted to know if this is a reported side effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
bilaterial enthesitis in toes, foot, heels, knees, hips, lower back, elbows
SPOTS THROUGHOUT THE BODY; BUMPS ALL OVER THE FACE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced spots throughout the body. On 12-APR-2021, the subject experienced bumps all over the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bumps all over the face and spots throughout the body was not reported. This report was non-serious.
Patient received a dose of Pfizer COVID-19Vaccine (PEDS) pediatric formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Patient started having difficulty breathing, rapid heart rate, dizziness, headache, and fatigue about 20 minutes after injection.  Patient was monitored, antihistamine was given and patient recovered.