chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; little headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 26-year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "little headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red, swollen, warm elongated area extending partially around leg from where inject was given; inc severity 3rd-5th day p/vax; Augmentin given for 10 days w/improvement;
ear pain in left ear; Pain worsened over 6 weeks; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 11Jan2021 (at age of 25 years old, no pregnant, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, also not received other medications within 2 weeks of vaccination. The patient not diagnosed with COVID-19 prior to vaccination also not tested for COVID-19 since the vaccination. The patient experienced ear pain in left ear and pain worsened over 6 weeks on 11Jan2021 after 1st vaccine.  Have been seen by ENT. The events result Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events was serious, seriousness criteria is Life threatening. The outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between events "ear and pain worsened over 6 weeks" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
left ear tinnitus; This spontaneous report was received from a Registered Nurse concerning a 43-year-old female patient. The patient's concurrent condition included asthma and hypothyroidism. Her concomitant medication included cholera vaccine (unspecified), and the patient's drug allergies include penicillin and sulfa.  On 12-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported; lot # R034390 and expiration date 27-NOV-2020) as prophylaxis (the patient was planning international traveling).      On 13-JUN-2019, the patient experienced left ear tinnitus (tinnitus). The patient went back to the office and she was examined by the unspecified doctor on the same date. The nurse reported that the patient saw an unspecified Otolaryngologist on an unspecified date and received a dose of prednisone. On an unknown date, the patient had an audiogram (result was not provided).   The outcome and causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX)  and tinnitus was not reported.
6/8/16 - presented with fussiness, irritable, inconsolable crying. Evaluated in office and ED. Work-up for intussusception negative. D/C home and did better. 6/13/16 - vomiting and inconsolable crying - evaluated in office. Started omeprazole - very large stool noted - doing better.
My symptoms after my second shot were temperature, chills, headache, body aches and fatigue.
On the day I tested positive for COVID-19 I  had a scratchy throat and clear nasal discharge. The next day I woke up with a 102 fever, dry cough, and really tired. I called the doctor and she prescribed me Paxlovid. My symptoms lasted for 2-3 days.
Vaccine (MCV4) given at 9:30 AM in clinic and pt return to clinic after lunch at 1:30 pm with rash, mild hives, itching in her upper torso, face, arms area. Tx: Loratadine 10 mg.
24-26 hours after the shot I started to have a fever and chills. Woke up the next morning and felt like I had been hit by a big truck. I got up to brush my teeth and got a drink of water and broke out in a sweat. I passed out and wasn't breathing for 42 seconds. I was taking to the emergency room cause my blood pressure kept dropping. I was giving an anti-seizure medicine and sent home and told to follow up with a neurologist.
The Pfizer (orange cap) vaccine was administered to this patient who is 4 years old. The nurse accidentally administer this vaccine to the patient even though he has not reach the age limit required for the orange cap vaccine (5-11 years old). The patient was given the vaccine and monitored during the observational phase. No adverse event was seen.  Contacted representative for more information regarding future vaccination schedule. representative stated that the patient should just continue the vaccination schedule normally as indicated by the CDC guidelines.
Chest Pain - All across the upper chest - pain scale 5/10; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 14Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 in Feb to Mar2020 (patient could have had COVID-19, No COVID tests were available). The patient's concomitant medications were not reported. The patient experienced chest pain - all across the upper chest - pain scale 5/10 - no other symptoms on 15Jan2021 11:15. The event resulted in emergency room/department or urgent care. The patient was given aspirin 325 mg as treatment. The patient also underwent lab test which includes EKG, XR Chest, two blood samples on an unspecified date. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
Vaccine was at room temperature for>6 hours at time of administration. Headache and very sore arm.
4- 3-2021 at 9:00 am I suffered; body aches, joint pain, headache, swollen at injection site, pain and swelling , dry cough, fatigue, chills, fever 101.7 4-4-2021 all of the above symptoms with a fever of 100. 4-5-2021 all of the above symptoms with a lower fever 99.2
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 19 years old male patient who received a 0.5 mL third dose of MENACTRA (lot number: U5917AA, expiry date: 30-Jun-2019) intramuscularly in left deltoid instead of BEXSERO (lot number and expiry date not reported) on 07-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient complained of vision problems, about an hour later. "Eyes felt like they were dilated". Reported today vision is fine now, but still present today just for a few minutes (not all day).
This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Decreased eating by half or more. Hard time keeping down fluids. Intense smelling cradle cap/ worsening cradle cap.
Immediately after first 2 doses my periods skipped every other month; Immediately after first 2 doses my periods skipped every other month; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2021 11:00 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and administered in arm left, administration date 26Jan2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Verbatim: Hashimotos. Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Amoxicillan, reaction(s): "known_allergies: Amoxicillan", notes: known_allergies: Amoxicillan. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 05Jan2021, outcome "not recovered" and all described as "Immediately after first 2 doses my periods skipped every other month". The event "immediately after first 2 doses my periods skipped every other month" and "immediately after first 2 doses my periods skipped every other month" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstrual disorder, menstruation irregular.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient have always been regular, since her period started. Her booster shot was on the 25Oct2021. The 26Oct2021 she had her period for 5 weeks. Patient received estrogen and progesterone treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/5 I felt stiffness in the evening. About 2:00 AM on 11/6 I awoke with severe pain over entire body and inability to lift either leg off of bed. Was transported to ER via ambulance and admitted. Was catheterized and given IV - also developed violent migraine. Temp of 100.9. Discharged on 11/7 with limitation in TKR.
Information has been received from a registered nurse concerning a 22 year old female patient with amoxicillin allergy who on unspecified date was vaccinated with the first series of RECOMBIVAX HB (lot number, dose and site of administration not reported) when the patient was a child. On 18-OCT-2011, the patient was vaccinated with a second of RECOMBIVAX HB (lot number, dose and site of administration not reported) on public health clinic. On an unspecified date, the patient had a titer drawn recently and it was low for Hepatitis B. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up was received from the registered nurse who stated that the patient had low titer from initial doses received as a child. The patient need it a booster for RECOMBIVAX HB. Additional information is not expected.
Information has been received from a female consumer stating that she refused to give her children the MMR II because three male children that she knows developed autism immediately after they were given the shot. One case concerned a 4 year old male pt who was vaccinated with a dose of MMR II vaccine live. It was unknown if there were any concomitant medications, or if the pt had any past medical history or allergies. Subsequently, the pt developed autism. The three boys were six (WAES0206USA01723), four and two (WAES0206USA01827) years of age. It was reported that they had always been very cognitive and always made eye contact. The reporter noted that "ever since they were given the shot, they developed autism." The pt's autism persisted. It was unknown if medical attention was sought. No other info was provided. Follow up info received from a registered nurse indicated that she did not recall any male children in her practice that had received the MMR II vaccination and then were diagnosed with autism. She could not provide any additional info. *Additional follow-up info received indicated that the MD's office was "unable to assist at this time due to no PT name." Upon internal review, autism was determined to be an other important medical event (OMIC). No further info. is available.
Nurse gave patient Moderna booster vaccine and he is under the age of 18. Patient did not have a reaction or complications from this vaccine or dose, but is not the correct age.
a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included FAMOTIDINE and PLECANATIDE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.    This case was linked to MOD-2021-073815 (Patient Link).   Reporter did not allow further contact
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PAIN (Pain on the vaccinated arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. Concomitant products included SPIRONOLACTONE for Acne, CYCLOBENZAPRINE for Muscle relaxant. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the vaccinated arm). On 07-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site). On 14-Apr-2021, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Pain on the vaccinated arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported. This case was linked to MOD-2021-110398.
On day 7 after the vaccine, I had 5cm round area of erythema on left upper arm where I had my injection. I developed red itchy bumps. I took Loratadine 10mg and Benadryl 25mg which did not really help. It lasted about 2 days and slowly got better.
02/02/22 presents to Surgery for "Laparoscopic Gastric Bypass". PMHx of "morbid obesity"
Loss of feeling in right arm within 10 mins  and arm turned white/black.  Had chills nausea  and fatigue  **diagnosed a few  days later with Atrial Fibrilation with rapid ventricular response
No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA), 1 time dose, lot #3397T1, expiration date on 30-NOV-2023 (dose, dose number, route of administration, and anatomical location were not provided), administered for prophylaxis. Lot number 3397T1 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).    It was reported that on an unspecified date, the vaccine was exposed to a temperature of -40 degrees Fahrenheit (F) for 70 hours and 5 minutes. There was no previous temperature excursion. No other adverse events were reported.
After receiving the vaccine my left arm was very sore. A knot appeared on my arm afterwards and it stayed on there for a month. It was very sore at first. It was aching and it never stopped. It progressively got worse. Then I just tried to ignore the pain. One of the knots I had for either the 1st or 2nd dose stayed for about 3 months after receiving the vaccine but its gone now. I put some Bengay and alcohol on my arm and it helps with the pain. My arm is still hurting and it is worse. It's just the arm that the shot was given in.
Appendicitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 12:00 (Lot number: EW0151) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CIPRO allergy" (unspecified if ongoing); "Flagyl allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number: EP6955, administration time:12:00 pm, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 19Jan2022, outcome "recovered", described as "Appendicitis". The patient was hospitalized for appendicitis (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (17Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of appendicitis. Clinical course: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Appendicitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9, injection, intramuscularly (dose, lot # and expiry date were not reported) for prevention of Human Papillomavirus (HPV). On the same date, while still in the physician's office, the patient experienced dizziness and vomiting immediately after receiving GARDASIL. The patient recovered from these symptoms before leaving the office. The reporter did not assess the relatedness between the events and GARDASIL. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA001248.
I began getting dizzy about 3 days after I got my first shot. At first, the dizziness occurred mostly at night when I laid down and tried to close my eyes to sleep. It then progressed to dizziness throughout the day -- notably whenever I try to walk for more than a few moments or have to turn my head suddenly. I am now on week 3 of dizziness.
went out positive on 01Feb; This is a spontaneous report from a contactable other health care professional (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and Expiry Date: Unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced went out positive on 01Feb. 27Jan2021, The patient stated that she had COVID-19 symptoms. The patient underwent lab test which included SARS-COV-2 test with positive result on 01Feb2021. The patient second dose is scheduled on 11Feb2021 and enquired if she can get the second dose or wait longer. The caller mentioned she finished the quarantine on 07Feb2021 and went back to work The outcome of the events was unknown.  Information on the lot/batch number has been requested.
GOT UP AROUND 3 AM, BEGAN TO FEEL AS THOUGH HER HEART WAS POUNDING.  STATES SHE FELT DIZZY AND WEAK, HAD TO CRAWL BACK TO HER BEDROOM SO SHE DIDN'T FALL.  STATES SHE NOTICED A BLISTERED RASH IN THE OCRNER OF HER MOUTH AND ON HER CHIN.   DAUGHTER CALLED ER.  ER TOLD DAUGHTER TO "WATCH HER".  THE FOLLOWING MORNING PATIENT FELT WELL ENOUGH TO WORK.  STATES SHE LEFT V/M AT DR'S OFFICE.  DR.'S OFFICE RETURNED CALL, LEAVING V/M TELLING HER THEY WOULD "NOTE IT IN YOUR CHART".
Patient was receiving 4 month vaccines in office today. 0.7 ml of the Rotateq was administered before the mom noted that this was the first time patient had received this vaccine. Infant is over 15 weeks of age at this time. No previous dose of Rotateq has been administered. 0.7 ml of the Rotateq was administered and the rest was discarded. No reactions or side effects noted at this time.
Pt vaccinated with MMR/HIB developed puffy eyes seen in office dx allergy given Benadryl; Seen 8AUG some vomiting, 9AUG admitted  more puffiness & edematous See WORM for more details.