chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 54-year-old female patient (not pregnant) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 54, in left arm, on Aug 31, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing), and asthma (unspecified if ongoing). The patient took concomitant medications. The patient experienced alopecia (rapid and complete hair loss), and diagnosed with alopecia universalis (all evaluated at a physician office visit), with outcome of not recovered. Therapeutic measures were taken as a result. Additional information: Patient did not take any other vaccine in four weeks. Treatment included corticosteroids injections to scalp and eyebrows. Patient did not have COVID-19 prior to vaccination. Patient has not tested for COVID-19 post vaccination. Follow-up attempts completed. No further information expected.
Arthralgia, Fever, NauseaVomiting, inj site soreness, chills, upset stomach Narrative:
8/2/03 Lymph nodes began to swell, pt experiences difficulty swallowing, was driven to hospital ER. Received Benadryl IM.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 4:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:38 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 63.40 for dose administered on 03-Mar-2021 and 63.47 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 23-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, frequency, route, anatomical location and lot number were not reported), which was expired. The expiration date was 06-MAR-2015. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
lower back pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain in muscle) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BACK PAIN (lower back pain in muscle). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain in muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Itching of limbs and back.  Benadryl IM administered in the Emergency Dept of Coney Island Hospital
Asymptomatic thrombocyctopenia, platelet count of 41 (with plt clumping on micro) on routine screening 2 weeks after vaccination. Pateint had a normal platelet counter for years up until this draw. Again, no abnormal bruising or bleeding.
Patients symptoms consistent with GBS.  12/4/09 Medical records and discharge summary recieved for DOS 11/03-11/17. Final DX: Guillain-Barre  Presents w/c/o R side tingling progressing to arm and L leg. Progressive weakness. SOB.  Diff ambulating. Pleural effusion.  Serum protein increased.  ICU. IVIG x5 days. 11/15- Hematuria/flank pain. Poss bladder ureterocele.   12/24/09 and 12/30/09 Consultant Records received. Service date 11/4/09. Assessment: Early acute inflammatory demyelinating polyneuropathy. Patient presents with 4 days of progressive loss of sensation and weakness in arms and legs.
Significant cognitive decline, brain loss, memory loss, massive energy decline making getting out of bed a difficult proposition. Major depression. Looked into lawsuit, disability, etc.
Flu Mist administered as part of annual physical exam caused a severe allergic reaction in right nostril and eye.  Paient started losing vision in right eye (upper visual field) and was diagnosed with Optic Neuritis and brain lesions.  Patient was treated with IV and Oral Steroids at Hospital.  Vision and visual field restored in several days, but brain lesions persist.  Patient diagnosed with "post-vaccinial ADEM" (Acute Disseminated Encephalomyelitis) and currently working with a nuerologist hospital.  Recent EEG showed "damage" caused by the Optic Neuritis. 3/19/09 Received Neuro clinic medical records 10/9/08-2/20/2009. FINAL DX: ADEM & optic neuritis s/p vaccination per neurologist.   Records reveal patient experienced optic neuritis, diagnosed at outside facility & seen starting 10/10 for IV steroids x 3 days.
I started with a terrible headache on the afternoon of 4/21.  On 4/22 I became nauseous, had a mild fever, terrible headache, slept most of the day/evening and that morning my legs developed multiple blister type spots  that itched.  There was around 25 spots on each leg.  I used calmine lotion for the itching. The blisters started to dry up and go away after 3 days.  The first day was the only day that the blisters appeared and only on my legs. All the other symptoms went away after 4/23 and I felt fine.
Severe pain and swelling at site. Large, hot, red lump 3 inches in diameter, tired, aches, irritable, loss of appetite. Currently, 10/18/10... still experiencing severe swelling at site, lump and redness.
redness, swelling, tenderness lt thigh;tx cool compresses, APAP & DPH;
Hospitalized for COVID19 on 7/1/2021  presents with fever, nausea, vomiting, diarrhea. She reports having chills all week but worsening fever and symptoms since last night. Fever peaked at home ~103.0F.
My left knee swelled up a lot larger than my right knee and it hurt quite a bit, especially when I bend it. It felt like it might have fluid in it. Symptoms around 3 days after I received my 1st Anthrax shot.
Pt.'s Aunt states that after receiving the 1st dose of Phizer 11/09/2021, started experiencing symptoms 11/10/2021 of swelling in the (Right) testicle, dizziness, and headache. No noted Primary visit/communications.
Pt had Reaction of Rash to body after influenza vaccine. Provider Reports "Developed itchy maculopapulaR Rash on left aRm within 3 hours spread to entire body. 0 anaphylaxis oR uRticaRia."
Started as a small nodule at vaccination arm site a little itchy. Next day nodule has gotten bigger maybe the size of a nickel. It is red and very itchy.
Information has been received from a medical assistant concerning a 65 year old female who on 04-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included doxycycline. On 06-AUG-2009 the patient experienced cellulitis and a red, swollen, painful rash at the injection site after vaccination. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient was recovering. Additional information has been requested.
No adverse effect reported; Administered improperly stored VARIVAX; Information has been received from a certified medical assistant concerning to a 4 year old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 18-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration not reported), Lot No. S024369, exp. date 06-AUG-2021 or S032356, exp. date 14-OCT-2021 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot number S016837, exp. date 01-FEB-2022, S032591, exp. date 16-AUG-2022 or T000495, exp date. 03-JUN-2022 (the report did not know exact used lot numbers, so she reported all possible numbers). No adverse event was reported.   Temperature/timeframe: -9°C to 8°C: -7.18°C for 30 hours Previous temperature excursion: Yes, -14°C to -10°C: -10.44°C, multiple for 2 hours; -50°C: -14.79°C, multiple to -15°C for 1 hour. Call was made because of data logger.
About 10 p.m. on 2-22, sore arm. About 2 a.m. on 2-23, very dizzy During the day on 2-23, headaches, muscle aches, fatigue About 7:30 p.m. on 2-23, chills and fever
Vaccine exposure during pregnancy (Drug exposure during pregnancy); A non-serious report of vaccine exposure during pregnancy has been received from a nurse concerning a 38-year-old female. No medical history nor concomitant medications were provided. The patient received FluMist on 06-Nov-2007. The patient was pregnant at the time that FluMist was administered. No outcome for the event was provided by the reporter. Dechallenge and rechallenge did not occur. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Day of vaccine- has increased HR within 3 mins but resolved within an hour; severe headache, lip tingling, "loopy feeling" Day after vaccine: facial swelling, daily headache, fatigue 3/7: Itchy between her breasts and bilat arm, arm pit itching, lip burning, described "spiderweb like rash with visible capillaries"; throat itchy/swelling intermittently  Taken benadryl without improvement H/O asthma, allergies:
Rash, irritable behavior, screaming in pain, bowl movements changed, not able to sleep and seemed over stimulated.
Gave ZOSTAVAX. Pt's arm became red and swollen. Marked 2 spots with Sharpie marker. Redness went outside marks w/in minutes. Gave 25 mg liquid BENADRYL. Pt seemed to be better w/in 20 min. Pt complained of itching.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 75-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, fever and tendonitis. On an unknown date, the outcome of the pain and fever were recovered/resolved and the outcome of the tendonitis was not recovered/not resolved. It was unknown if the reporter considered the pain, fever and tendonitis to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was reporting the adverse event on behalf of the patient. The patient received SHINGRIX vaccine in the left deltoid. The pharmacist stated that the patient experienced aches and fever after receiving the SHINGRIX vaccine. The pharmacist stated that the patient also developed pelvic tendonitis around the same time that she received the SHINGRIX vaccine and the patient was not sure if it was related to or caused by the SHINGRIX vaccine.
Pt had a freezing sensation on arm that was injected and both feet felt like the were frozen in blocks of ice.
About 5 minutes after administration, patient passed out, hitting his head on the privacy screen. He was very groggy, lost color in his face, his skin got clammy and his pulse was low. He cut above his eye so we put pressure and ice on the wound. We elevated his feet and his color came back and he was able to talk and tell us where he was. We called 911 and they took BP, EKG, and pulse; all were within normal. Pt was dizzy when he stood up, and told EMT he "didn't feel right", so they took him to Urgent Care per mom's approval.
I am experiencing fever, chills, headache, body aches and extreme pain of 8/10 on my right arm. My neck feel heavy. My headache is pounding sharp type . My temperature was 102.3 orally and 103.1 rectally this morning
Patient presented to the office with <20 erythematous vesicular lesions on torso. No fever or any other sx at this time.
Patinet reported a small rash and redness on the upper arm that was injected. Sensitive to the toouch, no fever. Stated he felt fine.
Tinnitus increased sound louder and pressure in my ears Chest pain for short time not long after getting the shot
rapid heart beat,rapid heart rate; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia). At the time of the report, HEART RATE INCREASED (rapid heart beat,rapid heart rate) and TACHYCARDIA (tachycardia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (High) rapid.         Reporter family member is experiencing heart beat, like tachycardia after a month of getting the shot. Reporter does not want to provide further information nor consent for Safety to follow up. No concomitant medications were provided by reporter. No treatment medications were reported.   Reporter did not allow further contact
Patient received first dose of Moderna vaccine on 8/27/2021.  She came in today to get a 2nd dose and mistakenly received Pfizer
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
Site: Pain at Injection Site-Mild, Systemic: Nausea-Mild, Additional Details: Patient felt nauseous and light-headed. She recovered after 5 minutes while laying flat on the ground with feet elevated.
Nausea and Significant Vomiting; Nausea and Significant Vomiting; Felt ill; This is a Spontaneous case report received from a contactable consumer. A 12-year-old female patient received first dose of BNT162B2 (Pfizer, Solution for injection) via an unspecified route of administration on an unspecified date (Lot number/NDC number/Expiry date: Unknown) (at age of vaccination) as single dose for Covid-19 immunization. Time the vaccination was given: afternoon. Anatomical location of vaccine: Unknown. The patient's medical history was not reported. Concomitant medications: Caller stated she knew the patient did take several medications because she had babysat her, but she did not know what they are. History of all previous immunization: none. On an unspecified date, the patient experienced nausea and significant vomiting and felt ill (afternoon). Caller was reporting what she heard about an adverse event in her daughter's friend with her first dose of the Pfizer Covid Vaccine in the newly approved age group, 12. Caller stated the patient had no other illness or notable cause for the nausea and vomiting. Caller stated the patient received the vaccine in the afternoon and then next morning she felt ill and then in the afternoon she had the nausea and vomiting. Caller stated dates were unknown, but she did know it was only on one occasion, she vomited a few times on that day and not any additional days. Caller stated she encouraged the girl's parents to call the number and she was hoping they would report it. Adverse event details: Provide the time of onset of AE(s): Morning. Treatment was unknown. Outcome of the events was recovered on an unspecified date. Communication: Caller provided with Report Reference Number.  Information about the lot/batch number has been requested.
Nurse reported a 2-year-old patients developed appendicitis 1 week after receiving vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "Nurse reported a 2-year-old patients developed appendicitis 1 week after receiving vaccine". It was unknown if therapeutic measures were taken as a result of appendicitis.  Additional information: It was unknown whether the patient received other vaccine in four weeks, unknown if received treatment for adverse event, unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event appendicitis  with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201110824 same reporter/product/AE, different patient;
Low grade temp approx 48 hours after administration of MMR, then "measly" rash all over his body. These are small papules on face, trunk, extremities and diaper areas, buttocks. Feeling OK, behaving normally today.
Tongue and lip numbness since Thursday morning at 1am I took a Claritin at that time and same Friday morning at 1am; however tongue itching and hives on tongue persist
I got the Pfizer COVID vaccine (1st shot on 4/26/21 and 2nd shot on 5/17/21). I have always had regular periods and when I got my period on 5/16, this was the first time I had it since I took the first dose of the vaccine. I noticed a change in the bleeding pattern. I typically use 4-5 maxi pads/ day on the 1st and 2nd day of my period but this time, I only had spotting on the first day that a liner was adequate for and on the second day (5/17) I used the smallest pad. The bleeding increased on days 3 & 4 for which I used a small pad but overall the amount of bleeding was significantly less than normal.  I also noticed a small nodule under the skin on my lower back. It doesn't hurt and you can't see it from the outside but I can feel it if I run my fingers over my back.   My next period was on 6/13 and bleeding was light on day 1 but more than what I had in May. Bleeding increased on days 2 & 3 and ultimately tapered off but over all, I just used small pads as opposed to a maxi pad the entire time.  The nodule is still present and has not changed in size. I plan to continue to monitor my cycle.
Patient fully vaccinated with Pfizer COVID-19 vaccine on 01/29/2021 lot# EN5318; and second dose Pfizer COVID -19 vaccine on 02/19/2021 lot# EN6200. Contracted COVID-19 on 8/2/2021 with mild symptoms.
24 yo F with PMH of SLE, ESRD on HD and HTN presented to ED on 10/17/06 with RUE cellulitis at injection site after getting a flu shot 3 days PTA at clinic. Over two days she experienced increased R arm pain, redness and swelling. She also had a fever of 101, Mild HA and chest pain, In ED, she denied dysuria, cough, SOB, orthopnea, PND and joint swelling. U/S of arm showed no abscess. She was admitted and was given amocixillin/Clavulanic acid 500/125 mg po once. Additional doses would be given post HD. 02/07/07-records received and reviewed for DOS 10/16-10/17/06 DC DX: Cellulitis Medical records document that administered vaccine was pneumovax on Friday 10/13/06 prior to admission and not flu vaccine.  Seen in ER with temperature 101.3 at home in ER temp 98.3. Upper respiratory symptoms including rhinorrhea, nasal congestion, nonproductive cough. Left sided chest pain and right deltoid redness at site of pneumovax injection. PE: right deltoid with 10cm area of erythema and induration.  Follow-up: The pt rec'd flu shot on 10/14/06 @ HD clinic.