chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; lost control of her blaster as soon as she stood; dull headache; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er2613), via an unspecified route of administration, administered in arm left on 17Mar2021 12:00 as a single dose for covid-19 immunisation. The patient had no other medical history. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient was not pregnant at the time of vaccination. The patient did not have any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6202), administered in left arm on 24Feb2021 12:00 PM (at the age of 75-years-old) for covid-19 immunization. The patient did received other medications in two weeks. On 18Mar2021 02:00 AM, the patient experienced seizure, recovered from the desire about 30 minutes after stood up, lost control of her blaster as soon as she stood, and dull headache daily. The patient did not received any treatment for the events. The outcome of the events was unknown.
This spontaneous report was received from a pharmacist and refers to a 70 year old female patient. The patient's concurrent conditions and medical history were not reported. On 13-MAY-2016, the patient was vaccinated with a unspecified dose of ZOSTAVAX which had a lot # of L033790, expiration date of 30-DEC-2016, injected in the left arm (concentration, dose and route were not reported). Information regarding concomitant therapies were not reported. On 14-MAY-2016, the patient did not notice any problems. Then on 15-MAY-2016, the patient woke up and noticed that her arm was "super swollen", very painful, and that there was a knot in her arm. Nevertheless, it was unknown if there was any relevant laboratory test performed. At the time of reporting, the outcome of pain in extremity, peripheral swelling, and nodule was unknown. Additionally, the reporter did not provide a causality assessment between the events and ZOSTAVAX. Additional information has been requested.
Initial report was received 03 January 2011 from a consumer, who was a friend of the patient. An 80-year-old male patient had received a left deltoid injection of FLUZONE SV, lot number U3351AA on 27 September 2009 and three days later, he developed itching which began on his hands, then spread to his arms, and now he has itching on his back. The patient was seen by a dermatologist and an allergist and he received multiple courses of steroids and topical medications as corrective treatment. A skin biopsy was negative. He had no illness at the time of vaccination and he had been taking PLAVIX concomitantly. Past medical history consisted of a formaldehyde allergy and a heart valve diagnosis. It was further noted that the patient had received prior doses of FLUZONE in the past. At the time of the report, the patient had not recovered. Documents held by sender: None.
redness; pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection) and VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). On 23-Jan-2021, VACCINATION SITE PAIN (pain at injection) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment was provided.
Rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alzheimer" (unspecified if ongoing), notes: his illness of Alzheimer. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash".  Additional information: It was reported that, caller mentioned her husband got as clarified the Pfizer Covid shot and he got a rash. Caller initially said she is not even going to report what happened to her husband. She then went on to explain her husband got a rash and they feel its from the shot. However, the doctors do not think so. They think its from his illness of Alzheimer. Caller does not believe this as she has never heard this happening with Alzheimers.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the wrong second dose vaccine. Patient told staff that he received the Moderna  as the vaccine first dose so the vaccinator administered the moderna as the second dose. After applying the information to the patient's vaccine card, it was noted that the patient had received  the Pizer as a first dose, not the moderna.  Patient was alerted of the mistake and has no questions/concerns at this time. Contact information was given for site coordinator in the event that questions or concerns arise.
Patient was administered Bivalent vaccine which was 2 days beyond the 30 day; No adverse event; Patient was inadvertently administered the bivalent vaccine which was 2 days beyond the 30 day to a patient on 20Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered the bivalent vaccine which was 2 days beyond the 30 day  to a patient on 20Feb2023), PRODUCT STORAGE ERROR (Patient was administered Bivalent vaccine which was 2 days beyond the 30 day) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose , Lot number: 033C22A) on 01-Jun-2021, Moderna COVID-19 Vaccine (2nd dose , Lot number: 047C21A) on 29-Jun-2021, Moderna COVID-19 Vaccine (1st booster dose , Lot number: 033H21A) on 10-Jan-2022, Moderna COVID-19 Vaccine (2nd booster dose  and Lot number: 016B22A) on 09-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 20-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered the bivalent vaccine which was 2 days beyond the 30 day to a patient on 20Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered Bivalent vaccine which was 2 days beyond the 30 day) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered the bivalent vaccine which was 2 days beyond the 30 day to a patient on 20Feb2023), PRODUCT STORAGE ERROR (Patient was administered Bivalent vaccine which was 2 days beyond the 30 day) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered the bivalent vaccine which was 2 days beyond the 30 day to a patient on 20Feb2023) and PRODUCT STORAGE ERROR (Patient was administered Bivalent vaccine which was 2 days beyond the 30 day).    Patient medical history information included high cholesterol.  No concomitant medications were reported.  No treatment information was provided.
Redness and edema on left deltoid around vaccination site, edema and redness is circular about 6 inches big, no tenderness to touch. Ibuprofen and Diphenhydramine HCI were prescribed.
vomiting; diarrhea; difficulty breathing; gastro intestinal issues like inflammation; gastro intestinal issues like inflammation; testing positive to strep throat without symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; GASTROINTESTINAL DISORDER (non-serious), GASTROINTESTINAL INFLAMMATION (non-serious), outcome "unknown" and all described as "gastro intestinal issues like inflammation"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "testing positive to strep throat without symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that someone she knows had list of symptoms after getting the Pfizer COVID-19 Vaccine and then said that a nurse in their school told them that those are invalid symptoms and no correlation could be made with the vaccine. The symptoms were vomiting diarrhea, difficulty breathing, gastrointestinal issues like inflammation, testing positive to strep throat without symptoms. Caller wanted to know if this symptoms could be related to the vaccine or not. Asks if it was possible there are other side effects you can get from the vaccines that are not in the listed as side effects?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Felt poor all over, temp 98.9, now 102, eye hurts when he closes it; dry cough, no coryza;
This spontaneous report was received from male patient (who is a physician) of an unknown age referring on himself. The concurrent condition and medical history were not provided. On an unspecified date in 2011 (reported as: approximately four years ago), the patient was vaccinated with an improperly stored dose of ZOSTAVAX (route, dose and lot number were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality issue as involved. Additional information has been requested.
Patient called on 08/30/2005 stated that approximately 2 weeks ago that she started with a pain at the injection site and now has decreased range of movement in her right arm.
In my legs I had fluttering spots all over my legs for about two weeks.  Then it finally landed in my left calf with an ach deep in the inner side of the calf.    Ultra sound -no cluts  Physical therapy.  Finally in the end of Feb, 2022 the pain started to go away.
Large knot near shoulder where injection was made. Pain occurred within hours after vaccination. Large knot showed up next day. Applied biofreeze topically to area to reduce pain and any possible swelling. Knot lasted nearly a week after vaccination. Pain about 2.5 days.
Muscle spasms, dizzy, vomiting, nausea lasted 3 to 4 days, started 15 to 20 min after flu shot Pt couldn't get out of bed, muscle spasms and vomiting.
I had a slight fever and I felt achy for a day after receiving the vaccine. I started feeling symptoms that I was getting sick with feeling very tired, achy and a cough 07/23/2022. I tested positive with a home test for COVID-19 on 07/25/2022. I contacted my doctor and was given the option for Paxlovid, but I did not take it. I took ibuprofen for the fever and achiness and a cough syrup to help with the symptoms.
Patient is a 10 Y female  Responded to a TEAM ALERT - ADULT CALL.  When arrived at 0950 pt is a 10 y/o female.  Pt just received 1ST COVID VACCINE at 0941am. NAME: PFIZER DATE: 11/12/21 DOSE: 0.2ML  ROUTE: IM SITE: LEFT DELTOID MANUFACTURER: PFIZER, INC GIVEN BY: LVN   Pt was on the gurney drinking apple juice.   A&Ox4.   Pt is pale in color.   Pt said she felt a little dizzy.   No pain.   Pt's dad she said she got vaccinated around 930am and around 945am post vaccine she was sitting but fell slumped to the side.   VS taken: O2: 98% RA RR 20  Small cuff used: BP 1:127/82 HR:102 BP 2: 123/81 HR 97  Pt was given water to drink.  BP cuff changed to larger cuff: BP 3:122/77 HR 100 BP 4: 100/68 HR 83  Dr. came to respond as well.   Doctor listened to her breath sounds and heart rate.   Pt's color has returned and pt said she was feeling much better.   A follow up appt was made to see doctor and next COVID VACCINE appt was made as well.
Day one, near syncope 10 minutes after injection. Day 3 chills and fever. 1 month later abdominal distention and swelling after eating. Month 3 severe intermittent abdominal pain. Month 4 diagnosed with Autoimmune hepatitis.
Starting on 03/14/21 rash developed on both arms and back. Area red, itch and burns.
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 07-MAY-2015, the patients were vaccinated with doses of PROQUAD (Merck), lot number reported as K025764, expiration date 08-JUN-2016, (dose, route of administration and injection site were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, vomiting, diarrhea, fever 101.4, whole body ache, heat at injection site.
Soreness, redness, itching onset 2 days after injection.  Patient seen by doctor and Allegra was given.
Child c/o discomfort left deltoid and mother noted redness and swelling left deltoid up to shoulder area. Mom stated this was noted on 4/13/06. She applied ice and gave Ibuprofen. Mother states completely resolved in 5 days.
Beginning on October 6, 2014 at 5:00 PM, patient began crying uncontrollably until she fell asleep around 6:45 PM. Patient slept until 6:15 AM and began crying uncontrollably again at 9:00 AM and continues to do so unless she's sleeping or breastfeeding. Patient is inconsolable when she is awake.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860:
itches really bad; warmness at the injection site; 1 inch and half wide by 3 inches long at injection site welt and redness at injection site; Redness at injection site; arm swelled up; Broad lump that was hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches really bad), INJECTION SITE MASS (Broad lump that was hard at the injection site), INJECTION SITE WARMTH (warmness at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE SWELLING (arm swelled up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE MASS (Broad lump that was hard at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE SWELLING (arm swelled up). On 26-Feb-2021, the patient experienced PRURITUS (itches really bad), INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (1 inch and half wide by 3 inches long at injection site welt and redness at injection site). On 21-Feb-2021, INJECTION SITE MASS (Broad lump that was hard at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved, INJECTION SITE SWELLING (arm swelled up) outcome was unknown. At the time of the report, PRURITUS (itches really bad), INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (1 inch and half wide by 3 inches long at injection site welt and redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment included Aloe vera
I began to have chills, fever, headache, joint aches and feeling weak.  These symptoms persisted for 5 days with fever up to 102.6.  These symptoms completely mimicked a bad case of the flu. Also by day 3 I had a stuffy nose. Today, one week later, I am not 100% strong, but better. My husband who is supposed to also receive Prevnar 23, is probably not going to get it after watching what happened to me.
Already being treated, via medication for frequent PVC/arrythmia. 2 weeks after the 2nd vaccine, PVC's/arrythmia more than doubled, resulting in Cardia Ablation in September, 2021; 4 months after the 2nd dose.
Developed symptoms; Positive test post immunization/ tested positive for covid today; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Developed symptoms) and COVID-19 (Positive test post immunization/ tested positive for covid today) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced ADVERSE EVENT (Developed symptoms) and COVID-19 (Positive test post immunization/ tested positive for covid today). At the time of the report, ADVERSE EVENT (Developed symptoms) had not resolved and COVID-19 (Positive test post immunization/ tested positive for covid today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive post immunization.         Concomitant product use was not provided. Treatment information was not provided.
Patient had extreme pain in her entire arm and went to the Emergency Room 1:49 AM on 1/1/20; patient was given a shot of morphine per spouse to help with her pain, spouse said pharmacist giving shot probably hit a nerve.
On July 2 I was stung on the left shoulder by an unknown insect. Within 2-3 minutes I started having Anaphylaxis reaction. Swelling on lips, eyes, throat, fingers and feet. I had chest pains and hives broke out on my back.  It should be noted that I have been stung many times throughout my life, by many different types of bees and insects and I have NEVER once had an Anaphylaxis reaction. I was stung in the leg in 2020, three times in the same incident by yellow jackets and I did not have a reaction.  My sting on July 2 2021 resulted in being rushed to the Emergency room where I was treated with Antihistamine, steroid and Epinephrine.  I was released after 2 hours.
sore arm, chills, shivering, body aches and pain, headache, slight nausea.
Vacci nation site sore; the injection site became warm to touch; Flu-like Symptoms  on the same day as the vaccination.; the injection site became itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.), VACCINATION SITE PRURITUS (the injection site became itchy) and INJECTION SITE PAIN (injection site sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.) and VACCINATION SITE PRURITUS (the injection site became itchy). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.), VACCINATION SITE PRURITUS (the injection site became itchy) and INJECTION SITE PAIN (injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-218957 (Patient Link).
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age, who was a college age student. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, as a child, the patient was vaccinated with VARIVAX (strength, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient showed no immunity to the varicella virus after serologic testing. The outcome of the event and the causal relationship between the event and VARIVAX were not provided.