chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning/her arm started to burn; Swelling; Itching; couldn't sleep; Swell up on her side and her legs and shoulders; she might have a little fever; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry date: not reported), via an unspecified route of administration in left arm on 09Feb2021 09:30 (at age of 71-years-old) as dose 1, single for covid-19 immunisation at military facility. Medical history included disability (Patient mentions she is disabled). Family medical history was none. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. When the patient got home at 11:30 and her arm started to burn and swell up on her side and her legs and shoulders; whole arms and everywhere was swollen and itching like crazy; and she felt like she was on fire, burning. She took two Tylenol and that didn't help. She felt like she might have a little fever but it didn't help with the burning on her skin. She took two brand Tylenol, 500mg Extra Strength UPC 122101; Lot SLC220; Expiration Date Jul2024. Mentioned that she also bought some cortisone to rub on, the intensive healing one. The patient tried it this morning and just put it on so she was waiting to see if it works. Later mention she thought the cortisone helped with the itching and burning. Added that the patient couldn't sleep at all last night. The patient was scheduled to receive the second dose of the bnt162b2 vaccine 02Mar2021. Added the patient drank vitamin C and D. History of all previous immunization with the bnt162b2 vaccine considered as suspect was none. Additional vaccines administered on same date of the bnt162b2 vaccine was none. Relevant test were none. Therapeutic measures were taken as a result of burning/her arm started to burn, swelling, itching, couldn't sleep, swell up on her side and her legs and shoulders and she might have a little fever. The outcome of the events burning/her arm started to burn, itching was recovering and the outcome of the events swelling, couldn't sleep, swell up on her side and her legs and shoulders was not recovered. The outcome of the event she might have a little fever was unknown.  Follow-up attempts are completed. No further information is expected.
Daughter given 3rd shot of GARDASIL on 10/17/2012. Had severe headaches and stomach pain/cramping starting on 10/19/2012. Threw up 4 times that night. Did not eat and limited liquids. Took to Hospital ER early on Saturday 10/20/2012. IV, pain medication for headache and medication for cramping. Pain and discomfort subsided some. Blood and Urine tests came back with no issue. Xray of stomach showed no issues. Discharged in the afternoon with prescription for Mirasol. Sunday late, threw up again after attempting to eat some. Stayed home from school on Monday and Tuesday. Tuesday morning, pain and discomfort spiked again similar to Saturday morning. Took to ER again. Blood work normal again. Ultrasound done with no findings. IV given again. Pain subsided again. Doctors unable to determine cause of issues. Symptoms experienced list as potential side effects.
Papular rash face, arms.  Treated with Benadryl by mouth as needed.
Viral symptoms onset 24-36 hours after injection, headache, body aches, sore throat, fatigue, cough, fever up to 102 degrees F onset 72 hours later. Treated with OTC Ibuprofen, ALLEGRA, FLONASE and decongestants.
It was reported that a 35 year old male pt received TD ADS ADULT, lot number not reported, administered IV in error, on 5/31/03. Six to seven hours later, the pt experienced uncontrollable vomiting and then went unconscious. The pt was admitted to the hospital. The pt is currently experiencing signs and symptoms of headache and hot flashes, which are persisting. The reporter will obtain the lot number from the hospital records and provide it at a later time. At the time of this report, the pt had not recovered. From additional info received on 12/18/03 from a health care professional, the pt's full name was provided. According to the hospital records received, the pt received the vaccine in the ER on 6/1/03, where he was seen due to an infected injury to his right hand. The injury had occurred three days prior but the pt thought it was minor. On 6/1/03, in the ER, he was treated ith 2 grams of Ancef for the infection and Td 0.5 cc by IV route. The pt had to return six hours later due to nausea, vomiting and fever. Hospital records do not mention the episode of unconsciousness as was on the initial report. The pt also develpoed headaches with tension and migraine as well as photophobia and phonophobia and was referred to the headache clinic. He described his headache as a constant painful sensation extending from his temporal areas bilaterally to the frontal bilateral areas. Pt noted the acute onset of the headache occurred when he was administered Td vaccine IV. Pt has been on multiple medications for treatment including Elavil, Celebrex and hydrocodone, but he was unable to tolerate due to side effects. On 6/18/03, the pt was still complaining of headache. At that time, the pt's review of systems was negative for fever, chills, weight change, vision change, nasal congestion, sore throat, swallowing difficulties, cough, chest pain, shortness of breath, nausea, vomiting, diarrhea, frequence, dysuria, depression, anxiety, head trauma, seizures or loss of consciousness. His physical exam showed his weight to be 193 lb., blood pressure 118/90, pulse 80, respirations 18 and temp of 98.3 deg F. The HEENT exam revealed to pt to be atraumatic and normocephalic. On 7/9/03, the pt presented to the headache clinic for follow-up of his chronic daily headache with features of both tension and migraine. He has been on Vioxx 25mg q.d. in addition to Effexor XR 150mg q.d. x 2 weeks. The pt reported the chronic daily headache has subsided completely at this point. He did have an occasional headache one to two times a week triggered by sound and light. Pt was encouraged to continue his medication therapy and to avoid triggers. On 8/14/03, it was stated that headache continued if pt missed medication Effexor. Follow up on 01/21/04: "No additional information is anticipated. Case is closed."
My arm was still sore/my arm is still really hurting; got a huge red blotch on my arm It was a big welt that look like a cloud; It became swollen and hot; It became swollen and hot; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and had experienced her arm did become sore. Reporter states, on an unspecified date the patient reported having really weird side effects after getting the first dose of the Pfizer BioNTech covid vaccine. The patient had received both doses of the vaccine in left arm. The patient arm was still sore when she went back to get the second dose. The second shot was really bad. The patient got a huge red blotch on arm and it was a big welt that look like a cloud. It became swollen and hot. Every time, the patient did search for a picture of Pfizer and swollen arm, a picture of Moderna Arm' would come up. The patient was concerned because she got the doses local. On an unspecified date (2 weeks later), the patient arm was still really hurting but not red, hot or swollen. Outcome of the event My arm was still sore/my arm is still really hurting was not resolved and rest all events was resolved on an unknown date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt with history of B cell lymphoma of skin, developed acute autoimmune hemolytic anemia
Pain in the left arm after first booster (3rd shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 047B21A and 001B21A) for COVID-19 vaccination.     Previously administered products included for Shingles: Shingles vaccine on 06-Apr-2022. Past adverse reactions to the above products included No adverse event with Shingles vaccine.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Dec-2021, the patient experienced VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)). On 01-Jan-2022, VACCINATION SITE PAIN (Pain in the left arm after first booster (3rd shot)) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-537571, MOD-2022-537568, MOD-2022-537573 (Patient Link).
Member presented with profuse sweating and said he did not feel well at all. Because I do not have aassigned to the clinic, I went to ask an to do a physical examination on the member. The went retrieved water for the member to help him cool down and another patient was in need of my assistance. As I returned I saw the conducting his physical examination of the patient where he started to examine the member where the member did not present with any hives on his body but his tongue was slightly larger than normal and he started to clinch his stomach and he could not physically drink the water and he then fell over gasping for air and eyes bulging(you could hear him
This case was reported by the mother of a consumer and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had a history of allergies to various bovine products. Specific details were not provided. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified. The lot number was reported as 8C14B140BA from the reporter; however, based on an INFANRIX lot number check, the lot number was updated to AC14B140BA.
Information has been received from a physician via a company representative, referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (subcutaneous; dose, lot# and expiration date were not reported). Approximately one week after the vaccination, the patient experienced hearing loss. He contacted the physician to seek medical attention. The outcome of the event was not reported. Causality assessment was not reported. Upon internal review, the event hearing loss is considered to be medically significant. Additional information has been requested.
Had a low grade fever for about 12 hours and felt very tired and just not well for the next 18 hours but felt fine again after a total of 24 hours.
COVID vaccine was given to patient under 18 years old.  Unknown adverse effects, was unable to contact parent to discuss.
Soreness, tenderness, pain, swelling extending down arm (to elbow) of left arm. Tx w/ IBU and ice.
The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; Pain keep her up all night; Patient's left hand felt numb; Patient's left arm got very painful; This spontaneous information has been received from a registered nurse, concerning a 69-year-old female patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.    On 11-OCT-2019 the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (IM) in the left arm for prophylaxis (reported as routine) (lot number R018731 with expiration date on 27-FEB-2020). On the same date, immediately after getting the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, the patient's left arm  got very painful (vaccination site pain), and the pain kept her up all night (insomnia), and lasted approximately 10-12 hours after getting the vaccine. The patient's left hand felt numb (hypoaesthesia), and the patient had upper back, neck and chest pain. There was no lab diagnostics or studies performed and it was unknown if there was treatment given for the adverse events. The patient recovered from the abovementioned adverse events on 12-OCT-2019.
it itched like crazy; it was hives she would guess.; started getting a rash on the back of her neck and head and shoulders; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, Expiry date: unknown) via an unspecified route of administration on 05Feb2021 (at the age of 79-year-old) as single dose for covid-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took hydrocortisone. On 11Feb2021 the patient experienced a rash on the back of her neck and head and shoulders, it is not quite recovered, it was still a little bit on her tummy and sometimes the back of her neck felt a little like she wanted to scratch it, but she tried not to. It had just been in the last 3-4 days that it was finally clearing up. She was taking Zyrtec, 2 per day with the 10 mg and it itched like crazy, it was hives she would guess. She wanted to know how long she could wait to take the second shot or if she shouldn't take the second shot. She had the bottle of Zyrtec sitting there she was sure the expiration was good because she just bought it. She saw lot number 1801793 expires Sep2023. She did go to her doctor, and he gave her a cream to put on it. She did not know how to pronounce it, but it said Triamcinolone Acetonide, and it is 0.1% he told her to put that on it and she also had used something that she had from before Hydrocortisone USP 2.5%, she used that before she got the prescription. She just got it short time ago imagine it would be good, she did not see anything on that. He gave her a prescription for 4 tubes of that Triamcinolone Acetonide 0.1%. She said she had the box, and it says NDC 52565-056-30. She saw expiration Oct2022 and lot number 16090. Description of Product Complaint included she wanted to know how protected she would be with just one dose of vaccine, should she choose not to get the second dose. She wanted to know if she could receive a different product to potentially avoid another rash. Therapeutic measures were taken as a result of the events. The case assessed as non-serous by the reporter. Therapeutic measures were taken as a result of the events. The outcome of the event rash was recovering and that of itching and hives was unknown.  No follow-up attempts are possible. No further information is expected.
Patient reported to ED with shortness of breath and flu-like symptoms that started over 1 week ago. Patient confirmed to have COVID pneumonia, given remdesivir, dexamethasone. Patient still in hospital for treatment. Of note, he has his first COVID vaccine on 8/4
Pt received a light dose of vaccine.  Vaccine was reconstituted with 0.8 mls of .9 NS. One 0.3 dose was removed from the vial and administered. After that dose was taken out 1 mL of NS was added to vaccine vial. This pt received a lower concentration Covid 19 vaccine dose. Pt was contacted and reported no adverse reaction.
Approximately 6 hours after 2 vaccination in left arm  I experienced pain and soreness. The following day my arm became bright red from shoulder to almost my elbow, raised up, hard and hot with spot by red edges. I also experienced headache, mild nausea and discomfort in throat (similar to congestion/cold). Swollen, hot, red, painful arm persisted for 4 days. Arm is now back to normal at 5 days. (Note: I likely have the Inflenza shot type inncorrect. The sheet I was given says Flu H.D. Also, I received PCV 13 12/10/15 with no adverse effects.
Headache; Chills; Fever; Stomach cramps; Vomiting; Aching; This is a spontaneous report from a contactable consumer, the patient. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 02:30 the patient experienced headache, chills, fever, stomach cramps, vomiting and aching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fever, stomach cramps, vomiting and aching were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a 61 year old male patient, via a company representative, reporting on himself. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose, lot # and expiration date were not reported. It was stated that after receiving ZOSTAVAX the patient developed a headache that lasted 3 days and developed a rash on his back. It was not a product quality complaint involved. At the time of reporting the outcome of Rash was unknown. The causality assessment between the events and the suspect therapy was not reported. Additional information is not expected as not contact details were provided.
My sense of smell greatly diminished, nearly to zero. Food tasted bland or bad. My sense of smell is still diminished as of this report. Only strong odors are mildly noticeable.
After I received the vaccine my platelets dropped to 14 and had to take steroids and almost had to get a blood transfusion.
stomachache; small headche; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012120A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (stomachache), HEADACHE (small headche) and CHILLS (chills) had resolved.            No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-019373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR added on 25-MAY-2021 and outcome of the events are updated and contact details updated
Normal arm pain. plus pain under the arm and pain radiating to center of back and up the left side of neck. Pain started radiating to neck at day 5 and symptoms lasted until 8-21-18.
Lethargic, fever 102.3, myalgia onset at 2pm resolved next morning 10am
COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 76 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE, start date: Oct1988. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" (2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID: Lot Number: 1925343A) from 04Aug2023 to 09Aug2023.
Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; No adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
This spontaneous report was received from a 65 year old female consumer reporting on herself with high blood pressure and no drug reactions/allergies who on 26-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included: enalapril maleate (manufacturer unknown). On 26-JUL-2012, the patient developed itchy rash around the injection site after she received ZOSTAVAX and it was sore. She also stated that on 27-JUL-2012 "the next day", her hip became very stiff and could not move. The consumer visited the physician's office and was applied kinesiology. No laboratory tests were performed. At the time of the report, the patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Fever, chills, myalgia. This pt received vax in an unspecified deltoid and within 4 hours post vax, experienced low-grade fever, chills and myalgia. The pt recovered.