chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From H&P: "Patient is a  72 y.o. male who presented to the emergency department due to shortness of breath.  According the patient symptoms started after he was diagnosed with Covid 19 on 9/29.  Reports initially was mild shortness of breath but progressed to severe thus presented to the emergency department for evaluation.  The patient reports symptoms were associated with mild epigastric pain and nausea.  Reports constipation.  Denies chest pain, fever, chills, hemoptysis, lower extremity edema, orthopnea.  Evaluation emergency department included chest x-ray which was negative.  CBC revealed mild leukocytosis with white count 12.7.  Sodium is 131. Lipase was normal.  BNP was normal in trop was negative.  With ambulation the patient required 2 L nasal cannula thus admission was requested.  Upon evaluation patient continues report shortness of breath.  He continues to deny pertinent negatives outlined above.  Does not appear to be in acute distress."   Hospital Course: The patient was admitted to Hospital COVID-19 medical unit for hypoxic respiratory failure secondary to COVID-19 viral pneumonia on 10/04/2021.  He reportedly received the Jansen vaccine, single dose March 2021. Upon admission he was started on dexamethasone, Remdesivir and therapeutic Lovenox.  Patient was diuresed as needed throughout hospital stay and pulmonary was consulted.  Unfortunately the patient continued to have increased oxygen requirements and worsening respiratory distress requiring heated high-flow nasal cannula and was transferred to the ICU on 10/12/2021 and placed on AVAPS.  Patient was started on a Precedex drip for agitation also started on broad-spectrum antibiotics as superimposed bacterial infection cannot be ruled out.    Morning of 10/13/2021 code blue was called, CPR was started immediately and patient was intubated. Several rounds of ACLS were performed and patient was also given bicarb, calcium and dextrose. Unfortunately patient remained asystole or PEA and the code was eventually called. Time of death 0640 October 13th, 2021.    Disposition: Deceased
Information has been received from a nurse practitioner concerning a 48 year old male with no medical history or allergies who on 04-MAY-2007 was vaccinated with a 0.5 ml dose of MERUVAX II (Lot # 655408/0036U). Concomitant therapy included "numerous vitamin supplements". On 23-MAY-2007 the patient experienced joint aches, leg muscle contractions, and some fatigue. The patient's pain was not constant and it comes and goes. The pain was localized around the calves, knees and legs. it was reported that the patient was an amateur competitive cyclist who often biked about 30-40 miles a day. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/29/2007. Additional information has been received from the nurse pratitioner who stated that on 18-May-2007 the patient expereinced muscle cramping and joint ache during bike riding on 23-May-2007 the patient was seen in clinic on 10-Jul-2007 the patient was again seen in clinic for sinusitis symptoms. On 30-Jul-2007 patient was seen in clinic for ployjoint pain, fatigue. On 01-Aug-2007 the patient was seen in clinic and was very concerned regarding vaccine and felt it damaged his immune system. The patient was advised to follow-up his primary care provider for arthritic testing. At the time of report the patient had not recoverd. Additional information received from the patient indicated that several days after he received the vaccine (04-May-2007), he developed symptoms that was diagnosed as "a vaccine reaction". At the time of this report the patient had not recovered. Additional information received indicated that the consumer was interested in information concerning the negative vaccine reaction issues to his body he has experienced and what might develop in the future. No further information is expected.
pt recv vax & reported a yellow bruising that started @ the site of the inj & travelled down arm to wrist;pt reported that also had blood drawn on the same day;
Temperature excursion 5.76 degree fahrenheit for 20 sec, Vaccine given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Temperature excursion 5.76 degree fahrenheit for 20 sec, Vaccine given). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2023 The healthcare professional stated that according with original thermometer inside refrigerator, the lowest temperature was 5.76 degree Fahrenheit for 20 seconds on 27-MAR-2023. No alarm. However, on the same day, the backup thermometer showed a lowest temperature of 36.21 degree Fahrenheit. The healthcare professional stated that they had been using these vaccines. No Kinrix lot numbers available at the time of reporting. The reporter consented to follow up.  Kinrix was stored below recommended storage temperature which led to incorrect storage of vaccine.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629:
This is a spontaneous report from a contactable consumer (patient). A 59-years-old female (non-pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient received other medications in two weeks. The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on 04Feb2021 14:00 (at the age of 59-year-old), as dose 1, single for covid-19 immunisation. 05Mar2021 14:00, within 24 hours after receiving the 2nd COVID19 vaccine the patient began to feel pressure around my eyes. They were red, watery, and swollen. The patient thought it was a sinus infection so she was prescribed an antibiotic. But after 2 weeks her eyes were still red, swollen, and very painful. The patient finally went to an eye doctor and he gave eye drops (steroids) and referred to a specialist for right angular closure/glaucoma. The eye drops cleared the problem in her eyes but just saw the ophthalmologist last week. After an extensive evaluation she determined that it was most likely a reaction to the vaccine because she had seen at least 2 other patients that had a similar response after receiving the vaccine. The patient received treatment with eye drops (steroids). The events resulted in doctor or other healthcare professional office/clinic visit. The events were recovered on an unspecified date in 2021.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a 32 years old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 25-MAY-2016, the patient was intended to receive M-M-R II and VARIVAX, but was inadvertently vaccinated with a dose of PROQUAD (dose, route, lot # and expiration date not reported) and a dose of VARIVAX (dose, route, lot # and expiration date not reported) due to nursing error. No adverse effects were reported. Additional information is not expected.
Per Patient's husband, patient was very hot in the middle of the night and when patient got up at 5:30 AM patient passed out. Patient again passed out later that morning. Per patient's husband patient felt awful for 2 additional days before finally feeling better. Patient has had fluarix and flublok before with no issues.
Experienced Fever,Hot sensation to the right ear lobe,fever,Loss of appetite,back pain,felt strange,Figure out if it is Covid; This is a spontaneous report from a non-contactable consumer or other non health care professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: EW0196) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that his right ear lobe started to get very hot. Then on 21Jun2021 when he woke up and he started a high fever on his head. He bought a forehead thermometer and it said 102. He took an Advil, and it went down to 98 or 99. side effects like that to happen 10 days after or a week after receiving vaccine. he did not feel right. He also had a backache and he never had a backache. He also had loss of appetite. he woke up he had a strange ache in his back. Also, he usually woke up very hungry, but when he woke up, he was not hungry. He did eat and he still had his senses like smell and taste, and he was just wondering and trying to figure out if it was Covid or was it some side effect of the drug. Patient has never had a fever for years and all the sudden he takes this shot and then he was getting all this events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Severe body aches, fever, chills, headache and nausea. After each dose.
The day of the shot I experienced a moderate headache throughout the evening as well as soreness at the injection site. The day after I received the shot I experienced severe muscle fatigue and a red rash, bruising, and swelling around the injection site.
Twitching of muscles, pain in bones, rash, throat constricting, anxiety, severe fatigue, muscle weakness in legs and arms.
Two days after flu vaccine pt had left hand-wrist and hand swelling with some broken capillaries. Pt now has dryness of skin over that area. No swelling or redness at site.
Rash down Left arm, macular, lacy, red-pink, also mildly on the Right arms.
Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) lot number N008378 with expiration date on 08-JUN-2018. On an unspecified date in 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot number N017397 with expiration date on 07-JUN-2019; lot number M047662 with expiration date on 02-DEC-2018 or lot number M043582 with expiration date on 28-OCT-2018 (anatomical location and administration route were not reported) for prophylaxis. On an unspecified date in 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot number N016993 with expiration date on 29-NOV-2018 or lot number N004631 with expiration date 07-AUG-2018 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The VARIVAX and PROQUAD vaccines had a maximum temperature excursion of -9°C to 8°C (7.2°C) during 5 hours 30 minutes, with a cumulative of 7 hours (-14°C to -10°C) and 16 hours 30 min (-9°C to 8°C). It was reported that a digital data logger was involved.
tickle in throat/ throat itching, feeling flushed, sensation of throat closing and hotness in throat. Epi Pen given x 1 and patient transported to ED via EMS.
My son had a febrile seizure 8 days after MMR shot. His temp was 100.6 at 7PM and by 7:30PM in ER his temp was 103. Seizure lasted about 1 minute. At ER, pt's blood was checked and everything came back negative. On 09/29/2004 he had a rash that lasted 4 days and he was fussy.
Patient is a 39 year old woman  G2P0101 with Estimated Date of Delivery: 3/17/22 at 32w3d weeks gestation who is being admitted for leaking of clear fluid that started around 2:30 this morning  01/23/2022. She received a dose of covid vaccine 01/10/2022. Per guidelines, all hospitalization are reported.
pt recv vax 16DEC96 & 20DEC96 a home pregnancy test was positive;date of last menstrual period was unk;pt had a miscarriage on 20JAN97;hosp is presumed, although not documented;
I do not recall having any reaction to the vaccine. On 11/26/ 2022, I had symptoms of congestion, sore throat, cough and a runny nose.  I went to the doctor for an upper respiratory infection and received prescriptions for an antibiotic and steroid. On 11/29/2022, I tested positive for COVID-19 with a home test and on 11/30/2022, I tested again with a PCR and it confirmed I was COVID-19 positive.
60 seconds after receiving varicella vaccine, pt developed trunk itching and then rash over her trunk, pt was given 25 mg diphenhydramine and this all resolved. Pt then was observed for 1 hour in office.
Started off with Cough  lost taste and smell .. Tested positive for covid on  12/28/2020
Maderna Covid Vaccine 2nd dose Extreme chills that night, got up to go the bathroom,, had sweats and  suddenly felt very dizzy and fainted on the bathroom floor. Felt very weak and couldn't get off the floor. Had a fever of 101.6, Wife had to help me get up after some time on the floor.
twitching on the side of her face; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching on the side of her face) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced MUSCLE TWITCHING (twitching on the side of her face). At the time of the report, MUSCLE TWITCHING (twitching on the side of her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
The night of receiving vaccine had bad headaches. On 11/14 she had chills, sweats, body aches, no fever. Reports new onset of blurred vision L-eye. Eval by eye doctor 11/16. Is on prednisone drops.
Information has been received from a physician concerning an 11 year old female patient, who was vaccinated with GARDASIL. The patient has a history of unspecified reactions to unspecified vaccines in the past. The physician reported that on 19-SEP-2012, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml in her left arm (Lot number not reported). The physician reported that the patient experienced warmth and swelling at the injection site a few hours after administration. The patient was referred for evaluation on 20-SEP-2012 due to the area of reaction was worsening. It was reported that the patient had not recovered. Additional information has been requested
On 6/27/22, patient received Moderna COVID vaccine (lot # 014B22A) that has been left on in room temperature since 6/24/22. Moderna was contacted and they performed an analysis of the vials associated with the storage excursion for this event.  They found that the vaccine administered on 6/27/22 from lot # 014B22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Patient was informed of the incident and to watch for any signs of infection (which did not occur).
Developed fever on 7/23/04; then subsequent seizure (thought to be febrile). Received work up at hospital: BC, Spinal Tap. Discharged on IV Rocephin until initial cultures required. Discharged home on 7/25/04.  Nurse follow up on 08/25/04 states: "No new information."
pt recv vax & approx 4:30 returned to check w/remarkably swollen eyes approx 5PM;no resp distress;DPh given;BP 98/48, P100, R24;
Immediately after the injection, patient felt poorly and was nauseous. About 30-60 minutes later, she started having a dull headache. Dull headache transpired into severe migraine that required an urgent care visit for management; patient was given Dilaudid due to severity. The next day after the severe headache, she reported left sided facial droop, involving the nasolabial fold (with slight drooling), inability to close her eye (with eye injection/tearing) and inability of frontalis contraction, all on the left; most likely Bell's Palsy. Had to be treated with prednisone, gabapentin, and PT. She denied any prior history of Bell's Palsy prior to this episode.
Patient took vaccination on 23rd Sept 2022 (4:30 pm ) and from next day around 12:00 pm he started developing hives ,rashes with itchiness. Hives,rashes would come and go after 1-2 hours and randomly re-appear on other parts of body(arms,hips,thighs,face,neck). We haven't given him any medication yet except Tylenol which we gave him after vaccination around 9:00 pm.  We are still seeing symptoms as of 09/27/2022 9:55 pm CT.
Chills for 12 hours, achy, low grade fever took ibuprofen before bed at 9, fever broke and sweating around 2 am. Woke up at 5:30 am and felt fine
Patient stated that within 24 hours the right arm became swollen, hot to touch and red in appearance from underside of arm to the elbow. She was treated at a walk-in clinic at 48 hours, given a prescription for an antibiotic to take for 10 days and advised to ice the arm.
Raised, redness, warmth surrounding injection site about 1X1. Noticed it was smaller yesterday and has been getting larger. No other S/S. Infection. 7:00 - came in - assessed RXN. Likely infection/temp increased. Sent to ER/urgent care."
Fatigue; Redness around injection site; Tenderness at injection site; Swollen and tiny bit raised at injection site; Arm is rashy and velvety; Defined dark circle at injection site; A spontaneous report  was received from a consumer concerning a female patient who experienced fatigue, injection site erythema, injection site pain, injection site swelling, rash and injection site discoloration.   The patient's medical history and concomitant product use were not provided by the reporter.  On 30 Dec 2020, several hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020 the patient developed a fatigue; redness, tenderness, discoloration, and swelling around the injection site; and rash.  She treated the events with Tylenol.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Syncopal episode 10 min after admin flu vaccine. Fell backwards from standing position, striking occiput on carpeted floor. Dazed when arrived he does not remember fainting. Presumed brief LOC.
Hiccups; Bedridden; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Hiccups) and BEDRIDDEN (Bedridden) in an 80-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HICCUPS (Hiccups) and BEDRIDDEN (Bedridden). At the time of the report, HICCUPS (Hiccups) and BEDRIDDEN (Bedridden) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient sprouted dozens upon dozens of "hives" on his upper body - some 50-60 of them, Not one hive below the navel. Hives were increasing and "spreading" when we sought treatment. Reaction started within 18 hours of COVID "booster" shot.
Pt had redness and swelling at site of injection (about 2 inches in diameter) with quarter sized darker red raised bump in center.  Pt was examined by Dr.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a adult female patient who received SHINGRIX (batch number 7A55L, expiry date 16th April 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, pain, muscle pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the nausea, pain, muscle pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the nausea, pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported however it could be 54 or 55 years old. The patient probably received SHINGRIX subcutaneously, which led to incorrect route of vaccination. The patient had body aches and muscle aches. This is 1 of the 2 cases reported by the same reporter.
Swelling of her lips; Swelling of her throat; She had burning in her throat; Lost her memory for the next hour and a half,  so it was not a great experience; This is a spontaneous report from a contactable consumer (son of patient).   A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown single dose for immunisation.  The patient's medical history and concomitant medications was not reported. The had the Prevnar 13 vaccine and about 10 hours after the vaccine she experienced, swelling of her lips and her throat and we went to the hospital and she had some burning in her and they gave her like pills of Benadryl (Treatment) and 'not clear', she had burning in her throat, lost her memory for the next hour and a half, so it was not a great experience. Everything turned out to be okay and start to work post that everything was okay.  Treatment was received for burning in her throat included Benadryl. The outcome of events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.