chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, fever, myalgias, swollen and painful arm surrounding injection site. Developed within 24 hours of injections.
broke out on arm @ inj site;then whelps over different parts of body;itching;better in 2 days;mom gave DPH;
Left deltoid muscle very tender,  red , swollen. In addition, in am following receiving the vaccine, had headache, left shoulder and neck tenderness and felt sick like coming down with flu--low grade temp. Was very tired and slept for hours. Felt better the second day post vaccing, but deltoid still very red, swollen and tender to touch.
FEELING OFF/NOT AS PRODUCTIVE AS USUAL; FELL ASLEEP; MILD FATIGUE; SORENESS IN ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient does not normally need to lay down and nap heavily; described as only in dozing mode when napping. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced soreness in arm at injection site. On 07-MAR-2021, the subject experienced feeling off/not as productive as usual. On 07-MAR-2021, the subject experienced fell asleep. On 07-MAR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling off/not as productive as usual, fell asleep, and mild fatigue on 09-MAR-2021, and was recovering from soreness in arm at injection site. This report was non-serious.
The LPN administering the shot failed to verify the patient's age at time of medication administration.  The patient under the age of 18 received the Moderna vaccine.
fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills).   At the time of the report, PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
My symptoms included a bad cough, headache, and sore throat. I went to a clinic and was told to gargle with salt water. Then I went to my doctor and I was prescribed an antibiotic. I am still dealing with these symptoms weeks later. I've rarely ever been sick like this before. I try to take TYLENOL to deal with the symptoms. I also have been dealing was ear aches and it's hard for me to swallow.
Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information indicated that the office felt that "no specific patient had a reaction directly related to GARDASIL". Additional information has been requested.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Very painful/achy muscles and joints + massive headache all night through mid-morning the next day.  Took 2 ibuprofen upon waking.  Also awoke with a low-grade fever (90.5) that lasted through the next morning.  On 10/29, took repeated doses of 2 ibuprofen at 6-8 hour intervals, which eased the muscle/joint achiness.  Low-grade fever and mild headache, however, persisted into the next day.  Have never reacted to a vaccine before, beyond minor soreness at injection site.  NOTE: Also had an influenza vaccination at the same time.
Itching and then covered in rashes on torso (stomach, chest, and back). Gone after 48 hours (took antihistamines which helped the itching; took longer for the rashes to disappear). Arm is still sore however; comes in waves (daily) and it's going on 4 weeks since injection.
Information has been received from a physician concerning a female who in September 2008, was vaccinated with the first dose of GARDASIL (route and site not reported). It was reported that 2 to 3 minutes after recieveing the vaccine, the patient experienced dizziness and blacked out. The patient was unconscious for approximately 1 minute. The patient recovered. No further information is available.
Upon administration there was a "tingling" sensation at the injection site and a heaviness feeling of the arm.  Pain at the site which did not improve and progressively got worse< to the point now of limited range of motion.
Starting in September of 2022 I experienced foot pain with a shocking sensation, causing things to swell and get red.  Stepping on the foot caused it to be too sore to walk on.  This was right foot.  Doctor consulted.  Doctor X-rayed the foot and referred to podiatrist.  Podiatrist examined foot and provided shoe inserts.  and asked to review in 6 weeks, which has not happened at time of report.
lump on her underneath her arms; on her neck, there was a lump there also; body was aching; she has a lump on her underneath her arms and lymph node swelling on the underarms and neck; Felt really sick; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Jul2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation. Medical history included having had the Covid virus before. The patient's concomitant medications were not reported. On 11Jul2021 (Sunday) in morning, the patient felt really sick and had a little bit of fever, body was aching and in afternoon, she had a lump on her underneath her arms and lymph node swelling on the underarms and also in her neck next to collarbone which began on Sunday. Then on 11Jul2021, she started feeling the lumps under the arm and on her neck, there was a lump there also. Patient further wanted to know if these were normal and if patient needs to go to the doctor. The outcome of events was unknown.  Information on lot/batch number has been requested.
She received her vaccine on 10/4/05 and on approximately 10/17 she developed a red, indurated area of skin around the administration site. Red area is approximately 3cm in diameter. This is also warm, itchy and tender.
high fever; chills; headache; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about 8 years ago, lasted for few weeks or months). Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concurrent medical conditions included pain (still had a pain in some area due to shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and experienced high fever, chills and major headache.  All the events were lasted for 18 hours after receiving 2nd injection.  The patient reported that, this was the booster shot, he or she read 80 percent given had a reaction, it was still a lot better than getting it again. The follow-up would not possible as no contact details were available. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163744:Same reporter
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On 18-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot # L027733, expiration date: 13-SEP-2017) for prophylaxis. No adverse effects were reported.
Breakthrough COVID Infection Dose 1: 02/04/2021, Pfizer, EL3248 Dose 2: 02/25/2021, Pfizer, EN6200
Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. The outcome was unknown. No other information is available at this time. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from a physician concerning this 7 month old male infant with gastrooesophageal reflux disease (September 2007) and bronchitis and a history of pyloric stenosis repair (03-SEP-2007), urinary tract infection, otitis media and methicillin-resistant staphylococcal aureus infection who on 15-FEB-2008 was vaccinated with a third dose of ROTATEQ (lot # 659772/1636U) on 14-DEC-2007. Subsquently, on 14-MAR-2008 the patient vomited and had diarrhea. On 20-MAR-2008 the patient complained of stomach tightening, gas problems and had crying episodes. It was noted that the diarrhea continued but there was no vomiting. A GI doctor was consulted, but was never seen. It was noted that the patient was started on soy formula. At the time of the report, the patient recovered on 15-MAY-2008. Additional information is not expected. This is one of several reports from the same source.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
8 days post vaccine, left arm became itchy. Then started to swell, turn red around vaccination site, and is warm to the touch. When trying to lift arm past 90 degrees it is uncomfortable due to the swelling. Arm is sore and feels tight at site of swelling.
Patient should have received Menveo vaccine instread of Boostrix.  No adverse problems were noted .
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (more than 3 months since first dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment information was provided.
soreness at site, chills, Temp: 100 degrees F Took Ibuprofen 400 mgm
Sept 29th 2021 Sore arm after shot was given 11:00  fever and sore to touch or lay on at 9:00 PM and all night     Also had a flu shot on same arm same time  Sept 30th around noon really tired and achy all over still fever and sore arm to touch.   Oct 1st itchy rash, redness, fever and sore until Oct 4th.  Tried cortizone-10 one night and Neosporin one night to relieve itch, Tylenol for fever at site of shot.  Oct 4th better and Oct 5th almost all gone for rash, and fever is gone.
One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 16-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients). On 16-Mar-2021, INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On morning of 16-Mar-2021, between  8:30 am to 9:15 am, one of the nurses gave 1 ml dose instead of a 0.5 dose to three patients.  No concomitant medications reported.  No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to event was not applicable.
Injection site on left thigh is red, swollen and hot to the touch. Was advice to watch for now, apply cold towel compresses, give Tylenol as needed.  Call us back immediately if symptoms worsen or do not get better. Will schedule a doctor visit.
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
Initially I had the pain in the arm which I anticipated.  Several hours later I noticed that I had flu like symptons and my bones seemed to be painful.  Eventually I began having intermittent rapid heart beat.  I thought this may have been induced by tea (caffeine).  This rapid heart beat lasted until Monday (Feb. 15) I think.  As I mentioned it was intermittent.
This spontaneous report as received from a pharmacist and pharmacist technician refers to a female patient of unknown age. The patient's medical history included herpes zoster (date not reported). On 16-JAN-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin, enalapril maleate/ hydrochlorothiazide, levothyroxine sodium and gabapentin. On an unknown date, it was reported that the patient after being vaccinated with ZOSTAVAX experienced a "mild case of shingles." The outcome of herpes zoster is unknown. Additional information has been requested.
Pt experienced a red rash at both injection sites. Appeared approximately 3 minutes post vax. Benadryl injection was given.
Dry mouth in the lower mouth area: under the tongue and lower lip area.  I went to my dentist and told him about that and he recommended to take a dry mouth wash. I have been using a dry mouth wash since, but the problem still persists.
chills; fever of 100.8; I feel very tired; ache; malaise; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (also experienced tiredness, malaise and headache after receiving the 1st dose on 2nd September 2020, refer case US2020178075).   On 5th November 2020 11:00, the patient received the 2nd dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fever, tiredness, pain and malaise. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, tiredness, pain and malaise were unknown.   It was unknown if the reporter considered the chills, fever, tiredness, pain and malaise to be related to Shingrix.  Additional details were reported as follows: The patient reported this case in the morning of 6th November 2020 (before 9:00 AM). On 5th November 2020, 11:00 am EST, the patient received 2nd dose of Shingrix and had chills all night. In the morning of 6th November 2020, the patient had fever of 100.8 degree F. The patient felt very tired, ache and malaise. The patient stated that he had a similar reaction in the beginning of September for his 1st dose but this reaction was more severe with a temperature. The patient took Tylenol for the 100.8 degree F fever. The patient stated that he was going to wait until tomorrow to see if the symptoms subside, if not then would see a physician but with Covid it was very difficult to see anyone. The patient confirmed that he did not have Covid 19.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178075:Same reporter
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever and incomplete course of vaccination. On an unknown date, the outcome of the fever and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller stated she was sick with fever after the first shot. The caller also did not get the vaccine in the 6 months, from the 1st dose, which led to incomplete course of vaccination.
Information has been received from a licensed visiting nurse (LVN), via a company representative, concerning a female patient (age not specified), who on an unspecified vaccinated with a dose of Gardasil (Lot # not provided). Immediately after the vaccination was administered the patient fainted. The outcome of the event was unknown. The nurse reported that another female patient (age unspecified) also fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA04608). Additional information has been requested.