chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did not have a adverse reaction to the vaccine.  On 04/16, I began not feeling well and tired all day. I developed a cough on 04/17. On 04/21, I woke up with my left eye was swollen and glued shut like I had conjunctivitis. I went to an urgent care facility and got antibiotics for the infection. The eyedrops they gave me for the eyes did not work so I had to get another prescription.  I tested negative for COVID-19 on 04/16/2023.
Hyperventilating; This is a spontaneous report from a Pfizer sponsored Support program. A contactable consumer reported for his elderly female neighbour that: An elderly female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer called in on behalf of his elderly neighbour he stated that she had her first dose and had an adverse reaction to it did not state what it was, only that she was hyperventilating he said. The Vaccination centre advised his neighbour not to take the second shot. He wanted to call for her to get additional information. The outcome of the events was reported as unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
day of vax pt devel nausea, muscle aches, h/a & high fever (103) fever cont 100-101 p/that w/ha/ & malaise w/pt pretty much bedridden;AM of 7APR96 broke out in pinpoint red raised papules similar to chickenpox;MD suspects viral & bacterial
Temperature peaked on December 5th to 101 degrees F and then to 105.8 degrees F on December 6th and took to Emergency room. Crying, very irritable that day, fussy. The next day Dec. 7th, very lethargic, loss of appetite, didn't eat much also constipated and very gassy. Dec. 10th - emergency room visit. See attached paper.
Rash, redness and itching around vaccine site. Tops of feet very itchy. Slight tingling in fingertips.  Treating with ice and calamine  lotion.
Chills; Headache; Felt really lousy; This is a spontaneous report from a contactable consumer (mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient had chills, headache, and felt really lousy after 1st dose of vaccination. Reporter reported that people with history of COVID-19 experience more side effects with the first dose, it was happened to patient and heard that people feel sicker after receiving the first dose of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results (Patient had history of Covid). Reported mentioned that patient was due for the second dose the day before her sister's graduation, and they were not sure if they should postpone it. Reporter wanted to know if people experienced side effects after the second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
I experienced and having severe headaches and never had headaches before the vaccine. I've had a latest headache for nine days. I am actually going to the doctor this afternoon. I am still sore, my head is sore.
an extra dose was given of Hep B vaccine. Pt has no reactions to vaccines she tolerated well; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2388371-1. The original narrative from the sender is the following:  Pt came in for a well child (4 month )check today the chart was not matched with the system and a extra dose was given of the hep B vaccine. Pt has no reactions to the vaccines she tolerated well.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "a extra dose was given of Hep B vaccine. Pt has no reactions to vaccines she tolerated well".  No further information is expected.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided, all remaining doses of Moderna with Lot# 076C21A was wasted.
I am self reporting this, as I have a very large mass under my right arm by my lymph nodes.  Approximately, lemon size.  I called the doctor's office and they said this wasa completely normal reaction.I disagree, and am submitting as an adverse reaction.  I was told to ice, take Ibuprofen and range of motion exercises.  I want to go on record to report this, however "normal" it is believed to be.  As for Item 21, the outcome is unknown as of 6.22.22.
nausea next day on second day 3 pm shaking, shot of breath then - had  chill then fever, 3 day another  chill and fever - lose of appitite
first dose of Shingrix on 2/26/2022 and never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix on 2/26/2022 and never came back for the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Aug-2023 The pharmacist called to inquired that the patient should repeat the whole series or could get the second dose. The reporter declined to follow-up from safety. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician concerning a patient who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient developed a high fever.  It was reported if medical attention was sought.  The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Initially, I was "sick" the following morning after the shot with fever of up to 102-degrees, body aches, headache.  By Friday (shot received on Tuesday), I had (and still have) hives on the palms of my hands and on the back of my legs.  I had the Pfizer shot for 1 and 2, as well as booster #1. Moderna shot was booster #2.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (3 doses of lot # L026405 and expiry date: 15-JUL-2017 and 3 doses of lot# L018002 and expiry date: 19-MAY-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Diagnosed with DVT and PE on March 29, 2023.  Subsequence blood test revealed no genetic inclination for blood clotting.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic for follow-up visit. Patient received vaccine and reported rash five days after immunization. One day later reports nausea/diarrhea that resolved.  Three days after vaccination reports severe headache that resolved with acetaminophen but residual dizziness and nausea. Headache returned six and eight days after immunization  and improved with migraine medication but returned. Patient went to an urgent care then to primary care provider: administered ketorolac and anti-nausea medications. Advised to take migraine medications and over the counter analgesics. Patient discharged home with instructions to follow-up as needed.
light headed and dizzy.  Prolonged lasted <30 minutes so called EMS.  EMS looked over patient and was okay and released pt and did not take with.  Followed up with patient next day and fine no other adverse effects.  Vasovagal event.  Patient had not eaten before vaccine and was very nervous.
This spontaneous report as received from a consumer refers to a female patient of unknown age. The consumer reported that on 03-APR-2013 the patient was vaccinated with a standard dose (0.5 mL) of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014) (route unspecified). The consumer reported that approximately on 03-APR-2013, the patient experienced arm pain, and redness immediately following vaccination. At the time of the report the outcome of arm pain, malaise and redness was unknown. This is one of two cases from the same reporter (MARRS # 1305USA001147). Additional information has been requested.
Case previously recorded as MA2009-5497. Initial report received via MedCom, from a health care professional on 20 NOV 2009: A 7-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1013263R) i.m. on 18 NOV 2009 at 3:00 p.m. On 19 NOV 2009 1:00 a.m. the patient experienced vomiting. It was reported that the patient was exposed to gastroenteritis during week before. The patient had recovered at reporting date. Ref. no.: NA09-008670.
No other AE; The caller said an expired dose was administered to a patient; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age or gender. Information regarding the patient's medical history, current conditions, concomitant therapies and historical drugs was not provided.  On 17-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T036444, expiration date: 09-APR-2023 (expired product administered), administered for prophylaxis (strength, and route of administration were not provided).  No adverse symptoms were reported.
Information has been received from a nurse practitioner concerning a 20 year old female with no known drug allergies and a history of dizziness, nausea and sweating following blood draws, who on 02-MAY-2007 at 14:45 was vaccinated IM into the left deltoid with a second 0.5 ml dose of Gardasil (lot 655205/1426F). There was no concomitant medication. On 02-MAY-2007 at 14:45, the patient experienced dizziness, paleness, sweating, nausea and ringing in ears. It was noted that the reaction appeared to be a vasovagal response to the injection. The patient sought unspecified medical attention. No diagnostic studies were performed. Within one minute, the patient recovered from the ringing in ears. Within a few minutes the rest of the symptoms resolved. it was also reported that the patient was seen for another reason on 08-MAY-2007. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age regarding herself. Approximately on 28-SEP-2012 (reported as last Friday) the patient was vaccinated with VARIVAX (lot # not reported) single vial dose. The patient stated that instead of receiving the ZOSTAVAX (Merck) her physician had accidentally given her the VARIVAX (merck). The physician may have ordered the incorrect product for the patient. No adverse reactions. No further adverse event (AE) information was reported. Additional information has been requested.
This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 46-year-old male patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. It is unknown if the suspect product (AFLURIA) was tolerated in the past. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 13049221A. The product was stored correctly. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time. The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; After the second injection, in her right arm: "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills.; it may have been a skin infection; This is a spontaneous report from a contactable consumer.   A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration administered on right arm on 22Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1  on 17Feb2021  for COVID-19 immunisation and after first injection in her left arm, her left arm felt "a little bit sore, for about 2 days, had chills, fever, feeling unwell generally almost like the flu then it went away, in 3 or 4 days it was gone". Patient stated that after the second injection, in her right arm, "My right arm got a really big lump, that was hot and hard, and really really sore, had bad fever and chills. It took about 2 weeks to resolve, and I ended up having some antibiotics my Doctor said it may have been a skin infection? they did not clean it properly or something?, but I am better now." The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt warm and had some tightness in her chest which subsided and changed to intermittent sharp pain at sternum. Physician's who had just received vaccine asked for her to be sent to the ER.
Fatigue - within one hour  Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrhea- within four hours, still present after 23 hours
Day after (2/8/21): Severe chills, tiredness, body aches, headache, loss of appetite, fever (101.4), bloody nose w/blood clots (left nostril only). 2 days after (2/9/21): Intermittent headache, aches in joints, bloody nose w/blood clots (left nostril only), hive around injection site.
Moderna COVID?19 Vaccine EUA Sx appeared 2 days after injection: *Soreness to injection site - lasted x3 days *Underarm pain/swelling - remains ongoing
Monday-My left lower arm and hand were getting weak and tingly and hand kept curling in. Then my right arm and hand started feeling tingly and weak and that hand kept curling in. Then there was some tightness/tensing up in my neck. It became hard to talk-not swelling of throat but tight jawish area.  Today-Wednesday-right arm is extremely weak and heavy. Right hand fingers keep curling in and spazing out Going to doctor today. Left arm is still a little weak, hand keeps curling
Itchy Injection Site; Sore Injection Site; Tender Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Red "ring" around injection site, about 4" in diameter, hot and itchy.  "COVID Arm"
Pain in arm and additional pain in armpit approximately 1 day after 3rd dose; Pain in arm and additional pain in armpit approximately 1 day after 3rd dose; 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF8839) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "3rd dose"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset 15Dec2021, outcome "not recovered" and all described as "Pain in arm and additional pain in armpit approximately 1 day after 3rd dose". Therapeutic measures were not taken as a result of pain in extremity, axillary pain.  Additional information: Pain in arm and additional pain in armpit approximately 1 day after 3rd dose. Armpit pain was not experienced from the first 2 doses. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored PROQUAD (lot # M029598, expiry date 10-DEC-2017) for prophylaxis. The vaccine were exposed to a temperature of 21F at a time frame of 8 hours. No adverse effects reported. Additional information has been requested. This is one of the two cases received form the same reporter. Sender's Comments: US-009507513-1612USA011236.
she felt something drip down her arm, no AE; she felt something drip down her arm, no AE; Fluzone Quadrivalent not High Dose because she wasn't aware there is a HD available, no AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 66 years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE (Fluzone quadrivalent) and during the administration she felt something drip down her arm (exposure via skin contact) (underdose), she also did not have a bump, like she always does after an injection. She also stated that she received Fluzone Quadrivalent and not INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Fluzone High Dose) because she wasn't aware there is a HD (high dose) available (wrong product administered).  The patient's past vaccination included IMMUNOTHERAPY.  At the time of the event, the patient had ongoing Asthma.  Concomitant medications were not reported.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported for both the vaccines) not reported via unknown route in unknown arm as prophylactic vaccination.  It was a case of medication error due to wrong vaccine administered and exposure via skin contact.(latency same day).  It was also a case of vaccine underdose (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information in the batch number for this case.
Pt got birth dose of Hep B 7/31/10 SIDS baby.
102.5 degrees F oral, cough, nasal congestion, headache. Began 10/28/2009. Lasted until 11/1/09. Still has cough.