chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1 - Received Vaccine 4:45 pm, Day 2 - woke up around 3 am with cold chills, fever of 102 and nausea. Later that day nausea became more severe, couldn't keep anything down, couldn't sleep but extremely tired. Fever went up and down throughout the day.  Barely had the strength to get  up to go to the bathroom or kitchen. Symptoms were similar to when I had Covid but worse. That evening I had to call a friend to come help me as I was afraid I was dehydrating. Was able eat a few crackers and ginger ale. Slept that night and felt better on Day 3 - still having symptoms but much milder and low grade fever. Day 4 - woke up with hives on my neck and chest.  Primary told me to go to emergency room. Was told I was having  allergic reaction.  I was given a shot of Solu-Medrol and a prescription for prednisone. Also, advised to take Benadryl.
The patient's mom called to verify that we had the Janssen COVID vaccine in stock and stated that she would be sending her son. The patient arrived with his father to the pharmacy. The father asked me for the single dose COVID vaccine for his son. I confirmed that he wanted the single dose Janssen COVID vaccine. I administered the vaccine. When processing the vaccine later in the evening, I discovered that the patient is only 17 (3 weeks shy of 18).
vaccine stored out of range - in freezer for greater than 14 days; offered revaccination and patient denied
This spontaneous report as received from a consumer via company representative refers to her daughter, a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or past medical history provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (dose, concentration, exact route of administration, albumin status, lot # and expiration date were not provided) and (unspecified) DTap (dose, concentration, exact route of administration, lot # and expiration date were not provided), both for prophylaxis. On an unknown date (reported as 24-48 hours post vaccination), the patient had a fever with a maximum temperature of 103.5 (unit not provided) which lasted approximately 36 hours. No other associated symptoms were reported. The outcome of fever was unknown. The relatedness between the event and the suspected vaccines was not provided.
Patient presented to emergency department on 11/3/21  because she had lost consciousness after hitting her head on a door frame in her home. she had gotten up from bed to go to the restroom and got dizzy and fell patient was found to be covid-19 positive on 11/3/21, but did not require treatment for symptoms associated with covid. Patient was discharged to home on 11/4/21 with family.
Patient came in on 10/30/20 and asked if arm should still be sore after getting the shingles shot on 10/1/20. Was using diclofenac gel on her own. Referred patient to her doctor if continues. Area of concern was within the shot range of immunization administration when asked where arm pain is located.
Outbreak of rash on buttock similar to past experience with shingles, sore throat, arm soreness at injection
This spontaneous report as received via a company representative from a physician refers to a male patient of unknown age. The patient's current conditions or medical history were not reported. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX vial 0.65 ml subcutaneous injection (lot number and expiration date not reported). On an unspecified date in 2008, shortly after receiving ZOSTAVAX the patient developed a rash on a small area on one unspecified side of his buttocks. The patient sought for medical attention and received LYRICA as treatment. Outcome of rash on a small area on one unspecified side of his buttocks was unknown at the time of the report. Additional information is not expected.
Pt saw NP at clinic on March 15th regarding the redness around the injection site. Pt reported no fever or signs of malaise, however the injection site remained sore & swollen for 3 days post vaccination. Pt was given KEFLEX 500mg Q6h x 7 days by the clinic.
cold sweats; couldn't stand more than 15 sec; Knocked out; Felt like she was either going to sleep and waking up or passing out and waking up after the second dose; extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and C12A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea). At the time of the report, COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow up received contains no new information added.
VAXELIS was administered to a patient after his 5th birthday; This non-serious spontaneous safety Report with reference number 2022SA161948, was received by Sanofi, on 03-May-2022 and forwarded on 05-May-2022 from a HCP.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported off-label event, "VAXELIS was administered to a patient after his 5th birthday".  No further information is expected because HCP does not want to be contacted
When I started to get ready for bed I was overcome with fatigue, and I went to sleep and I woke up two hours later with terrible pain in my muscles and joints, and the injection site was sore. I woke up two other times throughout the night. I was weak, and yesterday the pain was somewhat lessened, but I had an intermittent mild head ache throughout the day, and I went to bed early last night. This morning the ache was still a little achy and tired, but that had cleared up by noon.
Mild swelling on legs. Slightly raised red rash on arms, legs, face, torso and back. 1 Temp 100.5.
Fever for 24 hours followed by migraine-like headache and eye pain that has lasted through 5/5/21
no additional adverse events; Vaccine administered from expired lot; This spontaneous report was received from an unspecified health professional and refers to a 17-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated from an expired lot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, once, lot #T028583, expiration date: 04-MAR-2023, administered intramuscularly for prophylaxis (strength was not provided) (expired product administered), and requested guidance for revaccination. No further information provided, no additional adverse event (AE).
This spontaneous report was received from a healthcare worker via company representative refers to a male patient of unknown age. On 12-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J006827 (dose, route and frequency were not reported). Concomitant therapies included PROVENTIL. On an unknown date, the patient experienced a rather large rash after receiving ZOSTAVAX. The reporter stated that the rash was below chest on left side and extended around to flank area. The physician was interested in collecting specimen from rash. The patient sought medical attention and saw the physician in office. On an unknown date, isolate collected from the patient. The patient was treated with ZOVIRAX tablets and ointment. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
No further adverse events; Caller is nurse reporting administered dose of expired MMR II.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 17-MAY-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) 1 dose, lot #: T016196, expiration date: 11-MAY-2022 (strength, site and route of administration were not provided) for prophylaxis. There was no further adverse events reported.
mild lethargy; Mild soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0162) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot No: EN6202) in left arm, at 01:30 PM), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Mild soreness at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021 12:00, outcome "recovered" (Apr2021), described as "Mild soreness at injection site"; LETHARGY (non-serious) with onset 15Apr2021 13:30, outcome "recovered" (Apr2021), described as "mild lethargy". Therapeutic measures were not taken as a result of vaccination site pain, lethargy. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
14 employees recvd 3 doses of Engerix-B & all were titered; 5 did not respond;
Nausea, fever, body aches. Took Tylenol for body aches. Waited out the fever and nausea. By 10pm April 24, symptoms were mostly gone.
Was not able to sleep due to the pain; Eyes, ears and forehead hurt; Eyes, ears and forehead hurt; Pain in the arm of the injection (right arm); Strong headache/ forehead hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Was not able to sleep due to the pain), EYE PAIN (Eyes, ears and forehead hurt), EAR PAIN (Eyes, ears and forehead hurt), VACCINATION SITE PAIN (Pain in the arm of the injection (right arm)) and HEADACHE (Strong headache/ forehead hurt) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INSOMNIA (Was not able to sleep due to the pain), EYE PAIN (Eyes, ears and forehead hurt), EAR PAIN (Eyes, ears and forehead hurt), VACCINATION SITE PAIN (Pain in the arm of the injection (right arm)) and HEADACHE (Strong headache/ forehead hurt). At the time of the report, INSOMNIA (Was not able to sleep due to the pain), EYE PAIN (Eyes, ears and forehead hurt), EAR PAIN (Eyes, ears and forehead hurt), VACCINATION SITE PAIN (Pain in the arm of the injection (right arm)) and HEADACHE (Strong headache/ forehead hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received contains no new information
I had horrible body aches all over my body, felt like flu. I was sneezing and throwing up. I had a horrible migraine. I had a temperature of 104.
pt recvd vax; c/o cough; lab eval revealed sputum culture neg; blood culture pos for strep pneumoniae;
Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling and burning sensation present accompanied with itching around lips and face. Benadryl, Claritin and Pepcid are currently being taken to reduce swelling.
immediately after the vaccination: dizziness, fast herat beat, short of breath, weakness, stiff neck  -couple hrs later: weakness, slightly feverish
FEELING TINGLING IN THIGH; BURNING PAIN; VACCINE DESTROYING BODY; PAIN IN FEET; INJECTION SITE VERY PAINFUL; MUSCLE STIFFNESS AT INJECTION SITE; INFLAMMATION IN THIGHS, BILATERAL FEET, ANKLES AND ARCH OF FEET; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included plantar fasciitis, prp in bilateral feet, and surgery, and concurrent conditions included carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle stiffness at injection site. On MAR-2021, the subject experienced inflammation in thighs, bilateral feet, ankles and arch of feet. On MAR-2021, the subject experienced burning pain. On MAR-2021, the subject experienced vaccine destroying body. On MAR-2021, the subject experienced pain in feet. On MAR-2021, the subject experienced injection site very painful. On 06-MAR-2021, the subject experienced feeling tingling in thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in feet, feeling tingling in thigh, inflammation in thighs, bilateral feet, ankles and arch of feet, burning pain, vaccine destroying body, muscle stiffness at injection site, and injection site very painful. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a nurse practitioner concerning a 15 year old female who on 27-Feb-2009 was vaccinated intramuscularly. 0.5ml, with the first dose of GARDASIL (lot# 661046/0546X). Concomitant therapy included montelukast sodium (MSD) and Ortho Evra. The patient experienced a cough after receiving GARDASIL on 27-Feb-2009. The patient was brought to the emergency room due to her difficulty in breathing. The patient sought medical attention by speaking to the nurse practitioner and recovered. Follow up information has been received from the office manager who reported that no other vaccines were given at the time of GARDASIL vaccines dose. It was confirmed that the patient was not admitted. Emergency room treat included Acetaminophen and Ibuprofen (dose and duration not reported) for fever and pain. The patient was discharged home in stable condition. The emergency room records stated, "Impression: Drug Reaction. No further information is expected.
Booster dose two weeks ago; Pain in my arm; I am having very bad chills; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EW0186) via an unspecified route of administration on an unspecified date in Oct2021 (reported as two weeks ago) as dose 3 (booster), single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included, patient previously received dose 1 and dose 2 of COVID-19 Vaccine (unknown manufacturer) via an unspecified route of administration, on unspecified dates for covid-19 immunization. On an unspecified date in Oct2021, booster dose two weeks ago was reported. On an unspecified date in Oct2021, patient experienced pain in the arm and patient was having very bad chills. Patient reported that patient had no reaction from first two shots patient had, patient was still having pain in the arm and patient was having very bad chills, patient had called the primary care doctor. Patient also asked have you ever heard anyone having a reaction last 2 weeks and reported that patient was having a reaction that lasted for 2 weeks. Outcome of the events pain in my arm and I am having very bad chills was not recovered.  No follow-up attempts are possible. No further information is expected.
Above person c/o pain to (R) arm and fever x 2 days after receiving vaccination. No redness noted at site. No edema noted.
Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male adult patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunization. No Known allergies. Facility type Vaccine was Workplace clinic. No other vaccine in four weeks. No covid prior vaccination, No covid tested post vaccination. Medical history included hypertension, diabetic. Concomitant medications in two weeks included metformin (METFORMIN); nebivolol hydrochloride (BYSTOLIC). On 28Jan2021, the patient experienced sore arm, fever of 100.2, blood sugar keeps dropping. No treatment provided for the events. The patient underwent lab tests and procedures which included blood sugar keeps dropping, body temperature was 100.2. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
A week after I received my flu shot I fell ill with a severe flu?/viral infection? that took me six weeks to recover from. Symptoms: On the first day, severe dizziness (could not get out of bed), strong headache, nausea, low-grade fever, fast pulse, restlessness. Dizziness better after first day. Low-grade fever continued for a week. Outbreak of flu?/viral infection? may or may not be connected to flu-shot. At the time I took the flu shot I did not show any symptoms of being unwell. I have been having a flu shot for over ten years and have never shown a reaction. PS: I don't know the name of the vaccine manufacturer health center used.
Patient had soreness that started at the wrist and migrated toward injection site. No redness noted. Pt. said felt like "carpal tunnel" issue. Talked to patient, doing better, 2 days after injection.
Red/pink maculopapular rash on anterior and posterior trunk.  No vesicles noted.  Mild discomfort or itching.  Rash is most prevalent on anterior trunk.  No fever or signs of illness present.  Pt's brother with a few very similar lesions to trunk without any other symptoms.  Varicella vaccine given on 8/13/2013 with other routine immunizations.  Rash is most consistent with varicella.
Pt vomited in his personal car while driving out of County Health Dept. parking lot.  When I arrived at pt's location in lot, he stated he felt "fine" now and denied nausea, vomiting, dizziness, ringing in ears, visual disturbances.  He was able to ambulate independently without difficulty and his skin color was within normal limits. Pt recovered completely before leaving parking lot.
After 5-6 days of 1st dose injection, I was occasionally experiencing irregular heartbeat. It can stop itself after taking a rest.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 12:30 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure under controlled" (unspecified if ongoing), notes: high blood pressure under controlled. Concomitant medication(s) included: LISINOPRIL. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset Apr2021, outcome "not recovered", described as "After 5-6 days of 1st dose injection, I was occasionally experiencing irregular heartbeat. It can stop itself after taking a rest.". The event "after 5-6 days of 1st dose injection, i was occasionally experiencing irregular heartbeat. it can stop itself after taking a rest." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate irregular.  Additional information: The patient received second dose of vaccine on 27Apr2021. No other vaccine in four weeks. Other medications in two weeks: Lisinopril. The event does not affect her daily activities. No covid prior vaccination and no covid tested post vaccination. Allergies were not known.  No follow-up attempts are possible. No further information is expected.
Fever; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (body aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), EMPAGLIFLOZIN (JARDIANCE), SPIRONOLACTONE, METOPROLOL, baby asprin and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, PYREXIA (Fever), MYALGIA (body aches) and CHILLS (chills) had resolved. Not Provided    This case was linked to MOD21-051345 (E2B Linked Report). This case was linked to MOD-2021-040760 (Patient Link).; Sender's Comments:  MOD21-051345:cross linked id
Patient called with c/o skin rash on forearms several days after his receipt of SPV and AVA #2.  8/8/08 Autoinnoculation (active)  Symptoms: Rash, focal, Pruritus
The patient had a heart attack and died two days after his second COVID-19 vaccine. He was taken to the hospital. Their phone number is (Privacy).
pt recvd vax 19AUG92 & 2 hrs following the vax exp a systemic react including flushing & itching on chest & arms; sx persisted for approx 30 mins & recovered; No further details were provided;
Lightheadedness, vertigo, nausea . Sense of smell has changed. Have a strong metallic smell that smells like garbage that never goes away.
Enlarged pustule approx 3cm x 3.5 cm with crusting and blisters.