chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pneumovax 9/8/04 seen 9/10/04 c/o left arm sore immobile, Temp 101.3 x1d Rx Advil-Tylenol for relief. Dx Cellulitis Rx Augmentin 500mg tabs 1 BID x 10d and Claritin 10mg 1 QD x 10d. Rechecked 9/13/04- afebrile x/d- seen at urgent care 3 days ago- Dc'd Augmentin changed to Omnicef. Put on Prednisone 4cm diameter left deltoid, fading erythematous area with firmness. Warmth at site of injection. Dx resolving cellulitis 2 hours Pneumovax.
Red welt on thigh. Child is 14 months now and welt is still apparent.
T105 & fluctuated down to 102-101 until 10JUN91; Lt leg inject site swollen for about 2 wks; Seen by MD 6JUN91; Given Ceclor 125mg for poss infect;
Patient said she walked two miles and didn't eat breakfast before the vaccine and doesn't do well with needles. Patient has had fainting spells in the past from vaccines. She reports feeling much better is eating, drinking and taking it easy today. If she experiences other symptoms she will contact her PCP.
Patient stated she had swelling of lips and face about 6 hours after receiving HBV, MMR, and Td. No difficulty breathing.
No adverse event.  Reporting a vaccine administration error.  Administered the Kinrix vaccine to an 8 month old when the vaccine is only approved for children 4 through 6 years of age.
Hit me a little faster - arm was sore and tired when I got home (within an hour); within two hours I had chills but felt hot to touch and a headache. I got under the covers. It hit 99.9 (fever). I slept hard for most of weekend. Arm was really itchy - I had swelling again. I didn't see a doctor. A couple of days after I got my shot - stomach issues, diarrhea, flu, body aches - those lasted a couple of days by Tuesday. Except the stomach pain lasted about a week. High blood pressure and migraines was having these too. Have struggled with heart palpitations and insomnia at night because blood oxygen level at night is in the low 90's. Doctor has said to wait a little longer to see if goes away. Metropole - or Toprol was added either right before the second dose or right after second dose of vaccine. Migraines and sleep issues are still an issue - as well as the low blood oxygen level. The symptoms that are typical vaccine related side affects have resolved.
Adult dose given to pediatric patient. Hepatitis A (GlaxoSmithKline).
Dizziness; Shoulder Pain; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A 21A) for COVID-19 vaccination.     The patient's past medical history included Dog bite.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, DIZZINESS (Dizziness), ARTHRALGIA (Shoulder Pain) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medications are Provided.
Wife came back to fill NORCO and ZOFRAN. Wife states that pt has a hematoma resulting from the vaccination.
This spontaneous report has been received from a pharmacist, concerning a 79 year old female patient. It was reported that the patient had no current conditions as well as drug reactions, allergies or pertinent medical history. Concomitant therapies included CRESTOR, nitroglycerin, EFFEXOR and lorazepam. On 22-AUG-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously, lot number N014019 and expiration date 04-JUL-2018 for prophylaxis which was reconstituted with sterile diluent (manufacturer unknown) lot number N015478 and expiration date 28-SEP-2019. At the same date, the patient was vaccinated with tetanus toxoid (manufacturer unknown). On 22-AUG-2017 (reported as immediately after getting the vaccines), the patient did not feel good, felt light headed and stayed in the pharmacy for a little while. On 23-AUG-2017 (reported as the next day), the reporter stated that the patient still did not feel right. Approximately on 10-OCT-2017 (reported as now it has been 6 weeks since she got the shot), the patient's injection site was still red and warm, she was still irritable and the patient did not feel right. On an unknown date, the patient went to the doctor's office and was treated with PHENERGAN for the adverse event and nausea as well. The reporter stated that the red and warm injection did not look like a rash or rash-like lesion. It was reported that no laboratories were performed. The outcome for malaise, felt light headed, injection site red and warm, irritable and nausea was reported as not recovered. The causal relationship between the adverse events and the therapies of ZOSTAVAX and sterile diluent (manufacturer unknown) was not assessed.
Patient presented to health clinic as a walk-in for COVID-19 vaccination.  Patient self-disclosed as NOT having received  any prior COVID-19 vaccines.  Patient vaccinated with J&J vaccine per our protocol with questionnaire and consents signed.  Upon entry of vaccination record into our EMR system, it was discovered that the patient had in fact received one dose of the Pfizer COVID-19 vaccine on 03-23-2021.  Patient had no ill effects from J&J vaccine administration.  This was a matter of additional vaccine given as well as different manufacturer.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Woke up on 9/5 with 3 bumps on right arm in crease and a straight line in crease of left arm that itched.  Took shower and went away.  Around 11:00a, back started itching.  Within 15 minutes entire back was covered in hives.  Took 2 Benadryl; went away.  On 9/6, woke up at 2:00a with swollen hands and feet - no intervention taken.
About 2 days after receiving the second dose I started experiencing redness and pain at the injection site. It was also warm to the touch. It was about almost 2 in in diameter. It got worse on the next day and it slowly started getting better, it went away in about 4 days. Then I had a gallbladder surgery that was scheduled on 01/29/2021. On 02/03/2021 I was feeling excruciating pain that I believe it was related to the gallbladder surgery. I went to the ER, the same hospital where I got the vaccine at and they ran a lot of tests on me, blood work, CT scans, ultrasounds and they told me my D Dimer was elevated: 2371. They attributed it to my recent surgery and told me to FU with my PCP. When I FU'd with my PCP Dr., she requested new blood work and this time my D Dimer was even higher than the results at the ED: 2610. That was on 03/01/2021. She is trying to get me in the Clinic she is concerned about cancer. I think it might be something regarding the vaccine.
Suicidal thoughts; Both ears ringing, nonstop; Can't sleep; No appetite; Either hot or cold, no in between/hot and cold sweats; Feels boxed in; Having weird thoughts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), TINNITUS (Both ears ringing, nonstop), INSOMNIA (Can't sleep), DECREASED APPETITE (No appetite), BODY TEMPERATURE FLUCTUATION (Either hot or cold, no in between/hot and cold sweats), FEELING ABNORMAL (Feels boxed in) and THINKING ABNORMAL (Having weird thoughts). On 26-Mar-2021, DECREASED APPETITE (No appetite) had resolved. At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), INSOMNIA (Can't sleep), FEELING ABNORMAL (Feels boxed in) and THINKING ABNORMAL (Having weird thoughts) was resolving, TINNITUS (Both ears ringing, nonstop) had not resolved and BODY TEMPERATURE FLUCTUATION (Either hot or cold, no in between/hot and cold sweats) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On Wednesday, 24-Mar-2021 the caller stated that out of nowhere, his ears starting ringing, both ears. The ringing is like yelling in his ear.   Ringing in his ears had not stopped yet and continued to drive him cray. He feels boxed in and can't sleep. He has no appetite and either feels extremely cold or extremely hot, it's one or the other, no in- between. Yesterday, 25-Mar-2021, the caller went to the emergency room due to these symptoms. He was not admitted. Caller stated that things are so bad  that he  even had suicidal thoughts and was prone to anxiety.  On the follow up report patient reported the ringing was in his left ear only and the other reported symptoms had started to get better. Since 26-Mar-2021, his appetite had returned and the felling of hot, cold sweats had gone away. Treatment was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: added additional reporter information, race, weight,; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Dx with erythema multiforme on 10/8/13. FLUMIST was administered 7 days ago per staff.
feeling nauseous and achy, had a sore back; feeling nauseous and achy, had a sore back; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; had fever and fatigue after the first two doses, a sick feeling; feeling nauseous and achy, had a sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling) and FATIGUE (had fever and fatigue after the first two doses, a sick feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBAMAZEPINE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (feeling nauseous and achy, had a sore back), BACK PAIN (feeling nauseous and achy, had a sore back), ILLNESS (had fever and fatigue after the first two doses, a sick feeling), PYREXIA (had fever and fatigue after the first two doses, a sick feeling), FATIGUE (had fever and fatigue after the first two doses, a sick feeling) and NAUSEA (feeling nauseous and achy, had a sore back) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included carbamazepine XR.   This case was linked to MOD-2021-345463, MOD-2021-345470 (Patient Link).
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 20-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 28F for 408 hours, Dates of excursions: 01-FEB-2014 to 20-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
FEVER; MUSCLE ACHE; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart attack 2 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 05-AUG-2021, the patient experienced fever. On 05-AUG-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle ache. This report was non-serious.
RN Called to the Waiting room by another member- reporting Pt was having a "seizure" Upon arrival to the waiting room patient was awake and able to speak verbally.  Assisted patient to recliner in the vaccine room.  Two  Members in the lobby described the event stating patient was on his phone, dropped his phone, muscles tensed up, head fell back and was groaning.  Estimated the event lasted 10-15 seconds total. Pt taken to clinic for observation.  Md suspects vasovagal rx and and not seizure activity necessarily. Pt d'cd home to family after returning to baseline and requesting to go home.
Interchange of vaccine products; Revaccination with different COVID-19 vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    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, first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. Patient took first shot of Pfizer, second shot of moderna and booster shot of Janssen. 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.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was on an unknown date. On 26-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The estimated due date was End of JUL2021. Concomitant product use was not reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090470 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090470:2nd dose case
1st dose was not fully administered, solution leaked from patients deltoid, nurse confirmed syringe/needle was secured, 1st dose of the series was re-administered per guidelines
She got her vaccine, she had noticed it about 3-4 hours after vaccine having palpitations, real bad with shortness of breath.  She kept doing her errands and then went to work.  She works night shift and got home about 12:00 and took a shower and was tired.  Went to bed and woke up around 6:00 AM and she couldn't back to sleep anymore and had red eyes, and went to UC and told her that her palpitations were gone, and had no shortness of breath and asked them to check her thyroid.  They did thyroid test.  Her red eyes were gone, and she said that everything was fine.  Her lungs were checked and she did not hear anything, and was sent home.  She is OK, and able to go to work.    She has had 4 COVID vaccines and has had no reactions.
5 days after receiving her 2nd varcilla vaccination, patient developed a small erythematous papule on her abdomen.  Over subsequent several days she developed more lesions on her trunk, arms, legs, and face.  No vesicle.  + itching.  On exam, only papules visualized in different stages of development.
I became pregnant in between my first and second dose of the series; This is a spontaneous from a contactable consumer. This female consumer reported that a female patient of an unspecified age received first and second dose of BNT162B2 (solution for injection) both doses via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that became pregnant in between my first and second dose of the series. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
given a dose of Infanrix instead of Boostrix; given a dose of Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. Manager stated that a female patient was inadvertently given a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up via email.
This spontaneous report as received from a physician refers to a 45 year old female patient. There was no concurrent conditions, medical history, and concomitant medications. Patient had allergy to latex. Approximately in 2006 (reported as 10 years ago) the patient received a full series of an unspecified Hepatitis B vaccine (manufacturer unknown) (dosing details, route of administration, lot# and expiry were not reported). The patient tested negative for Hepatitis B titers after she had an occupational exposure to saliva in 2015. The patient consulted the physician because of the workman's compensation claim, and the physician discovered the negative Hepatitis B titers during routine tests regarding that claim. The physician also tested the patient for Hepatitis B surface antigen, and the patient did not test positive for Hepatitis B surface antigen. The physician was not able to provide the name of the Hepatitis B vaccine that the patient received "10 years ago", or the dates that the patient received the doses because the patient received the series under the care of another provider. The physician does not have access to the patient's records from the previous provider at the time of this report. Since testing negative for Hepatitis B titer, the patient received a dose of RECOMBIVAX HB (lot # L010595, expiry: 12-NOV-2016) and (lot# L029631, expiry: 14-MAR-2017) on 30-SEP-2015 and 13-NOV-2015 respectively. The patient was otherwise healthy. The outcome of the event was unknown. The reporter did not provided the causality between the event and the suspect therapy. Additional information has been requested.
Redness, swelling and hives on upper left arm, where injection was. Approx 52 hrs after injection.
Person developed slight rash and itch at 11:25 AM.  BP 118/80.  11:40 developed diffaculty swallowing.  11:50 EMS arrived and took charge of management.  Follow-up attempted.  Phone not in service.
Patient complained of pain, soreness at site same day when given. Patient was seen that afternoon and ordered Prednisone 4mg dose pack for allergic reaction. Patient complained of chest pain night of 10/29/02 and advised to see medical provider/ER. Seen on 10/31/02. Site on arm 10/30/02 - 1/2" redness.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of VAQTA (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.