chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case received on 21 October 2014 from a healthcare professional. An adult male patient, date of birth reported as 1949 was vaccinated on an unspecified date with a first dose of FLUZONE High dose (batch U5042AA, route and site of administration were not reported) and simultaneously with a first dose of "Pneumonia vaccine" Pneumococcal vaccine, manufacturer, batch route and site of administration were not reported. The patient has a history of seasonal allergies and a reaction (rash to "HCTZ" hydrochlorothiazide). He has also never had the flu. Within 2 hours of vaccination he started to experience severe bloodshot eyes with some swelling, severe chest and throat swelling and throat soreness and difficulty breathing. Symptoms progressively worsened to the point that he contacted the office. He was advised to go to the emergency room but he refused and came to the office instead. The patient was treated with IV steroids and BENADRYL and had significant resolution within 2 hours. The patient's concomitant medications and laboratory tests were not reported. No further details were provided at the time of this report. The patient outcome is recovering. Documents held by sender: None.
6cm in diameter erythematous area, over the deltoid, w/ a central red spot, non fluctuant, pt has a sl fever;
MMR and Varicella were combined in one injection. MMR reconstituted with one 0.5ml vial of Sterile Dilutent. Added to Varicella vial to reconstitute and given as one injection. No adverse reactions noted by family as of 04/08/2019.
3 month old child presenting with fever of 102 degrees and generalized seizure 4 days after receiving his 2 month old vaccinations. Admitted at hospital. Also with diagnosis of UTI.
Fever and chills on the 8th and  9th; Over the last couple of weeks, several times that I've gone to doctor. On May 18th, she had what was considered to be  a pre-syncope event (almost passed out). And she had a pretty large migraine headache as well - the headache lasted for days - for probably three days. 18th, went to dr and they took her vitals. They were under the impression she passed out from having the migraine (her blood pressure is low but normal, in general). Dr was called on Monday 24th - doctor wanted tests. She had another pre-syncope event on May 1st in school and then had  a fever the rest of the week. (From 6/1/2021 - 6/6/2021 - fever and threw up and bad headache - fever until yesterday). I did take her pediatrician. Negative for COVID and Strep on 2nd . She had another migraine on Tuesday. Pediatrician said it could be a viral infection of some sort. Neurologist believes the migraines were exacerbated by the viral infection as well. This one has lingered and it's the first time she had a migraine within a week or two  weeks of each other. She was out of school was out 2 1/2 days last week and the week of the 18th she was out of school the 19th and got sick again the 20th and was out.
reporter states "we believe the pts are experiencing fever, pain, & lumps on their arms more often w/Tetramune;
Headache, Myalgia, Fever, NauseaVomiting, fatigue Narrative: Employee reported moderate fever 1/26/2021, severe headache 1/26/2021 to 1/27/2021, moderate muscle pain 1/26/2021, moderate fatigue 1/26/2021, moderate nausea 1/26/2021 to 1/27/2021. Resulted in unable to work 1/26/2021. Did not see medical attention and symptoms resolved 1/28/2021.
Sore to even touch; Terrible pain in her right leg all night long for about a week/ her leg is sore every day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT) for Acid reflux (esophageal), IRON for Anaemia, PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, LOSARTAN for Hypertension, TRAZODONE for Sleep disorder.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day). At the time of the report, PAIN (Sore to even touch) and PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/ her leg is sore every day) had not resolved.            Patient's height was 5'5". Patient did not have any allergies.  Patient did not tested positive for COVID-19 and did not receive any other vaccine 1 month prior to Moderna. At the time of the vaccination, she did not have any acute or chronic illnesses. She never experienced a similar event in the past.  Booster Dose was given on the 17 Dec 2021 every dose in her right deltoid and she doesn't know which dose quantity was applied for those 3 doses. She did not receive a third dose of the Moderna Covid-19 vaccine  The symptoms were ongoing and no treatment had yet been applied.   This case was linked to MOD-2022-485263, MOD-2022-485316 (Patient Link).
This spontaneous report as received from a certified medical assistant to a 13 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
Administered the High-dose Fluzone to a pregnant woman. No adverse events have yet resulted from this error.
Headache, body aches, tongue discomfort. Denies difficulty breathing or swallowing.
Delayed Hypersenstivity Rheumatoid Reaction.  Inflammatory edema hands and feet, rash on legs, severe muscle and joint pain.  Worst joint and muscle ever. Pain worse than a case of chikungunya virus in the past.
Long lasting headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Long lasting headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-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 HEADACHE (Long lasting headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Long lasting headache) had not resolved.            Patient experienced event for the first vaccine dose which lasted for one day two weeks after administration.  Patient informed she also experienced headaches on a daily basis.   Action taken with mRNA-1273 in response to the event was not Applicable   This case was linked to MOD-2021-053416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14 MAY 2021 and does not contain any new information.
Patient received 1st dose of Pfizer and immediately had clammy hands, blood pressure was low 57/45 and hr 50.  EMS was called and patient assessed.  Patient remained in observation for about 30min until recovered and sent home with husband.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included PNEUMOCOCCAL VACCINE. On 25th May 2018, the patient received SHINGRIX (intramuscular). On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever. On 18th June 2018, the patient experienced rash. On an unknown date, the patient experienced injection site reaction. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the rash was recovering/resolving. The reporter considered the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: Three weeks prior to getting SHINGRIX, the patient received a Pneumonia shot when she was at her physician's office for a physical. In the night of vaccination day, the patient experienced redness and swelling at the injection site. The patient also had a lot of shivering and because of the shivering thought she must have had a fever, though she did not get up to take it. The patient had severe body aches as well. The patient did not feel good for a couple of days after, feeling run down and fatigued. Less than a month after vaccination, the patient experienced mark at injection site. All symptoms were resolved other than a mark on her arm at the injection site. Around 18th June 2018, 24 days after vaccination, the patient experienced a rash on ankle. It was not itchy or painful and she put Hydrocortisone on it and it had mostly resolved. The patient thought it was probably not related to the vaccine and she must have picked it up outside.
received 4 Full doses of the Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine). In September 2021, EXTRA DOSE ADMINISTERED (received 4 Full doses of the Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-422916 (Patient Link).
ITCHING, MILD UPPER EXTREMITY PAIN, SKIN RASH AT INOCULATION SITE 3 DAYS AFTER VACCINATION. 3/17/19 - PT C/O OF BODY ACHES, STIFF NECK AND LEFT SHOULDER.
I got an illness that had all the symptoms of Covid-19 but I tested negative. I had chills, fever and difficulty breathing for two days. I had no energy, and I could not function. I was sick for seven days total and unable to work for 5 days. I was surprised that my Covid-19 test was negative.
2 hours after second vaccine I covered in hives.  They have not stopped with andiogemia.  Light Kappa Chain Protein is appearing in lab work as positive.  Chronic problem.  Under oncologist care.
100.2 temp, body aches, headache, stomachache, vomiting.
12 mos old female with low grade temp, URI was given vaccines 930AM tactile temp at home then approximately 7 PM seizure approximately 5 minutes nonfocal no fever in ER O2 sats 100%. (Given TYLENOL 330PM).
Fever, Achy, and weak on the night of immunization. 2 days later her arm was red, swollen, patient couldn't lift her arm.  She went to see her Dr on 10/8/2015.  The doctor said injection may have gone into her rotator cuff, causing the swelling and pain. The doctor told the patient it was not the vaccinator's technique that caused the problem.  He told her she may have had a stress reaction to the injection or just be sick.  He drew blood to check her WBC count to see if she might have a virus.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. In an article, Patient stated to have experienced first hand what it was like to be a breakthrough case. Patient believed to be exposed at a family gathering on a holiday weekend. In patient's immediate family, patient was the only one sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210668131-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Mildly sore injection site for 24 hrs post. Pressure headache with sore neck for up to 24 hrs post inj.
Information has been received from a physician concerning a 70 year old female who on 12-JUN-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 659487/1960U). On 13-JUN-2008 the patient experienced an injection site reaction after vaccination. She experienced redness, swelling, and soreness at the site of injection. It was also noted that the swollen area was warm to touch. The patient sought medical attention at the practice. At the time of the report, the outcomes of the injection site redness, swelling and swollen area was warm to touch were unknown. Additional information has been requested.
I had trouble concentrating and grogginess. I couldn't really do my job. It lasted for a couple weeks.
1) Showing Pfizer COVID vaccine in Facility when Novavax was given 2) Novavax was outdated on 4-30-23
Patient came into the pharmacy on 12-19-2021 and requested to received Pfizer vaccination. Patient filled out a vaccination consent form where he signed and reported that he received a dose of Janssen Johnson COVID-19 vaccination on 04/16/2021. His CDC card also reported that he received Janssen Johnson COVID-19 only. The pharmacist made the clinical decision that it would be appropriate to administer Pfizer COVID-19 vaccine as a booster shot to the patient. Patient was monitored for 15 minutes and did not report any adverse health effects. Patient was healthy after her received the vaccination and left the pharmacy. Later, the pharmacist discovered that patient received Moderna COVID-19 vaccination at another pharmacy. Pharmacist called the patient to inform that it is no recommended by the CDC to receive 3 doses of each covid-19 vaccines and Pfizer vaccine that was received on 12-19-21 was inappropriate because it was not recommended by the CDC. Patient admitted that he wanted to get a booster of Pfizer because he is afraid of the COVID-19 virus. Patient deceived the pharmacy team because he did not report verbally or in written language anywhere that he received Moderna on 10-26-2021 at another Pharmacy.
body wide tingling; both hands became clenched and paralyzed; tachycardic; hurting pretty badly/shooting pain down both legs; not feeling so good; shortness of breath; Arm soreness; severe chills; extreme muscle pain; body wide muscle aches; intense headache; been in bed all day; fever of 102; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PARALYSIS (both hands became clenched and paralyzed) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MALAISE (not feeling so good), PAIN (hurting pretty badly/shooting pain down both legs), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (Arm soreness), CHILLS (severe chills), MYALGIA (extreme muscle pain; body wide muscle aches), HEADACHE (intense headache), FATIGUE (been in bed all day) and PYREXIA (fever of 102). On 07-Apr-2021, the patient experienced PARALYSIS (both hands became clenched and paralyzed) (seriousness criterion medically significant), TACHYCARDIA (tachycardic) and PARAESTHESIA (body wide tingling). At the time of the report, PARALYSIS (both hands became clenched and paralyzed), MALAISE (not feeling so good), TACHYCARDIA (tachycardic), PAIN (hurting pretty badly/shooting pain down both legs), PARAESTHESIA (body wide tingling), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (Arm soreness), CHILLS (severe chills), MYALGIA (extreme muscle pain; body wide muscle aches), HEADACHE (intense headache), FATIGUE (been in bed all day) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 f High. On 07-Apr-2021, Electrocardiogram: 108 diffuse NS ST/T abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the patient was en route to the hospital because both hands became clenched and paralyzed during her ER visit. No treatments were mentioned by the reporter. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Significant follow up- new events  added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Unpleasant symptoms; Serious Aches; High fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unpleasant symptoms), PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Unpleasant symptoms), PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Unpleasant symptoms) had not resolved and PAIN (Serious Aches), PYREXIA (High fever) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relavent concomitant medications and treatmen information provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: event added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mother states child had temp of 100.5 for 4 days, giving fever reducing medication only at night.  States has running nose, cough (did not say if productive or not), sore throat, swollen glands in neck, redness in eyeballs with irritated eyes, and raised red spots on back chest and face.
her arm got swollen; Warm to touch; developed rash; received the first dose of Shingrix on 11Feb2019 /  has not received the second dose yet; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, skin warm, rash and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, skin warm, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the swelling arm, skin warm and rash to be related to Shingrix.  Additional details were provided as follows: The patient's arm got swollen, warm to touch and developed rash after received the 1st dose of Shingrix.  The patient had not received the second dose yet, this led to incomplete course of vaccination.
48 y.o. male with PMHx of Muscular dystrophy, Scoliosis, Chronic Hypercarbic Hypoxic Respiratory Failure 2/2 restrictive lung disease on 2-3L home O2, HFpEF, and OSA not on BPAP presented on 9/26/2022 with c/o dyspnea with associated nonproductive cough and pleuritic chest pain. Prior to presentation, tested positive for COVID-19 by PCR.
From initial information received on 3/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 53 year old patient received a dose of DECAVAC, lot number U1206DA, administered IM in the left deltoid on 2/22/05. Seven days later, on 3/1/05, the patient experienced a deep throbbing sensation in her left arm with limited movement. Per the reporter, the patient had been moving furniture that week. Upon examination, no tenderness or inflammation was noted. The patient self-medicated with ibuprofen and was to follow up with an orthopedic specialist. Her recovery status was reported as unknown.