chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; she had red arms; she couldn't sleep; Allergic skin reaction; swollen and itchy; swollen and itchy; sharp abdominal pain; bloating and gas; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201, patient was 52-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing Hashimoto's thyroiditis, it was diagnosed at least 10 years ago, maybe more, probably closer to 16 years. There were no concomitant medications. Reported that her first dose was injected to her left arm between 01:30-01:45PM. She says that her side effects were that first she had a sharp abdominal pain around 06:00PM, dinnertime, and she lay down because it was so sharp, it was right on liver or gallbladder area. She says that the last several days, and also today, she has had bloating and gas like crazy. She says that the next day probably closer to noon she had diarrhea very bad, and that still goes on, though it slowed down today. She says finally yesterday afternoon, which was almost 48 hours, she started having an allergy skin reaction to her arms, face, forearms, they were swollen and itchy, she had red arms and she couldn't sleep. On 12Feb2021 at 06:00 PM, the patient experienced sharp abdominal pain, on an unspecified date in Feb2021, the patient experienced bloating and gas, on an unspecified date, the patient experienced diarrhea, she couldn't sleep, and she had red arms, on 14Feb2021, the patient experienced allergic skin reaction, swollen and itchy. Patient received treatment for events (bloating and gas, diarrhea, allergic skin reaction, swollen and itchy, she had red arms and she couldn't sleep with Benadryl to go to bed last night, and her doctor wants her to come in to see them. Benadryl caplets/Ultra tabs: UPC: 312547170314, LOT: SBF081, EXP: Aug2021. She says each caplet is 25mg, she took one caplet by mouth around midnight to go to sleep last night because she couldn't sleep. She says that she did no treatment for the gas, bloating, or diarrhea. She says she has been drinking green tea and avoiding irritating foods or anything heavy. She says for her question she may wait to talk to her doctor, it seems like a moderate reaction kind of like those described on the sheet. She says she is supposed to get her second dose in three weeks, and would like to know if she should get that after this, but she will see her doctor tomorrow to talk to them about it. Caller says something about how the information says only 5 cases that were severe were reported, for carrier of PGE, it seems read those with the signs and symptoms reacted to PGE. Unable to clarify with caller what PGE might be. The outcomes of events (sharp abdominal pain, bloating and gas, Allergic skin reaction, swollen and itchy. she had red arms, she couldn't sleep) were unknown, and the outcomes of events (Diarrhea) was recovering.  Follow-up attempts completed. No further information expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer on 08-May-2021 and Pfizer on 08-Jun-2021.Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient). On 12-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration error,Moderna vaccine given to a 17 y/o patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported.No treatment details were reported.
herpes zoster on the left and mid back in the L1 distribution; This is a spontaneous report from a contactable physician (patient). A 34-year-old non pregnant female patient received bnt162b2 (lot number: EK9231), via an unspecified route of administration on 22Dec2020 in left arm at single dose for Covid-19 immunization. Medical history was none. There were no other medications the patient received within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On unspecified date, the patient experienced herpes zoster on the left and mid back in the L1 distribution. She was not otherwise immunosuppressed and never had zoster before. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with sequel (reported as Recovered with lasting effects). Therapeutic measures were taken as a result of the event which included Valacyclovir. The event was considered as non-serious.
numbness pins needles in hands legs, arms numbness in face and lips, very sick and dizzy feeling as I was going to have a stroke lasted several days till weeks.  still have some side affects
tachycardia; throat tightness; tingling lips and under tongue; itching face; This is a spontaneous report from a contactable physician. This physician reported for a 43-year-old female patient.  A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: EN5318), intramuscular on 11Feb2021 09:30 as 2nd dose, single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and ongoing.. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL), levothyroxine (LEVOTHYROXINE). Allergies included Sulfa, iodine contrast media, latex, Levaquin, penicillin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: unknown), via unspecified route on 21Jan2021 (at the age of 42-year-old) 1st dose, single dose for covid-19 immunization. On 11Feb2021 at 09:30, the patient experienced tachycardia, throat tightness, tingling lips and under tongue, itching face. Therapeutic measures were taken as a result of events of Benadryl, Pepcid, prednisone. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were resolved in 2021.  Follow-up attempts completed. No further information expected.
day four severe pain in muscle in left leg where leg meets trunk  muscle in waist above navel to left hip
My menstrual period which has always been on time my entire life was 11 days late. It was due to occur on 4/13/21 but did not come until 4/24/21. I took two pregnancy tests in between those dates and both were negative. When my period did come the blood was darker than usual, the clotting heavier, and the cramping was more intense.
Pt got first SHINGRIX shot 8/15/18 reports that on Friday she developed "U shaped" rash below collar bone and then reports warmth at the injection site and rash on elbows that started 1-2 days later.
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) had resolved.            Concomitant medications  was not reported.  The patient had chest pain, 5 to 6 days after receiving vaccine and was admitted to the ER. The condition later cleared up on its own. But She was left with medical bills and attributes the chest pain to receiving the Moderna mRNA-1273 bivalent booster.  No treatment information was reported.   This case was linked to MOD-2023-703380 (Patient Link).
I woke up around 1am. My left ear was ring so loudly and I can barely hear from it. It still continues to ring constantly and the hearing is still decreased.
The patient donated plasma and then had rabies immunization #3.  After he got home he felt feverish and had a headache for 2 or 3 hours.
Patient developed redness, swelling and scattered blisters at injection site (left thigh) approx. 24 hours post injection. Presented to Urgent Care on 4/14/2017 (same location as shot given). Return call pending.
Vaccine at 16:30 with physical exam. No problems 4/5/02. 4/6/02 around 04:30, woke with inconsolable crying for 1 hour plus. 4/6/02 cranky and irritable. No temperature, thick, yellow nasal drainage and watery eyes, decreased appetite. 4/7/02 bouts of crying nonstop for 30 minutes or more, nasal drainage, yellow and thick, watery eyes. 4/8/02 watery eyes, crying and cranky. Took to see doctor at 18:30. Diagnosed with an ear infection and put on medication. Did not acknowledge why there were no problems on 04/05/02 when vaccine was given.
Patient reported nausea and dry heaves, as well as diarrhea and some vertigo.
Started getting excruciating joint pain; Stiffness; Knees and elbows get warm; Shoulders and hips hurt so badly; Shoulders and hips hurt so badly; Have extreme fatigue; Pain is debilitating; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727), via an unspecified route of administration on 19Mar2021 at 10:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included systemic lupus and rheumatoid arthritis. The patient did not have any allergies to medications, food or other products. Concomitant medications included labetalol (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, after the first dose, the patient started getting excruciating joint pain and stiffness, knees and elbows get warm, shoulders and hips hurt so badly and had extreme fatigue. The patient was concerned and the pain is debilitating. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events started getting excruciating joint pain and stiffness, knees and elbows get warm, shoulder and hips hurt so badly, extreme fatigue and pain is debilitating were not resolved at the time of reporting. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included dialysis and shellfish allergy.  Concurrent medications included Multiple unspecified medications.  On 12 February 2007 the subject received the 1st dose of Engerix B (40 mcg, unknown, unknown arm).  On 14 February 2007, 2 days after vaccination with Engerix B, blood work was completed, and the subject was found to be hepatitis b surface antigen positive.  Previously, the subject had been hepatitis b surface antigen negative.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Nausea and vomiting that started a little the day of but mostly the following day and that has now persisted daily for 11 days.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who received an expired PENTACEL 15 days after the expiration date, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. On 01-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 2 weeks after second the injection i developed significant pain in shoulder and intermittent numbness and nerve type pain in my left should, forearm, hand, thumb and fingers.
Information has been received from a licensed practical nurse concerning a 26 year old female with an allergy to penicillin, amoxicillin, morphine and acyclovir who on 21-AUG-2007 was vaccinated with the first dose of Gardasil (lot# 654539/0742U) intramuscularly in the left deltoid of the upper arm.  Concomitant therapy included birth control (unspecified) and vitamins (unspecified).  On 23-AUG-2007 the patient broke out in rash from the waist up, red but not itchy.  She did not feel right.  She felt "crappy".  The patient had not recovered.  No lab testing was performed.  Additional information has been requested. This is in follow-up report(s) previously submitted on 9/17/2007. Information has been received from a licensed practical nurse concerning a 25 year old white social worker female with an allergy to penicillin, amoxicillin, morphine, and acyclovir who on 21-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 654539/0742U) intramuscularly in the left deltoid of the upper arm. Concomitant therapy included birth control (unspecifed) and vitamins (unspecified). On 24-AUG-2007, three days after the vaccination, the patient broke out in rash from waist up, red, itchy. She did not feel right. She felt "crappy". Unknown medical attention was sought. The patient had recovered. No product quality compliant involved. Additional information is not expected.
Patient first complains of muscle pain at site of injection on right arm, where the Prevnar 13 was injected. Later on, the muscle pain progressed until she noticed swelling on 02/09/2016. Patient's daughter gave the patient Aleve and topical arnical gel to try and relieve pain/swelling. Still swollen. No reaction on the left arm.
Patient stated that the next day she went to work and had chills and fainted. The paramedics came and helped her regain consciousness and evaluated her. She had no further incidents and felt fine the next day.
Headache starting 10:00AM. Fever and chills starting during sleep, but gone bye 4:00AM.
Patient felt nauseated and turned pale, mother stated patient had just gotten up and hadn't eaten all day, 3:15PM.
Pt reports waking up after receiving 2nd Twinrix vaccine 8/3 with sore throat, lymphadenopathy of throat, fatigue, achiness. This has continued off and on for two weeks.
Patient fainted after immunization and had a ~15 second episode of shaking/tremors.
Pt reported a generalized non pruritic skin reaction, pt sent to hosp for evaluation. Vital signs were stable. Target like erythematous macular raised lesions, measuring ca.3mm in diameter were noted on both upper extremities high anterior chest, high back and and couple on left calf. No signs of respiratory compromise or other signs of anaphylaxis were noted. Cold compresses were recommended.
Felt light headed briefly gave juice and pt felt better. Pt was DC home with stable vitals no airway or SOB
Pt. states he had a flare of his rheumatoid arthritis in June, 1 month after receiving ZOSTAVAX. He states it flared "everywhere" (hands, feet, knees) Pt. saw MD on 8-3 & was prescribed MTX, folic acid, & CELEBREX. Had F/U appt. with Dr on 9/7 - L/M with pt for details regarding this visit.
At 5:46pm = Vomited and starting itching all over O2 sat RA 92%, gave EPI 0.15mg IM x 1, Albuterol 0.083% solution via neb mask with O2 5l-7l/n O2 sats 98-99% skin pink - sl. rash but not at injection site. 10 ml of BENADRYL given 6:00pm. Sent ED via ambulance. Per mom had reaction to flu vaccine in 2008 & 2009. Pt was seen outside of practice for these injections. This was stated post-reaction.
This case was reported by a other health processional and described the occurrence of therapy non-responder in a adult patient who received HAB. Co-suspect products included HAB and HAB.  On an unknown date, the patient received the 1st dose of HAB, the 2nd dose of HAB, and the 3rd dose of HAB. On an unknown date, an unknown time after receiving HAB and HAB and 7 days after receiving HAB, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was  unknown. It was unknown if the reporter considered the therapy non-responder to be related to HAB, HAB and HAB. Additional details were provided as follows: This case was reported by a medical assistant. The patient was following an accelerated schedule of HAB, with the intention of starting HUMARA. One week after receiving the 3rd dose of HAB, the patient underwent laboratory test which revealed negative titers for hepatitis A and B antibodies. Thus, the patient became a therapy non-responder. This case was received via Merck National Service Center. No further information was provided.
8mm by 2mm wheal and redness, itching in arm that got Dtap and MMR. Appeared one day after shot, BENADRYL.
On the second day after the vaccine, I had swollen, painful gums.  My gums bled off and on all day (5/14/2021, vaccine was 5/12/2021).  On 5/15/2021 the bleeding gums stopped but the swollen gums continued through 5/18/2021.    Other than that, I had typical side effects:  pain near the injection site, fatigue, extremely swollen and painful lymph nodes.
BODY ACHES; SICKNESS; DISCOMFORT; CHILLS; MASSIVE HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced sickness. On 13-APR-2021, the subject experienced discomfort. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced massive headache. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sickness, discomfort, chills, massive headache, fatigue, and fever on 14-APR-2021. This report was non-serious.
Patient developed headaches after 1st AVA and that they worsened with each dose. Continues with migraines currently 2x/week and daily lesser headaches. No prophylactic tx has been successful thus far.
Patient presented to ER 3 days after Tetanus Shot with Right Arm Red and Swollen.  SYmptoms began the day of the shot (5/19/2007
BABY WAS IN BREECH OR ABNORMAL PRESENTATION; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.06 kilograms, and height was 20 inches. No past medical history or concurrent conditions were reported. The parent initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, for baby (transplacental), batch number: 1802072 expiry: UNKNOWN) dose was not reported, frequency one total, administered on 09-MAR-2021 for covid-19 immunisation (Dose number series 1). No concomitant medications were reported.  On 09-Mar-2021, at gestational age 24 weeks, the patient experienced foetal exposure during pregnancy. On an unspecified date, baby was in breech or abnormal presentation. At gestational age of 39 weeks and 3 days, live male neonate delivered by caesarean method of delivery. The neonate spent two days in the hospital after birth. It was reported that reason for caesarean method of delivery was breech or abnormal presentation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from baby was in breech or abnormal presentation, and foetal exposure during pregnancy. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related and between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation as related. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210763277.; Sender's Comments: V0: 20211238278 - covid-19 vaccine ad26.cov2.s- Foetal exposure during pregnancy. 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   20211238278 - covid-19 vaccine ad26.cov2.s  Breech presentation. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Anxiety, itching, watering eyes, agitation, anaphylaxis, chest pain, congestion, nasal, dyspnea.
Developed redness, swelling at area of injection. Symptoms started few hours after receiving vaccines. Continued to increase. Started tx with KEFLEX 2 days after getting vaccine for cellulitis. Symptoms got better, then worsened again on day 6 of abx. -> switched to BACTRIM.
Developed redness, swelling and slight discomfort at injection site of MMR vaccine 2 days after injection. Was seen in the office for follow up. Diagnosed with cellulitis of (L) upper arm. Placed on CEPHALEXIN 250 mg/5ml oral liquid.