chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 26AGU93; mom called today 9SEP93 stating pt had cold, sniffles, cough 3 days p/shots; taken to hosp dx w/pneumonia; ATB treatment better today but mom is taking to ENT this PM for f/u;
seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid; My TSH is low; TSI high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs; "Hashimotos disease" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious), outcome "unknown", described as "My TSH is low"; THYROID STIMULATING IMMUNOGLOBULIN INCREASED (non-serious), outcome "unknown", described as "TSI high". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (unspecified date) Low, notes: My TSH is low; (Apr2021) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Jun2022) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Sep2022) Low; Thyroid function test: (unspecified date) Normal, notes: I had 3 Covid vaccines in the time between when my Thyroid tests came back Normal; Thyroid stimulating immunoglobulin: (unspecified date) High; Thyroxine: (unspecified date) Normal; Tri-iodothyronine: (unspecified date) Normal. Clinical course:After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. - It seems after receiving 3 Pfizer Covid Vaccines patient have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid. Her TSH was low - T3 and T4 normal- and TSI high. Nothing had changed for Me except that patient had 3 Covid vaccines in the time between when her Thyroid tests came back Normal. In Apr2021 and then in Jun2022 and Sep22 when TSH was low. Patient inquired would this resolve on it's own.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd vax 24JAN96 & c/o abd cramps,n/v on 28JAN96
12 hours after shoot temp of  102.4. Severe body aches, chill.
Client recvd Tdap vaccine on 6/25/13. He seemed fine, but was woken up at 2am with extreme jaw pain. He took 2 aspirin with no relief after 30 mins, he took an ibuprofen. Client was able to fall asleep again. This morning he woke up with little improvement. He states his jaw still hurts and it is difficult chewing his breakfast. Advise client to go to his physician for further evaluation, as this is not a typical symptom after vaccine. He stated he will wait a few hours to see if symptoms improve. If not improvement or worsening symptoms, he will go to his doctor or walk-in clinic.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 27-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
irregular periods, migraines, lower stomach pains, constant tiredness, dizzy, mood changes, insomnia, nausea, lowered immunity to other illnesses
patient received  vaccine at held clinic shortly after complained of chest tightness that she has experienced in the past but more severe. reports hx of seasonal asthma but no rescue inhaler. monitored for 5 minutes with symptoms not improving attempted to call 911 patient refused because she did not want to be billed instead had husband drive general aprox 20 min drive. EMT on site also examined patient and recommended 911 call again patient refused
1-2 days ago itchy rash back, trunk. Office visit 7/2/03 - erythematous vesicular rash on face, trunk, extremities. Some lesions in mouth. No fever. Lesion culture done (many lesions on back). Follow up on 07/31/2003: "She did not give immunizations in question.  Please refer to immunization record provided to you in my report as well as responsible physician.  Thank you."
Received moderna lot# 013A21A on 02/24/2021.  Received Pfizer for second dose.  Pt. admits to guessing that 1st dose was Pfizer.  Apparently vaccinator did not check records.
Patient didn't exhibit any adverse reactions. Patient denied receiving other COVID-19 vaccines. He also denied it to the other Registered Nurse that put him in the system. He verbalized that it's his first dose and has not received any COVID-19 vaccines in the past.
Started w/fever @ approx 530PM on 19MAR92 on 20MAR92 had febrile seizure 430AM went to ER p/seizure for checkup;
Right thigh injection site started swelling and reddened approximately 24 hours after. Approximately 36 hours after had bleeding from site. Redness and swelling cont to increase. Red area 14 cm x 7 cm.
Patient received vaccine on 5/22/15. 3 days later she noticed a chick-pox type lesion on her left eyelid. The next day she had a row of very painful shingles type lesions on her right calf.
Swollen arm. Bump on rt side of neck-painful to the touch, no fever.
fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced fever, pain, aches and fatigue. The symptoms lasted for 24 hours and then resolved. Lot number was not provided. The reporter consented to follow up. For tolerance of 2nd dose, refer case; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223956:same reporter US-GLAXOSMITHKLINE-US2020AMR224583:same reporter
pt recv vax; 2 mo later, devel hives & lymphadenopathy;
A few local hives around injection sites within 20 minutes. Hives gone over night. Never seen by MD. Palpitation in chest on 05/2/02, nausea, chills, headache, anxious feeling, emotional dis, decease in energy, feels disoriented.
Lip swelling with ulcers  Itchy rash to bilateral forearm  "a few hours after vaccine"- unable to determine time frame
Child given VARIVAX and MENACTRA on 9/19/2011 - Complaint of headache, tinnitis and dizziness evening of vaccines and in AM 9/20/11 seen by me.
Approx 5 min after receiving flu shot pt suffered vasovagal reaction, fainted and hit her head on the floor. Was taken ambulance to hospital. Has had previous vasovagal reactions.
eyes ache a little bit; a little bit of a headache; pains in his legs; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pains in his legs), FATIGUE (felt tired), HEADACHE (a little bit of a headache) and EYE PAIN (eyes ache a little bit) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).   On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (pains in his legs) and FATIGUE (felt tired). On 17-Feb-2021, the patient experienced HEADACHE (a little bit of a headache) and EYE PAIN (eyes ache a little bit). On 14-Feb-2021, PAIN IN EXTREMITY (pains in his legs) and FATIGUE (felt tired) was resolving. At the time of the report, HEADACHE (a little bit of a headache) and EYE PAIN (eyes ache a little bit) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Error - Discovered after vaccine administration that the Pfizer Bivalent Covid vaccine for ages 5 to 11 years was not diluted as instructed so patient received a higher than intended dose.
Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023; No adverse event; expired doses were given to 7 patients/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, 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. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial was initially stored in the refrigerator on 06-Dec-2022 and patient received vaccine on 12-Jan-2023. Vial did not undergo any temperature excursions. Caller stated that they received the vaccines they were refrigerated so they put them in the refrigerator, they were not put it in the freezer. Treatment medication was not reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 24-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Headache, Arthralgia, chills, malaise, injection arm swollen with redness  and heat at injection site Narrative:  Other Relevant History:
Pain after I've had my vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain after I've had my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain after I've had my vaccine). At the time of the report, VACCINATION SITE PAIN (Pain after I've had my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Reporter did not allow further contact
Pt received immuniz at well visit and was diagnosed with asymptomatic R OM concurrently.  He received one dose of Amoxil around 11:30am.  He was in a carseat approx 12:15pm with mom waiting for a sib to get out of school when mom noted him to be groaning, staring to the right, and jerking as if something was repeatedly startling him.  This lasted 15 minutes.  Mom took him to his primary doctor where he was noted to have a temp of 102.  He was then transferred to our hospital. Discharge Summary received on 2/07/2005 states grunting.
Initial unsolicited report received from a medical representative on 03-Jul-2018. This case involves a male patient (age not reported) who was wrongly vaccinated with a 3.0 ml dose of IPOL (Batch number: M1453, expiration date, dose in series, route and site of administration were not reported) instead of 0.5 ml of on an unknown date. It was a case of actual medication error due to overdose since medical assistant thought that was a single dose vial and drew up the remainder of the vial. At the time of reporting, the patient didn't experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
pain in the injection site; rash on her arm; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in the injection site) and rash (Verbatim: rash on her arm).  The outcome of the injection site pain and rash were not reported.   It was unknown if the reporter considered the injection site pain and rash to be related to Shingrix.     It was unknown if the company considered the injection site pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter vaccinated another (unspecified) that had pain in the injection site and developed a rash on her arm. The reporter did not consent to follow up.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (1st dose received on 18th June 2018, refer case US2018227685). In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 1 day after receiving SHINGRIX, the patient experienced shoulder pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose of SHINGRIX in the right shoulder. The patient claimed that after about a day or two of receiving the injection, he experienced a feeling like someone punched him on his shoulder. The patient claimed that, at the time of reporting the feeling was still unresolved and it would become agitated if he moves a certain way or lies down on that side of his body. There was a consent for follow up.
HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor was reported as unknown.     On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD.).    No concomitant medications were reported. HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent BUD. HCP mentioned 2 doses were given on 19FEB2023, 1 dose on 20FEB2023, and 1 dose on 10MAR2023. Caller did not specified which date corresponded to patient 4  but HCP stated patient 4 did not reported any AEs. No treatment medications were reported.  This case contains information for the 4th of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715325, US-MODERNATX, INC.-MOD-2023-715347, US-MODERNATX, INC.-MOD-2023-715348 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715325:Patient 2 US-MODERNATX, INC.-MOD-2023-715347:Patient 1 US-MODERNATX, INC.-MOD-2023-715348:Patient 3
Pt stated that he was having an allergic reaction  to the vaccine. He appeared with swollen and red face ( eyes and ears). He stated he has NKDA and had no reaction to first dose. He also stated that he didn't know if it was due to vaccine or bug bite. We gave him two Benadryl 25mg tablets and had him sit in waiting room for observation. After 15 minutes, he stated that he felt better , would continue Benadryl and contact doctor if symptoms worsened. I followed up the following day, he stated that reaction resolved completely within five hours.
Pt reported that about 3-4 days post vaccine she experienced at the injection site a red itchy rash that was circular shaped that lasted 2-3 days.
Heart palpitations; Scared; Sick as a dog; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), FEELING ABNORMAL (Feeling bad), ILLNESS (Sick as a dog) and FEAR (Scared) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad). On 30-Apr-2021, the patient experienced ILLNESS (Sick as a dog). On 01-May-2021, the patient experienced PALPITATIONS (Heart palpitations) and FEAR (Scared). At the time of the report, PALPITATIONS (Heart palpitations), FEELING ABNORMAL (Feeling bad), ILLNESS (Sick as a dog) and FEAR (Scared) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: irregular (abnormal) Irregular.         No relevant concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101771 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101771:Son's wife Case