chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm immobility,pain,swelling in left lymph node areas near cervical area,muscle contraction,pain and inflammation,, vision cloudiness,extreme tinnitus,stiffness,timgleing/numbness ,left shoulder pain,jaw pain and cervical pain,. I  still am suffering from the symptoms. I did not receive any n feedback from this doctor visit regarding a possible adverse reaction. I have reiterated in message to clinic regarding a probable vaccine reaction since it was next day that I had appointment.
7 months after testing positive for covid and 2 months after receiving my second dose of the Pfizer covid vaccine, I began experiencing a distortion of smells. It started with urine and feces smelling strongly of yeast, so I assumed my son and I both had yeast infections. It then progressed to now nearly all foods smelling overwhelmingly like yeast. I found out I was 3 1/2 weeks pregnant in June, so my sense of smell is heightened, but the distortion of smells is so intense and began before I was pregnant.
choking; tight chest; coughing; Face turned red; itchiness; whole body rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "thyroid problem" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; METFORMIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: CHOKING (medically significant), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest"; COUGH (non-serious), outcome "unknown", described as "coughing"; ERYTHEMA (non-serious), outcome "unknown", described as "Face turned red"; PRURITUS (non-serious), outcome "unknown", described as "itchiness"; RASH (non-serious), outcome "unknown", described as "whole body rash".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
herpes zoster; ill-defined disorder; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 03-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date (reported as subsequent to inoculation), the patient experienced herpes zoster and other zoster-related conditions (ill-defined disorder). The patient was treated with unspecified medications. The patient would continued suffering ongoing injuries. Significant medical and related expenses included care for hospitalization.  The outcome of the events was reported as not recovered.     The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
He had a syncopal episode that lasted a few seconds. He laid down for a few minutes and drank water and was back to baseline.
patient contracted COVID 1 month after vaccination.; patient contracted COVID 1 month after vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "patient contracted COVID 1 month after vaccination.". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
ANTIBODY LEVEL OF 14; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient's antibodies level was a 14 with the SARS-Cov-2 semi-quantitative total antibody. Patient stated that she was immunocompromised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody level of 14 was not reported. This report was serious (Other Medically Important Condition). The suspected regulatory authority has been confirmed to be voided (did not meet criteria as this record states the patient antibody level. there is no issue reported. approval to void this record due to no identified.) based on the evaluation/investigation performed.; Sender's Comments: V0: 20210904072-COVID-19 VACCINE AD26.COV2.S- antibody level of 14. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
L deltoid-warm, non-tender with demarcation area 12.5 x 15cm dx vaccine reaction, Benadryl 2 top pm-if increase pain re-evaluate and consider cellulitis. Still swollen (getting better).
The mother of this patient thought she needed another Hep B vaccine, she was in with her mother who did need a Hep B. Her chart was not immediately available so the shot was given. Later we found out it wasn't needed. About 2 months later vitiligo lesions started developing, multiple seen at time of evaluation on 07/27/01.
feels agitated; a lot of headache; their whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00LCA1A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts). At the time of the report, AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up document received on 16-JUL-2021 contains event outcome updated as recovered/resolved for all event
leg cramps Narrative: At the time of 2nd covid vaccine injection, pr reported after Moderna dose 1: a " charley horse" type leg cramps that hurt really bad and then went away, started 12 hr after injection and lasted 1/2 hr, no other complaints. Pt did not report any treatment medications.
Approximately three weeks after second Pfizer COVID-19 vaccine, I was diagnosed with two pulmonary embolisms, one in each lung.  I was hospitalized for four days and was on oxygen for two months.
7 days post vaccination, I developed a hot, itchy red welt at the injection site along with local swollen lymph nodes, specifically the left supraclavical node. I felt chills but no fever and a general feeling of fatigue. This was not bad enough to send me to the doctor.  Treated so far with ice and ibuprofen. Not resolved yet.
PT HAD A SYNCOPAL EPISODE AFTER ADMINISTRATION OF SECOND VACCINE. PT CAME BACK TO AFTER 15 SECONDS. NO OTHER COMPLICATIONS OR ISSUES.
Patient found unresponsive with no pulse, 2 rounds CPR necessary to bring  patient back, All testing negative for heart problems after the fact.
Headache, nausea, fever, chills, fatigue, body aches, joint pain  Tylenol and ibuprofen
Patient reported onset of tongue tingling and throat numbness 5min following injection of Pfizer vaccine. Patient received 25mg of Benadryl oral. Patient was monitored for 30min, vital signs stable, and exam unremarkable besides continued subjective symptoms of numbness and tingling. Patient given second 25mg of Benadryl oral. Patient was monitored for another 1.5hrs and symptoms resolved. Patient was cleared to return home and advised to have friend drive him home for safety.
For both doses of the vaccine I was breastfeeding. Both times, my milk supply dropped down to almost nothing for 18 hours or so. It then returned to normal. 18 hours is to long when referencing loss of nutritional needs for an infant less than 1 month old. Dose 1 FG3527 11/3/2021; Dose 2 FG3527 11/24/2021.
This spontaneous report was received from a pharmacist, via a company representative, and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 route reported as "intramuscularly or subcutaneouslly" for prophylaxis (strength, dose, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included unspecified "flu shot", influenza virus vaccine inactivated (unspecified) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date, after received the therapy the patient "had a rash", and that night after therapy the patient had "vomiting and fever (pyrexia)".  The outcome of rash, pyrexia and vomiting was unknown. The causality between rash, pyrexia and vomiting with PNEUMOVAX 23 was not reported.
pt recvd vax 26AUG85 & devel erythema nodosum & Takayasu's arteritis;reporting MD was contacted & more info has been requested
Cellulitis on (L) vastus lateralis noted 24-48 hours after admin. No tenderness 5cm x 6cm. Warm to touch.
Headache, Arthralgia, Fever, NauseaVomiting, fatigue, chills,  Narrative:  Other Relevant History:
(?) swelling, redness (ie cellulitis) (?)(?) IM and Duracef BID
Pain when lifting arm up, pt reports usual soreness the day after receiving shot however the pain when lifting/raising his arm started the same day and hasn't gone away within the week.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. On an unspecified date was vaccinated with the second dose of GARDASIL 0.5 ml, injection (route). 24-48 hours after receiving her second dose of GARDASIL, the patient experienced rash on her face that went into her ears. The patient sought medical attention. The outcome was not reported. Additional information has been requested.
Patient presented for Hepatitis B vaccination. Patient screened and ordered to receive HepB vaccination and was charted in chart and immunization registry to have received HepB vaccine. After completing vaccine inventory, it was found that nurse could have administered Hepatitis A vaccine instead and it narrowed between 2 patients in which the error could have occurred. Immunization branch contacted and as recommended, patient notified of error and encouraged to come in for re-vaccination.
Severe pain at site (burning) briefly, headache off and on, severe dizziness, light-headed, disoriented, almost passed out, arm pain on and off.  Day 2 same except no burning at site,  getting sick, some coughing, Day 3 Coughing, slight headache off and on.  Decreased energy and sleeping more, still disoriented.
About 2hrs after receiving vaccine started with asthma symptoms - lips tingling, swelling of tongue used inhaler x 4. Took BENADRYL and went to ER.
Patient inadvertently given expired TDaP vaccine. Per CDC and manufacturer, patient was re-vaccinated with fresh vaccine.
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinemia.    No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In 2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) was resolving.            No concomitant medication was provided.  Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of chest pain after third COVID vaccine with imbruvica ibrutinib was no reasonable possibility.
Lost taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste) 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.    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 AGEUSIA (Lost taste). At the time of the report, AGEUSIA (Lost taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
t104 R x 24 hrs p/shot; screaming during 6-8 hrs p/shot; swelling & redness of leg x 24 hrs p/shot;
14 years old patient was administered with Infanrix; administered with Infanrix by mistake; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 as follows: The age at vaccination was not reported. The patient administered with Infanrix by mistake instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Left her leg was was frozen; Flu-ish; Hot; Slept for 3 days; Body painful; Tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days) and MYALGIA (Body painful) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), MYALGIA (Body painful), FATIGUE (Tired) and NAUSEA (Nausea). At the time of the report, LIMB DISCOMFORT (Left her leg was was frozen) had resolved, INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown and MYALGIA (Body painful) had not resolved.            Concomitant medications were not provided.  The patient could not remember if Tylenol was taken or not.
Case number PHEH2013US009705, is an initial spontaneous report received from the nurse on 29 Apr 2013 with the follow-up received on 08 May 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M12023) reconstituted with sterile water diluent intramuscularly on 19 Apr 2013. No adverse reaction reported following this administration error. Follow-up received from nurse on 08 May 2013: Updated patient demographics (initials, date of birth and gender) and date of vaccination.
Info has been received from a Pharm. D. concerning a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). On the same day, the pt was vaccinated in the opposite arm with a dose of concomitant therapy influenza virus vaccine. Subsequently the pt developed itching, swelling and redness on the underside of her arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm. D. reported that the pt sought unspecified medical attention. Additional info has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies/reaction and concurrent conditions were not reported. The reporter stated that on 21-DEC-2018 a patient was vaccinated with an expired dose of ZOSTAVAX (expired product administered) lot # N025704,expiry date 16-DEC-2018, subcutaneous (dose, frequency unknown by reporter) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (dose, frequency, lot# and expiration date unknown by reporter). No adverse effects was reported. The outcome of the events expired product administered and no adverse effects was unknown.
The patient had an apparently spontaneous anaphylactic type reaction with facial hives, eye redness and swelling, diffuse hives on trunk, lips, and extremities, tongue swelling, difficulty swallowing, and itchy tongue. The only thing had had had to eat or drink was a cows milk latte with hazelnut 2 hours prior to the reaction. No fever. The family gave her 2 tabs of Benadryl (50 mg total) at home and brought her to urgent care whereupon her hives and tongue swelling had decreased substantially. They showed photos of her face and skin prior to the Benadryl. She was given 60 mg prednisolone and observed for over 30 minutes. She improved substantially and was discharged home with her mother pending results of allergy testing.
Per mother: client developed fever of 103.6 and arm numbness 2 days after administration.  Declined going to MD ER, has no insurance.  Took Tylenol only.  On third day no fever and moderate soreness in arm going about normal daily activities.
Administered an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, Genital herpes, Hyperlipidemia, Type 2 diabetes mellitus and BPH. Concomitant products included TAMSULOSIN for BPH, VENLAFAXINE for Depression and Anxiety, METFORMIN for Diabetes, ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension, OMEPRAZOLE for an unknown indication.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired dose). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took first dose on 22-Sep-2021 at 10.46 am and dose 2 on 20-Oct-2021 at 09.02 am. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received on 26-OCT-2021. Added secondary reporter details, patient details, added suspect product anatomical location, route,  concurrent conditions, added new concomitant medications. On 26-Oct-2021: Follow up received on 26-OCT-2021 and does not contain any new information
01/03/04: Onset redness, swelling, warmth, tenderness around area on injection.  Approximately 2 inches in diameter.  Resolved over period of 4 days.  Treated with Benadryl.  No systemic adverse symptoms.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she was aware of two other patients that got the shingles after getting the SHINGRIX, the same day that she received the SHINGRIX. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. Consent to follow up was given. Limited information was provided. This was 1 of 3 cases reported by same reporter.