chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous retrospective pregnancy report was received from a current 26 year old female patient, reporting on herself. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date in "2012 or 2013", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not provided). The patient reported that she completed a three-dose series of GARDASIL on unspecified dates. The patient also reported that she suspected she may have been inadvertently administered doses of an unspecified "birth control shot" instead of the intended doses of GARDASIL, because she became pregnant an unspecified number of times after completing the GARDASIL series on unspecified dates, but each pregnancy resulted in miscarriage (MARRS # 1507USA005633). The patient reported that she had two positive pregnancy tests on unspecified dates which confirmed her most recent pregnancy (exposure during pregnancy). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. The patient reported that she then experienced vaginal bleeding which was considered as a vaginal haemorrhage and another miscarriage "5 months ago" in approximately February 2015; as a result, the patient went to an unspecified local and was given unspecified "pain pills" as treatment. The patient reported that in order to determine why all of her pregnancies had been resulting in miscarriages, she had Human Immunodeficiency Virus (HIV)/ Acquired immune deficiency syndrome (AIDS) testing on an unspecified date which was negative. Patient also reported that her "human chorionic gonadotropin (HCG) level was 57 (units not provided)" on an unspecified date; the significance of this result or relationship to the patient's event was unspecified. The patient also reported that she was taking unspecified vitamins (since on an unspecified date), and also was taking unspecified pain medication (manufacturer unspecified) "whenever she had pain" on unspecified dates and unspecified antibiotic (manufacturer unspecified) "whenever she had a cold" on unspecified dates. It was additionally reported that it could not be confirmed whether patient experienced unspecified pain or developed a cold after receiving GARDASIL. No product confusion was reported. At the time of the report, the patient's outcome from abortion spontaneous, pain and cold was unknown. Upon internal review the event of abortion spontaneous was considered to be medically significant. Additional information has been requested.
Pain in shoulder/ joint pain in that shoulder; pain in left upper arm; a rash under the arm she had the injection in (left); Decrease in range of motion/ trouble getting dressed; Trouble sleeping because of the pain; Initial information received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Information Media..  This case involves a 61 years old female patient who had pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  patient did not received concomitant medication(s).   On 30-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiration date: not reported) via unknown route in the left arm for prophylactic vaccination.  On 30-in Aug-2021, the patient developed a non-serious pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), on the same day following vaccination.  In Aug-2021, The patient developed a non-serious trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), [unknown latency] following the administration of vaccine.  It was reported "The caller stated that she is having side effects from a tetnus vaccine she received on 8-30-2021. She does not have the brand name of the vaccine. She did say that Pasteur is the manufacturer. She stated that the decrease in range of motion and pain are still present today, 10 days later. She has been in contact with her Dr about the issues. The patient is also not sure of the dose she received."   No laboratory data reported.  The patient was given Cold Packs and PARACETAMOL (TYLENOL) as a corrective treatment.  At time of reporting, the patient did not recovered from the reported events.
shingles; Information has been received regarding a case in litigation which referred to a currently 80-year-old patient (gender was not specified). Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) by a pharmacist (the patient was approximately 76-years-old when the vaccine was administered). Afterwards, on an unknown date (reported as subsequently), the patient was treated by a physician for the following injury resulting from zoster vaccine live (ZOSTAVAX) used: shingles (herpes zoster). As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer personal injuries, loss of services and loss of consortium damages. The outcome of the event herpes zoster was not reported. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.
Within 5 minutes of injection, upper lip began to swell slightly and I started sweating profusely. Symptoms started getting better about 30 minutes after.
experienced injection site pain, pain at the site of injection; a mild headache; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Jan2021 as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization. The patient's medical history was not reported. The concomitant medications included acetaminophen for his back and cosmetic fillers. After both doses of the vaccines he experienced injection site pain, pain at the site of injection and a mild headache the next morning on 11Jan2021. He wanted to know if this was related to the vaccine and if this meant the vaccine worked. The patient had read that he should not take acetaminophen before the vaccine, but he takes a dose every morning. He wanted to know if that affected the vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & exp localized skin rxn w/ swelling & soreness 3 cm around the inject site;
Patient received MMRV at age 13 when it is only indicated for 12 and below. No adverse event noted.
Arm soreness lasting 24 hours; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK5730, intramuscularly on 15Dec2020 14:00 at the right arm at single dose at workplace clinic for COVID-19 immunisation. There were no medical history and no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient experienced Arm soreness lasting 24 hours on 15Dec2020 16:00. The event was reported as non-serious. Treatment was not received for the adverse event. The outcome of the events was recovered on an unspecified date in Dec2020.
sinus infection symptoms, burning feeling in arm into mid chest and back, nausea, headache
I had a sore throat. I thought it was strep, but the test was negative. I did not receive any antibiotics. It turned into a severe cold with runny nose, nasal congestion, chest congestion, and shortness of breath. These symptoms lasted 2-3 weeks. I took a maintenance inhaler which I usually only take when I feel compromised. I also used over the counter cough medicine and TYLENOL to treat these symptoms.
Received extra dose of Hep B vac on 3/13/23.  No adverse effects reported
Client reported mild redness around injection site which resolved within 36 hours and a severe headache that he could not relieve with over the counter pain medication. The injection was administed at 9:30 AM 10/13/2011 and the headache and injection site redness was noticed by the client at approximately 8:00 AM 10/14/2011. Client went to Urgent Care and received a IM Morphine injection and the headache resolved shortly after the injection. The injection redness resolved on its own.
Patient states that right wrist was swollen on 01/10/09 about 24 hours after MENACTRA and HAVRIX was administered in right arm.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (COVID-19 VACCINE MODERNA), on 05Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 02Feb2021 as dose 2, single (Lot number: 012M20A), in left arm and on 21Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ampicillin, reaction(s): "Known allergies: Ampicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid after Paxlovid course of treatment; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment was given of Paxlovid from 15Jul2022 till 20Jul2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201046264 Same patient, different product and event.
Patient may have been given an additional dose of the original Pfizer Shot instead of a dose of the bivalent booster, LOT GH9702.  No adverse reactions have been reported to us at this time. It was either her or her husband that received the incorrect dose but it can not be determined who it was
MA intended to obtain dose of MMR and Var as separate antigens from freezer. Obtained MMRV instead of Var. Caps are different color but did not note that she had MMRV in hand. Read label while drawing from vial, did not note that she had MMRV rather than Var. Administered to patient. Error found when documentation was being done after the administration.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Same reporter
08/01/2018, six PM experieced nausea, headache, feverish, shivering, muscle aches throughout the night. Tired the next few days. 08/10/2018, respiratory infection, severe coughing and copious amount of nasal mucous, 3 nights of extreme coughing. To date a slight lingering cough. 08/18/2018, 10AM back of upper arms and upper forehead developed red, raised, itchy rash lasting 2 days treaated with BENADRYL.
got pretty sick with the second dose/just sick all over; just felt terrible/felt real bad; Felt nauseated /nauseous; felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish). On 26-Mar-2021, ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish) had resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient asked whether the patient could take a booster or third dose or not.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information included updated narrative
28OCT stomach flu that lasted 3 days; 7NOV bad cold, sore throat, lung congestion, temp;
my hair started to fall out at an alarming rate/lost 50% of my hair mass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: ALOPECIA (non-serious) with onset Apr2021, outcome "unknown", described as "my hair started to fall out at an alarming rate/lost 50% of my hair mass".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
acute onset of redness to his neck and trunk, including swelling and tenderness to knees L>R, L thigh particularly and has been less active/willing to bear weight/walk with diffuse patchy erythematous, urticarial rash to upper torso, neck, arms, diaper area and mild erythema to face,
I had a runny nose and a mild sore throat and I was tired. I was also living with someone who tested positive for COVID-19. Not much of an appetite. May be due to prior to COVID-19 or the PAXLOVID.
Information has been received from a physician concerning a 4 or 5 year old patient who in approximately 2003, at 12 months of age, was vaccinated with a dose of Varivax. Subsequently, the patient experienced breakthrough chickenpox. She had one lesion on the scalp and a "few" on the body. It was a very mild case. Unspecified medical attention was sought. NO product quality complaint was involved. Additional information has been requested.
Patient developed a large bruised area at the site where his Fluzone HD vaccination was given.  Patient received both Prevnar13 (high on left arm) and Fluzone HD (lower on left arm).
Fatigue, muscle ache, fever and soreness that resolved on its own after 4 days.
muscle jerked and twitched; sore on left arm/it is been hurting since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscle jerked and twitched"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore on left arm/it is been hurting since".  Additional information: the patient reported that when the vaccination provider put the shot in his arm, his muscle jerked and twitched, then the patient stated that his arm has been hurting since and it's been a month. The patient put hot packs on his arm, however they have not worked. Patient stated that he is going to try ice on it now.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Other complications following immunization, not elsewhere classified, initial encounter on 2021-12-14.
sick with the flu harder than ever; sick; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported sick with the flu harder than ever and sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "sick with the flu harder than ever" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick with the flu harder than ever, sick).  At time of reporting, the outcome was Unknown for the event sick with the flu harder than ever and was Unknown for the event sick.
Information has been received from a physician and a nurse concerning a female who on 17-OCT-2008 was vaccinated with PNEUMOVAX (lot #660685/0619X). She subsequently developed a reaction to the vaccine, a large axillary adenopathy. At the time of reporting, the patient's large axillary adenopathy persisted. This is one of several reports from the same physician. The physician stated he was given a "bad batch" of PNEUMOVAX. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Patient was given .25 ml dose of LOT# A51416B Moderna ages 6m-5years
Itchy throat, difficulty breathing, slight fever and green drainage to both eyes. Advised Benadryl.
Initial unsolicited report received from other health professional on 14-Aug-2018. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml dose of ADACEL (used around the time or after the time of the excursion) (Batch number: U5810AA, expiration date: 22 Nov 2019, dose and site of administration was not reported) via intramuscular route on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (excursion was actually for 9 days, starting in May, and ranged from 48-49 F). It was unknown if patient had adverse event. 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 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. List of documents held by sender: none.
Breakthrough case admission after 3 vaccines Pfizer 4/7/21 Lot# Ew0158;  Pfizer 4/28/21 Lot# Ew0158;  Pfizer 2/16/22 Lot# 330368D
Woke with generalized red, maculopapular rash from head to toe this AM. (8 days after vaccine) confluent redness on face some papules/vesicles on red base throughout body. Some hive appearing lesions. No other signs of illness. Vaccine rxn vs allergic rxn to other. Seen this AM.
Intermittent left arm pain at area of 1st COVID Moderna shot for almost 6 months after injection. Initially had localized reaction and swelling of his arm but still has pain at times even 6 months after. No radiculopathy.