chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl.  It was just for a day after I took the Benadryl the next day all was back to normal.
Heart palpitations, dropped beats, V-fib, tachycardia, dizziness, muscle weakness and left side chest pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Hx of 2 separate breast cancers" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: ESCITALOPRAM; METFORMIN; DIAZIDE [GLICLAZIDE]; ALLEGRA; NAMENDA; MELATONIN; L-THEANINE; PROOMEGA; QUERCETIN; ESTRADIOL; SKYRIZI [RISANKIZUMAB RZAA], start date: 18May2022; COSOPT ophthalmic; SINGULAIR; NORDIC NATURALS ARCTIC D COD LIVER OIL. Other concomitant medications included Multi vitamin mineral, Women's Formula once a day, and We like vitamins. Vaccination history included: BNT162b2 (lot number: FK9729, dose number: 4, location: left arm), administration date: 08Feb2022, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: FD8448, dose number: 3, location: left arm), administration date: 28Aug2021, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: EL9264, dose number: 2, location: left arm), administration date: 02Feb2021, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: EL1283, dose number: 1, location: left arm), administration date: 10Jan2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient started Paxlovid on 05Jun2022 (also reported as 06Jun2022) within 24 hours of the first symptoms. The patient had very mild symptoms of sore throat and fatigue. Expedited PCR positive because of known exposure. No problems tested negative on 13Jun2022. On 15Jun2022 and progressing to 16Jun2022, the patient felt rapidly worse with 101 of fever; the patient tested positive. The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (unspecified date) Positive, notes: PCR positive; (13Jun2022) Negative; (15Jun2022) Positive; (16Jun2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the event  and suspect drug  cannot be excluded.The case will be reviewed further with FU information. 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
got blood clots in his lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "got blood clots in his lung". Therapeutic measures were taken as a result of pulmonary thrombosis. Clinical course: Reporter's husband got his last shot and got blood clots in his lung. He had to take medication so he wouldn't get clots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a consumer refers to her daughter, a 26 year old female patient with allergy to an unspecified antibiotics. The patients' medical history was not provided. On 17-JUL-2009, reported as "6 years ago on July 17", the patient was vaccinated with the first dose of GARDASIL, intramuscular injection, (anatomical location, lot number and expiration date were not reported). There were no concomitant medications provided. On an unspecified date, in September 2009, the patient started to loss of consciousness reported as "past out a lot". There was no product quality issue involved. The patient did not continue with the series of GARDASIL. The outcome of loss of consciousness was reported as recovered on an unspecified date. The reporter did not assess the relatedness of loss of consciousness with GARDASIL. Additional information is not expected since the reporter did not want to be contacted.
Started experiencing cold sensations in my hands, fatigue, severe joint pain, high cholesterol, high triglycerides, recent skin cancer diagnosis with many more moles appearing on my body.  Foggy brain
7APR95 TC to MTR-states pt woke up screaming # 230AM on 7APR95 screamed & could not be comforted for 1 hr; would not walk until 3PM 7APR95, just laid in bed; to see MD today talking & playing # 3PM as usual
Light headed. Redness on arm. Threw up 8 times, paleness, and very tired and weak.
2 lumps developed 15 hours after shot on right neck near collarbone; lumps about 1.25? apart; 3/20/21 and lumps still there but slightly smaller and less painful
Area is red on left outer leg and swollen. The reddened area is the size of a baseball.
Slight cough; stuffy nose; muscle aches - I had those symptoms about two days (they almost resolved before I had the test).
Post vaccine patient reports breathing issues lasting approximately 1 month. These breathing issues resulted in multiple trips to the emergency department at which she received breathing treatments. Patient states that 5/24/2021 was the first day that she was well enough to speak on the phone to discuss her adverse effects.
A report received from a consumer on 10/27/2003 concerning a 48 year old female vaccinee who was administered a brand unspecified influenza vaccine via an unlicensed rout developed an injection site bump, and had a sore arm on the same day of receiving influenza vaccine on 10/17/2003. On 10/17/2003, the vaccinee was administered influenza vaccine subcutaneously, developed an injection site bump, and had a sore arm. The injection site bump and sore arm resolved on 10/27/2003. Update 1, 05/06/2004: Further information was received from a consumer indicating that she was not administered the influenza vaccine by her primary physician therefore her physician was unable to fill out the health professional form. No follow up pending, no further information available.
Subject is a 14yo male who received dose 1 of Pfizer Covid19 vaccine on 7/22/21 in Left arm without incident. Then on 7/23/21, subject with c/o swelling/edema and discomfort of left axilla. Applied ice pack and took ibuprofen. Swelling and discomfort still present as of the time of this report, 7/27/2021.
ROTATEQ vaccine expired 09-04-2022; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2464591-1. The original narrative from the sender is the following:  ROTATEQ VACCINE EXPIRED 09-04-2022.  The causal relationship between Vaxelis and the reported event "Expired Product Administered" is assessed as not applicable due to the nature of the event.   No further information is expected.  Note: Based on the available information, the event was not related to Vaxelis but to Rotateq vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from reporting system and information was kept as reported in the form.
Patient started to feel dizzy about 7 minutes after vaccine administered. She then reported squeezing in the chest. Called for RN and provider help in the pharmacy. Patient O2 was 100% and blood pressure was in 120s/80s. Pulse increased to 112 at its peak. Patient reported squeezing would come and go. She thought she might faint, but never fainted. Provider decided to bring her up to clinic for an EKG and further testing.
I administered first covid vaccine and patient seemed like she got a seizure about 1 minute after administering vaccine. mother had patient on her lap because patient was scared and patient started stiffening up with eyes rolling back making stiff jerking movements. I assisted mom with moving patient on to exam table. when I stepped out to get help from the RN patient came back to. pt was crying and seemed confused. Mother was comforting pt.
Initial and follow up information has been received from a medical assistant a physician concerning a 15 year old female patient, 131 pounds, 63.5 inches height, with no known drug reaction/allergies and no pertinent medical history, who on 11-NOV-2008, at 15:00 was vaccinated with the first dose of GARDASIL, 0.5ml (Lot # 661046/0546X), intramuscularly, in the right gluteus. There was not concomitant medication. The physician reported that after receiving the HPV vaccine, the patient fainted.  Since then, the patient had been consistently feeling a tingling sensation throughout her body.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  Additional information has been requested. Follow up information indicated that the patient experienced fainted after vaccination, fall, hit back of head. The patient had been feeling a dizziness when puts head down and as patient described "tingly" feeling all over body. Patient is unable to give specifics on symptoms. A brain MRI was performed and resulted normal. It is unknown if the patient recovered. There were no illnesses at timeof vaccination. No further information is available.
FEVER; COMING DOWN WITH SOMETHING; This spontaneous case report was received from a pharmacist (PVX2019-645) on 13-Mar-2019. It described a 17-year-old adolescent consumer who had "fever" and "was coming down with something" following the intake of Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif either on 11-Mar-2019 or 12-Mar-2019 and then, had a "mild fever" and "was coming down with something", may be flu.  The action taken with Vivotif with respect to the events "fever" and "coming down with something" was unknown.  The clinical outcome of the events "fever" and "was coming down with something" was unknown.  Company's Comment: In this case, it was reported that a 17-year-old adolescent consumer had "fever" and "coming down with something" following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 17-year-old adolescent consumer who had fever and coming down with something following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
pt recvd vax; fever w/in 24 hrs w/ v,d for 4-5 days;also,local rxn w/ swelling & soreness; possibly exposed to flu-like disease; no rxn p/ 1st dose;31aug93 f/u: series completed on 27jul93 w/out addtl rxn;
Lump on the mouth; Eliminated a lot of saliva; 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 ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva). At the time of the report, ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
herpes zoster; knee swelling; rash outbreak with raised papules; numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-JUN-2015 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for routine health maintenance and fot its intended purpose: the prevention of shingles(herpes zoster). Shortly on an unknown date, the patient suffered a rash across her lower back, waist and right leg and was diagnosed with herpes zoster. It was also reported that subsequently, the patient suffered another rash outbreak with raised papules, knee swelling and numbness. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms have resulted in physical limitations not present prior vaccination; serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, los of enjoyment of life, phycical impairment and injury. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling.
pt recv vax MAR97 & 20NOV97 pt was dx w/chickenpox w/an unk number of lesions;
After my second shot I first developed a large hot red lump in my arm. It was very painful and didn't go away fully for about a month. I became ill with fever, body aches and fatigue 2 days after the shot. Ever since that time I have been experiencing extreme fatigue. I am unable to do things I could do previously due to this. I also still get pain in my arm around the injection site and I have had tender lympnodes since that time as well. I went to my doctor this last week due to these continued issues and we cannot find an explanation.
Within 8 minutes of the vaccination - throat muscles began clenching, sinuses became stuffy with some difficulty breathing, toes tingling, heart racing - Blood Pressure checked - 122/82. Took Benadryl - 3 doses through evening hours
Client got his vaccine. He moved to a different chair so his son could get questioned. About 2-3 minutes after shot, he felt faint, looked pale and was clammy.  Client was pale and clammy. Assisted to EMS room. Client reclined to cot. Ice pack to head. Given water, rested and reclined for 10 mins then sat on the side. BP: 140/120.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-MAY-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml injection, lot # H022280, expiration date 16-JUL-2014 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 2892 hours, with the lowest recorded temperature of 20 degrees Fahrenheit (-6.666666667 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient reported that on 29-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported) and was at the time of the phone call being prescribed ENEBREL (manufacturer unknown). The outcome of the event was unknown. The reporter considered that the event was not related to ZOSTAVAX. Additional information has been requested.
Pt received dose underage; CDC guidelines followed to administer second dose; Consent was signed for both doses
This case was reported by a healthcare professional (nurse) and described the occurrence of expired vaccine used in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline), influenza virus vaccine (unspecified). On 7 November 2013 at 22:00 the subject received a dose of FLULAVAL (.25 ml, unknown site, unknown deltoid) and experienced expired vaccine used, underdose and off label use. Per the nurse, all the vaccine was "a GSK flu vaccine from a multi-dose vial" so the reporter believed that the vaccine was "most likely FLULAVAL." Per the nurse, "a nurse in the facility inadvertently administered the expired vaccine." The vaccine expired May 2013. The subject had a "history of getting ill from the flu vaccination so they split the dose giving 0.25ml initially and then another 0.25ml at a later date." Per the nurse, the subject's body temperature had been monitored every 4 hours and "not noted any changes or any other adverse events." It was unclear from the report when the maladministration was discovered and when monitoring every 4 hours began. On an unspecified date the subject received a dose of Influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified) and experienced unwell. Per the nurse, the subject had "a history of getting ill from the flu vaccination." At the time of reporting the outcome of the event was resolved.
Duplicate vaccine administered.  Patient was signed up for an offsite flu clinic.  Vaccine was administered - Was not noted until a few weeks later that patient had already received annual flu vaccine at PCP office prior to vaccine clinic.  There was no indication onsite that this was the case.
After receiving the flu vaccine, patient had a reaction to the adhesive bandage. There is a permanent mark on her arm where the adhesive touched her skin. She states that her arm hurts, shoulder hurts, and she can't sleep on that side and that her shoulder/arm is swollen. She has an appointment to go to the doctor on Friday, October 19, 2018.
08/31/22 presents to EC ED for "generalized fatigue, shortness of breath, weakness". PMHx of "asthma, COPD, GERD"
Headache, Diarrhea,  Sore left arm, Backache Narrative:  Other Relevant History:
Shingles - rash and itchiness around right breast that spread to back over 2 days. Blisters formed in 5 days. Started taking antiviral Valcyclovir on 4th day from rash onset. Pain intensified on day 4.
felt a little run down; sore arm; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (felt a little run down) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt a little run down) and MYALGIA (sore arm). At the time of the report, ASTHENIA (felt a little run down) and MYALGIA (sore arm) outcome was unknown.            concomitant medication information was not provided.   Reporter did not allow further contact
spending dollar 70 at the pharmacy for nothing/dried mine up/Suspected vaccination failure; dried mine up; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: spending dollar 70 at the pharmacy for nothing/dried mine up/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: dried mine up) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that best thing he/she found was cornstarch.  The reporter stated that washed the area and dried well.  Then just pat cornstarch on the area of shingles.  The reporter further stated that definitely dried his/her up, almost overnight and it stopped the pain also.  The reporter further stated that that was after spending dollar 70 at the pharmacy for nothing. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 40th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Pain; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain) and HEADACHE (Headache) 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 PAIN (Pain) and HEADACHE (Headache). At the time of the report, PAIN (Pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.