chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fifteen minutes after being vaccinated,  upon exiting the facility, the patient became nauseous and dizzy.  Her husband lowered her to the ground.  Breathing, pulse, awareness, speach, and swallowing all normal.   911 was called, perimedics arrived, evaluated the patient and she was released.
loss of taste after 10 minutes, headache, nausea, vomiting 2 to 3 hours after injection. Conditions persisted more than 24 hours
Pt died on 1/12/22 due to recurrent bouts of sepsis. He developed hypoglycemia, hypotension and encephalopathy and became unresponsive. Pt required pressors.
Extreme dizziness and nausea  resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking.  Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills  but still nauseous, diarrhea all day.  No energy or appetite.
Starting Monday February 22 (six days after second dose), I experienced moderate muscle cramping and soreness in the back of the neck, lower back, and buttocks/legs. I am also experiencing headache, dizziness, and diarrhea, all moderate. Symptoms are temporarily relieved by massage and stretching, but pain is still ongoing. This has persisted until today (Thursday, February 25).
Current Issues - Shortness of breath and difficulty in breathing, Chest Muscle tightness and heaviness. Difficulty in talking or speaking. Body fatigue,  weakness/tiredness.  Did Heart EKG but result came out normal.  Chest X-Ray was normal Urgent Care and PCP prescribed "Albuterol Sulfate Hfa" through Nebulizer, taking while difficulty in breathing
No adverse event; ROTATEQ was administered after a temperature excursion to a patient; This spontaneous report was received from certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 13-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) after temperature excursion, orally, lot number 1742433 and expiration date of 19-SEP-2022 for prophylaxis (dose was not reported).  The vaccine was exposed to a temperature excursion of 9.47°C with a time frame of 15 minutes. There was no previous temperature excursion. No additional adverse events were reported. There was not product quality complaint involved.
Syncopal episode approx 10 mins s/p vaccine at check out desk. + trauma to head-immediate return to consciousness. Symptomatic care with ice, snack, H2O. Normal vital signs and neuro exam after 30 mins observation.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 dose 4 for prophylaxis. On an unknown date the patient experienced extra dose administered and no adverse event. The outcome of extra dose administered and no adverse event is unknown. The reporter considered extra dose administered and no adverse event to be not related to GARDASIL 9.
rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; This is a spontaneous report from a contactable consumer reported for herself.   A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL8982 via intramuscular route at right deltoid on 26Jan2021 16:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. On unknown date the patient experienced rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain as recommended by her HCP. The patient was unable to remember if she took an Aleve before or after she received the vaccine. She would like to know if this will interact with the vaccine. The outcome of the events was unknown.
Guillain Barre syndrome:  symptoms (paresthesias in hands and feet) started on 7/13/2019.   Symptoms progressed, with paresthesias in hands and both legs up to the mid-thighs, and included difficulty walking due to weakness,   Diagnosis made by lumbar puncture at Medical Center on 7/23/2019.  Patient is being treated with IVIG 0.4 g/kg/day for 5 days (7/24/2019 to 7/28/2019).  Today (7/28/2019), the patient reports 50-60% decrease in paresthesias in hands and legs, but no significant improvement in weakness in his hands and legs with ongoing difficulty walking.  Tomorrow, we will be consulting Neurology for further treatment recommendations.
Daycare sent child home for fever up to 100F and swollen thigh. Left thigh swollen about 3-4 inches in length and around thigh, warm to touch. Swelling stops above the knee. Lower leg normal. Cap refill on left big toe brisk. No swelling of toes. Right leg normal looking, no swelling.  Swelling started today at daycare. No symptoms noted the night of vaccinated day.
29 y/o male presents to clinic c/o a questionable Tdap injection site reaction x3 days. The injection was given on Monday, symptoms started on Saturday. Patient is experiencing numbness, burning, weakness, limited ROM and is so painful it woke him up. The site is not discolored or warm. He has not any issues with any vaccines. He can't hold a coffee cup with this hand and the pain is severe 9/10. He has been working out and working manual labor. Denies any known injury to arm. Pt received his TDAP for a cut that occurred at work on his right arm.        Per immunization record at this clinic, the Tdap vaccine was given in his right deltoid. Pt is c/o left arm pain. Denies fever.        He has been referred to Neurology and Physical Therapy - he has an appt with Neuro this Thursday, 7/9/2020.         His history is significant for complex regional pain syndrome. He uses lidocaine patches and medical marijuana to treat. Physical exam wnl. I have no concerns at this time. Pt will f/u with Neurology and PT for further evaluation. Discussed with pt that I suspect symptoms are secondary to complex regional pain syndrome.
For 3 days following my Cov19 Moderna booster vaccine I experienced strong muscle aches and pains that made it difficult for me to get out of bed and walk and do things for the day. I saw no dr for this and had no tests or treatments for this. After 3 days the problems went away and I was good good as I was before the booster vaccine and had no further problems.
Noticed swelling & redness under left eye & cheek. Later became SOB took BENADRYL resolved SOB. Swelling & redness continued with tenderness.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # not reported). The medical assistant reported that on an unknown date, the patient experienced mild case of chickenpox long after the (Oka/Merck) VARIVAX was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Redness and swelling 10 x 14 cm on thigh where vaccines administered.
I have had numerous side effects from the vaccine.  The chills, flu like symptoms, cough and chest congestion continue to linger on a week after the vaccine was received.  I am not running a fever however I do feel feverish. I still feel tired and have no energy.  I contacted my primary health on Friday 3/12 concerning the pain in my chest cavity from extreme coughing attacks.  I was instructed to take some Tylenol and Mucinex.
Allergic reaction; This case was reported by a physician and described the occurrence of allergic reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included upadacitinib (Rinvoq) unknown for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Rinvoq (oral) at an unknown dose and frequency. On 13th February 2020, unknown after receiving Shingrix, the patient experienced allergic reaction. The action taken with Rinvoq was unknown. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix and Rinvoq and experienced allergic reactions. No other information was reported. The reporter's causality for Rinvoq for event allergic reactions was not provided.  It was unknown if the reporter considered the allergic reaction to be related to Rinvoq .
pt recv vax & devel an inj site rxn characterized by swelling, redness, warmth, & tenderness;also exp shoulder & elbow pain;
No present adverse events reported. Ct received #3 MMR 8/4/04. No 1 MMR given 2/27/04. No 2 MMR given 4/27/04
pt recvd vax in FEB93 & w/in 5 days of the vax pt began to have sz-like activity intermittently w/2 to 3 szs per day; pt was hospitalized; @ the time of this report pt having 1 sz per week & was collapsing;
pt recv vax 23FEB95 & pt exp short feb sz w/t105;5MAR97 pt taken to ER & hosp;rash initially thought to be chicken pox dx as roseola the following day;mom reported child devel autism p/vax;pt stopped all devel & lost little bit of speech ha
pt recv vax DEC95 & 7DEC96 pt devel clinical varicella disease that was attenuated, w/only 10-20 lesions on face, chest, & abd;
Information has been received from a healthcare worker and the nurse concerning a 63 year old female who on 02-AUG-2008 was vaccinated with a dose of VARIVAX rather than ZOSTAVAX. The healthcare worker reported no product confusion, just nursing error. No problems reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. The nurse said that she did not known how the error occurred. But the patient was notified and had no adverse event. Follow-up information was received from the healthcare worker which reported that she could not provide additional adverse events information. The patient had no problems, and the patient will get ZOSTAVAX in 28 days.  Additional information is not expected.
About 7PM started screaming-calmed p/talking-t102 w/APAP during noc; this AM fine red rash @ the site & cult of leg-tummy, chest, arms & other leg; refuses APAP et juice;
This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site joint pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site joint pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site joint pain, injected limb mobility decreased and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were reported as follows: The reporter was a patient. The patient experienced shoulder pain in the same arm where he received the injection and that it persists now. The patient was unable to lift his arm up to shoulder level without experiencing a tremendous amount of pain and that exercise had not helped it. The nurse giving him the shot told him that she does not give it in the muscle, and caller was unsure if the shot was administered in his muscle or not, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Narrative:  62yo male patient with cancer of soft tissue, lymph nodes in face, liver, & bone with new spinal cord involvement per 9/13/2021 MD note died on 9/27/21 at HOSPITAL. Pt had received covid vaccines on 1/28/21 & 4/6/2021. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
This case was reported by a healthcare professional and described the occurrence of unresponsive to stimuli in a 4 month old male subject who was vaccinated with Pediarix, plus separate injections of Prevnar and Hib vaccine (unspecified manufacturer) for prophylaxis. The subject's medical history included acid reflux. Concurrent medications included Panitidine hydrochloride (Zantac). The subject had no adverse events following receipt of prior immunizations. On 14 November 2006 the subject received 2nd dose of Pediarix, 2nd dose of Prevnar and 2nd dose of Hib vaccine. On 14 November 2006, immediately after vaccination with Hib vaccine, Pediarix and Prevnar, the subject "screamed" for about 20 minutes. After the 20 minutes, on 14 November 2006, the subject "became unresponsive to external stimuli" and experienced "lack of movements, for approximately 45 minutes. The healthcare professional reported that there was no fever and after the 45 minutes, the symptoms resolved on 14 November 2006. The healthcare professional considered the events were possibly related to vaccination with Pediarix, Prevnar and Hib vaccine. Comment: unresponsive to stimuli was assessed as medically serious by manufacturer.
ITCHING ON THE SKIN, ALLERGY ON THE SKIN SUCH AS SPOTS OR MOSQUITO BITES, TURNING RED, ITCHING ALL OVER THE BODY, PALATE AND TONGUE. RASH ON THE LEGS, THIGHS, ABDOMEN, ARMS, CHEST, SOMETIMES THEY ARE NOT SEEN BUT THEY FEEL TO THE TOUCH. I AM TAKING BENADRYL SINCE SUNDAY AND PUTTING IN THE RASH BETAMETHASONE VALERATE
Breakthrough case. Started having a cold for a couple of weeks, then symptoms started getting worse. I took a home test and tested positive for COVID-19. Had a houseguest that was positive for COVID. Started have severe throat pain and blocked ear canal. Went to my Dr. was prescribed Augentin and felt better within 2 days. Started feeling better and didn't test again.
Caller reported patient received 1st dose of VARIVAX in 2017 and did not receive a second dose.; No additional AEs; This spontaneous report has been received from a pharmacist concerning a currently 53-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unspecified date in 2017, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, anatomical location, route of administration, lot# and expiration date were not reported) for prophylaxis. At the reporting time, the patient had not received a second dose (Routine immunization schedule incomplete).  No additional adverse event was reported.
This is a spontaneous report from a contactable physician. A 19-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, batch/lot# unknown), via unspecified route of administration, on Jul 20, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. The reporter stated on an unspecified date, patient experienced tingling and swelling of her lower face about 1-2 hours after her injection. The patient has no throat swelling or difficulty breathing at that time. Patient given Benadryl by her mother and reactions resolved within a couple of hours. Patient queried regarding the second dose. The reporter was trying to determine whether patient's reaction constitutes a severe allergic reaction, which patient already reported at the end of July (exact date unknown). Outcome for the severe allergic reaction unknown and for other two reported events recovered. Information on the lot/batch number requested.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "tinnitus" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "supraventricular Arrhythmia" (unspecified if ongoing); "Morphine allergy and Entereg allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 01Jun2021; METOPROLOL, start date: 01Sep2022. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events,Linked Report(s) : US-PFIZER INC-202300177712 Same patient, different drug, different event;
Patient was given an expired dose of VAQTA. Admin on 10/31/2022; This spontaneous report was received from a physician and refers to a 34-year-old patient of unknown gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 13-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U024378, expiration date 22-OCT-2022 (strength, route and site of administration were not provided) for prophylaxis (expired product administered).
1-2 minutes after the vaccine, I got  very hot then my chest got very heavy. I never struggled to breathe, but it was harder to breathe. My pulse and blood pressure went up. I got dizzy and lightheaded. Maybe 5-7 minutes after the onset, it started to get better on its own. No medicine was given. The paramedic did an ekg which was normal. My blood pressure and pulse also went back to normal.  My oxygen level was normal. Later that evening and the following day, the only noticeable difference was extreme fatigue and a headache. I was dizzy and lightheaded for a few hours after.
I was given the order from provider to give immunization to pt. I went to the med room I got the immunization, went to go give them to the patient, then went to chart them I realized that I administered the wrong vaccination.
Information has been received from a physician concerning a 12 month old female who was vaccinated with MMR II. Concomitant therapy included VARIVAX (Merck). It was only known that they received MMR II and VARIVAX (Merck). It was not certain if they were administered concomitantly or in what order. Subsequently, the patient experienced rash and fever of 101 degrees F. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). The patient experienced faint and injured head on floor. Subsequently, the patient recovered from faint and injured head on floor. The patient sought medical attention. Additional information has been requested.
The same day post vax, this pt experienced a severe headache, severe abdominal cramps and watery diarrhea. The pt sought unspecified medical treatment. The pt was treated with 800mg of ibuprofen and acetaminophen (Exdecrin). On the following day (04/02/99), the pt experienced two black eyes 'like some one punched." On an unspecified date, the pt recovered. No further information is available.
Muscle soreness and light headed. Cannot sleep toes going a but numb.  Feel like I got hit by a truck. Also head ache
Nosebleed, fatigue, headache. The nosebleed was first thing in the morning. The other symptoms did not display until later in the day (afternoon sometime).
Rapid heartbeats; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heartbeats". The event "rapid heartbeats" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 22-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 05-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain".  Additional information: Reporter had two male patients yesterday (21Feb2021) that asked for a booster [Pfizer BioNTech Covid-19 Vaccine]. 14 years old and 15 years old. Their last doses were given in the summer. Their mother was telling that they were given in Aug2021. She gave them the booster, 0.3mL, to both. The LOT number was FK9896. She made a mistake and did not ask for their vaccination cards until after and saw that their first dose was 11Aug2021 and their second dose was 12Oct2021. She was counting the interval between their last dose and the booster, and it was 19 days short of five months. They did very good with the first two doses. Just a little pain. So, she was hoping they do okay with the booster even though they got it early. Reporter have one or two patients to whom the first dose was given and didn't come to get their second dose for a month or two after the first dose, but reporter went ahead and gave the second dose. Some had diarrhea and vomiting after eating something, but it was not related to the vaccine. Two patients reporter before had a big interval before the second dose. Reporter also asking, the booster dose was 0.3 (mL) Or was it 0.5, and thought it was 0.5mL for adults.  The lot number for bnt162b2 was not provided and will be requested during follow up.Sender's Comments: Linked Report(s) : US-PFIZER INC-202200315805 same reporter/different patient/same AE