chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 03-MAR-2022. 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAR-2022, the patient experienced covid-19 test positive (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint 90000219964. The suspected product quality complaint has been confirmed to be voided this case does not meet the definition for a  since the only indication is that the patient had covid but does not refer to any symptoms or PCR tests. Based on the  evaluation/investigation performed.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 2 hrs after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site induration and fever. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site induration and fever were recovered/resolved. The reporter considered the injection site pain, injection site erythema, injection site warmth, injection site induration and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported by a sales representative on behalf of physician. The patient was daughter of reporter, who experienced significant soreness at injection site (unknown arm). The injection site was also described as hot, hard and red. The patient also felt as though she had a fever. The body temperature was not officially measured. The patient was treated with MOTRIN (800mg).
mom stated pt stiffened up, started shaking & hands & feet turned purple the evening following vax;fever was measured 103 & pt screamed excessively x2hr;1 day f/u vax: cont w/fever & considerably cranky;
Stiffness in arm/stiffness in a couple of her fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness in arm/stiffness in a couple of her fingers".  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: Linked Report(s) : US-PFIZER INC-202201282842 similar report from same reporter;
Symptoms started as headache & chills approximately 3 hrs after injection, continuing  through the next day. By  27 hours after injection I had severe headache, entire body ache, sore throat, chills and fever.
No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Large rash developed at injection site 5 days post vaccination. Intensely itchy, reddened and warm to touch. Injection site still generally tender but less so than day after injection.
Patient received covid-19 booster (pfizer) and fainted upon leaving the pharmacy .  Patient was with her mother when she fell and hit her head outside of the store.  According to mom, patient was nervous about getting the shot.  Patient was awake, breathing and had no obvious bleeding.  Ambulance was called , patient was evaluated and discharged .
administration high in his left arm, right in joint between arm and shoulder; no able to sleep at night; Hurts like hell; touch is hurting; This spontaneous case was reported by a consumer and describes the occurrence of DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder), INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder), INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting). At the time of the report, DOSE CALCULATION ERROR (administration high in his left arm, right in joint between arm and shoulder) had resolved and INSOMNIA (no able to sleep at night), PAIN (Hurts like hell) and PAIN (touch is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case included information of patient 27th out of 190 reported patients.  No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 190 patients received a vaccine past the beyond use date from 9 different lot number vials.  No treatment medication reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
"The evening after I got my first varicella shot I started to break out on both wrists and hands. It looked like a food allergy but then progressively got worse and blisters formed. It itched and ended up scarring both my hands and wrists.
Nausea, heartburn, tiredness, dizzyness, urge to lay down, slight headache
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCEACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM ALLERGIC REACTION, INIT ALLERGIC REACTION, SUBSEQ 12/25/2021 -- RECURRENCE OF SAME SYMPTOMS
FIRST:  Within approx. 24 hours after vaccination, my left foot/toes began to swell.  Feverish to the touch.  Pain in toe joints and ball of foot.  Awaiting lab results from PCP.  Symptoms persist 5 weeks after vaccination.   SECOND:  Two weeks after injection, detected rapid heart rate.  Sought medical attention...104 resting heart rate .  EKG showed mild abnormality to be compared to previous EKG 7 years ago.  No known heart issues prior to injection.  Awaiting doctor's directive to see a cardiologist for heart monitor.  Heart does not race constantly...seems to be worse in the morning after rising.
I  had a break through case of COVID with 10.8 fever the first day and fever of 99 degrees on day 2 and day 3.  I also had a slight cough.  I tested positive on 08/05/21.  I took monoclonal antibody treatment on 08/0821.Covid
Red rash 2-3 inches around injection site. Flu-like symptoms including nausea, headache, and chills.  Left arm muscle soreness.
Pt's right thigh red, swollen, indurated X 4 days. Treated with warm packs, Tylenol, observation.
ACUTE RESPIRATORY FAILURE 2/28/2023 SIGMOID VOLVULUS ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/21/2023 SIGMOID VOLVULUS
having headaches after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: HEADACHE (non-serious), outcome "unknown", described as "having headaches after getting the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is doing fine, no ailments - was just given a third dose due to facility paperwork error
Approx. 30 min. after receiving three vaccines, the client returned to the clinic area exhibiting angioedema (especially peri orbital edema), urticaria/erythema of the face and neck, she was very anxious and complained of tightness in her throat and shortness of breath. We administered Epinephrine 1:1000 0.3 ml IM and Diphenhydramine 25 mg IM at approx. 10:25 AM. Her vital signs were B/P 90/70; pulse 96/min; and resp. 22/min. In the course of about 15-20 minutes she improved with improved breathing, fading of erythemic areas, still had puffiness in her face; but overall she was feeling better.
Case number PHEH2016US029589, is an initial spontaneous report received from a consumer on 08 Nov 2016. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: not reported) at a dose of 0.5 ml, intramuscularly 24 Oct 2016. On 25 Oct 2016 in the next morning when she awoke, she was dizzy also had swelling in lymph nodes in neck and throat. The swelling lasted for a week. She went to ENT (ear, nose and throat) physician. The physician stated that the swelling was from the FLUAD. She was still having dizziness from the FLUAD. The final outcome of events dizzy was condition unchanged and for lymph nodes in neck and throat was complete recovery. The seriousness events dizzy and swelling in lymph nodes in neck and throat was not reported. The causality of event swelling in lymph nodes in neck and throat was assessed as suspected to be related to treatment with FLUAD and causality of event dizzy was not reported.
Hives occurring 18 hours after administration. Tried Benadryl with partial improvement. Went to urgent care and prescribed steroid burst and taper.
Left eye twitching, tingling in hands feet, legs and left side of face. Fatigue. Fuzzy vision. Pain in legs and feet.
I received first Moderna dose on 3/17/2021.  I got very sick with fever/body aches was out sick for 2 days.  Horrible aching. I received second Moderna dose on 4/14/2021.  I again got very sick with fever/body aches, also sick for 2 whole days.  Same reaction as 1st dose. I received Moderna Booster on 11/12/2021.  Within 4 weeks I started having Trigeminal Nerve pain.  The pain worsened as time went on.  I have been back and forth to Kaiser doctor and neurology.  I am reluctant to take drugs/medications.  I have been in severe pain for the past 5 months with no relief.  This pain is debilitating.  I cannot eat, drink, speak.  I am worn down constantly.  Prior to any Covid vaccine doses I was healthy and motivated.  I used to Hike 3-4 times a week.  I love the outdoors/nature.  For the past 5 months I have lost extreme amounts of time at work.  I am unpleasant due to the debilitating pain.  I no longer hike.  This horrible pain is located under my left jaw.  I cannot eat, drink or speak.  I feel almost paralyzed.  I strongly believe this onset is from the vaccine.  I would like some answers.  This as affected my livelihood for the past 5 months severely.
Facial Paralysis/Bell?s palsy; Was given 60 mg oral steroids on site and 40mg prescription for 5 days. Follow up in 3 days. Showing no improvements 8 hrs after first dose.
experiencing shortness of breath; elevated heart rate when she walks; This is a spontaneous report from a contactable consumer. A 63-years-old female patient reported pfizer-biontech covid-19 vaccine (Formulation: Solution for injection, Batch/Lot Number was EW0168, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, administer in Left arm on 24May2021 (age at vaccination 63-years-old ) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date a few days later, patient started experiencing shortness of breath and an elevated heart rate when she walks. The symptoms were still ongoing and have worsened, Heart racing when walking was reported as worsened. Patient also added that She was due for her second shot Monday. Ever since the first shot she has had shortness of breath. When she was walking, her heart also races. She was wondering if she should get the second shot. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Received vaccines 7/14/14. Was well. Next 2 days was very irritable, crying all the time, not high pitched. 100.8 fever. No other symptoms. Cried throughout visit in office 7/16/14.
The first event started on 4/22/21.  I go into an altered state where I can?t stay awake and I go into kind of a blackout that lasts for hours.  I?ve been hospitalized twice, discharged on 6/2/21.  My blood pressure is dropping sometimes which has made me pass out.  I have slurred speech also during these episodes.
Sores on bottom of feet after wearing shoes with hard soles; Forearm muscles felt extremely tired; This spontaneous case was reported by an other and describes the occurrence of SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired) in a 68-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) tablet for Chronic lymphocytic leukaemia and Lymphocytic lymphoma.    The patient's past medical history included Plantar fasciitis. Concurrent medical conditions included Chronic lymphocytic leukaemia, Lymphocytic lymphoma, Joint pain since June 2020, Myalgia since July 2020, Bone pain since July 2020, Diarrhea since July 2020, Welts since 2020, Sleep disorder and Muscle pain. Concomitant products included TRAMADOL for Muscle pain, TRAZODONE for Sleep disorder.   In May 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired). At the time of the report, SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) had not resolved and MUSCLE FATIGUE (Forearm muscles felt extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies.         Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.
Started with rash on lower back; by morning it had spread to abdomen, arms and legs - none on head. No breathing probs (+) itch. Has had flu vax for past 15 yrs (12 at DOH). No fever, no swelling, on forearms only had blister-like spots. Saw PCP - given hydroxyzine pills for itch.
Diagnosed with HSP/ After the second shot of Pfizer it shows on his knees down to his feet. It went away but stayed on the leg.; This is a spontaneous report received from a contactable consumer (parent) by a Pfizer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  Medical history included henoch-schonlein purpura (hospitalized at 10 years old and diagnosed with HSP). The patient's concomitant medications were not reported. On an unspecified date after the second shot of Pfizer COVID vaccine, the patient experienced HSP showed on his knees down to his feet. It went away but stayed on the leg, it didn't go to rest of the body. The outcome of the event was not recovered.   The lot number for BNT162B2 was not provided and will be requested during follow up.
At 1618 the RN adminiters three of the four vaccines to the patient whom is sitting on the exam table. As the RN reaches to retrieve the varicella syringe (1619) the patient starts to lean back, the RN's hand is on the patients thigh, thus far the patient has tolerated the procedure well and smiling. The RN notes that the patient continues to slump down and her eyes begin to roll. THe RN quickly guides the patient's head down to the exam table as she begins to sieze. The RN keeps the patient safe on the table as the parents finally notice something is wrong. The RN calls out the room for an additional RN. Once the two RNs communicate the additional RN brings in the emergency kit and has the front desk personnel activate 911 (1622). The additional gets help from the medical director to assess the patient(1623). The doctor is doing a neurological exam and the additional nurse calls the language line (1623) to assist the doctor. This RN is consoling the patuient as she answers questions related to orientation. This RN begins to take postictal vital on the pt, pulse 49bpm, temp 98.1 (pt was unable to close her mouth completely), BP 116/70 (1625). The EMS arrives (1630), one Spanish speaking, and begins to recieve a report from this RN. The EMS begin to lissten to heart tones on the patient and stated that her hears a rub. The EMS and family decide to take the patient to clinic (1631). A copy of the child's shot record was given to the EMS and parents. The mother informs everyone, after being questioned by the doctor, that she was told the cause of the previous two seizures were due to premature birth and delayed brain development. THe past two seziures happend as the patient was standing and she collapsed onto the floor and they weren't vaccine related.
An expired 2nd dose administered to a patient; An expired 2nd dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose administered to a patient) and PRODUCT STORAGE ERROR (An expired 2nd dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was opened and punctured on 18 Sep 2021 at 10 AM. The vial was at room temperature for 26 hours. A dose was administered on 19 Sep 2021 at around 11 AM. Patient had received 2nd dose. Pharmacist wants to know if the dose needs to be repeated. No Treatment medications were provided No  Concomitant medications were provided
SHE DEVELOPED BIG RASHES ON ON HER ABDOMEN WHICH LASTED ABOUT 3 DAYS
post vaccine syncope. did not fall. brought to observation tent. monitored for 25 minutes and sent home.