chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she felt something was wrong with the left side of her face. She described it as "numbing and swelling".; she felt something was wrong with the left side of her face. She described it as "numbing and swelling".; 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 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Jan2022 (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: SWELLING FACE (medically significant), HYPOAESTHESIA (non-serious) all with onset 30Jan2022, outcome "recovered" (Jan2022) and all described as "she felt something was wrong with the left side of her face. She described it as "numbing and swelling".".  Clinical information: The female patient stated that she received her first dose last 30Jan2022 and on the way home, she felt something was wrong with the left side of her face on same day(30Jan2022). She described it as numbing and swelling. She said that it lasted between 1hr to 1hr and 30 mins (Jan2022). She mentioned that she spoke with her doctor and was told to call Pfizer MI for information. She wanted to know, should she take her scheduled second dose after experiencing the mentioned side effects. Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1. Signs of a severe allergic reaction can include as Swelling of your face. Referred to her HCP for appropriate recommendations.  The lot number for bnt162b2 was not provided. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received VARIVAX on 3/22/10. On 3/23/10 mom noticed arm swollen and red and puritis. Seen on 3/24/10 still red but with less swelling.
During the 15 minute observation following the 1st Moderna vaccine dose, the patient reported her tongue 'felt thick,' flushed skin, redness on face, neck, hands, BP=98/60, HR=100.  Patient felt 'jittery' and 'heart racing.'  Was transferred to ED for evaluation given that patient reported her tongue 'getting tighter.'  In the ED, the patient was treated with diphenhydramine 25mg x 2 doses, methylprednisolone 125mg x 1 dose, famotidine 20mg x 1 dose, and NS IV fluids.  Hypoglycemia was ruled out with CBG=87.  The physician avoided treatment with epinephrine due to it being listed on her allergy list with a reaction of 'shortness of breath.'  Symptoms resolved over the next 3 hours.  The patient was discharged home with a new prescription of oral prednisone taper.  Subsequent follow-up with her primary care provider, in consultation with an ID provider, recommended that this patient NOT get a 2nd dose.  Covid-19 vaccine was added to her allergy list with a reaction of 'anaphylaxis.'
Hives upper chest and neck, redness at site of MCV vaccine (upper right arm). No respiratory problems. Gave 50 mg of BENADRYL/at 1615, rash subsided.
Patient died 8/6/07 presumed SIDS, autopsy pending.  8/23/07 Received prelim autopsy report from coroner.  COD is pending.  Patient was 34 wk preemie twin.  Mother had been hospitalized x 1 mo prior to delivery for uterine rupture.  Patient was on home monitor.  Found lying on side co-sleeping w/twin in crib.  10/5/07 Reviewed autopsy report which states COD as SIDS with prone sleeping position; twin gestation & manner of death as natural.  Pathologic dx include: premature birth (34 wk), mild right ventricular dilatation and pulmonary edema.
Arm pain and very severe pain and had rash on the pain and it is slowly going to my back and also in my other arm. The pain after the second vaccination the lump and the pain got worst. i could not take the pain so i went to the doctor and they did xrays and everything was fine but just the arthritis. i am really concerned about my health
arm pain while I was shaking out towels; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain while I was shaking out towels) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain while I was shaking out towels). On 28-Feb-2021, PAIN IN EXTREMITY (arm pain while I was shaking out towels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
red flushed face-4hrs;h/a-4hrs;hives 24hrs;tightness in chest-24hrs
I had both shots WELL I have the shingles/suspect vaccination failure; I have the shingles; RED SPOTS; BUT SOME PAIN; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red spotty rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, red spotty rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, red spotty rash and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine and had shingles, red spots and some pain. The patient stated that the vaccine sure did not help him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of PNEUMOVAX23, lot # L014458 and expiration date 11-FEB-2017, (routes of administration and anatomical locations were not provided). No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has bee unspecified.
headache; lightheaded; chills; tingling; flushed face; hot flashes; fatigue; feeling unwell; This is a spontaneous report received from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included the patient was allergic to 23 medicines and got hives from them. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient called her physician before the first shot and her physician thought that the patient should not taking diphenhydramine hydrochloride before the first shot and she followed his advice and she did not take it. The patient did have some reactions on the 3rd and the 4th in Mar2021; headache, lightheaded, chills, tingling, flushed face. After 2 days it was okay and the patient was fine. The patient stated that yesterday it was all back again for no reason and the patient felt lightheaded and had a headache, hot flashes and fatigue in Mar2021. The patient had a bad night and she tried ibuprofen (ADVIL) and then she switched to acetaminophen (TYLENOL) as she was feeling unwell in Mar2021. The outcome of events, headache, lightheaded, chills, tingling, flushed face, hot flashes, fatigue and feeling unwell was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
vomiting, dizzy, severe headache, ?passed out?, currently remains tired with headache she has taken ibuprofen
Hives, difficulty breathing, coughing, labored breathing, shortness of breath by morning after.  Continued breathing and coughing for two weeks after.   Bruised ribs, lost voice after 6 days for a week.
Temporary tachycardia; This is a spontaneous report from a contactable Physician. This physician reported similar events for 3 patients. This is the second of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced temporary tachycardia on Dec2020 with outcome of recovered. The reporter monitored the patient using a pulse ox with a heart monitor. Let the patient drink water. She has monitored the patient for about 30 minutes and tachycardia has resolved in 30 to 40 minutes. The reporter was a bit concerned about what to expect and how to prepare for the patient's 2nd dose of the vaccine.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520685 Same reporter/drug/event, different patient;US-PFIZER INC-2020517983 Same reporter/drug/event, different patient
23 week pregnant patient received second dose of Moderna COVID vaccine on 6/24/21 and started developing a rash that night underneath the injection site. Rash was warm to the touch and slightly itchy, but no other adverse effects or signs of anaphylaxis. I recommended the patient use hydrocortisone cream to help with itching and to contact pharmacy and OB if rash worsened or did not resolve in a few days.
About 8 or 9 days after Covid vaccine, I developed an itchy red area on upper left arm around 9pm. I started taking Benadryl, but the area is still red and itchy.
Pt recv vax on 4/13/98; on same day pt exp rash of left upper arm, upper chest &back.  Pt tx=epinephrine .25ml/SC &Benadryl 50mg/PO
Patient's left arm was infected per doctor.  It looked red and inflammed. Patient is currently taking antibiotic( Keflex 500, Take one capsule by mouth 4 times a day)
Patient had syncope immediately after Hep B vaccine. When he regained consciousness he vomited and had urinary incontinence. Again began to feel faint, then had another episode of emesis. 911 called due to slow recovery at 12:15pm - EMS arrived at 12:23pm Transported to hospital 12:51PM. Patient was given 3rd Hepatitis B vaccine in R.D. Immediately patient became pale and began to faint. Ammonia Inhalant activated under patient's nose and he opened his eyes. A cold compress was applied to the back of his neck. No respiratory distress. Patient then had an episode of emesis and began to feel faint again. Ammonia Inhalant again used. Pt became more alert but again had an episode of emesis and urinary incontinence. Vital signs taken. 6-24-16 phone call to patient's mother. She states that when they arrived at the hospital patient had something done to see if he had an enlarged heart. Heart tested fine-no problems. Patient is home today-No complaints.
Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM. The event was considered as serious due to resulted in disability or permanent damage. No treatment received for the event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.
Site of administration very swollen, red, hot to touch, pt now running fever (may or may not be related).
Breaking out / Splotches all of her body/ Red splotches; Painful splotches; This case was reported by a physician and described the occurrence of red blotches in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced red blotches and painful rash. On an unknown date, the outcome of the red blotches and painful rash were unknown.   The reporter considered the red blotches and painful rash to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix about a year ago. After the Shingrix dose, the patient started breaking out in red painful splotches all of her body. The reporter thought it could be related to her Shingrix. The reporter consented to follow up.
Information has been received from an RN concerning a 48 year old Hispanic female dietary aide who on 6/25/01 (also reported as 6/27/01 and 6/22/01), sometime in the PM, was vaccinated IM in the LA with a 3rd dose of Hep-B vaccine recombinant (yeast) (lot NDC0006-4775-00, also reported as lot 637691/1454K). On 6/27/01 (also reported as 6/26/01), at approx. 14:00, the pt experienced pain in the joints (wrists, arms, and knees), joint swelling and had a rash. It was reported that the pt was sent to the ER and was treated with Benadryl and prednisone and was released. It was noted that the pt continues to have mild symptoms for which workman's compensation will not cover. Follow-up info has been received from an RN which indicated that there might have been a temperature stability issue with the product due to the wholesaler and their shipping methods. It was noted that the vaccine was packed on an ice pack and "it took at least 3 days to arrive". Addition follow-up has been received on 10/22/01 from an RN which indicated that the pt had not completely recovered from the experience. It was reported that the pt also experienced "nerve damage", aches, could not go out into the sun for a long period of time and could not work in the heat (pt did kitchen work). The pt's aches and pain in joints, joint swelling, photosensitivity, head sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and "Other Important Medical Events". Additional information has been requested. Follow-up information has been received on 10/29/01 from an RN which indicated the pt was "fine". It was noted that she was still having a problem going out in the sun for long periods of time and that she could not work in the kitchen because of the heat. It was reported that the pt had not been dx'd with any other disorder and that the problem was both sunlight and heat. Follow-u[ info received from a registered nurse indicated that the pt had not recovered from her experience. The pt's aches and pain in joints (wrists, arms, and knees, joint swelling, photosensitivity, heat sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and other important medical events (OMIC). Additional info has been requested.
fainting; pain; sleep walking; dizziness; Anemia; was very thirsty/drank lots of water, around 2-3 gallons a day; three interventions on her bladder; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criteria hospitalization and medically significant), PAIN (pain) (seriousness criterion hospitalization), SOMNAMBULISM (sleep walking) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), ANAEMIA (Anemia) (seriousness criterion hospitalization), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) (seriousness criterion hospitalization) and BLADDER DISORDER (three interventions on her bladder) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (fainting), PAIN (pain), SOMNAMBULISM (sleep walking), DIZZINESS (dizziness), ANAEMIA (Anemia), THIRST (was very thirsty/drank lots of water, around 2-3 gallons a day) and BLADDER DISORDER (three interventions on her bladder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.; 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.
This spontaneous report was received from a Medical Assistant referring to a 17 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with PROQUAD (Strength, route, dose, frequency, and anatomical location were unknown) lot # N020620 and expiration date 22-JAN2019 for prophylaxis reconstituted with sterile diluent (MERCK). No adverse effects were reported.
body aches , headache, chills, weakness, fever 100.2  3/14/2021, weakness persting  3/15/2021, weakness 3/16/2021
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 19:00 as dose 4 (booster), single (Lot number: CUS9602) at the age of 37 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. Concomitant medication included: SERTRALINE, start date: 09Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive, notes: Took a Covid test Friday night and the positive mark showed up and was at about 50% opacity compared to a full blown positive test.   Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.
like a runny nose, it was liquid non stop; her body hurts worse than usual; feel like she have the flu; tired afterwards; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date), via an unspecified route of administration, administered in arm on an unspecified date as single dose for COVID-19 immunisation. Medical history included medical disability because she has had 3 shoulder surgeries, within the last month she had a fall and she fractured her back, she also mentioned that she was a diabetic and she has all of the comorbidities on the list and she has had pneumonia 4 times out of 5 years and her doctor said that if she gets covid then they can just go on and call her dead. The patient's concomitant medications were not reported. The patient reported that she had her vaccine this past Friday (as reported) and she had some reactions like a runny nose, it was liquid non-stop and her body hurts worse than usual. She reported that she was going to be just fine. She refuses to have anything else, she has enough. She knew that it was normal to feel like you have the flu and tired afterwards and that was exactly how she feels. The patient mentioned that she was told to get the covid vaccine in her dominant arm. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor.   32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to  septic shock and respiratory failure, and he was placed on a ventilator at  Hospital.   On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL.  On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy.   He remains there today.   We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.
Patient with h/o hives from first dose (12/26/20) became lightheaded and dizzy 20-30 minutes after second dose. Received 25 mg Benadryl and Epi-Pen before being sent to the ED.
Information has been received from a 63 year old female patient with none pertinent medical history and allergic to penicillin and KEFLEX. In March 2014 the patient was vaccinated with ZOSTAVAX (route, lot# and dose were unknown). None concomitant therapy was reported. On 28-AUG-2015, 6 days ago approximately 17 months after receiving ZOSTAVAX she now had shingles. The patient initially believed her spots were caused by poison ivy until they began to spread from an unspecified location to her buttocks. The patient did go to an unspecified dermatologist and was diagnosed with shingles. Valaciclovir (1 gram, tid, for 7 days) was given to treat the event. None lab diagnostics studies were performed. The outcome of shingles was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.