chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and itching of head and forehead; Redness and itching of head and forehead; hypertension; This is a spontaneous report from a contactable Pharmacist. A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3302, expiry date: May2021, NDC number: 59267100001) intramuscularly in deltoid right on 20Jan2021 at 0.3 ml single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporting pharmacist works with a group of five pharmacists. Colleague administered Covid-19 Vaccine to the patient an hour ago. Patient presented with side effects. Pharmacist clarified adverse event as itching of the head and forehead. Forehead looked pretty red and as if there were pimples, but patient was scratching hard. Occurred 15-20 minutes after vaccination (20Jan2021). Pharmacist checked patient for other symptoms of breathing and swelling. Patient stated he was ok in that aspect. Pharmacist gave patient two 25 mg tablets of Benadryl. Pharmacist states patient is healthy and just has hypertension (20Jan2021). Patient is still at the clinic and is going to check back in with caller about how he is doing. Doesn't have exact time of vaccination. Seriousness: At least medically significant. Patient was able to go back to the kitchen and do his job. Pharmacist asked how would he know that is not an allergic reaction and if the second dose should be given. Sticker states NDC is 5926710001, but pharmacist believes NDC is 59267100001. Vaccination Facility Type was Nursing home. Additional Vaccines Administered On Same Date Of Pfizer Suspect was No. Pharmacist makes sure other vaccinations are separated by two weeks. All events required Physician Office Visit. Prior Vaccinations Within 4 Weeks was Unknown. AES Follow Prior Vaccinations was Unknown. Relevant Tests was None. Benadryl allergy tablet, 25 mg NDC: 50580- 226-51 Lot: SFF084 Exp: Feb2022. Pharmacist asked if second dose should be submitted. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events pruritus, erythema and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.
Moderate pain at site. Next day started with fever of 102.3, chills, severe body aches. Headache as well. Fever subsided by end of first day but started again the next day.
pt states she started having left leg pain.  She has muscle aches and pains in her leg so bad that she can hardly lift it and has not been able to climb her stairs in her house.  She is sleeping sitting up since she cannot lay down.   She says her pain level is still a 6 out of 10.  Both feet are swollen and lower part of her legs are cold and stiff and the upper part of legs are warm.  She has been taking naproxen 520mg to help with the pain.  She says this has not helped with the pain.  Pt will contact her PCP.
Approximately 7 x 12 cm erythematous, warm to touch, inflamed area surrounding the point of SQ injection, projecting distally toward elbow.
2nd dose given 5 months after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 5 months after the 1st dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 5 months after the 1st dose). On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 5 months after the 1st dose) had resolved.            No concomitant medications provided. No treatment details reported.
Narrative: 83 yo male received covid vaccines on 2/5/2021 & 3/9/2021. Past Medical History: hx carcinoid resected duodenum Gastroesophageal reflux disease Hyperlipidemia Neck pain Bilateral arthritis of knees Aneurysm of right iliac artery Abdominal aortic aneurysm without rupture Hyperlipidemia  Abdominal pain  Generalized headace  Urticarial rash  Angioedema of lips  Acute lower urinary infection  Urolithiasis  Multiple nodules of lung  Low back pain (ICD-9-CM 724.2) Renal mass (ICD-9-CM 593.9) Carcinoid tumor of intestine (ICD-9-CM2Chronic nonspecific abdominal pain Crohn's disease  Benign essential hypertension  Hyperlipidemia (ICD-9-CM 272.4) Health Maintenance (ICD-9-CM V65.9) Hearing loss (ICD-9-CM 389.9) Vision, Subnormal (ICD-9-CM 369.9) Osteoarthrosis involving the spine (ICD-RA notified pt died on 10/30/2021 - at nonRA facility Likely not related to covid vaccine This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Started with a mild rash in between her eyes on Monday. Started Cortisone cream. However, rash has continued to spread on face. Nose is bright red and both eyes are very puffy and swollen. Received a topical steroid from urgent care and after putting on, the rash has continued to spread on the face. In the process of receiving liquid steroids and liquid antibiotics to try to stop the spreading. No issues with breathing and will follow up with pediatrician this week.
This spontaneous report was received from a nurse via referring to a 11 years old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 11-OCT-2018, the patient was received one dose of improperly stored GARDASIL 9 (lot # R003557 with expiration date 20-DEC-2020; strength, dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. Temperature/Time frame: 47 degrees Fahrenheit (F) to 77F for 9 minutes and below 0 F for 24 hours. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter (linked case # 1810USA007667).; Sender's Comments: US-009507513-1810USA007667:
inappropriate route; pain; swelling; redness; headache; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, headache and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, headache and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The nurse administered Shingrix subcutaneously to four patients. One patient developed redness, pain and swelling at the injection site. No additional details were provided. The reporter declined to provide identifiers or additional adverse event information until she would discuss the issue with her supervisor. This is one of the 4 cases, reported by the same reporter.
irregular heartbeat/ spell where it was out of rhythm; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (lot number HAH8A21A) on 22-Feb-2021 and Moderna covid-19 vaccine (lot number 027H21B) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 03-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2023, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm). The patient was treated with METOPROLOL SUCCINATE for Tachycardia supraventricular, at a dose of 25 milligram once a day. At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (irregular heartbeat/ spell where it was out of rhythm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Electrocardiogram ambulatory: supraventricular tachycardia. In 2023, Ultrasound scan: supraventricular tachycardia.         No concomitant medication was reported.  Company Comment This spontaneous case concerns  a 72-years-old-female patient with medical history of appropriate Primary schedule of moderna vaccination without adverse events who experienced the AESI of supraventricular tachycardia approximately 11 months after 3rd. dose of mRNA-1273 BIVALENT .222 vaccine. At the time of the report, the event had not resolved.    The age could be a contributor for events  The benefit-risk relationship of mRNA-1273 BIVALENT .222  vaccine  is not affected by this report.
Narrative: Fully vaccinated, COVID positive on admission for respiratory distress. Patient was treated for COVID and PNA.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
This spontaneous report as received from registered nurse refers to unknown number of patients who have been administered improperly stored VARIVAX over the last 2 years (since approximately December 2010). No other co-suspects were reported. No concomitant medications were reported. It has been determined that the thermometer used to monitor the freezer temperature in the last 2 years may have provided inaccurate temperature readings. The nurse was not able to confirm the exact number or identities of the patients at the time of the report. No adverse effects reported. Patients outcome was uknown. Additional information has been requested.
Whole body ache. Shoulder pain. Tingle in extremities. No redness/discoloration at injection site.
Fever 103.5,  whelp on injection site , migraine, muscle tightness in neck and back, soar throat, dry cough
Patient felt warm and cloudy immediately after the vaccination.  She was given a cold pack and bottle water and remained under supervision for 30 min by the pharmacist.   After 30 min, she felt a lot better.
Hearing loss; This case was reported by a non-health professional and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss unilateral was unknown.   It was unknown if the reporter considered the hearing loss unilateral to be related to Shingrix.  Aditional information was received as follows: The age at vccination was not reported. The patient received Shingrix and experienced hearing loss to his right ear post immunization.
MMR #2 vaccine was given 6/27/07. Expiration date on vaccine box 3/29/07.
Injection site reaction with redness, itching, swelling, 2 inches around.  Resolved3/19/2021
Started getting mild headaches on 1/1/2021 which comes around noon and goes away in evening after 6-7 pm. Still getting headaches everyday since 1/1/2021 in same pattern and at same time. Also feeling little nauseous over past few days.
redness and itching at injection site 5 minutes after receiving varivax.  Benadryl elixir 25mg given po.  Observed an additional 15 minutes.  Redness resolving.  No additional s/s noted.
A 4 year old male child with with no known allergies and history of asthma developed a large reddened and warm area at the injection site at an unspecified time the day he received IM influenza vaccine (Fluzone SV 2005-2006), lot no U1838AA in the right thigh on 10/25/05. He had also received, the same day, IM Tripedia in the left thigh, IM inactivated poliomyelitis vaccine (IPOL) in the left thigh and SC MMR vaccine in the right thigh. He was concomitantly taking  albuterol PRN. Flovent and Singulair QD at the time of the report. The pt consulted the physician on 10/29/2005, and he was recovering slowly at the time of the report. Follow up information received on 1/30/06 from a health care provider. The pt had received two previous flu vaccinations without any reaction. At the time of this report, the pt had fully recovered.
Patient received Shot on 10/26 roughly around 11am. On the following Sunday 10/28, patient felt soreness and pain in upper arm and axillary area, worsening throughout day. Pain and discomfort peaked around hours 72-96 after shot. Patient took celebrex that he had been prescribed for lower back pain in the past. Patient now is taking prednisone due to possibility of brachial plexopathy.
She slept the entire day; Nausea; Headache; Her arm was sore where they gave the shot.; She felt dizzy which lasted 5-6 minutes.; She had a reaction where her arms felt funny.; Her body started heating up more and more; This is a spontaneous report from a contactable consumer (patient) via telephonic call. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 15:00 (Batch/Lot Number: EW0164) as single dose in arm left (at 57-year-old) for COVID-19 immunization. Medical history included ongoing seasonal and chemical allergies. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, and no prior vaccinations within 4 weeks. She went to the state fair grounds. It was put on by the local agency. She gained the COVID 20lbs. She does have seasonal and chemical allergies so maybe that made her have a hypersensitive reaction to it. When she got the shot on 18Apr2021 she felt like she was fine, and then less than 5 minutes later, probably about 3 minutes later she started to feel very funny. She had a reaction where her arms felt funny. Her body started heating up more and more. She felt dizzy which lasted 5-6 minutes. She hasn't recovered completely. Then, she got dizzy and got a headache. Her arm was sore where they gave the shot. On 19Apr2021 morning, she had a tiny headache right after the shot and dizziness that went away. Her head could clear up a little more though. She had nausea and was very nauseous on 19Apr2021 night. The nausea went away after 3 hours. On 19Apr2021 (Monday), she had dizziness again. Currently, she felt fine. On 20Apr2021 (Tuesday), she slept the entire day. She didn't wake up until 4. She got the vaccine in her left arm which is the side she sleeps on. She went and got a physical before the vaccine to make sure she was in good shape. She did not go to the ER or physicians office. No relevant test. The outcome of events nausea, and headache was resolved on 19Apr2021; of event vaccination site pain was resolved on 20Apr2021; of events dizziness and feeling abnormal was resolving, while of other events was unknown. communication: The caller was provided Medical Information's number of (#), option 3, and placed in queue due to high call volumes.  No follow-up attempts are needed. No further information is expected.
Approx 8 pm (8+ hrs after injections) "sudden onset" c/o chest feels heavy; arthralgias nausea fever 101.0 *? vaccine reactions vs. viral GI*
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with a dose of PEDVAXHIB (lot number not provided). Route was not reported. The patients received a dose of PEDVAXHIB that had been stored improperly. The nurse could not provide more detailed information. This is 1 of 3 reports from the same source (other case numbers 1212USA000912 and 1212USA001482). Additional information has been requested,
Approx 20 minutes after patient received vaccine she complained of not being able to take a deep breath. Patient appeared to be short of breath but no signs of acute respiratory distress.  Patient expressed that she had been "extremely anxious" regarding receiving the vaccine. Patients skin was warm and dry to touch Patient's vital revealed BP 104/80, Respirations 36/minute, pulse 125 beats per minute.  Patient stated she was currently seeing a psychiatrist and taking daily meds for anxiety.  Patient also stated a history of panic attacks. Upon further assessment patient states her throat feels scratchy and swollen.  Benadryl 50mg po was given.  Patient attempted controlled breathing exercises and symptoms did subside. Vitals were taken again approx 10 mins after Benadryl was administered, BP 122/78, Pulse 64 beats per minute, respirations 18/ minute.  Patient was monitored for approx 20 more mins. Patient denied any complaints, states all symptoms had resolved.  Instructed patient to seek medical attention if symptoms returned.  Patient discharged home with family member.
Pt recvd vax 14APR93 AM & to ER 14APR in PM swollen face, resp difficulty, t101.3;
It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch; It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch; It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch; It was like a horrible sunburn reaction on arm that got the vaccine it hurt, burned and itch; This is a spontaneous report from a contactable consumer or other non hcp based on information received by Pfizer (manufacturer control number US-AMGEN-USASL2021056027).  A 47-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included ongoing Rheumatoid arthritis. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis, start and stop date were not reported. It was reported that on an unknown date, the patient stated that seven to eight days after the first shot it was like a horrible sunburn reaction on the arm that got the vaccine it hurt, burned and itch. Subsequently, The patient followed treatment with ice and Tylenol (paracetamol). It lasts for three days before it went away. Therapeutic measures has been taken as the result of events with ice and Tylenol (paracetamol). The outcome for the events was reported as resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021461658 Same patient for different vaccine dose/events
This spontaneous report as received from Register Nurse refers to unspecified patient of unknown age and gender. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I rush to the hospital with abdominal pain; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient was a bariatric patient and had gastric sleeve done. Concomitant medication was not reported. On an unspecified date, the patient rushed to the hospital with abdominal pain. The event caused hospitalization. The patient said that he just wanted to know was there any connection between the COVID-19 vaccine in bariatric patient that get bariatric sleeve. he outcome of event was unknown.  Information on the lot/batch number has been requested.
pt stated that had to sit down suddenly this morning while making her breakfast as she thought she was going to faint. She described it as "collapsing into her chair" but never lost conciousness. she said she felt better after sitting and after eating her breakfast. at the time that she called she said that she felt normal but wanted to let us know about that.
Patient was administered both improperly stored Vaxelis and Rotateq; This non-serious spontaneous safety report with reference number 02125894 was received by the partner on 10-Mar-2022 and forwarded to Agency on 15-Mar-2022 from another health care professional.  The causal relationship between Vaxelis and the reported event is not applicable due to the nature of the event.  Further information is expected.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild.
On  04/26/2021 felt short breathlessness and dizziness. also Blood pressure is elevated and in between 150-160. Heart rate was also high. Immediately went to ER to check. Was treated for palpitation and dehydration. Felt normal after couple of days.  I took second dose on 05/06/2021. I felt normal for about a week. After that i started feeling heavy or pressure in my head and also dizziness. For past one week I'm feeling acid reflux and heartburn. Considering i had history of acid reflux I never had this issue for past few years. I'm not sure if my GERD issues are induced by vaccine. I'm having controlled diet with fruits and veggies but i still have  heartburn and frequent burps. Also my Blood Pressure is still elevated around 130-140 and feeling tired and pressure in my head even now after  18 days of taking 2nd dose. I had consulted my physician on 05/20/2021, and she prescribed a medicine to take only when my blood pressure is above 140.   Just to summarize, I still have dizziness and occasionally elevated BP and acid reflux, heartburn/burps. This is impacting my day to day home and office works