chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a consumer who is also the patient on 25 OCTOBER 2012. An 85-year-old male patient with the history migraines, hay fever and heart condition and concomitant medications was not reported, had received a dose of FLUZONE HD (lot number U4530AA) intramuscularly in the left deltoid on 20 OCTOBER 2012. On OCTOBER 2012, shortly after vaccination, the patient began having migraine. It was reported that he had migraine every day since the vaccine. Previously he would get it only once a month. The patient also complained of stiffness in his neck. The  laboratory investigations were none. The patient was prescribed pain reliever. At the time of this report, the patient's outcome was not recovered. Documents held by sender: none.
blood pressure that was at 229/147; a terrible headache that continued to the next day to a migraine; terrible headache that continued to the next day to a migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure that was at 229/147) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine). On 31-Jan-2021, the patient experienced HYPERTENSION (blood pressure that was at 229/147) (seriousness criterion intervention required). On 31-Jan-2021, HYPERTENSION (blood pressure that was at 229/147) had resolved. At the time of the report, MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure abnormal: 229/147 (abnormal) 229/147.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  On 31-Jan-2021, the patient went to urgent care due headache changing into a migraine. The reporter stated, urgent care would not provide treatment due to how high the blood pressure was and advised the patient to go to the emergency department. The patient went to the emergency department around 6:00 pm and was treated for elevated blood pressure of 229/147. The patient was not admitted nut was advised to follow up with a primary care physician.  Treatment details were not provided.  Company comment: 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 case was linked to US-MODERNATX, INC.-MOD-2021-114821 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114821:
THE JANSSEN COVID 19 VACCINE THAT WAS ADMINISTERED TO THIS PATIENT EXPIRED 2 DAYS BEFORE THE ADMINISTRATION DATE. THE BEYOND USE DATE WAS OMITTED ON THE LAST BOX CONTAINING THE VACCINE VIAL. I ASSUMED IT WAS STILL IN DATE WHEN I PULLED THE PRODUCT. EXPIRED VACCINE IS USUALLY NOT STORED IN THAT SPECIFIC REFRIGERATOR. I WAS THE ONLY PHARMACIST AND WE WERE BUSY. THAT SPECIFIC REFRIGERATOR WAS WHERE IN DATE CURRENT VACCINES ARE TYPICALLY STORED.
COVID-19 VACCINE WAS GIVEN TO  THE PATIENT THAT DID NOT MEET THE AGE REQUIREMENT AT THE TIME OF VACCINATION
11-19-12 1014/AM FLUZONE (not preservative free) administered left deltoid area. That evening, parent reports child had walnut size reddened area. 11-20-12 Reddened area 3 inch diameter - warm to touch. Taking BENADRYL. 11-21-12 Reddened area 3 inch x 4 inch today - warm to touch.
Erythema and induration along front and lateral aspect of left thigh about the site of injection.
4/11/21 - 0400 - awoke with nausea/diarrhea; 0900 - vomiting/diarrhea; 1300: rash/hives started at neck and spread to all areas; 1530: went to ED - treated via IV with zofran, benadryl, pepcid and prednisone.  Discharged 1900 - symptom-free with orders to continue meds prn 4/12/21 - 0400 - awoke with diarrhea, swelling to lips, rash/hives. 0800 - fever noted at 103.3.  0830 - Went to ED.  Treated via IV with  decradon and benadryl.  0130 - Discharged with symptoms and orders to continue zofran, prednisone, benadryl, pepcid PRN. 1420 - Went to clinic physician.  Recd orders for continue all prev prescribed meds plus claritin, PRN. 4/13/21 - symptom-free
A report was received from a healthcare professional in the USA on 7/5/04 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
I have pressure over 180/ blood pressure was really high; my monthly period was been really strong for example in one period, I got like twice, if like I had two periods in one month; Head hurts; Body ache; Felt really bad; all the time I feel really nervous; sickness, of course for a week of sickness; I have headache like stains on my hair; I haven't been sleeping/ not able to sleep; I have headache like stains on my hair; I feel really bad since I got vaccinated, I don't know if there was any ingredient that mad me reaction; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient was not doing well and felt really bad since get vaccinated, the patient did not know if there was any ingredient that made her any reaction. It was reported that the patient experienced symptoms since the first dosage. The patient haven't been sleeping, had pressure over 180, headache like stains on her hair (further clarification required). The patient monthly period was been really strong for example in one period, patient got like twice, if like patient had two periods in one month and all the time patient felt really nervous. The patient cannot sleep a long ago, had the body ache and taken treatment with Advil that Ibuprofen, but still felt that. The patient was can't even stand sometimes, head hurts a lot. The patient husband stated that his wife felt ill, could not sleep and so not feeling well the problem was that we tried to take her to the emergency room then told that we shouldn't be taking her to the emergency room but on the computer to get the pills and they give to her but that's not because they told not to go back anymore. The patient felt sickness, of course for a week of sickness. It was stated that the patient was not able to sleep because her blood pressure was really high and she was not having any issue with her blood pressure. The patient received second dose of bnt162b2 on 19Apr2021. The clinical outcome for the event of body ache was not recovered and remaining all events outcome was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
pt recvd DTP/IVP on 26FEB92 & on 28FEB92 started running a fever 102; mom gave APAP; On 29FEB92 pt ran fever of 105 & mom took pt to ER; ER MD told mom it was a resp infect; CXR dx pneumonitis & cough & some sternal retraction;
1 week after vaccination development of redness/hive-like rash/warmth/pruritis/pain distal to injection site.   Have been monitoring, no medication started.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly store dose of ROTATEQ injection (lot # M002252 with expiry date:28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a 25 year old female patient without pertinent medical history. The patient had no drug reactions or allergies. The patient was not pregnant. On 15-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H015863, expiration date 24-MAR-2015) (the physician stated the lot number for the GARDASIL in question was either "H-zero-15863" or "H-letter O-15863") (dose, route and injection site were not reported). Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL and XANAX. On 16-MAR-2013 the patient developed itchy rash on her face, arms and legs after receiving her first dose of GARDASIL. There was no laboratory diagnostics study performed. Treatment BENADRYL was given for adverse event. The action taken, causality and outcome were not provided at the time of the report. The patient sought unspecified medical attention. Additional information has been requested.
COVID Vaccine #1 event, patient arrived to receive first dose of Pfizer vaccine.  The patient has no allergies or medical history. Vaccine was administered at 1353.  Patient was discharged at 1409 without any adverse events. Patient ambulated with mom to exit from the event.  At 1515, I was informed the someone was having shortness of breath and chest pain.  When I arrived with the vital machine the patient was sitting in a chair, skin color was normal but he had facial diaphoresis. Patients mom had brought patient back to mobile event.  BP 146/90 HR101 RR 20 Oxygen saturation 98% on roomair.  Patient complains of shortness of breath and constant chest pressure.  Patient hair removed from face, ice pack applied to neck, patient mask removed so air intake was not restricted patients feet elevated on a chair. NP present assessing patient with MA interpreting in Spanish. NP verbalized to continue monitoring vitals every 15 minutes. At 1530, vitals BP 145/91 HR96 RR18 O2 Sat 96%RA. There were no changes in the patients complaints. NP reassesses patient recommends patient may need further evaluation.  At 1543, vital remained stable BP 131/79 HR 103 RR18 O2 sat 96%RA. At 1547, EMT arrived.  Patient ambulated to gurney and was transported to Hospital per patient mom request.
Fever; Chills; Joint pain; Headache; Sore throat; Muscle weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril", notes: Known allergies: lisinopril. Vaccination history included: BNT162b2 (Dose:3, Lot number: 30135BA, Location: Right Arm), administration date: 15Oct2021, when the patient was 75-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); PYREXIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Fever"; HEADACHE (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); ARTHRALGIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Joint pain"; MUSCULAR WEAKNESS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Muscle weakness"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Sore throat".  Additional information: Patient did not have Covid prior vaccination. Patient did not receive other vaccine in four weeks. Patient received other medication, Pirtobrutinib, in four weeks. 12 hours after shot, fever, chills, joint pain, muscle weakness sore throat, headache lasting almost two days. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Intense itching and chronic hives about 10 days after shot, has lasted now for 6 weeks. Doctors believe it is spontaneous urticaria resulting from the moderna booster.
This spontaneous report was received from a pharmacist referring to an unspecified number of elderly patients of unknown gender. On an unknown date, the patients were vaccinated with ZOSTAVAX, 0.65 ml, (route of administration, lot # and expiration date were not provided). Concomitantly, the patients received high dose flu (manufacturer unknown). On an unspecified date, the patients were complaining of lethargy or complaining of injection site soreness. No treatment was given. At the time of reporting, the outcome of lethargy and injection site soreness was reported as recovering. Additional information has been requested.
Moderate pain at site: 11/2/11 - 11/4/11. Moderate tenderness at site: 11/2/11-ongoing. Moderate erythema at site about 1 1/2": 11/2/11-ongoing. Moderate warmth at site: 11/2/11-ongoing. Moderate fatigue: 11/2/11 - 11/3/11. No treatment for all AEs.
This is a spontaneous report from a contactable registered nurse via a sales representative. This report is in addition to original Reportum, 1HZFXE5S to report an adverse event. A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13, (with lot number, NDC number, expiration date not provided) 0.5 ml single IM in the deltoid (unknown which) on 24Nov2014, administered in the clinic office. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced redness, swelling, warm to touch, discoloration like a bruise on an unspecified date, and unknown if occurred immediately or the next day. The reporter did not know if the redness, swelling, warm to touch, and discoloration has resolved. Follow-up (23JAN2015): Follow-up attempts completed. No further information expected.
Information has been received from a nurse practitioner concerning a 31 year old male with no known allergies or significant past medical history. On 10/13/2000, the pt had serum varicella zoster vaccine antibody test of 0.23 negative. The pt was vaccinated with the first and second dose of varicella virus vaccine on 11/03/2000, and 12/13/2000 SQ in the left arm, respectively. Subsequently, the nurse reported that the pt had no detectable titer after vaccine series was given. On 01/17/2001, the pt had another varicella virus antibody test which was negative, no detectable antibody. Unspecified medical attention was sought. Additional info has been requested.
About three days after my 5th dose, I noticed that I had decreased appetite. That morning I did miss breakfast because I did not feel hungry, and it continued on throughout the day.  This has continued up until now.  Today I have felt hungry and had more of an appetite.  I do have an appointment today to have blood work done to check my thyroid and A1C.
Minutes after receiving the injection I felt a horrible taste in my mouth. I asked the woman who was scheduling my next vaccine if this was normal. Then began feeling dizzy, nauseous and heart was racing and felt flush in my face. They sent 2 EMS people to take my blood pressure; i actually don't remember what it was because i felt a bit disoriented. The man EMS person said the BP was high and asked me to wait. They came back 15 minutes later and took it again and it went down but I still felt my heart racing and nauseous. I waited for a half hour then called a car service to take me home. I felt extremely tired achey, and head ache for 3 and 1/2 days. The foul tase in my mouth lasted about 4 days. I spent most of the 3 days just resting. I felt back to normal after day 5 but feeling very apprehensive about getting my second dose.
Case number PHEH2014US015162 is an initial spontaneous report received from a nurse on 28 Jul 2014 with a follow up report received from the nurse on 28 Jul 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) intramuscularly at a dose of 0.5 ml on 21 Jul 2014. On 24 Jul 2014, the vaccination site became red, warm and raised. She also had a painful area at the vaccination site. The outcome of the events was condition unchanged. The seriousness and causality of the events was not reported. Follow up report received from the nurse on 28 Jul 2014: Added MENVEO batch expiry date (30 Sep 2014).
he had an allergic reaction to the vaccine; This is a spontaneous report received from medical information team. A contactable consumer (patient) reported that a 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration in left arm (at the age of 58-year-old) on 24Mar2021 at 13:30 at single dose for COVID-19 immunisation. Medical history included diabetes, diagnosed about four years ago, he believes; blood pressure diagnosed about the same time, about 4 years ago; cholesterol levels were diagnosed about 15 years ago, probably more than that, all ongoing. Concomitant medications included ongoing metformin orally at 500 mg once a day for diabetes; ongoing lisinopril orally at 5 mg once a day for blood pressure; ongoing gemfibrozil orally at 600 mg twice a day for high cholesterol. The patient previously received acetylsalicylic acid (ASPIRIN) in 1994 and that's the last time he took it and was allergic to it. He took it once. The first time he took it, he got a very severe allergic reaction, his whole face was swollen. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. After he took the first dose of the vaccine, he developed swelling to the left side of face near to his lips that night, and it was gone the next morning. He just had a little swelling on his lips up into the face. He got vaccine on 24Mar2021 at 13:30, the swelling, he got that at 00:00 on 25Mar2021 at night and the next morning, he still saw it and by noon it was gone. The 2nd dose was supposedly on 14Apr2021 but no available schedule so he booked today (15Apr2021). When he went to get the second dose of the vaccine, there refused to vaccinate him because they said he had an allergic reaction to the vaccine. Nurses and the doctors at the facility refused to give him the 2nd dose, instead advised him to report it to Pfizer. He already talked to his primary care physician and said that he can take at his own risk. A visit to Emergency Room or Physician Office was not required. The outcome of event was recovered on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
A report was received from a health care professional on 11/10/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. On 10/29/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
I knew I had been exposed to COVID-19. Tuesday morning I woke up with sore throat and stuffy nose. I took a home test early morning, it had a faint positive line waited and took another home test later and still a faint line, went to the doctor's office to have test and it was positive. I had 3-4 days very sore throat, congestion. Wednesday Paxlovid started taking that night, cold symptoms eased up, still have fatigue and some dizziness and nauseous.
pt recvd vax; was noted later that vax had expired on 30SEP90
patient had a grand mal seizure 3 hours after receiving the bivalent Moderna; This spontaneous case was reported by a nurse and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Epilepsy.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (patient had a grand mal seizure 3 hours after receiving the bivalent Moderna) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Moderna COVID-19 vaccines previously received are  1st Dose: Administered on 30-JAN-2021, Lot number- 037K20A, Expiration date - 22-JUN-2021 2nd Dose: Administered on - 27-FEB-2021, Lot number - 024M20A, Expiration date - 3-AUG-2021 3rd Dose: Administered on 27-OCT-2021, Lot number - 036C21A, Expiration date - 1-NOV-2021, Dosage administered was 100 mcg. It was reported that patient experienced seizure in her vehicle. No treatment drug details was reported. Company comment- This is a spontaneous case concerning a 51-year-old patient, with concurrent condition of epilepsy and immunocompromised, who experienced the unexpected and serious (medically significant) AESI generalised tonic-clonic seizure 3 hours after a dose of mRNA-1273.222 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. It was reported patient experienced the seizure in her vehicle. Concurrent condition of epilepsy remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old patient, with concurrent condition of epilepsy and immunocompromised, who experienced the unexpected and serious (medically significant) AESI generalised tonic-clonic seizure 3 hours after a dose of mRNA-1273.222 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. It was reported patient experienced the seizure in her vehicle. Concurrent condition of epilepsy remains as a confounder. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.