chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 05Jan2021 17:30 in right arm at single dose for COVID-19 immunization. Medical history included hypopituitarism from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 (lot number: EJ1685), on 18Dec2020 10:45 in left arm at single dose. Concomitant medication included second dose of varicella zoster vaccine rge (cho) (SHINGRIX) for immunization, hydrocortisone acetate (CORTEF), levothyroxine sodium (SYNTHROID), desmopressin acetate (DDAVP), simvastatin, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and losartan potassium (LO). On 06Jan2021 08:00, the patient experienced chills, fever, intense body pain all over, headache and nausea. No treatment was given to the patient for the events. The patient recovered from the events in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient received SHINGRIX within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy.  Mental fog and exhaustion.  Symptoms lasted through. 1/21/2021. Today mental fog lifted, lightheaded but not dizzy. Not as sleepy. Seems to be lessening as day goes on (1/22/2021)
Back of hands, elbows, thighs, knees have been itchy; Flushed; Regular rash. Knuckles, elbows, knees flushed in red and warm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 21Apr2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as no. Concomitant medications were reported as not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, a week after receiving the vaccine the patient experienced itchy and flushed on back of hands, elbows, thighs, knees for past 4 days. No visible, regular rash. Knuckles, elbows, knees flushed in red and warm. Therapeutic measures were taken for the reported events and included treatment with oral antihistamine(unspecified). Itching had minimally reduced with oral antihistamine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Itchy rash, flushed and red rash was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 92 year old female who in "October 2007", was vaccinated with Zostavax (Oka/Merck). Within the "past week" in approximately Jan 2008, and approximately three months after receiving Zostavax (Oka/Merck), the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a 18-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site lump and injection site induration. On an unknown date, the outcome of the injection site lump and injection site induration were unknown. It was unknown if the reporter considered the injection site lump and injection site induration to be related to BEXSERO. Additional information was received as follows: The caller stated that the patient was the son of the physician that the nurse worked with. The age at vaccination was not reported. The patient received BEXSERO on an unknown arm. The nurse reported that the patient experienced a hard lump at the injection site. The caller had limited information regarding the patient's demographics and details surround the event.
Syncopal episode, weakness, body aches, fatigue for the last week to 2 weeks. Passed out woke up on the floor.
On Thur, Feb 25, my left shoulder at the top on the back started to itch and there was a rash there. My neck on the left side started to ache. My left arm, where a vein was torn during a colonoscopy procedure on 3/9/2020 and had been black and blue, started to ache and the black and blue became prominent slightly but hurt in the crook of my arm. The next day in the afternoon on Fri, the spot in my left arm where I'd gotten the vaccine started to hurt and it has gotten progressively painful over the last few days. it's the exact spot where I'd received the shot, it hurts as if I've torn or pulled something and yanks up to my neck. It's painful. Rash stopped itching but that spot was numb in places. Emailed doctor
Arm Hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Hurt". Additional information: The patient stated that she had the second shot that day, she felt fine and her arm did not hurt like it did after the first one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received expired ActHIB vaccine that expired on 3/5/2023. Patient has no adverse reaction at this point.
PATIENT RECEIVED 2ND DOSE PFIZER 6 DAYS BEFORE IT WAS DUE. SHE WAS MONITORED FOR EXTENDED PERIOD OF TIME AND SHE EXHIBITED NO ADVERSE REACTIONS DURING OBSERATION AND WAS DISCHARGED IN STABLE CONDITION
Increased HR, Weakness, Throat Irritation, Diaphoresis.  Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
I do not know the exact date of the first or second Moderna Vaccine. I am the PICU attending who cared for the patient after her cardiac arrest which we believe was about 3-4 days after her second Moderna Vaccine
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male 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 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant medications were reported.  It was reported that 113 Bivalent doses were administered after the BUD to patients 12 and up. 51 doses were administered from Lot AS7140C, and 60 doses from Lot AS7148B.  No treatment medications were reported.
The patient received his second shot of Moderna vaccine on 6/14/21. That night he felt ill with headaches, fever and nausea.  On Friday morning (6/18/21), the patient developed a 15-minute episode of chest discomfort. He described it as a moderate midsternal chest soreness radiating to his left arm at rest and worse with a deep breath, not positional.  That same evening, the patient had an even worse episode of the same chest discomfort prompting his trip to the emergency department.  The patient was admitted to the hospital with an elevated troponin level.  He was started on colchicine and ibuprofen.
She went to HCF and received a J&J COVID vaccine around 1000.  She then became nauseous and left work at 1300 and went home to rest.  On Thursday at 0100, states she woke up and could not lift head up due to her head hurting so bad.  She did get up and went to bathroom and nose started bleeding continuously until 0400.  Slept through the rest of night and rested all day Friday (headache and tired).  Friday night into Saturday, was hot/cold states she took Tylenol for headache.  Sunday stated she felt much better and was fine.  Reported to work this am at 0800 and started feeling dizzy/lightheaded/nauseous.  Co-worker took BP which was elevated (172/120).  Manager sent her to ED where she was subsequently sent to a stroke recovery unit and has had 2 CT scans and additional testing.  She does have slight left leg weakness and was ordered TPA tre atment which she refused. She remains in observation at this time for more testing and dependent upon results may be kept overnight.
on 5/1/2019, the patient was adrninistered one dose of MMR II and on 5/8/2019, the sarne patient was adrninistered one dose of VARIVAX; No adverse effects were reported; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On 01-MAY-2019, the patient was vaccinated with a one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 08-MAY-2019, the patient was vaccinated with a one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R029519, expiration date 14-OCT-2020 (dose, frequency and route of administration were not provided), that was reconstituted with a one dose of sterile diluent (DILUENT MRK) (dose, frequency, route of administration, lot number and expiration date were not provided), for prophylaxis. No adverse effects were reported.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "unknown" and all described as "Tested positive for Covid". The event "tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive; (23Jul2022) Positive, notes: Patient now testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Antiviral details included product for COVID-19 Treatment. Patient had taken both doses of Pfizer Covid vaccine. Yet, patient got tested positive for Covid at the ER on 14Jul2022. They prescribed PAXLOVID. After 3-4 days, patient was feeling ok. Patient completed the five doses. Patient now tested positive for Covid with mild fever, cough, and little runny nose. Patient questioned about , "What next step should patient have to take. Some new medication, quarantining for many more days or something else. Patient has his wife with him and she was okay". Adverse event start date/time reported as 23Jul2022 at 12:00 AM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns a 55 years old female patient. No changes in her routine. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s). The patient received AFLURIA on the left arm for indication prevention of influenza on 07-Oct-2015- 07-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. She received AFLURIA through work. This was the first time being vaccination with CSL and did not know if she had received AFLURIA in the past. No other vaccinations were received on 07-Oct-2015. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On the evening of 07-Oct-2015, after starting/ treatment with AFLURIA, the patient experienced spasms at injection site arm/ The (spasms) "kept coming"/At the injection site of left arm, she can feel her "artery bounce up and down"/She can feel the spasm-it feels like pulse (non serious, outcome: Not Recovered/ Not Resolved). When she was working, she could sometimes see her bumps moving (injection site) (non serious, outcome: Not Recovered/ Not Resolved). They were mild and compared them to 'eye spasms'. Event treatment: She had not self-treated with spasms. For relevant test results see appropriate report section.
Started 15 minutes after vaccination and it lasted for 30 minutes. Tingling arms and fingers and heaviness in shoulder. Resolved.
patient got her first dose of GARDASIL 9 on 08-JUN-2021 and got her second dose of GARDASIL 9 on 22-MAR-2022.; No additional AEs reported.; This spontaneous report has been received from a registered nurse and refers to a female patient of unknown age. The patient's current conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 08-JUN-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, as prophylaxis (lot number T024831 has been verified to be valid, expiration date 18-NOV-2022); and on 22-MAR-2022, she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, as prophylaxis (lot number U008897 has been verified to be valid, expiration date 16-MAY-2023) (routes of administrations and anatomical locations of vaccinations were not provided) (inappropriate schedule of product administration). No additional adverse events were reported.
headache; tingling on face; numbness on her face; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on face in 2013).   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th September 2019, 1 day after receiving Shingrix, the patient experienced headache, tingling and numbness facial. On an unknown date, the outcome of the headache, tingling and numbness facial were recovered/resolved.   It was unknown if the reporter considered the headache, tingling and numbness facial to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced headache. She also noticed numbness and tingling on face where she previously had shingles.   It lasted a couple of days and symptoms appeared very quickly, on the day of vaccination. The pharmacist was transferred to MI for questions as patient was concerned about getting her second dose of shingrix after her experience.
Narrative: i. 68 year old male developed dyspnea, wheezing, and sweating immediately after receiving his booster dose of the Moderna Covid vaccine and influenza vaccine ii. BP spiked to 220s/180s iii. Received diphenhydramine 25mg IV, famotidine 20 IV, and methylprednisolone 125mg IV in the ER, along with albuterol/ipratropium nebs and symptoms dissipated. iv. Patient had no issues with previous doses of COVID-19 vaccine and no hx of reactions to the influenza vaccine. 1. Received an influenza vaccine every year for >10 years v. Admitted to medicine and monitored overnight, no new symptoms observed vi. Discharged the next day, recommended to only receive vaccines in a monitored setting in the future.
fever, cough, sob, brain fog, chills, congestion, diarrhea, eye redness, fatigue, headache
Seizures which are worst before, during or after her menstrual cycle, arms and legs numbness, anxiety, memory loss, no being able to focus and concentrate, can't deal with any level of stress, just a little of stress causes seizures (her entire body shakes like she is being hit with electricity, when this happen she is dropping things, she falls and she is hurting herself).
Pneumococcal vaccine given on 05/19/10 IM on left arm deltoid.  Several hours later she got redness and bruising around injection site.  Two days later she came in and there is some redness and swelling extends to proximal elbow.  Feels warm and burns a bit.  Was given CEPHALEXIN 500 mg and take BENADRYL.
Significant fatigue and malaise and localized warmth, tenderness at injection site for 4-5 days.
bloody nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor XI deficiency (but hadn't had a bloody nose in 2 months.). Concomitant products included SODIUM CHLORIDE (SALINE SPRAY) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (bloody nose). On 10-Feb-2021, EPISTAXIS (bloody nose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient's medical history updated. On 28-Jun-2021: Possible NNI
Orange cap 5 - 11 year old vaccine given 6 days after beyond use date of 3/8/2022.
Starting 05/07/2021, I went into the ER due to having red fluid filled bumps all over my hands and feet. I thought it was an allergic reaction but was informed it was a rheumatological response to the vaccine (Gottron's papules). I was given an appointment for rheumatology and discharged. On May 09,2021 I had my first seizure when I was at my parent's house. I felt lightheaded and then don't remember what happened next. I awoke to my mom comforting me and telling me I had a seizure. We didn't immediately go to the ER due to thinking it was a onetime event. On 05/12/2021, I was taken to the ER due to having a seizure while working at around 8pm. They prescribed me Keppra 500mg BID and I was referred to Neurology. On 05/15/2021, I got the second dose. I was unable to get into neurology until 07/12/2021 and at that visit they did a bunch of tests and determined they needed to have me come in for 3 days in order to do a continuous EEG to determine whether they were Epileptic seizures or not. It wasn't until 09/22/2021 that I went in for the 3 days stay and was taken off Keppra for the time being. They did a continuous EEG and determined that my seizures were not epileptic but possibly could be a conversion disorder but couldn't rule out anything else due to them starting after I received the vaccines.
Patient made an appointment for his bivalent Pfizer booster today. He had filled out the consent form saying he had 3 doses prior, and his last dose was 09/30/22. I saw he had one J&J, and 2 Pfizer doses so I assumed he would be due for his bivalent since it was more than  2 months since his last dose and he only had 3 doses prior. Upon processing, it rejected through insurance and I checked data which stated he already had his bivalent booster (the dose received in September) and he also received an additional dose of the regular Pfizer in May 2022.