chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pit pain in right arm pit.; Itching at injection site.; Nausea.; Fatigue.; Headache.; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the right arm on 12Apr2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced arm pit pain in right arm pit, itching at injection site, fever, nausea, fatigue and headache. No therapeutic measures were taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of armpit pain in right armpit, itching at injection site, fever, nausea, fatigue and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax & 15 mins later exp h/a; pt was seen in the ER & was treated w/APAP; Pt exp nausea, dizziness & achiness; pt was prescribed Percocet; exp 1st migraine h/a;
Pt recvd DTP/OPV/HIB 8MAY91 & @ 9PM devel fever to 105, would not come down w/APAP, on day 3 called MD, on day 4 became lethargic w/high pitched cry, on day 5 seen by MD treated for sore throat & ear infect; Fever came down;
On the evening of 8/3, the pt began experiencing body aches and feeling bad, he experienced achiness, cold chills, dizziness and headaches. Symptoms worsened. On 8/6/00 the pt was admitted to the infirmary with a fever of 103.5. On 8/7 the fever was 102.6. After night time dose of Motrin on 8/7, his temp the following morning was 97.3. He was discharged from the infirmary and given a  bottle of 800mg Motrin. He continued to feel bad and took Motrin every 6-8 hours. On 8/10 after eating breakfast and taking Motrin he began having seizures. He had 35-40 seizures from 8/10 to 8/17. Also he experienced pain in his eyes, fatigue, sleepiness, eyes are sensitive to light, cannot think clearly and cannot remember things. Diagnosed with epilepsy.  Follow up on 10/12/2000: "The immunization clinic told us that they do not track lot numbers.  We cannot supply this information."
After getting the second dose of the Moderna vaccine I started having appendix pain the next day 1/26/2021. The pain became progressively worse during the week and I went into the ER on the morning of 01/29/2021. I had testing which included blood work and a CT scan. I was diagnosed with appendicitis and had an appendectomy that same night.
Feels warm; Swelling pink; Temperature 100.6F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN and ATORVASTATIN CALCIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feels warm), SWELLING (Swelling pink) and PYREXIA (Temperature 100.6F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6F.         No concomitant medications were reported.   Action taken with mRNA-1273 in response to the events was not applicable.
1442: After receiving COVID vaccine, pt c/o itch on buttocks, legs, ankles & nose 1445: Benadryl 12.5 mg po given 1500: HR 80 SpO2 98%  Released home
Patient called and reported redness, itching, small patch hives, fever (>100 degrees Fahrenheit). Injection was in left arm. Patient was instructed to follow up with PCP if symptoms ongoing or worsen within 7 days.
Soreness on injection site day and day after that resolved.  Axillary lymphadenopathy on CONTRALATERAL side started day 4. Painful.
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-11-2022
p/vax pt exp intermittent fever, diarrhea w/cramping & nausea;
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Lot number: F54989), in left arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3. Past drug history included: No, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications with in 2weeks product vitamin d3, brand nature made; product= centrum silver, brand= centrum.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Over the course of the next several days post vax, the pt experienced discomfort to the arm at the injection site. During the night of the 3rd or 4th day post vax, the pt woke with excruciating pain radiating up and down the left upper arm. Generally the entire muscle seemed severely cramped and the pt was unable to relieve the pain. Limiting movement helped to ease the pain but only a limited amount.
pt c/o itching on arms & legs w/in 1min of vax;was scratching on arms & legs;hep b given 1st, followed by MMR;no rash appeared;no resp difficulty;
Horrible Pain in left breast. First occurred at 2  am 4/8. Loss of vision occurred at 3:05. Fell backwards onto floor 3:05 am.  Diarrhea, nausea, labored breathing and sweating profusely. Unable to walk. 3:05 am. Thought was having stroke.
Low grade fever, symmetric erythema, induration, slight increased warmth right upper thigh beginning about 20-24 hours after injection 10 1/2 cm diameter
got GBS as side affect; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received both the Shingrix shot. A week after the second shot, the patient experienced Guillain Barre syndrome (GBS) the side effect from hell. The Guillain Barre syndrome was over year ago from reporting but the patient still dealing with it. Additional Supportive Information: The follow up would not possible as no contact details were available.
arm is a little sore; Initial information was received on 24-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (demographics unknown) whose arm was little sore (pain in extremity), when received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor,  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a little soreness in his arm (pain in extremity) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available  It was not reported if the patient received a corrective treatment.  At the time of this report, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Patient reported her throat closing 15 minutes after the vaccine. She declined care and her spouse transported her to the ER.
Similar to my reaction to wheat or egg. Asthmatic tightness, wheezing, cough, raspy voice.  I left the area and went to my car where my husband was and took Zyrtec, benadryl and famotidine as my allergist had instructed for allergic reaction and improved within 15 minutes.  I had a much milder reaction with the second dose because I took those meds before vaccine.  After the first dose my COVID and post COVID syndrome symptoms returned for four days then resolved (aches, palpitations, heart rate above 100, shortness of breath, exhaustion, brain fog).  I'm reporting now at the suggestion of my PCP, I didn't report at the vaccine site.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 27-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Vertigo commencing 10 days after injection.  Condition is ongoing with duration of 1 day at time of reporting.  No treatment of symptoms as of time of reporting.
The pt reports severe itching and rash over entire body. The rash lasted 2-3 days. Responded to Benadryl. No MD contacted.
IM given in left arm 3rd dose. (Booster) Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/2021 @ 11:45 am. Given on 11/5/2021, out of time range. Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up on them once we heard back from them. Called patient today 11/17/2021 and let him know that Moderan let us know the vaccine was viable, no additional booster vaccine is required.
Pt arrived @ office after 3d of fever "red bumps" & c/o mouth pain, 20 lesions seen on exam - rec'd vaccine #1 - 11-14-08 vaccine break thru.
The first time you know typical soreness; 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 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The first time you know typical soreness".  Additional information: caller was experiencing side effects from the COVID vaccine and she wants to know if she should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04Apr, the second time it was a full blown feeling like she have the flu with a full grade fever, then the third time she had her ears swell up to the point she cannot hear in any ears now. Caller mentioned that now it was time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that she seek medical advise from her doctor and they don't know what to do as well and referred her to Pfizer MI. The first time typical soreness, the second time was actually Flu like symptoms and then the third was the bad reaction. Proprietary medicinal product name was Covid-19 vaccine. Batch or lot number was FH8028, Unspecified medication manufacturer was Moderna. Can someone tell her should she continue with Pfizer or should she switch to different like Moderna (Unspecified medication) because each time it got worse. Patient have Pre diabetes, Blood pressure and Cholesterol medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was hypersensitivity, state that her throat felt tingly and she can't breath. Her face turn to pink to red, she was shaking, sweating and states that her chest for tight. She was given 2 capsules of BENADRYL total of 100mg by mouth with water. She was fan for her because she felt hot and sweaty at the time. From administer of shot to RXN was in little as 5 min. After BENADRYL was given, symptoms resolved in 15 min. BP/HR normal range per paramedic.
Child given IM DTaP and SQ IPV on 05/09/2005. 05/10/2005- Child had difficulty walking. Left thigh and knee swollen with erythema, blotchy. Saw MD and got RX for Benadryl. As of 05/11/05- some redness and swelling improvement. Rx prednisone liquid 15mg PO TID x4 days.
TENIVAC WAS GIVEN ON 8-29-22 BUT WAS EXPIRED ON MAY 15 2022.  PER CDC GUIDELINES DOSE WAS REPEATED ON 8-30-22.
if it is okay to get the first dose of Covid-19 Vaccine if her husband had an x-ray test which was used with dye for the procedure two weeks ago; This case has been considered invalid as there is no indication that the consumer experienced an event under suspect vaccine BNT162B2.  This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient(husband) that:   Is the Reporter a Healthcare Professional (HCP)? No ; Occupation/Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party? Unknown  Is the reporter the prescribing HCP? No  Suspect Product(s): Pfizer Covid 19 Vaccine  Start Date: 11Feb2021   Verbatim and Event Description:  Caller is asking if it is okay to get the first dose of Covid-19 Vaccine if her husband had an x-ray test which was used with dye for the procedure two weeks ago and she on the other hand is taking blood pressure and cholesterol medications.  Information on the lot batch number has been requested.
I had a breakthrough case of Covid-19 with coughing , headache, fever, body ache I had a lot of fatigue I was prescribed Amoxicillin, Zythromiacine
Cold Symptoms appeared after immunization given, patient is insisting it is due to vaccination despite education, counseling.
Telephone call from client: Nickel to eraser size hives around pneumonia injection site (6-7).  Doctor said to take Benadryl and not to ever repeat pneumonia shot.
Light headed since vaccine, area red, warm, 2.5 x 3.5 inches, non indurated.
Patient woke up on 03/12/2021 to severe spike in long-term unchanged Tinnitus (T): doubling of patient perceived volume; addition of intermittent pure tones at varying volume and for varying duration in one or both ears (9-12x per day, unilateral/both ears, lasting for 30-90 seconds); frequent intermittent unilateral hearing loss of short duration (45 seconds-2minutes, both ears, 5-6x per day).  Note onset of T at patient's puberty (~1975-76), note no change in perceived volume or composition of T since 1975-76.  Note no prior intermittent additional pure tones or previous intermittent, short-term changes in patient's hearing sensitivity.  Note also increase in hyperacusis.  These issues have not resolved in the 12+ months since injection.
hurt and itch a bit; red patch; aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain). At the time of the report, PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt received 0.5 ml of Moderna Booster in left deltoid. No adverse side effects noted during observation period, or  patient exit
Facial redness on left side of face with mild swelling. no difficulty breathing or stridor.  Self resolved after 2 days.  Received phone call from patient's father. Family declined visit as symptoms had resolved.
Patient states she received a PREVNAR vaccine and had stiff neck the next day. She said she could not turn left or right.
10 April 2021: 14:00 J&J Covid-19 vaccine. No issues whatsoever throughout day, neither muscle soreness at injection point, nor fatigue etc.  11 April 2021:  Woke having had headache and left shoulder/neck muscle soreness affect sleep.  Woke ~09:00.  Headache became worse, & minor chills. Had breakfast (toast w/Vegemite).  Drank lots of water.  Through day, felt worse (notably headache, fatigue).  Had lunch ~12:30 (salad and jerkey), but quickly felt unwell with it.  Interrupted phone call at ~13:45 to go to bathroom, feeling nauseous  Felt a bit dizzy, having to stabilize my walking around apartment a couple times, but mostly feeling mentally foggy/unclear.  Struggled with some sentences on phone calls.
Swelling, warmth and tenderness at injection site. Rxed TYLENOL prn pain and application of ice.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 09Apr2023 to 14Apr2023 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Interchange of vaccine products , Drug ineffective , Covid-19  and the use of suspect product cannot be fully excluded.
Patient presented today for her 2nd dose of menveo and her first dose of bexsero. Patient received Bexsero in the right deltoid and tolerated well. Patient then received menveo in the left deltoid and after injecting the immunization patients eyes dialated and patients arms stiffened up, mother yelled at patient and both her and I laid the patient back on the bed, patient was non responsive to our voices for 45 seconds to 1 minute. I called for help and staff brought some water and Dr.  walked into the room and ordered to take the patients blood pressure and she felt her pulse, patients blood pressure was 122/66. Patient stated that she was okay but her head hurt. Dr.  stated to let the patient rest for 10 minutes and recheck her vitals, at this point her mom went to get the patient something to eat we checked patients blood sugar and it was 112. Patient continued to lay down and rest while mother went to get her food, while monitoring the patient she stated she felt that her head hurt pretty badly. We took the 2nd set of vitals for the patient and her BP was 106/64 her temp was 97.8 her O2 was 98% and her pulse was 57. Mother came back and wanted patient to eat some blueberries but after eating a few the patient stated that it made her nauseous. Dr. advised for the patient to lay there with her legs elevated for 15 more minutes. Patient soon after complained that she was cold so I put 2 sheets and a patient gown over her to warm her up, again the patient stated her head pain was getting worse on a pain scale it would be an 8, I told mother that I would speak with Dr. about her headache. Dr. stated that patients chilliness is a reaction to the injection. Dr. then went into the room to speak with the patients mother. I then went back into the room to take another set of vitals her BP was 110/64 temp was 97.9 O2 was 98% and her pulse was 58. Patient stated at this time her head would still be an 8 on the pain scale. Patient was given 20ml of mapap acetaminophen liquid. She laid there for 25 more min and Dr. went in one last time to check on the patient. Dr. released patient and advised her to come in for a nurse visit on Friday however patients mother asked if it could be moved to Thursday between 2-3 Dr. advised that was okay and also to order a CBC, CMP, and a CK for the patient to have done tomorrow before the nurse visit. Patient and mother both verbalized good understanding and stated they would be here tomorrow between 2 and 3.