chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In March 2019 I developed shingles on my left face, ear, throat, gums, and tongue (possible Ramsay Hunt Syndrome). Treated with valacylovar, prednisone, gabapentin, lidocaine. Rash disappeared within two weeks or so. I still suffer from PHN.
Patient returned to urgent care minutes after leaving and complaining of numbness to arms and legs as well as chest tightness and dyspnea. She was given DEPO-MEDROL 40 mg and given 1 Liter of Ringers Lactate. Given O2. Also experienced dizziness and tongue numbness.
The patient developed L axillary lymphadenopathy on the day after vaccination. Ten days later, she was hospitalized for cervical transverse myelitis, from which she is slowly recovering.
Patient was admitted with primary diagnosis of COVID-19 pneumonia on 9/15/21 after presenting to the ED with stable symptoms given his history of renal transplant (2017). At the time of this report, patient is still admitted receiving remdesivir, dexamethasone, and 3L oxygen through nasal cannula.
Received shot in left arm.  Developed arm swelling and erythema from upper arm to mid forearm.  Seen by pediatrician.  Started Keflex.
Pain all over the body back pain more severe and hard to breath in the beginning for 17 days now after the second doze Hard to straighten up to walk
Swelling and tenderness under left arm; Tenderness under left arm; Fatigue; Itching and soreness at injection site; Soreness at injection site; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 14Dec2021 at 15:00 (Lot number: ED7218) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER9735, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0182, Anatomical location: Left arm, Administration time: 10:30, Route of administration: Intramuscular), administration date: 03May2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 at 15:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Swelling and tenderness under left arm"; AXILLARY PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Tenderness under left arm"; FATIGUE (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Fatigue"; VACCINATION SITE PRURITUS (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Itching and soreness at injection site"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 at 19:00, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of swelling, axillary pain, fatigue, vaccination site pruritus and vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
I have been bleeding since I got the second dose of Moderna. I have had my Menstrual Cycle nonstop since then & I am already borderline anemic so I am very concerned. I have had mostly blood clots coming out. I also now have lumps in my breasts that I have to see a breast specialist to address. I have never had any of these problems prior to receiving the second dose.
This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. On 13-JUL-2017, the patient was vaccinated with an improperly storage dose of PNEUMOVAX 23 lot number m042324 with expiration date on 10-JUN-2018; lot number reported as "m044564" with expiration date on 22-OCT-2018 or lot number n001007 with expiration date on 09-SEP-2018 for prophylaxis. No adverse effects were reported. The doses of PNEUMOVAX 23 were exposed to a temperature of 47 Fahrenheit degrees (F) to 77 F for time frame of 1 hour 20 minutes. There were no previous temperature excursions. Digital data logger was involved. No symptoms reported. This is one of several reports received from the same source.
extreme leg pain; unable to walk; Dose: 1=02Sep2021/ Dose: 2= 20Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 11:30 (Lot number: fh8028) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose lot number=fc3183,, prev dose lot unknown=False,, prev dose administration date=02Sep2021,, prev dose administration time=14:00, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 02Sep2021, when the patient was 14 years old, for Covid-19 immunization, reaction(s): "Initially had slight pain at injection site", "extreme leg pain in both legs below the knees", "Both the front of the leg and the calf were experiencing pain". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021 11:30, outcome "unknown", described as "Dose: 1=02Sep2021/ Dose: 2= 20Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021, outcome "unknown", described as "extreme leg pain"; GAIT INABILITY (non-serious) with onset 23Nov2021, outcome "unknown", described as "unable to walk". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, gait inability.  Additional information: Patient took tylenol to deal with pain. It took almost 10 weeks from initial dose for extreme pain to subside. Advised by pediatrician to not receive 2nd dose of pfizer until test result came back and constant leg pain subsided. Patient did not receive any other vaccine in four weeks. Patient was tested for blood panel test as negative (Leg pain had diminished to uncomfortable instead of extreme pain) on 08Nov2021 and COVID-19 (test name post vaccination was Binax, test type post vaccination Nasal Swab) with result as negative on 16Nov2021.   No follow-up attempts are possible. No further information is expected.
2 weeks after 2nd Pfizer vaccine I developed abnormal bowel movements. I have had Colonoscopy, stool testing  and EGD without finding a cause. Every stool stains the inside of the toilet bowl as if something has changed in my ability to digest fats.
No additional AE reported; A dose of GARDASIL 9 was inadvertently administered to a 1 year old patient.; This spontaneous report has been received from a nurse referring a 1 year-old patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, lot number U028826, expiration date: 04-NOV-2023, as prophylaxis (vaccination scheme anatomical location and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported. The outcome of the event was not reported.
A week after vaccination, itchy rash .  Worse on left arm and side-torso, same side as vaccination.  A few hives on belly and right arm.  One week course of prednisone, after stopping itching returned.  Currently in 2 week prednisone treatment.  Rash has improved, almost gone but still occasional itchy.  I had Covid19 in January, 2021 also.  I felt this information was important to document as this disease is still so knew.
really bad; shaking; whole body tremor; she would stand up with cane; she can barely talk; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced really bad, shaking, whole body tremor, she would stand up with cane, she can barely talk. She has called many times; she doesn't think anybody is listening. They are still putting it on the news, they are still giving the vaccine that is causing many problems she has videos of what these people are going through. She is calling about the Covid 19 Vaccine. She gets in-formation every day from the nursing home. She will provide the name of the Nursing home, she just forgot to put it down. The nursing home people are reporting a lot of thing as well as people in the hospital. They Won't put this in the news, it is not being reported, there are thousands of people online on social media. People are not being warned, people are going and doing it in other ways. She can give all the videos and have it all documented. It's not all in ER's and Hospitals. She has proof. It's a safety issue, she has videos. Most people die. It effects the body causing tremors. There's one where she was really bad, shaking, whole body tremor, she would stand up with cane, and she can barely talk. A lot of people are getting it, they are getting paralysis of the face, bell's palsy, a lot of that sometimes, that symptom goes away, it's a lifetime effect, people in bed with diarrhoea gas. There were 600 deaths just the other day, deaths in a lot of people 30 deaths in a nursing home in the (country name). There was a death of a 42-year-old doctor, he stated his name, and within 2 days dead from it, he was perfectly healthy. There's a whole school closed down completely, she has tried calling. She had Lot number of the covid vaccine that she is referring to in any of the cases. she has all the people's names, and they can be contacted, but she does not have the Lot number on hand with her. Caller responds stating that whatever the Lot number is, it isn't working. Caller states that the vaccine is very dangerous, and many doctors came on social media and said do not take this vaccine. Caller states that the vaccine is not fully tested. Caller was informed that Pfizer has submitted a request for Emergency Use Authorization for our potential COVID-19 vaccine and it is now in the FDA's hands. For more information, please go to (Web ad-dress). Call was then disconnected per guidance. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had H1N1 and seasonal flu vaccine at 8am on 11-19-2009. At 3pm noticed rash to chest, shoulders, back and flushing of face, ears and neck.
my hair is falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Mar2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "my hair is falling out". Additional information: Patient was healthy before the vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Immediately after flu shot was given, pt said she felt nauseous. Pts eyes rolled back and I gave her breaths and 911. She fainted (no breathing). Came. She was brought back before 911 arrived. I also gave her OJ - Pt taken to ER.
6min p/vax pt stated "I don't feel good" became unresonsive for 2min; PMD was notified; mean time pt came around, was hot & clammy to touch; pt c/o feeling numb, VS BP 110/90, P 74, R 28; PMD said episode due to neurogenic shock from needle
1400 recvd flu vax; went to work @ 1645 felt like throat is closing up; itching of skin-face on fire; DPH, Pred, Tagamet; plenty of fluids; d/c on pred to taper, tagamet, DPH;
Patient overdue for 2nd dose of vaccine; A spontaneous report  was received from a consumer, who was a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patient overdue for 2nd dose of vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 13-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly on left arm for prophylaxis of COVID-19 infection. The patient reported that she was overdue to receive her second dose of the two planned doses and it had been past 42 days.  Action taken with mRNA-1273 was unknown.  The outcome of the event patient overdue for 2nd dose of vaccine was considered resolved.; Reporter's Comments: Based on reporter's causality and nothing refers to the product being administered due to a "missed dose" the event is assessed as unlikely related to mRNA-1273.
Res. rec'd HIGH DOSE flu vaccine on 10/11/15 (L) deltoid. 10/15 (L) arm red, warm, pain, itchy. Moist heat pad after ice for 20 min. DURICEF 500 mg q 12 hr x 7 days.
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
Pt experienced joint pain in knees, neck, lower back, shoulder, elbow. Arthritis type pain, requiring elbow surgery and fatigue. Pt saw 9 MD's from 6/25/99 to present. Annual follow up states patient still has joint pain and fatigue.
Fatigue; Pain in legs; Redness around injection site; Warmness/firmness around injection site; Shoulder hurts/stiffness; Shoulder hurts/stiffness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jul2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing); "Depression" (unspecified if ongoing); "OCD" (unspecified if ongoing), notes: OCD; "known allergies: Lactose" (unspecified if ongoing), notes: known allergies: Lactose. Concomitant medication(s) included: VIIBRYD; ARMODAFINIL; NORETHINDRONE [NORETHISTERONE]; REXULTI. The following information was reported: FATIGUE (non-serious) with onset Jul2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "recovering", described as "Pain in legs"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jul2022, outcome "recovering", described as "Redness around injection site"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset Jul2022, outcome "recovering" and all described as "Shoulder hurts/stiffness"; VACCINATION SITE WARMTH (non-serious) with onset Jul2022, outcome "recovering", described as "Warmness/firmness around injection site". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vaccination site erythema, vaccination site warmth, arthralgia, musculoskeletal stiffness.  Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19, since the vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was reported as: 14Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen at site of injection. Area became red, itchy bump. Resolved on its own.
severe allergic reaction; permanent damage to the veins in my legs; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction and skin lesion. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the skin lesion was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and skin lesion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: The case was self-reported by the patient. The patient received a dose of Shingles vaccine and experienced severe allergic reaction and reported last year (the day before the reporting). The patient asked what other steps were available. The patient just received the email where the Shingles vaccine was not a covered vaccine for reimbursement. The patient now had permanent damage to the veins in legs due to the change in the second vaccine. The patient asked advised what he/she was supposed to do.
This spontaneous prospective pregnancy report was received from a registered nurse refers to a 19 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medications included vitamins. On 29-JAN-2019 the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date and dose were not reported) intramuscularly to prevent Human papilloma virus(prophylaxis) during pregnancy. The second dose of GARDASIL 9 was administered on 27-FEB-2019(inappropriate schedule of product administration). On an unknown date, urine pregnancy test was performed. The patient became pregnant with last menstrual period of 21-DEC-2018(also reported as about 10 weeks on date of report) and estimated date of delivery (EDD) of 27-SEP-2019. Initial exposure to GARDASIL 9 was at 5 weeks. The pregnancy outcome was pending. Patient sought medical attention by visiting office. No product quality complaint was filed.
14 weeks 1 day pregnant. Adverse event: headache, body aches, and fever of 101 lasting 16 hours.
Screaming consistently for 4 hours evening of injection. Temp 99.6 (Sy) mild swelling right leg.
Infant seemed fine except for cold (clear drainage) and was teething (2 teeth trying to come in). 4/23/04 PM, infant became more upset. Mother gave infant Tylenol Elixir with hydrocodone and infant spit it out on clothes. Infant was alive at 2 AM on 4/24/04 and was not breathing at 8 AM. Mother took her to ER. Autopsy report received which revealed COD to be SIDS & cosleeping.
No additional adverse effects reported; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 6-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 09-JUL-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038701 was verified to be a valid lot number, expiration date reported and established as 01-DEC-2021 (dose, route of administration and anatomical reaction were not provided) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 15 to 46 Fahrenheit degrees (also reported as 32.9 Fahrenheit degrees) for 5 hours. There was no previous temperature excursion. Digital Data Logger was involved.  The patient did not experience any additional adverse effects.
The night after I experienced some diarrhea , fogginess in my thinking , tiredness . Took hours for it to go away .  Also had some chest pain that night too . Went away quickly.
Bruising at or below the injection site; Rash rash at or belowinjection site; This case was reported by a pharmacist and described the occurrence of injection site bruising in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site bruising and injection site rash. On an unknown date, the outcome of the injection site bruising and injection site rash were unknown.   It was unknown if the reporter considered the injection site bruising and injection site rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The batch number was not reported. The patient experiencing bruising and rash at or below injection site after receiving Shingrix.  The reporter would try to go back and look at patient vaccine history and call back if she needed to. The reporter was agreeable to follow up. This case linked with US2019179984, US2019179981 and US2019179979, reported by same reporter.
soreness, rash, swelling, warmth, itching ice, benedryl cream continues with pain, itching, swelling and warmth
This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of M-M-R II lot # M008588 expiration date 13-JUN-2018, lot# M008588 expiration date 16-FEB-2018 for prophylaxis. The temperature excursion lasted 15 minutes. Concomitant therapies included sterile diluent. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010515: US-009507513-1708USA010532: US-009507513-1708USA010531.
Immediately after the shot I had fever and chills. I saw the doctor and they told me I have Acute Urticaria. I get these large red welts all over my body that itch and burn and they come and go. And I still have it. The doctor prescribed me ZYRTEC and topical cream and one course of prednisone.
Began with H/A, vomited 3x, diarrhea, treated with Tylenol, 100.5 10AM today. Symptoms began 3-4 hrs post injection
Pt called, then came in. Location of PNEUMOVAX: swelling at above injection site around whole arm. Started by evening of injection, had on 17th, improving. ZOSTAVAX: painful and itchy to start, then red dot that has continued to grow. Currently measures 3 1/2" diameter and raised approx 1/2". She had just taken BENADRYL and we marked around the area to be better able to judge worsening/improving of the welt. She is seeing her son/MD tomorrow and will follow up with her as well.
patient came in to get booster vaccine and received janssen booster dose at 4:18pm. however, the vial was initial puncuntred at 10 am so patient received dose after 6 hour window. BUD for vaccine 10-4pm. We contacted pt and left message to come in and redue vaccine as per cdc guidelines recommendation.
Grand mal tonic clonic siezure lasting about 1 minute.  Post ictal/unresponsive for 15 -20 minutes.