chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE NOT BEEN AS EFFECTIVE; This solicited report received from a physician via JS2020-26741: Healthcare Dialogue concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine not been as effective. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine not been as effective was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and lack of effectiveness as related. Company causality between covid-19 vaccine ad26.cov2.s, and lack of effectiveness was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700371-Covid-19 vaccine ad26.cov2.s- "vaccine not been as effective". This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
administered with a Boostrix dose Subcutaneously.; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number E55XZ, expiry date 24th June 2022) for prophylaxis.   On 7th September 2021, the patient received Boostrix. On 7th September 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were reported as follows: This case was reported by nurse. The nurse reported that patient was administered with a Boostrix dose subcutaneously, instead of intramuscular route, which led to Intramuscular formulation administered by other route. The reporter consented to follow up.
passed away; received second vaccine 44 days after receiving the first dose; Pain the injection site from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain the injection site from the first dose). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose). On 05-Apr-2021, VACCINATION SITE PAIN (Pain the injection site from the first dose) had resolved. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose) had resolved. The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.  Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273,  with  associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject  who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-132760 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Case upgraded to Serious due to death.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273,  with  associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject  who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time.  Further information has been requested. US-MODERNATX, INC.-MOD-2021-132760:Son; Reported Cause(s) of Death: Unknown cause of death
Site of injection right deltoid with swelling extending up neck, armpit to breast and down arm approx 7" from injection site. Flu like symptoms. Symptoms noted approx 12 hours after injection and duration of 5 days. No neurological component. No loss of sensation or tingling evident. Felt miserable.
Pain from left arm down left side of body about 1 hour after had tdap on 5.26. Did also have blood drawn from same arm here that day. Was initially swollen on arm and left knee swollen- within an hour. States was not experiencing any of these symptoms at the time of the visit. Never experienced this with any other vaccine.  left knee swelling persists.
Severe Myositis and Hepatitis, Ataxia (leg pain). CPK = 30,000. LFT - 800 range. One wk after H1N1 mist. (Given 10-13-09). 11/20/2009 ED records for 10/20-21/2009.DC DX: post vaccine myositis with rhabdomyolysis  Patient with c/o's balance problems, ataxia, myalgias, headache, fever, cough and weakness of LE's. Tx: IVF . 12/03/09 Labs recieved for DOS 12/03.  Also discharge note for 10/21/09. D/C to home w/family. 12/23/09 Pediatric records recieved for DOS 10/13/09, 10/20/09,10/22/09 DX: Ataxia; viral myositis  Pt. presented with leg pain, fever, headaches, cough. Tx. with nebulizer for cough. Sent to ER. . Addendum: leg pain greatly improved, walk normal  following hospitalization
got COVID and I have been battling with it for over four months; got COVID and I have been battling with it for over four months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "got COVID and I have been battling with it for over four months". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Thank you for all the COVID shots. He had received all three, plus the one (Bivalent, on 11Nov2022, at Withheld. He somewhere, somehow, got COVID and he have been battling with it for over four months. Last time he went to the Dr's PA (Physician assistant), with all the appropriate meds taken, how long will it take be do he have before he was rid of it? Response "Never" then why was he putting chemicals in his body, when it was obvious that he was going to the end.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Night sweats; Fever; This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), via an unspecified route of administration on an unspecified date at the age of 60 years old (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Night sweats and fever for 2 days before subsiding. Events took place after use of product. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within 12 hrs post 2nd vaccine I was febrile with 101.4 temp. Full body aches. Headache,  I stayed febrile for the next 36 hrs 101-102.9. vaccinated on Monday afternoon, fever finally broke Wed afternoon. I have had an intense headache since the night of receiving the vaccine. Also have injection site swelling, redness, pain. The headache is very distinct, it is like no other headache I have had before. It is the same one I felt with the first dose of vaccine but didn't last this long. This time my neck is also very stiff.  My headache is so bad that when I sneeze I feel like my brain rattles against my skull.  Today is 3 days post vaccine and I feel like I've had the flu. I am still not 100% . I am still very fatigued. Minor sore throat but my lymph nodes in my neck are slightly swollen too so I'm associating the soreness to that.
Swollen armpit at the arm of injection; Sore armpit at the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen armpit at the arm of injection) and AXILLARY PAIN (Sore armpit at the arm of injection) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen armpit at the arm of injection) and AXILLARY PAIN (Sore armpit at the arm of injection). At the time of the report, VACCINATION SITE SWELLING (Swollen armpit at the arm of injection) and AXILLARY PAIN (Sore armpit at the arm of injection) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
A report was received from a health care professional on 12/16/03 concerning an 18 month old male vaccinee who inadvertently received Fluvirin on an unknown date in December 2003. On an unknown date in December 2003, a vaccinee was inadvertently vaccinated with Fluvirin. No adverse events had occurred at the time of this report. There is insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient Received Corminaty 30 mcg/0.3ML inj PFizer dose on September 28th, symptoms started on September 29th. Symptom was a rash that started across chest and arms. Patient went to see doctor who prescribed clobetasol propionate external ointment 0.05% on 10/03/2023.
Patient received her 1st dose of Pfizer.  Patient stated that se began to feel her face swelling.  I asked her to remove her mask and could see the her face, mouth and tongue was swollen and she was tachypneic.  I called a Nurse Alert (Rapid Response) and the Nursing staff brought the emergency kit.  911 was called by another nurse. Epi and Benadryl were administered intramuscularly.  Patient was placed on continous pulse ox and vital sign monitoring.  O2 was given to the patient. Clients vitals began to stabilize despite the continued swelling of her mouth and tongue.  Firetruck arrived at 733pm and the ambulance arrived approx 3 minutes later.  Patient transported to the hospital accompanied by her spouse.
Pt states that she has always experienced bruising and swelling after flu shot but that this time she experienced more bruising, swelling, and redness than previous times. Redness extends from injection site to right above her elbow, and area is warm to the touch.
Was hospitalized 11/26 to 11/29 at Medical Center for abdominal pain with discharge diagnosis of 'abdominal pain 2/2 bowel obstruction vs ileus, improved'.  During hospitalization, developed weakness and was re-hospitalized from 11/30/09 to 1/4/10.  Discharge diagnosis is atypical GBS.  GBS Surveillance neuro consult indicated this case to be variant of GBS (Axonal variant of GBS, AMAN) but still meeting Brighton Criteria Level 1.  Per MR relevant to 11/30 visit: Pt presented in Nov for abd pain/ileus, hospital stay complicated by acute flaccid paralysis of UE and LE sparing head and trunk c/w atypical GBS. Pt states he had some diarrhea for several days prior to admission without fevers.  Per conversation with patient 2/16/10: Pt not recovered, paralyzed from neck down, at home; Patient's wife states that pt had flu-like symptoms on the week of 11/26/09, also hit his head the week before.  Given 2 courses of IVIG but no improvement except for minimally move some toes.
04/02/04 @ 15:00: TD vaccine received.  Pt felt fine until 04/03/04 @ 19:00, had pain and swelling of upper arm and shoulder. Also, chills, fatigue, and light headache.  Pt took 1 Tylenol. 04/04/04 Noon: Itchiness, and redness of area started.  Pt took Tylenol once a day until now.
So I had some excess vaginal bleeding to the point I thought I was going to the emergency room. This was May the 2nd 2021. On the 3rd of May I phoned the DR and they gave me Tranexamic acid tablets. I took that for several days until the symptoms subsided. I did have this happen seven years ago and had to get blood transfusions. This time, it started on that Sunday night and had resolved by Thursday.
Case number PHEH2014US006659 is an initial spontaneous report from a physician on 02 Apr 2014. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: J008423) at a dose of 0.5 ml intramuscularly on 18 Feb 2014. It was reported that on the same day after vaccination, his arm was swollen and he required prednisone, BENADRYL and MOTRIN. It was reported that he also had pain. Pain and swelling resolved 3 days after the initial injection. The seriousness and causality were not reported.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have recieved 0.5mL per dose insted of 0.25mL. The manufacture provided 0.5mL per single dose vial.
Severe cluster like migraine just like when I had Covid-19 in November! Fever 101.2 aching all over. Pain at injection site(to be expected) lasted all Friday evening and night and all Saturday.  Fever finally broke around 6 pm. I took a triple dose of meds to break headache in the end, excedrin, topiramate and benadryl! Got to feeling better Saturday evening,  a little dehydrated but better.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
Janssen COVID-19 Vaccine EUA Around 7:00 PM, I started to get mild chills, a slight headache, and ran a temperature of 100.5. I did not take anything for treatment. The next day, the symptoms started to lessen around 1:00 PM, and by 4:00 PM the fever and chills were gone. That evening I felt just fine.
Information has been received from a health professional concerning a 40 year old male who on 5/5/99 was vaccinated with unspecified vaccines for travel. On 6/11/99, the pt was vaccinated with a 2nd dose of Hep-B. The pt was vaccinated concomitantly with IPOL. On 6/17/99, the pt developed severe pain and burning in all 4 limbs and trunk, tremors and fatigue. The pt was dx'd with small fiber neuropathy. The pt was treated with prednisone. At the time of this report, the pt was being followed and was reportedly on a modified work schedule. Small fiber neuropathy, severe pain and burning, tremors and fatigue were considered to be disabling. No further information is available. A follow up report received 1/17/2003 adds: This pt had no previous history of neuropathic pain. On 06/11/1999 the pt received his 2nd injection of Engerix-B and an injection of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). It was originally reported that "soon after the injection", the pt became immunosuppressed. However, on follow-up, the event was reported as chronic neuropathic pain which began on 06/17/1999. The reporter indicated the pt had "many lab tests" (not specified), computed tomography, magnetic resonance imaging, X-rays (not specified), nerve conduction studies, electromyography, electrocardiogram and lumbar puncture (dates and results not provided). The pt was treated with oral narcotic pain medication and oral steroids. The most recent info received, on 03/22/2002, indicated the chronic neuropathic pain was "severe", ongoing and possibly related to both Engerix-B and IPOL. The outcome of the immunosuppression was not provided. The Engerix-B immunization was discontinued.
FEVER OF 37.8, CORPORAL PAIN, MALAISE, FATIGUE SINCE SUNDAY MARCH 21, 2010.
Approximately 5 days after vaccine, I was going on vacation. On the car ride, it started with an itch on my palms and felt burning. The itch was unbearable. I used regular lotion. We had stopped and got different lotion. Once I got to my vacation area, I went to urgent care. By that time the rash was all over my body. The doctor thought it was ring worms and suggested OTC Lotrimin. I was there for a month and the rash was bad the whole time. Once back, I called my doctor. My doctor stated it was not ring worms. He referred me to an epidemiologist. It took 2 weeks to get into epidemiologist. I was prescribed Triamcinolone acetonide cream. I went through a whole tube and was on my second tube before the rash went away. I still would get a few little breakouts but not as bad as before.
Patient stated that she experienced a rash and swollen arm after getting PNEUMOVAX 23.
-Rash on arms an legs -vision Blurry and brighter, as if eyes have been dilated, impaired night vision -disorientation, imbalance. -hydrocortisone cream for rash, no vision treatment.
Daughter came to pharmacy 12/4/17 and told us that her mom is  fainted and admitted to ER 10/26/17. MD at hospital did blood work as well as urine test result are negative. Discharged home the next day and again fainted episode again.
This report was identified from a line listing obtained on request by the Company from the FDA under freedom of information Act. A patient with no pertinent medical history or allergies who on 28-AUG-2008, was vaccinated with GARDASIL (lot# 659441/1446U) IM into the right arm and MENACTRA (lot# U2621AA) IM, into the left arm. There was no concomitant medication. On 28-AUG-2008 the patient complained of feet swelling, about double sizes after receiving the vaccine. The patient's mother stated that the patient had no pain in her feet. It was reported that her feet started swelling about 45 minutes after receiving the vaccines and the swelling went away 90 minutes. She denied another problem. No laboratory tests were performed. The original reporting source was not provided. The VAERS ID # is 324371-1. No further information is available.
raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; experienced a sore arm for a day and half that soon; generalized outbreak consisting of raised, pimple-like; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; This is a spontaneous report from a contactable Nurse. A 38-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced raised red area, pustule, and rash at the injection site on an unspecified date. It was reported that Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose 2 weeks ago later report experiencing a "raised red area, pustule, and rash at the injection site. It was reported that the morning after she experienced a sore arm for a day and half that soon went away but returned a week later. Yesterday she noticed that there was a red raised pimple with a white head at the injection site. And for 4-5 days had a generalized outbreak consisting of raised, pimple-like areas on her face. She mentioned that her physician advised her to take Benadryl or Zyrtec for these reactions considering that it may be allergic in nature. The outcome of events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
11 hours after the second Pfizer Covid dose I started experiencing fatigue, mental cloudiness, and neck pain. Around 18 hours post vaccine I had sever body aches, headaches, and chills. I have had to take extra strength Tylenol and Motrin to combat the symptoms.
nausea; headache; pain all over her body / Laying in bed was painful; pain on her skin / pain when skin was touched / hurt to have covers on. Laying in bed was painful; could not move her body due to pain when skin was touched; could barely get up the stairs due to the pain; This case was reported by a consumer and described the occurrence of general body pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose in October 2020. For the tolerance of 1st dose, refer linked case US2021038354).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced general body pain, skin pain, mobility decreased and activities of daily living impaired. On an unknown date, the patient experienced nausea and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, skin pain, mobility decreased, activities of daily living impaired, nausea and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain, skin pain, mobility decreased, activities of daily living impaired, nausea and headache to be related to Shingrix.  Additional details were provided as follows: Within 2 hours after receiving Shingrix, the patient experienced pain all over her body.   It was not muscle pain. It was described as pain on her skin.   The patient could not move her body due to pain when skin was touched. She said it hurt to have covers on.   Lying in bed was painful.   She could barely get up the stairs due to the pain.  The patient experienced exact symptoms with same onset date and same resolution time after both doses. All the symptoms last 7 days before resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038354:same reporter 2nd dose
Information has been received from a health care worker concerning an patient in their "60's" who on 24-JAN-2008, was inadvertently vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The patient sought unspecified medical attention at a clinic. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Pt complaint of itchy 'bumps' after vaccination.  Initially she thought they were bug bites and she scratched them.  Distributed on arms, shoulders, chest and face.  Pt feels they look like bug bites and itch, but for a longer period.  Maculo-papular lesions.  Slightly erythematous.  Not confluent.  Appearance consistent with nonviral pustulosis.