chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Encountered Rash with fever 4-5 days later. Severe Rash from Head to Toe. After about 2 weeks had a hard time walking and started to regress. Very pale and withdrawn. Not interested in eat. She was a very mellow baby and now cries a lot and becomes agitated. After many doctor visits and going to the hospital, no doctor can tell us if this is from the MMR shot. She now is getting severe diarrhea and doesn't show any sign of improvement.
no adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a vaccine coordinator, referring to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, or medical history was provided. The concomitant therapy included sterile diluent.  Since 24-APR-2019, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD), lot # R030801 and expiration date 22-APR-2020, for prophylaxis (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent.  The administered doses of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius (C) for 1 hour and 12 minutes and of -9 degree C to 8 degree C (-0.04 degree C) for 6 hours and 50 minutes, as recorded by a data logger. The vaccine had had previous temperature excursions of -14 degree C to -10 degree C (-11.6 degree C) for 28 minutes and of -14 degree C to -10 degree C (-13.12 degree C) for 25 minutes. There was no adverse effect reported. No product quality complaint was involved.  This case is non-valid due to lack of patient identifiers.  Follow-up information was received from the vaccine coordinator on 20-APR-2020. The reporter was ready to provide the requested information like administration dates and patient identifiers but, would have to search for the information. The reporter would call back to provide the information.  Follow-up information was received from the vaccine coordinator on  30-APR-2020. The individual patient identifiers and details were reported and the case has become valid. This case was regarding a 8 year old male patient who was vaccinated  with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD) on 06-AUG-2019 (previously reported as since 24-APR-2019).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1910USA010836:
Fever 102  Fatigue   Terrible Muscle aches   Nausous    headache
Following day:  vertigo, nausea, fatigue, chills, throbbing pain in both legs (all over), headache, sore arm, had to urinate every 15 minutes for approximately 12 hours.  These symptoms lasted about 48 hours.  Morning vertigo or just dizziness every  morning since day of shot.  Nausea every day since day of shot.
This is a spontaneous report received from contactable other HCP (patient). A 32-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# EH9899), at the age of 32, intramuscularly, in left deltoid, administration date Dec 22, 2021, at 19:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The following information patient reported vaccination site pain/injection site soreness, onset Dec 23, 2021, with outcome of recovered (Dec 24, 2021). No therapeutic measures taken as a result of vaccination site pain. No follow-up attempts possible. No further information expected.
This spontaneous report was received from a Nurse refers to 2 or 3 school aged patients of unknown demography. On an unknown date, the patients were vaccinated with VARIVAX (Merck) lot # J003705 (dose, route and frequency were not reported). On an unknown date, the patients experienced high fevers and swelling at injection site. The outcome of high fevers and swelling at injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA014484 and 1404USA014725 (same reporter link). Additional information has been requested.
She said she felt a little achy for 1-2 days afterward; her neck was hurting; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular on 18Dec2020 12:30 at a single dose on left deltoid for COVID-19 immunization. Medical history included COVID-19 from 14Oct2020, no sense of smell and taste from 16Oct2020, she kept falling asleep in the evening from 15Oct2020, severe fatigue, fever of 100.3 (no unit reported) from 16Oct2020, and SARS-COV-2 infection from 16Nov2020 to an unknown date. There were no concomitant medications. The patient reported that she received a Vaccine on 04Dec2020. On 18Dec2020, the patient felt a little achy for 1-2 days afterward. She said her neck was hurting on 18Dec2020, but she thought the neck pain was because her and her husband were remodeling their bathroom. She said after the first COVID-19 vaccine dose, she had no injection site soreness. She said she was excited that she did not experience any real side effects after her first COVID-19 vaccine dose. The patient recovered from the events on an unspecified date.
stayed in bed all day; terrible stomach pains; gas; diarrhea; Not able to eat anything; everything tasted bitter; sick all day/feeling sick; felt like she had COVID symptoms; feeling cold; bringing up mucous; terrible headache; achy all over; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick all day/feeling sick), SUSPECTED COVID-19 (felt like she had COVID symptoms), FEELING COLD (feeling cold), SECRETION DISCHARGE (bringing up mucous) and MOVEMENT DISORDER (stayed in bed all day) in a female patient of an unknown age 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced SUSPECTED COVID-19 (felt like she had COVID symptoms), FEELING COLD (feeling cold), SECRETION DISCHARGE (bringing up mucous), HEADACHE (terrible headache), MYALGIA (achy all over) and CHILLS (chills). On 04-Apr-2021, the patient experienced MALAISE (sick all day/feeling sick), MOVEMENT DISORDER (stayed in bed all day), ABDOMINAL PAIN UPPER (terrible stomach pains), FLATULENCE (gas), DIARRHOEA (diarrhea), FEEDING DISORDER (Not able to eat anything) and DYSGEUSIA (everything tasted bitter). On 04-Apr-2021, MOVEMENT DISORDER (stayed in bed all day), FEEDING DISORDER (Not able to eat anything) and DYSGEUSIA (everything tasted bitter) had resolved. On 05-Apr-2021, MALAISE (sick all day/feeling sick), SUSPECTED COVID-19 (felt like she had COVID symptoms), FEELING COLD (feeling cold), ABDOMINAL PAIN UPPER (terrible stomach pains), FLATULENCE (gas) and DIARRHOEA (diarrhea) had resolved. At the time of the report, SECRETION DISCHARGE (bringing up mucous), MYALGIA (achy all over) and CHILLS (chills) outcome was unknown and HEADACHE (terrible headache) had resolved.            Concomitant product details not provided.  Treatment details not provided.
total body rash w/all sorts red blotchy across the discrete appearance of papules all over face & head that look like measles then amoxicillin rash seen 7MAR98 was given MMR 24FEB98;given med rash disappeared Sunday
The patient told me that her arm was red and very swollen. She went to the doctor's office and they though it was due to the Shingrix shot. The patient notified me a week after she started having the symptoms and she said that her arm was not swollen anymore but she still had red spots on it.
Large, red, swollen, warm-to-the-touch spot at injection site. Pt. says about the size of a lime. Recommended cortisone cream & call M.D.
Covid breakthrough. I started experiencing cold like symptoms that Friday. I took a covid test and tested positive. I locked myself down for a couple of days. I felt horrible, light headed, achy and my sense of smell went away. I also experienced diarrhea. It made it hard to work and move. I only went to urgent care due to my migraine. I took a second test midweek and still was testing positive.
Huge welts covering his leg. Told it was normal. Stopped getting vaccines after this.
In January 2023, I tested positive for COVID-19, I called my doctor received a prescription for Paxlovid, I went back to work in ten days. I got rebound COVID-19. I stayed home from work for a couple of days. I had a routine for lymphoma, they discovered fluid on my lungs. I was given four different antibiotics, none of them helped at the time and five-day prednisone. I was admitted to the hospital as I was having daily high fevers for three weeks. I had many tests ran, bloodwork I was diagnosed with hypogammaglobulinemia, I was able to receive the treatment and care that I needed. I was sent home after eight days to continue to recover.
Nausea ,vomiting 48hrs fever 101  maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm.  Took anti nausea meds for 4 days.
Given in upper left arm. Swelling and redness in mid upper arm. Still red, but much better. Took BENADRYL and applied ice pack per doctor's instructions.
Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,; Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 08:30 as dose 1, single (Lot number: EP6955), in left arm and on 28Apr2021 at 08:30 as dose 2, single (Lot number: EW0162) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 058F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Anti viral details: product: COVID 19 Treatment, Brand: Pfizer,". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid Treatment start date: 04May2022, Treatment stop date: 08May2022, As treatment of COVID-19.
Initial unsolicited case was received on 05 February 2015 from a consumer who is also the patient's daughter. A male patient (date of birth not reported) with an unknown past medical history had received on an unspecified date "four months ago" an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed encephalitis. The event was considered life-threatening and required an ER/doctor visit. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
I had irregular periods and it stop for three months and when it did come back I had to go see my doctor because of my flow was very, very severe and I never bleed like that before. So I had to go see my OB GYN Dr. and she prescribe  Tranexamic Acid to stop the heavy flowing. Am still having had very heavy flow. I didn't have any of this before getting the vaccine. I had heavy periods but nothing like this. I started with dose 2 & 3 of the vaccine.
cough, 40 minutes after event, wheezing, rash over body/itchiness. 60 minutes post immunization patient had orbital swelling and facial/lip swelling. Benadryl given and driven to emergency room. Decadron and albuterol given. Started on oral pred for 5 days, claritin.  Following day left arm rash still present. As day progressed  rash spread, swelling, red, warm (looked like cellulitis). Urgent care- monitor and provide support.
5 week old female was given Trumemba (Menigococcal B vaccine) instead of Hep B monitored in office for 45 minutes spoke with vaccine nurse educator, for instruction called Pfizer to report as well
had no smell; had no taste; Stated that he has sensations in his legs; he has sensations in his legs was reported as worsened; stated that when he walks that it is like pens and needles; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient's mother) reported for a patient (reporter's son). A 19-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Jul2021 (age at vaccination was 19 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 19 years) as dose 1, single for COVID-19 immunization. It was unknown if there was history of any previous immunization with the Pfizer vaccine considered as suspect. It was unknown if any additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller reported that her son received his second Pfizer COVID 19 vaccine two weeks ago. The patient experienced side effects that were described as a unique situation. On an unspecified date in 2021, the patient had no smell, no taste, sensation in legs, when he walked it felt like pens and needles. The caller stated that the patient lost sense of smell and taste about a week ago. The caller stated that when the patient walked that it was like pens and needles and had sensations in his legs that started about 3-4 days ago. The caller stated that the sensations vary from day to day. The caller asked if the symptoms were normal and if the symptoms will go away. The caller stated that the patient went to urgent care and was given medication and recommended that he see a neurologist for walking like pens and needles. The caller stated that the patient stopped taking medication because he did not like the way it made him feel. The event did not require visit to Physician Office. No relevant tests were done. The outcome of the events was not resolved.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Beginning 4/23/2021  Tightness and slight pain in and around left chest, collarbone area.  Slight numbness and tingling on left half of left hand  No loss of motor function or strength. Just noticeable discomfort and slight pain. Pain rating 1-2 out of 10.
Initial and follow up information has been received from a licensed practical nurse (LPN) concerning a male who on 22Sep2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647271/1138N). On approx 23Sep04 the pt developed redness from his shoulder to his wrist (site unspecified), and reported that the area was very painful and appeared to be swollen. The pt's events persisted. In follow up, the LPN reported that the pt was seen in the physician's office, and was administered oral prednisolone and diphenhydramine (Benadryl) as a precautionary measure. Subsequently, the pt had complete resolution within 24-48 hrs. The LPN reported that the pt had received vaccinations with pneumococcal 23v polysaccharide vaccine in the past without incident. No further information is expected. The LPN also reported a male pt who developed similar events after vaccination with pneumococcal 23v polysaccharide vaccine (lot647271/1138N) (WAES0409USA02081).
This case was reported by a nurse via call center representative and described the occurrence of unilateral blindness in a 17-year-old male patient who received Meningococcal B vaccine for prophylaxis. Previously administered products included HPV vaccine with an associated reaction of headache (see case: US2018GSK207759). On 5th November 2018, the patient received 1st dose of Meningococcal B vaccine. On 6th November 2018, 1 days after receiving Meningococcal B vaccine, the patient experienced unilateral blindness (serious criteria GSK medically significant), headache and spots before eyes. On an unknown date, the outcome of the unilateral blindness, headache and spots before eyes were unknown. It was unknown if the reporter considered the unilateral blindness, headache and spots before eyes to be related to Meningococcal B vaccine. Additional details were reported as follows: This case was reported by the patient's mother who herself was a nurse. The patient's historical vaccine included HPV vaccine and experienced recurring headaches after it. On Monday from the reporting date the patient received Meningococcal Group B Vaccine. The patient experienced left sided blinding headache and went to the nurse with spotty vision. The reporter had provided her contact details. On the reporting date, the reporter called the pediatrician. The patient had left sighted blindness and severe headache, went to the nurse and had to come home. The patient had black spots in front of him too. The representative stated to the reporter that, this was the type of information that safety department like to capture in an effort to monitor the ongoing safety of our medications and asked for the patient consent. The reporter asked whether the patient could receive the 2nd dose of BEXSERO in the next month. The reporter was trying to find out if a meningococcal group B Vaccine was a live vaccine or not. The reporter was referred to a medical specialist for meningococcal group B Vaccine. The reporter was a nurse hence she had a concerned about getting 2nd dose of Meningococcal Group B Vaccine. The reporter was not sure if the patient received BEXSERO or not. The medical specialist stated that he need to escalate this chat within his department because all of the information that representative was having at GSK was for the BEXSERO, and advised to the reporter that if she find out later her son's men b vaccine was a different manufacturer, she need to contact the that particular manufacturer.
bleeding from her eye; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported that a female patient of unspecified age received first and second single doses of BNT162B2 (Pfizer Covid-19 Vaccine) for COVID-19 immunization; route and therapy dates were unspecified. Medical history included bleeding disorder. Concomitant medications were not reported. The patient had a bleeding disorder and when she received both doses, she started bleeding from her eye on an unspecified date. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Got Covid-19; Got Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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) all with onset 2021, outcome "unknown" and all described as "Got Covid-19".  Clinical course: Patient got Covid around Christmas of 2021. She and their son got Covid, but caller did not get it. Declines report for wife. She didn't get the Covid this time. She got Covid after the last shot. The Covid was very mild  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm became very painful and swollen. Swelling goes from around the bicep up to the shoulder. Fingers felt weak, but that went away today. Swollen and sore to the touch but not red.
36 hours after shot woke up with extreme dizziness, still experiencing it; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 17Sep2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Sep2021 at 08:00, 36 hours after the shot, the patient woke up with extreme dizziness, still experiencing it. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with ondansetron (ZOFRAN) and dimenhydrinate (DRAMAMINE). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 36 hours after shot woke up with extreme dizziness, still experiencing it was not resolved at the time of this report.
Patient was admitted for Acute hypoxemic respiratory failure due to COVID 19 pneumonia. He required max dose high flow oxygen from the time of admission. He was placed on IV steroids, singular, vitamin-C, zinc, mucolytic and antitussives.  He was placed on Remdesivir. His CT angiogram was negative for PE. Overnight his condition worsened, and he went into sever respiratory distress that required intubation and mechanical ventilation. He was moved to another facility for higher level of care in unimproved condition.
Severe rigors, fever, headache, starting 7 hours after dosing. Temperature to 103F. Took naproxen 2 tablets. Went to bed. Around 3 AM next day (15 hours after vaccination), woke up with heavy sweat. Still had headache. In the AM, had muscle pain from the previous day's rigors. Felt shakey and febrile. Took two more naproxen at 8 AM. Now, at 26 hours post-vaccination, no fever, rigors, or headache finally!  Also,severe pain, left arm (injection site), that became worse over 2 hours, limiting mobility. Then, after a few hours, pain subsided. It is still present now (26 hours after injection) but at lower level.
Patient was given the correct Pfizer intended for patient's age group (5-11 years old). However, it was documented in patient's record that 0.3mL was given and not the manufacture's recommended dose of 0.2mL for children this age. The NDC, Lot number, and Expiration documented matches the intended Pfizer vaccine.
received their second COVID19 vaccine one day earlier than the recommended intervals.  The recommended intervals are 28 days apart form dose 1 and 2 with a four day grace period of 24 days or later. She received the vaccine 23 days later.
3 circular erythema 5 cm diameter coalescing patches near the site of injection  They started as small red areas that have increased in size the last 4 days.  Quite pruritic Warm/ to touch slightly raised  No purulent areas.