chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient required hospitalization due to breakthrough infection.  Patient was given the J&J vaccine on 03/11/2021. Patient was hospitalized from 07/25/2021 - 09/08/2021. Below is copied from patients discharge summary:   Hospital Course: HPI:  Patient is a 74 yr old female with PMH HTN, CKD? who initially presented to the ED via EMS for SOB. EMS found the pt satting in 30s with poor waveform, was placed on 3L NC and brought to the ED where she was found to be satting in the 40s. Pt was placed on HFNC on setting of 60L and 80% FiO2 with pt satting in lower 90s, tested positive for COVID. Pt was seen in the ED and was visibly working to breath, though was able to speak full sentences. Pt reports she has been feeling SOB for approx 1 week, also endorsing mild nausea and fatigue. Pt denies having any abd pain, chest pain, cough, dysuria. Pt was able to produce vaccination card which showed pt received Johnson and Johnson vaccine on 3/11/21
Fever; Chill; Body aches; This case was reported by a consumer via sales rep and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient reported that the she experienced fever, chill, body aches starting approximately 8 hours post administration. The reporter did not consent to follow up.
One full week following the vaccination, I woke up to find that my body  my body broke  out in hives, and my left hand was extremely swollen.  The day before I had an x-ray taken of my right leg due to an earlier  injury, and I had blood drawn from my left arm at my facility. Now, weeks later, I still occasionally  wake up with my left hand asleep. The hives lasted for three days, and I took Benadryl to relieve the itching.
This spontaneous report as received from a Registered Nurse via a company representative refers to a 14 month old (currently 4 years old) male patient. On an unknown date when the patient was 14 months old he was vaccinated with a single dose of both VARIVAX (Merck) (lot#, expiration date, dose, route, indication not reported) and M-M-R II (lot# expiration date, dose, route, indication not reported) on an unspecified date about a month after first dose of VARIVAX (Merck) and M-M-R II were administered on an unspecified date. No adverse effects reported. Additional information has been requested.
Pain in arm; She was slightly dizzy; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 11Feb2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer. A 81-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL8982), via an unspecified route of administration in the left arm on 10Feb2021 18:30 (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included (caller mentions she dyslexia but this was prior to the COVID vaccine). Concomitant medication included apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date (taking for 6-7 years) at unknown dose and frequency for an unknown indication. On an unspecified date the patient experienced pain in extremity and dizziness. Caller, reporting that she took the COVID shot and was told that if she is on a blood thinner she shouldn't have gotten the vaccine, is that true. She asks if we make Eliquis. The only small issue she had after the vaccine was some pain in her arm. She worked the pharmacy at one time. She got the shot on 10Feb2021 at 6:30pm. Treatment: Hot compress to the area. Caller remarks that just now when she stood up, she noticed she was slightly dizzy. Could that be caused by the vaccine. Therapeutic measures were taken as a result of pain in arm (pain in extremity). The clinical outcomes of the pain in extremity and dizziness were unknown. No follow-up attempts are possible.
Teaspoon of bright red blood on diaper the afternoon after Rotateq vaccine; increased fussiness.  Improved over next 24-48 hours, stool guiac testing negative on 12/10/11.
LIGHT HEADED; HEADACHE; NAUSEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 270 pounds, and height was 68 inches. The patient's concurrent conditions included alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stomach pain. On APR-2021, the subject experienced nausea. On 15-APR-2021, the subject experienced light headed. On 15-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, and had not recovered from headache, nausea, and stomach pain. This report was non-serious.
C/O EYES PAIN SINCE HAVING, SAW PROVIDER TODAY, STATES EYES ARE GETTING BETTER AND SHE IS STABLE
I am not sure it is an adverse event but I was diagnosed with Metastatic B-cell lymphoma in 10/2021.  I had  been having hip pain for several months and also noticed enlarged lymph nodes in my neck in early September 2021.  I also had some joint pain and generalized fatigue in 2/2021
felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown.   Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Second dosage two weeks after the first; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   In October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, unknown after receiving Shingles vaccine and an unknown time after receiving SHINGLES VACCINE, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received second dose from drug store two weeks after the first dose, which led to shortening of vaccination schedule. The patient enquired if he/she needed an additional shot. Follow-up would not be possible as no contact details available.
Exaggerated local reaction 13x17cm on thigh.  In process of recovery.
Post vax, the pt had a low grade temperature and developed red measle-like bumps all over body 7 days post vax. He was also irritable.
Patients states to have experienced a fever of 105 degrees, shaking, teeth chattering about 24 hours post immunization.  She later called back to state she may have been in a coma and did not eat, or drink for 2 days
Bivalent Pfizer incorrectly given instead of Monovalent Pfizer for primary series
After about 1 hour noted mild numbness of face. Started on right. Transitioned to entire face. Lasted about 20 hours leaving a mild stiffness in the cheek/facial area. Right arm injection site is sore.
The night before I was seen for the first time after the initial vaccination, I was experiencing redness and swelling at the site of injection which spread rapidly around my arm.  My arm was very sore and I was unable to move it easily.  I was diagnosed with cellulitis and given and antibiotic.  There was a lot going on in the room but did notice after the fact that the nurse was not wearing gloves and I'm not sure if I was swabbed with alcohol prior to injection.  These concerns have been addressed with the Director of Convenient Care at Clinic.
Patient states that her arm is sore, red, and knotted up to "golf ball size."  It is not warm to the touch.
3.5 hours after receiving the vaccine, the patient was killed in a head-on collision. The patient was driving when her vehicle crossed the centerline and struck a second vehicle head on. It is unknown if the COVID19 vaccine contributed to the collision and death.
PROQUAD was given instead of MMR by MA, Varicella was also given on same day. Was also documented wrong in MCIR, documented as MMR, though in patient's chart was clearly given the PROQUAD. MCIR updated to reflect the PROQUD that was given.
Day 1: Chills, fatigue, aches, low grade fever (under 100). Day 2: Intense fatigue Day 3: Some fatigue Day 4: Light fatigue Day 5: Sore neck on left side, as if in muscle or lymph node, slight swelling along neck, intermittent recurring rash, extreme skin sensitivity, periodic itching various sites Day 6: Same as above. Last day reported. Symptoms still existing as of writing.
Headaches; Pain; Swelling arm; Lips dry; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10-MAR-2023, the patient received Shingles vaccine. On 10-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headaches), pain (Verbatim: Pain), swelling arm (Verbatim: Swelling arm) and lip dry (Verbatim: Lips dry). The outcome of the headache, pain, swelling arm and lip dry were not recovered/not resolved.   It was unknown if the reporter considered the headache, pain, swelling arm and lip dry to be related to Shingles vaccine.     It was unknown if the company considered the headache, pain, swelling arm and lip dry to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-Mar-2023 The heath care professional reported that the patient (reporter's mother) got the vaccine 4 day ago and since day one still had headaches, pain, swelling in the arm and lips dry. The follow-up could not be possible as no contact details were available.
Received second dose of Covid Vaccine. Patient alerted EMT and reported difficulty inhaling, dry mouth and throat. Pt reported feeling hot, flushed, had rapid breathing and headache. Vital signs were taken by EMT at 10:05 Pulse: 90, BP: 150/90. EMS was activated at 10:05. Hospital offered patient adult dose of oral Diphenhydramine 2x, 25mg/ml. Patient agreed to Diphenhydramine. Hospital gave Diphenhydramine to patient at 10:08. Fire Department arrived on scene at 10:11. Fire Department administered epinephrine Intramuscular injection at 10:15. Patient transported to Medical Facility by EMS on gurney at 10:18.
Information has been received from a registered nurse concerning a patient who on on 09-JUN-2008 was given the second oral 2 mL dose of ROTATEQ (Lot# 660292/1832U) and the third 2 mL dose of ROTATEQ (Lot# 660292/1832U) on 16-JUN-2008. The nurse stated that the third dose of GARDASIL early. The patient sought treatment at the physician's office. No product quality complaint was involved. Additional information has been requested.
Used gray-top Pfizer Covid-19 instead of bivalent booster 11/22/2022
Severe headache for three consecutive days, accompanied by nausea.  Presented to emergency deparment on 10/6 as symptoms were worsening and became unbearable.
N/A. No adverse event. Would like to report and document administration of FLUZONE MDI (w/ preservative) when patient requested FLUZONE preservative-free formulation. Pt. has been contacted.
Information has been received from a nurse practitioner concerning an approximately 6 month old patient who in August 2007, was vaccinated with a second dose of Rotateq and three weeks later came into the office for a regular check up and "did not look good".  The physician prescribed some medication and sent the patient home.  The next day, the patient's mother brought the patient back to the office and the patient was already in shock.  The patient was taken to the emergency room and has been hospitalized since November 2007.  Onset date reported as mid November 2007.  The nurse practitioner also mentioned that "the baby may not make it".  It was reported that the patient was "fine" after the first dose of Rotateq.  There was no product quality complaint.  The patient "did not look good" and shock persisted and were considered to be immediately life-threatening.  Additional information has been requested.
Menstrual period ended two days before the injection, then vaginal bleeding and another period began the day after. Since then, menstrual period has been extremely irregular- either occurring for two weeks per month, not at all in the month, or extremely heavy and painful for one week in the month at an indeterminable time. Before this event menstrual periods were extremely regular and able to be tracked nearly to the day they would start.
Started with shaking chills, aches then low grade fever (100.5 even after taking 600 mg ibuprofen the morning after vaccination) and extreme fatigue. Symptoms resolved after 36 hours.
4/6/21 (2pm) Arm slightly sore after shot. No symptoms at all for 32 hrs.  4/8/21 (3:12am) woke up to use restroom and I felt as though I was spinning. Dizzily staggered to the restroom and back. Laid down and my body felt like it was slowly spinning. At (7:45am) called my employer to work from home. Checked my blood pressure (8am) and it was elevated at 142/96. Throughout the day everytime I stood up I felt like I was dizzy as though I was walking on a moving boat. With the dizziness I felt nauseated. I had diarrhea several times during the day especially within an hour of eating anything. If I bent down I was dizzy. Looking to the left or right dizzy. My dizziness would subside when I was sitting stationary and looking forward. Blood pressure at (4:20pm) 142/95. At (9:15pm) I started to get a headache so I took one Excederin Migraine and it went away.  Blood pressure at (10:09pm) 144/91.  4/9/21 (6:15am) Dizziness 50% better, no spinning but feel unbalanced. Feel weak and shaky even after eating. No diarrhea so far and current time is now 1:11pm. Blood pressure at (1:11pm) 130/91. My blood pressure before taking Jansen was 118/80 on 3/27/21.
Diluent was drew up by 0.8ml instead of 1.8ml and mixed with vial of pfizer.
initial routine soreness, 4 days later developed significant difficulty in using shoulder for any activity. Planned on seeing orthopedist.
All over body aches, headache, malaise, and fatigue. I took 4 ADVIL shortly after getting the shot, which is my second dose of two doses, because I had such pain with the first shot. I have taken 800 mg of ADVIL every 4-6 since getting the shot and it has not helped ease the achiness and pain considerably. I hurt with rest, I hurt with movement, and I am easily fatigued.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received on an unknown date see case US2018GSK175746). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 70 or 71 days. The patient recently had SHINGRIX vaccine and had worse pain in his arm than with the flu vaccine. The patient had a fever of 101 after SHINGRIX. This case has been linked to the US2018GSK175746, reported by the same reporter. Lab Comments: On an unknown date, the patient's body temprature was 101 degree F.
HCP reports a nurse from his clinic was trying to administer the vaccine to a child when the vaccine accidentally splashed her in the eye.; No side effects or symptoms reported. No additional AE; This spontaneous report has been received from a pharmacist, concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-SEP-2023, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) Injection, lot number W019423, expiration date not reported, but upon internal validation established as 20-JUN-2024, as prophylaxis (strength, dose, vaccination scheme, frequency, route of administration, and anatomical site of injection, were not reported).   On that same date, a nurse was trying to administer the vaccine to the patient when the vaccine accidentally splashed her in the eye (occupational exposure to product). No side effects or symptoms reported. No injuries reported. No additional AE. No other medical information known.
Had flu shot and pneumonia shot 9/30/2004. On 10/1/04, headache, fever, muscle aches.
After vaccination in exam room, client sent to observation room for 30 minutes. About 5 minutes in the observation room, client started to feel light headed. Client sent back to exam room to lie down. At 2pm, client's blood pressure 107/70 with 98 pulse. At 2:15pm, client's blood pressure 128/79, 99 pulse, and O2 sat at 99%. Cold compress place on client's forehead with knees elevated. Water and snack provided.
After receiving the vaccine I experienced muscle aches, body aches, a fever of 101, a massive headache, and a bacterial infection. I had a red rash all over my neck and under my armpits and breast. I have not been my self since getting the vaccine. I can only do minimal things. I had loss of appetite, fatigue, and exhaustion. I had lower abdominal pain. It was painful prior urinating and after urination. On 10/30/2021 I went to see the doctor. I was prescribed phenazopyridine 200mg 3xday and Bactrim 800mg 2xday for the UTI. My thighs also hurt really badly. I have recovered from everything expect from the poor appetite and fatigue.
24 hours after injection, mom noted edema and warmth.  No Pain no fever.  acting well.  Area of erythema and edema measured 12 x 9 cm.
dizzy; headache; This is a spontaneous report received from a contactable female consumer, the patient. A 29-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced dizzy and headache, both on an unspecified date. The patient received the first dose on 06Mar2021, and on Wednesday, the patient started experiencing a headache and felt dizzy. The patient went to the doctor who said he was normal. The first day after receiving the vaccine, the patient felt normal but on Wednesday, she started with a headache and was told these can also be symptoms for a COVID infection. Clinical outcome of the events dizzy and headache was unknown.  Information about lot/batch no. has been requested
two vaccines underwent a temperature excursion and were both administered to patient; No further AE/PQC reported; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 07-JUN-2020, the patient was vaccinated with a dose of vaccines following temperature excursions. The vaccines involved are: varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, intramusculary, lot # S036636 (expiration date 14-NOV-2021) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin)(M-M-R II) 0.5 milliliter, intramusculary, lot # S018594 (expiration date 17-JUN-2021 ) for prophylaxis.  The improperly stored suspect vaccines experienced all a temperature of 28.04 degree fahrenheit (°F) for one hour and 22 minutes with no previous temperature excursion.   The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA011763:
Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.
I tested positive for COVID-19 on 7/8/22. I developed a scratchy throat on 7/3/22 and developed sore throat on 7/6/22. Started experiencing congestion and sinuses w/ a few body aches. I spoke to doctor on 7/9/22.