chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe diarrhea; Had the third dose on 26 Aug 2021; Had the third dose on 26 Aug 2021; body aches as though he has the virus, which he doesn't; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received the third dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route left arm on 26Aug2021 13:00, at 69 years of age, (Batch/Lot Number: 47823300) as single dose for COVID-19 immunization. Medical history included kidney damage and lung problems from medication and he spent 65 days in the hospital when he had Methicillin resistant Staphylococcal infection (MRSA) about 5 years before this report, all from an unknown date. Family Medical History was none. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot/ Batch number: FVP63021, administered via an unspecified route in left arm on 05Mar2021, at 68 years of age, as single dose for COVID-19 immunization and the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot/ Batch number: EN6202, administered via an unspecified route on 26Mar2021, at 69 years of age, as single dose for COVID-19 immunization. The patient had no problems with vaccines in the past. He stated he felt fine until he got the third shot. The patient didn't receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. The patient's concomitant medications were not reported. On 26Aug2021 an extra dose was administered, the patient received the third vaccine shot because his immune system was compromised because of MRSA and "they were putting in a funeral for him". His sister sent him a text message about the third shot and told him where he could go to get it. He has to be really careful since he has kidney damage and lung problems from medication and spent 65 days in the hospital then when he had MRSA. He was in 3 hospitals and in a rehabilitation center. Moreover, on 28Aug2021, he experienced severe diarrhea, body aches as though he had the virus, which he didn't. On 29Aug2021 he felt a little better "but really feeling good overall". He went to the emergency room/hospital on 30Aug2021 and just got home at the time of the report: he specified he stayed there from noon to 2pm and he was feeling a little better, but not 100%. The outcome of the extra dose administered was unknown at the time of the report, all the other events had not resolved yet at the time of the report.  Follow-up attempts are completed. No further information is expected.
Patient reported having a fluid filled bubble under skin at injection site. Bubble was noticed following day after removing bandaid placed over vaccination site. There was some blood on the bandaid after removal so patient did have some bleeding after vaccination. Bubble was about 1 centimeter and filled with clear fluid. Vaccine administered on 11/9 and patient reported adverse event to pharmacy on 11/11. Patient sent pictures to their doctor and they were unconcerned. Doctor told patient they believe the vaccine may have been administered too shallow and not deep enough into the muscle. Patient did not report any irritation, bruising or soreness at injection site. Did not have any systemic effects associated with normal immune response post-vaccination.  Pharmacist (myself) followed up again with patient on Monday 11/14 and he reported no change in size or appearance of bubble other than some slight redness. Counseled to follow up with doctor if bubble does not disappear on its own or gets worse.
Medium grade headache, Onset at ~16 hours after vaccine, lasted  8 hours-took Advil. Lethargic, onset at ~16 hours, lasted ~20 hours.  Low grade fever, onset at 32 hours after vaccine, lasted -5 hours.  Took Tylenol.  All symptoms subsided ~40 hours after vaccine.
pt recv vax 30SEP96 & 16DEC96 devel chills, cough, high fever, diff breathing;pt was eval by MD who dx flu & prescribed PCN & cough syrup;pt has not yet recovered;
Mom was holding child?s head off to the side. Employee came on opposite side to administer vaccine, child jerked. All of vaccine wasn?t administered. Mom was upset and asked for child to have an additional vaccine given ASAP. Staff called mobile manager who told them our policy and said we can?t give an additional dose because child received half of the dose. Mom got upset and grabbed consent form and ripped it up. Team was done so they packed up and left. Mom was upset saying she?s a nurse and she felt as if he didn?t get the full dose so she wanted an additional dose administered. She didn?t believe the team and that if a person receives half the dose, it?s considered a full dose. She contacted someone, who contacted us. We explained the current CDC guidelines. Person was updated and told the team lead thgt she was going to call the mom of the patient.
he was doing okay and no side effects were reported; An expired PROQUAD was inadvertently administered; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On an unspecified date in 2017 (reported as "when he was 1 year old"), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), second dose, 0.5 ml subcutaneous booster injection (anatomical location was not provided) (lot# S002490 with expiration date 23-JUL-2020) for vaccination.  At the time of the call, the patient was "doing okay" and no side effects were reported. As of 29-JUL-2020, it was unknown if he will receive another measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection.  This is one of two reports received from the same reporter (linked case was captured in # 2007USA012091).; Sender's Comments:  US-009507513-2007USA012091:
Rash, UrticariaPruritus, NauseaVomiting, rash started 10 days after vaccine, 1/21/2021 Narrative:
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Within 48 hours of oral vaccine visible blood in stool x 2. Heme (+) samples.
Patient was sitting in observation area and got up to notify a tech that they weren't feeling well. He fell into the rope dividers that divide pharmacy lanes and was helped onto a chair. He immediately regained consciousness. We gave him orange juice, put his feet up and took his blood pressure. He was monitored for an additional 30 minutes.
She felt very anxious beforehand and got dizzy with hot flashes after receiving the vaccine. She sat on the floor afterwards and drank some orange juice and I gave her a cold pack for her neck and a fan to cool her off. After about 30 minutes,  her daughter came to pick her up. She was feeling a little better and her daughter drove her home.
Site reaction - redness slight swelling left lower delt to elbow. Patient states it is a radiating burn feeling. More when he lies down on it. Symptoms began evening of Oct 7 2015 and still occurring 2 days later.
Golf ball sized lump appeared under right arm approximately 36 hours after injection.  Very painful.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 30Jun2022) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; METFORMIN. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2022, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 2022, outcome "not recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: She states she was allergic to Penicillin and takes cholesterol medicine. She stated that she was currently at the hospital and her doctor was planning on giving her Paxlovid but it was not FDA approved. She don't want to take things that are not approved and be used as a guinea pig. She states "she was calling because the doctor was not giving her the information she need that would make herepor feel a lot better utilizing Paxlovid." she was asking "have people died from, been hospitalized, or gotten sick from taking Paxlovid". She was asking "can she take Paxlovid with these medications and allergy to Penicillin". Response: Established and Other Potentially Significant Drug Interactions. VR-Consumer Inquiry Management (Off-Label or No Info) (v17.0)" under "Safety: Adverse Reactions or Side Effects" and "Drug or Food Interaction /Concomitant Administration." Referred patient to follow up with her doctor for clarification." She stated "stop cutting her off and just listen. As a response acknowledged complaint and offered assistance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In January 2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up TCR is attached : Email id updated. On 24-Apr-2021: ADR form is attached on 24-APR-2021-First dose and Second dose information updated, Patient Race and Ethnicity updated, Event outcome updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache upon waking. Flu like nausea and fever by midday. Joint pain by early evening
Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
15 minutes after receiving Tdap she became flushed on left side of neck, progressed to bottom lip becoming numb & burning. Scalp started itching, burning and swelling. Ears felt like they were swelling and hearing became hazy. Back of tongue & throat started swelling, face was hot to touch but no fever, reported o trouble breathing. Took 50 mg benadryl at 5pm & again at 9pm. Pt states symptoms subsided after 15 minutes taking first dose of benadryl. All symptoms were gone by midnight but not felt good today, fells achy. Pt has not seen doctor for adverse event. Encouraged to see her provider, APN, she states she will notify her office now.
Headache (After Second Dose); Fatigue (After Second Dose); Diarrhea; Diarrhea (After Second Dose); Sore Left Arm (After Second Dose); Dizziness (After Second Dose); Heart palpitation (After Second Dose); A little Sick for one day (After First Shot); This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (A little Sick for one day (After First Shot)), PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)) and HEADACHE (Headache (After Second Dose)) in a 61-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.     The patient's past medical history included BP.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (A little Sick for one day (After First Shot)). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), FATIGUE (Fatigue (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)). On an unknown date, the patient experienced HEADACHE (Headache (After Second Dose)). On 31-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm (After Second Dose)), DIARRHOEA (Diarrhea) and DIARRHOEA (Diarrhea (After Second Dose)) outcome was unknown. At the time of the report, ILLNESS (A little Sick for one day (After First Shot)), DIZZINESS (Dizziness (After Second Dose)), PALPITATIONS (Heart palpitation (After Second Dose)), HEADACHE (Headache (After Second Dose)) and FATIGUE (Fatigue (After Second Dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A few days following the second dose of the Pfizer Covid 19 vaccine, I experienced mid-cycle menstrual bleeding. This is not something I typically ever experience. My menstrual cycle was also longer with heavier bleeding following vaccination.   This should be advised as a possible side effect so that  the lack of reporting doesn?t sow distrust in women. If a sore arm is advised as a possible side effect, then this should be as well.
approx 1/2 hr p/recvd vax eyes rolled back in head, collapsed, tremors; then curled up in ball p/1-2 minutes regained consciousness, started vomiting; mom could not arouse; called clinic referred to ER; dx neurogenic shock;
62 YO female presents to the ED on 6/4 with complaints of non productive cough, chest congestion, post-nasal drip, nasal congestion, chills, SOB, sinus pressure, and sore throat. Denies fever. COVID rapid  test results back negative the same day. Vitals were stable and pt was discharged with COVID-19 diagnosis. She is s/p J&J vaccination on 5/11.
Pt came to the pharmacy on 11-16-13 and stated that she developed "neuritis" 2 weeks after receiving the flu shot. Pain initiated from the left shoulder in the back and radiated down the left arm. Symptoms started on 11-13 and lasted for 3-4ds - pt took 1 dose of EXCEDRIN - pt stated that she is 80-90% recovered at this time. Advise pt to see personal physician for follow up.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. No treatment information was provided.  Nurse informed that 319 patients received the expired dose of vaccine.   This case was linked to MOD-2021-363032, MOD-2021-363226 (Patient Link).
drug intolerance; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included INFLUENZA VACCINE (received vaccine when the patient was young and very healthy) and TETANUS VACCINE (received about 8 years ago, after standing on a rusty nail).   On an unknown date, the patient received the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine which the patient never wants. The patient wish that she could tolerate the vaccine but she can't.  The patient relies on those around me getting the vaccine so I did not get exposed.
Mother reports patient began to experience chest pain and SOB on Saturday.  Took Advil on Sunday.  Did not seek medical care.
Pt recvd vax & caused the entire leg to be very swollen & cherry red w/flush areas; leg was hot to touch; pt was extremely irritable; afebrile; no reaction following 3rd vax DT given instead of DTP;
Headahce,NauseaVomiting, Fatigue Missed work following second dose due  to flu-like symptoms
About 5 hours after the shot, my RIGHT (opposite from injection) arm/shoulder experienced intense muscle/joint/tendon pain/weakness. Massage did not seem to help. This arm feels incredibly tired and sore. I am physically active and lifted weights earlier in the day ? but nothing out of the ordinary until this totally random flare-up. No pain, swelling, or anything anywhere prior.
NUMB IN HANDS; SHOCKING PAIN/EXTREME PAIN; NEUROPATHY PAIN; CRAMP IN HANDS AT NIGHT; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 240 pounds, and height was 76 inches. The patient's concurrent conditions included diabetes, high dose penicillin allergy, adhesive tape allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had otc drug allergy. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 21-MAR-2021, the subject experienced shocking pain/extreme pain. On 21-MAR-2021, the subject experienced neuropathy pain. On 21-MAR-2021, the subject experienced cramp in hands at night. On 02-JUL-2021, the subject experienced numb in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy pain, shocking pain/extreme pain, cramp in hands at night, and numb in hands. This report was non-serious.
Fever, Headache, joint pain, muscle pain, local swelling, redness, itching
DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.
Information has been received from a pharmacist concerning a patient who on 14-AUG-2007 was vaccinated with Zostavax (Oka/Merck). Subsequently, the patient developed a lump at the site of the injection. On 14-SEP-2007, the patient was examined and had a 3 x 4 x 0.9 cm cystic mass. Additional information has been requested.
Pt developed recurrence of her shingles on her R chin (where she has had before) the afternoon of receiving Shingrix. She then developed lesion on her L abdomen and on her R shoulder.  She contacted my office that afternoon at which time she had very few lesions and I had recommended she hold on using Valtrex as it was still early and my understanding was that Shingrix could not cause shingles. She was agreeable to this but 3 days later, she contacted the office to report continued spread to new locations. I recommended she resume Valtrex at that time.
Patient complained of feeling flushed approx. 1/2 hr after receiving vaccine - her chest was reddened. This subsided after approx 15-20 min. Her BP was 124/80 left arm - she placed a cool pack on her chest - redness subsided. At 1:50 pm she stated she was fine.
1 day after shots - ran 104 temp and nonstop crying for 3 or more hrs.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Nurse had previously called on 21-JUN-2013 to discuss vaccine temperature stability data but at that time reported no patients had received improperly stored vaccine. On 27-JUN-2013, nurse reported that she discovered 3 patients received improperly stored vaccine. On 20-JUN-2013, one of the patient received an improperly stored dose of GARDASIL (lot #, expiry not reported). No symptoms reported. This is 1 of 3 reports received from the same reporter. Additional information is not expected.
He developed Superficial Phlebitis in the left lower leg on 3/31/21, and was seen in the ER.    He reports concern to me on 4/14/21 that due to reports of blood clots with the Janssen vaccine, that he is concerned that his vaccine on 3/9/21 may have provoked the blood clot.  He still has some phlebitis in the lower left calf.   Note, he is on self given testosterone, which may also contribute.
Headache, lightheadedness, body aches, rashes throughout body, lethargy, loss of kidney function
Patient stated she felt nauseous about 5 minutes after shot was administered. She stated that she got tunnel vision, could not feel her hands. A few minutes later she stated that she felt vibrations in her hands, felt like she could not move her hands. She was visibly pale and clammy. Patient was given an ice pack and 25 mg dose of oral Benadryl liquid. Her symptoms resolved within 25 minutes of onset and she was able to leave the pharmacy feeling back to normal
pt recvd vax & became fussy; would not sleep on back; pt found in bed w/ vomitus around mouth;