chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting the next day after the vaccine (04/05/2021) I started feeling poorly but it wasn't until the following day that I felt extremely bad (04/06/2021). I was unable to get up out of bed (I couldn't straighten myself up). Every step I took hurt so badly and I ended up doing a telehealth visit. After a bit, I called my PCP and she finally had me go to urgent care and get an x-ray (thought I had a possible bone injury) but I never fell. After this I talked to my PCP again, she sent in an anti-inflammatory and pain medication. Once I got a little better, I was referred out to physical therapy, which was extremely painful to begin with but eventually improved. I ended up doing physical therapy for 3.5 months.
About 2 hours after vaccine administration, patient's wife called and reported the patient experiencing dizziness, nausea, and slight fever.  I spoke with the wife again at 7:30pm, she reported he had improved significantly, but still did not feel like getting up.  The patient completely resolved by 9:00pm.
Hard, reddened area 2 x 2 cm.  Increased warmth.
Right arm induration, pain, tenderness, increased warmth, and erythema. Rash at site and wrapped around right deltoid. Better today, erythema and warmth down towards right elbow now and right forearm tingles.
Myalgia, Arthralgia, chills, stomach spasm, chest pain, injection site pain, tender and swollen Narrative:
bloody nose; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. On 17Mar2021, the patient had a bloody nose while he was exercising in the morning. He was asking if it was a common side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Baby fussy all day after receiving vaccine, started wheezing slightly in evening.  Baby awoke at 5:00am next morning with fever, 101.2.  Baby stripped, given Children's Tylenol and juice/water mix.  Slept additional hour.  Second Children's Tylenol given at 9:00am.  Fever subsided by 10:30am.
Patient states: "I had (still have) a swollen lymph node so bad that Saturday and Sunday I could not wear a bra not just because it hurt so bad, but because it was so swollen. It is going down now, but still super sore... I felt like I got hit by a truck on Saturday too, slept all day, achy, sore throat and stiff neck, sore right flank (got shot in right arm), and heart palpitations."
Pt recvd DTP/OPV/HIB @ 10AM 22JAN92; Mom called office about 1PM & stated that pt had been crying continuously & that pts body was jerking; Pt was referred to MD; MD felt was a rxn to pertussis;
Delayed reaction to the COVID vaccination; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the COVID vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the COVID vaccination). At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the COVID vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Concomitant product use was unknown by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.
Pt became limp, pallor, diaphorectic & had low grade temp 100.3 at ER. Severe symptoms lasted 10 minutes. No further espisodes reported during hospital stay.60 day follow-up dated 06/29/00 provided no additional data.
MMR administered 12/27/07. Rash onset 1/26/08. Started on anterior legs, "bumps, filled with fluid", pruritic. Lasted 3 days, resolved fully. Took Benadryl. Resolved by the time seen by undersigned.
Twelve hours after administered arm became swollen, red and painful. Lasted one week severe the progressively improved over another week.
mild chills; mild body ache; fever 100.8; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (age at the vaccination 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil, ciclosporin (RESTASIS), risperidone (RISPERDAL) and multivitamins. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 PM for COVID-19 immunization. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient got second shot on 16Feb 1:30 pm. patient did not experience anything on the same day. Patient got mild chills and mild body ache and fever 100.8 on second day on 17Feb2021 09:00 am. Patient was fine on the third day. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 100.8 on 17Feb2021. The outcome of the events was recovered on an unspecified date in 2021. .  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
At first only arm pain. A couple of days after shot I started having a constant low-grade headache, then serious depression, suicidal thoughts, and difficulty functioning. The side effects subsided on Friday 16, about 8 days after injection with first shot and my head went back to normal.
She started with symptoms of not breathing,turning purple,turning limp on 07/01/2018  when they were out in the swimming pool with mom and the 3  older siblings. She had a tactile fever and mom blew in her mouth.The episode lasted a few minutes?? Was seen at ER and treated as a case BRUE..
R09.02 HYPOXEMIA 6/3/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXEMIA 6/3/2022 ACUTE NON ST ELEVATION MI
Sinus issues since 2 days after first shot. Been almost 2 months of congestion/ runny nose. daily OTC medicine including Zyrtec, day-quil sinus helps for a little while but have to keep taking it. Never had allergies last this long. EVER..
Feeling lousy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  An 83-year-old male patient received tofacitinib citrate (XELJANZ XR), (ongoing) (Lot number: FA0918, Expiration Date: 31Aug2023) at 11 mg 1x/day for rheumatoid arthritis; BNT162b2 (BNT162B2), on 23Aug2021 as dose 3 (booster), single (Lot number: FC183, Expiration Date: 31Oct2021) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "compromised immunity" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: FC183), administration date: 23Aug2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "Feeling lousy". The action taken for tofacitinib citrate was dosage not changed. Additional information: When he got his first booster he didn't stop his Xeljanz XR because it wasn't recommended. He was feeling lousy a couple of days after it, but he was sure it was the booster and then he was okay.
rash and red spots around her body.; The caller gets these little red things on her skin that itch a lot; This is a spontaneous report received from a contactable Nurse. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced rash and red spots around her body and the caller gets these little red things on her skin that itch a lot. It was reported that She received the first dose of the Pfizer COVID-19 vaccine 27Jan2021 and the second dose 22Feb2021. She recently been developing rash and red spots around her body. The red area was itchy. This occurred 6 weeks after she received the second shot. She wants to know if this a latent response to the Pfizer COVID-19 vaccine. She states Its not uncommon for me. I always have rash around my neck and on my body. Its the itchiness that keep coming back. I tried some home remedies. I don't like to take medications. I was glad at least I have the antibodies against covid-19 infection. Maybe this was all part of immune response. I just don't know if this was something I was going to have to live with for the rest of my life or would this go away. She received the 2 doses of the Pfizer Biontech vaccine, caller had her first dose on 27Jan-year not provided as caller was unwilling to complete report, and second dose on 17Feb-year not provided as caller was unwilling to complete report. The caller had a rash develop on her upper body, a red diffuse rash. It wasn't really bothersome. It didn't show up right away, maybe 4-6 weeks after the vaccine. The caller gets these little red things on her skin that itch a lot. The caller gets them mostly on her arms and legs. She has noticed the last couple of days she has noticed at night when the caller gets undressed to shower, she has noticed a rash under her breast to her waist, it doesn't itch. These bumps will finally dry up and go away but they keep reappearing. The caller was 80 years old now. She has an appointment later this month with her primary care doctor just for a routine visit. She hasn't had any life-threatening sort of thing, does not feel like she was in danger or anything. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)) and DRUG INEFFECTIVE (possible rinvoq was not working) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In May 2022, the patient experienced DRUG INEFFECTIVE (possible rinvoq was not working). On an unknown date, the patient experienced UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)). At the time of the report, UNEVALUABLE EVENT (issues with covid shot with rinvoq (upadacitinib)) and DRUG INEFFECTIVE (possible rinvoq was not working) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication was provided. The patient was starting new medication. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of possible rinvoq was not working and issues with COVID shot was not provided. Treatment medication was not provided by the reporter. Company Comment: This is a Spontaneous case concerning a 50-year-old, male patient, with underlying Rheumatoid Arthritis treated with Upadacitinib, who experienced the non-serious, unexpected adverse event of Unevaluable event in an unknown date, in the context of the administration of a dose of the mRNA-1273 vaccine (unknown dose number and sequence of administration). The underlying medical condition remains as a contributor for the event. It is reported in this case a situation of Lack of drug effect, attributed to a co-suspect UPADACITINIB. But is not mentioned for the COVID-19 vaccine shut. No further clinical information was available for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a 50-year-old, male patient, with underlying Rheumatoid Arthritis treated with Upadacitinib, who experienced the non-serious, unexpected adverse event of Unevaluable event in an unknown date, in the context of the administration of a dose of the mRNA-1273 vaccine (unknown dose number and sequence of administration). The underlying medical condition remains as a contributor for the event. It is reported in this case a situation of Lack of drug effect, attributed to a co-suspect UPADACITINIB. But is not mentioned for the COVID-19 vaccine shut. No further clinical information was available for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Flu-like symptoms,  I took Tylenol for soreness in arm. I was having nausea, headache, tired and dragged out feeling. It didn't last long. It lasted about 48 hours. I have had a cough now for about four months, I got it after the second dose of vaccine and I keep getting an earache, too. I am on my third round of antibiotics. I'm on Z-Pac. I was on Doxycline before that. I can't seem to get rid of this cough and fluids. Sore throat; sores in my mouth and earaches go along with it.
Received vaccination 10-13-2023, admitted to ER 10-14-2023 with forgetfulness, crackling sounds in my head, etc.  I thought I was having a stroke as I forgot route to ER and could name the rooms/or location of rooms in our house
p/vax pt exp malaise; fatigue & myalgia; 4/19 dx w/lyme disease; tx: doxycycline; pt again bitten by tick (deer tick); saw MD w/T99; h/a; fever; malaise & no rash;MD felt pt had lyme disease again; tx: doxycycline again;
Information has been received from a physician concerning a 13 month old female patient who on 19-AUG-2010 was vaccinated with a dose of MMR II, a dose of VAQTA (MSD) and a dose of VARIVAX (MSD). Concomitant therapy included PREVNAR. On 19-AUG-2010, the patient experienced full body rash while being administered with the vaccines. The physician said the patient had a tendency for hives. At the time of the report the patient had recovered. No lab diagnostic studies were performed. Patient did not seek medical attention. Follow up information has been received from the physician concerning the 13 month old female patient with teething at the time of vaccination and a history of getting hives from bananas who on 19-AUG-2010 was vaccinated with the first dose into the right arm of MMR II (Lot # 666824/0034Z) (Route not reported). On the same day, the patient was vaccinated with the first dose into the right arm with of VARIVAX (Merck) (Lot # 665974/0068Z) (Route not reported). Concomitant vaccine given on the same day included a first dose of BOOSTRIX (Lot # AHAVB431BA) and a third dose of PREVNAR (Lot # E47474) both given into the left arm. The physician reported that on 30-AUG-2010 a rash started. On approximately 27-AUG-2010 2-3 night previous to 30-AUG-2010 the patient had fever. On an unspecified date temperature taken at the doctor's office revealed 98.8F. The patient was treated with warm bath and CALAMINE LOTION. She was diagnosed with a not specified rash. On an unspecified date, the patient had recovered. No further information is expected.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with (Oka/Merck) VARIVAX injection (strength, dose, frequency, route of administration and indication were not provided) that reach 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality (PQC) was reported. The outcome of events was unknown. No further adverse event information was available.   Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#100481) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes.  This is one of several reports from the same source. Additional information has been requested.
Narrative:  Received 2 doses of Pfizer COVID vaccine( 2/4/21 and 2/25/21 and tested COVID + during dental pre-procedure screening. Only symptom reported in "dry Cough" on follow up call on 3/4/21.
Mild soreness when using shoulder on vaccine arm (left) at 7:58am Sudden headache, at 9:45pm Arm soreness increases substantially (cannot comfortably raise whatsoever) 9:45pm Chills at 9:50pm Fever 100 degrees F at 10:30pm Fever broke and chills stopped at around 3:00 am on 3/31 (the next day) Headache where it hurts to look to the side persists until 4/2 after which it gradually goes away becoming negligible by 4/4
2 days after receiving the dose, he began to have tingling in bilateral feet and arms/hands. With this tingling, it did not cause him to fall or lose grip on anything. With some time the tingling did lessen but has not gone away. He did come get his 2nd dose on 4/16. He did call his provider Dr. prior to receiving second dose and was given the okay to proceed.
PATIENT REPORTS REDNESS, SWELLING, ITCHING AT INJECTION SITE BEGINNING 3/26/21, WORSENING ON 3/28/21, AND BEGINNING TO IMPROVE BUT STILL PRESENT TODAY 3/29. ADVISED PT THAT SHOULD IT WORSEN THAT SHE SHOULD SEEK MEDICAL ATTENTION BUT EXPLAINED THOSE TYPES OF REACTIONS AFTER VACCINATION ARE COMMON. ADVISED PT THAT HER EVENT WOULD BE REPORTED. ADVISED PT THAT IT IS STILL RECOMMENDED SHE GET  HER SECOND VACCINATION AND TO ASK THAT IT BE PLACED IN THE OPPOSITE ARM IF THAT IS WHAT SHE REQUESTS. PT UNDERSTOOD.
first Shingrix vaccine in 2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml in 2019 intramuscularly in unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first Shingrix vaccine in 2019). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-JUN-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. the highest temperature recorded was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Seven weeks after the vaccine I was hospitalized with Dissection Type B. I woke up in the morning and I got a severe pain in my back. I was also sweating profusely. I went to the hospital by ambulance on 04/22/2021 and I was released on 04/29/2021. I returned to the hospital on 04/30/2021 with a Pulmonary Embolism in my Upper Left Lung and released on 05/05/2021. I am scheduled to go back for a CT scan to check on healing in the Dissection. The previous CT scan showed some healing. I had Covid-19 in March of 2020.
I started getting symptoms of dry cough and malaise with low energy. Within 4 days, I felt somewhat better. I received a positive COVID-19 test the next day at a doctors office. A week later I did an antigen test. I have had chronic diarrhea ever since I have had COVID that has continued to this day. I feel like this is due to long COVID. I do have a doctors appt in the future to get blood work and lab work.
This is a spontaneous report from a contactable physician. An 85-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unknown, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient had allergies: pneumonia vaccine: severe swelling of site. Outcome of the events was unknown. Pfizer is a Marketing Authorization Holder of [Pneumococcal 13-Val Conj Vac] in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of [Pneumococcal 13-Val Conj Vac] has submitted the same report to the regulatory authorities.
Patient reported redness on arm that she received the injection in. Inspected redness and it appears to be very mild and is not at the site of injection, but lower on the arm. Doesn't appear to be related to the injection. Recommended observing and taking Benadryl or applying hydrocortisone cream if needed. Contact primary care physician if worsens or persists.
Redness, swelling and pain in right deltoid.  2 days after vaccines had mild fever.  Three days post vaccines was seen for PPD reading in Primary Care Clinic. Redness measured 3.5 x 3.5 inches, was slightly warm, and redness was beginning to fade.
hives on 26MAR96;evening on 25MAR96;pt w/temp up to 103;p/shot devel spots & temp;mom states wasn't usual self;advised appt to r/o allerg react;27MAR96 post shots rash DPH relieved rash; now rash-welts on legs, t100.6;
12 CM X 9.5 CM Wheal on the right deltoid.  No pain or fever.  No cellulitis.  Local reaction.