chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Nausea; Headache; A spontaneous report was received from consumer concerning a 61-year-old male patient who received Moderna's COVID-19 vaccine and developed headache, fatigue, and nausea.  The patient's medical history, as provided by the reporter, included human immunodeficiency virus (HIV). Concomitant medications reported included metoprolol, acyclovir, baby aspirin, clopidogrel, tramadol, atorvastatin, raltegravir potassium, diazepam, and edesse.  On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 28 Dec 2020, the patient developed a slight headache after receiving the vaccine. On 30 Dec 2020, patient developed fatigue, nausea and still had an ongoing headache. Treatment for the events included acetaminophen.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.    The outcome of the events headache, fatigue, and nausea was not reported.; Reporter's Comments: This spontaneous report concerns a 61-year-old male patient with medical history of HIV infection who experienced non-serious events of headache, fatigue and nausea. The event of headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025J20A, expiration date-Unknown).  The events of fatigue and nausea occurred the following day after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and outcome is unknown. The events of headache, fatigue and nausea are consistent with the safety profile for mRNA-1273 vaccine.  Based on the information provided, including temporal association a causal association cannot be excluded.
Received shot on thursday by the following Monday. On side of left bicep/tricep an area  had swelled and was red.
Chills, dizziness and a fever over 101 degress, called on call physician for practice and he said he had never heard of reaction, child receive HEP A and 1st dose Gardasil vaccine.
Pt reported that her "throat felt like it was closing up and diffuse itching (no rash)" within 15 min of receiving flu & HPV vaccine - but only reported these symptoms upon 2nd visit 12/3/10. Pt stated she was "not concerned" on 10/4 so did not report sx which resolved spontaneously.
Initial report received from a health care professional (nurse) on 09 May 2010. This patient was vaccinated with MENVEO (batch no: 028011), (dose: unknown) intramuscularly on 07 Jun 2010. The patient received only liquid conjugate component of MENVEO that was not reconstituted before administration and the lyophilized portion was not administered. No adverse event had occurred. Following an internal review on 07 Jul 2010 of the data received on 09 Jun 2010, the following information was added: Initial report was received on 09 Jun 2010. Follow up report received from the health care professional on 07 Jul 2010: The patient was also vaccinated with GARDASIL (batch number 11784), (dose: 0.5 ml) intramuscularly on 07 Jun 2010.
pt recv vax & approx 30min post vax pt devel a h/a;MD indicated that 8 other pt had similar exp (WAES97100694, 97100696through 97100698 & 97100700 through 97100703);
Pt received shots Monday afternoon. States he felt sick all day Tuesday and took BENADRYL that afternoon. Wednesday morning, he states he noticed a rash on the front of his left shoulder near the armpit. No problems breathing. Itching on rash only. Was seen by a provider and was given instructions on further care.
late second doses / received his first dose on Dic 2020 / due Covid situation.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, the patient late for 2nd dose of Shingrix due to covid situation. This case was linked with case US2021AMR143241, reported by same reporter for different patients. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR143241:same reporter
Inadvertent administration of FLULAVAL vaccine to a 16 year old patient. Dose 0.5 mL.
the next morning awoke w/severe sore throat which lasted 2 days & progressed to head & chest congestion;6 days p/inj devel a migraine which eventually led to hospitalization for treatment w/Demerol;MD said was allergic to the flu shot
The pt experienced a large local reaction that was 6 x 7 cm of redness and induration.
Started feeling chilled around 10 pm.  By 11:30 pm I was freezing and shaking uncontrollably for almost 3 hours.  I put on warmer clothing and took two Aleve.  Symptoms were gone by 2:30 am.
Pfizer-BioNTech COVID 19 Vaccine  Starting at 20-minutes post vaccination and lasting for approximately two hours, patient experienced episodic tachycardia (HR 123-200), flushing of face and arms, and tingling sensation in upper body lasting up to 5-minutes per episode.  Episodes were 20 minutes apart and decreasing in severity.  Patient medicated after second episode with 25mg/Benadryl, 40mg/prednisone, and 20mg/pepcid.  Side effects resolved within 40 minutes of medicating.
2nd vaccine administered 30 days after first.2nd vaccine came down with severe sweating and chills neck pain flu like feeling body aches .lasted about 12 hours
Bells Palsy: discomfort of L eye, strange taste in mouth, followed by weakness of L side of mouth and L eyelid. Tx w prednisone 60mg/day x 1 weeks and acyclovir 400mg qid x 1 week. 10/28 sx are improving, but still with inability to close L eyelid and weakness and decreased movement of upper lip on L. Local pain when face is touched.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 16:00 as dose 1, single (Lot number: EN6201), on 06Mar2021 at 10:00 as dose 2, single (Lot number: EN6198) and on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENALAPRIL; AMLODIPINE; LEXAPRO; SYNTHROID; SINGULAIR. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: Other medication details other medication in 2weeks product was enalapril, amlodipine, lexapro, synthroid, singulair. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No adverse event from vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the COVID-19,Drug ineffective cannot be completely excluded.
For about three months I have been having joint pain and inflammation and pain in my bones. I was donating plasma and during my 12th donation I just had this feeling that something inside of me that kind of blew up and it spread throughout the inside of me. It was this tingling sensation and it just spread throughout me. After my donation and I thought maybe it was something from my donation and maybe it was something from that. I went to go donate again and they said that I could no longer donate, and I needed to reach out to my health care provider and that my viral load is very high, but they could not disclose the information and I had to reach out to my health care provider. I could not see the doctor for two months and I was so sick I was in so much pain in my bones they ached, my fingers and my joints, my head felt like it was three times its sizes there was also this ringing in my ears. I had pink welts on my torso, I had a pink rash and broken blood vessels on my arms and legs as well, I have this feeling of a sunburn on my skin, and bugs that are crawling under my skin. I have a rapid pulse very randomly when I have not been doing something that would cause it to be high. I finally followed up with my health care provider and we did more testing and everything came back negative. I was sent to my PCP who has me going to a neurologist to follow-up. The thing that we have come up this far is that it is an auto immune disease or fibromyalgia. I am seeing a rheumatologist as well.
chills; fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumonia vaccine (manufacturer unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (manufacturer unknown), via an unspecified route of administration on an unspecified date (at the same time with pneumonia vaccine) (Batch/Lot number was not reported) at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever on an unspecified date. She told the pharmacist about the adverse effects and pharmacist told her they were not from the flu shot, it was because she got the pneumonia shot. The outcome was unknown.   Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Patient came by pharmacy today (3/11/21) to talk to us about the allergic reaction she had to the Shingrix vaccine she got from 3/3/2021.  She stated that it started about a couple of days after the vaccine and she got a rash from her body around waist down to her bottom.  She kept scratching so it got really red.  She also had headache and felt tightness where her lungs are.
Soreness/tightness/swelling L arm worsening gradually reacting peat at 2nd day after shot. L hip pain/stiffness day after shot. No fever, no SOB, no erythema. Symptoms resolved within four days.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 17-FEB-2016 the patient was vaccinated with an improperly stored (at 9.4 Centigrade for 1 hour) dose of ROTATEQ (lot # L013202, expiration date 27-JAN-2017, dose unknown) orally (incorrect product storage). No adverse effect was reported. There were no temperature excursion issues previously. This is one of several reports received from the same reporter. Additional information has been requested.
By morning was sick, it started with a cough which became productive during the day, and was thick, chunky and clear. By the end of the day had fever of 102.7 degrees. Did no have body aches but was coughing to the point that could hardly catch breath. Went to doctor who got blood work done: White cells count and live enzymes off. Doctor prescribed TAMIFLU. General health ok but by weekend had off and on nausea--no vomiting--and loose stools. Went to the ER for possible dehydration. Got some IV fluids and some medication for nausea/vomiting which was effective ER run blood work but numbers out of range earlier in the week went back to normal. Fever did break. ER prescribed anti-nausea medication when released lung xray also done and was ok. Today cough still is productive; continuous. On day 17th, don't have voice back. It is disturbing that there still is stuff on lungs. During first week was to weak to get out of bed and had headache.
gurgling noises from her stomach; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LISINOPRIL, EZETIMIBE, OMEPRAZOLE, PROBIOTICS NOS and VITAMINS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach). At the time of the report, DIARRHOEA (Diarrhea) and GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       o No treatment medications provided by the reporter
Redness, swelling, warmth. Using ibuprofen, tylenol, and cold compress. monitoring growth
The mother noted a golf ball sized swelling on 2/6/01 one day post vax. It progressed the next day to involve entire thigh from knee to inguinal area with redness, firm to touch non-tender. The pt still acting normal. Swelling down slightly on 2/8/01.
area of injection site ( upper arm) redness, swelling,extreme sensitivity to touch, itching, hard knot at site, and heat reaction started within hours of injection and gradually got worse for 3 days then symptoms started to get better but area looked bruised and splotchy red and had periodical itching. At this time there is brown splotchy areas around site and occasional itching.
headache 10 min after injection-tired and heavy chest within 2 hrs of injection-unable to sit up due to lack of energy-slept through the night-next day I was dizzy, and exhausted with difficulty in breathing-chills and fever-all my joints ached-slept all day and night-third day was able to walk around the block-still sluggish-no chills or fever or aching on third day-fourth day  after vaccination (vaccine admin on Monday @ 1:15-Friday morning back to normal) 100% back to normal
Swelling and itching at injection site. Colloquially referred to in media reports at "COVID Arm."
uterine cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: UTERINE CANCER (medically significant), outcome "unknown". Therapeutic measures were taken as a result of uterine cancer. Clinical course: It was rapidly progressing and they removed her uterus. She saw an online video that the vaccine contains sv40 which is a cancer causing virus, and a DNA virus which causes antibiotic resistance. She listened to a gentleman from privacy that had terror in his voice about what was in the vials. That the vaccines are causing antibiotic resistance and turbo cancer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Inappropriate schedule of vaccine administered; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ILLNESS (Sickness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In September 2021, the patient experienced ILLNESS (Sickness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ILLNESS (Sickness) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-622841 (Patient Link).
Began around 10 minutes after vaccine was administered. I became nauseous and shaky, with gagging. I had Tachycardia. I was carried into an exam room for around an hour. I was given Ondansetron to control the nausea and I was taking it for about a week. Body aches, fevers, shakes, severe headache, dizziness and fainting, really fast heart rate.
I was diagnosed with shingles on 5/20/21. I was prescribed valtrex and gabapentin. I am still in the middle of my treatment.
Individual presented with a rash on her torso. It didn't look like hives--more like lines.  Said she did not remember seeing this rash prior to receiving the Moderna vaccine.
Child's MCIR had Hep B scheduled for 5/23/2015, and Hep A was scheduled for 5/23/2016.  Hep A was given 5 months early.
I happened to counsel patient's husband about his prescription 2 days ago and hear that his wife died of stroke approximately a month after the second dose of  Moderna vaccine. I could not ask him further about exact date when she was admitted at the hospital because he was sick. I am not sure whether moderna vaccine caused her stroke, or not.  Her husband said his wife had high blood pressure.  They got Moderna vaccine on the same date.  Her husband  thought her high blood pressure caused the stroke. I don't have any info about  her medical progress at the hospital.
Left arm: Pain, Swelling, Lump around injection site, Itching, warm, red
Shortness of breath, hives, chest discomfort, face red & flushed, swollen glands, arm red & pink & swollen.
I started to have a mild sinus headache, a mild fever at 100.6 degrees, I was coughing, I had congestion, I was super tired, and a little bit of nausea. I was taking Tylenol and Mucinex.  I tested with a COVID-19 home test.  I called the nurse line and I had to go in and they prescribed me Paxlovid.
chills, body ache, left arm/injection site redness, swelling and warm to touch x 4 days; R hip, low back, left thigh posterior area pain; intermittent fever, headache, sore throat, right eye pain, bilat knee pain, nausea, fatigue, nose bleed x 2 (mild). These symptoms lasted x 2 days after vaccine.  Persistent fatigue and migraine days 3-4 after vaccine; asthma symptoms starting day 3 post-vaccine, lasted x 3 days.
I had a few symptoms on 11/28/2022 that I didn't think much of. I had a sore throat and a fever on 11/30/2022. I took an at home COVID-19 test and it was positive. I called my doctor and had a telehealth visit with him. He prescribed Paxlovid. I took the Paxlovid for 6 days. By the third or fourth day, the fever was starting to go away along with a lot of the symptoms. I took another at home test, and it was positive. The first time I had a negative test was 12/08/2022, 9 days after my first positive test. I tested twice more after that in two-day intervals and both were negative. I had a fever of 99.8, a sore throat, and a runny nose for a few days and that was about it. I did have some aftereffects of some rashes and a runny nose for a few weeks after.
10 days after receiving the first dose of Moderna, patient presented at the ER with difficulty breathing. CT revealed bi-lateral pulmonary embolisms. A few days on anti-coagulants and was released. She returned a couple days later with worsening breathing.  Patient received bi-pap oxygen then underwent procedure to place filter to prevent blood clots from traveling. Patient was intubated and placed on mechanical ventilation and diagnosed with multiple system organ failure. Patient succumbed to the vaccine injury September 29, 2021.
sensitive to noise; not feeling good; Rapid heartbeat; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness). At the time of the report, HYPERACUSIS (sensitive to noise), FEELING ABNORMAL (not feeling good), HEART RATE INCREASED (Rapid heartbeat) and DIZZINESS (lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Rapid heartbeat. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
On 10/31/2000, the patient experienced clinical varicella with multiple lesions. Unspecified medical attention was sought. Follow up information from the registered nurse indicated that the varicella was not related to the varicella virus vaccine live. No further information is available.
Woke up with body aches/joint aches and a low grade fever. Lasted approximately 8 hours
48 hours headache; lethargy; This is a spontaneous report from a contactable consumer. A (non-pregnant) female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:  Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks and COVID prior vaccination were unknown. On an unspecified date the patient experienced 48 hours headache, lethargy. It was unknown whether patient tested for COVID post vaccination. The outcome of event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.