chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had sore throat, mild body aches and was tired. These lasted for about a week. On Feb 1st, I tested positive for COVID-19. I had heart complication. I was getting dizziness, lightheaded, and could not breath. I went to the ER. They did EKG, blood work, and chest x-ray, showed that I had premature ventricular contraction. These is still ongoing and I am seeing a cardiologist for it.
pt recv vax 18OCT95 & exp severe ache for 3 to 6 days;there was a reddened area @ the inj site about the size of a quarter;
Patient complains of pain, swelling and limited range of motion over a month after injection.  Patient has not sought any medical treatment for complaints.
Case number PHEH2014US025031, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 84-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 17 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was in between 46 tot 49 degree F during excursion. No adverse events reported after the maladministration.
Morning of 9/18, baby awoke fussy, afebrile. Within 15 min of waking up, parents noted that she had an episode that lasted several minutes of looking pale while, cool distal extremities, decreased alertness (but no loss of consciousness), decreased tone. Still alert through this time. Duration of experience was 5-15 min. By the time of the exam approximately an hour later, she had normal exam, stable vital signs. No abnormalities on exam. Discharged to home from clinic.
Patient got FLUZONE & had rash & hives reaction locally at the site. Recommended use of BENADRYL topical.
Ulcerative colitis relapse; Allergy; Sinus disorder; Headache; Nausea; This spontaneous case was reported by a physician and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis relapse) in a 43-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.     Concurrent medical conditions included Ulcerative colitis since 21-Jul-2020, Anxious mood (Felt anxious, scarred) since 21-Jan-2021, Feeling sad (Felt sad/blue), Fatigue (Fatigue returning) since 21-Jan-2021, Diarrhea (DIARRHEA/4-5 DIARRHEA EPISODES, Daily semi formed stools) since 21-Jan-2021, Constipation, Rectal bleeding, Stomach pain (PAIN IN THE STOMACH/ABDOMEN), Decreased appetite (NOT FEELING HUNGRY), Joint pain, Difficulty sleeping, Pain and Social problem (NOT ABLE TO KEEP UP WITH FRIENDS/PEERS). Concomitant products included ADALIMUMAB (HUMIRA) from 21-Jul-2020 to an unknown date for Ulcerative colitis.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis relapse) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis relapse), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) No antibodies for Humira found. On an unknown date, Weight: lost few pounds (Inconclusive) Lost few pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's allergy and sinus events were treated with Fexofenadine (ALLEGRA). Treatment of other events were not reported.  Company Comment  This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on 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.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on 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.
Redness the size of a half dollar; Raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised). At the time of the report, ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: from vaccine card: EL then either 0 or O 142), via an unspecified route of administration by injection once to left arm on 13Jan2021 at single dose for prevention (covid-19 immunisation).  Medical history was none.  There were no concomitant medications. Patient was diagnosed with shingles about 3 weeks after receiving his first injection of the Pfizer covid-19 vaccine. This male consumer received his first injection of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021. He reported being diagnosed with shingles last Thursday (04Feb2021) and stated his symptoms started that same week (Feb2021), which were described as rash and shoulder pain. He reported his shingles are improved and are scabbing over. The consumer was prescribed and was taking valacyclovir for treatment of the shingles. Shingles was now (base on 09Feb2021) healing. Shingles occurred after the first dose, he was not blaming the vaccine, he did fine, he had no reaction, his first dose was on 13Jan2021, and shingles came up last week (on 04Feb2021). The consumer's second dose of the covid-19 vaccine was supposed to be last week (base on 09Feb2021) but this physician recommended he delay due to the shingles. Currently on an antiviral, getting better, feels great, wondering if he can proceed with second dosage. The consumer was wanting to get his second dose this week (base on 09Feb2021). No investigation Assessment. Outcome: he scabbed up, he never had fever, just a rash and the little nerve pain thing (Feb2021), that's it. Stated he had no reaction to the vaccine whatsoever. The outcome of shingles was recovering, of other events was unknown.   Information on the lot/ batch number has been requested.
Woke Friday 11/05/2021 to sore, swollen, painful arm and H/A, stayed in bed for 36 hours and c/o  disorientation. Woke up Saturday afternoon feeling normal.
This spontaneous report as received from a pharmacist via Company Representative refers to 2 patients of unknown age. On unknown dates the 2 patients were vaccinated with ZOSTAVAX (lot# not reported) (start date, route, dose# and dosage not reported). On unknown dates the 2 patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
pain, She has been in constant constant pain; can't use my shoulder; they found it was arthritis; trouble breathing, affected her breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U7B21A and 007321A) for COVID-19 vaccination.     The patient's past medical history included Polio. Concurrent medical conditions included COPD, Emphysema and Heart failure.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg twice a day; OXYCODONE for Pain, at an unspecified dose and frequency and EUPATORIUM CANNABINUM ESSENTIAL OIL (HEMP SEED OIL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: arthritis (abnormal) Arthritis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Verified with pediatric department provider who stated that adverse reactions would be mild if any. I called parent, informed her what happened, what her child's PCP had said and asked if there were any adverse reactions to which she denied any. She stated that there wasn't so much as a fever.
Powder component of Menveo reconstituted with sterile water; Powder component of Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 8mza576a, expiry date 31st July 2022) for prophylaxis.   On 4th March 2022, the patient received Menveo. On 4th March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: The patient was administrated with the powder component of Menveo reconstituted with sterile water.  No adverse event was reported. The reporter consented to follow up. The health care professional wants to remain anonymous. Additional Supportive Information:  The patient was administrated with the powder component of Menveo reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Shortly after receiving vaccines, patient complained of severe lower back pain, weakness, and a tingling sensation all over her body. After resting on a bench and drinking a Sprite, she started feeling much better. She had noted that she had eaten very little today, just some crackers and coffee in the morning (vaccines were given at 12:30pm). It is possible that she was experiencing low blood sugar. I followed up at 5pm same day and she noted that she is feeling much better, though still with some back pain and feeling "freezing."
11-19-09 office visit for decreased energy level, not sleeping well. On 11-24-09 office visit for paralysis of face, unable to close left eye, malaise. 12-6-09 called with difficulty walking, fatigue, difficulty breathing, increased pain in limbs, no fever, balance disturbance-sent to ER. Hospitalized 12-6-09 through 12-9-09.
"Mentally fuzzy", body aches, arm pain, increased panic attacks, red, warm swollen at injection site, covering large portion of outer upper arm.
Severe pain in lower back; Dizzy; Headache; Fever; Chills; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8735) via an unspecified route of administration in the right arm on 21Apr2021 at 08:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergy to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 08:45, the patient experienced headache, fever, chills, severe pain in lower back, dizzy and nauseous. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fever, chills, severe pain in lower back, dizzy and nauseous were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Swelling started on Sunday morning.  Today doctor saw hard, red, swollen area that was 3 inches.
Mother of pt called said pt had vomited once. After advising mother to watch pt for continued vomit or fever she states "what about chest pain" at that time I advised her to seek emergency care immediately.
Redness, sore, large bump and itching - no change since original symptoms.  3 days later still have a large bump under site given, itching and soreness.
About 1 week after 1st dose, had severe itching under in both armpits. Noticeable swelling in RIGHT armpit that still remains (injection was in LEFT arm). Consulted a dermatologist who didn't believe it to be lymph node related.  A day after the second injection, swelling and slight pain in LEFT armpit.  As of this date, neither side has resolved.
This spontaneous report as received from a other health professional refers to a 4 year old patient. On 26-SEP-2013 the patient was vaccinated with M-M-R II (dose not reported, lot# reported as 0599AA, expired date: 26-APR-2013). No adverse effects reported. Additional information has been requested.
mild lower body muscle cramps; This is a spontaneous report was received from a non-contactable consumer or other non hcp (patient). A female patient of age greater than 65 years received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient 's medical history and concomitant medication were not reported. On an unspecified date, It was reported that approximately 12 hours after receiving the first dose of the Pfizer COVID vaccine, the patient woke from sleeping feeling very mild lower body muscle cramps. Muscle cramps were transient, did not last, and went away with movement. The outcome of the events was recovered on an unspecified date.  No follow up attempts are possible. Information about Lot/batch cannot be obtained. No further information is expected.
After the first dose I had muscle soreness and a headache the first day, and then it resolved, but, one week later I developed a rash about 4 inches below the injection site that was red, hot to the touch, hard, and painful. It was about 1inch by 4inches. I called my doctor thinking it may have been a blood clot, but she said it will likely go away in a couple days. It did, but, wanted to report it.  After the second dose I had the same red rash, but it showed up within the first 12 hours of the vaccine. I was rotating ibuprofen and and Tylenol every 3 hours, so I didn't have a fever, but, I had muscle pain and night sweats for about 5-7 days, with the second night being the worst.
This individual received the flu shot in the am of 8/24/09. About 1 hour later, he developed sneezing, a runny nose, and a sore throat. The following day, 8/25/09, he stayed home from work due to sore throat, runny nose, head congestion, and a flushed feeling (temp was normal). Today, 8/26/09, he states that he feels quite a bit better with just a few lingering symptoms: scratchy throat and stuffy nose.
Yesterday it started itching; injection site is like the size of an egg; very hot; raised; painful; very noticeable.; has 4 little white rings with a dot on it that is about the size of a pinky fingertip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised) and PAIN (painful) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip). At the time of the report, PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Immediately after receiving immunization, Donor became pale, lips cyanotic.  Assisted to lie down, ice packs applied, and legs held up until Donor was turned in bed an foot of bed was raised.  Donor stated was feeling better and was assisted to chair with help of two.  After eating snack, Donor stated was dizzy again so was returned to bed with bilateral ice packs placed front and back again.  Donor again stated felt better and was assisted to sitting position and additional snacks provided.  Donor had eaten well just before noon, stating had tator tots, turkey sandwich, and chicken quesadilla.
27y/o Male reporting Chest pain s/p COVID19 Vaccine administration. Patient received COVID19 Vaccination Pfizer 2nd Dose on 13OCT21 @1120 and completed a 15min observation period. After leaving the clinic area, patient returned to car and noticed an abrupt onset of Chest pain and returned to the clinic at 1145. Patient evaluation: A&Ox4. Speaking full clear sentences. Chest pain "pressure" like feeling to chest with radiation to flank area. Chest pain aggravated by deep inspiration but otherwise denying sob or difficulty breathing. Pt heart rate regular and strong. Pt lung sounds clear bilaterally. Patient denies any nausea. Vitals Signs BP 145/95, HR 64, RR 18, T 96.6, pain 6/10, po2 100%. EMS notified. EMS arrival @1215 and patient transported to the local Hospital @1225. No emergency medication was given to patient at Vaccination Clinic prior to EMS Arrival.
Case number PHHY2011US40501 is an initial spontaneous report received from a health care professional (HCP) on 02 May 2011 with a follow up from HCP on 23 May 2011. This report refers to an 18 years old female patient. She was given the lyophilized Men A component of MENVEO vaccine (batch number A100034 and expiry date: Sep 2012) reconstituted with sterile water instead of the MenCYW conjugate component, intramuscularly into the right arm deltoid on 02 May 2011. On the same day, she was also vaccinated with DTaP vaccine (batch number: AC52130) into the left arm deltoid. No other adverse reaction was reported. Follow up information received from HCP on 23 May 2011: Updated information about patient's demographic concomitant medication and site of application of MENVO vaccine.
My tinnitus (ringing in the ears) went from very minor nuisance to almost unbearable.
PATIENT IMMEDIATELY BEGAN TO FEEL DIZZY AFTER THE ADMINISTRATION. SHE LAID HER HEAD ON THE TABLE AND WHEN SHE SAT UP SHE  SAID SOMETHING DIDN'T FEEL RIGHT. SHE BEGAN TO CONVULSE FOR A PERIOD OF POSSIBLY 30 SECONDS TO A MINUTE. AFTER SHE BECAME COHERENT SHE REPEATED THAT SHE WAS OK. HER MOTHER WAS ALSO IN THE IMMUNIZATION ROOM AND BEGAN TO HOLD HER, AND THE PATIENT BEGAN TO CRY. I CALLED 911 EMERGENCY RESPONSE WHICH ARRIVED SHORTLY, MEANWHILE TH PATIENT WAS CALMED AND HAD NO OTHER SIGNS OF ISSUES. SHE AND HER PARENTS SPOKE TO MEDICAL PERSONEL AND THEY TOOK HER WITH THEM.
8 days post-injection, developed shooting pains down left arm with tinglin sensation to fingers. Injection site soreness for 3 days.Induration but no erythema noted at injection site 11 days post-injection.
In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and  still on steriods and breathing treatments and still haven't gone back to work.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received dose 2 on 04/09/21.