chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later). At the time of the report, COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Information has been received from a physician concerning a 2 month old female, with no medical history and no allergies, who, "8 days ago," on 20-SEP-2007 was vaccinated with a first 2 ml oral dose of Rotateq. Concomitant vaccines included a dose of Daptacel, a dose of IPOL, a dose of Comvax and a dose of Prevnar. "7 days ago," on 21-SEP-2007 the patient presented with hematochezia. It was reported that the patient had been having blood in her stools. At the time of the report the patient had not recovered. It was noted that the patient saw the physician. Upon internal review, the patient's hematochezia was considered to be an other important medical event. Additional information has been requested.
Early morning of 4/12/21 (4th day following second shot of Moderna vaccine), I woke to be very dizzy. I had to lean against the wall to reach the bathroom. I had to be very careful sitting down and standing up from the toilet. That day dizzyness was severe. Next day moderate, Third day mild. Fourth day slight. Fifth day, recovered. Looking online, I found a couple of sites where other people reported similar symptoms only for some of them, the dizzyness persisted for days and weeks. Since that fifth day, I've had no recurrence.
The patient was given an injection in the left arm on deltoid muscle. Pt was relaxed, but immediately after the needle ejected the site started to swell and become inflamed. The site did bleed but stopped when compressed. Swelling went down after pt was injected w/EPIPEN .3 mg.
Fever; Chills; Lethargy; Tired; Weak; (L) armpit pain and swollen lymph node in (L) armpit; (L) armpit pain and swollen lymph node in (L) armpit; Was in bed Saturday night and all day Sunday; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. Concomitant medications included salbutamol (ALBUTEROL), taken from an unknown date. The patient previously took benzoyl peroxide (CLEARASIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 18:45, about 7 hours after the second dose, the patient experienced fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side. For about 32 hours, the patient was in bed on Saturday night and all day on Sunday, ate homemade chicken soup and drank one fizzy drink. The patient took albuterol for her asthma. It was bearable and she thought that it was just her immune system responding to the shot, her blood type. The mild symptoms of the side effects did not last very long about a day and a half. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and the treatment included cough and throat relief, mucus which contained vitamin C, dark honey, ivy leaf and elderberry extract, zinc etc. The clinical outcome of the events fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side and was in bed all night and day were resolved on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from medical assistant on 09-Jul-2018. This case involves a nine-months old male patient who was vaccinated once with a 0.5 ml dose of QUADRACEL (batch number: C5248AA, expiration date: 21-Aug-2019, dose in series and route of administration was not reported) in the right vastus lateralis instead of PENTACEL on an unspecified date (reported as today). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included HEPATITIS B VACCINE (Lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong vaccine administered. It was not reported whether the patient had experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
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 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single and administration date 30Sep2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Endometriosis" (ongoing), notes: Stated that she was diagnosed when she was 18. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Caller reports that she has not had her period since receiving the first dose of the Pfizer Covid-19 vaccine"; MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "not recovered", described as "Has not had a menstrual cycle since getting the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She wants to know if any clinical trial with menstrual cycles on Pfizer vaccines. She got the first dose of the Pfizer vaccine on 08Sep2021, and before it, she had a regular 28 day cycle every month. Coincidentally, the day she got vaccine, she has missed having her cycle since then, so it has been for 3 months. She has negative pregnancy test results. Since the day she got the vaccine, she has not gotten a cycle yet. She spoke with the pharmacist and they said there is no correlation. She was supposed to get her period in Sep2021 and never got her cycle. She wanted to know if this is a side effect from the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt called the clinic on 12/9/01 to report abdominal cramping and with an urge to vomit (no emesis) several hours, post vax, of taking 1st dose (capsule) of oral Typhoid (on 12/3/01). This resolved spontaneously. (No rash or itching). It was taken on an empty stomach as per instructions.
A the injection, I had feeling of prick of a hard material (bone?). Since the vaccine yesterday, I felt tired. The injected arm was not only sore,  but also tense, which makes it impossible to raise my arm.
2 hours after receiving the vaccine on Sunday, I had significant fatigue and sensitivity to light with watery eyes and a headache and was in bed all day. The next morning on Monday I woke with a pressure headache that was kept at bay with Advil. The headache stayed the same on Tuesday and Wednesday. By Thursday the headache was so uncomfortable I was having trouble working. It stopped responding to Advil and the pressure continued to increase on both sides of my head with sharp, shooting pains throughout that would come and go with the constant pressure. By Friday, I couldn?t co to use work and ended up calling into my PCP and advising them that I had a migraine that was very different from my normal migraines that I get (pain on left side behind eye, very nauseous, sensitive to light, always responds to OTC meds) and it wouldn?t respond to Advil and asked them to call in something. They called in generic version of Imitrex that evening; but since this migraine was so different than my normal pattern, I went to the ER on Saturday. They did a CT scan to make sure there were no  brain bleeds and gave me IV magnesium and steroids. I declined the torodol and Benadryl. The headache was still there, but bearable finally when I left. It got worse again that evening and I ended up taking the imitrex at 3am and falling asleep, only to wake up at 7am with a skull splitting feeling. That feeling stayed for the next 4 days, slowly getting less intense. I was unable to workout any of these days (I workout for about an hour daily for the past 3 years) because it was extremely exacerbated by activity. I was not hungry. Finally on Thursday I felt more like my normal self but the headache remained slightly and now on Sunday all that is left is the sharp, shooting pains that come every so often and light sensitivity.
Patient informed us that she has a vasovagal reaction sometimes to vaccines/needles.  We talked and made sure she was comfortable, had some ice and water available, and a space to lie down if needed.  After the vaccine  was given she did feel nauseous and hot so we had her lie down with her feet up.  She had ice water and we provided a glucose tablet for her which she said made her feel better as well.  After about ten minutes she felt better and we had her wait the 30 minutes after the shot to make sure she did not have further reactions.
This spontaneous report as received from a pharmacist refers to a 68 years old female patient with Bells Palsy "20 years ago". The patient had no drug reactions or allergies. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number 0618AE; expired date 23-JUN-2013) subcutaneously in the left deltoid region on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-SEP-2012 the patient experienced neck and ear region "tightness up". The patient was diagnosed with Bells Palsy "20 years ago", and the tightness that she was presently experiencing in her neck and ear region was the same area of her face and neck that had been effected by the Bells Palsy. At the time of the call the patient was still in the pharmacy and continuing to experience the neck tightness. The pharmacist believed that the patient's neck tightness was improving, and patient would contact her primary healthcare provider. There was no treatment given for the adverse event and no laboratory diagnostics study performed. The patient was recovering at the time of report. The patient had consulted with pharmacist for medical attention. Additional information has been requested.
Lethargy/feeling comatose; Can't really use his joints; Headache; Hurts all Over; Shakes/ hard shakes; Night sweats; High fever of 103-104F; Joint pain; A spontaneous report, was received from a consumer  (patient), concerning himself, a 51 year-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "feeling comatose" (lethargy), shakes/hard shakes (tremor), night sweats, lethargy, can't really use his joint (mobility decreased), high fever of 103-104 Fahrenheit (pyrexia), joint pain (arthralgia), headache, and hurts all over (myalgia).   The patient's medical history was not reported. Concomitant medications reported included losartan, amlodipine, vortioxetine hydrobromide, pregabalin, clonidine, prazosin and ropinirole.  On 10 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, 30 minutes after the vaccination, the patient experienced bad side effects "like" joint pain, shakes, high fever of 103-104 F, and night sweats. The patient was still experiencing the side effects. On 12 Mar 2021, two days after vaccination, the patient had fever 103 Fahrenheit, hard shakes, headache, lethargy, can't really use his joints, "feeling comatose" and hurts all over. The patient took acetaminophen as treatment medication for the events but hasn't helped. The patient still has a fever at 101 Fahrenheit all day. No other treatment information was provided. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, "feeling comatose", shakes/hard shakes, night sweats, lethargy, can't really use his joint, high fever of 103-104 Fahrenheit, joint pain, headache, and hurts all over, were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1 hours after administration, pt became fatigue followed by body aches, fever and headache. Symptoms lasted 2 days. No s/sx of injection site reaction.
Pt recvd 1st dose of Engerix-B 22JAN92 & same day exp swelling @ inject site, fever, h/a; Also LP was done & viral meningitis is suspected; Reporter indicated info regarding tx is not available; 27JAN92 events still present;
Information has been received from a nurse concerning a 7 month old child who was vaccinated with the first dose of Hep A (no lot number provided). At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow-up information was received from an office manager who was able to clarify that 7 month old male patient without a pertinent medical history or drug reactions or allergies on 26-NOV-2008 at 3:00 PM was vaccinated intramuscularly at right leg with his first dose of Hep A (Lot # AHAV3330AA). Suspect secondary therapy included HAVRIX. No laboratory or test diagnostics were performed. The reporter indicated that the Dr. had ordered the child receive Hep B however, due to human error the child received Hep A instead. The reporter also mentioned that the office normally orders their Hep A supply from Merck Sharp and Dohme but at one time when they were low on supply and Merck Sharp and Dohme did not have it, did order from Glaxo Smith Kline. Additional information is not expected.
Patient received 5 vaccines then felt warm according to him and fainted, got patient to sofa took vital signs 100/60, 62, 20, regained consciousness within 30 seconds. Vital signs retaken 15 minutes later 94/50, 60, 20.  Stayed in clinic 20 more minutes.  Left after oriented with mother
sore throat; itching; chills; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Cataract.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). In October 2023, PYREXIA (fever) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) to be related.    No relevant concomitant medications were reported. Patient did run a fever on day one and two. Felt so on day 3. On day 4,5 &6 patient did not had fever but chills, sore throat, headache and itching. On the day of reporting patient was feeling better. Patient was having cataract surgery on Thursday morning and do not want to cancel. Patient do not feel sick-sick which was why patient was wondering if it was the shot. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2023: Follow-up information included no new information.
HYPOTENSION 3/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
red flushed face, eyelids w/inj watering eyes bilat, occasional cough & mild distress/dizziness;full aeration bilat negative wheeze;given epi & DPH;
WARM TO TOUCH AT INJECTION SITE; LUMP AT THE INJECTION SITE; RED RAISED RASH AROUND THE INJECTION SITE THAT WAS VERY ITCHY; PAIN AT INJECTION SITE/TENDERNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obese, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at injection site/tenderness at injection site. On 04-APR-2021, the subject experienced red raised rash around the injection site that was very itchy. On 05-APR-2021, the subject experienced warm to touch at injection site. On 05-APR-2021, the subject experienced lump at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red raised rash around the injection site that was very itchy, and had not recovered from lump at the injection site, warm to touch at injection site, and pain at injection site/tenderness at injection site. This report was non-serious.
no adverse event; a patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002874, expiration date: 29-JAN-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported. This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005525: US-009507513-1909USA005468: US-009507513-1909USA005424: US-009507513-1909USA005375: US-009507513-1909USA005139: US-009507513-1909USA005134: US-009507513-1909USA005129: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005078: US-009507513-1909USA005220: US-009507513-1909USA005223:
Within hours I experienced dizziness, chills, and extreme fatigue, in addition to muscle pains. The worst has been the increasing tremors in my head and hands.  This is what I am most concerned about. I have a history of tremors, but since the vaccine, there has been a marked increase in the tremors. I did not report this right away because I thought it would go away, but now on the eve of my second shot I am very nervous that it will get even worst.  My physician encourages me to continue and get through the side effects than to get COVID with my underlying lung condition. I want to take the vaccine but am nervous that I am experience so much shakiness even a month after the first shot. Would you advise me to take the second shot? My shot is scheduled for tomorrow, February 17.
I received Moderna vaccine dose #1 on 04 May 2021, and dose #2 on 03 June 2021.  One week after dose #2, right foot got inflamed with red welts, did not seek care for this.  Being seen at the VA Clinic for recurrent flares of hives and swelling.  Sxms wax-wane and have affected feet, hands, areas of clothing-pressure, face, and even throat over last 6 months.  Had blood tests, food tests, and tests for hereditary angioedema and all results were normal. I was diagnosed with [chronic urticaria and angioedema.]   Sxms were controlled after taking a tapered dose of steroids and prn Benadryl, given an EpiPen, currently taking Zyrtec and doing well.
Part of lip went numb right after, started getting nauseous, threw up several times. right breast ached. Slept all day yesterday. since injection no apatite. Had night sweats.
TRANSIENT CEREBRAL ISCHEMIA 2/3/2023 TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 2/3/2023 TRANSIENT CEREBRAL ISCHEMIA
Headache, Myalgia, Arthralgia, Rash, UrticariaPruritus & Diarrhea Narrative:
patient received 0.2ml of the diluted adult covid19 pfizer vaccine instead of the pediatric vaccine.  patient didnt have any side effects from vaccination