chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his wife who on 16-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient's diagnosis was confirmed by a physician and the patient was treated with anti-viral medication. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Hives that lasted for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the left arm on 16Feb2021 at 09:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation followed by second dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE (lot number: EM9810) via unspecified route of administration on 17Mar2021, as single dose for COVID-19 immunisation. Medical history included high blood pressure, swelling in my legs, allergies, mild asthma, currently having issues with low potassium and sodium. The patient had known allergies to shellfish, codeine, and carmine. The patient received unspecified medication in two weeks of vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021 at 15:00, the patient experienced I got hives that lasted for 4 days (evenings and overnights mostly) 1 week and 2 days after the first dose. Therapeutic measure was taken as result of event and included treatment with benedryl. Event didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for event hives was recovered (lasted for 4 days) on an unknown date at the time of the report.   No follow-up attempts are needed. No further information is expected.
The pt's mother reports on 04/25/2002 that the baby had stiff joints primarily on the left side. Also states that the pt could not stand or crawl for periods of time and then he would be fine. This ocurred after child sat for a period of time (15-20 mins). On 04/26/2002 the mother took him to a physician who stated that the stiffness shouldn't last more than three days. Advised to give Motrin. On 04/30/2002, stiffness had moved from left side to the right side occurring after sitting. More than 15-20 rash on one side of buttocks. She also found a scratch and the child appears to be very sore around that area. The symptoms still continues.
Dizziness, lightheaded and fainting spell in the evening. Extreme fatigue for the next 2 following days. Treatment: rest.
10 days later severe abdominal pain, later shortness of breath, then pulmonary embolisms were found
patient developed symptoms of COVID on 4/15/21 and tested positive for COVID on 4/16/21.
HUSBAND REPORTED THAT PATIENT FELT DIZINESS AND VERTIGO RIGHT AFTER VACCINATION, LASTING FOR OVER A WEEK. HE DID REPORT THAT IT IS GETTING BETTER. PATIENT ALSO REPORTS HIVES WITH ONSET A WEEK AFTER VACCINATION. HIVES ARE DESCRIBED TO BE SMALL, INDIVDUAL DOTS LOCATED ON THE BACK AND ON ARMS. PATIENT OOK ALLEGRA AND TYLENOL PM (CONTAINING DIPHENHYDRAMINE) WITH SOME RELIEF.
Received ADACEL 12 hours later c/o flu-like sx - chills - then hot.
Shoulder has certainly been inflamed; It turned to right arm; General flu-like symptoms; In left shoulder had severe pain; Bursitis kind of pain; It was on the shoulder capsule, and would radiate down towards the elbow; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm), PAIN (It was on the shoulder capsule, and would radiate down towards the elbow), INFLUENZA LIKE ILLNESS (General flu-like symptoms) and PAIN (In left shoulder had severe pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (General flu-like symptoms). On an unknown date, the patient experienced INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm), PAIN (It was on the shoulder capsule, and would radiate down towards the elbow) and BURSITIS (Bursitis kind of pain). an unknown date, the patient experienced PAIN (In left shoulder had severe pain). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Shoulder has certainly been inflamed), PAIN IN EXTREMITY (It turned to right arm) and INFLUENZA LIKE ILLNESS (General flu-like symptoms) outcome was unknown and PAIN (It was on the shoulder capsule, and would radiate down towards the elbow), PAIN (In left shoulder had severe pain) and BURSITIS (Bursitis kind of pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-066923, MOD-2021-064167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24 May 2021. it doesnot contain any new information.
Headache; Injection site pain; Red rash under arm; Injection site swelling; Fatigue; Muscle pain; Joint pain; Chills; Nausea; Fever; A spontaneous report was received from a consumer concerning a 66-year old female patient who developed headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of the two planned doses of mRNA-1273 (Batch number: 010M20A) on 16 Feb 2021 for prophylaxis of COVID-19 infection.  Reporter got the vaccine on 16 Feb 2021 and that afternoon headaches started. She mentions she has all the listed side effects and the injection site swelling, pain, redness and inside the arm is the rash. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event(s) headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever, was unknown.
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 11-MAY-2016, the patient was administered an expired dose of RECOMBIVAX HB (Batch/lot# reported as L022261 with expire date of 01-APR-2016, dose not provided) intramuscularly. This dose of RECOMBIVAX HB was administered because when the patient was administered the original three-dose series of RECOMBIVAX HB (vaccination dates, dose, route, lot# and expiration dates were not provided) as an infant over 10 years ago, the third dose was administered before the patient was six months of age (inappropriate schedule of drug administration). This was outside the labeled recommendations in the RECOMBIVAX HB prescribing information. No adverse effect was reported. Additional information has been requested.
Case number PHEH2016US029776 is an initial spontaneous report received from consumer on 09 Nov 2016. This report refers to 58 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. On the same day, at the time of injection the patient experienced pain in left arm from injection site all the way to the middle finger. The patient still had extreme pain in her left shoulder and elbow. The patient also felt like her left hand was asleep. The patient went to doctor and was prescribed with prednisone which helped for a while but pain and tingling sensation was back. The outcome of the events was reported as vaccination site pain, shoulder pain, tingling sensation, pain in elbow was condition unchanged, and numbness was reported as unknown. The final outcome of the events paraesthesia and arthralgia was condition unchanged. The seriousness and causality of the events was not reported.
Vaccine given 8/4/03. On 8/14/03 developed vesicular rash which looked like mild case of varicella. On 8/13/03 child felt "warm" to touch.
18 years old patient received an adult dose of VAQTA; NO ADVERSE EFFECT; This spontaneous report was received from a healthcare professional (Medical assistant) refers to an 18-year-old patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) vial 50 (unit unspecified) via intramuscular route for prophylaxis. (lot # S001832, expiry date: 12-MAY-2020).        On an unknown date, the 18-year-old patient received an adult dose of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered) and no adverse effect reported.  No PQC involved. The outcome of incorrect dose administered and no adverse event was unknown. Reporter's causality was not provided.
Dark red to purple spots under the skin on the forearms. Started on right  with a few then  spread, then occurred on left forearm.  A few appeared on left leg.   I still have these on my arms but some are fading.  Two blood blisters on the inside left cheek, disappeared within 2 days.
2mins post vaccination pt had a syncopal event w/ associated flushing/sweating and blurred vision Vitals: 12:38 103/49, 72, 18, 100% -- > 12:43 95/56; 106/72 (standing) Pt stable and released from the vaccination site.
This spontaneous report was received from a physician and refers to a currently 80 year old patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient was vaccinated with doses of PNEUMOVAX 23 (exact dose, route of administration, lot # and expiration date were not reported). It was reported that the patient was receiving PNEUMVOAX 23 every 5 years (it was unspecified when or at what age the patient started receiving the vaccine). No adverse effects were reported. Additional information is not expected as the physician did not wish to be contacted.
Received first dose of Pfizer on 4/5/21 (lot # ER8729) - left arm.  On 4/7/21 patient present to urgent care complaint with lower back pain.  Patient has medical history of anxiety, depression, hyperlipidemia, migraines, and right-sided sciatica presents to urgent care today with onset this morning of lower back pain, bilateral.  She is having no urinary symptoms, or fevers, and she has no weakness or numbness in her extremities.  Her range of motion is limited significantly due to pain.
PT WAS ADMINISTERED MODERNA VACCINE AT HD ON 12/23 AROUND 1540. PT HAS EXTENSIVE HISTORY OF  ALLERGIC REACTIONS (HEP A VACCINE AND TREE NUTS). PT ALSO COVID + ON 12/8/20 .  HX REVIEWED WITH HD RN  PRIOR TO ADMINISTERING. PT WAS ADVISED TO WAIT 30 MIN IN WAITING ROOM. EMS STAFF ON SITE FOR CLINIC.  PT STARTED COMPLAINING OF "ITCHY MOUTH" AROUND 1620 AT WHICH POINT EMS ATTEMPTED TO ESCORT PT TO PERSONAL VEHICLE TO DRIVE HER TO LOCAL ED. PT MADE IT TO THE THE VEHICLE BUT DEVELOPED INCREASED RESPIRATORY DISTRESS AND AIRWAY RESTRICTION. AMBULANCE WAS CALLED. EMS ADMISNTERED .3ML EPI AT 1631 AND APPLIED 8L O2 VIA MASK. ABUMBULACE ARRIVED AT 1636. PT TAKEN TO LOCAL ED VIA AMBULANCE
Incident occurred at Health Department mobile clinic hosted by County Public Health at County Fairgrounds. The clinic was staffed by Health Department staff, County Public Health volunteers, County Fire Department Paramedics and contract temp staff. Client received his first dose of Pfizer vaccine (lot #: EP6955 exp: 6/30/21) and was advised to wait in the waiting area for 15 minutes for recovery. During the recovery period, about 10 minutes post-vaccine, client was seated and reported to the monitoring paramedic that he felt "dizzy and might faint" and moved onto his knees. The paramedic immediately attended to the client and caught him as he fainted. The paramedic slowly brought the client to the ground in a supine position. A second parmedic called for an ambulance and Health Department RN also responded at 4:45pm. The client immediately regained consciousness. The client was alert and oriented. The client reported that he has never before fainted or had problems with vaccine administration. The client was returned to a seated position and provided juice and water.  EMS arrived with ambulance at 4:55pm, they conducted their assessment and were concerned about 'abnormal heart rhythms' found via EKG. Client reported no cardiac hx. They offered to transport the client to Hospital for further evaluation. The client accepted the transport. The client left County Fairgrounds via ambulance at 5:16pm.
sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 20-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number-Unknown),via an unspecified route of administration, administered in arm left on12Jan2021 19:30 (age at vaccination 20 years) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date in 2021. The outcome of event was recovered on an unspecified date in 2021.  Information about lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
experiencing intoxicated; I couldn''t drive; I feel like I went to a bar and had too much to drink like I am tripping; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2; Pfizer product), administration date 13Dec2021 (Lot number: 330308D) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 12Sep1984 (ongoing), notes: Verbatim: Blood pressure high; "Hypothyroidism", start date: 12Sep1984 (ongoing), notes: Verbatim: Hypothyroidism.  Consumer stated, "So I have hypothyroidism and I have High blood pressure. They are both primitive. I don't know if that matter some people give it to themselves some people born with it. I was born with it." The patient's concomitant medications were not reported. The following information was reported: POISONING (medically significant) with onset 13Dec2021, outcome "unknown", described as "experiencing intoxicated"; IMPAIRED DRIVING ABILITY (non-serious) with onset 13Dec2021, outcome "unknown", described as "I couldn''t drive"; FEELING DRUNK (non-serious) with onset 13Dec2021, outcome "unknown", described as "I feel like I went to a bar and had too much to drink like I am tripping". Therapeutic measures were not taken as a result of poisoning, impaired driving ability, feeling drunk. Consumer stated, "I am not sure if this is the correct number but I was calling to report strange side effects on the Pfizer vaccine the first dose. I don't know how to explain this. I feel drunk. I don't feel dizzy or injection site pain anything I feel 'frat'(not clear) boy drunk like I couldn't drive like when I open like I drink way too much kind of drunk, its very odd and I couldn't find anywhere. If I say I am experiencing intoxicated." Date of vaccination: Consumer stated, "Like 2 hours ago the 13Dec. I feel literally perfectly fine and drunk. I am perfectly fine otherwise I have no pain no swelling no coughing no sneezing nothing it just feel like I drink a whole bottle of wine by myself.  That's weird I couldn't find it anywhere I called my mom, my sister didn't feel it nobody its me. I looked it up online I didn't see it anywhere. I don't think it's normal. I never had surgery you know when you wake up after surgery and you are still under effect of anesthesia and you feel extremely like you feel euphoric and giddy and stuff (Not clarified further). I really I know its super weird I feel like I went to a bar and had too much to drink like I am tripping and I don't feel dizzy I feel okay that's why it's so strange that is the only reason I bothered you guys but its so odd I 'swirl' (not clear) like for about an hour." Consumer further stated, "I am sure you can not find it. Is that serious? I was just wandering if it had been like reported but I didn't find it anywhere and it is such a odd thing." Treatment: Consumer stated, "No the drinking water." Medical test (with a week): Consumer stated, "No."  No follow-up attempts are possible. No further information is expected.
Sore arm first two days that radiated into my left shoulder and neck with tingling in my fingers at times.  Since April the tingling has increased noticing muscle weakness in hand where I would drop things.  Since September this has increased to a tremor when I reach for things or try to grip things.  Also having trouble typing on the computer.
1st dose in 2018, no second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. No further details were provided. The consent to follow up was denied.
The husband came to pharmacy to receive his COVID vaccine and informed us of his wife experiencing a possible adverse reaction from her Janssen COVID shot.  He said the patient experienced fever of 101 and tingling/sharp prickling of the face the night of the vaccine and the following morning. She took an unknown fever reducer with success.  The following day her legs began looking dark and bruised and she was numb and tingling in the legs. As of today (the next day), the bruising (dark color) has reduced and she only has slight numbness and tingling in the legs. He said she had back surgery 3 weeks ago so is unsure of the cause.  We informed him that she should be taken to a doctor as soon as possible to rule out the possibility of blood clotting. He acknowledged and said they will discuss immediately when he gets home and either take her to the ER or keep a close eye on her and take her to PCP on Monday morning.
9-21-09: Pt. received MMR on 9-21-09 for college requirement. Swollen gland on (R) side of neck from about 10/3/09 to 10/10/09. Then (10/10) pt developed numbness in fingertips - lasts all day; is worse @ night - (still continuing at this time).
This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 6-month-old male patient who received ROTARIX for prophylaxis. Previously administered products included ROTARIX (1st dose received on 9th April 2018). Concomitant products included ROTARIX. On 17th August 2018, the patient received the 3rd dose of ROTARIX. In August 2018, less than a week after receiving ROTARIX, the patient experienced difficulty sleeping and emotional distress. On 17th August 2018, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the difficulty sleeping was not recovered/not resolved and the outcome of the emotional distress, extra dose administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the difficulty sleeping and emotional distress to be related to ROTARIX. Additional information was reported as follows: This case was reported by the patient's mother. On 11th June 2018, the patient received the 2nd dose of ROTARIX at a different clinic other than the 1st dose. The patient received 3rd dose of ROTARIX by mistake at a new clinic, which led to extra dose administered and inappropriate age at vaccine administration.  On the same day, the patient received 3 other vaccines, but the reporter did not have information about the vaccines, they were the standard 6 month appointment vaccines. The reporter did not know if this was due to the additional dose, but the patient had trouble sleeping and woke up every couple of hours inconsolable since vaccination with the 3rd dose.
Pt. started by stating she didn't feel any pain from the vaccinations at the time of injection but later reported some swelling, pain and discomfort. She didn't state the exact time when it started but presumable either Friday night or Saturday morning.  Symptoms as of the 23rd (when reported to pharmacy) are pain at the actual injection site (when touched), swelling, hot to the touch, and redness.  The redness has primarily dissipated from the injection site but has migrated down and around (migrated toward bicep and down to about 4in from elbow).  Pt. states the redness is dissipating slowly but still present. No breathing problems or other ADRs.  Pt. was told to take some diphenhydramine and her regular acetaminophen for pain. **NSAIDs not tolerated per pt.  Pharmacist, told pt. he would check with her Tuesday morning after starting diphenhydramine. **pt was counseled on safe usage and potential side effects of diphenhydramine tablets. Ice packs wrapped in a thin towel were also recommended to help reduce swelling and discomfort.  Lastly, pt was told to report to primacy or ED if symptoms worsen, ie breathing problems but pharmacist will check with pt. Tuesday morning.
Information has been received from an infectious disease control nurse concerning a grade school age child who was vaccinated between 1999 and 2000 with a dose of varicella virus vaccine live.  In approximately November 2005 (through December 2005), the patient developed varicella.  It was unknown if medical attention was sought.  No outcome was reported.  No product quality complaints were involved.  This is one of several reports form the same source.  It was reported that there was an outbreak of varicella in a school.  Additional information has been requested.