chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; dose #1, #2, #3: Pfizer / BioNTech/dose #4, #5: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Lot number: Cus397s) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: El9264), on 28Feb2021 as dose 2, single (Lot number: En602), in right arm and on 24Dec2021 as dose 3 (booster), single (Lot number: Fj8757), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jun2022 as dose 4 (booster), single (Lot number: Cj6ma1a) and on 07Sep2022 as dose 5 (booster), single (Lot number: As7143C), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: REPATHA, start date: 01Jan2020, stop date: 25Aug2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jun2022, outcome "unknown", described as "dose #1, #2, #3: Pfizer / BioNTech/dose #4, #5: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive.  Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19 from 26Aug2023 to 30Aug2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292506 same patient, different drug/event;
Constant vomiting after feeding or even when she is not feeding. Vomiting hours after eating.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium
71 year old female complained of weakness. Onsite EMS responded, vital BP 170/68 100% O2 BG 94 HR 81 she was transported to local hospital by EMS
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-367500 (Patient Link).
fatigue, extreme exhaustion, hot and cold flashes, shortness of breath, any time I do anything I tire out real easily.
Left side - Stiff/sore neck developed ~6-7 days after injection, painful rash on left side of neck developed 9 days after injection and continued to worsen. Doctor confirmed it is Shingles 12 days after injection
This infant screamed in pain for five hours after receiving her vaccine. She had to be held all day, and wouldn't nurse. We went to the ER and were told the reaction was likely from the Pneumococcal vaccine. Symptoms went away in time.
approx 30-45" p/inject, passed out 2x's; no forewarning;
PATIENT REPORTS DEVELOPING ITCHING AND BEGAN SCRATCHING AND HIVES BEGAN TO FORM.  PATIENT REPORTS TAKING BENADRYL ONE TIME BUT IT MADER HER TOO DROWSY.  PT REPORTS STILL HAVING SOME HIVE ON THE ABDOMEN STILL PRESENT BUT "BETTER."
Pain at site of injection, still present after 8 days of vaccine administration. No doctor's vist required so far, only Motrin 1-2x/day.
Headache ~ 14hours - 2Tylonal, Body aches ~ 12 hours, Exhaustion ~ 20 hours, itching/redness at injection site, skin sensitivity ~ 2 hours
Day 1: aches, slight fever, slight headache. Day 2: severe shaking over entire body 1-2 hrs. mid-morning.
On 29NOV92, @ 2mos old, pt recvd DTP/OPV/HIB ped vax & a few hrs later, began crying constantly & inconsolably for 5 to 6 hrs On 7FEB92, p/DTP/HIB/OPV #2 had same sx;
5 days after vaccination patient admitted to hospital with acute ischemic stroke. she was "dragging" her left leg
11/29 Red rash. 11/30 Horizontal linear rash lines (no fever) skin firmness (saw Rph). 12/1 Skin pain/increased hardening of linear rash. 12/2 spoke to staff-skin swollen/firm-housed to seek medical help-no fever. 12/3 Will wait to see MD-seems better/improving.
Redness, bruising, soreness, fever x 2 days, still lump redness spread and receded. Still present on 12/21/14. Tried ice packs and BENADRYL.
Patient presented to the vaccination site on 11/04/2021. The client reports that she received a single dose of CanSino COVID vaccine on 05/01/2021. RN submitted a medical consult via text message to Vaccine Operations, requesting to proceed with the Janssen COVID vaccine. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team from  Vaccine Operations Lead. Client received COVID vaccine (Janssen, Lot# 1855194) on 11/04/2021. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 12:15pm, walking with steady gait.
pt devel a 0.5cm nodule @ the inj site a few days p/vax;
Left thigh (Varciella)-hard, red spot, pain-feel when touched. Right thigh (MMR)- rash from groin to ankle. Mom administered BENADRYL about 30 minutes after admin. Phone cal to mom at 4pm pt doing good.
Information has been received from a pharmacist concerning a female consumer who was vaccinated with a dose of rubella virus vaccine live for a total of 3 doses, over a period of years with each dose given after delivery of a child. Subsequently, a titer is negative for seroconversion with equivocal results. The outcome of the seroconversion test negative was unknown. Unspecified medical attention was sought. Additional information has been requested. Follow up 03/03/05: Patient date of birth, Patient age at time of vaccination, adverse event onset information, lot number for vaccine number 1 and date/time of vaccine adminstration not provided.
Parent states patient felt fine after receiving the vaccine, was kept 15m after vaccination. She complained only of discomfort at the site rest of the day. At 3 pm began to "feel off" went to volleyball practice, used inhaler just before running laps. While running she experienced tightness in her chest, tingling in her arms and legs.
Pt recvd vax & devel red spots @ inject site which have persisted for 2 months;
She got her vaccine, her arm hurt, swollen.  She seemed to be fine all day except close to bedtime, around 10:30/11:00 she started getting body aches, her neck hurt, her head hurt and every muscle in her body hurt.  She tried putting a cold pack on her neck and did not sleep at all that night.  It took her a couple of days to recuperate.  Then finally the symptoms went away.   She used cold packs and Tylenol, just couldn't sleep.  Since the symptoms have gone she is able to sleep better.
Pt explained that she felt flush, and had rapid heartbeat after receiving injection. Recovered soon after
Did not reconstitute Saline with HIB component, patient just received Saline.  Called mom and informed, Dr. informed, supervisors informed.  No adverse effect.
"The RPh that administered the vaccine accidently left the shot in my arm for a short period of time when pulling it out lost grip and I believe I got surprised and flinched at the sight of the accident"  "By day 3 arm very sore and had little to no range of motion. By day 15 I went to see my doctor who believes I got nerve damage and she referred me to get an MRI.
Tremor in left hand which is less often now but has not disappeared. Sciatic pain which has disappeared.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jun2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (16Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. 3 days after completing the 5 day Paxlovid treatment, the patient had tested positive for covid-19 again. Her symptoms returned for another 5 days. These symptoms included fever, sorethroat, coughing, and congestion and sneezing.
Bright red, warm to touch, extremely itchy and raised at injection site. Was approximately the size of a golf ball has been going on for 4 days and still present. Has been taking an allergy pill daily since 9/22/22 to reduce swelling and itching.
tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient and her husband received their first Pfizer Covid vaccine dose on 06Mar2021. On 09Mar2021 they both tested positive for Covid-19. She stated they were both negative now. She stated that her husband had to be hospitalized and an infectious disease. They had both tested negative since then. MD told her that they should wait 90 days and try to start over again with another series of Covid vaccines. She wanted further guidance for her situation. They were scheduled for the second one and she was asking if they should still get the second covax. The HCP from the hospital told vaccine was breached. Caller enquired, if we waited 90 days after the first dose, should we start over with a whole new series of vaccines. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
vaccines given post excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who experienced vaccines given post excursion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].     The patient's past medical history, medical treatment(s),  and family history were not provided.  Concomitant medications included hepatitis a vaccine (Hepatitis A); measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (Varicella vaccine) for Immunisation.  On 04-May-2022, the patient received a dose 0.5 ml once of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine suspension for injection Strength: standard lot UJ613AAA via intramuscular route in the right thigh for Immunisation.  On 04-MAY-2022 the patient was given vaccines post excursion with no reported adverse event (product storage error) Latency: same day.   Action taken was not applicable.  Outcome was Unknown.   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 the guidelines. 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.
efficacy data on second SHINGRIX shot being given at 30 days instead of 60 days; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: efficacy data on second SHINGRIX shot being given at 30 days instead of 60 days).The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The Medical Information Department received the following inquiry throughout channel that healthcare professional requesting safety and efficacy data on second Shingrix shot being given at 30 days instead of 60 days. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Initial and follow up information has been received from a physician concerning a 77 year old white male with no pertinent medical history, drug reactions or allergies who on 31-JUL-2007, at 13:30, was vaccinated intramuscularly into the right arm with a first dose, 0.65 ml, of Zostavax (Oka/Merck) (Lot #656858/0356U).  Concomitant therapy included oxaprozin (Daypro), metoprolol succinate (Toprol XL tablets), simvastatin (MSD), famotidine (MSD) and amitriptyline hydrochloride (MSD).  Approximately two days after receiving "the shot", 01 AUG 2007, at 9:30, the patient developed a rash, four or five itchy pimples and three pea size pimples on his back, leg and armpit.  Medical attention was not sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  There was no illness at the time of vaccination.  At the time of reporting it was unknown if the patient had recovered from the reported events.  Additional information is not expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a physician's office manager refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # J004747, 20-JUL-2014) intramuscularly. On an unknown date, the patient was hospitalized for a severe case of cellulitis in an unspecified hospital for an unspecified length of time shortly after receiving PNEUMOVAX23. A lot check was being requested for this vaccine. Patient sought medical attention. Patient received an unspecified treatment for the event. The outcome of cellulitis was unknown. Another anonymous patient who was already reported for having the same adverse experience (see related case) after received PNEUMOVAX 23 that was in the same lot number. The office manager was extremely concerned about this lot# and would like to be contacted for follow up and with lot # check results as soon as possible. It was reported that the office manager previously requested a lot check for the initial patient, but the request seemed like it was not taken seriously. She feels that when she called the first time, the request was pushed aside and not taken seriously. This is 1 of 2 reports reported by the same reporter. Additional information has been requested.
Seizure involving left side approximately 2 hours after receiving immunizations lasting about a minute. 3 days later another seizure involving all extremities, vomiting, and blank stare lasting about 90 seconds. His body was extremely hot when this was happening. Had another one involving one side of body and blank stare with rhythmic blinking of eyes 3 days later.
Case number PHEH2013US016542, is an initial spontaneous report received from a health care professional on 01 Aug 2013. This case refers to a 59 years old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: not reported), intramuscularly on 03 Jul 2013. No adverse event was reported following this administration error.
Stopped speaking, stopped standing, regressed in walking, mood changed to constantly unhappy and upset, always crying or grumpy.
After first shot: painful tops of ears. After 2nd shot: I have had extreme changes in joint/connective tissues, specifically pain in sciatica, TMJ and cartilage on top of my ears within a few days of the vaccine.    TMJ included ear pain and I did compresses and isometric stretches to relax the area.  Sciatica has not been a problem for some time and I do not think it was disease-caused. Had two chiropractic adjustments, KT tape of area, Lidocaine patches; PT stretches.  I believe some inflammation resulted.  It is slowly getting better at 11 days after shot.  No chills or other effects listed as side effects.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: The patient stated that he felt lightheaded and then fainted. He stated that he had not eaten much all day. He drank orange juice and sat for a while and felt better.
About 11 pm my armpit became sore and grew increasingly so until to move it was painful.  Upon inspection the following morning there was a nickel-sized black and blue mark and some yellow discoloration beneath that of an area about four inches by 5 inches to the side of the breast. The black and blue marks continued to appear over the next several days. The pain lasted for three days before subsiding enough so that it was not painful to move. My GP was consulted on day 5 and confirmed the lymph nodes were swollen and painful upon applying pressure.
diagnosed with Afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with Afib) 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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (diagnosed with Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (diagnosed with Afib) outcome was unknown.            Patient diagnostic data included echocardiogram, ultrasound with unknown results. No relevant concomitant medications were reported. Treatment information included blood thinners & meds to slow his heart down.  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date, while the second dose of the Moderna Covid-19 vaccine was received in March 2021. The rechallenge is not applicable since no information was provided of the other dose. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-028042 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date, while the second dose of the Moderna Covid-19 vaccine was received in March 2021. The rechallenge is not applicable since no information was provided of the other dose. The benefit-risk relationship of the vaccine is not affected by this report
inflamed a little bit in the areas to the interior of my knee toward her upper leg; very painful to stand on or walk on; Very painful to stand on or walk on; left knee had some pain and like a swelling; left knee had some pain and like a swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included blood cholesterol (abnormal) and psoriasis. Concomitant medications included ixekizumab (TALTZ) for psoriasis and statins for cholesterol. The patient took injection on Thursday (21Jan2021) morning. Yesterday (22Jan2021) the patient began to get, her left knee had some pain and like a swelling. The patient didn't know if that's related to the injection. It was not her right knee also, it was only her left knee and it looked like it's inflamed a little bit in the areas to the interior of my knee toward her upper leg. It was very painful to stand on or walk on. The patient did not have any pain at the injection site. She did not have any fever that she was aware of, she had no nausea, she was not dizzy. The patient wanted to know if the reaction that she had in her left knees was possibly connected to the injection. The patient put some ice on it and had no other treatment. Outcome of all events was unknown.   Information on the batch/lot number has been requested.
Swelling pain redness at the injection site L arm c/o feverish and chills.
COVID 19 Treatment; COVID-19/Tested positive on 6/24/22; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL3246) at the age of 66 years, in left arm, on 27Jan2021 as dose 2, single (Lot number: EL8982), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperparathyroidism" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL; ATORVASTATIN; COQ10; ASPRIN. Other medication in 2 weeks included Vitamin B complex with zinc and vitamin C. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Jun2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset 24Jun2022, outcome "unknown", described as "COVID-19/Tested positive on 6/24/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (03Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.