chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent, Dose Number: 2; SOB; weakness; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 2, single (Lot number: GJ6665) at the age of 83 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "TIA" (unspecified if ongoing); "Heart Failure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Pax AFIB" (unspecified if ongoing). No known allergies. No other vaccine in four weeks. No covid prior vaccination. Was not covid tested post vaccination. Concomitant medication(s) included: COUMADIN; POTASSIUM CHLORIDE; DONEPEZIL; LEXAPRO. Vaccination history included: Covid-19 vaccine (Dose 1, Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: DYSPNOEA (medically significant) with onset 08Nov2022, outcome "recovering", described as "SOB"; ASTHENIA (medically significant) with onset 08Nov2022, outcome "recovering", described as "weakness"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Bivalent, Dose Number: 2". The patient underwent the following laboratory tests and procedures: Electrocardiogram (EKG): unknown results. Therapeutic measures were taken as a result of dyspnoea, asthenia. Events treatment included oxygen and EKG.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events dyspnoea, asthenia with the suspect product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),  cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
patient had difficulty resting at night and had trouble breathing, was feeling somewhat better the next day though patient has a history of asthma. stated if felt worse later or symptoms did not go away would follow up with md
Severe headache, seen in the ER, improved after treatment with Ibuprofen.
The bride had covid; The bride had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The bride had covid". Clinical course: There was a super spreader event at a wedding that I think had 800 people. The bride had covid and did not know.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Episodes of R thumb ecchymosis, a little tender, lasting 24-48 hours, self-resolving, and occurring monthly starting about a month after receiving the Covid booster.
Very tender right leg and unable to walk. Had Motrin and warm packed leg and was able to walk with a limp. Resolved the following day but still complaining of right leg pain. Onset at 11 PM on 8/23/08. No complaint of right leg pain on 9/2/08.
DUE TO NEEDLE MALFUNCTION, PATIENT ONLY RECEIVED A HALF DOSE (0.25ML) ADMINISTERED IN LEFT DELTOID. FORTUNATELY, DUE TO BONUS DOSES DRAWN UP FROM VIAL, PATIENT WAS ABLE TO RECEIVE THE REMAINING ONE HALF DOSE (0.25ML) ADMINISTERED IN RIGHT DELTOID IMMEDIATELY FOLLOWING MALFUNCTION.
internal burning sensation all over her body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (internal burning sensation all over her body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced BURNING SENSATION (internal burning sensation all over her body). On 19-Sep-2021, BURNING SENSATION (internal burning sensation all over her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment  medication was provided.
Noted increased weakness on R side compared to L side - appears drowsier than baseline.  HEMIPLEGIA, UNSPECIFIED AFFECTING RIGHT DOMINANT SIDE
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient described a tingling in her arms approximately 15 minutes after injection. Hives had also began forming across her chest. Benadryl was administered and patient was monitored for an additional 30 minutes. Hives began disappearing and patient stated she felt better and was ready to go home.
Rosacea flare up; Weird vomiting; Little itchy rash patch under my chin; migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Little itchy rash patch under my chin), MIGRAINE (migraine), ROSACEA (Rosacea flare up) and VOMITING (Weird vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Rosacea.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH PRURITIC (Little itchy rash patch under my chin), MIGRAINE (migraine) and VOMITING (Weird vomiting). On 14-Apr-2021, the patient experienced ROSACEA (Rosacea flare up). The patient was treated with HYDROCORTISONE (topical) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Little itchy rash patch under my chin), MIGRAINE (migraine), ROSACEA (Rosacea flare up) and VOMITING (Weird vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  Patient took advice from her dermatologist and started a three week treatment which included a face cream and low grade antibiotic for rosacea flare up.
This report describes the occurrence of vomiting in a 66 y.o. female who was vax'd w/Hep A vax for prophylaxis. This report was received from a subject and has not been verified by an MD or health care prof'l. Reportedly, the subject was in "good health" and received no concomitant medications. She stated that she experienced no adverse events following previous immunizations. She reported that on 8/19/02, she received her 2nd injection of Hep A vax. 5 days later, on 8/24/02, her skin felt "different", she had an "odd feeling in head", and she felt cold, but her skin was warm to the touch (her oral temp was reportedly 97 deg F; her rectal temp was reportedly 98.2 deg F). She reported that additionally she experienced tingling, "no appetite", stiffness, backache, increased pulse (reportedly 89 beats / min), eye pain, nausea, and vomiting. She stated that she was seen in the ER and was sent home "because nothing was wrong w/her." As of 9/6/02, the events reportedly persisted.
2 days post vaccination patient developed hives--parent treated with Benadryl, 3 days post vaccination--patient's finger began swelling, worsening symptoms over following 4 days included increased difficulty walking (started with a limp), diarrhea, extreme pain with inability to walk Patient went to ER--admitted and given IV Toradol
Initial unsolicited report received from Physician on 04-Jan-2018. This case involves a patient of unknown age and gender, who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as one year ago). Patient medical history and concomitant medications were not reported. On unknown date, following the vaccination the patient experienced hives and shortness of breath. Lab data and corrective treatment were not reported. On an unknown date, patient recovered from both events. List of documents held by sender: none.
Superficial thrombosis of calf vein - symptoms began 9 days after vaccination, diagnosed 14 days after vaccination.
About an hour after the vaccine I had a pounding headache.  The next morning (12 hours later) I had nausea, chills, sweats, body aches, pounding headache that lasted for another 10 hours. 48 hours after the vaccine my neck was extremely tight and sore, tender to the touch.  I have limited mobility in my neck.
pt recv vax & 15OCT97 pt devel a knot @ the site of inj;@ time of report, it was noted that knot is still there, if presses on it;the area that cont to be tender was the size of a half dollar;knot felt like muscle just stayed swollen;
After approx 30 min pt Began getting flushed face and neck. Proceeded to ER began getting swollen esophagus.  Treated with diphenhydramine and released.
Headache, Sedation, Arthralgia, Diarrhea, Diarrhea & NauseaVomiting Narrative:
So it started with a cough on that Sunday and then the following day I woke up cold and dizzy and I had a fever 100.3F I developed Monday excruciating headache and it was difficult to see. The fever and headache lasted for about 2 days and I developed a cough again and it lasted a couple of days. Fatigue lasted for about 12-14 days. I was tested for COVID on Monday 12/28 and results came back positive on 12/29
Pt was given 0.3ml of UNDILUTED purple top Pfizer vaccine earlier this morning as a booster. She got Jansen 6/9/21 for initial vaccine. No symptoms at this time.  We are trying to contact her to come in for evaluation.
Pt received his 2nd Pfizer vaccination too early.   No known adverse reactions.  1st Pfizer vaccine: 04/09/2021 2nd Pfizer vaccine: 04/24/2021
Noticed on Nov. 1, 2015 red, rash left arm w/no itch. A little tender w/touch.
Received 15mo vaccines on 9/16. Mom called our office 9/17/16 patient cranky, eyes swollen, clear nasal drainage, no cough. Mom reported same symptoms occurred last time vaccines given. Mom did not call at that time. All symptoms improved on 9/18-9/19.
kind of confused with this shingles my brain is not acting right; kind of confused with this shingles my brain is not acting right; Shingles; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date on Mar2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient initially reported rash, swollen lymph nodes, and asthma on 25Mar2021 . Patient reported that it was getting painful and he/she went to the doctor. Patient was then diagnosed with shingles on 26Mar2021 as confirmed by his/her doctor (reported as developed 36 hours after the shot). Patient also reported on an unspecified date that he/she was kind of confused with this shingles, his/her brain was not acting right. Patient went to the doctor as a result of shingles. The outcome of all events reported was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever, 101 degrees; head congested; headache; body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the right arm, on 09Mar2021 at 11:00 (at the age of 50 years old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. The patient had no known allergies. The patient's concomitant medications were not reported. On 09Mar2021, 10:00 PM, the patient experienced fever, 101 degrees, head congested, headache, and body aches. The patient reported that the events lasted for about 5 hours then he felt fine and they started 10 hours after he received the shot. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 09Mar2021. No treatment was received for the events. The outcome for the events was recovered on 10Mar2021, at 03:00.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Severe myalgia, chills x24hr.  Moderate Myalgia  at 48hr.  Minor myalgia at 72hr. Ibuprofen, acetaminophen
Information has been received from a 72 year old male patient with allergic to sulfa drugs and an unspecified beta blocker and no other medical history who on 10-NOV-2008 was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included FROTONIX, and AVAPRO.  On 11-NOV-2008, at 03:00, the patient experienced stomach pains and gas, he also noted that his face "was warm and red" but he confirmed that it was not a rash.  The patient also developed high blood pressure, trouble sleeping and his left arm occasionally twitches.  No lab diagnostics studies were performed.  Therapy with ZOSTER (Oka/Merck) was discontinued.  Subsequently the patient recovered from stomach pains and stomach gas after stopping therapy, but he was still experiencing the other symptoms to a lesser degree.  The patient did not seek medical attention.  The patient also reported that he experienced stomach pains, gas and high blood pressure after receiving an unspecified corticosteroid (manufacturer unknown).  No further information is available.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 12-NOV-2014 the patient was inadvertently vaccinated with a dose of expired VARIVAX (Merck), expiration date 09-OCT-2014( dose, site and route of administration, lot# not reported). No adverse effects were reported. Additional information has been requested.
Tremors, muscle pain and weakness, fuzzy brain, forgetful (more so than usual), some slurred speech or slowed speech, severe fatigue, possible abdomen and chest pain.. Currently in the process of seeing a primary care physician, Neurologist, Gastrointerologist, and nuero at hospital.
Patient received Jassen vaccine @ 1:49pm, while in the recovery area, @ 2:00pm c/o feeling lightheaded, no other symptoms. VSS taken promptly by recovery RN: 112/80, 97,18, Sats 97.1 on RA, neuro status wnl, skin wnl, general assessment stable, client stated did not eat lunch prior to vaccine, nothing to eat or drink since early am. Provided w/oral hydration, monitored, Vitals rechecked 2:06 pm: 112/81, 86,18 Sats 96.1 on RA, monitored for additional 15 minutes, symptoms resolved, denied any further c/o anykind, dc from recovery area @ 2:20 PM stable.
Arm has been very sore now for 2 days, day after vaccine I was very ?out of it?, almost disoriented. My blood pressure spiked as did my heart rate the morning following, although those have now returned to normal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 at 12:00 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 at 12:00 as dose 2, single (Lot number: ER2613), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 3014SBA), in left arm and on 05May2022 at 12:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BRCA-1" (unspecified if ongoing), notes: BRCA-1; "MAC lung disease" (unspecified if ongoing), notes: MAC lung disease. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2022) Positive; (10Oct2022) Negative; (12Oct2022) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and the patient got Paxlovid treatment initiated on 02Oct and finished last doses on 06Oct.  Clinical Course: The patient had no known allergies. It was reported that the patient received vaccine.   No follow-up attempts are possible. No further information is expected.
Patients consent form list age as 12 but patient was only 11-  date of birth listed correct  Patients should not have received dose   until 9-6-2021
The evening after PNEUMOVAX vaccination her shot area down to swelled up. More notable the next morning Thursday. Called her Friday afternoon to check how she was doing.
Approx 7.5 h after injection - redness, heat swelling pain at injection site. Approx 24h after initial injection pain, swelling from shoulder to elbow, redness, very hot, no temperature ROM, myalgia especially in legs and pain in all joints. Spiked 102 temps for 2 days. Took 50 mg Benadryl every 6 h for 2 days and 650mg Tylenol every 4 h for pain & fever for 2 days. Today - and 650mg Tylenol every 4 h for pain & fever for 2 days. Today - 10 days later - 9 1/2 dollar size lump at injection site & pain. Full ROM back. (2 wks later there is still a quarter size lump at the injection site) 10-18-09.
Chills. Aches. Fever. Vomiting. Nausea. Weakness.
Tightness in neck muscles. Then lips swelled. Then inside of nostrils swelled. All fairly slightly.  Was all over by 3:15pm same day
I tested positive for COVID-19. My fever got up to 101-degrees and lasted two days. The cough started on the second day. It lasted two weeks. I quarantined for five days and wore a mask everywhere. I didn?t receive treatment. I let it run its course.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (lot # L033707 with expiration date 18-MAY-2017 and lot # L014876 with expiration date 13-JAN-2017; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD , VARIVAX (Merck), but none of these vaccines have been administered to the patients. This is one of several reports received from the same reporter. Additional information has been requested.
Roughly 8 hours later after recieveing the flu vac. Patient stated that he was ill.  Nausea, vomiting, shaking, fever.
I experienced a sudden onset of symptoms approximately 7 hours post-vaccination. Symptoms started with severe chills, elevated heart rate, fever (~102), and progressed into muscle and joint soreness, severe migraine with sensitivity to light, and strong fatigue, coupled with insomnia. The symptoms were severe enough that I considered going to the hospital, but ultimately did not. Fever, chills, and elevated heart rate subsided by the next morning (~12 hours after onset), but muscle soreness, migraine, and fatigue lasted for another 12-24 hours, along with a loss of appetite.  I am an otherwise healthy, male adult with no outstanding medical conditions whatsoever. This was one of the most severe immune responses I have ever had, including actual illnesses. I have received other vaccinations in the past and never had any response nearly as severe. I was significantly concerned for my overall health during the height of the vaccine response, and I wanted to report this to ensure that is aware of these types of responses, and can help prepare others by informing them adequately of the types of responses to expect from the vaccine. This response very much took me by surprise in terms of severity -- I had to call out of work at a critical time.
20 minutes after vaccine c/o dizziness, "fuzziness", started crying. Become diaphoretic, flushed, described hotness and weakness. Became nauseous as time advanced.  0915-188/92, 92 0917-20ml/50mg Benadryl liquid oral 0927-190/100, 90 0934-190/118, 92, feet raised 0935-Epi Adult Pen, R thigh (KN) 0939 20ml/50mg Benadryl liquid oral 0941-188/90, 88 0942-Epi Adult Pen, L thigh 0947-194/104, 104, R32 0952-178/105, 80, R28 0953-EMS Arrival, pt taken to ED
covid vaccine breakthrough case  dose 1 Pfizer 1/13/21  EL1283 dose 2 Pfizer 2/3/21  EM9810 dose 3 Pfizer 9/25/21  FF2587
FLUVIRIN PFS administered 10/13/16-pt experienced post vaccine site pain for 1-2 days after: 10/25/16. Pt calls the Pharmacy saying she woke up with arm pain and bruising. She reported no other symptoms. Time between vaccine related arm pain and 10/25 report of pain she was fine with no arm pain. No other reports from pt. since 11/3/16. Per pt.
positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3182), on 17Aug2021 (at the age of 45-years-old) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a concern about getting the 2nd dose of BNT162b2 vaccine. She got the 1st dose on 17Aug2021 and then she tested positive for COVID on 18Aug2021 and did not know if she already had COVID by the time she got the 1st dose, so she got the results of the positive test for COVID on 18Aug2021; stated she missed the 2nd dose of the vaccine, that was scheduled for 07Sep2021, because of this and testing positive. Patient did not have smell, but she could taste; the doctor said it could take months to get rid of that. She would like to know when she could get the vaccine. Patient was getting conflicting information from her primary care doctor and another doctor and asked the pharmacist when she came in to get the 2nd dose and they said to call the company to get recommendations. Patient stated she just needed to know this information and was frustrated from being transferred around and declined to complete report. The outcome of the event was unknown.   Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
5 minutes after receiving the vaccine, I had a severe flushing throughout my body and my throat began to swell.  My blood pressure spiked and I got nauseous and felt like I was going to pass out.  I immediately took 2 benedryl tablets and went to the ER to get Prednisone.  It lasted throughout the night and seemed to be better in the morning.  However, I continued to have allergic reactions daily, for the next 3 weeks.    I believe I then caught Covid 19 from the ER.  I got monoclonal antibodies treatment and my case of Covid did not require hospitalization.   I now have Long Covid, and have for the last 5 months.  I have not developed MCAS