chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4, single (Lot number: GJ5342) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Coronary artery calcification" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2012, stop date: 26Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 26Aug2023 to 30Aug2023.
Day after injection muscle aches and mild fever. Day 2 woke with shingles rash and blisters over face.
painful, pruritic rash on back 1 wk p/2nd dose; resolved;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 4:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 4:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.11.  Concomitant medication of the patient was not reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature of 35 degrees Fahrenheit at 08:00 AM and 35 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 18-May-2021 and beyond use date for the vials was reported as 17-Jun-2021. The vaccines moved to clinic on 24-May-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
At about 23 minutes broke out in a cold sweat. At 26 minutes, became hoarse (always my first symptom of anaphylaxis). Progressed to coughing and feeling a lump in my throat and then tightness in my chest. My blood pressure elevated to 152/100. At that point I self administered epi pen and paramedics called 911. This provided relief but after about 5 to 10 minutes the tightness in my chest and the feeling I couldn?t get a deep breath began to return and the paramedics administered two puffs of an albuteral inhaler and transported me to the hospital. At the ER, they did an EKG, started an IV and administered fluids, prednisone and Benadryl. I was discharged about 90 -120 minutes later with a prescription for 3 days of prednisone (50mg) and instructions to continue to take 25 mg oral Benadryl every 4 hours.  The next morning my face and chest were red and looked like I was sunburned. My face was also swollen.
Pt recv vax on 2/23/99; 20 min post vax pt exp warm/ induration/ erythema red rash at vax site-lt leg; tx=Benadryl, warm compresses
Provider ordered Pediarix, Hib, Rotarix, and Prevnar 13 on 10-29-19 at well baby. Nurse administered Pediarix, Hib, Rotarix and HPV9. On 10-29-19 at well baby exam
patient was inadvertently given a dose of expired Daptacel in the right thigh, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA, expiry date: 05-Oct-2019, via unknown route in unknown administration site on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
nausea, couldn't get out of bed, couldn't concentrated, couldn't walk, exhausted 7pm 1/6/21 til 1/8/21
I had my first shot on 03/15/2021 with the only side effect was extreme tiredness for the first 24 hours, no other side effect. I had my second shot 0n 04/05/2021 with no reaction for the first 6 days.  On day 6 in the afternoon my arm started itching, but I didn't look at it until I went to put my pajamas on and I noticed a red rash on my left arm (vaccine arm).  The rash looked like a poison ivy rash a bunch of little blister, but it itched like hives,  The bumps were so close together it looked like a raised red rash.  The next morning I looked online and it said this reaction is called COVID arm, so I didn't call my doctor.  I did take Benadryl and put cortisone cream on it to help with the itching.  The rash lasted 6 days.
2 weeks after vaccination, started feeling like I had a cold, took a Home COVID-19 test and it was positive. Took a course of Paxlovid and tested negative on 10/11/2022.
Received DTaP (left thigh) on 06/16/2003.  Swollen, red, warm to touch, hard knot.  Advised to see physician, give Tylenol, and warm compress.
Parent noted redness and swelling of Lt arm increasing 24 hrs after injection. Increasing at 48hours. No fever. Marked erythema and induration of Lt arm from shoulder to above elbow.
Reports c/o muscle soreness from elbow up through her shoulder-under axilla. Arm is swollen from her shoulder to elbow but no redness other than at injection site. Treated w/ ibuprofen, cold compresses, BENADRYL.
pt exp t104 R 1 hr p/recvd vax on 19NOV92 & 20NOV92; temp on 21NOV92 & 22NOV92 was 102 R; no elevated temp on 23NOV92; had diarrhea x 4 day; irritable w/high pitched cry; devel a red rash over entire body on 23NOV92;
PAIN; DEATH; HEART FAILURE; This spontaneous report received from a consumer concerned a 57 year old female. The reporter obtained the information from news/media.  The patient's height, and weight were not reported. The patient's concurrent conditions included bronchitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient took vaccine and experienced pain. On 09-MAR-2021, the patient experienced wet cough; she said her cough was different. On 11-MAR-2021, the patient went to work and sweat profusely and blamed the A/C in her office. On 12-MAR-2021, the night before the patient passed, she was exhausted and went to bed. On 13-MAR-2021 08:00, the patient made a horrible noise, tried to revive in her bed to no avail. The paramedics worked on her on the floor of her bedroom, ambulance and finally the hospital. On 13-MAR-2021, the patient experienced heart failure. On 13-MAR-2021 09:00, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure and pain was not reported. This report was serious (Death, Other Medically Important Condition).; Sender's Comments: V0: 20210417613 -covid-19 vaccine ad26.cov2.s -Death and heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Case number PHEH2014US007035, is an initial spontaneous report from a consumer received on 08 Apr 2014. This report refers to a 70-year-old female patient. Past medical history included allergic to dust, dust mites, weeds, grass, mold and cats. She was not allergic to any foods. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date at the end of Jan 2014. One to two days after vaccination she experienced sneezing, runny nose and her eyes were weeping. Later her eyes on the rim began to itch badly. Approximately four days after vaccination, lips became very swollen (three times of normal size), chapped, and peeled. Also her lips are burned, raw, itching, stung with blisters and continue to ooze lymphatic fluid. It was reported that couple of days her symptoms diminish but the symptoms continue to recur. She met her primary health care profession three times. She was on a six day regimen of prednisone. She had a relief for three days and in the evening of the fifth day on prednisone symptoms returned. She saw a dermatologist and had skin biopsy; result was negative. Also had a blood work done which was negative. The outcome of the events sneezing, runny nose, eyes weeping and eyes itching was recovered. The outcome of the rest of the events was unknown. The seriousness and causality was not reported.
Within minutes of receiving vaccines patient felt very dizzy and turned pale. we observed patient for 20-30 minutes and at that time patient was able to leave and felt better. This is the 1st time pt has had this kind of reaction.
collapse of unknown etiology ? syncopal episode, no cardiac or neurologic etiology of event identified; struck head during fall resulting in skull fracture and subdural hematoma requiring neurosurgery, had work-up to identify possible cardiac or neurologic (seizure) causes of collapse and no specific causal etiology was identified
The problem got worst recently; Had hives; Had an immune response to the vaccine a skin rash; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 016M20A and 041L20A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash). The patient was treated with CETIRIZINE at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. A few weeks after the first booster patient had hives and rash and had to go to the emergency room. They gave strong antihistamine. At the emergency room they told to go see an allergist. The allergist told that patient had an immune response to the vaccine a skin rash. Now patient had been taking Cetirizine for two years. It had been helping now the problem got worst recently. The allergist recommended more medication and increase dosage.
Initial information received from a health  care professional on 19 January 2007. A 42-year-old male patient a first dose of Fluzone SV 2006-2007, lot number U2253AA, on 05 December 2006, the  patient developed numbness and tingling in his feet. By 17 December 2006, his back hurt and he was fatigued. He was seen in an emergency room the following day and was admitted to the hospital because he could not walk. On 20 December 2006, the patient was transferred to the intensive care unit (ICU) and was treated with immunoglobulins and plasmapheresis. His right side was paralyzed, and he was in severe pain. He was treated with Percocet. He was diagnosed with Guillain-Barre Syndrome. The patient has a past medical history of poorly controlled diabetes. On 03 January 2007, the patient was transferred to a rehabilitation facility after having been hospitalized for 16 days. His recovery status is unknown.  3/15/07 Medical records reviewed which reveal patient experienced tingling sensation & numbness of palms of hands & soles of feet.  Then lower leg muscles became weak & he became unable to walk.  S/S began 4 days prior to admit on 12/20/06-1/3/07.  Treated w/IVIG but continued to worsen.  Treated w/plasmapheresis, pain management consult & PT.  Improved s/p 5th session plasmapheresis.  D/C to rehab facility. FINAL DX: Guillian Barre Syndrome.
Patient developed deep vein thrombosis (DVT) on 5/10/2021. Received rivaroxaban therapy.
Full body maculopapular rash, occipital lymph node enlargement, spots in mouth.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, joint pain, muscle pain, nausea, swollen lymph nodes, feeling unwell, tired, headache
pt recv vax 26FEB97 & 5MAR97 pt devel a pink rash that was warm to touch around the inj site; 1 days p/onset pt recovered from sx;
Eyes was slightly swollen,trouble opening his eyelash; Temperature was around 101 degree; This is a spontaneous report from a contactable consumer. A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:30 (at the age of 12 years old) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EW0175), via an unspecified route of administration, administered in Arm Left on 14May2021 17:30 as dose 1, single for COVID-19 immunization. The consumer stated lot number for 2nd dose, It is EW0185 I don't know its 5 or S. I think it is muscular they did not find any veins I believe because it was in the top part of the left arm is where they gave here the shoulder so I think it is muscular. The patient medical history was not reported. There was no family medical history. There were no concomitant medications. My son who is 12 years old got the second dose of Pfizer vaccine on Friday evening which is 04Jun and he had a temperature on Saturday, 05Jun and his temperature was around 101 degree and we gave him Tylenol (treatment), 2 dose, one was on Friday evening other one was on Saturday morning and he took the third dose on Saturday night as well and the issue is when he woke up  morning on Sunday 06Jun his eyes was slightly swollen and we just wanted to report that would be a possible side effect of taking the vaccine but currently he doesn't have any body temperature, he is normal at 97 degree and he doesn't have any breathing related issue, we just wanted to report about his swollen eyes. And he has swollen eyes and that's the main concern for me and you know for him it's like he has trouble opening his eyelash, but he is feeling normal right now, no breathing related issue. He doesn't have any fever or temperature. For swollen eyes we gave him Claritin (treatment) and we are observing him. All doses of 10ml for both Tylenol and Claritin. The patient underwent lab tests and procedures which included body temperature: 101 on 05Jun2021, body temperature-97 on 06Jun2021.Therapeutic measures were taken as a result of temperature was around 101 degree and eyes was slightly swollen, trouble opening his eyelash. The outcome of event was unknown for eyes was slightly swollen, trouble opening his eyelash. The outcome of event was recovering for experienced temperature was around 101 degrees.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Patient was initially documented to have received the Moderna vaccine.  However, when the vaccinator was questioned they clearly recalled giving the Pfizer vaccine.  They stated that documentation for another family member who was in the same car was accidentally mixed up (other family member received Moderna).  It is believed that this was an error of documentation only and that patient care was not affected.  The error has since been corrected.
Systemic: Anaphylaxis-Mild, Systemic: trouble breathing, wheezing; symptoms lasted 1 day
Developed a fever around 2am 04/16, severe pain in joints since getting the vaccine, noticed pain on skin all over torso that was sensitive to touch on rubbing of fabric, developed red rash resembling hives
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced chills, fever and tremor. On an unknown date, the patient experienced injection site muscle pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site muscle pain, chills, fever and tremor were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site muscle pain, chills, fever and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received 1st dose of SHINGRIX on the left arm. After receiving SHINGRIX, the patient experienced that the muscle at the injection site and 2 to 3 inches out was very sore for two weeks. After that, it took months before the site felt normal again. Within 36 hours after receiving 1st dose, the patient also experienced worst chills, could not stop shaking, and felt like he had a fever of 106 degrees. The patient never checked the temperature because he felt so bad. The chills resolved within 30 minutes. The patient was overdue for receiving the second dose of the SHINGRIX vaccine. Till the time of reporting, the patient did not receive the second dose of SHINGRIX, which led to incomplete course of vaccination. The patient consented to follow up.
Seriousness criteria Other medically significant (OMIC). Initial report received from a health care professional on 5/2/2006. A four year old male patient with a medical history of reactive air way disease, had received a fourth dose of Daptacel, lot number C2431AA, in the right deltoid, a dose of Ipol, lot number Y0824-2, in the right deltoid, and a dose of measles, mumps and rubella vaccine MMR in the left deltoid on 4/24/2006. The routes of administration were not reported for any of the products. The Daptacel vaccine was administered with a 5/8 in 25 gauge needle. Three days later, on 4/27/2006, the patient developed right arm swelling, which was described by the reporter as involving a large area. In addition, the patient had itchiness at the injection site and pain in his arm. He was seen by a physician that same day and was diagnosed with possible cellulitis. No laboratory results or culture results were reported. The patient was treated with Admacef 250 mg. At the time of this report he had not recovered from the events. The reporter of this case is the same as for the non serious cases 200601015 and 200601017.
Varicella Information has been received from a physician and a school nurse concerning an 8 year old male who on 29-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 21-SEP-1997 and 26-JUL-2001. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
pt recvd vax; extreme irritability;started w/in hrs of shots, persisted x 3 days;extreme crankiness; no swelling; no fever; emesis t;
Narrative:  Patient is a 64 year old female patient who attended her primary care visit on 8/3/21 where she received the Shingrix vaccine. Nursing noticed a knot immediately appeared at injection site and alerted the provider that the patient had a swelling reaction on her right arm and them started to become faint and diaphoretic. Her blood pressure initially dropped to 75/45, her blood glucose was 108, she was alert, and appeared nervous. EKG showed no acute changes. EMS was called to evaluate the patient and at that time her blood pressure increased to 103/72 and she reported feeling better. The patient did not want to go to the hospital and was picked up by her husband.