chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose on 16Mar2021/did not do the second dose of vaccine yet; tested positive for covid; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported herself that on an unspecified age she received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for COVID on 21Mar2021, first dose on 16Mar2021/did not do the second dose of vaccine yet on an unspecified date. Patient was supposed to take her second dose 06Apr but was in quarantine until 08Apr2021 then tested negative for COVID. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on Apr2021, SARS-CoV-2 test: positive on 21Mar2021. The outcome of event tested positive for COVID was recovered on 08Apr2021 and for other event outcome was unknown. The patient asked if she should get the second vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Welt appeared around injection site.  Continued to grow and became red.  Mom treated with Benadryl.  Our nurse practitioner diagnosed with early cellulitis and prescribed a course of amoxicillin, cool compresses, and tylenol as needed.
rash all over her body; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic skin reaction and immunocompromised.   On 12th July 2019, the patient received the 2nd dose of Shingrix .5 ml. In July 2019, several days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The patient report that within a few days after receiving of Shingrix in left arm, she experienced a rash developed all over her body. The patient described it as little dots on her torso, legs, neck and face.  The rash came and went but had not resolved and had become a little worse.  The reporter consented to follow up.
Post vaccine pt felt warm a light headed. Pt laid down independently and symptoms went away but returned upon standing up. Pt laid down again until brought to Medical Observation. Vitals obtained and monitors. Water and food provided 1626 LYING BP 125/75 HR 93 Sp02 100% 1631 LYING BP 126/69 HR 93 RR 16 Sp02 98% 1636 LYING BP 128/85 HR 89 RR 14 Sp02 100% 1648 STANDING BP 150/81 HR 94 RR 14 Sp02 98% 1650 STANDING BP 128/74 HR 93 Sp02 99%
Started a couple hours after vaccine administration (approximately 4 hours). Aches from shoulder all the way down to hip; very sore. Arm became very swollen, hard, and red. Felt as if a tourniquet was wrapped around it. The next morning, developed a low grade fever (approximately 100 F).
an expired (exp date 8/12/2020) dose of PNEUMOVAX 23 was administered to the patient on 9/30/2020; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 30-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004547 with expiration date 12-AUG-2020, 0.5 milliliter(frequency, route and anatomical location were not provided) for prophylaxis. The reporter inquired about revaccination.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Swelling from hip to above knee, 2 times size of normal leg; red and tough; painful and itchy; hot to touch.
very swollen, red, tender deltoid area;APAP/Ibuprofen;
Left upper extremity cellulitis (pain and swelling in his left deltoid area with lymphadenopathy under his arm). Required antibiotic therapy.  10/29/2008 MR received for ER visit 10/08/08 with DX: L arm Cellulitis, Pneumonia, Fever and DOS 10/10-11/2008 with D/C DX: Allergic Reaction to Flu and Pneumonia shot.  Probable Cellulitis, L arm.  Non-ischemic cardiomyopathy.  Bronchial asthma.  Depression.  Anxiety.  HTN.  Hyperlipidemia.  Chronic shoulder pain. Pt presented to ER 10/08/08 with c/o pain, redness and swelling in the L deltoid/triceps/axilla, mild cough with increased wheeezing and H/A.  PE(+) for 14x10cm area of irregular erythema, swelling and marked tenderness. Tx with pain meds, nebs and steroids. Returned 10/10/08 with worening sx including fever and nausea. Injection site itching and painful, with tightness noted near the elbow.. TX with keflex and Prednisone with improvement.
80 mm x 50 mm redness, swelling at site.  Plans to use over-the-counter medications and ICE to area as needed and return to Occupational Health if increased symptoms.
BP measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110; feel flushed; 10 weeks post partum; 10 weeks post partum; This is a spontaneous report from a contactable other healthcare professional (patient). This reporter reported information for both mother and fetus. This is the maternal report. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at arm left via an unspecified route of administration on 08Feb2021 16:45 at single dose for covid-19 immunisation. Medical history included 10 weeks post partum vaginal delivery without complications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included colecalciferol (VITAMIN D), enzymes nos, fungi nos, herbal nos, minerals nos, nutrients nos, probiotics nos, proteins nos, vitamins nos (ATHLETIC GREENS), and prenatal vitamin. The patient, 10 weeks post partum without any PHMx of hypertension (HTN), received vaccine and immediately started to feel flushed, was laid supine and Blood pressure (BP) measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110, unable to be controlled w amlodipine prescribed by MD. Event onset date was 10Feb2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events malignant hypertension and feel flushed was not recovered.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product.    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 ,Linked Report(s) : US-PFIZER INC-2021167922 mother/child cases
pt recv vax 30SEP96 & 25NOV97 pt devel chickenpox;pt exp a secondary skin infect from scratching. This is in follow-up to report(s) previously submitted on 1/16/1996. Information has been received from a health care professional concerning a 29 month old Caucasian female with no known allergies and mild cold symptoms who on 30-SEP-1996 was vaccinated with one dose of VARIVAX. Concomitant vaccinations included the first dose of PROQUAD administered in left thigh and HIBTITER administered in right thigh. There were no other concomitant medications. On 01-DEC-1997 the patient was diagnosed with chickenpox. She subsequently experienced a secondary skin infection from scratching. The reporter described the case as moderate to severe. Subsequently, the patient recovered. No further information is available.
Redness on the injection arm; hardnes on the injecton arm; A spontaneous report was received from a Consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness on the injection arm , and hardness on the injection arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events redness on the injection arm . which returned on January 31st, 2021, hardness on the injection arm..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, redness on the injection arm , was not resolved, and outcome of hardness on the injection arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Shortly after the injection, the client started feeling dizzy and lightheaded. Injected with Morderna COVID 19 vaccine Lot 009C21A in LA via IM.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FF2593) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 20Dec2020, stop date: Jan2021; "GERD" (ongoing). There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 11Dec2021, outcome "recovering", described as "tired/very tired"; PAIN IN EXTREMITY (non-serious) with onset 11Dec2021, outcome "recovering", described as "arm was very sore/Arm sore"; CARDIAC DISCOMFORT (non-serious) with onset Dec2021, outcome "recovering", described as "It felt awful for my heart"; CHEST PAIN (non-serious) with onset 11Dec2021, outcome "recovering", described as "Left side of chest started burning"; RESPIRATORY RATE DECREASED (non-serious) with onset 11Dec2021, outcome "not recovered", described as "I had chest pain and lot of sighing"; HYPOKINESIA (non-serious) with onset Dec2021, outcome "unknown", described as "became hard to move items from one side/had to raise left arm and eventually just went super slow". The events "left side of chest started burning", "i had chest pain and lot of sighing" and "became hard to move items from one side/had to raise left arm and eventually just went super slow" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got vaccine for the first time recently. Patient was very tired the day after and arm was very sore. So tired patient didn't want to get off the couch. But heart felt fine. Then patient went to work. That was a mistake. The patient got vaccine on 10Dec21. The patient waited for vaccine was outside for ventilation, it was cold and patient didn't have good jacket so was a little numb when patient got vaccine and took a long shower after to warm up. The patient had Arm sore and very tired next day but went to work. Left side of chest started burning shortly after starting work at patient's normal pace , became hard to move items from one side to offer , had to raise left arm and eventually just went super slow. worked for several hours that day in pain. At night, patient called online store doctor service to get doctor note for work so patient would not have to go in and be in bad pain again, he said to go to ER since patient said had chest pain + a lot of sighing. ER did chest x-ray, ECG , blood tests, said results were fine-sodium potassium low but that was to be expected, asked for doctor note for work, he gave that one. The patient went to follow-up appointment few days later, ECG normal, listened to heart was fine, patient was feeling better but still some sighing and told to report back with how patient was doing to see if second shot advisable or not.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist. The pharmacist reported that an unknown number of doses of RECOMBIVAX HB, that were improperly stored at 15 degrees F for 21 hours, the doses may have been administered. Additional information is not expected.
c/o heavyness of head-no focal neuro sx; BP uncontrolled to 190/110 even w/meds;
Pain my left arm, shoulder, shooting up into my neck and down my back. I've also been having chills.
pt recvd vax; screaming  4-5 hrs,same day as shot; swollen leg
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from other company (Pfizer) and from a patient concerned a 63 year old female. Initial information was processed along with the additional information received on 18-AUG-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: asthma and drug allergy (Cholesterol Meds). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, dose 1, 1 total administered to the right arm on 09-MAR-2021 15:00 for covid-19 prophylaxis. Age at time of vaccination 61 years old. The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 017F21A and expiry: UNKNOWN) dose was not reported, administered to the right arm on 26-OCT-2021 10:00 for covid-19 prophylaxis. Age at time of vaccination 62 years old. The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and were not reported, batch number: 037A22B and expiry: UNKNOWN) dose was not reported, administered to the left arm on 29-MAY-2022 11:30 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number and expiry were not reported) dose was not reported, administered from 26-JUL-2022 to 30-JUL-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. No concomitant medications were reported. After starting treatment with Paxlovid on 26-JUL-2022, the patient's symptoms gone in a day and a half and she tested negative for covid on 30-JUL-2022, 31-JUL-2022 and 01-AUG-2022.  On 06-AUG-2022, the patient started getting symptoms (coded as confirmed covid-19 infection) (dose number in series 3) which led to confirmed clinical vaccination failure (dose number in series 1). On 07-AUG-2022, the patient tested positive. As of 10-AUG-2022, the patient was still testing positive for covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 9000024698.; Sender's Comments: V0:20220834440-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Initial report was received 24 August 2011 from a health care professional. A 51-year-old female patient had received a first dose intramuscular left deltoid injection of ADACEL, lot number C3727AA on 05 April 2011, and seven days later on 12 April 2011 during an office visit with her physician, she reported swelling and rash at the injection site, fever of 103 Fahrenheit and joint pain in both wrists, knees and ankles. At the time of vaccination the patient had no concurrent illness. Other medications were reported as "none", however the patient had been taking PROTONIX and RABEPRAZOLE. Past medical history was not reported. At the time of the report, the patient continued to experience pain in both her wrists. Outcome was not recovered. Documents held by sender: None.
Bleeding that started off as spotting then progressed to heavier bleeding producing blood clots and passing tissue.
Patient claims she cannot move her arm at all. She thinks the needle may have gone into the bursa.
I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling  in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.
I received the first dose of the vaccine on Friday 4/16 at 2:24 PM.  I experienced the normal side effects of a sore arm and fatigue all weekend.  On Monday 4/19 around 4:00 AM, I woke up choking/coughing on my vomit.  I ran to to the bathroom to clean up and experienced some coughing for a few minutes.  The amount of vomit was slightly less than a handful and the color did not look out of the ordinary.  After an hour, I went back to sleep for a few more hours. I woke up tired with a slightly sensitive stomach but no nausea. Physically, I feel ok.  I reached out to an  on-call nurse and she doesn't believe it was a side effect to the vaccine but encouraged me to submit my symptoms on here just in case.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Additional Details: Patient passed out and lost conciousness. EMS called. Patient was breathing. O2Sat >95%. EMS arrived after patient regained conciousness. Patient refused transport to hospital.
Received Pfizer-COVID-19 vaccine on 5/18/2021 and 4/27/2021 (lot number EW01562).  Presented to ED 6/19/2021 with painful mass in inguinal area thought to be a hernia.  CT scan with contrast showed occluded main portal vein, masses throughout liver and kidney suggested of spreading hepatocellular carcinoma, no inguinal hernia.
09/29/09 client called stating she had Flu shot on 9/24/09 (Thurs) on Fri 9/25/09 in evening & Sat 9/26 developed sore throat along with achey feeling & congestion in chest. Took Dayquil med with relief. Had "mild" fever not tested. Site of injection has no lump, no redness & not warm but has residual pain in arm from elbow to shoulder & into neck, no pain med. Advised to use heat for pain med & see private Doctor if persists, 10/2/09 return call from client. States heat & pain med helping as well as hot shower & cold relievers. Did not see pp.
Extremely painful recurrence of bulbous phemphigoid  covered most of body.  3.5 weeks after initial vaccine. Required hospitalization 3 times and admission to rehab twice. Unable to walk, difficulty breathing, swollen legs,  2nd hospital. Unable to speak or walk 3rd hosp, ended in death/ bacteremia.
Narrative: patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing and adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient deceased after falling and hitting head. Patient had a h/o of ICM with an ICD and was already being seen by palliative care/hospice prior to COVID vaccinations.
Passed out around noon today + diarrhea, been mostly sleeping since 8 PM yesterday
Pt was found unresponsive on floor, pale, diaphoretic with BLEs elevated on chair. Pt became responsive in under 10 seconds. No head injury. VS laying down as follows: BP 111/66, HR 99, sats 99% on RA. Pt given water, snacks, cold compress applied to forehead. After 10 mins, pt was assisted to seated position on floor, VS as follows:  BP 139/81, HR 85, sats 99% on RA. Pt recovered within 20 mins, ambulated out of clinic in NAD and was escorted to car by staff, driven home by friend.
Broke out in a rash on my chest, both thighs, both arms  Nothing until the next day and took one Benadryl  seemed to help and stopped the itching. They are  barely visual enough today  I also had a tingling in the upper part of my mout about a half hour after the shot
Caller reporting an AE for PROQUAD being administered after an excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2022, it was stated that measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was storage in a temperature of minus (-)10 Celsius degree (C))  up to 8C (7.3 C) for 2 hours 37 minutes 0 seconds; then a temperature excursion (temperature -2 C) (Incorrect product storage) occurred during 1 hour and 12 minutes. After the excursion, the vaccine temperature was reported as -10C up to 8C (0.7 C) for 2 hours 56 minutes 0 seconds.    On 05-MAY-2022, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot #U029319 has been verified to be valid, expiration date: 19-MAR-2023) 0.5 milliliter (strength and route of administration were not provided) as prophylaxis.
Swelling to posterior of left arm with redness, lump, hot, painful and itchy. Employee was seen in the ED on 7/20/13 IV therapy and antibx given (Clindamycin and oral AUGMENTIN).
Patient received H1N1 injectable vaccine and ENGERIX B in AM. At about 6:30 pm had a blackout, fell, hit corner of table. Seen in ER, CT (-)
Pt had a syncope after the 9th vaccine that lasted few seconds. Pt become complete alert/Oriented X4, cooperative. Pt ambulatory without complains at time of discharge.
Case previously recorded as MA2009-3781. Initial case report received from a physician via Novartis Pharma on 04 NOV 2009. A 3-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008136P) i.m., on 04 NOV 2009. MedCom reference no.: NA09-007589.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: symptom onset after patient left pharmacy, after the 15minute observation was over
On 7/22nd I had a fever of 101 and had a virtual doctor visit. I began to feel sharp abdominal pain similar to cramps.  It felt like there was some inside my lower intestines and it would hurt to sit down or stand.  I saw a Dr. on 7/29.  Received diagnosis of Sigmoid Diverticulosis after CT scan on 8/12.  Will discuss treatments during next visit