chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2022 at 12:15 as dose 3 (booster), single (Lot number: 33025BD), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 at 10:30 as dose 1, single (Lot number: 036021A), in left arm and on 07May2021 at 14:30 as dose 2, single (Lot number: 025C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline HBP" (unspecified if ongoing); "Grave's Disease", start date: 2012 (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL, start date: 01Feb2019, stop date: 01Jan2023; SYNTHROID, start date: 11Jul2012, stop date: 01Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Jan2022 at 12:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for COVID 2 days after completing the 5 day treatment of Paxlovid; Positive, notes: 4 days after completing the Paxlovid, I am testing COVID positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Treatment start date was 23Dec2022 and stop date was 27Dec2022  Clinical course: After having a moderately bad COVID infection (my first one) Patient took Paxlovid for 5 days, tested negative for COVID 2 days after completing the 5-day treatment of Paxlovid, and now 4 days after completing the Paxlovid, Patient testing COVID positive again with minor symptoms. Patient had no risk factors, Patient had daily runner, never smoked and had no significant medical history and Patient not immuno-compromised in anyway. Patient had COVID, took Paxlovid, felt better each day, tested COVID negative after completing the 5 days of Paxlovid.
pt recv vax 24SEP96 & 25SEP96 pt exp numbness in rt arm, severe pain @ site of inj, nausea & a feeling of not wanting to move;f/u from reporter indicated pt ended up having something completely different;sx not dx as rxn to vax;
10 days after my shit I broke out in severe hives. They they turned into one large rash all over my arms, under arms, torso and inner thighs. The rash was very red and burned. That night my esophagus started spasms. I have had an itchy red rash for 3 weeks now and hives every day.
p/vax pt had stabbing pain under rt shoulder blade;next morning pain returned in same place;took APAP;sharp pain remained all Friday;felt bad all week end but somewhat better;pain cont ;to MD who felt r/t shots;
Pt. states when receiving the Flu shot 10/02/2020 immediate pain in the left arm. Unable to use or extend arm. Dr. visit beginning of Feb. X-Ray preformed (no known ab.), MRI recommended.
There were no S&S or treatment needed. Extra Hep. A was given, he was all ready complete with the series. Discussed with mom what happened and the rest of vaccines he was due for were given.
3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that then spread to my mouth, throat, and tongue. I asked the nurse if my lips were swollen, and she said no.  A few minutes later my heart rate increased and I felt really lightheaded. After 7-10 minutes I felt my tongue tingling and it had become swollen. I told the nurse that I think my tongue was swollen and she said it looked okay. I had a hard time talking because I wasn't used to be tongue being so large. The nurses stayed and talked to me for the rest of the 30 minute waiting period. I was able to talk and breath while making a conscious effort.  I wasn't sure whether the high heart rate and lightheadedness were associated with my condition, Postural Orthostatic Tachycardia Syndrome. I kept checking my tongue to see how swollen it was.  After the 30 minutes, the nurses had me stand up to see if I could. Once I could, they said I was all set to go. They did not get an Epi-pen for the swollen tongue or give me instructions on how to treat it. They were insensitive and dismissive of my symptoms. they kept repeating "I think your just nervous." Once I got home, I still had the swollen tongue and tingling, but was able to go up and down stairs and go about my day. It was a little difficult to swallow one of my pills when I got home, but I was able to. I checked my blood pressure around 4:30 p.m. and it was 121/84 and my pulse was 79 bpm sitting. I did not take anything to treat my swollen tongue. The swollen tongue and tingling feeling in my throat continued for another 2.5 hours, until 6:00 p.m. Once the swelling was down, my tongue felt like I burnt it on a hot beverage, almost a numb feeling. I also experienced more common side effects such as body aches, fatigue, and feeling feverish.   After this episode I had extremely high anxiety where it was difficult for me to sleep the following night. I called a 24/7 nurse line and she said to talk to my doctor. I had less than 4 hours sleep the night after I had my vaccine.  I called my doctor's office this morning and I spoke to a nurse who worked as a nurse on the COVID Vaccine hotline.  She relayed the message to the doctor who was covering for my doctor while she's on medical leave. I received a call around 9:30 a.m. saying that the doctor on leave recommend I should talk to my PCP but that she thought I had an allergic reaction to the Pfizer vaccine and that I should not get the second dose. She said they were not sure how I would react with the second dose, and they're afraid that my allergic response might be more severe and life threatening.  I hope this report helps other people who experience these symptoms.
RA flare; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional and consumer reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had rheumatoid arthritis (RA) flare. The outcome of the event was unknown.  Follow-up attempts are needed; information on the lot/batch number has been requested.; Sender's Comments: The event rheumatoid arthritis (RA) flare was considered as due to underlying condition and unlikely related to the use of BNT162B2. Patient had rheumatoid arthritis as medical history. The impact of this report on the benefit/risk profile of the Pfizer product 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.
This spontaneous report as received from a healthcare worker refers to a currently 19 years old female patient with polycystic ovarian syndrome (PCOS) and drug reactions/allergies to amoxicillin. On 31-DEC-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J015378, expiration date 09-APR-2016, dose and frequency not reported). On an unknown date (also reported as reported as immediately) the patient developed fever, nausea, dizziness, stiff back, stiff neck and muscle pains. It was stated that the injection site had swelling and erythema. All events worsened by day three post injection and resolved by day 7 post injection (07-JAN-2015). The patient sought medical attention and contacted the office. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Vaccine administrator went to administer the patients Pfizer vaccine and vanish point needle retracted too early. The administrator felt that he received less than half the original dose so he vaccinate him with a second dose.
Patient received recombinant zoster vaccine on 5/8/19. Per telephone call with provider on 5/13/19, patient declines completing the vaccine series due to severe pain, chills, and fatigue after first dose. Per patient, couldn't get out of bed for two days due to fatigue. Symptoms improved by time of telephone appointment. & Pain, chills, fatigue
Itchy ears & throat, rapid heart rate within 5 minute of injection, followed by fainting.  First responders on-site responded within 1-3 minutes. Initial blood pressure was <80/60, which recovered to normal within 20 minutes. During that period, experienced shortness of breath / gasping (though 1st responders noted clear airways and no wheezing in lungs), nausea (did not vomit), and disorientation / dizziness. No medications or interventions were administered
2/11/21 wife and I both took 1st Vaccine Shot 2/23/21 Wife and I Both Tested Positive for Covid. Oxvgen level for patient 93. X-RAY SHOW COVID SPREAD 2/24/21 Admitted to (hospital). Low Oxygen/elevated heart enzymes 2/25/21 Released with Oxygen
Rash on abdomen looks more like folliculitis with white pustules. Treated with BACTROBAN.
Weakness, muscular aches and pains, fatigue, headache, fever & Chills, nausea.  Really sore injection site. Worse than the first dose.  First dose gave me no side effects other than the sore arm.
Varicella-like rash on face and arms, approx. 6 crusted vesicles. No fever. No other symptoms of illness noted.
Information has been received from a RN concerning a 16 month old white female with "aszma" who on 18May05 at 15:00PM was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (lot 649481/0764P). Concomitant vaccinations given on the same day included: the second dose of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (Infanrix) (lotDTPA620A9) given intramuscularly in the left thigh, the second dose of Hib conj hep B vaccine (lot646451/0560N) given IM in the right thigh, the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 647113/0346P) given SC in the right deltoid, the second dose of  pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR) (lot A67182A) given IM in the right thigh and the second dose of poliovirus vaccine inactivated (Ipol) (lot X1038) given IM in the left thigh. There was no known illness at the time of vaccination. In the evening of 24May05 the pt developed a low grade fever and on 25May05 the pt was seen at the health dept with approx 10 vesicle lesions on her neck, chest, and arms. The pt was diagnosed with varicella disease (noted to be possible vaccine induced). The family was advised to consider the child contagious for at least 4-5 days until all of the areas were scabbed over. No further information was available at the time of this report.  The reporter also noted the pt's previous immunization record: the first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine given on 05Oct04, the first dose of poliovirus vaccine inactivated (unspecified) given on 05Oct04, the first dose of hep B virus vaccine (unspecified) (+) Hib vaccine (unspecified) given on 05OCT04 and the first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR) given on 05Oct04. The nurse also reported three siblings of the girl who had adverse experiences (WAES0507USA03557, 0507USA03558, and 0507USA03559). Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 06-NOV-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L000453 with expiration date of 06-JAN-2017, dose, strength and route unknown) that was improperly stored. No adverse effects reported. Additional information has been requested.
Bilateral swollen eyelids, lower > upper, and eyes mildly red; No discharge, no eye pain, no headache, no fever, no reaction at the injection site.  Benadryl was helpful, and 24 hours later eyelids only minimally edematous at 10/05 medical encounter.
Patient received 1st dose of Shingrix on 8/02/19 and noted on 8/04/19 6 small red  dots at injection site which began to merge. Patient phoned clinic on Monday 8/05 and reported rash was now approximately 4 inches by 4 inches. Patient was given same day appointment around 2:30pm. Primary physician diagnosed right arm with cellulitis and prescribed Cephalexin 500mg to be taken two capsules every 12 hours for 14 days. Patient was given follow up appointment on 8/09/19. Patient was also advised to seek ER if she began having any respiratory symptoms as itchy throat , tingling or numbness aroud mouth or throat or any difficulty swallowing or breathing. Patient verbalized understanding.
Vaccination administered too early in series - administered after a 2 week interval rather than 28 days. No adverse effects or symptoms reported by patient. Patient is scheduled to receive an additional dose to replace the early dose.
C/O "Room spinning upon awakening this A.M." (11 19 09).
MODERNA COVID VACCINE #3 GIVEN 11/19/21, LOT #039F21A; pt had a positive COVID test 6/13/22; 6/18/22 admitted to hospital with hypoglycemia, AKI/volume depletion due to intractable diarrhea probably due to COVID; pancytopenic; developed severe sepsis with occult septic shock; CT of abdomen/pelvis showed possible psoas abscess; given broad spectrum ABX/antifungal/antiviral; not a surgical candidate; pt worsened; increased encephalopathy and renal failure; transitioned to hospice; while still in CCU, pt passed away before hospice
sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly; sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of unspecified age reported for herself that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 09Jun2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Jun2021, after the second dose of vaccination, patient experienced sore arm and right now patient is having a hard time trying to raise her arm/ can't lift shoulder and arm hardly. Patient asked if she had any question then what are the option that is should need to go to hospital or go to the emergency room and how long does it going to take. Patient was advised to call nearest physician in case of any emergency. The outcome of both the events was unknown.   Information on batch/Lot number has been requested.
Shortly after injection, pt developed dizziness/near syncope. He was noted to be very pale and was reclined in his chair. He improved after appx. 5 minutes and symptoms resolved.  BP 110/80, HR 72, 99%. No signs to suggest anaphylaxis. He felt completely back to normal when he drove home. Symptoms likely consistent with vasovagal response from injection. Pt notes he did not eat much during the day
Arthritis is acting up; A spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced arthritis is acting up (Arthritis).  The patient's medical history was not provided. Concomitant medications included rivaroxaban, omeprazole, thyroid.  On an unspecified date, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   Approximately about a week after receiving the vaccination, the patient experienced arthritis is acting up. Treatment included methylprednisolone.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, arthritis acting up (Arthritis) was not reported.; 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.
Information has been received from an administrator referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored VARIVAX (strength, dosage, frequency and route unspecified) for prophylaxis (incorrect product storage). Temperature was -0.8 C with time frame of 4 hours. No previous temperature excursion was reported. No adverse symptom was reported.
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #u024221, expiration date: 04-AUG-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of -12.5 degrees Celsius (C) for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Local erythema & swelling on back of R arm.  Swelling measured approx 7 cm x 6 cm in diameter.  Started 1-29-08, symptoms have improved since yesterday (site warm & tender).  Swelling decreasing per mother.  Site examined by Dr.
left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient's left side of lower lip swelled up, about 18 hours after the second dose. The patient had no trouble in breathing. The patient did not receive any treatment for the event. The clinical outcome of the event left side of lower lip swelled up was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.
I got my shot on 5/18 and was amazed that I didn't even really feel the needle going in. The next day, it was a bit itchy but wasn't a problem. That Sunday, 5/20, I began to experience some respiratory issues and aches, but that is somewhat normal for me. However, it got a bit more severe and spread to my back and shoulders and was accompanied by a headache. I took my temperature and it went from 99.3 to 99.8. I took a Tylenol and around 11pm. That night, I called my doctor's office and spoke with the on call doctor who advised that I check in with my PCP on Monday and to continue alternating Tylenol and Ibuprofen and to seek emergency medical care if I began to have shortness of breath. On the morning of 5/23, I was feeling better and was able to go 6 or 7 hours without medication and wouldn't spike a fever. I've just been having some runny nose and cough but nothing too out of the ordinary. My doctor prescribed a Z Pak and a steroid medication which I have not begun taking yet.
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). It was reported that the patient developed an anaphylactic reaction which manifested as a rash on her arm. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. No further information is available.
Fever; Muscle Spasms; Pain Lower Legs; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MUSCLE SPASMS (Muscle Spasms) and PAIN IN EXTREMITY (Pain Lower Legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MUSCLE SPASMS (Muscle Spasms) and PAIN IN EXTREMITY (Pain Lower Legs). At the time of the report, PYREXIA (Fever), MUSCLE SPASMS (Muscle Spasms) and PAIN IN EXTREMITY (Pain Lower Legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medications were not reported.
Itchy, Swollen, Red - entire Body; BENADRYL 25mg x3, CLARITIN Per PMD.
Sudden onset of diabetes after Covid 19 vaccination. Diagnosed by primary care doctor 2/10/22 after suffering symptoms for several months.
Pt complained of soreness, swelling, redness, weakness in arm where vaccine given. Pt stated she couldn't lift the affected arm.  4/15/2010 pt stated she had blisters in her mouth.
Bright red rash on facial cheeks, across eyelids and left rash scarring.
lt arm painful p/vax remained so;very heavy, difficult to move;early evening gait unsteady, confused, restless sleeping, talking in sleep;incontinent of urine x 2;husband unable to read MD so called 911;T101.5, tachycardia;saw MD in AM;
Developed shingles on 05/27/2022.  As of 06/24/2022, I am still experiencing symptoms - rash, numbness, tingling, pain, itching