chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown, single (Lot number: FD0809) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Iodine, reaction(s): "allergic to iodine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Patient received Anti-viral COVID 19 Treatment with Paxlovid from 02Aug2022 to 04Aug2022, lot number: 19119252A.
weakness, Lethargy, uncharacteristic irritability beginning one day post vaccine 3/23/21.       Labs:  Thrombocytopenia: PLT 85 4/23/21, repeat PLT 4/26/21  75,   repeat PLT 4/28/21 pending
Rash in arm injection site area.  Patient stated she felt stiff, difficult to walk, feverish, and felt bad. She went to her doctor and was told to apply ice and some topical hydrocortisone cream.
That afternoon (3 hours) pain in upper left arm, swelling, and redness. Body aches. Fever (101). Hyperglycemia 300-350. Took Tylenol with no relief. Took extra units of insulin (long-acting). Took Glyceride. Really sick days 1-3. Blood sugar was out of control. Felt better after about 4 days.
I had the first vaccine with no adverse side effects and had no adverse side effects right after the second dose but approximately 2 or 3 days after I had facial swelling about my eye lids. Then, the evening of 1/20, I developed hives all over both legs. They were still there the next morning and I took Benadryl and later loratadine and they eventually went down. Later in the evening on 1/21 they came back so I took a Zyrtec and the next morning they were worse and were on my legs and arms and shoulders. I called employee health and the doctor directed me to take Zyrtec twice daily and also to take a Pepcid daily. At this point in the afternoon on 1/22, I still have the hives but they seem to be slightly improving as the day goes on.
RED WELT AT SITE OF INJECTION (QUARTER SIZED) PINK AREA ABOUT BASEBALL SIZED SURROUNDING RED WELT; BURNING LIKE A SUNBURN, PER PT.
Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant details were not reported by the reporter. Treatment details were not reported by the reporter. Patient reported that he did not took any treatment and had tested negative.
injection site red and hot to touch, fever 99.9, headache, body ache, sore throat, lethargic.  This lasted 4 days.  I had the virus in June 2019 and I had a lot of the same symptoms I did at that time.
Extreme fatigue, headache and elevated heartrate came on 4 days after injection and 2 days after more moderate side effects had cleared; I called nurseline two nights and doctor's office on 9/14; all said my symptoms were within normal range, but to call back if they got worse. I self-treated with tylenol, heat wraps, hydrating and rest. I still feel mild headache and fatigue, but better than yesterday and through the night last night.
Sore Throat; Feeling tired; Runny nose; Fast heartbeat; Come down with a cold; Left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 31st October 2020) for prophylaxis.   Concurrent medical conditions included joint replacement (Artificial right elbow).   On 1st November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd November 2019, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. On 3rd November 2019, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the sore throat, tiredness, runny nose, pain in arm and cold were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, tiredness, runny nose, heart rate increased, pain in arm and cold to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 3rd November 2019 around 6:30 pm, 2 days after vaccinaiton, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. The patient reported that, had fast heartbeat while sitting down watching television. The patient statyed that, had left upper arm pain for the past 3 days from the date of reporting and on the day of reporting the arm hurts only if pushed down. This was one of 2 linked cases, reported by same reporter.
muscle cramps; weakness; muscle pain; very high fever; chills; severe headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Previous vaccines were of Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache). At the time of the report, MUSCLE SPASMS (muscle cramps), ASTHENIA (weakness), MYALGIA (muscle pain), PYREXIA (very high fever), CHILLS (chills) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication information was not provided.  The patient was wondering if these adverse effects were common and were to be expected. The patient had several patients who experienced similar severe reactions from Moderna vaccine. She never had a reaction like this strong before (previous vaccines were Pfizer).  Treatment information was not provided.
COVID VACCINE GIVING 2 WEEKS BEFORE ACTUAL TIME. 6 MONTHS APART 3RD VACCINE FROM 2ND INSTEAD OF 8 WEEKS
11/16/05 Swelling and pain. Severe local reaction at Pneumovax site
Itchiness at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Patient received ZPSTAVAX, should have received VARIVAX per patient age and request - needed 2 shot series to immunize against chicken pox for school requirements.
Large red raised hive with itching and burning lasting for 6 days. Benadryl (treatment)  Spotting for one day
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 23 April 2007 at 3:00 p.m., the subject received 1st dose of Engerix B (20 mcg, unknown, right arm).  On 25 April 2007, 2 days after vaccination with Engerix B, the subject "tested positive for hepatitis B surface antigen."  At the time of reporting the outcome of the event was unspecified.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was  136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
A LITTLE BIT DEPRESSED; PAINFUL SKIN; HAS NOT HAD GOOD SLEEP AT NIGHT; ATOPIC DERMATITIS; ITCHY LIKE CRAZY; DRY SKIN PATCHES; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, and propranolol for blood pressure.  On APR-2021, the patient experienced atopic dermatitis. On APR-2021, the patient experienced itchy like crazy. On APR-2021, the patient experienced dry skin patches. Laboratory data included: Blood test (NR: not provided) Normal, and Skin biopsy (NR: not provided) atopic dermatitis. On MAY-2021, the patient experienced has not had good sleep at night, and painful skin. On an unspecified date, the patient experienced a little bit depressed. Treatment medications (dates unspecified) included: triamcinolone, diphenhydramine hydrochloride, pramocaine hydrochloride, prednisone, dupilumab, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atopic dermatitis, itchy like crazy, dry skin patches, painful skin, and a little bit depressed, and the outcome of has not had good sleep at night was not reported. This report was non-serious.
I had this adverse reaction with both shots, however, it was much worse with the second shot. I ended up with vertigo and headaches for 2 weeks and I'm still recovering. In addition, I did have fever and chills. It's been the vertigo that had been most impactful and has caused me to miss work.
This spontaneous report was received from a Registered Nurse concerning a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 01-JUL-1993, the patient was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml, intramuscular (lot Number and expiration date not reported). On 25-SEP-1993, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route, lot Number and expiration date not reported). On 26-FEB-1994, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route, lot Number and expiration date not reported). There were no concomitant medications. The Register Nurse reported that the patient who completed the series as a child, showed negative titers for Hepatitis B antibody. No treatment was given to the patient. Hepatitis B antibody Titer laboratory test was performed which showed negative titers. The patient sought unspecified medical attention. The outcome of patient was unknown. Additional information has been requested.
RASH ON ARMS,BACK,FACE AND CHEST .TWO DAYS AFTER COVID VACCINE .TREATMENT PREDNISON..CYCLOSPORINE NOW 7 MONTHS 5 BIOPSY AND CT SCAN, THEY FOUND I NOW HAVE SUBACUTE CUTANEOUS LUPUS ERYTHEMAATOSUS
NS dilusion was done incorrectly.   Only 0.8 ml was drawn up and mixed with the concentrated PFizer vial.  Patient was still given the 0.3 ml injection but the concentration was stronger (approximately 2 times normal dose).   Patient was called a few days later (5 days) after mistake was realized.   Patient had no abnormal side effects and said she felt completely fine.    Following phone call will be done with patient after another 7 days.  Primary care physician was contacted about dose given.
Patient received vaccine and under the age of 16. No other signs or symptoms displayed during time of observation.
2 hours and 30 minutes after the shot, I realized I could not tell where my body ended and my clothes began, or where my clothes ended and the air began. Though sitting fully clothed with feet apart, I could not tell that there was space between my feet, either. This lasted for 4 hours wherein I thought I should just lay my head down on my work computer and take a nap, but the odd feeling of not feeling my boundaries was gone. I was tired for the entire 30 hours after the weird feeling.
received Pediarix and Infanrix on 25Aug2022; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: An health care professional (HCP) reported that a patient received Pediarix and Infanrix (double dose of DTaP) on the same day.  The health care professional (HP) did not have the patient's date of birth (DOB) or the lot/exp dates at the time of report. The consent to follow up was granted. Additional Supportive Information: As patient had Pediarix and Infanrix having same antigen on the same day, which led to overdose of DTPa component.
Patient came with fever for 3 days, swelling to the left thigh with tenderness on palpation.  Treatment: Keflex 250mg/5ml: 2ml every 6 hours for 10 days.
Site was inflamed, red and hot to the touch, pain. Was put on amoxicillin, prednisone and TYLENOL with codeine.
Approximately 5 minutes, post vax, pt fainted and struck her left temple on the floor. She then had clonic/tonic type seizure. She was revived with ammonia inhalant. Pt was seen by PMD and he felt that the seizure was related to hypoxia, secondary to orthostatic hypotension from fainting; not vaccine related.
20 minutes after receiving the the the back of my head starting burning then the whole left side of my head; Whole left side of the face started hurting; Face started hurting and went numb; My sinuses on the left side felt swollen and inflamed; Trouble talking; Couldn't concentrate; A few hours later the tops of my feet swelled up; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease). Concomitant medications included rabeprazole (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food, or other products. Prior to the 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 receive any other vaccination within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 12:45, 20 minutes after receiving, the patient's back of the head starting burning, then the whole left side of the head and face started hurting and went numb. The patient's sinuses on the left side felt swollen and inflamed, had trouble talking and couldn't concentrate. A few hours later, the tops of the feet swelled up. Even after almost 24 hours, the head still didn't feel normal, left side of the head still didn't feel right and sinuses on left side were still inflamed. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events back of the head starting burning, whole left side of the head and face started hurting and went numb, sinuses on the left side felt swollen and inflamed, had trouble talking and couldn't concentrate, the tops of the feet swelled up was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
New redness, swelling, tenderness that began 6 days after vaccine (4 days after previous redness/soreness ended and many days without symptoms). Frequent to constant itching at injection site.  Increasing in size/severity over the past 2 days.
pt states lt upper arm began hurting approx 10-12 hrs following vax; contacted MD 17NOV92; recommendation of ice packs to site; & rx for pain; recontacted MD by phone 24NOV92;
NO adverse event, just vaccine error. Bivalent COVID-19 Pfizer booster vaccine inadvertently given as 1st COVID vaccine. Monitored after 15min and was well. Well next day on phone call.
Muscle aches and fever by 6pm vaccination day. Major soreness in arm that has lasted to date. I have needed to be treated for limited right arm motion and pain by a doctor at least three times since vaccination. Pain subsides to 1-5 scale when I don't use my arm but returns 6-7 when use arm. Very limited strength and range of motion still persists.
Narrative: Received COVID vaccine on March 22, 2021, and visited ED on March 23, 2021 with a 102F fever. Diagnosed with COVID, and admitted to the hospital.
Severe rash on back, legs, and tops of feet. Treated with Econazole Nitrate 1% and OTC moisturizing lotion. Rash was severe for 10 days and lasted beyond two weeks.  Itching was so severe that it was impossible to sleep without pain medication.  Benadryl did not help.  Quite a lot of bleeding from scratching the rash where it itched the most, and massive amounts of dead skin on the rash.
Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
Patient had not had menstruation since July 2020. Menstruation started on Sunday, April 11. Continuing through Tuesday April 20. Typical menstruation for this patient was up to 5 days
SPLOTCHY RASH FROM LEFT SIDE STERNUM TO AXILLA ALONG T4 DERMATOME.
Patient presented to the ED on 4/2/21 and 4/7/21. He presented to the ED on 4/13/21 with suicidal ideation and was subsequently hospitalized. He is still currently hospitalized.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The day after receiving the Pfizer COVID vaccine, my son broke out in a rash all over his body. The rash was worse on the arm where he got the shot and on his hands and feet than on the rest of his body, but it was pretty much all over. He hadn't seen the new doctor listed on his insurance yet, and she refused to see him because she does not see new patients online and refused to see a patient with a rash in person because she said it could be a COVID symptom. There is no way he had COVID as he hadn't gone anywhere in months due to the pandemic and going to school online. The rest of our household had been previously vaccinated for COVID. We called the nurse helpline and a friend who is a physician's assistant. Both told us to give him Benadryl, which we did. It took 3 days before the rash disappeared. He had about another 3 days with no rash before it came back just on his hands, including the palms of his hands. We gave Benadryl again and the rash went away 2 days later and hasn't come back so far.
Extremely dizzy days 2-5, headache days 2-11, muscle aches days 8-11, fever days 8-9
this is 1 of 2 pt who devel an inj site rxn 24hr p/vax;
Employee received her third dose of moderna vaccine thinking it was her second and final administration resulting in full immunization.  Employee and staff were educated that if a recipient of the vaccine did not receive their second dose within the defined time line, that the recipient would be required to start the vaccination process over again.  Therefor the recipient and the administrator of the vaccine were under the impression that the june vaccine was indeed the second and final vaccination.  It was per new defined timed guidelines actually the recipients third vaccine.   Recipient denies and adverse effects.