chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd shot- Extreme illness, missing 1 week of work; 3 weeks later Congestive Heart Failure, requiring 2 hospitalizations, and currently waiting on a CRT-D Implant for CHF; This is a spontaneous report from a contactable consumer. This case is for the second dose.  A 43-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 13Apr2021 at 09:00 (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Hyperthyroidism, Migraines, Glaucoma, IBS (Inflammatory bowel disease), Anxiety, Eating Disorder, Gallbladder Disease, Pancreatitis and Known allergies: Sulfa (Sulfonamide allergy). Concomitant medications included levothyroxine (LEVOTHYROXINE), escitalopram oxalate (LEXAPRO) and buspirone (BUSPIRONE) all taken for unspecified indications, start and stop dates were not reported. The patient previously took Ceclor and Augmentin [amoxicillin;clavulanic acid] and experienced drug hypersensitivity. The patient experienced 2nd shot- extreme illness, missing 1 week of work and 3 weeks later congestive heart failure, requiring 2 hospitalizations, and currently waiting on a crt-d implant for chf on 14May2021 at 13:00. Seriousness of the events includes hospitalization, disability, life threatening. The patient was hospitalized for the events for 6 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jun2021 (Covid test type post vaccination: Nasal swab). Therapeutic measures were taken as a result of the events. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101048018 Same reporter/Drug, Different dose/event
face and eyes swelled up - neck as well; face and eyes swelled up - neck as well; face and eyes swelled up - neck as well/face swelling worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 at 14:30 as dose 1, single (Lot number: EN6205) at the age of 54 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EYE SWELLING (non-serious), SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "face and eyes swelled up - neck as well"; SWELLING FACE (non-serious) with onset Mar2021, outcome "not recovered", described as "face and eyes swelled up - neck as well/face swelling worse". The events "face and eyes swelled up - neck as well" and "face and eyes swelled up - neck as well/face swelling worse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Doctors appointments after 1st vaccine. 24Mar2021: Face and eyes swelled up- neck as well. 25Mar2021: Face swelling worse.  Follow-up attempts are completed. No further information is expected.
Low grade fever, nausea, complete fatigue, difficulty concentrating, whole body aches, headache, dizziness.
I have had mild to severe  headheaches  every single day since recieving the vaccine .  In the beginning an OTC  would help the headache but now they are constant and persistent.
This spontaneous report as received from a registered nurse refers to a 95 year old female patient. On 19-SEP-2013, the patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was unknown), subcutaneous instead of ZOSTAVAX. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
8pm severe arm pain started in arm.  Painful to lift arm over head.  5am woke to low grade fever and increased pain in arm and arm pit.  Injection site arm was painful to the touch.  Low grade fever fluctuated between 99 and a little over 100 until 3pm.  Extremely tired all day.  Moments of dizziness started in morning and have lasted to now (3pm).   General aches since woke up and up to now.
Change in blood work- liver enzymes shot up following the vaccination. I was diagnosed with Autoimmune Thyroid and Autoimmune Hepatis liver. I am currently taking Prednisone for these Autoimmune diseases.
COVID 19; COVID 19; Dose 1/Dose 2: Moderna; Dose 3: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 5 (booster), single (Lot number: 910446) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Feb2021 as dose 1, single (Lot number: 013L20A), on 02Mar2021 as dose 2, single (Lot number: 010M20A) and on 08Jul2022 as dose 4 (booster), single (Lot number: 088A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications included: COQ10 [UBIDECARENONE]; FISH OIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021, outcome "unknown", described as "Dose 1/Dose 2: Moderna; Dose 3: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid 5-day dose from 26Jun2023 to 01Jul2023.
devel clinical varicella APR97;20+ 2mm erythema pap vesicles lesions;excoriated;looks like chicken pox;
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age group adult selected as per vaccine specification.  The reporter stated that, almost everyone complained of a sore arm after Shingrix similar to what people feel after the flu shot. The reporter did not consented to follow up.  The reporter could not provide any additional details regarding patients.  This case was linked with case US2020050264 (flu vaccine case), reported by the same reporter.
covid positive pt, who has received 5 COVID vaccines, began experiencing covid symptoms shortly after taking Bivalent Pfizer vaccine on 11/21/2022.  Pt is now hospitalized
Patient described feeling an irregular heart beat that began 2 hours after the vaccination was administered. It lasted for 2 hours and was treated with metoprolol. The sensation returned the next day at 10:00am and lasted about 5 hours. It was again alleviated with metoprolol. The sensation returned 1 week later and lasted the majority of the day and was then treated with metoprolol. The irregular heart beat was confirmed by the patient's cardiologist.
My arm is red and raised at injection site. It is very tender to touch and painful. Also feels hot.
Pt rec'd varicella vaccine on 1/22/02.  SC in R upper arm (Merck Lot# 1146, exp date 2/14/03) On 2/1/02) On 2/1/02 pt developed erythema and induration at injection site the size of a quarter. On 2/2/02 pt began out break of chickenpox - like lesions on back, chest and head.
Pt reported cough on & off after J&J COVID vaccine. She has been to hospital, urgent care and clinic due to unresolved cough.
returned to clinic site with her manager stating that she felt yucky, little nauseated. No hives, no tingling, no numbness, no abdominal pain, no SOB, no chest or throat tightness. Sent Home. Called back and stated got dizzy so husband picked her up and took her to ER, they gave her a note and now she is home.
Patient waited 15 minutes after receiving vaccine as advised, with no side effects during monitoring window. Patient left the pharmacy and approx. ~20 mins after receiving vaccine, she started to experience hives and shortness of breath, at which point she turned to come back to pharmacy for medical advice. By the time she got back to parking lot <5 minutes later, the side effects had subsided. She described this reaction as similar to her shellfish allergy. She returned home after feeling fine and called her PCP, who advised her not to receive second dose and continue to monitor side effects. Patient was fine with self-observation and never had to seek emergency care.
Took baby to the hospital because she was screaming on controllably. They diagnosed her with a slight ear infection. She was given ear drops and amoxocillin. Then on 12/09/2011 at 9:00 PM we noticed a rash all over her body. By morning on 12/10/2011, it was all over her scalp down to her toes. It looked like the measles.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 22-JUL-2012 the patient experienced staph infection (staphylococcus) on face after receiving ZOSTAVAX. The patient sought unspecified medical attention from the pharmacist. He was treated with sulfamethoxazole, BACTRIM. At the time of reporting, the outcome of staph infection (staphylococcus) on face was not recovered. Additional information is not expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unspecified dates since 30-NOV-2015, doses of GARDASIL 9 (lot # L019286, expiration date 14-SEP-2015) (dose and route were not provided) which were exposed to temperatures outside the recommended range, were administered to unspecified patients. No adverse experience was reported. This is one of the several reports from the same reporter source. Additional information has been requested.
massive headache, hot face and ears with very flushed face but no fever; total lack of energy
Started feeling nauseous around 3. Had something to eat and went away. At 7pm I was dizzy and nauseous. I went to bed and stayed in bed u til 3 pm the next day. That?s when I could finally sit up. The nausea went away. Still dealing with some dizziness into today. This evening I feel pretty much back to normal.
Abdominal discomfort on 9/8/18. Extreme fussiness. Diarrhea on 9/10/18. Blood in stool 9/11/18.  Cramping and screaming fits until 9/15/18.
No adverse event; pediatric patient receiving bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 10-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving bivalent booster).    No concomitant medication information was provided. No treatment medication were provided.
so sick; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who was so sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown)  in unknown administration site as prophylactic vaccination (flu vaccination).  On an unknown date the patient developed a non-serious event "so sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (so sick).  At time of reporting, the outcome was Unknown for the event so sick.
No additional adverse effects reported.; on 13-MAR-2020 an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection as prophylaxis (strength, dose, anatomical location, and vaccination scheme frequency were not reported; lot number S022755 verified to be a valid lot number; expiration date was reported as 07-FEB-2021, but upon internal validation established as 22-JUL-2021). The vaccine was stored at a temperature of -13.4 celsius degrees (C°) for a timeframe of 1 hour and 30 minutes (product storage error), without previous temperature excursion. A digital data logger was involved. No additional information or adverse effects were reported.
Severe muscle aches; Fatigue; Headache; Fever; aching bones; swelling in dermal fillers at lips; sensitive/sore skin; sensitive/sore skin; sinus swelling; sinus swelling; Labored breathing; heavy and sore chest muscles; heavy and sore chest muscles; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Aug2021 17:00 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included levonorgestrel (SKYLA) taken for an unspecified indication. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 26Jul2021 17:00 (at the age of 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. 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. On 18Aug2021 06:00 the patient experienced severe muscle aches, fatigue, headache, fever, aching bones, swelling in dermal fillers at lips, sensitive/sore skin, sinus swelling, labored breathing, heavy and sore chest muscles. Patient was currently at 36 hours post-vaccine with no improvement. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature with unknown results on 18Aug2021. The outcome of all events was not recovered.   No follow-up attempts are needed; information about lot/batch number can not be obtained.
c/o local soreness immed p/vax;redness noted @ inj site 13JAN98 PM;14JAN98 redness spread w/swelling occurring @ inj site;15JAN98 AM rt arm edematous w/redness & warmth from deltoid to elbow;
5/28/21 ABDOMINAL PAIN 5/29/21 HEADACHE, NAUSEA, FATIGUE
Chronic effects from series of vaccines 1, 2 & 3. Substantial increase in PVC?s / PAC?s following vaccine doses 2 and 3 in February and March 2021. Then following booster in January 2022 significant jump in blood pressure which is now unable to control through blood pressure medicine (Verapamil). Also prevalence following booster dose. These are chronic effects not short term.
h/a & sore throat; spitting up green/yellow flem, running nose, sore chest went on for @ least 10-14 days;
Red circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2021.  Concurrent medical conditions included Allergy, Asthma and Arthritis (Pretty bad). Concomitant products included OXYCODONE, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle at injection site) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Treatment information was unknown.   This case was linked to MOD-2022-444851 (Patient Link).
Patient started feeling aching and pain. Her range of motion froze up. 3hrs after the vaccination. The patient went to her provider the next day. NP could move her arms with full range of motion. The patient could not. NP felt that the muscle was inflamed and in spasm. Patient's arm was better on the 10th, but she still could not raise it above her shoulder.
Severe allergic reaction shortly after vaccine. Hives and swollen face. Started itching. Was given an Epipen injection and given multiple oral medications. The Doctor on site observed me and informed me that if I was not better within 15 minutes I would have to be taken to the hospital by ambulance.
Pt passed out and was sweating the moment after she got the shot. Was hot, dizzy, and her B pressure was high. Since that day, Pt has suffered from extreme high blood pressure, dizziness, nausea, swollen never in left eye. In the hospital for days and as she gets older more symptoms appear. Symptoms started immediately with passing out and nose bleeds. Then more symptoms appeared as time went on.
On 10/2/18 at approximately 1:30 PM, I administered a flu vaccine per protocol to patient at employee/spouse clinic. Since it was her first flu vaccine, I asked her to stay for a 15 minute observation in the event of any untoward reaction to the vaccine. After 10 minutes elapsed, patient complained of dizziness, lightheadedness and visual disturbances. She was fully oriented, heart rate was palpable and approximately 70, she answered questions appropriately and was not experiencing difficulty breathing. Her eyes closed and she had difficulty sitting up and supporting her head. 911 was called for assistance. I moved her to a supine position which helped somewhat, but she still complained of the above symptoms although they were less severe. In addition, she started complaining of lower abdominal discomfort. Vital signs before EMTs arrived were 86/54, 78 and 20. After EMTs arrived, her vital signs continued to be on the low side. Blood glucose was 129. The decision was made to transport her to the ER for further evaluation. Her husband had been called and arrived to accompany her in the ambulance which departed at approximately 2PM.
No additional AEs; Caller reported child received first dose of PROQUAD on 7/21/2011 and 2nd dose on 1/12/2023.  No other information provided.  No additional AEs or PQC reported.; Caller reported child received first dose of PROQUAD on 7/21/2011 and 2nd dose on 1/12/2023.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a child patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 21-JUL-2011, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. On 12-JAN-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis(Inappropriate schedule of product administration, Product administered to patient of inappropriate age). No additional adverse events or product quality complaint were reported .
Had flu shot on 10/08/2003. Got sick 10/10/2003. Headache, heavy coughing, Drowning sensation. Spine felt like hit with ice cold axe. exhaustion, and extreme shortness of breath. Shortened my life. Follow Up: Pt is a 59 year old woman who experienced intermittent chest discomfort and profound shortness of breath over the last couple of weeks since she got her flu shot. She has a history of dyslipidemia and hypertension. She had a symptomatic but electrically uneventful adenosine phase with a lot of flushing and symptoms associated with vasodilation. She had no EKG changes and no arrhythmia. She had a left bundle branch block as the baseline EKG tracing which precipitated the adenosine test. She was recovered to baseline and stable on transfer to nuclear medicine for follow up imaging.  Medical Records states pharyngitis. msv
On 04-07-2021- I experienced a lump on my neck and developed pain to both of my shoulders. I went to the ER where x-rays and lab work was done. X-rays showed that my lymphatic glands inflamed. I also experienced a cramps from my neck that radiated upwards to the base of my head. My pain was so intense that I took OTC Tylenol to help with my pain. I went again to the ER eight days later because I was having pain to my heart, chest, neck and shoulders and x-rays again demonstrated lymphatic glands inflamed and was told to take Ibuprofen for pain.   To this day I continue to have pain to my shoulders, neck and head but the pain is not as intense as before although the pain is still present daily. I can not work my full 8 hours of work due to my symptoms and can not over-exert myself in performing my daily tasks at work.
On day 3 - 4 developed chickenpox like rash. Redness and about seven blisters around injection site.