chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health professional (reported for himself). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 17Dec2020 10:00 at single dose on left arm for COVID-19 immunization. Medical history known allergies: PCN (Penicillin). The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at Hospital. 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. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab and the test name was PCR with the result of positive on 22Dec2020 (12:00). This wasn't really an adverse event but the reporter thought it may be useful for studies taking place. On 22Dec2020 12:00 PM, the patient was diagnosed with COVID-19 5 days after vaccination and was currently self-isolating. The adverse event result in Emergency room/department or urgent care. No treatment was received for the adverse events. The events were considered as non-serious by the reporter. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.
Patient having local reaction to tetanus diptheria vaccination.  Edema and erythema to upper arm.  Rash to face and arm.  Fever and pain - severe to right arm.
Entire body hurt for several weeks.  Affected muscles, skin and joints.  Now pain is mostly in my arms.  Have been experiencing fatigue and dietary issues.  Also experienced hot flashes and chills, those have mostly dissipated.
The Pneumococcal vaccine was placed with the Flu vaccine by the other pharmacist. When I came on duty the tech ask me to do a Flu shot. I grabbed the open vial out of the same place as always. It was the wrong vaccine I gave the correct vaccine later the same day.
sore arm/body aches; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/body aches) and PYREXIA (mild fever) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYALGIA (sore arm/body aches) and PYREXIA (mild fever). At the time of the report, MYALGIA (sore arm/body aches) and PYREXIA (mild fever) outcome was unknown.            No concomitant and treatment medication were reported. The patient had a sore arm, a mild fever and had body aches.
hot; tchy; red spot, size 2 coins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U31620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 2. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# K010336 with expiration date 22-JUL-2016 (dose, frequency and route were not reported). Information regarding concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Over age recommendation by Doctor; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy. Additional patient notes included the patient had no spleen.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: Over age recommendation by Doctor). The outcome of the intercepted drug prescribing error 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: 09-MAY-2023 The patient had no spleen. The product had not been given. The patients demographics were not provided. The reporter granted consent to follow up. The physician sent a patient who was above the age of 25 to get Bexsero dose, which led to intercepted drug prescribing error.
I have developed pain in my armpit and halve had a fever for 24 hours now.
It was reported that a 35 year old male experienced an allergic reaction from the start of the post exposure rabies series, consisting of rash and throat swelling. The pt was initially treated with Benadryl, Epinephrine, Zantac and Tagamet. The pt stated this reaction occurred with subsequent doses and he had to be treated with Benadryl each time. The pt also reported experiencing migraine like headaches.
8  days after injection, swelling, itching and redness at site. Measured at 3"x 2". Following day felt dizzy and nauseous with overall arthralgias and malaise.  On day 9 symptoms started to subside but injection site was still swollen and painful and had increased in area to 5"x 3". On day 10 symptoms had completely disappeared and only an outline of reaction area was visible. No symptoms had been noted at all before day 8.
Swollen chapped lips, post nasal drip which provokes cough which provokes headache and jaw pain
This case was reported by a physician, via a GSK representative, and described the occurrence of muscle pain in a 49 year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 19 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route). On 21 October 2011, 2 days after vaccination with FLUARIX, the subject experienced "severe" muscle pain and tiredness. The physician considered the events were disabling. The subject was unable to go to work. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with FLUARIX. The physician reported 2 subjects who experienced adverse events following vaccination with FLUARIX. This is case 2 of 2. See case ID A0950519A for details of the other report.
Woke up 0630, unknowingly had diarrhea,sat up, felt wet, went to toilet and had explosive  diarrhea, showered, finished toweling when it began again and continued uncontrollably for about 40 min.  Have been tired since.     NEVER EVER HAPPENED BEFORE!
Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
The pt experienced a migraine due to neck and shoulder pain, temp of 38.5-39.8 Celcius in the (Ear), shivers, pain in whole body, sharp pain within left side of rib cage. Received cortisone shot.
Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: pt stated pain on first day and 2nd day very painful 3rd could not lift arm and swollen under the arm pits and painful on left side of breast-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: patient stated her left arm was painful on first day and 2 nd day the left side of arm hurt on the third she was unable to lift her arm and under the armpit it was swollen and left side of her breast hurts
I had my vaccination on 09/09/2022. I started to experience sneezing runny nose throat felt funny with body chills. I tested COVID-19 Positive on 01/17/2023. I was prescribed Paxlovid on 01/18/2023. I presently feel better on 03/14/2023.
Information has been received from a female, for the Pregnancy Registry for GARDASIL, concerning her 16 year old daughter with no pertinent medical history or drug reactions/allergies who on 10-APR-2009 was vaccinated with one dose of GARDASIL. The patient became pregnant. The urine pregnancy test was performed in the office. The patient's last menstrual period was 25-MAR-2009, her estimated delivery date was 30-DEC-2009. It was reported that her pregnancy was normal to date. Additional information was received from a health professional concerning that a 16-year-old female patient with no per-existing allergies, birth defects or medical conditions was vaccinated IM in the deltoid region of the right arm with the first dose of GARDASIL vaccine (Lot # 661046/0546X) at 16:00 PM on 10-SEP-2009. The patient was unaware of pregnant at the time of injection. There were no adverse events reported. The patient had no illness at time of vaccination. The patient had no other concomitant medications. Follow-up information has been received from a physician indicated that the patient with no significant past medical history and no family history or smoking history with no obesity and with no previous pregnancies, no pre-term deliveries, no spontaneous abortions, no elective terminations, no stillbirths and on full term delivery who was vaccinated with the first dose of GARDASIL on 10-APR-2009. Concomitant medication included prenatal vitamins from June 2009 to December 2009 daily for pregnancy. The prenatal testing included: On 23-JUN-2009 at 13 weeks and on 18-AUG-2009 at 21 weeks ultrasound for survey of anatomy revealed normal female, on an unspecified date amniocentesis revealed fetus, on 23-JUL-2009 MSAFP for screening for anomalies revealed WNL. On approximately 22-DEC-2009 the patient experienced protracted labor as complication during labor/delvery. On 22-DEC-2009 the patient delivery a normal female infant with weight 6 pound 13 oz, length 19.5 inch, Apgar score 7/9, head circumference 14 inch. The weeks from LMP were 39 weeks. There were no congenital anomalies and no other complications or abnormalities. There was no complication during pregnancy. The diagnostic test during pregnancy were ultrasounds at 13 and 21 weeks respectively. There was no infection or illness during pregnancy. Follow-up information has been received from a physician indicated that on 22-DEC-2009 the patient delivered a normal female infant with a weight of 6 pounds 13 oz by caesarean section due to failure to progress and breech position. The newborn noted as MMC had no known drug allergies looked good overall and well hydrated. All the examinations for the baby were normal. Upon internal review, caesarean section due to failure to progress and breech position was considered to be an other important medical event. Additional information is not expected.
Body aches, upset stomach, mild chills:  lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)
No fever, heavy duty cough, sore throat, malaise. Had flu shot Wednesday. Pt saw MD on Saturday: MD prescribed antibiotic and MUCINEX.
Information has been received from a medical assistant concerning a 4 month old female who at approximately 16 weeks of age was vaccinated with a second dose of COMVAX (lot 657380/0377U). Subsequently the patient experienced cellulitis. The patient was taken to urgent care and was treated with KEFLEX. Subsequently, the patient recovered. Additional information has been requested.
there was bleeding at the injection site more than from a typical vaccination I have recieved in the past. I sat to wait and within five minutes was lightheaded, overheated but having chills and having intense abdominal cramps. My pulse ox and bpm were fine but my blood pressure was low for me; normal is 110/70 and emt's confirmed that I was 90/60 and then 98/62 after 40 minutes post vaccine.  I waited longer and then not feeling worse left. Advil fixed the cramps. So far it's only been pain at the injection site.
Sharp pain in neck, back, upper shoulder and little finger.Pain extends to finger when moving hand. Arm "swollen, tight" no redness. Client states Tylenol does not help.  Suggested use of anti-inflammatory and alternating use of heat and cold. Also recommended client see physician.
Day after receiving immunization patients arm became swollen and developed hives down the arm. Recommended BENADRYL or ZYRTEC c/o help w/hives. Cool compressed to injectoin site, TYLENOL or ibuprofen for pain.
This spontaneous report as received from a medical assistant. The medical assistant reported that the packaging of the M-M-R II, (Oka/Merck) VARIVAX, and (Oka/Merck) PROQUAD was similar, and this could potentially cause confusion between the products. The medical assistant stated no misadministration has occurred. Additional information has been requested.
10 min after receiving vaccination mom returned with baby. Rash noted on stomach back and face. None noted on legs or feet. Client does not appear to be in any resp distress. Afebrile. Benadryl 0.5cc PO given. Instructed to give every 4-6 until rash resolved. If not resolved in 24 hrs instructed to go to hosp with shot record. No hives, but rash slightly bumpy. No welts noted. 5/30/06 12:50PM Rash slightly bumpy, no welts or hives noted. Dr stated that client should be given Benadryl prior to next vaccination. Follow up: 4:40PM: called to check up on client, mom states baby doing okay. Rash remains same. States no resp. Problems, playful after waking up after taking Benadryl and Tylenol earlier. Encourage to continue to give Tylenol. Benadryl 0.5cc q 4-6hrs today. Will call back tomorrow to check on cond of rash. 5/31/06 (Wednesday) Follow up:10:15A called this morning to check on client. Mom states rash resolving cont to be afebrile. Only a few spots noted. Mom says baby playful normal behavior. Told her to continue with Benadryl rest of day.
The wrong vaccine was selected; 3-year-old received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number T031201, expiry date 14th June 2022) for prophylaxis.   On 17th September 2021, the patient received Boostrix (intramuscular) .5 ml. On 17th September 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was a representative of a pediatric medical facility. The 3 year old patient received Boostrix vaccine instead of Hepatitis A vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up with health care profession.
constant pain with occasional sbooting pain in his right ann since the VAQTA administration; This spontaneous report as received from a pharmacist refers to a 69-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 05-DEC-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) in the right arm (dose, lot # and expiration date were not reported) for prophylaxis.   On an unknown date, the patient experienced constant pain with occasional shooting pain in his right arm since the hepatitis a vaccine, inactivated (VAQTA) administration. The patient sought for medical attention by visiting the pharmacist.  The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and hepatitis a vaccine, inactivated (VAQTA) was not provided.
patient experienced tongue numbness during the first 15 minutes after the vaccine was administered. Patient received diphenhydramine and felt better shortly after taking the diphenhydramine
shoulder pain/joint pain; headache; Joint and muscle pain; cold; Little Lump; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain/joint pain), NASOPHARYNGITIS (cold), VACCINATION SITE URTICARIA (Little Lump), HEADACHE (headache) and MYALGIA (Joint and muscle pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and VACCINATION SITE URTICARIA (Little Lump). On 16-Mar-2021, the patient experienced ARTHRALGIA (shoulder pain/joint pain) and MYALGIA (Joint and muscle pain). 16-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 16-Mar-2021, NASOPHARYNGITIS (cold) and VACCINATION SITE URTICARIA (Little Lump) had resolved. At the time of the report, ARTHRALGIA (shoulder pain/joint pain), HEADACHE (headache) and MYALGIA (Joint and muscle pain) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-049535 (Patient Link).
Patient was booked at facility under incorrect name and birthday on 3/14/2022. Patient verified this was correct and age appropriate vaccines were agreed upon by clinician and guardian and administered due to no shot record available.  Age appropriate vaccines included Menveo, Bexsero, and Gardasil 9.  During follow up visit, 4/18/2022, patient corrected name and birthday.  Upon looking up this given name and birthday information in system, nurse found patient had already received one dose of Menveo after age 16.  Per CDC guidelines, this patient did not need second dose of Menveo administered 3/14/22.  It was also found that patient had 2 previous doses of Men B.  The Men B, Bexsero, dose administered on 3/14/22 was dose #3.
fever,chills and  arthralgias days #1-3 post vaccination then - Bilateral eye redness with c onjunctivitis both eyes onset days #4 post vaccination
contracted COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant products were reported.  No further information and no additional adverse events reported.  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date and on an unknown interval (vaccination date not provided) after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-648378, US-MODERNATX, INC.-MOD-2022-648379 (Linked Report).; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date and on an unknown interval (vaccination date not provided) after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-648378:Father case US-MODERNATX, INC.-MOD-2022-648379:Mother case
shortness of breath, swollen face, extremely swollen foot (right), extreme fatigue  Dr. suspected gout, but the swelling was not accomapied by pain to the touch. Naproxen helped  with aches and swelling within a few day.
Patient's mother stated that they have been monitoring his fever for 4 days, alternating ibuprofen and tylenol. Mother stated that patient has no other symptoms, but started a dry, occasional cough on 9/5/22.
Encephalitis. Lethargy, alt. conscious, personality, extreme irritability, somnolence, seizures. A 60-day follow up report received 6/10/2003 adds no new info. The discharge summary states CVA.  Annual follow up on 03/17/04: "It is unknown if the pt recovered from the adverse events."