chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling cold; relatively mild symptoms of chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), CHILLS (relatively mild symptoms of chills) and FATIGUE (tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), CHILLS (relatively mild symptoms of chills) and FATIGUE (tired). At the time of the report, FEELING COLD (feeling cold), CHILLS (relatively mild symptoms of chills) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-060668, MOD-2021-125978 (Patient Link).
Initial report received on 18 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance database. The subject had received 4 doses of PENTACEL; lot number C3498AA received on 03 December 2009, lot number C3579AA received on 02 February 2010, lot number C3608AA received on 09 April 2010 and lot number C3801AA received on 22 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 08 June 2012, approximately one year and two months after the last dose. On 10 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 15 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 15 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
suspected vaccination failure; got the shot and still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Patient started to feel shaky, hot and had trouble breathing about 10 minutes after receiving the vaccine. Patient was given 50mg of diphenhydramine and one epi-pen and 911 was called. EMS arrived about 15 minutes after the reaction began. They monitored the patient, checked her blood pressure, heart rate and pulse ox. The patient has began to recover at this time and EMS released her. The patient's son was present the entire time.
Headache, fever, chills, body aches, lethargy and rash for 14 days, post vax.
ventricular tachycardia: A ventricular high rate detection on 2/12/2021 at 2259 hrs. lasting 6 seconds and 13 beats with max V rate 213 bpm; EGM appeared to show sudden onset and conclusion of V>A on remote device check 2/19/2021.
Rash in my face and neck . Started like I had sand in my yes  and now progressed with red spots on my face . I never had that before I took a vaccine . I?m looking to know if this is possible results of allergies to the shot .
Localized hematoma/swelling on dorsum of right foot. Hurts when walking. Also had nausea and abdominal pains. No fainting and no vomiting.
SUFFERING AFTER EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the patient experienced suffering after effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering after effects. This report was non-serious.
I was soooo sick; didn't take the second injection / will NEVER take the 2 injection vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follow: The patient received 1st dose of shingles vaccine on an unknown date. The patient experienced sickness. The patient decided not to take 2 dose of shingles vaccine, which led to incomplete course of vaccination. No further information was provided.
Red, raised area around injection site approx. 3cm x 6cm.  Hives on trunk and both arms. Swelling of facial area. Dizziness and blurred vision. Temperature of 101.4. Pulse of 118. Parent gave Benedryl at home and saw little improvement. Pt seen in Emergency Room at 11:00 PM. Physician gave Benedryl and steroid by IV. Pt condition improved.  Discharged to home.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tylenol
2/4 itchiness @ site, sore 2/5 L arm red and inflamed below inject site.
Patient called pharmacy 11-10-19 and stated extreme pain in left arm  for approx. 7-10 days after receiving Fluad Vaccine. Patient  taking 2- Aleve tablets and applying ice on arm to reduce swelling. Pharmacist advised  patient to contact physician concerning this reaction and if pain does not subside.  No other allergic reactions noted.
Client was given a Pfizer COVID-19 vaccines for 5- 11yo that had expired the previous day 09/30/2022. No symptoms or adverse event noticed by child or Mother of child.
Information has been received from a certified medical assistant (CMA) regarding a patient of an unknown age and gender who on 25-JUL-2013 and 22-OCT-2013 was vaccinated with an improperly stored dose of GARDASIL exposed of 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a medical assistant concerning a 15 year old male patient who on 27-APR-2011 was vaccinated intramuscularly with the first dose of GARDASIL (lot # and expiration not reported). It was reported that on 27-APR-2011 the patient experienced extreme dizziness. The patient's blood pressure dropped to 100/60 and 10 minutes later it raised to 122/60. Patient did not seek medical attention. Unspecified treatment was given for this adverse events. The patient recovered from the adverse events on 28-APR-2011. Additional information has been requested.
Joint Pain, Soreness at the injection site: Report 2001015472-1 described joint pain in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the vaccines and has not been verified by a physician or other HCP. Reportedly, the pt had no known drug allergies. Per medical history included psoriasis,. The pt did not have gout or Crohn's disease. Pt had no history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. She rec'd birth control medication (NOS). In 9/99, the pt rec'd her 1st Lymerix L arm, within 24 hrs post vaccine, the injection site was very sore. Her arm was difficult to move. In approximately 1/00, she reportedly began experiencing R hip soreness, bilateral knee problems of soreness and grinding noise and bilateral elbow soreness. She stated that none of her joints have been swollen, warm or red. The pt stated that her joint complaints have not been evaluated by a physician, and she has not rec'd any medical treatment for the joint pain. As of 6/27/01, her joint pt was getting worse. The outcome of the soreness at the injection site was not specified. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA per the 6/28/00 letter.
Patient reporte that the arm she received the vaccine in was swollen, sore, red and warm to touch.
Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diaphoretic.  Cold packs applied. (BG = 126, BP180/100, T 97.2, HR 60, R 18, 18:16 time O2 was 94% room air, EKG Normal Sinus Rhythm  Alert and Oriented.  Repeat BP 98/78. Patient taken to ER or Clinic for further observation unknown if was a ER or clinic
red warm welt at injection site; red warm welt at injection site; welt at injection site; This is a spontaneous report from a contactable nurse via a Pfizer sponsored program. This contactable nurse reported same event for two patients. This is the second of two reports. A 15-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, 0.5 ml, lot number: DL2971, expiry date: 30Nov2022, NDC number of Prevnar 13: 0000519-71-02) via intramuscular route in right thigh on 12Jan2021 at 0.5 mL, single for immunization. Patient had no medical history. Concomitant medications were not reported. It was reported that, she is calling about Prevnar 13, states she just opened a new Lot of the Prevnar and the first two doses administered, both patients had adverse reactions. States that she was no longer going to use that Lot number at this time for fear that it may continue. Agent state the product information is: Patient was 27lb 8 ounces at time of injection. Gender not provided, Patient received vaccine on 12Jan2021, on 14Jan2021 a warm red welt at the injection site was reported. Reporter considered events as non-serious. Treatment was a cool compress to the site and the welt resolved in a couple of days. Outcome of events was recovered on 16Jan2021. The relatedness of event red warm welt at injection site was unknown. Relatedness of drug to reaction(s)/event(s) for Red warm welt at injection site at Source of assessment was Primary Source Reporter and Method of assessment was Global Introspection.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058499 same reporter/drug/event, different patient
Patient received full dose of Moderna vaccine instead of the intended booster (half dose). Patient experienced similar side effects with first vaccination.
Information has been received from a nurse practitioner concerning a 17 year old female who on 06-MAY-2008 was vaccinated with GARDASIL intramuscularly 0.5 mL.  Subsequently the patient developed intermittent "aching" to her hips, knees and right ankle after vaccination.  The patient visited the office.  At the time of reporting, the patient's intermittent "aching" to her hips, knees and right ankle after vaccination persisted.  No further information was available.
Urticaria all over the body, now presents with dermatographism.  Antihistaminics such as benadryl or allegra are ineffective.  Itchy skin all day long.
4/13/2021-  Ocular Migraine, and Vision Loss for about 20-30 minutes and it happens about 2 times a week
itchiness in bilateral arms and neck, pt refused Benadryl, pt verbalized feeling better in 10 minutes and left hospital symptom free
06/26/2021  swelling began around eyes and face , next was extreme swelling , and then everywhere pt. had fillers done was extreme pain and swelling. eyes felt like could not be opened (swelling  in filler areas)
Per caller Pneumovax was admin but the name charted for the medication given was Prevnar 13.; This spontaneous report was received from a licensed practical nurse and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unspecified date in 2016, the patient was supposed to received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # reported as 165N56, expiration date reported as an unknown date in October 2017, however the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) lot # reported as 165N56, expiration date reported as an unknown date in October 2017 (dose, route and site of administration were not reported), for prophylaxis. No additional adverse event was reported.  Lot number 165N56 is an invalid lot number for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23. Lot number 165N56 does not match any Company product as confirmed by Lot Verification team.
Information has been received from a physician concerning a 52 year old male with "unremarkable" past medical history and no allergies, who in early April 2002 and early Mary 2002 was vaccinated with a first and second dose of hep B vaccine recombinant. There was no concomitant medication. One week after the first vaccination, in April 2002, the pt developed muscle pain. Approximately one month after the second vaccination, in June 2002, the pt reported that the pain and aches became more severe. The physician described the pt's pain as musculo-skeletal pain, rheumatoid arthritis like symptoms. A rheumatoid factor level done on 8/1/02 was 15.9. Unspecified medical attention was sought. Additional info has been requested.
2:00 am: chills  8:30 am: 102.2 fever with chills and throbbing headache fever continued throughout day
to not being able to get from his bed to the bathroom without help/to not being able to manage a phone call; From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 05Jan2021 at 03:00 PM as a single dose, for COVID-19 immunization, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included amlodipine besylate, finasteride, hydrochlorothiazide. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 08Jan2021 at 08:00 AM (3 days after the vaccine) patient experienced a drastic decline. From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help. From still driving his own car, to not being able to manage a phone call. Events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient was treated for the events. Since the vaccination patient had not been tested for COVID-19. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Lose her taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lose her taste) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Back disorder NOS (Back issues). Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Back disorder NOS.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Lose her taste). At the time of the report, AGEUSIA (Lose her taste) had not resolved.            In early April 2021, the patient started to lose her taste. She currently still has this problem. She can taste a little bit of sweetness and saltiness. No treatment medications were reported.  On 17-Nov-2021, the patient received the third dose of Moderna vaccine (Lot 058F21A).  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history reported who experienced the unexpected non-serious AESI of Ageusia approximately one month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable, as the event had not resolved. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-409951 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history reported who experienced the unexpected non-serious AESI of Ageusia approximately one month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable, as the event had not resolved. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt received Peadiarix #2 Hib #2 and Prevnar #2 on 9/20/02 then fever that NOC 103, then rash 48 hours lateer.
Vaccination failure; COVID-19; Blood sugar went high and she believes it was because of her COVID in Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM5318), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 05Jan2022 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood sugar abnormal" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Blood sugar went high and she believes it was because of her COVID in Jul2022"; COVID-19 (medically significant) with onset Jul2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood glucose: (2022) high; SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Prescribed Paxlovid and then last Jul2022, she did Paxlovid for 5 days. Husband had COVID too. Both of them got COVID, but he was given IV because he was past the 5 days. He did not want to test and she did. Mom passed away in 2013 and had Diabetes. She takes Blood sugar and blood pressure medication and had been taking it and nothing new. She had those before the very first Pfizer COVID vaccine - over 5 years. Maybe 7 years ago. Blood sugar went high and she believes it was because of her COVID in Jul2022, because nothing changed. Exercise and everything was the same.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159823 Same patient/drug/ different dose/event;
This spontaneous report as received from a register nurse refers to a newborn female patient. On 01-JUL-2014 at 19:04pm, the patient was vaccinated with RECOMBIVAX HB lot # J012520, expiration date 30-JAN-2016, intramuscular. On 01-JUL-204 the patient received improperly stored RECOMBIVAX HB. Vaccine storage temp dipped to 0-1 X 18 different episodes according to min/max. All recorded temps are within 2-8 deg. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Patient was observed for 15 minutes after influenza vaccine administration.  Patient denied itching, rash, chest tightness, shortness of breath, stomach cramping, lightheadedness, or dizziness. Approximately 1 hr after vaccine administration, patient reported chest tightness, tingling and swelling around mouth.  Patient was treated with epinephrine and 911 was called. Symptoms improved. Upon arrival of EMTs, 25 mg of IM Benadryl was administered by paramedic. Patient was transported to hospital.