chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 03 November 2011, 12 January 2012 and 13 February 2012 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 19 July 2012, approximately 5 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 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.
Information has been received from a female consumer concerning herself who on approximately 17-JUN-2010 was vaccinated with a dose of GARDASIL (lot # not reported). On 01-JUL-2010 the patient experienced a reaction 2 weeks after getting the vaccine, a red outline on where shot was given. At the time of this report, the patient had not recovered. No further information is available.
administered Daptacel to a patient 3 days after its expiration date.; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a patient of unknown demography who received expired vaccine of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-MAY-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE expiry date: 17-May-2019 lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender: none.
Marked swelling of entire upper arm extending down to mind lower arm (L) and up to distal clavicle. Prescribed Benadryl, Clautar, cool compresses.
SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Bad anxiety; It's been 7 months since I got the first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (Bad anxiety) and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Bad anxiety) and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot). At the time of the report, ANXIETY (Bad anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot) had resolved.        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.   No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Transferred from hosp. to ER 02-03-11 with 2 day history of fever (100.9) jerky abnormal movements and vomiting. Diagnosis pending.
Rash (full body) extremely itchy, muscle aches, fever, swelling of neck muscles, scratchy throat. Not yet treated. Patient has never had reaction in past.
The arm of the injection swelled considerably from shoulder to wrist, I would not call it a rash, per se. Instead it is more of a solid red color over the entire arm. Also arm is incredibly sensitive and painful in a 4 inch radius around the injection site.   I received the injection around noon today- symptoms appeared ~8 hours later. it is now roughly 12 hours later and it is still too sensitive to touch- even by clothing, red and swollen.
patient was due for Monovalent Moderna and Bivalent Moderna was given in error. team did check online data and vaccine card and nurse gave wrong dose  . Patient notified once we could reach her. Error was discovered after she left the clinic
THE PALMS OF MY HANDS STARTED TO ITCH. THE ITCH SPREAD TO MY ENTIRE HANDS. MY BACK STARTED TO ITCH AND MY ARMS TOO. TOOK 1 BENADRYL AND WILL TAKE 1 MORE IN ABOUT 1 HOUR IF THE ITCHING HASN'T SUBSIDED.
Information has been received from a 60 year old female pharmacist referring to herself. Concomitant therapies included naproxen, a whole bunch of different vitamins and COSOPT. The patient's pertinent medical history and drug reactions/allergies were reported as no. On 03-AUG-2017, the patient was vaccinated with one dose of RECOMBIVAX HB (lot # and expiration date were unknown) intramuscular for prophylaxis. On 05-AUG-2017 (reported as two days after got the shot), the patient's vision started going bad. It was all fuzzy. Her glasses were not even working. She had an appointment on Wednesday to see her doctor. No treatment was given. No lab diagnostics/studies were performed. The outcome of the events were reported as not recovered. The causality assessment was not provided. The reporter considered the events were significant disability or incapacity.
02-13-12, approx. 10 hrs after HPV injection, client c/o nausea, abd. discomfort. Sl. fever & headache. Mom took child to urgent care on 02-14-12 (evening) she was told to take child to DCP the following morning. 02-15-12 mom states child is no better and now has "flu like symptoms". Advised to take child to PCP.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Information has been received from a physician concerning a 4 month old female with a family history of intussusception who on 10-JAN-2008 was vaccinated with a dose of ROTATEQ.  Subsequently the patient experienced intussusception and was hospitalized.  On 06-APR-2008 the patient had surgery, but the present status was unknown.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery).  Additional information has been requested.
Patient returned to pharmacy 10/11/23 with complaint that he has felt ill for the past month and stated he has never felt like this before in his life.
COVID-19/tested positive with a home test today; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/tested positive with a home test today) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypothyroidism and Allergy NOS. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 22-May-2022, the patient experienced COVID-19 (COVID-19/tested positive with a home test today). At the time of the report, COVID-19 (COVID-19/tested positive with a home test today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) felt good and tested negative with at home tests.. On 22-May-2022, SARS-CoV-2 test: positive (Positive) tested positive with a home test today.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after completion of the 5 day course of paxlovid and 8 days total, He felt good and tested negative with at home tests.  It was reported that 7 days later he started to have symptoms including coughing, runny nose and slightly tired. Patient tested positive with a home test today and had persistent cough.  No treatment medication were reported. COMPANY COMMENT: This is an spontaneous case concerning a 68-years-old male patient with medical history of Hypothyroidism and Allergy NOS, Concomitant products included LEVOTHYROXINE for Hypothyroidism, RITONAVIR on 09-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 156 days after  3rd  dose of  mRNA-1273 vaccine. On 22-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 68-years-old male patient with medical history of Hypothyroidism and Allergy NOS, Concomitant products included LEVOTHYROXINE for Hypothyroidism, RITONAVIR on 09-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 156 days after  3rd  dose of  mRNA-1273 vaccine. On 22-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients on an unspecified date received improperly stored GARDASIL (lot No, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
Within one hour of receiving the vaccine client noticed hives on chest and neck. Face turned pink and warm. Got better with Benedryl. Resolved by the time client woke up from nightly sleep.
Consistent, recurring enlarged lymphnodes under my armpits, but mostly my right armpit that are very painful and the size of a large marble.
4 hrs p/receiving HIB/DTP/OPV & APAP pt devel labial edema which progressed to feet & hands; blotchy, mauclar rash on the neck; pt normal 48 hrs later;
I got  Covid from my husband which he tested positive on 12-26-2020.  On 12-26-2020 I tested positive for Covid.   I  developed headaches, cough, congestion along with a sinus infection and had left arm soreness.  I also received my 2nd dose injection on 01-06-2021 at 9:30am.
Localized reaction at injection site. Swelling, redness some warmth, soreness upon touching.
Sore Arm; fatigue; Chills; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient was taking concomitant medication but information was not provided. No treatment information was reported.
Mom noticed a few weeks ago an raised ring on pt's left thigh at site of administration. No other adverse events noted after administration of vaccine. Area not irritable to pt.
Every night since the injection he wakes up with numbness in fingertips; Pain at the injection site; Every night since the injection he wakes up with severe pain in his arm; Its a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation). On 19-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, HYPOAESTHESIA (Every night since the injection he wakes up with numbness in fingertips), VACCINATION SITE PAIN (Every night since the injection he wakes up with severe pain in his arm) and VACCINATION SITE PAIN (Its a burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Symptoms included fatigue, headache, muscle and joint pain, chills, nausea, dizziness starting approximately one hour after the injection and lasting 4 days for most all the symptoms.  The dizziness lasted for 2 days and the body aches for three.  Still with a slight headache and nausea today 12/28/20 5 days after the injection.
Patient received PREVNAR 13 on 4/6/16 and a few weeks later had vision changes. He saw eye doctors and PCP to assess cause and was referred to endocrinologist to assess thyroid contribution to vision changes. Cause unknown. Patient asked if vaccine could be responsible - no reports of vision changes per Pfizer.
Muscle aches, fever, chills, palpitations about 12 hours after vaccine.
About 24 after injection patient had redness, tender, warmness at injection site of ZOSTAVAX. Prescriber gave patient BACTRIM DS for 5 days.
2/26/21  left arm red -hot- itch with swollen at 5pm and 2/27/21 mild soreness with 2 inch rd diameter  2/26/21  took antihistamine with benadryl cream 2/27/21 no symptom at 10 pm
This case was reported by a healthcare professional by email, via a sales representative, and described the occurrence of nonresponsive in a 8-week-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX,(non-gsk)  ACTHIB and (non-gsk) PREVNAR.  On an unspecified date the subject received unspecified dose of PEDIARIX (unknown route), unspecified dose of ROTARIX (unknown route), unspecified dose of ACTHIB (unknown route), unspecified dose of PREVNAR (unknown route) and experienced possible inappropriate route of vaccination. The healthcare professional stated via email that "while it is hard to pinpoint which vaccine caused the adverse reactions, your comments on possible ROTARIX adverse reactions may be helpful in aiding our provider decide whether to give more ROTARIX shots". ROTARIX is indicated to be administered orally not as a "shot". Immediately after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTARIX, the subject experienced "briefly" cried, pallor ("turned pale and limp") (nos), eyes rolling "without shaking" and more sleepy. The subject's respirations and pulse were normal. The subject was treated with "blow by oxygen" and the mother was instructed to breast feed the subject (had not eaten in 2 hours). The subject's color returned to normal and he was more active within about 15 minutes. He was still more sleepy than usual (but still was feeding well) at home. Then later that evening, the subject again looked pale and experienced nonresponsive. The subject was taken to the emergency department (ED) and pediatrics were consulted and a septic workup was recommended (possible sepsis). The parents refused and left the ED against medical advice (AMA) because the was looking "normal" again few hours later". "By the next morning, the baby was behaving normal without further episodes". The healthcare professional stated that this appears to be an adverse reaction to the vaccines. This case as assessed as medically serious by GSK. At the time of reporting the events were resolved. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX, ROTARIX, ACTHIB and PRVENAR.
Flu and Hep B vaccine given in left arm on 9/7/16. Pt c/o pain with ROJM, rated "10" on 0-10 scale. Started after immunizations constantly since.
Started getting hives beginning 3/7/13 at 10:00 AM & progressed all day until she went to the ER at midnight. MD rx'd steroids & PEPCID. States sxs are decreasing today (3/8/13).
Patient was given influenza shot and pneumonia vaccine.  (pt does not know which pneumonia vaccine) in a different facility. Pt had visit with our provider after going to the ER and leaving before being seen due to wait time. Pt states about 4 hours after receiving the vaccines he had arm pain, headaches, shivers and had a temp of 104 that has since resolved. The back of his head is sore with general headache. His left arm where the injection was has been red and feels a lump, but no spreading red skin rash or pus. No current signs of cellulitis. Pt referred to follow up with primary care provider as well as Doctor on Demand provider. Pt to seek immediate medical attention if persistent temp above 100.6, nausea and vomiting, or severe worsening of your skin condition.
Left thigh warm/red/blanching. Ordered hydrocortisone cream, Atarax, cool compresses, and return to clinic Monday if no improvement.
This is a spontaneous report from a contactable pharmacist. A 58 years old male patient received PREVNAR 13 on an unknown date in 2015 (4-5 weeks before the report), at single dose. Medical history and concomitant medications were not reported. The reporting pharmacist mentioned that the patient received the vaccine and got really sick, had initial fatigue, headache and achiness. The reporting pharmacist stated that sometimes the patient was "scared" of vaccine and after that he was ok, but then he started feeling really ill, he was admitted to the hospital with no diagnosis. The patient recovered from fatigue. Outcome of the other reported events was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable healthcare professional. The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "PE" (not ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovered with sequelae" (26Feb2023) and all described as "COVID-19". As therapeutic measures to the events, the patient started nirmatrelvir/ ritonavir (PAXLOVID) on 18Feb2023 and finished on 22Feb2023, tested negative on 26Feb2023. The patient had 3 vaccines and 2 boosters (unspecified). This was the patient's first time getting COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.