chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE details. No PQC.; Personnel called to request information on if MMR II can be given with Normal Saline instead of the Sterile Diluent that is supplied with the vaccine. Caller is not a licensed HCP, and further research for MIR was not able to be conducted. C; This spontaneous report was received from Other and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); sterile diluent (STERILE DILUENT) solution for injection/infusion, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and  sodium chloride (NORMAL SALINE),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, military personnel called to request information on if MMR II can be given with Normal Saline instead of the Sterile Diluent that is supplied with the vaccine. Caller is not a licensed HCP, and further research for RA was not able to be conducted. Caller states all other staff has left for the day and that they will reach out to the RA tomorrow for RA. Caller reports that the Lot and Exp date are unknown by the reporter. The dose was given on 8/10/2023. Permission to contact the lead military equivalent to medical assistant given. No further AE details. No PQC.
21AUG94 rash onset on face, spread to trunk, back & under arms; swollen gland behind ears; h/a, nausea, & vomiting x 2 days duration 23AUG94 bilateral knee pain w/lt knee more severe;
Patient lost consciousness immediately after injection. Presumed to be syncope. Parents of patient reported patient had previously lost consciousness during an x-ray. Patient regained consciousness in approximately one minute.
swelling to lower lid of right eye only; no pain, no redness, no itching, no watering; no treatment done.  As of reporting time, 14 1/2 hours after swelling was first noticed, the appearance is the same
Information has been received from a physician concerning a pt who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 30May05 the pt experienced breakthrough chickenpox with only a few lesions. It was noted that the lesions started developing on 30May05. Unspecified medical attention was sought. The pt was not recovered. No product quality complaint was involved. Additional information has been requested.
Patient said that she began to have trouble breathing and also noticed an allergic reaction in her eyes as manifested by redness and a thin film covering the eyes. After about an hour, she decided to head to the emergency care where she was treated for what was thought to be an allergic reaction to the vaccination. She was then sent home with prescriptions for a ProAir inhaler, a course of prednisone, and eye drops.
missed her four dose of the booster dose of HIB; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via The Agency (Reference number- 00319395) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 5-years-old patient who was vaccinated with HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (suspension for injection), (suspension for injection, batch number, expiry date not reported, it was not known on which arm the vaccine was administered) (product dose omission issue) on an unspecified date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to missed dose (latency: same day).  At the time of reporting, no adverse event was reported.  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.
Pt recv vax on unspecified date; on unspecified date pt exp prolonged myalgia.
Pt reported hx of fainting to vaccines. Made sure she was comfortable sitting in her car. I attempted to distract her, but she still fainted. She was out for approximately 3 seconds before recovering spontaneously. I applied ammonia inhalants as she was awaking, and she immediately came to. Afterwards, she complained of HA, lightheadedness, + fatigue. On exam, lungs: CTA B/L; Cardio: normal RRR, no murmurs, gallops, rubs; HEENT: no erythema or edema of face or throat. Denied CP, palp, SOB, pruritis, dizzy Ammonia inhalant used. Post-vaccination wait for 30 mins. HA, lightheadedness, and fatigue resolved w/in 30 min wait. Pt went home.
Pulmonary hypertension; Doing a lot worse after 2nd moderna covid shot; This spontaneous case was reported by a health care professional and describes the occurrence of PULMONARY HYPERTENSION (Pulmonary hypertension) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced PULMONARY HYPERTENSION (Pulmonary hypertension) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) (seriousness criterion medically significant). The patient was treated with OXYGEN for Condition aggravated, at a dose of UNK dosage form. At the time of the report, PULMONARY HYPERTENSION (Pulmonary hypertension) and CONDITION AGGRAVATED (Doing a lot worse after 2nd moderna covid shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Company causality between co-suspect product, macitentan and the event, condition aggravated was reported as not related.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time.
it is really bad, like someone hit him in the back of the head; Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck/like throbbing headaches; Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2022 (Lot number: FK97Z9) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 23Jan2022, outcome "not recovered", described as "it is really bad, like someone hit him in the back of the head"; HEADACHE (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck/like throbbing headaches"; NECK PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck". Therapeutic measures were taken as a result of headache, neck pain.  Additional information: Reporter stated that he went to the dentist 2 weeks prior to the shot, but he didn't have any headaches then so he does not feel its relevant.  Reporter stated that 2 hours after receiving his dose, and persisting today he's been having really bad headaches. Feels like someone hit him in the back of the head. Reporter says at times it is really bad, like someone hit him in the back of the head. So intense that he wants to go down onto his knees. States its so intense he sticks his fingers in his ears, like you do on an airplane. States he is leaving work right now because of one. Response given from attached doc, also provided data.  No follow-up attempts are possible. No further information is expected.
Lower back pain; Fatigue; Vaginal sores/rash; Vaginal sores/rash; Abdominal rash/itching; Abdominal itching; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and eosinophilic asthma. Concomitant products included cortisone (non-proprietary) (Cortisone Cream).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus. On an unknown date, the outcome of the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus were recovering/resolving.   It was unknown if the reporter considered the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. This case was received from GlaxoSmithKline response center. The patient received 2 doses of Shinges vaccine and was not sure if that was causing her symptoms of abdominal rash, vaginal sores and rash, fatigue and lower back pain. Consumer was referred to see her Health care professional for medical advice. The reporter consented to follow-up. The outcome of the event was captured according to the xml sheet provided.
This spontaneous report was received from a registered nurse and refers to two patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # R002521, expiration date 18-SEP-2019 (dose was not provided) for prophylaxis. The vaccines were exposed to a temperature from 9°C to 25°C for 1 hour and 20 minutes. It was reported that digital data logger was involved. No adverse effects were reported. Follow-up information was received from a nurse on 08-FEB-2019. The two patients received the improperly stored doses of ROTATEQ on an unspecified date in December 2018. The vaccines were exposed to a total and highest previous temperature excursion above 9 °C for 2 hours and 20 minutes. On an unspecified date in November and December 2018, vaccines were exposed to temperatures excursion of 10.8 °C for 1 hour and 20 minutes and 11.5 °C for 1 hour, respectively. This is a non-valid case due to the lack of patient's identifiers.
I have fever 10 days after the 2nd vaccine; Second vaccine made me have deep body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have fever 10 days after the 2nd vaccine) and MYALGIA (Second vaccine made me have deep body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Tumor (hemotherapy which has protocol of chop-bleo and methrexate for tumor in throat) in 1986, Chemotherapy (took chemotherapy which has protocol of chop-bleo and methrexate for tumor in throat) in 1986 and Anesthesia (patient had anesthesia with which she took 18hrs to wakeup and she was delicate person.). Concurrent medical conditions included Drug allergy (allergic to nausea medicines) and Penicillin allergy.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have fever 10 days after the 2nd vaccine) and MYALGIA (Second vaccine made me have deep body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (I have fever 10 days after the 2nd vaccine) and MYALGIA (Second vaccine made me have deep body aches) had resolved.            Concomitant products included Thyroid pills and Antidepressant pills. patient had extreme immune response. Patient have extremely delicate constitution.   This case was linked to MOD-2021-104509 (Patient Link).
Migrating hives all over body, swollen lips, hives lasting for more than 4 weeks
had covid; had covid; This is a spontaneous report from a contactable other health professional (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient had covid on 14Jan2021 and was due for his second vaccine today. He was advised not to get it because he got Remdesiver. The reporter wanted to know where he can get the second dose. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
This case was reported by a nurse and described the occurrence of injection site warmth in a 71-year-old female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). Previously administered products included flu (few years ago, patient got really sick). Concurrent medical conditions included house dust allergy and pollen allergy. Concomitant products included aspirin, caffeine, salicylamide. On 27th October 2014 11:00, the patient received FLUARIX. On 27th October 2014, less than a  day after receiving FLUARIX, the patient experienced injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes. The patient was treated with MOTRIN and BENADRYL. On an unknown date, the outcome of the injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes were unknown. It was unknown if the reporter considered the injection site warmth, swelling of fingers, tissue puffing, pain in arm and watering eyes to be related to FLUARIX. Additional information received: ?Per HCP, patient was administered FLUARIX TIV yesterday and reported symptoms of soreness, watery eyes and swollen fingers.
The symptoms began immediately after administration of the vaccine.  The symptoms were: tingling of her back / spine and then two hours later had itching swelling of the throat like she couldn't swallow felt lightheaded and dizzy and took benadryl with improvement. On day 2 felt feverish with sore arm and then on the 3rd day developed the same symptoms as the first day and went to the ED after taking benadryl x2 with no improvement in her symptoms.   Objectively there is no wheezing, swelling, or rash but the provider does note that there were 3 small excoriated spots on her wrist one of which looked like a hive.  The treatment of the reaction was:   o Antihistamines: benadryl 50mg at home and ibuprofen  o Steroids: IV solumedrol  o Epinephrine: x1   o ED admission
Injection was given with 5/8 inch needle, resulting in sub-q administration versus desired IM administration with 1 inch needle.
Case previously recorded as MA2009-5164. Initial case report received from a physician via MedCom, on 19 NOV 2009. A 1-year-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008308.
Pt given vaccine and after a few min. later had asthenia, numbness and tingling down (L) arm, dizzy, ringing in ears, frontal headache, no SOB. Cough, lethargic. Pt had wheezing increased and was given Nubulizer and albuterol. 083%. wheezing decreased sent to ER see there discharge instructions. Seen 1/5/09 still with cough and asthenia + non HA, smug tenderness.
I traveled for a trip and had been there since December 1st. I returned December 05, 2022, and that when I developed runny nose, cough, and fatigue. On December 06, symptoms also included a stuffy head and sore throat. I took an over-the-counter COVID-19 test that was negative. My husband had the same symptoms and also tested positive on December 6, 2022. On December 7, I tested positive with an at home test. I contacted my clinic and was prescribed PAXLOVID. I completed the full 5-day course of PAXLOVID and then tested negative for COVID-19 on the 5th day. 3 days later symptoms returned, and I was again testing positive. I remained positive for 5 days. I treated the symptoms with over-the-counter TYLENOL and decongestant. Most of the symptoms subsided but fatigue and tiredness lingered. I still have these symptoms to date. I began to receive medical treatment for respiratory symptoms that began March 07, 2023, and again March 09, I had respiratory symptoms and saw a physician for them. I tested negative for a number of conditions and was prescribed AUGMENTIN for 10 days. My symptoms improved very slowly. I am still taking it with 1 day remaining. I am still coughing currently.
Dr received phone call from ER at 9:46 am. Dr at ER states child presented to the ER via personal automobile. Mom states patient was gagging all night. Child was in cardiac arrest when she arrived in the ER at 8:16 am. Pediatric advanced life support protocol active for one hour using every cardiac drug per Dr.
hand and wrist joint pain; Right elbow pain with movement 24 hours after injection/ followed by hand and wrist joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself) via COVID-19 portal. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 28Dec2020 at the age of 48 years old (Batch/Lot Number: EL1284, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was  at the hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included hypothyroidism and known allergy to Penicillin (PCN), both from an unknown date and unknown if ongoing. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right elbow pain with movement 24 hours after injection on 29Dec2020, followed by hand and wrist joint pain on an unspecified date. The reporter assessed the events as serious, as they resulted in disability or permanent damage. The patient did not receive any treatment for the events. The patient was not recovered from the events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Had first Hep B on Friday afternoon, by Saturday morning c/o right arm pain, warmth at area, stiffness radiating to neck, also right sided headache. 4/26/10 Area is red and warm.
Patience experienced sweating, dizziness, nausea, and weakness. Recommend patience to rest and stay hydrated and will be monitor by family.
I awoke around 4:30 am on 1/4/22 with an extremely rapid heartbeat. This lasted until the afternoon of 1/5/22. My heart rate was as high as 142 and would alternate between that high and the mid-60s until it settled down on the afternoon of 1/5/22.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#, expiration date, dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Almost fainted from extreme dizziness. Laying down and having a drink prevented fainting and improved symptoms.
administered which is out of date; This non-serious case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered which is out of date).  The outcome of the expired vaccine used 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: 12-Sept-2023 The pharmacist had a query with regards to a Bexsero vaccine, to which a general practitioner had administered which was out of date.  The reporter need guidelines to advise on this matter. No further information was available.  Medical Information was emailing directly to safety on 13th September 2023 as it appears this has not yet been forwarded to safety. The patient received an expired dose of Bexsero, which led to expired vaccine used.
C/O itchy, red, round knot on arm in area of PCV 7 injection.