chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: coviD-19 vaccine (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Aug2021, when the patient was 27-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 01Aug2021, when the patient was 27-year-old, reaction(s): "COVID-19 immunization". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "I barely can walk on"; PERIPHERAL SWELLING (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "My fingers swallow"; FATIGUE (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "My leg so fatigue"; RASH (non-serious), URTICARIA (non-serious) all with onset 27Oct2022 at 12:00, outcome "not recovered" and all described as "Rashes and hives through my body". Therapeutic measures were taken as a result of rash, urticaria, peripheral swelling, fatigue, gait disturbance.  Additional Information: It was reported that, patient developed rashes and hives through her body on the 2nd day of the shot. still having rashes which comes and goes since the shot also her fingers swallow and her ring doesn't fit any more. Patient's leg so fatigue, she barely can walk on. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Face was swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of hypersensitivity (received 1st dose and had swelling arm, red and itchy in deltoid.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial swelling (Verbatim: Face was swollen). The outcome of the facial swelling was not reported.   It was unknown if the reporter considered the facial swelling to be related to Shingles vaccine.     It was unknown if the company considered the facial swelling to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067377   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the patient via interactive digital media. The patient had severe allergic reaction, arm swelled up and was red and itchy on deltoid for a month. Second time the patient took Benadryl just in case.  When it worse off my face was swollen. Went immediately to get medical help.  The patient would not ever get another vaccine for this. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067377:Same patient
Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and stroke, T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning, deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash, wheeze, and difficulty breathing. Son was with patient throughout the day. In the evening, when preparing for bed, he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes, last evening she did not regain consciousness, experiences a brief period of labored breathing, and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx:  Symptoms: & Death Treatment:
Had the worst cold sore/ herpes outbreak ever. it spread to my genitals, went to doctor and confirmed its still HSV1 and not HSV2. also spread to the inside of my mouth and nose. skin was sloughing off the inside of my nose and the roof of my mouth.
Appetite change, pale, apnea spells, bradycardia in the 50's.
In June 2021, my heart rate was up to 140 and I went to the ER and it was at 160 and would not go down. I had to be hospitalized in June 12 2021 for AFIB. I have never had heart problems before then. I was hospitalized for the weekend and had a follow up with a cardiologist. I am now on medication for atrial fibrillation (AFIB). I was diagnosed with breast cancer in October 2021 and have had a double mastectomy. There is no history of breast cancer in my family.
I developed a cough, which isn't unusual for me, since I have asthma. I then started to run a fever of about 99 in the night, and I think it possibly reached 100. I took a home antigen test and got a positive result. We called the advice nurse, who sent the message to my doctor that I had COVID-19. My doctor prescribed Paxlovid, which I began taking 4/8/2023. On 4/9/2023, I felt better. I then continued to rest, drink plenty of liquids, and test myself about every other day until I got a negative result. On 4/10/2023, I contacted my allergist and told her that I had COVID-19. She had me alter my medication dosages. I was to take two doses of Asmanex every six hours. I was also told to take albuterol every six hours, or every four hours, if needed. She also told me to take Robitussin DM every four to six hours to treat my cough. I finally tested negative on 4/19/2023.  I am presently over COVID-19, but COVID-19 triggered my asthma, and I am still dealing with the asthma. Typically, if I have a cold, flu, or bronchitis, it triggers my asthma. I then have to deal with the asthma six to eight weeks afterwards. I am currently still taking the medication dosages recommended by my allergist. My asthma is currently out of control, and I am trying to control it by increasing the frequency of albuterol and Robitussin DM.  If I can't get my asthma under control, I will call my allergist, who will prescribe me cortisone to control the asthma.
Myalgia, fever & fatigue Acetaminophen 650 mg once take now, one dose
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-SEP-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 09-NOV-2015, the patient was treated for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed topical creams for the management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Site: Pain at Injection Site-Mild, Error: Patient Too Young for Vaccine Administered-, Additional Details: Patient's parents registered child under false birthday, errantly creating a situation where the pharmacy unknowingly administered the vaccine to a child that is too young.  Pediatrician and health department notified the pharmacy staff of the difference in the reported birthdays.
Information has been received from a physician referring to a 16 year old female patient. The patient's medical history included liver transplant on an unspecified date when she was an infant. On an unknown date (reported as "years ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). Concomitant medication included acyclovir. On an unknown date after the vaccination, the patient had her second liver transplant. On 02-NOV-2015 the patient developed a "varicella zoster virus (VZV)-like rash". A polymerase chain reaction (PCR) swab sample was done on 05-NOV-2015, revealing a low positive result with a cycle threshold (CT) value of 39.2. The reporter stated that the rash developed along the scar line from the liver transplant (onset date of scar was unknown). At the time of reporting, the outcome of the events was unknown. Upon internal review, the event "liver transplant" was considered as medically significant. Additional information has been requested.
Site of injection had swelling immediately after her shot. No fever or respiratory distress noted. There was burning at the site that lasted 5 minutes. Observed for 15 minutes returned to family with instructions to call family doctor if symptoms reoccur.
This spontaneous report as received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Information about the patients' pertinent medical history and drug reactions/allergies was not reported. It was reported that since 16-MAY-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as K025764 with expiration date 08-JUN-2016, lot # L050907 with expiration date 14-JUN-2017 and lot # M001152 with expiration date 05-JUL-2017, (dose, frequency and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. The PROQUAD was exposed to a temperature of 21F for 63.5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Additional information has been requested.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ELAGOLIX SODIUM (ORILISSA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ELAGOLIX SODIUM (ORILISSA) (Oral) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On an unknown date, the patient received Moderna COVID-19 vaccine and experienced headache. Patient had headache and she took Excedrin. She had off Excedrin a week and a half because she had not been able to take it and now she was having withdrawals at the time of report.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
muscle aches; pain in lower legs; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a health care professional.  This case is linked with case 2019SA322627 (same reporter)  This case involves a male patient of unknown age who experienced muscle aches (PT: myalgia), pain in lower legs (PT: pain in extremity) while he received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE, patient experienced muscle aches (myalgia) and pain in lower legs (pain in extremity).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome for both the events was reported as recovered (took about 2 months to get better).  Information on the batch number was requested.
Patient returned to store approx 10:30 am on 8/15/18 and stated that he woke up in the morning with pus oozing out of injection site. He squeezed out what he could, and covered with non-stick pad. I advised patient to visit urgent care immediately for follow-up.
Patient received a flu vaccine on 12/6/13. He experienced severe soreness in his arm after receiving the vaccine. Patient contacted his Dr. and is now on a 10 day course of anti-inflammatory.
Testes felt very tender; especially on the right side of my body; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: MRN:70697732, Expiration date: unknown), dose 1 via an unspecified route of administration in left arm on 25Feb2021 at 12:30, as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had any known allergies. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccine. Post vaccination, the patient did not had COVID test. On 25Feb2021 at 14:00, the patient experienced testes felt very tender, especially on the right side of his body. Therapeutic measures were not taken as a result of event. The outcome of the event was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt under age for current authorization for booster # 2. Pt contacted and no ill effects.
fever; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The patient experienced fever and muscle aches. The reporter asked how long did this last
red blood cell problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 17Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: RED BLOOD CELL ABNORMALITY (non-serious) with onset 2021, outcome "unknown", described as "red blood cell problems".  Additional information: Reporters sister has red blood cell problems now, and patient not getting the booster. The patient was fine after first one, this was after the second one 17Sep2021. Her sister's red blood cells are also small. The patient is now receiving iron transfusions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired) and RASH (Rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced RASH (Rash). In 2021, the patient experienced FATIGUE (feeling tired). At the time of the report, FATIGUE (feeling tired) and RASH (Rash) outcome was unknown.            This case was linked to MOD-2021-262966 (Patient Link).
Swollen armpit on arm of injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, high cholesterol and seasonal allergies. The patient had known allergies to cefaclor (CECLOR) and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), montelukast sodium (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced swollen armpit on arm of injection site. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen armpit on arm of injection site was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe kidney pain right knee swelled could not walk. Then left knee. Extreme pain.Still in pain 4 months later still undiagnosed.Unable to work.
Patient was nauseous evening after getting vaccine. The next morning she woke up and was still nauseous, had a headache and turned "gray" and then fainted. She did not report any injury from fall and woke up. The arm below the injection site was red and hot/swollen the same day and the swelling decreased slightly with Benadryl she took at home. Patient went to doctor the next day and received prescriptions for prednisone and Benadryl. Two days after vaccine patient still has some swelling and redness.
No additional adverse event; an expired dose of ROTATEQ was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was reported.  On 29-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, orally, once, lot # 1660948 was confirmed to be valid, expiration date 22-MAR-2021, for prophylaxis. It was also reported that the vaccine had never undergone a temperature excursion. No additional adverse event was reported.
Head start hurting; Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up; Start feeling bad; Got really from bad to worse/I am not feeling a 100%; Not have an appetite; Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling; Start throwing up the water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: High blood pressure Consumer stated, "I do have high blood pressure but I went to the doctor and my blood pressure is normal.". Concomitant medication(s) included: HYDROCHLOROTHIAZID taken for hypertension. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Unknown manufacture, Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day), for COVID-19 Immunization, reaction(s): "Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day". The following information was reported: DIZZINESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling"; HEADACHE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Head start hurting"; DECREASED APPETITE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Not have an appetite"; FEELING ABNORMAL (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start feeling bad; Got really from bad to worse/I am not feeling a 100%"; PAIN (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up"; VOMITING (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start throwing up the water". Therapeutic measures were taken as a result of headache, pain, feeling abnormal, decreased appetite, dizziness, vomiting.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 4 month old female who on 08-MAY-2007 was vaccinated with a 2 ml oral dose of Rotateq. No adverse effect was reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.