chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle soreness; trouble sleeping the following night; fatigue; low grade fever (1.3 F higher); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 12:15 as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "Muscle soreness"; FATIGUE (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "low grade fever (1.3 F higher)"; INSOMNIA (non-serious) with onset 07Sep2022 at 21:00, outcome "recovering", described as "trouble sleeping the following night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, insomnia, fatigue, pyrexia.  Additional information: The patient had no known allergies. Prior to the 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 four weeks prior to the vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295064 same reporter, same patient, different dose, different AEs.;
abdominal cramping, fatigue Narrative:  Employee developed abdominal cramping and fatigue about an hour after the vaccination. The cramping self-resolved after around 30 minutes and the fatigue resolved upon resting/napping soon after. She reported no other common adverse effects including nausea, vomiting, and diarrhea. She did not feel the need to take any therapies or reach out to EOH.  Other Relevant History:
Patient was meant to be given HD flu shot, was given standard dose (Flucelvax) in error. Error was caught and patient was given Fluzone HD as well.
terrible stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (terrible stomach pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history information was reported.  Concomitant products included RITUXIMAB and OCRELIZUMAB (OCREVUS) for an unknown indication.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (terrible stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.
did not feel good the next day; it was like she had Covid, weak and had some shakes two days after; it was like she had Covid, weak and had some shakes two days after; it was like she had Covid, weak and had some shakes two days after; This is a spontaneous report from a contactable consumer (patient). A 76-year-old Patient of an unspecified gender received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection) via an unspecified route of administration in arm left on 20Mar2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was stated that patient wanted to report  side effects from the Pfizer Covid vaccine. Stated that patient had Covid in December. Stated that that the vaccine did something to nervous system like shaking that patient took it and for over 2 hours had chills. Later clarified that these side effects were from the second one. Stated that the pharmacist told if patient had antibodies not to get the shot. Stated patient had it checked and had antibodies left. Stated that patient had asked doctor if patient should get the vaccine since it was past 90 days since patient had Covid and he stated yes. Stated that patient took the first one. Stated patient did not feel good the next day on 20Mar2021. Stated that it was like patient had Covid, weak and had some shakes two days after on 20Mar2021. Stated that with the second one that patient had blurred vision and woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down. Stated that in the afternoon that patient had another spell of this. Stated that patient just felt better today. Stated that patient had heard others that had Covid and then had reports of them getting sick. No further details provided. Declined to complete a report about the others. Stated that Pfizer should know that people should not take the vaccine if they have antibodies. Stated that hair started coming out before the vaccine. Clarified that patient had antibodies checked three weeks before patient had first shot. Stated that that one pharmacist stated not to have it until summer and then another stated to go ahead and take it. Stated that patient had back and hip trouble and cannot get up the stairs good before the vaccine. Stated that the vaccine is supposed to protect you but who knows. Stated that patient took both doses of the vaccine. Stated that the pharmacist told if patient had antibodies not to get the shot. Stated that that one pharmacist stated not to have the vaccine until summer and then another stated to go ahead and take it. Outcome of event Shaking was recovered  on 11Apr2021, while with other events was recovered on 21Mar2021.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
itching; hot; red; slightly swollen 2" round circle at injection site on left arm; no pain; no fever
Patient complained of tingling/numbness in her hands. She became dizzy and needed to sit down. Symptoms progressed to what the nurse practitioner called  "strokelike symptoms". She was conscious but could not respond to requests such as smile or say your name. Her blood pressure was high when taken. It was probably 30 minutes before the EMTs took her to the hospital.
Information has been received from a registered nurse concerning a 13 year old male pt with no known drug allergies and no past medical history who in the AM of 11/20/02 was vaccinated SQ with the third doses of MMR II (639692/0635M). Concomitant medications that day in the AM included the third dose of hep B vaccine recombinant (641741/0153M) given IM. Concomitant medication on 11/19/02 in the AM included the second dose of MR II (639692/0635M) given SQ and the second dose of hep B vaccine recombinant (641741/0153M) given IM. There was no illness at the time of vaccination. Subsequently, on 11/20/02 at 10am, the pt experienced a headache and arm soreness. Unspecified medical attention was sought. The reporter indicated that on 11/20/02, the pt recovered. No diagnostic tests or lab data were reported. No further info is expected.
An unk # of pt recvd vax & exp vomiting hrs p/inject; No further details are available; THis case is considered to be invalid;
Pt recvd vax 5JUN92 & on 12JUN92 episode of serum sickness following vax w/horse serum-based tetanus antitoxin when pt was 6 yrs of age; 12JUN92 pt exp myalgia, arthralgia, tingling of legs, malaise, tender soles of feet;
Injection site soreness dissipated as expected. However, shoulder soreness increased. Patient did not otherwise injure shoulder. Patient continues to receive PT to relieve symptoms.
Ringing in ears continually. Low level of volume but clear and persistent. Occurs continually 24x7
Local reaction of redness and swelling. On and off episodes of dizziness and heart palpatations.
LITTLE CHILLY; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 1), (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered for prophylactic vaccination. No adverse events reported following vaccination (dose number in series 1). The patient received tylenol unspecified (coated tablet, route of admin, and batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced little chilly (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol unspecified was not reported. The outcome of the little chilly, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Headache; Tiredness; Pain around the area of the injection site; Poor sleep; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old 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 an unknown date in Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to unspecified medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and multivitamin supplements (MANUFACTURER UNKNOWN), taken for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in Apr2021, the patient experienced headache, tiredness, pain around the area of the injection site, and poor sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, tiredness, pain around the area of the injection site, and poor sleep were resolving 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.
Pooped EVERYTHING out off & on for several hours, took Pepto Bismal, was back to normal the next morning March 12, 2021.
Broke out with rash all over head, face and neck. Within 72 hours went to Dr. Said it was shingles. Gave him an antiviral. Took 3 wks to get better. Still feels creepy/crawly on head.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year  female. The patient's height, and weight were not reported. The patient's past medical history included: liver issue, and concurrent conditions included: non alcohol user, and social smoker (smokes once a while), and other pre-existing medical conditions included: Patient had no known allergies and patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802070, and expiry: unknown) dose was not reported, 1 total administered on 11-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On around 15-AUG-2021, patient tested negative for antibody test. On 15-SEP-2021, patient again tested negative for covid-19 antibody rapid point of care (POC) test and type was immunoglobulin G(IgG)/immunoglobulin M(IgM) and had confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193491. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210928925-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
delayed reaction of a rash on arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (delayed reaction of a rash on arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (delayed reaction of a rash on arm). At the time of the report, RASH (delayed reaction of a rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056129 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056129:patient 1- first dose
temp of 100; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache). At the time of the report, PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100 Temp of 100.         No concomitant medication use was provided by the reporter.  Treatment of events was not reported though patient inquired if taking acetaminophen (Tylenol) was okay.
Recently noticed that injection site is swollen and itchy and red, as well as multiple red patches surrounding the injection site
arm felt tight & itchy, had little bumps like hives which lasted couple of days; same arm as inject was given; inject area warm to touch OK next day; itch & tightness for approx 2 days; not too swollen;
Initial case received on 16 September 2010 from a patient. A female patient received an injection of FLUZONE (lot number not reported) on 11 September 2010. She experienced a "racing heart", elevated blood pressure, and dizziness five minutes post vaccination. She treated herself with an "extra dose" beta-blocker. She was evaluated at an urgent care facility, where an electrocardiogram (EKG) was performed. Per the patient, the EKG was normal/negative (no report was provided). Her pre-existing medical conditions included a latex allergy and supraventricular tachycardia (SVT). Concomitant medications included beta-blockers. She denied any acute illness at the time of the vaccination. The patient fully recovered and "felt better" by evening of the same day. Documents held by sender: None.
Severe dizziness and weakness right after the vaccination. Foggy brain, light headed, nerves problem since then.
Redness, swelling 2 cm induration cephalexin 500mg QID x 7 d - recheck in 1 week - 1/22/15 - DNKA pt called to cancel - feeling better.
severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EN5318), via an unspecified route of administration on 11Feb2021 15:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included magnesium, cannabidiol (CBD) and docusate sodium (COLACE) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 (lot number=EL1283) on 21Jan2021 15:00 in the left arm for COVID-19 immunization and experienced extreme muscle cramps in both legs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 13Feb2021 19:00, patient experienced severe abdominal pain with a low grade fever and body chills. Patient visited her primary doctor the following day, and then went to the ER on day four of the onset of her symptoms. Patient had an appendectomy in Feb2021 at the ER. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included surgery to remove appendix. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (post vaccination): Negative on 15Feb2021 and 16Feb2021. Outcome of the events was recovering. The report was assessed as serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183649 same patient, different AE/dose
Patient parent signed consent form verifying and misrepresenting patients age, then upon verbal verification misrepresented a second time
This child had a seizure in the afternoon, paramedics were called. Arrest- stabilized and transported to CMH. EEG, Spinal Tap with CNS done, MRI completed on 08/16/2001. No diagnosis yet. Child still hospitalized.
Subsequent to Plaintiff's ZOSTAVAX inoculation, Plaintiff was treated by a healthcare provider, at Medical Center, for Bells Palsy.; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis).         On an unknown date, the patient was treated by a healthcare provider for bells palsy.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  At the time of this report, the outcome of the event was unknown. The relationship between zoster vaccine live (ZOSTAVAX) and the event was considered as related by the reporter.  Upon internal review, bells palsy was determined to be medically significant.    Additional information has been requested.
Achy arm in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy arm in injection arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D 3), LANSOPRAZOLE, PROBIOTICS NOS, MAGNESIUM OXIDE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achy arm in injection arm). At the time of the report, PAIN IN EXTREMITY (Achy arm in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Estrogen Vaginal Cream, Omega 3 Esters, Ferrous Fumarate, Cranberry Capsules, Calcium Carbonate for an unknown indication. No treatment information was provided.
my back hurts; pain in my legs; my bones hurt; my head hurts a lot; I get very tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications included medication for cholesterol  and Medication for blood pressure, not specified.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Email response received On 11-Jun-2021: Translation received on 29-JUN-2021 and does not contain any new information.
pt recvd vax 11NOV92 & devel high fever, spotted red skin & became lifeless; pt seen in ER on 11NOV92; pt recovered w/in 24 hrs; no further details were provided;