chrisvoncsefalvay/vaers-outcomes huggingface dataset:
grand mall seizure; mouth foaming; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mall seizure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Penicillin allergy and Allergy to animal. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM ASCORBATE (VITAMIN C [CALCIUM ASCORBATE]) for an unknown indication.    On 22-Mar-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 5:30 AM, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mall seizure) (seriousness criterion hospitalization) and FOAMING AT MOUTH (mouth foaming). The patient was hospitalized from 23-Mar-2021 to 24-Mar-2021 due to GENERALISED TONIC-CLONIC SEIZURE. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mall seizure) and FOAMING AT MOUTH (mouth foaming) 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.   Treatment of these events were not provided.; Sender's Comments: This case concerns a 73-year-old female hospitalized with a serious unexpected event of generalized tonic-clonic seizure, and nonserious unexpected foaming of the mouth. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded.  When I woke up I was fine!
Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continued to this day; joint swelling and pain. Joint swelling and pain has continued to this day; This is a spontaneous report from a contactable other health care professional. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EK9231; Age at vaccination 44 Year), dose 2 via administered in Arm Left on 06Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included Allergies to peanuts, tree nuts. Concomitant medications included famotidine. The patient previously took zithromax and experienced Allergies, bnt162b2 (Lot number: EK5730; 17Dec2020 17:00, Left arm, dose number=1). the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination: Famotidine; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 06Jan2021 22:30, Fever to 103.9, severe muscle cramping, joint swelling and pain. Joint swelling and pain has continued to this day. ae resulted in Disability or permanent damage; Recovered with lasting effects. The patient not received treatment AE. The outcome of the events was resolved with sequel. ~; Sender's Comments: A possible contributory effect of suspect BNT162B2 on the reported events cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I was short of breath, had Chills, temperature of 102.3, generalized body aches, nausea,  headache and left leg dull pain.
This spontaneous report was received from a nurse practitioner refers to a 40 year old patient of unknown gender. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. Reporting nurse stated that the patient was indicated for vaccination with M-M-R II and VARIVAX (Merck), but was administered with one dose of PROQUAD (Merck) (lot # L040415, expiry date: 13-APR-2017) instead (inappropriate schedule of drug administration). There was no product confusion. No adverse effect was reported. It was reported that M-M-R II and VARIVAX (Merck) appeared on the product list, but were not administered. Additional information has been requested.
Severe lower back pain, shoulder pain, and continuous joint pain in the legs since receiving all 3 series of doses.
Moderna COVID-19 Vaccine EUA Headache, body aches, shaking chills - starting approx. 6 hours post injection. Continue with headache, body aches at time of report (34 hours post injection).
Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
4DEC96 1115PMM t99.2, rash, diarrhea;dx gastritis, conjuncitivis;5DEC96 235PM t99.9, vomiting noc w/temp up to 103 -104ax, not wanting to eat;FNP noted weak crys;responsive to stimulip;pt referred to MD;
runny & itchy nose; runny & itchy nose; bad joint inflammation; pain in her great toe; toe has appeared to be dark pink in color with improvement noted; This is a spontaneous report from a contactable consumer reporting for mother in low  An 87 year old female patient received first dose  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 06Mar2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 09Mar2021 the patient experienced runny & itchy nose, bad joint inflammation, pain in her great toe. It was also reported that toe has appeared to be dark pink in color with improvement noted. At the time of the reporting events outcome was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained
This spontaneous report as received from a physician refers to an unspecified numbers of patients. Pertinent medical histories were not provided. The physician reported that an unspecified number of physicians (unspecified physician names) have told him that they had some new patients came to their offices with vaccination records which showed the patients received a dose of PROQUAD (Merck) (lot#, dose and route were not provided, unspecified if the dose was dose 1 or dose 2) when they were older than 12 years of age. The ages of the patients when they had received PROQUAD (Merck) were in the age range of 13 years to 15 years of age. No symptoms reported. The outcome of the events was unknown. Additional information is not expected.
Nightly sleep seizures/spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg; Temporary, passing paralysis; spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg; longer aphasia (inability to speak); severe migraines; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Ew0179) on 13May2021 at 02:45 PM into left arm for COVID-19 immunisation. Medical history included Hypermobile Ehlers-danlos syndrome, non-epileptic seizures, migraines, mild traumatic brain injury, intractable pain, severe food allergies. Known allergies: Wheat, gluten, eggs, soy, estrogens. Historical vaccine included 1st dose of BNT162B2 (lot Ew0171) on 22Apr2021 at 02:45 PM into left arm for COVID-19 immunisation. Concomitant drugs included Morphine, hydrocodone bitartrate, paracetamol (NORCO), diazepam (VALIUM), Propranolol, Hydroxyzine. The patient had a non-epileptic seizure disorder that was well controlled. After the second dose she began to have nightly sleep seizures, severe migraines, but am writing because of a spastic seizure lasting 5 minutes of uncontrollable myoclonus only of the left leg, with longer aphasia (inability to speak) and temporary, passing paralysis. The symptoms passed in an hour but an epileptic patient could have died. Event onset time was 19May2021 06:30 PM. No treatment was received. The outcome of the event was resolving.
Patient received full dose of Moderna (0.5 mL) as a booster dose (should have been 0.25 mL).  In addition, the immunization was supposed to be a booster dose of Janssen (first dose of Janssen administered 5/15/21). No known adverse reactions present
Heavy nosebleeds on more than 4 occasions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 14Nov2021 10:00, outcome "not recovered", described as "Heavy nosebleeds on more than 4 occasions". Therapeutic measures were not taken as a result of epistaxis.  Additional information: No other vaccine was taken in four weeks. The patient did not have covid prior to the vaccination. The patient was not covid tested post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous prospective pregnancy report as received from a 34 year old female patient refers to herself. The patient became pregnant with last menstrual period (LMP) of 12-SEP-2014 and estimated due date (EDD) of 19-JUN-2015. On 09-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, RECOMBIVAX HB, and VAQTA (lot #, strength, dose, frequency and route unspecified). The patient stated that she discovered she was pregnant on 10-OCT-2014 a day after she received the three vaccines. Initial exposure to (Oka/Merck) VARIVAX was at 4 weeks. The pregnancy outcome was outcome pending. The outcome of the event was unknown. Additional information is not expected as there was no contact details.
3 cm diameter red induration at injection site. Hives present all over within 48 hrs after injection. BENADRYL 25-50mg every 6-8 hrs prn.
Per Dr symptoms fever, rash (measles) symptom occur 6 days after immunization.
Breakthrough case admission after 4 vaccines Pfizer x4; Pfizer 3/15/21 Lot# EN6207;  Pfizer 4/5/21 Lot# EW0150;  Pfizer 8/23/21 Lot# FC3183;  Pfizer 4/13/22 Lot# FK9896
Blowing stuff out of my nose; Muscle soreness; Coughing; Wakes up with sweat; Fever (99-100 F); Has the chills; Cold like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    A spontaneous report was received from a healthcare professional concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold like symptoms/nasopharyngitis, fever (99-100 f)/pyrexia, wakes up with sweat/hyperhidrosis, has the chills/chills, muscle soreness/myalgia, blowing stuff out of my nose/productive cough, coughing/cough  The patient's medical history was not provided. Concomitant medications reported were clarithromycin ,diphenhydramine and oxygen for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L00A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) cold like symptoms. On 16 Feb 2021, the patient experienced the event(s) fever (99-100 f), wakes up with sweat, has the chills. On an unknown date, the patient experienced the event(s) Muscle soreness, Blowing stuff out of my nose, coughing.  Treatment details included Guaifenesin and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cold like symptoms, fever (99-100 f), wakes up with sweat, has the chills, muscle soreness, blowing stuff out of my nose, coughing was unknown.
Complained of left arm pain after getting flu vaccine 11/4/09.  Intermittent pain, numbness and tingling from upper arm to hand.  Ibuprofen, ice, heat recommended, x-ray, follow up appointment if no improvement in 7-14 days.
pain in arm; Stiff Neck; Pain down arm to wrist; stiff neck; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist), MUSCULOSKELETAL STIFFNESS (stiff neck) and PAIN IN EXTREMITY (pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 02bL20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist) and MUSCULOSKELETAL STIFFNESS (stiff neck). On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 20-Jan-2021, MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist) and MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. On 18-Feb-2021, PAIN IN EXTREMITY (pain in arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PAIN IN EXTREMITY (Pain down arm to wrist) to be possibly related. No further causality assessments were provided for MUSCULOSKELETAL STIFFNESS (stiff neck) and PAIN IN EXTREMITY (pain in arm).    No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-090696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Pt recvd vax & exp a migraine h/a, nausea & vomiting; migraine h/a lasted 24 hrs;
Patient received expired dose of Act-Hib/no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-APR-2021 from a health care professional via Global Medical Information (Reference number- 00544865) and transmitted to Sanofi on 01-APR-2021.  This case is linked to case 2021SA108007(same reporter).  This case involves a 18 month-old female patient who was vaccinated with 0.5 mL(total) expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch number UJ143AAA; expiry date 22-Mar-2021; frequency: once; strength: standard) via an intramuscular route at the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vacciantion.  Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-HIB and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, Still using product: No.  At the time of reporting, no adverse event was reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
fever; mild headache; achy joints-especially hips; very fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips), FATIGUE (very fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), HEADACHE (mild headache), ARTHRALGIA (achy joints-especially hips) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling and redness to both arms.  Mother states R arm is going down but L arm does not appear to be going down.
On 8/23/21 the patient began experiencing symptoms of COVID-19 including sore throat, myalgias, congestion, shortness of breath, and cough. Patient presented to ED to receive a scheduled Regeneron COVID-19 monoclonal antibody therapy, but the patient was found to have an O2 sat of 88% with exertion, improving to 90% with exertion. Patient was no longer a candidate for antibody therapy and signed in to ED for evaluation. Patient was placed on 2L O2 via nasal cannula and had improvements of shortness of breath and O2 sat increased to 97%. Patient was started on 6 mg dexamethasone. The patient will be admitted to the hospital.
constant migraine headaches and nausia for 7 days.  Excedrin taken every 3 hours to make this manageable.   Also seasonable allergy reactions stopped during this time.  Could not work.
This spontaneous case, initially received on 29-Nov-2016, was reported by a health professional and concerns a(n) 59-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 19-NOV-2016 to 19-NOV-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. On 19-Nov-2016, the patient was administered AFLURIA vaccine that underwent first excursion. It was stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Sore, stiff arm, knot at injection site, red and fevered. Treated with ice pack, heat and Motrin.
Arm pain; Not know where I was; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm and disorientation. On an unknown date, the outcome of the pain in arm and disorientation were unknown.   It was unknown if the reporter considered the pain in arm and disorientation to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm, for few days after receiving Shingrix. The patient taken a nap a few hours latter and woke up in home not know where was. The reporter asked is this a side effect.
cellulitis lt leg-poss local rxn to inject; given Ancef 500mg IM-to take augmentin; 7-10 days, elevate leg, rest, warm compresses;
pt recv vax 12JUL95 & mid APR96 pt exposed to natural chickenpox;27APR96 exp itching over entire body, devel 50 gen vesicles & fever 99.3;29APR96 to MD;had papular rash in various stage from pustular lesions to drying poss chicken pox
feeling similar to a slight hangover; This is a spontaneous report from a contactable consumer and a non-contactable consumer.  These two consumers reported for a female patient of an unspecified age who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 17Dec2020 as a single dose for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported.  The patient experienced feeling similar to a slight hangover on 18Dec2020. The clinical outcome of feeling similar to a slight hangover was unknown.  The lot number for the vaccine, VACCINE BNT162B2, was not provided and will be requested during follow up.