chrisvoncsefalvay/vaers-outcomes huggingface dataset:
98.5 temp; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (98.5 temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (98.5 temp). At the time of the report, BODY TEMPERATURE INCREASED (98.5 temp) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
headache; fever; chills; weakness; nausea; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 7th August 2019, the patient experienced headache, fever, chills, weakness and nausea. On 10th August 2019, the outcome of the injection site pain was resolved with sequelae. On 11th August 2019, the outcome of the headache, fever, chills, weakness and nausea were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, headache, fever, chills, weakness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain, headache, fever, chills, weakness and nausea. The patient planned to follow up with the physician on an unknown date. The patient consented to follow up.
Administered expired second dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired second dose of Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Narrative:  70 year old patient with PMH of small bowel obstruction, renal cyst, mass of urinary bladder, tinnitus, actinic keratosis, bilateral age related nuclear cataracts, congenital anisocoria, HTN, COPD, hx of hematuria, hypothyroidism and compression fracture (2016) received Pfizer vaccine (30mcg/0.3mL) as a booster dose on 5/17/2022. On 5/18/2022, when a dietitian called patient for a follow (unrelated to vaccine), the dietitian was notified by the family that patient passed away on 5/18/2022. According to progress notes, patient tolerated the fourth dose with no issues. Patient received Moderna x3 for the previous 3 doses. Reporting this event even though we are unsure of the correlation since patient passed away the next day post-vaccine. No other progress notes found regarding the situation in CPRS. PCP has been notified.
The employee complains of heart like it was racing, the night after vaccines were administered, the next day left upper arm was red about the size of half dollar, no swelling or lump palpated.  Afebrile.
Area of the upper right arm, swell up and itchy; Upper arm is swell and itchy; Right arm is bigger; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03DM20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger). At the time of the report, PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ASTHENIA (feeling weak). At the time of the report, ASTHENIA (feeling weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 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.
Initial unsolicited report received from other non-healthcare professional (medical assistant) on 03 June 2016. This case involves 11-year-old male patient who was vaccinated with a first dose of ADACEL (batch number- U5278AA, expiry date- 25 February 2018) intramuscularly in right deltoid, first dose of MENACTRA (batch number- U5180AA, expiry date- 22 January 2017) intramuscularly in right deltoid and also received first dose of HPV (batch number- L016429, manufacturer- Merck) intramuscularly in right deltoid on 01 June 2016. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergy. Concomitant medications were not reported. On 02 June 2016, one day following the vaccination, the patient had experienced 3 mini seizures vs syncope episodes (according to ER record) and the patient was warm, nauseated and lightheaded and fell to the ground, the patient's mother reported that patient's eyes rolled up into head and arms and legs tightened up and were shaking. On 02 June 2016 in the evening, one day following the vaccination, patient vomited 3 times. On 02 June 2016 at 2:44 pm, the patient was seen at emergency room. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event mini seizures. List of documents held by sender: none. Sender's Comments: Seizures may occur after administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is not sufficiently documented. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
BODY ACHES; CHILLS; LEG PAIN; HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced leg pain. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and leg pain, and had not recovered from chills, and headache. This report was non-serious.
Pt received Hep A vaccine approx 6-7 hours after vaccine she had a seizure. Seen in ER had 102 degrees fever. Full work-up done. Antibiotics given. Developed URI next am
She had a fever of 103 the night of 3/16/2010 and 102 in the morning of 3/17/2010. She has bitemporal headache and little appetite. Denies dysuria, cough, or any irritation on site of vaccination. She is somewhat dizzy. No fever in office at 10:45 AM on 3/17/2010.
Sore throat, Feverish, Sweating, Chills, Upset Stomach.
Within 15 min of receiving FLUCELVAX patient c/o bad taste in mouth, tongue felt heavy. Later that day LT arm pain, tingling, severe headache, nausea. The next day at work I called 911 and she was taken to ER. She is still out of work. She had all childhood vaccines and Hep B series with out events.
1 1/2hr p/vax pt broke out w/hives;no resp diff noted;
itching in feet; it's not normal; brain fog like she had a couple of drinks; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number: unknown, expiration date: unknown) via an unspecified route of administration on Feb2021, as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergy. Caller reported that her daughter (patient) got the Covid-19 vaccine today i.e. on an unknown date in Feb2021 and they could not get a hold of the place she got it and patient was experiencing itching in the feet and it was not normal, brain fog like she had a couple of drinks and reporter had concerned if these were normal side effects. Reporter stated that patient also has a penicillin allergy, but not a bad one. The outcome of the event was unknown.   Information on the lot/batch number has been requested.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt with tonic-clonic seizure about 15 hours after vaccination, lasting 10 minutes. Post-ictal lethargy. Seen in ER, all labs normal. Pt with no residual sxs/signs of illness.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac" (unspecified if ongoing), notes: Celiac; "Known allergies: Penecillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had not received other medications in 2 weeks. Anti-viral details: Product=COVID-19 Treatment. Treatment start date=30Nov2022. Treatment stop date=05Dec2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
horrible allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (horrible allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Paranoid personality.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced HYPERSENSITIVITY (horrible allergies). At the time of the report, HYPERSENSITIVITY (horrible allergies) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  It was reported that the patient believed allergies were related to mold in the hotel (since would impact both of us in restroom) also happened a couple other places that were older or in generally dusty as well, but those did not impacted the patient as much. Patient was not Pfizer vaccine (Moderna) and patient felt that this impacted .  No treatment medication were reported.  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.
Vertigo, dizziness. I have had vertigo multiple times in the last 10 or so years and do not know that this is related to this vaccine.  I am taking meclizine 25 mg 3 times daily until the vertigo stops, and also Zyrtec (cetirizine) 10 mg daily at bedtime.
Myalgias (severe) in both quadriceps, causing child to further tighten muscles and sustain pain.
Moderna COVID-19 Vaccine EUA  Rash on legs one hour after injection. Application of anti itch cream and took benedryll. Rash was gone the next day.
This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Mar 16, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced dizziness (dizzy). At the time of the report, dizziness (dizzy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine); intramuscular: unknown. Concomitant medication and treatment medication not reported.
Pain, nausea, fever - diagnosed with acute Appendicitis  - surgery to remove appendix (17 days after 2nd dose)
2 months of pain with pressure and certain common arm movements, sometimes with tingling or numbness. Can't sleep on that side secondary to pain. Referral made to P.T. for treatment. Pain started in 1 wk after injection, after normal post-vaccination soreness resolved. Pt didn't present to care for the problem until 2 months later w/persistent symptoms. First referred for treatment (P.T.) initiated at this visit. Focal point of pain is in deltoid, 3 cm below acromion. Pt. does have pain and impairment (likely secondary to pain) with focal musculoskeletal testing.
There was no adverse reaction to the vaccine. The patient received her 2nd dose of Moderna vaccine too soon. She had gotten her 1st dose on 6/9/2022 so she wasn't due for another week since the dosing interval between the 1st and 2nd doses is 4 weeks. The patient left the vaccine clinic after waiting the 15 minutes with no reactions to the vaccine.
Soreness at the injection site; Tired; Swollen ears; Congestion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication included escitalopram 40 mg (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced soreness at the injection site, tired, swollen ears and congestion. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, tiredness, ear swelling, congestion and treatment included BENADRYL. The clinical outcomes of the events vaccination site pain, tiredness, ear swelling and congestion were resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
After injections when he was walking home he started to feel tired. Since injections he is lethargic, coughing, fever, chills. Pt said he will go to the doctor today.
arm hurt /  achy; stiff arm/stiff ear; got a fever; sometimes couldn't even sip water; no energy; still feel sick; Ear achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water) and ASTHENIA (no energy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy). At the time of the report, MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter. No concomitant information was provided by the reporter.    This case was linked to MOD-2021-236380 (Patient Link).
administered an expired 20mcg/ml booster dose of Engerix -B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 3G535, expiry date 24th January 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown 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 details were provided as follows: The patient was inadvertently administered an expired dose of Engerix B 20mcg/ml as booster dose, which led to expired vaccine administered. The reporter would like to know the efficacy of vaccine after expiration. The reporter did not consent to follow up.
Pain in the left arm Diarrhea Fever Muscle pain throughout the body Headache Dry throat Insomnia Everything has been happening little by little
pt recv vax 18OCT96 & started having skin sensitivity, severe h/a, fever, skin disorders & mediastinal pain;1NOV96 T102 w/mediastinal pain;probably contracted some form of viral encephalomyelitis;fever, chills, vigorous shaking;
Injection site became red, slightly swollen and itchy on 3/19 and was approximately the size of a quarter. As of 3/21, affected is now 2-3 inches in diameter, still red and a bit itchy but less swollen. I had been reporting everything daily to vsafe, but the symptoms started after my check-ins stopped. Symptoms are mild.
NEUROLOGICAL ISSUES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the patient experienced neurological issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological issues. This report was non-serious. This case, from the same reporter is linked to 20221122808.