chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressure on the chest; weight on the head; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure on the chest), HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHEST DISCOMFORT (pressure on the chest), HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache). On 25-Mar-2021, CHEST DISCOMFORT (pressure on the chest) had resolved. At the time of the report, HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
The patient received the vaccine on 12/28/2020 around 2:45pm. She reported a headache the next morning which turned into body aches and a cough. She was sent home and advised to call occupational health.
I received the vaccine on 01/11/2021.  I had pain at the injection site that lasted two days.  On 01/18/2021, at the injection site area, my arm became red, slightly swollen, and slightly itchy.  The area is approximately 4 inches by 3 inches.   I still have the symptoms  at the time of this reporting (01/20/2021).
Patient reported about 10 minutes after administration of the first dose of the moderna covid-19 vaccine that she was having difficulty breathing. 911 was called and she was taken to the hospital. While waiting for EMT patient reported that she was feeling better and suspected it may be anxiety. at no point did she report, or did I notice swelling of her lips, tongue, mouth or throat. She also never reported difficulty swallowing. I sat and talked with her while waiting for EMT to monitor breathing or any changes in difficulty speaking. At no time did the patient have any difficulty speaking or have any signs that she was having breathing difficulty. by the time EMT arrived she was still alert speaking and had no signs of a true allergic reaction. EMT agreed. Pt still elected to go to the hospital to confirm that it was a panic attack.
Erythema and swelling; approximately 7 cm x 12 cm. Itchiness around the injection site. Pain over injection site and extending down the upper arm. Burning sensation at injection site and extending down arm. No treatment.
After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol/triglycerides" (unspecified if ongoing); "High cholesterol/triglycerides" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: Seriousness criteria-Results for death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect was reported as No. After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching began in left arm, moved across torso to right arm, itching also in mouth, tongue, throat and ear. Took 2 Benadryl and itching subsided after approximately two hours.
Report 20010212431 describe a seizure in a 71 year old female who received hep B vaccine recombinant (engerix-B). The vaccinee was allergic to sulfa. Her medical history included bipolar affective disorder. She was taking unspecified "long term medications." On 08/23/2001, the vaccinee received her first adult dose of engerix-b. Within 18 hours, she "experienced her first recorded seizure ever." She was then taken to the ER and admitted to the hospital on 08/24/2001. She underwent CT, MRI, and EEG. All tests were negative. She was discharged from the hospital on 08/27/2001. As of 08/31/2001, the vaccinee was taking two unspecified anti-epileptic medications. The outcome of the event was not reported. On 09/28/2001, the reporter stated, "I think it would be misleading to report this as a possible consequence of the vaccine." He stated that the vaccinee was learning to play the recorder and "It is much more likely that this results to playing the recorder" with resultant hyperventilation. He stated that the vaccinee had two seizures, both after playing the recorder. As of 09/28/2001, the outcome of the event was unknown.
On 4/10/98 pt recv vax and on 4/13/98 pt exp malaise, dizziness followed by seizure activity.  Pt hosp for one day.
This spontaneous report was received from a pharmacist via poison and drug center (Manufacturer# US15-045398) on 29-SEP-2015 and refers to a 63 year old female patient. There was no information about patient's concurrent conditions and medical history reported (no chronic health issues as hypertension or diabetes mellitus). On 13-OCT-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot#, expiration date, dose, site and route of administration were not reported). On 26-SEP-2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX 0.65 ml (lot# L020482, expiration date 02-SEP-2016, anatomical location was not reported) intramuscularly. Concomitant therapies included Tdap, influenza virus vaccine inactivated (unspecified), gabapentin, propranolol (manufacturer unknown), paroxetine, levothyroxine (manufacturer unknown), lamotrigine, fenofibrate and triazolam. No unwanted events and no lab work were reported. Additional information has been requested.
Family stated patient had been weaker since "last covid shot".   Patient death 5-5-2021 - 1 week after vaccination
About 1 week, post vax, pt developed recurrent a rash on his back and a flu-like illness for 1 month afterwards.
she is miserable; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (she is miserable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DEPRESSED MOOD (she is miserable). At the time of the report, DEPRESSED MOOD (she is miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
redness of the face; flushing of the face; high blood pressure; Heart enlarged on the right side.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.). At the time of the report, ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 183/103 mmHg high blood pressure. On an unknown date, Chest X-ray: The EKG, and Chest X-Ray were normal. On an unknown date, Electrocardiogram: The EKG, and Chest X-Ray were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow up- Narrative updated
Pt experienced shoulder pain on injection site side - vaccine given 1-19-11 - had discomfort - complained of worsening discomfort the last 3 days.
This spontaneous report was received from a male physician who was also the patient reporting on himself, via a field representative. The patient's concurrent conditions included post herpetic neuralgia. The patient's medical history included shingles. The concomitant medications, drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot #, expiration date, dose, frequency, route of administration, anatomical location and indication were not provided). Then on an unspecified time after receiving the vaccine, the patient experienced a reduced frequency of post-herpetic neuralgia (Pre-existing condition improved). No further clarification or information was provided. The outcome of the pre-existing condition improved was unknown. The action taken with the ZOSTAVAX was not applicable. No product quality complain (PQC) was involved. Additional information has been requested.
Patient was administered dose 1 moderna and dose 2 janssen.  no adverse reaction.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022, outcome "not recovered", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2023) Negative, notes: tested negative until 07Sep; (06Sep2023) Negative, notes: tested negative until 07Sep; (07Sep2023) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Aug2023 to 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At birth, the vaccinee received his 1st injection of Hep-B vaccine (mfr unk). At 1, 6 and 12 months, the vaccinee received Recombivax-HB. "A couple of months ago", a Hep-B antibody test was negative. The results of this test "suggested that the vaccinee was not sero-protected."
Red lesion appeared where injection was given the following morning. Very tender and warm to the touch. Large knot under skin that is bigger than red lesion.
A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional concerning a 25-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
he had tested positive for Covid-19 after receiving the first dose of Pfizer vaccine; he had tested positive for Covid-19 after receiving the first dose of Pfizer vaccine; Caller had shivers; cough.; This is a spontaneous report. A contactable male consumer, the patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had tested positive for covid-19 after receiving the first dose of Pfizer vaccine and experienced shivers and a cough. He has been coughing a lot and wants to know if he should continue with getting the second dose on 03Apr2021. Any unaddressed medical questions referred or can be forwarded to medical information. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant medication was not provided.  196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated narrative.
Left arm very painful; Left arm swollen; Red rash at the injection site; Warm to the touch at injection site; Left arm terribly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and PRURITUS (Left arm terribly itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE BESYLATE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and PRURITUS (Left arm terribly itchy). On 04-Apr-2021, VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site) and PRURITUS (Left arm terribly itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling at inject site with itching. No specified (?) induration. Mild erythema. No limitation of movement.
fatigue after 3 days light headedness, dizziness, vertigo after 14 days and continuing
Husband experienced seizure lasting 30min. after taking 2nd vaccine. 1st vaccine on 26/01/21 LOT# 00TM20A.  2nd on 23/02/21 LOT# 024M20A,5 Days after; the Ambulance took husband to hospital & Dr put the patient on a seizure med Levetiracitam 500mg; A spontaneous report  was received from a consumer, concerning 87-year-old male patient, who received his second dose of Moderna's COVID-19 vaccine and experienced seizure that lasted about a half an hour.  Medical history included: seizure 37 years ago during a stroke. There were no concomitant medications reported.  On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: LOT# 00TM20A) and on 23-Feb-2021, he received the second dose of mRNA-1273 (LOT# 024M20A), intramuscularly for prophylaxis of COVID-19 infection.  On 28-Feb-2021, five days post receive the vaccine, the patient experienced a seizure which lasted about a half an hour. The patient was taken to hospital and was treated with Levetiracitam 500mg.  Action taken with the dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was considered as resolved on 28-Feb-2021.; Reporter's Comments: Based on the current available information which show a temporal association between the use of the product and excluding all other etiologies as reported (subject experienced seizure 37 years ago), a causal relationship with the event cannot be excluded.
64 y.o. female who  is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little "woozy" Monday (3/8/2021).
Soreness at injection site. Soreness down the arm and into the neck. Fatigue.
I had a severe headache for 12 days, Tylenol was not helping. Went to Urgent care on 12th day was told it was a stress headache. 2 days after injection I had severe stomach cramps that lasted 1 day and body aches to right shoulder, hip and thighs. Today, May 1, 2021, I am still experencing headaches and neck, shoulder aches.
pt recvd vax; 48 hrs later devel rash & cellulitis;
13DEC97 rash to chest & back;16DEC97 malaise, aching all over, sore throat, cough, dizziness-lasted 2 wk;low grade fever;27JAN98 mild rash still  present;
Stops by today, reports discoloration to left deltoid. Dime size discoloration noted. Patient also voiced muscle aches to lower extremity for 1 wk following vaccination to Tdap.
My muscle was sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single and administration date 19Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Verbatim: COPD; "Hyperlipidaemia" (unspecified if ongoing), notes: Verbatim: Hyperlipidemia; "iliac artery" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for major depression; PLAVIX taken for iliac artery occlusion; LOSARTAN taken for blood pressure measurement; ROSUVASTATIN taken for hyperlipidaemia. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "My muscle was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The consumer stated regarding Plavix that she has 100% blockage in her iliac artery, so she was taking it to continue to walk (not further clarified). The patient has clinical depression since she was 15-year-old. The patient did not receive any other vaccines prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received via the Merck pregnancy registry, from a physician, concerning a 19 year old female patient with no known allergies and no pertinent history, who on 04-MAY-2007 was vaccinated with the first dose of GARDASIL (lot # not reported). On 18-JUL-2007, the patient had her LMP and was unknowingly pregnant, when on 20-AUG-2007, she was vaccinated with the second dose of GARDASIL (Lot #655617/1447F). The estimated date of delivery was 23-APR-2007. The patient sought unspecified medical attention. Follow up information has been received from a nurse who reported that the patient had a "slightly early" delivery on 07-MAR-2008, approximately 33 weeks from last menstrual period. No problems were reported with mother or baby. No further information was reported regarding the pregnancy outcome. Additional information has been requested.