chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just hit me, it comes real quick and make me breath kinda short; tight around the chest; CHILLS; fever (around 100); shaking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (just hit me, it comes real quick and make me breath kinda short) and CHEST DISCOMFORT (tight around the chest) in a male 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.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHEST DISCOMFORT (tight around the chest) (seriousness criterion medically significant), CHILLS (CHILLS), PYREXIA (fever (around 100)) and TREMOR (shaking). On 02-Apr-2021, the patient experienced DYSPNOEA (just hit me, it comes real quick and make me breath kinda short) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (just hit me, it comes real quick and make me breath kinda short), CHEST DISCOMFORT (tight around the chest), CHILLS (CHILLS), PYREXIA (fever (around 100)) and TREMOR (shaking) was resolving.            Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a male of unknown age with serious unexpected events of chest discomfort and dyspnea, along with nonserious unexpected tremor and expected pyrexia and chills. Event onset on Day 1 after first dose of mRNA-1273. Event resolving. 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.; Sender's Comments: This case concerns a male of unknown age with serious unexpected events of chest discomfort and dyspnea, along with nonserious unexpected tremor and expected pyrexia and chills. Event onset on Day 1 after first dose of mRNA-1273. Event resolving. 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.
After my first shot on 3/25/21, I reported fatigue, headache, upset stomach, and sore arm. My headache that started on 3/25/21, never went away.  Every day up until my second dose on 4/26/21, I've had daily headaches ranging in intensity. Additional side effects from my second shot included severe body aches and headache that would not subside for several hours. I took Tylenol, but it didn't work. The pain was so severe, I had to take Tramodol (100 mg). While Tramodol took the edge off, my headaches have continued. Today (4/30/21) my head feels like it is on fire. I have fatigue and what feels like an electric current through my whole body. I took more Tylenol about two hours ago and just took 50 mg of Tramodol. The pain has not gone away. I've been in regular communication with my doctor, but have not been able to get any relief. Last week I went to the ER because my headache was so severe.
Information has been received from a licensed practical nurse concerning a female with no drug reaction/allergies who was vaccinated with the first 0.5ml dose of GARDASIL.  After getting the first dose, the patient developed rash all over the body.  The patient recovered from rash all over the body on an unspecified date.  It was reported that the patient would not be getting the second and third dose.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient states he had swelling at the injection site and some lower abdominal pain. Abdominal pain started the next evening.
Arm soreness; Concerned about her age at the time of vaccination; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced arm soreness. This also resulted in the event, recipient of the vaccine who was younger than 18 years old.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient began to experience arm soreness, but no other symptoms, for 1-2 days. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event recipient of vaccine who was younger than 18 years old, was considered resolved on 30 Dec 2020. The outcome of the event arm soreness was resolved on an unknown date.  The reporter did not provide an assessment for the events.; Reporter's Comments: This report refers to a case of 17- year-old female patient who experienced non-serious unexpected event of recipient of the vaccine was younger than 18 years old (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. The patient experienced arm soreness, with no other associated adverse events. Based on temporal association and the known safety profile for the vaccine, a causal association with the event of arm soreness cannot be excluded.
Metallic taste in mouth (has occurred for the past 3 days). Chills for 1 day. Fatigue for 1 day
Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) 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 PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes).    No concomitant medications were provided. The patient received first dose of the Moderna primary series on 05-Mar-2021 with lot number 029A21A. Second dose on 08-Apr-2021 with lot number 027B21A. It was not known which arm patient received both first and second dose. First Moderna Monovalent booster dose on 20-Nov-2021 in left arm with lot number 939904. The expiration date was not known for first, second and first booster dose No other adverse reactions were reported after all 4 doses.  No treatment medication was provided.
Patient called the office on 8/17/2010 to report complaints of feeling hot, excessive sweating, and increased headaches since receiving Gardasil on 7/14/2010.  She was referred to her primary care physician for further evaluation.
Left hip began aching extended to calf ,like a "charly horse". during night slept poorly because muscle pain this morning both sides starts at hips/ extends to calf. Arm is sore, but not swollen. No fever
A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 10/30/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Eight hours post 4th vax, pt developed a rash around site of vax with itching. By the next morning the rash had spread to entire left arm. Rash was red with tiny papules and very pruritic. Also present in patches on the right arm, back, chest, abdomen, and ankles. Lesions persisted for 10 days. Skin was dry after rash faded.
pt reported tongue felt "thick", physical exam by provider negative. pt was given Benadryl 25mg 1 po x 1. no adverse events otherwise. Discharged after 45 min w/no further incident.
Patient came in for second dose of Covid shot. Patient circled Pfizer and did not have his vaccination card with him so was given a sticker to take home and update his own card. Patient's first shot was Moderna not Pfizer. Notified vaccine coordinator of this and then explained to patient that he had received a different type then his first dose. I offered for him to talk with someone, he declined and was ok with this.
Patient's twin sister had a lump start on her leg the day before. I had taken her to urgent care thinking it was a tick bite but found out it was where her injection was and it was cellulitis. I made an appointment to get them both into their pediatrician on Monday to find out more. It was the injection site of the Varicella vaccine for both of them. Something is wrong with this batch. They were both badly infected!! His sister didn't respond to the first antibiotic so they switched her and started him on the stronger one they put her on. They responded to the antibiotic but it took a few days. It was a nasty infection at the injection site. Please note that they had the MMR shot in the opposite leg with no reaction.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.64.   Concomitant products were not provided.  On 07-JAN-2021, Excursion time was reported at 9:00 A.M and 10:00 AM with  temperature as 34 and 34 degrees Fahrenheit, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-JAN-2021, vial was moved to clinic on 07-JAN-2021. 06 vials were sent to clinic. Vaccine BUD date was 27-JAN-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient reported blistering that subsequently fell off a few days later, but the arm/hand/shoulder remained numb and tingling at least for 9 days after receiving vaccine.
Received ZOSTAVAX 2-2-09, then developed rash to both lower extremities (below knees) on 2-7-09 - Only fine red rash, no blisters - Describes rash as itching and burning at times - Symptoms decreasing per patient as of 2-17-09.
VERY TIRED; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (VERY TIRED) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Mar-2021, the patient experienced FATIGUE (VERY TIRED). On 14-Mar-2021, FATIGUE (VERY TIRED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. 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.   This case was linked to MOD-2021-624907 (Patient Link).
Patient stated he had received first dose Covid Vaccine; he had actually received M.  He did not have his CDC card.
Felt sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Felt sick) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
MEMBER WAS PROVIDED THE SECOND DOSE OF PFIZER VACCINE AFTER BEING ADMINSITERED THE FIRST DOSE OF MODERNA. PROPER CDC RECOMMENDATIONS WERE FOLLOWED AND NO ADDITIONAL DOSES WERE ADMINSITERED.
received the first dose did not return within the recommended time frame to receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Warmth, hardness, pain and itching for 2 days  after shot but it then resolved, 10 days later on 8/17 the injection site became red, warm, hard and itchy
booster; I stopped menstruating, but as soon as I received my booster shot, I started cycling again.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 11:00 (Lot number: FL3197) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: no periods for over a year. There were no concomitant medications. Patient had no other vaccines in 4 weeks. Patient had no COVID prior vaccination. Patient had no known allergies. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "menopausal (no periods for over a year)/by the time I had my second shot, I started menstruating", "This lasted for 6 months, with extremely heavy menstruation"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 01Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "menopausal (no periods for over a year), but after the first shot, I felt abdominal pains". The following information was reported: IMMUNISATION (medically significant) with onset 06Jan2022 11:00, outcome "unknown", described as "booster"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "I stopped menstruating, but as soon as I received my booster shot, I started cycling again.". Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Patient was not tested for COVID post vaccination.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.
Chill, fever, headache; blotchy red rash on 5-26-2016.
Patient stated that after 1 week of vaccines administration, she noticed inflammation of lymph nodes on the neck, arm pit and groin area. Lymph nodes were painful. Doctor recommended fluid therapy and antiinflammatory.
neuropathy in her feet; could hardly walk for 2 & 1/2 months because they were so painful; Arthritis in her knees; could hardly walk for 2 & 1/2 months because they were so painful; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-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 NEUROPATHY PERIPHERAL (neuropathy in her feet) (seriousness criterion medically significant), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant), ARTHRITIS (Arthritis in her knees) (seriousness criterion medically significant) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) outcome was unknown.            No concomitant and treatment information were reported by the reporter  Company Comment: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.
Lethargic; aches and pains, soreness; migraine for three days; nausea; weakness; left side of head hurt and was swollen; left side of head hurt and was swollen; This is a spontaneous report received from a contactable consumer (Patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lethargic, aches and pains, soreness, migraine for three days, nausea, weakness, left side of head hurt and was swollen. The outcome of events 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.