chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:35 PM, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 44.73. No concomitant medications were reported. On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42and 5 PM : 42  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
fluttering heart; shortness of breath; legs started to swell; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 011J20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (legs started to swell). At the time of the report, CARDIAC FLUTTER (fluttering heart), DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (legs started to swell) had not resolved.            No concomitant medication were reported. No treatment medication were reported.  Company comment: This case concerns a patient, unknown gender and age, with medical history of pulmonary embolism, who experienced the serious, unexpected,  event of cardiac flutter. The event occurred  4 days after booster dose of mRNA 1273 vaccine. The patient's leg swelled up and experienced difficulty of breathing and fluttering heart, patient went to the ER where an ultrasound was done, no blood clots were found. The rechallenge is not applicable as there is no additional dose expected. The patient's history of pulmonary embolism remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-400023 (Patient Link).; Sender's Comments: This case concerns a patient, unknown gender and age, with medical history of pulmonary embolism, who experienced the serious, unexpected, AESI event of cardiac flutter. The event occurred  4 days after booster dose of mRNA 1273 vaccine. The patient's leg swelled up and experienced difficulty of breathing and fluttering heart, patient went to the ER where an ultrasound was done, no blood clots were found. The rechallenge is not applicable as there is no additional dose expected. The patient's history of pulmonary embolism remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
I have a large knot around the injection site, there is a red rash and it is hot to the touch. I am also itchy allover. Yesterday I felt like I was getting a cold. Today it is better but the itching allover my body is insane. No idea if related but felt like I needed to share.
Approximately 2 days after vaccine I developed minor case Shingles lower back. I contacted my PCP we did a Zoom visit she inspected the area. I was prescribed Valtrex after 4-5 days it was gone.
Delayed red, raised, itchy rash appeared on chest and neck. Sore throat, fatigue, headache. No treatment was sought.
receiving an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information reported.
Report any AE after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Report any AE after 2nd dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Report any AE after 2nd dose). At the time of the report, ADVERSE DRUG REACTION (Report any AE after 2nd dose) outcome was unknown. Not Provided          No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
No additional AE details are available; a patient who started the GARDASIL 9 series 2 years ago and came to their office yesterday (4/28/2021) to receive their second dose; This spontaneous report was received from a medical assistant referring to a 24 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  In April 2019 (also reported as 2 years ago), the patient started with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis.  On 28-APR-2021 (also reported as yesterday), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
A report was received from a health professional on 10/10/01 concerning a patient who experienced asthmatic symptoms and felt faint within 5 minutes of receiving Fluvirin. The patient has a history of allergy to latex and cats, but no known allergy to egg products. The patient began to cough and had difficulty breathing within 1 minute of the Fluvirin injection. She was given oral loratadine, but continued to have asthmatic symptoms and then began to feel faint, at which time she was given SC epinephrine hydrochloride. It took close to 24 hours for the symptoms to resolve. No reaction was seen at the site of the injection and there was no indication the vaccine may have entered a blood vessel. There was insufficient information to determine the reporter's causality assessment. Follow up information received on 2/8/02 stated that the patient was a 48 year old who had a previous flu vaccination on 10/6/99. Fluvirin was administered on 10/1/01 IM to the patient's left arm. Asthma-like symptoms developed within 5 minutes and persisted for 2-3 days, then resolved. In addition, the patient was treated with Fexofenadine hydrochloride. The reporter has indicated that he has sent the report to the regulatory authority. Following internal review on 5/7/02, this case was upgraded to serious. (OMIC)
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: pt stated visual disturbance. having trouble seeing. lightheadedness, vomited once. called ems monitored pt and mom refused to go to the hospital. pt stated feeling better when she left. called at end of shift no answer laeft message
Heavy, extended menstrual cycle.  On OCP (three week cycle with mild spotting, typically)
2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-APR-2023 A pharmacist called in to report that a patient received their first dose of Shingrix and had not receive the second dose yet.  They ended the call without giving information and proceeded to dismiss agent. The reporter ended the call while the medical information was given and did not provide more information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow-up.
After being innoculated with the H1N1 vaccine, both my daughter and I contracted the illness.
My daughter was fine all day the day of the vaccine but she then started vomiting at 2 am at night and continued to vomit 4 times until 6 am and again the following night. She has no stomach virus and has not been exposed to one and has never vomited before in her life.
ON MY WAY HOME FELT TIGHTNESS IN ARM AND NECK. PAIN IN RIGHT ARM LEADING TO RIGHT SIDE OF NECK - FELT LIKE PULLED MUSCLE. TOOK BENADRYL AND TYLENOL - WOKE UP WITH CHILLS THEN SWEAT - SLEPT 12 HOURS. (SOME ACHES TODAY - NECK AND ARM SORE)
SEVERE ABDOMINAL PAIN AT NIGHT AND IS LESS SEVERE DURING THE DAY TO JUST A SLIGHT PAIN; RED DOT AROUND THE INJECTION SITE AFTER BOOSTER 1/2 THE DIAMETER OF A DIME; SORENESS AT THE VACCINATION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN), 1 in total, dose was not reported, administered on 14-MAR-2021 on left shoulder for prophylactic vaccination (Dose series in number 1). It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (Dose series in number 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: UNKNOWN) dose was not reported, 1 total administered on 18-DEC-2021 on left deltoid for prophylactic vaccination (Dose series in number 2). No concomitant medications were reported.  On 18-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced red dot around the injection site after booster which was half the diameter of a dime, and soreness at the vaccination site. On evening of 19-DEC-2021, the patient experienced abdominal pain which was severe in night and is less severe during the day just a slight pain (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain at night and is less severe during the day to just a slight pain, red dot around the injection site after booster 1/2 the diameter of a dime, and soreness at the vaccination site. This report was non-serious.
Developed recurrent hives starting 2 days after vaccination, medicated with Zyrtec. Hives continued for a week.
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medication details was reported. No treatment medication details was reported.
pt recv vax 19JUL96 & 23JUL96 pt devel a rash @ the inj site & 1 lesions @ hand & leg;
Approximately 12 hours after receiving 2nd Moderna vaccination I spiked a fever and had severe chills.  I was too weak to get out of bed and took Tylenol.  This brought temp down to 99.7, but I'm certain it was much higher than this before (I couldn't check my temp before because I was too weak to get up and temp gauge was downstairs, luckily, Tylenol was close by).  I was also extremely nauseated and could not eat or drink anything except small sips of water.   I also had a terrible headache and body aches and I could not rest due to the extreme discomfort.  These symptoms lasted about 36 hours, and I'm still very weak at present.
I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.; I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "my immune system is compromised" (unspecified if ongoing), notes: my immune system is compromised; "I do not have a spleen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (non-serious), COVID-19 (non-serious), outcome "unknown" and all described as "I was one week away from getting my next booster when I contacted Covid. I am now taking Paxlovid.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: The patient was one week away from getting her next booster when she contacted Covid. She received Pfizer shots from the get-go. Now taking Paxlovid. The patient was on day two of this medication and believe it was helping. The patient wanted to say thank you for hard work and dedication.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
weak with no energy; pain in the arm; little fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain in arm, at a dose of 1 dosage form and IBUPROFEN for Pain in arm, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired) was resolving.            No concomitant medications was reported.
skin is really hot; felt really awful/bad; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 041L20A and 019B21A) for COVID-19 vaccination.     No Medical history information reported.  Concomitant products included SOTALOL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever). In October 2021, SKIN WARM (skin is really hot), FEELING ABNORMAL (felt really awful/bad), CHILLS (chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was reported.  It was reported that symptoms occurred 24 hours after the booster shot and lasted approximately 8 hours.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 contains Significant information. Outcome of events updated.
Headache 4 days Fever 3 days Body Aches 3 days Fatigue 4 days Loss of Appetite 2 days Sleep problems 4 days Rashes current
I have numbness in my left foot and arm; severe neck pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness in my left foot and arm) and NECK PAIN (severe neck pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) 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 HYPOAESTHESIA (I have numbness in my left foot and arm) and NECK PAIN (severe neck pain). At the time of the report, HYPOAESTHESIA (I have numbness in my left foot and arm) and NECK PAIN (severe neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. No treatment information was provided.
Started with slight nausea and loss of appetite. Within an hour turned into chills that became so violent I was shaking. Then fever (101.6) and body aches and headache. Fever and chills broke about 8  hours after symptoms started. Could not get out of bed due to aches and fatigue for 21 hours.
This non-serious spontaneous case, initially received from pharmacist on 26-Jan-2018, concerning a 56-year-old adult patient of an unspecified gender. On an unspecified date, the patient was administered with FLUAD (TIV) (dose, route of administration, anatomicl location, batchnumber and expiry date: not reported) under 65 years od age. It was reported that, the patient did not experience any adverse event after the vaccination.
I felt painful pressure/contractions for about an hour starting about 25 mins after shot. I also woke up in sweat  that night.
Sun evening received pfizer covid vaccine booster for variants. Monday morning woke up with skipped heart beats pvcs and unsafe slow heart rate and chest pain. Pain worsened through out day. Condition did not improve. Sought ER treatment by evening and developed an unsafe high bpm rate and continued pvcs confirmed by Dr. Through ekg in er. Given a beta blocker toncorrect the issue. Pain worsened and spread through entire body and had to seek additional medical treatment. Treated with steroid to reduce inflammation. Severe chest pain and pain throughout my body. Worst pain ever felt.
Noticed rash on both arms a few inches from armpit same day as vaccine. Next day, I noticed more rashes. Rashes have kept coming up all over body. Aside from fever, chills, fatigue, and migraine on Monday night, I haven?t had any other symptoms (besides rash). Doctor said it looks like I have Erythema Multiforme.