chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing; Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; vomiting and clammy; vomiting and clammy; headache; sore throad; Fever; chills; Chest tightness; coughing profusely; This is a spontaneous report from a contactable consumer or other non hcp.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jun2021 13:35(age at vaccination 21 years) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient got her first dose of the Pfizer Covid 19 vaccine on 14Jun2021 and is scheduled to get the second dose on 07Jul2021. On 19Jun2021 on Saturday, after they came home from an event the patient experienced coughing profusely, a lot of congestion in her chest, then she started vomiting, she was turning red and clammy and sweating and developing a fever, states initially she treated symptoms with a cold compress, headache, chills and cold sweats. yesterday afternoon she was clammy again and continued to vomit and complaining of chest tightness as well, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion. States today they decided to go to the ER, and she tested positive for Covid on 21Jun2021. she did not want to eat on an unspecified date. The patient treated with Advil and Ibuprofen/Motrin. The patient underwent lab tests which included sars-cov-2 test: positive on 21Jun2021. She Wants guidance on getting the second dose. The event outcome is Unknown for tested positive for covid, did not want to eat, flushed and hot and coughing profusely, Not recovered for Chest tightness, congestion in chest, mucus cough, sore throat and headache Recovering for vomiting and clammy, Fever and chills.
Tongue went numb.  No swelling or difficulty breathing reported.  Lasted around 45 minutes.
Erythema, swelling and tenderness within 24 hrs. No respiratory symptoms, Benadryl given. Will monitor to rule out cellulitis
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot # R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis. The sterile diluent (MERCK) (lot # and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Bad diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Bad diarrhea). At the time of the report, DIARRHOEA (Bad diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.
Experienced a hemorrhagic stroke on 4/30/2021.  Followed by brain surgery - STA bypass. Followed by numerous infections and wound revisions / hospital stays.
Pt recv vax on 10/23/98; 1 hr later pt exp raised pink rash under LA w/ itching.
COVID 19 positive on 08/16/2022. I had a sore throat; nasal congestion; body aches and a low-grade fever.
Pt started breaking out into rash on 5/14/09 around 7:00 pm.  The rash is red round areas from head to toe.  0 blisters.  Does not seem to be itching.
not talking right; sweaty; appeared disoriented; This is a spontaneous report from a non-contactable consumer. A 13-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Jun2021 11:00 (Batch/Lot Number: EW0171) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Unknown if Covid prior vaccination. The patient experienced not talking right, sweaty, appeared disoriented on 09Jun2021 11:30, was transferred to a clinic/hospital resulted in Emergency room visit. Treatment received first aid, vitals. The outcome of event unknown. Patient has not been tested for COVID-19 Since the vaccination.  No follow-up attempts are Possible. No further information is expected.
Caller stated that a male pt was inadvertently administered an expired (8/2001) dose of PNE-IMUNE23. The pt developed a local reaction of redness and swelling and pain. Pt was unable to sleep all night due to the pain. Additionally while reading the pt chart it was discovered that this pt had already received a dose of PNU-IMUNE-23 in January 2001. Field Alert being issued for a medication error that resulted in an adverse event.
Pain and redness on entire left side of face, pain in left temple and severe nerve like pain and pressure in left ear, difficulty hearing and sudden onset of tinnitus and hyperacusis in left ear within an hour afterward.    Symptoms that have developed later: 8 days later I got COVID arm on left arm and had it for a few weeks.  I also now have episodes of dizziness and nausea, rapid heart rate and pressure building in my head.  Also developed numbness and tingling in my left arm and sudden twitching and movements of my fingers on left hand.  I also now have Shaking, Weakness and inability to grasp items in left hand and some loss of fine motor skills.
8 days post smallpox vax, PT experienced high fever, dizziness, and headache x 8 days. PT extremely fatigued x 2 days. Swollen tongue, hands, feet, joints, glands, went to ER but not admitted.
Tinnitus. Perfect hearing before the shot, continuous ringing in both ears now since a week after the shot.
Information has been received from a pharmacist concerning a 67 year old female patient with an allergy to something the dentist gave her (not further specified) and a history of thyroid removal who on 22-JAN-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663175/1553X) subcutaneously. There was no concomitant medication. On 22-JAN-2009 the patient experienced numbness around her lips extending into her right cheek 15 minutes after receiving the dose. The patient's numbness around her lips extending into her right cheek persisted. Additional information has been requested.
Pt was given DT at midnight on 9/14/06, she woke up at 6am, her left arm was red, swollen and painful. She returned to the urgent care area erythematous on her left deltoid 13cm/12.5cm. Pt was treated with Benadryl 25-50mg 6h. Pepcid 20 mg BID x 5 days.
Fever, chills, body ache, headache,  arm- vaccine site pain, cold all day, very shaky
Subject experienced moderate (7x6cm) local reaction to 2nd BIOTHRAX vaccination on 12/1/08. Area warm to touch. Malaise 12/2/08, feeling better by 12/3. The subject has recovered.
I did not have anything as far as getting the shot but the second day of getting the shot I felt extreme fever, shaking in the bones and I did not go to work. I felt in extreme fever stage. Hot and cold. My body could not tell what was going on. Weeks later in May and June I was sick, and it lasted for a month and that was a lot of sinus infections, not having as good as taste I always had, lost of smell. I went to the doctor when both my ears were infected since I could not hear with either of them. They prescribed amoxicillin for 10 days because I had 2 ears infections. I still have coughing, nasal problems, half my smell is gone. I feel like I have a lingering cold. The first month I was not coughing at all, and when I cough I get a dry cough sometimes.
Pfizer gray top (old version) was given in place of bivalent booster in the series.
Information has been received from a physician concerning a 14 year old patient was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  The physician stated that this was not a case of product confusion.  The patient sought unspecified medical attention.  No product quality complaint.  Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 21-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 8 days (incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted in the bathroom 15 minutes after vaccine was administered.  Her mom was right there and caught her, no injury was done.  She sat at the pharmacy for 20 additional minutes and was able to walk out of store and felt fine after she rested.
Patient states that when she was on her way home from the store her lips started to tingle and when she got home they started burning and swelled up and the tingling went into her cheek. She said she was going to give herself her an Epipen that she keeps for allergic reactions to other medications but by the time she was going to give it to herself the swelling and tingling were completely gone. She told her doctor about it who told her not to get any more Covid vaccinations due to the reaction. She didn't alert the pharmacy of the reaction until 8 months later.
had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved,; CT scan at the end of February that the showed that the "saw improvement with the nodules" - new, is a "little slow" -new; This is a spontaneous report from a contactable consumer based on information received by Pfize (manufacturer control number HK-Fosun-2021FOS000486), license party for bnt162b2 (COMIRNATY). A 63-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 11Dec2020 (Batch/Lot Number: 1330511) and ongoing, at 14 mg, 1x/day, oral from 11Dec2020 (Batch/Lot Number: 1265576) and ongoing, at 14 mg, 1x/day for malignant neoplasm of endometrium. Medical history included malignant neoplasm of endometrium. Concomitant medications were not reported. Description of the event: Patient reported she had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved, CT scan at the end of February that the showed that the "saw improvement with the nodules"' - new, is a "little slow"-new. Description of the event: Patient reported 'the doctor told me to take 10 mg daily to help with being so tired and it seems to be helping'- New. 'my right foot has pain" - New, "my blood pressure is well controlled now'- Resolved, 'I had my 2nd Covid vaccine and my arm was sore and I felt achy for a day' - New, Resolved (patient gave verbal consent to be contacted by the manufacturer). Outcome: Unknown. Was the event considered a drug interaction: No. The patient underwent lab tests and procedures which included blood pressure measurement: well controlled on an unspecified date, computerised tomogram: improvement with the nodules on an unspecified date Feb2021. Patient received treatment for the adverse events. The action taken in response to the events for lenvatinib mesilate was dose not changed. Outcome of the event her arm was a little sore was resolved and saw improvement with the nodules" - new, is a "little slow"-new was unknown.
Flu shot given 2-5-16, pt. complained of itchy skin, achey, headache and 1 hive of face during the weekend. Mom called 2-8-16 to report symptoms.
pt recvd vax; pt exp high fever t 103-104; devel high pitch cry, had breath holding spell x 30-45; swelling in leg where vax was administered;
Painless redness and mild swelling approximately 8 days after vaccination. Redness has increased in size over the last few days but faded in color to a light pink at this time. Swelling has subsided.
Redness,  large swelling (3 inches) in area of injecting,  fever,  total body ache,  painful joints,  nausea,  headache,  lethargy
so sick; breathing difficulties having to take a nebulizer; trouble breathing with a bad cough; hasn't been able to work or get out of the house; can hardly walk; it's really kicking her butt; Her bones ache; chest congestion; fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house) and GAIT DISTURBANCE (can hardly walk) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026D21A, 027A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no COVID positive test or diagnosis.  Concurrent medical conditions included Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever). At the time of the report, ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever) had not resolved.            No concomitant medication was reported. It was reported that the patient did not receive any other vaccine 1 month prior to Moderna vaccine. Treatment included nebulizer for breathing difficulties.   This case was linked to MOD-2022-571279 (Patient Link).
NEUROPATHY 7/14/2021 CANCER METASTATIC TO BONE NEUROPATHY 7/14/2021 CANCER METASTATIC TO BONE
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: swelling at site of injection. ice given to pt-Mild, Additional Details: pt given moderna booster (previously recieved pfizer for primary series) and upon injection into the left deltoid the injection site swelled.
A report has been received from a physician via sales representative concerning several patients of unknown gender. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patients received FLUMIST (Intranasal). on an unknown date. A doctor mentioned in passing that sometime last season (2012-2013) more than one patient (exact number unknown) showed up in the ER after receiving FLUMIST. The time frame after receiving FLUMIST was not provided. The patients were swabbed in the ER and tested positive for the flu. The physician could not provide an identification for these patients. The outcome of the event of flu was unknown. The reporter considered the event to be non-serious.
First dose in Jul2019 and forgot about 2nd; This case was reported by a consumer  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 July 2019).   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. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient forgot about the 2nd dose and was asking if need to start series over again or not. The patient was also asking if he/she had any protection from his/her own shot.
Headache, Fever, body ache, hot and cold flashes Employee receive 1 dose of Johnson and Johnson Covid-19 vaccine on 16 March21 and developed symptoms on 17March21 at 0100. Currently employee is stable at home of record and advised to seek medial attention if symptoms become life threating. Informed employee to call supervisor of any intended absences.
Mild fatigue; Light chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue and chills. On an unknown date, the outcome of the fatigue and chills were unknown.   It was unknown if the reporter considered the fatigue and chills to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR019709   Additional Information: GSK receipt date: 06-FEB-2023 Reporter comment:  The first one caused mild fatigue and light chills.  The patient read online these were not common. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose refer case US2023AMR019709, reported with same reporter.; Sender's Comments:  US-GSK-US2023AMR019709:Same reporter
For the 3rd year in a row, I have developed a severe sore throat and URI within 36 to 48 hours after "high dose flu vaccine."  And I have not been around anyone with known URI!
Vaccine given. Less than 12 hours later, patient noted to have erythema and swelling at site. Treated with Keflex for cellulitis left leg.
right arms swelling, erythema, warmth, and tenderness since 9/11/2019 at 8 am and increasingly worsening. Patient re-evaluated on 9/11/19 at 5pm and treatment prescribed.  9/12/19 @ 0816a mother verbalized son feels much better, right arm swelling has decreased to half the size, and son reported been able to move the arm without pain.
After vaccination, I had a 101-degree fever. By the next day, I had nausea and my arm was swollen. It was a much larger reaction than I had previously. By the third day, I was better.
Hives, SOB and swelling approx 2 hrs. after administration of influenza vaccine. Taken to ER via ambulance. TX included oral and IV BENADRYL. At ER IV fluid and IV SOLUMEDROL administered.
Covid testing for surgical procedure and tested positive. Interviewed patient and he had experienced increased fatigue over the past week. Patient is fully vaccinated.
Patient reports onset of headache on 3 January, progressing to peak onset within 24 hours, then diminishing to intermittent and episodic over the next 72 hours.  Patient reports onset of left sided facial numbness on 5 January in the morning, progressing throughout the day.  Pt reports by the evening of 5 January he was unable to hold his lips closed while using mouthwash and experiencing dribbling on himself.  He presented to the clinic the following morning with c/o right sided headache and left sided facial numbness and weakness.  He was transferred to the Hospital and admitted for evaluation and treatment.  He was found to have left sided facial numbness and right sided facial weakness affecting the facial nerve.  He underwent at least two head CT's, had consultation with neurology and was treated with IV steroids x 7 days and then switched to po steroids for an additional 4 days.  He participated in speech therapy exercises for facial weakness.  His final diagnosis was peripheral lesion of facial nerve right, differential diagnosis:  multiple neuritis, secondary facial palsy after vaccination.