chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was just little tired with the first shot I received; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in the arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included clonazepam. On unspecified date, the patient was just little tired with the first shot he received. The outcome of the event was unknown.
A consumer report has been received. The report concerns a 14 year old male patient. The patient was diabetic. The patient started to receive Nasal FLUMIST during Nov-2012. The patient started to experience autoimmune issues including iritis, uveitis and ANA > 600 since 01-Feb-2013. At the time of reporting, the event of autoimmune issues was ongoing and the outcome of the event of iritis, uveitis and ANA > 600 was unknown. The report was considered to be non-serious by a company physician.
l got vaccinated but still l got it/Suspected vaccination failure; l got vaccinated but still l got it; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comment:  This case was reported by the patient via interactive digital media. The patient got vaccinated but still got it very horrible and painful. The patient had Shingles vaccine 3 years prior to the reporting and asked why he/she was still suffering it right now. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
patient felt sick after the second vaccine; no appetite for 24 to 38 hours after his second vaccine; patient was sleepy after the second vaccine; nauseous after the second vaccine; patient was coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine), COUGH (patient was coughing) and NAUSEA (nauseous after the second vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COUGH (patient was coughing). On an unknown date, the patient experienced ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine) and NAUSEA (nauseous after the second vaccine). At the time of the report, ILLNESS (patient felt sick after the second vaccine), DECREASED APPETITE (no appetite for 24 to 38 hours after his second vaccine), SOMNOLENCE (patient was sleepy after the second vaccine), COUGH (patient was coughing) and NAUSEA (nauseous after the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient has been very sick with Covid-19 like symptoms recently. The patient never got tested for Covid-19. The patient had coughing and is just getting past the sickness now. No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-381234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains no new information
"twitching" of head to the right, resembled a focal seizure; he also had periods of breath holding; he was admitted to the local hospital here and is in the midst of a work up for seizures and apnea.
stated verbalized dizziness at 1007 patients stated  "perfectly normal" dcd home
1 day after recipient received the vaccine she developed heart palpitations, chills, and shortness of breath that resolved within 12 hours.
2 days after school mandated Booster shot he began to experience a myriad of symptoms, including HIGH fever, EXCRUTIATNG headache, EXTREME fatigue, lethargic, vomiting upon any exertion, elevated heart rate, chest tightness, chest rash, sore throat, EXTREME body ache. Symptoms continued, relentlessly, 4 days later on 1/23 we went to urgent care, his blood test revealed increased level of d-dimer, and slightly enlarged right atria upon CTA chest.
I about a month after my vaccine I was one vacation when I started to feel pressure on my chest. Shortness of breath mostly. I noticed after I walked up 5 or 6 stairs, I needed to stop. It was grueling. At the hotel, I had to go up stairs for the bathroom and took my time going up and down the stairs. When I was leaving vacation, I was packing the suitcase and I noticed I was more winded then normal. Then I was driving and I noticed my breath was more labored. I stopped at a gas station and even taking steps I was very winded. I went into the urgent care and they did the blood pressure and informed me I needed to go to the ER and called an ambulance. I needed to have a stint placed in my artery and I was held there for 5 days.
66 YO female with PMH significant for T2DM received PNEUMOVAX 23 vaccine on (L) deltoid from clinic on 8/11/14. That evening, pt began to experience increased swelling in (L) arm with warmth, tenderness, limited movement, and reported neck/arm pain of 4/10. Pt took 1 APAP 325mg tablet that night and another dose the next morning but symptoms did not improve. Pt contacted the clinic on 8/12/14 and PCP instructed pt to apply warm compress 20-30 mins 4-6x/day and NSAID as directed per OTC label. Pt came to clinic for evaluation: no further information about symptom resolution.
chills; slight nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), NAUSEA (slight nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported No relevant medical history was reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), NAUSEA (slight nausea) and HEADACHE (headache). On an unknown date, the patient experienced CHILLS (chills). On 27-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills) had resolved and NAUSEA (slight nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Shot on 8/19/09.  Next day large red area around site small pimples within red area.  Pain, swollen & very itchy.  Had shingles - 10 yrs ago after death of husband.
Fever of 102, screaming, crying, red dots all over his torso and back, interrupted sleep.
16 years old patient got 2 doses of the Moderna COVID-19 vaccine; second dose was 40 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient got 2 doses of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 40 days after the first dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient got 2 doses of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 40 days after the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient got 2 doses of the Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 40 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
This spontaneous report was received from a medical assistant referring to a 4 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored Oka-Merck PROQUAD (lot: N025928, expiry date: 18-MAR-2019) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Flu shot given on 1/3/12. Requested thimerosal-free as I was 9 weeks 6 days pregnant. Estimated date of delivery was 8/1/12. I called OB from pharmacy waiting room to verify it was safe to receive vaccine as I had had a cold a few weeks prior. Verified it was safe. Prior to pharmacy employee giving the shot, again asked if it was safe. They confirmed it was. I received the vaccine. On Thursday January 5 I noted to a friend that my morning sickness had stopped and I was relieved to feel better. On Saturday January 7 I experienced spotting in my underpants. I spent the rest of the weekend in bed. Called my OB on Monday January 9 and was seen in the afternoon. Ultrasound showed the fetus had died. Went to Radiology the next day where intrauterine ultrasound confirmed fetal death. Evacuation of uterine contents occurred on Wednesday January 11.
24 hours after varicella vaccine #2 developed redness and swelling at injection site.  48 hrs post vaccine developed increased redness, swelling and heat to touch.  Sent to hospital for further evaluation.  Diagnosed with cellulites and started on Clindamycin tid x 10 days
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ, orally which had a lot # of M007124, with an expiration date of 05-OCT-2017 and lot # of M014753 and an expiration date of 11-OCT-2017 (concentration, dose number, dose and anatomical place of vaccination were not provided). Which were reported because of a data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
ITCHING IN A 3 INCH BY 3 INCH WELT AT INJECTION SITE.
Unevaluable event; PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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. and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.  No concomitant medications were reported. The patient was in bed for 18 hrs after taken the second COVID vaccination shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
The patient was supposed to get the Moderna vaccine but was given the Pfizer vaccine instead. No adverse event occurred with patient.
Developed injection site reaction characterized by redness, warmth and a lump the size of an orange. Child was taken to ER on 08/21/1999. On 08/26/1999, he was seen by the physician who noted that the lump was almost resolved.
The evening after receiving the vaccine it was around 9PM. She started to vomit profusely, she filled up a full size crib and it spilled it over on to the floor. She was not responding (lifelessness), had a really high fever and crying. I called the Pediatrician and spoke with the NP that was on call who suggested to try and give her little amounts of coconut water  to keep her from getting to dehydrated. She continued to throughout the night. The symptoms lasted for about 48 hours.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for this patient after the two month, four month and six month dose of PREVENAR 13. This is the six month report. A 6-month-old female patient was administered the third dose of PREVNAR 13 separately no an unspecified date. Relevant medical history and concomitant medications were not provided. Past product history included the first dose of PREVNAR 13 administered along with other unspecified vaccines on an unknown date at 2 months of age with apneic episode (not further specified). The patient received the second dose of PREVNAR 13, separate administration, on an unknown date at 4 months of age and within 48 hours the patient was found to be blue in her crib with an apneic episode. Subsequently, on an unknown date, the infant was then given her 6 month vaccine of PREVNAR 13 again given separately. Within 48 hours the apnea monitor alarmed, but she did not turn blue. The outcome of the event at the time of the report was unknown. Follow-up (21May2012): Follow-up attempts completed. No further information expected.
Case number PHEH2014US014815 is an initial spontaneous report from a nurse received on 23 Jul 2014 with a follow-up received on 25 Aug 2014. This report refers to an 11-year-old male patient. Past medical history was not provided. Concomitant vaccination included TDAP (batch number: FL2P2). The patient received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: A13047) intramuscularly on 22 Jul 2014. No adverse event reported following this medication error (inappropriate preparation of medication). Follow-up received from a nurse on 25 Aug 2014: Concomitant vaccination updated, Batch number of MENVEO amended.
Stored in the home refrigerator and sent to the group home where the patient lives; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 27-AUG-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Stored in the home refrigerator and sent to the group home where the patient lives).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-SEP-2023 The reporter reported that administration of the Boostrix vaccine that had an unknown time and temperature excursion. The reporter reported that the Boostrix vaccine was delivered to a patient's family as it was stored in the home refrigerator and sent to the group home where the patient lives and sent to their pharmacy for administration by the group home pharmacy which was 40 miles away in a cooler, which led to Incorrect storage of drug. The reporter consented to follow up.
stating he is also getting over Covid; Initial information received on 30-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was stating he is also getting over covid while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "stating he is also getting over covid" (covid-19) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "is reporting that a BD (full form not specified) needle was defective in the administration of Fluzone, he states this happened 2 weeks ago and that the incidence had nothing to so with the product, just the needle, he states he does not know if the product was able to be administered, he states that the Medical Office will not be opened until after the New Year because of Covid which he states has decimated the area and stating he is also getting over Covid."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (stating he is also getting over Covid).  At time of reporting, the outcome was Recovering / Resolving for the event stating he is also getting over covid.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
got the Pfizer booster yesterday and I just have a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-512561 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (Dose 1, Near death experience,), for COVID-19 immunization, reaction(s): "I felt like I was going to die"; Moderna (Dose 2), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (dose 2, I felt like I was going to die), for COVID-19 immunization, reaction(s): "I felt like I was going to die"; Moderna (Dose 3 (Booster)), for COVID-19 immunization, reaction(s): "headache", "nausea", "spasmodic dysphonia", "vomiting"; Moderna (Dose 3 (Booster), I felt like I was going to die), for COVID-19 immunization, reaction(s): "I felt like I was going to die". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "got the Pfizer booster yesterday and I just have a sore arm". Additional information: Moderna Tx. received a report of the below events experienced with the use of Moderna COVID-19 Vaccine: diagnosed with spasmodic dysphonia, headache/The headaches were so bad that I felt like I was going to die, vomiting, nausea. patient asked to treat horrible headache and barfing that I endured three different times for my three shots and got response as no worries now. Patient got the Pfizer booster yesterday and just have a sore arm. No vomiting or horrendous headache. It's a miracle! and doesn't some put out a news release to switch. Three Moderna shots and patient thought I'd die each time.Kindly find the response received from the reporter upon follow-up for the case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/25/2021 I began to have symptoms revolving around COVID-19. I began to have chills, body ache, fatigued, and lasted about 3 weeks. After reaching out to my medical professional they recommended over the counter medicine however no prescriptions. Until now I am still losing my voice. It comes and goes everyday and continues to happen.
Headache, Fever, Chills, Body ache, Fatigue, soreness to left arm Narrative:
Child ran temp 100 for 2 days. 06/10/02 irritability remains sleeping difficulties, no temp; regressed to crawling had been walking since 9 months. Currently continues to limp on right leg. Seen by PP 06/12 couldn't find anything wrong. Told to give Advil. Taken to ER 06/19/02-still limping.