chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt fidgety; No energy; Fells different behind her eyes; Fighting to stay awake; Exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake) and FATIGUE (Exhausted) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Anxiety.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills). At the time of the report, RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure and anxiety medications. No treatment details reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-Jun-2021 and Patient gender updated. outcome of all events updated from unknown to recovered. Patient didn't showed any interest to answer  questions and told doesn't want any phone.
Had flu shot, morning of 9-22-2014. That evening body aches, chills, runny nose. About one month later the pain in arm, shoulder and shoulder blade. Dec. went to Dr. was given Rx for MOBIC. Still the pain there. Back to Dr. Jan. 2015 more of same rx after X-ray. March 2015 saw item in paper about shots checked web. Still have pain. Ice used.
Fever, injection site soreness/redness (right arm only) and fatigue. Side effects resolved after 2 days, patient came to pharmacy on 9/16/2022 to report side effects - took his temperature during visit twice, had no fever (96.7F both times).
Tunnel vision, weak arms & legs, blurry vision, migraine, throwing up, confusion, trouble speaking.
sore throat; Muscle Spasms; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MUSCLE SPASMS (Muscle Spasms), PYREXIA (Fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
GOT SICK/ALMOST DIED THE FIRST GO ROUND; WAS IN BED SO ILL FOR 3 WEEKS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got sick/almost died the first go round and was in bed so ill for 3 weeks. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from got sick/almost died the first go round and was in bed so ill for 3 weeks. This report was non-serious.
temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; received both Daptacel and Acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 1 years old female patient and reporter reported temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event and received both haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post-temperature excursion where the vaccines were not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2023, the patient received a  dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot U026802, expiry date- 03-NOV-2023) via intramuscular route in the left arm for Immunization and also received a dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot C5969AD, expiry date- 17-FEB-2024) via intramuscular route in the left arm for Immunization.  Caller reported that temperature excursion for haemophilus type B (HIB) (PRP/T) vaccine and diphtheria-15/tetanus/5 AC pertussis vaccine as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and received both daptacel and acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA137908:01597142 US-SA-2023SA138048:01597145 US-SA-2023SA137832:01597167 US-SA-2023SA136956:01597157
She could not sleep well; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and INSOMNIA (She could not sleep well) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical history information was provided by the reporter.  Concomitant products included AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Back pain). On an unknown date, the patient experienced INSOMNIA (She could not sleep well). At the time of the report, BACK PAIN (Back pain) had not resolved and INSOMNIA (She could not sleep well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant product included Vitamin.  No treatment information was reported.   This case was linked to MOD-2021-117034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non-significant follow-up
No problems with vaccine 22 days later had T101 for 2days chills cough dizzy - Temp lasted for 2days after Tylenol started- called Dr
Gradual onset pain, redness swelling over 3 days since Tdap administration.  Day 2 with subjective fever, malaise Dx: Cellulitis Tx:  Rocephin 1G 1M, Keflex.
Pt's. sister noted injection site to be red and warm to touch from deltoid to elbow the morning after PNEUMOVAX 23 injection.
HIGH STRESS; This spontaneous report received from a patient concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high stress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high stress was not reported. This report was non-serious.
Pt recv vax on 10/5/98; on same day pt exp chills & sweating
Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache,bodyaches faligue,nausea,loss of appetite ,joint pain, unable to get out of bed due to weakness.  Severe symptoms lasted around 24 hrs , better next day but persisted for another 24 hrs then fatigue lasted another 7-10 days
Within 24 hours of receiving the vaccine the patient started having joint aches and pain as well as swelling starting with wrist  then involved all major joints (shoulders, ankles, elbows knees etc).
As malaise, fever, and myalgias abated during the first 24 hours after vaccination, the following symptoms began, gradually progressed, and now persist: dry cough, wheezing, shortness of breath, and complex migraine (with aura, left facial paresthesia, scotomata, photophobia). Respiratory symptoms have become persistent and now limit activity. Migraines occur 3-5 times per week unless treated prophylactically with beta blockers, but still occur , on beta blockers, once per week. The complex migraine neurological symptoms has not changed.
red, swollen & hard in area where vax was given;sxs started day vax given & lasted 2 days;
On-set of symptoms within hours of injection, body aches, joint pain, chills and sweats, fever (low and high) persisted over 2 1/2 days. Treated at home with OTC pain relievers, bed rest.
Hives, all over, red, swollen noted 2AM. 02/07/2010 lips swollen, eyes noted. 2/08/2010 on waking diphenhydramine 25mg. Prednison started yesterday 2/8/210 one QAM x 6 days.
Information has been received from an RN concerning an unidentified pt who was vaccinated with 4 doses of Hep-B vaccine and subsequently, the pt developed conjunctivitis, loose stools and a mild fever with achiness. The pt sought unspecified medical attention. Additional information has been requested.
Report vaccine side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report vaccine side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report vaccine side effects). At the time of the report, VACCINATION COMPLICATION (Report vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Abdominal cramps, pain to injection site, chills, fever, headache, body aches. Next day, redness and swelling spread close to elbow and injection site was hard to touch with limitation of movement.
3 hours of uncontrollable screaming/crying  without any obvious source. No fever.
Lt arm deltoid red/swllen 9x10cm DTaP IM Lt delt. 3/26/03 noticed 3/28/03 red/swollen. Benadryl/ Tylenol.
Flu shot administered 9-19-12 - pt had episode of vomiting 9-20-12.
Slight swelling (1/4" high) red and hot 2 1/2 diameter with some itching.
we had vial that was "left open" and the patient got the vaccine from that vial; we had vial that was "left open" and the patient got the vaccine from that vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial). At the time of the report, PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment medication was provided by reporter. Reporter did not allow further contact
Pain in the legs and inability to bear weight. Started on 11/5/09 (about 8 pm) and was seen in the medical office on 11/6/09 and then in the ER, (hospital) the same night; and again on 11/9/09. Transferred to another hospital; discharged on 11/11/09. Was still not ambulating. LP done - was normal.  12/2-12/8 Discharge summary and medical records received for DOS  11/9-11/11. Final DX:  Lower extremity pain. PTSD.  Acute onset tingling bil feet. Progressive sharp pain ascending to knees.  Fell to floor. Legs too weak to walk.  Transient macular rash on face resolved.  Knee/ankle joint pain. Diarrhea. Psych eval revealed PTSD and h/o abuse. All diags WNL.  Improved w/NSAIDs. OT/PT planned.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 33.88.  Concomitant products were not provided.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature range at 9AM-10AM: 35 Degree Fahrenheit. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  On 27-Mar-2021, no hourly temperature recordings available.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Big hive; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Big hive) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included LEVOTHYROXINE and AMLODIPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INJECTION SITE URTICARIA (Big hive). At the time of the report, INJECTION SITE URTICARIA (Big hive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included was diphenhydramine.   Based on the 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.   This case was linked to MOD-2021-117740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Upon internal review on 20-Sep-2022, non-significant correction was performed to update case level seriousness. On 07-Apr-2021: No new information received. On 14-Apr-2021: No new information received.; Sender's Comments: Based on the 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.
Information has been received from a nurse practitioner concerning a 4 year old female who on an unknown date was vaccinated with a dose of VARIVAX (Oka/Merck). The nurse reported that the patient had shingles reported by another physician (possibly within the last year). The child was healthy, no immunocompromised conditions. She did recover. Additional information has been requested.
This case was reported by a nurse and described a 45 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 01 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker.  At 2:30 a.m. on 1/15/2021 I woke up with severe rigors that lasted 2 hours.  Over the course of the day 1/15/2021 I had a second 2 hour episode of rigors. They were almost violent and seizure-like.  In addition, I had severe nausea, dizziness, decreased vision, fever, myalgia, and exhaustion.  My temperature reached 103.4 and lasted over 24 hours.  Ibuprofen would bring the fever down 1 degree and helped decrease rigors, but did not help the headache.  On 1/16/2021 I developed redness and swelling of entire upper left arm, and edema in arm pit.  I spent three days unable to work or sit up in a chair. Symptoms began to decrease after three days, but I was unable to resume full work days until 1/22/2021.  Vision returned to 100%, and nausea resolved, on 1/23/2021.  Decreased appetite and fatigue are still an issue as of 1/25/2021.
New onset tinnitus on day 4 after 3rd booster; Administration date 06Nov2021, dose number=3; This is a spontaneous report from a contactable physician, the patient. A 57-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06Nov2021 at 07:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and hypothyroid. The patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and levothyroxine sodium (LEVOTHROID); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 56-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 10Nov2021 at 08:00, the patient experienced new onset tinnitus on day 4 after 3rd booster. The event new onset tinnitus on day 4 after 3rd booster did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event new onset tinnitus on day 4 after 3rd booster. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event new onset tinnitus on day 4 after 3rd booster was not resolved at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt recvd DTP/OPV/HIB @ 9AM & devel temp @ noon; mom gave APAP, pt exhibited screaming for over 3hrs; mom called MD 6PM; didn't need medical attention; Mom states pt was limp like a ragdoll;