chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in throat, intense back pain, headache, secretions from eyes, flu symptons.  Patient suspects Thimersol, which she is hypersensitive to. Doctor prescribed prednisone.  Patient is to see her doctor within 24 hours.
Due to lack of data for Asian-descent - I hope this data is helpful to Moderna and CDC. Light adverse side effects right after the vaccine was administered. Remained under supervision for 45 minutes longer instead of 15 min. Within 5 mins, heat rose up to my head causing dizziness & head spin. Then loss of smell lasting for 10 min or a bit longer, then tongue tied hard / swollen for 3 hrs and lasting mildly 1 day after. Severe dehydration. Did not monitor heart beat due to severe fatigue. Took blood pressure rising and falling like roller coaster 2x. I stop and learned to relax and sleep throughout the day to calm the nervous system and the slight fever. Other normal aching pains as pre-described side effects. No nausea, vomiting, no rash as of 1 day after and no difficult breathing. Occasional and short loss of smell carried after 1st day.
Severe acid reflux triggering GERD/LPR symptoms including uvular ulcers and throat ulcers appearing after 36 hours.  Seemingly low resting heart rate, around 60 bpm while resting and frequent dropping into high 40s late at night. Chest pain off and on
Information has been received from a 66 year old female with reaction to BENEDRYL and reaction to cisplatin (+) doxorubicin (+) etoposide (+) vincristine sulfate and no pertinent medical history reported who on 31-MAR-2009 was vaccinated with ZOSTAVAX (Merck), 0.65 mL. Concomitant therapy included CLARINEX, RHINOCORT, "TRAVASTAND" and baby aspirin. The next day to the vaccine, on 01-APR-2009, the patient experienced a rash of 3 inches by 4 inches in the arm where ZOSTAVAX (Merck) was given. The rash was red with little bumps and sore to touch. The patient sought unspecified medical attention. No labs were done. At the time of reporting the patient had not recovered. Additional information has been requested.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:26 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 66.93.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09:00 A.M., temperature was 34 degrees Fahrenheit, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Immediatally after vaccine my son fainted and began a jerking movement this lasted only about 5 seconds. After that he became responsive, his color was very greenish/yellow at first. After about 5 minutes and some juice he started feeling better.
Patient stated that after receiving his second dose of SHINGRIX he woke up the next morning feeling like he had flu-like symptoms. His body felt achy and he was nauseated and could barely move from bed.
0943 - patient left observation area via self ambulation. States she got outside into parking lot and became short of breath and felt like she was having an asthma attack. Patient returned to clinic and assisted by paramedic and transported to private observation area via w/c. Patient has own inhaler and took two puffs of ProAir. Paramedic remains in attendance. HR 105; O2 sat 96% on r/a, BBS CTA per paramedic assessment. No rashes noted on arms, back, abdomen. Denies having itching, just c/o SOB.  0953 HR- 82, O2 99%. Patient has own insulin pump and electronic glucometer. States her glucose is 208. States she ate breakfast and has drank a lot of water this morning, 0958 - HR 80; O2 97% on r/a, BP 158/102  BBS CTA per paramedic reassessment. SOB subsided 1008: HR 76; O2 98%, RR 22; BP 138/98. Paramedic recommended ambulance dispatch for nebulizer treatment. Patient declined, stating she had some at home and wanted to use neb tx if her asthma worsened. Patient declined transport to hospital. patient was able to walk to her personal vehicle without assistance.  Patient signed recommendations per paramedic and left via personal vehicle - drove self.
vomited x1 yesterday and has been having nausea all day today. Patient c/o headache, congestion, loss of smell, and fatigue.
Realy sore arms; injection site is hard, raised and red; injection site is hard, raised and red; injection site is hard, raised and red; allergic reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really sore arms /pain in extremity, injection site is hard /injection site induration, raised /injection site swelling and red /injection site erythema, looks like an allergic reaction /hypersensitivity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) Really sore arms, Injection site is hard, raised and red, Looks like an allergic reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), really sore arms, injection site is hard, raised and red, looks like an allergic reaction was unknown.
No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to unknown number of patients of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  In 2019 (reported as since 20-JUN-2019), the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # N034411, expiration date 04-DEC-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023960, expiration date 01-SEP-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 9 Celsius degrees for 15 minutes. The storage temperature of varicella virus vaccine live (oka/merck) (VARIVAX) was 9 Celsius degrees to 25 Celsius degrees for 15 minutes. There was no previous temperature excursion for both vaccines. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Data logger was involved for both vaccines.   This case was considered non-valid due to lack of patient identifiers.  Follow up information was received from a medical assistant on 12-MAY-2020. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. The male patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 14-AUG-2019.; Sender's Comments:  US-009507513-2005USA003627:Original Case : 1911USA003982 US-0095075132-005USA003625:Original Case : 1911USA003982 US-009507513-2005USA003619:Original Case : 1911USA003982
Rash at injection site day 8 Itchy with small raised area initially progressed to about a 1 1/2-2? red area.  This is day 16 and redness is fading but can still see rash
Member received vaccine at clinic around 1002.  He then returned to work at clinic.  He reports he started feeling dizzy and nauseated around 1200.  A medical emergency was called around 1215.  Symptoms progressed to flushing, red raised rash and seeing spots.  Member was given epi 0.3 mg IM and Benadryl 50mg IM with resolution of symptoms.   Member was observed for 1 hour then discharged to home with a follow up phone visit 1/8/21 PM.   He was advised to continue taking Benadryl 50 mg PO every 6 hours x 24 hours and was given an epi pen to use in case emergent symptoms returned.
Patient recieved both FLUZONE and PNEUMOVAX immunizations on 8/15/2018. Next day noticed a skin rash spreading on arm. She went to her doctor, he said she had allergic reaction to one of the immunizations. He gave her a prescription for ibuprofen. She came to pharmacy and told me about reaction and I told patient I would report it.
tested positive for COVID- 19; Trouble breathing; blood clots in lungs; Chills; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in lungs) and COVID-19 (tested positive for COVID- 19) in a male patient of an unknown age 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 (No medical history reported).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced THROMBOSIS (blood clots in lungs) (seriousness criteria hospitalization prolonged and medically significant) and COVID-19 (tested positive for COVID- 19) (seriousness criterion hospitalization prolonged). At the time of the report, THROMBOSIS (blood clots in lungs) and COVID-19 (tested positive for COVID- 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Fever, chills and myalgua are consistent with the product known safety profile.   Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Fever, chills and myalgua are consistent with the product known safety profile.
This spontaneous report was received from a medical assistant referring to 15 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019128, expiration date 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was confirmed that sterile diluent (lot # M046371, expiration date 05-JUL-2019) used for reconstitution was properly stored. No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 56 hours 11 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
(First Moderna injection was February 28 and I had no reaction to it in my left arm) Second Moderna injection area became red, swollen, heated area with pain around injection site about 2"x 3";  started two days after second Moderna injection.   It became itchy and larger. about 4" x 5"--- 6 days after injection. There also appears to be some small fluid pockets/bumps, not really blisters, that break when I scratched it.  The pain stopped about 5 days after the injection and  it appears to be going away.
Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness on her bottom lip to the center of her lip.  It spread throughout the entire bottom lip.  Then it moved to the left hand corner of her mouth as well, and then moved up to the left side of her face to her eye, and then to the corner of the left hand of her head.  This is a tingly pressure, and it then developed into a hard headache concentrated in one spot.  She went into heavy sweating.  The pharmacist was watching her and came over to her, she was there for about an hour and a half.  She had a bottle of water trying to cool off, and her tongue was getting a bad taste in her mouth, and numbness in the back of her tongue.  The pharmacist gave her Benadryl to take and she sat there for a while and was starting to feel really shaky, and she thought she would go back to her apartment to get out of being around other people.  She was feeling weak to walk, and overwhelmingly tired.  Once she did get into her apartment she her taste buds felt dry.   After several days of this reaction, little by little it subsided, but the sweating and chills continue even up until today, 3/26/21.  She goes to bed dry and wakes up soaked from sweat due to profuse sweating.  She has been yawing a lot lately and if she does yawn she immediately has chills.  It's been back and forth with the chills/fever.  She can be perspiring on one end and the other end cold.  She tried to talk to her doctor but told her to seek out UC for her symptoms as he is too busy.    There is eye strain that is bothering her which leads her into wanting to sleep and sleeps for extended periods of time and really exhausted.  Has also had runny nose, hands and feet swelling.  Her right hand is kind of like a tingling/weakness sensation.
Narrative:  75yo male patient with cirrhosis with portal hypertension, ascites and splenomegaly died outside of facility, place & circumstances not mentioned in system. Pt had received covid vaccines on 3/29/21 & 4/26/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 1-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (dose and route of administration were not reported) lot # N019127 with expiration date 22-JUN-2019. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
I woke up at about 1 AM with a splitting headache. The next morning, I started having body aches. I went to the doctor, and they did a nasal swab and I tested positive for COVID-19. I was prescribed PAXLOVID. I didn't start to feel improvement in my symptoms until about 5 days later. I did not do much because I was tired.
Patient complained of arm pain that did not resolve since flu shot given.  She visited her primary care doctor and received ibuprofen on 10-17-19 and cyclobenzaprine on 11-21-19.  She says the pain is worse at night after sleeping and can't sleep on her left side.
States noted marked pain at injection site at time of injection, followed by marked burning pain of area/area of left shoulder bursa. Since then reports continued pain in upper deltoid/shoulder bursa, aggravated by abduction of left arm. Controlled with ibuprofen, but requires ibuprofen to be able to work. Pain/limitation has persisted x 2 weeks.
Erythema and edema right arm patient given Keflex and Ibuprofen.
9JUN93 physical & immun for kindergarten immun given @ 10AM; c/o sore arm, hot, red, swollen by 1PM;
Off label Dosing; Off label Dosing to 16 year-old patient; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) in a 16-year-old patient of an unknown gender 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 OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient). At the time of the report, OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication information was provided.  No treatment medication were provided.
Patient came in for his first pediatric covid vaccine which we gave to him.  Later it was discovered that an insufficient amount of diluent was added to the vial making the dose more concentrated than what was intended.  We contacted the manufacturer and reached out to the parent of this child to check on his well being  and explain the incident.  His mom said he was doing fine and had no adverse reactions from this vaccine.
High pitched unusual crying for 48hrs; fever 101 APAP given, did not help high pitched crying, mom stated; pt slept very little for 48 hrs; Pt will have DT from now on;
J96.00 ACUTE RESPIRATORY FAILURE 4/14/2023 ACUTE BRONCHOSPASM R09.02 HYPOXIA 4/13/2023 ACUTE BRONCHOSPASM
A pre-diluted grey-top Pfizer covid vaccine vial (adult) was diluted with 1.8 mL of normal saline. Subsequently, an over-diluted 0.3 mL vaccine was administered to the patient for their booster. The patient was called and notified of this and the CDC recommendation that they are to repeat the dose immediately. The patient stated that they will go to a pharmacy near their home to receive the booster. No adverse events or clinical consequences were reported.
Major pain at inject site around 8 hours after shot, pain migrated to right arm sometime while asleep same day. Around 2 weeks after shot started to experience ringing in ear (tinnitus), difficult to pin point exactly though was severe from November until January 2022, thought was related to head cold/sinuses. Ringing has been intermittent since, ranging in severity and length - still experiencing it multiple times a day.
Patients arm at injection site.Right anterior aspect was red,hot to the touch,and itching.None itching cream applied ie: Eucerin calming cream and cool packs applied to area.
Sore area of injection; Red area of injection; arm of injection was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm of injection was a little sore), VACCINATION SITE PAIN (Sore area of injection) and VACCINATION SITE ERYTHEMA (Red area of injection) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm of injection was a little sore). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore area of injection) and VACCINATION SITE ERYTHEMA (Red area of injection). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm of injection was a little sore), VACCINATION SITE PAIN (Sore area of injection) and VACCINATION SITE ERYTHEMA (Red area of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information also includes Ice Pack
REDNESS AND ITCHING AT INJECTION SITE FOR 7 DAYS.  NO TREATMENT NEEDED.
Fatigue set in early in the evening, around 5:00, accompanied by a mild headache. By around 9:00, I experienced chills and suspected I had a fever. I took my temperature using a digital under-tongue thermometer which registered 100.4.   It's currently 1:00 in the morning, and the fever is still present but slightly lower at 99.9 degrees. Although there is no pain or tenderness at the injection site, I feel mild systemic achiness.   I have not taken anything for fever or aches.
About 4 days after receiving vaccine, started to get a headache which lasted for about 1 week.  Also felt like I was coming down with something.  Felt nauseous at times but had no vomiting.  Spent about 2 days in my recliner because of overall feeling of unwell ness.
it was rpt fr HCP concerning pt who was vax 11feb97 & subsequently pt exp a varicella like rash. addl info requested
pain in the left shoulder followed by weakness in the left hand, left, left deltoid and mild weakness in the left tricep.  The pain was sharp and stabbing.   Over a period of hours the left hand became weak.  He returned to work on the 19th and struggled with manual tasks with his left hand (he is a dentist). Based on his symptoms of pain followed by limb weakness, the diagnosis of brachial neuritis was clinically suspected by his PCP. On the 20th he received a steroid taper starting with 60mg daily for 4 days, then 40mg for 4 days then 20mg for 4 days and then off.  Within a day of starting steroids, the weakness improved slightly and the pain decreased.  As of January 27th he still uses tylenol for pain and has mild left hand weakness that is residual.