chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Duration between 2 doses > 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Duration between 2 doses > 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Duration between 2 doses > 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Duration between 2 doses > 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The reporter informed that the patient took first dose and second dose was scheduled on 11-JUN-2021.The patient will be will be available only after 12-JUL-2021.
Pt with nausea, emesis, fever and rhinorrhea lasting 3-4 days. Pt took OTC Tylenol and other cold medication. Note: family/friends with same symptoms.
Information was received on 24-AUG-2017 from a pharmacist regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates in August 2017, an unspecified number of patients were vaccinated with doses of ZOSTAVAX lot # N012615 expiration 16-MAR-2018, subcutaneous for prophylaxis which were improperly stored. Concomitant therapies included sterile diluent (STERILE DILUENT) which was stored properly. The vaccines were stored at temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit for the cumulative time of 10 hours and 8 minutes. The vaccines were stored at temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 5 hours and 30 minutes and a previous temperature excursion of temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit (36.3 degrees Fahrenheit) for 4 hours and 38 minutes. The call was made due to a data logger. No adverse effects were reported. No further information provided. Additional information is not expected. No permission to contact.
Temperature started 02.25.21 temp at 100.4  to  102.00, feel like Flu, came on very fast.  Chills, nausea,  shaking
no adverse event; wrong technique; This spontaneous report was received from a medical assistant refers to a 9-month-old patient. The patient's medical history, current conditions and concomitant medications were not reported. On 18-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R002510 and expiration date 25-JAN-2020) (dose, units and frequency unknown). On 18-JUN-2019, the drug was reconstituted with non-company sterile diluent (lot # A31443 and expiration date 01-AUG-2021 NDC 0409 4887 17) to 9-month-old infant (wrong technique in product usage process). No adverse effect reported. No PQC (product quality complaint) was reported.
It was reported that a 38 year old female received Fluzone SV '98-'99 USP on 10/23/98, and 2 days, post vax, the pt experienced muscle aching, sore throat and fatigue lasting for 2 weeks.
Pt to ED 11/4 for shortness of breath and weakness. Pt COVID+ 11/5, wearing oxygen at 4L/min. 11/7  Pt with productive cough and is receiving breathing tx via respiratory. 11/9 pt is aox4, on 2L 02 NC no apparent distress noted, denies pain or sob. PT discharged 11/10.
Injection site ached a little bit for about 12 hours after the injection administered; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL3247) via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunization (at the age of 83-years-old). The patient medical history and concomitant medications were not reported. The previously took flu shot (brand name/lot/NDC/Expiry: Not provided) on an unspecified date and stated that it hurts a little bit. The patient stated that after receiving the dose of vaccine he had no symptoms, no side effects at all. The only thing he experienced with the Pfizer COVID-19 Vaccine was injection site ached a little bit for about 12 hours after the injection administered on an unspecified date in Feb2021. The patient further mentioned as the people at the administering site treated him great, he could not be happier. He would recommend the Pfizer COVID-19 Vaccine to anyone. The main reason he called was to ask how many days after the second dose of Pfizer COVID-19 Vaccine is administered does the immunity kick in. One person said it would kick in in 7 days, another lady said 21 days, someone else said 14 days. The outcome of the event was recovered.   Follow-up attempts completed. No further information expected.
Lungs weak.  Extremely fatigued Like when i likely had early covid jan 2020
Reported from patient over the phone after the incident:  tingling lips with swelling. Scratchy throat and  cough. Treated with oral Benadryl with relief of symptoms duration Approx  1 1/2-2hours
jerking movements @ head, seen in ER x2;circumoral cyanosis;temp next day 104 R;T100.4;exam nl 30min later;
This spontaneous report as received from a pharmacist refers to an unknown number of patient of unknown age. The patients were vaccinated with doses of M-M-R II (lot# not reported) stored as high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed in Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
Knot on arm, red, itchy chills sore throat Congestion gas achy It has been 7 days since the shot and I am still experiencing symptoms although my arm is getting better
Shingles; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first Shingrix shot and 2 days later was down with shingles.
Skin reaction all over body  - did one course of prednisone but hives came back after completing prednisone. Hives appear for about 30 minutes and disappear, come back every 2-3 hours. Itching, redness, swelling and hot skin present. Scratching makes red lines appear and spreads the reaction.
Patient presented to the hospital on 10/26/22 after a fall and tested positive for COVID. No significant COVID symptoms.
Got a vaccine for pneumonia and within a week I had the disease/I was in the hospital with pneumonia.; Inappropriate dose of vaccine administered; The initial case was missing the following minimum criteria: the suspect product is not reported or specified. Upon receipt of follow-up information on 08Jan2020, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer from a Pfizer sponsored program.  A 66-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on an unspecified dose for immunisation, recommended at a regular check-up.  The patient medical history and concomitant medications were not reported.  The patient got a vaccine for pneumonia and within a week he had the disease, he was in the hospital with pneumonia on an unspecified date. The outcome of the event was unknown. He thought just coincidence. The following year the same thing occurred. One week after the shot, in went to emergency room with pneumonia. High fever, lungs plugged, the whole thing. He knew that he was at risk for the disease but he was not sure the vaccine was giving me the disease or not. The only thing he knew about the vaccine was it was number 13. He won't get another.  Information on the lot/batch number has been requested.
Noon next day had fever 101 and headache,  given Tylenol and pain/fever gone.  Took bath at 5pm, broke out in hives.  Benadryl given and hives went away and didn't come back.
Mild local reaction lasting >24 hours.  Mild swelling and soreness.  Redness surrounding the injection site with radius of about 0.75 inches.  The patient was advised to apply a cold compress to the affected area for 15 minutes, take an antihistamine for swelling, and take acetaminophen for soreness. She was advised to report any worsening of symptoms.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein I Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
pt recvd vax; w/in a day p/ vax devel joint pain & rash then devel sores at inject site;as of 31oct94 open sores are healing but persist;size of a quarter & covered w/ blackened crust; no tx given;vax discontinued;
Enlarging arm redness at site of injection started after 1 week. Extremely itchy at site. Site extends about 5 inches below site but not to joint
I contracted Covid, confirmed by testing.  Symptoms: fever, cough, shortness of breath (O2 levels did not drop below 92), sore throat (extremely severe), loss of taste or smell, chills, muscle aches, headaches, fatigue (extreme), and nasal congestion.  Dr. put me on Paxlovid due to my being immunocompromised according to my rheumatologist (who had just moved out of state.)  I recovered from the worst of the symptoms and tested negative on day 8.  By the evening of day 9 my symptoms were returning and I tested positive again.  I then had a rebound case in which the sore throat was not as bad but the headaches were much worse.  I finally tested negative again 22 days after my original positive test.  I continue to suffer from fatigue and get winded very easily.  I also get low level headaches frequently now where I used to only get one headache a month or so.
Full body cramping initially, then localizing in lower back and groin, left leg goes numb when laying down
Fussy about 12 hours after vaccines. Screamed and inconsolable for 3 hours.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 45 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: About a month and half later after vaccination, the patient developed a case of the shingles. The reporter consented to follow up.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 14-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
3 cm diameter indurated lump in deltoid muscle at site of injection.  No infection or thrombosis.
15 minutes post vaccination, verbalizes feeling flushed; no respiratory symptoms noted/ reported, NAD  Vitals assessed: BP 122/86 P82 RR 18 Monitored additional 20 minutes, reports "feeling better", noted status improved Released from facility to home
This case was reported by a consumer and described the occurrence of vaccination failure in a 63-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 to 4 outbreaks per year) and painful rash (large and painful rash on legs). In March 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. Since getting the vaccine, she had got a shingles outbreak a few months before the date of reporting and another outbreak in the night of 1st May 2019. The rash appeared on her legs. The rash was not as large and painful as it was prior to getting the SHINGRIX vaccinations. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Diarrhea Information has been received from a physician concerning a 4 month old male who on approximately 17-MAR-2006 and on 03-MAY-2006 was vaccinated PO with the first and second 2.0ml dose respectively of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant therapy. The physician reported that on approximately 03-MAY-2006, after the second dose, the patient experienced eight days of persistent diarrhea. Unspecified medical attention was sought, but no laboratory/diagnostics tests were performed. At the time of this report the patient was recovering. Additional information has been requested.
I went a couple weeks after I started noticing changes in my skin at the bottom of my feet. A couple weeks after that I noticed it on my hands especially my fingers. It started out with sensitivity, the skin on my feet got hard and cracked. All the skin on my hands peeled off my hands/fingers were raw, I could not use a pen or a fork it was too hard. I made an appointment with a dermatologist. She prescribed steroid cream that ended up not working. I went back and she prescribed a stronger dose of steroid cream, we got no results with the second round of steroids as well. The dermatologist did an eczema test to rule that out and she ended up diagnosing me with psoriasis. She prescribed me some medicine for the psoriasis and told me to alternate that with Vitamin D it has helped but it has not gone away completely. I went back to the doctor because it was not going away, so she prescribed me, I have been taking the medicine for 4 weeks now.
Patient states that arm soreness is more than normal and believed from her training as an MA that it was given too high in the arm. She states it is difficult to lift her arm. She also wanted it noted that she had 102.9 F. fever
16 year old was vaccinated with Moderna on 3/11/21.  Error was found on 3/26/21 by staff reviewing registration list for upcoming covid vaccine clinics. Spoke with patient and her mother on 3/30/21 to report what happened.  Patient reported feeling very tired starting on the evening of 3/11/21 and continued until 3/12/21 around bedtime.  Also had chills that started on 3/11/21 in the evening and lasted until 5pm on 3/12/21.  Denies any other symptoms or problems.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies"; Bactrim, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included COVID 19 treatment from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient had hives in throat, that had pus the next morning very sore throat, with inflamed uvula tongue had a coating symptoms lasted about 4 days
VOMITING; CHILLS; NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, chills, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, vomiting and not feeling well was not reported. This report was non-serious.
PAIN (SORENESS) AT INJECTION SITE, KNOT UNDERNEATH ARM NOT AT INJECTION SITE, SWELLING NOT MUCH....
Chief Complaint  pt illness since 8/10, covid + fatigue, lightheaded, cough, shortness of breath, fever, chills, BA, HA, loss of taste or smell. nausea, recieved monoclonal antibodies last week. O2 sat 88% History of Present Illness: patient is a 68-year-old man with a history of CAD (s/p CABG), RA, hypertension, and DMII who presented to the ED with worsening shortness of breath in the setting of COVID-19 infection.   The patient developed fatigue and URI symptoms around 8/11. He tested positive for COVID on 8/11. He was able to be arranged to have monoclonal antibody treatment on 8/12.  Patient reports that since his monoclonal antibody treatment that he has continued to have ongoing fatigue.  He  has also had ongoing cough, fever,  and body aches.  Patient was seen by his PCP on day of presentation and reportedly had oxygen saturations in the high 80's.  Patient was then instructed to present to the ED for further evaluation.  The patient was admitted to the COVID step-down unit.  He received 5 days of remdesivir and dexamethasone.  The patient was initially on 4 L, but quickly over the last several days we have been able to wean him down significantly really to almost room air.  Today, the patient has actually gotten to room air, but when he gets up, he does desaturate with ambulation.  His creatinine was slightly elevated when he was admitted, his ARB was held because his blood pressure was a little soft.  His creatinine went from 1.3 down to 1.1 upon discharge.  Also, his platelet count was slightly low when he was admitted, which is fairly common with COVID-19.  His platelet count was initially 108, but on the day of discharge it had already rebounded to 148.    He is eating and drinking.  He had had a bowel movement, which is not  uncommon for him.  He has struggled with constipation at home. He is eating and drinking.  He had had a bowel movement, which is not  uncommon for him.  He has struggled with constipation at home.    In terms of his diabetes, the patient was taken off his Jardiance and his glipizide along with his metformin while he is in the hospital.  Obviously, he had some elevation of his glucose, is related to the dexamethasone.  I think that will probably resolve itself after he finishes tape his dexamethasone course.   The patient feels well.  He qualified for 1-2 L of oxygen mostly when he ambulates.  He did get down to 86, when he ambulated.  I basically outlined him that he will probably need it for 1-2 weeks.  He will be discharged in markedly improved condition.  His diet should be heart healthy.