chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 11:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:52 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 84.88.  Concomitant products were not provided.  On 03-Mar-2021, Excursion time was 9 AM, temp was 51, at 10 AM temp was 34 and at 1 PM temp was 35; total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 03-Mar-2021, Excursion duration At 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36, 4 PM: 36 and 5 PM : 36.  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.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were 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.
Bruising and bleeding from injection site. Pretty painful on his upper right arm. Patient went to urgent care 9/14/17.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pharmacist reported that unspecified patient, physician's office asked for stability of ZOSTAVAX (lot # J011335, expiration date 13-DEC-2014) exposed to 70F for total 40 minutes, in order to administer to patient. Unspecified patient might be receiving the improperly stored ZOSTAVAX (lot # J011335, expiration date 13-DEC-2014) on 19-MAR-2014. Additional information has been requested.
Patient stated she has history of fainting with vaccines. She ate and had something to drink today. She also had juice and candy in the office. After vaccine given, 5 minutes later she stated she felt ill, was pale, body became very tense for about 10 seconds during which time she did not answer and she drank water. She was able to move to sitting and standing. Color was improved. She felt well enough to leave office 35 minutes after vaccine. She was also examined by dr. while she was here.
Appendicitis and perforated appendix. Abdominal pain started on 3/26/2021 and intensified through 3/29/2021. Diagnosed with a perforated appendix on 3/29/2021. Appendectomy completed the night of 3/29/2021.
Approx 10:25 c/o feeling light headed, dizzy - chest pains. Student asthmatic with inhaler. and food, drink AM. Color good no SOB. nausea, vitals - 94/70 P-100 R-20. Student reclined - given PB crackers and sprite; 10:45 -sitting up = eating drinking - talking w/o difficulty. Reports mild improvement in dizziness. 11:00 98/68, P64, RR 16. Student reports feeling better and says she feels she can stay at school. Call made to mother to report condition, reaction to vaccine. Returned to class = instruction to see school nurse if sx's reoccur.
I had itching where I had calcifications removed from my breast; I had a burning sensation across the top of both breast; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ) in a patient of an unknown age and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ). At the time of the report, SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-302031 (Patient Link).   Reporter did not allow further contact
Muscle pain in neck (only on left side) started about an hour after vaccine.   After a few hours I started having pain on inspirational breathing on left side which progressively got worse over night.    breathing became painful, (only on left side) and on the advice of the on call doctor I went to the emergency room where x-rays, Cat scan and blood work, EKG, BP was done.   They determined it was muscle pain  as all test came back normal.
Hives/welts over all of body.  She treated with Prednisone and Benadryl.
not feeling good; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, MALAISE (not feeling good), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
The day following administration of Hepatitis A, Meningococccal and HPV vaccine, 6-18-09, patient ran a fever of 100.6 degrees F and complained of headache and malaise. 6-19-09 patient reported symptoms had resolved with no other problems.
Felt blah (I know, very technical, lol) Fever (98.8) Chills  Took Extra Strength Tylenol (1000mg)  and Advil 400mg alternating every 5-6 hours
A week after shot I woke up in the morning with pain in my right shoulder, same side the shot was given. The pain remains the same unless I take ADVIL or TYLENOL and that helps for 8 to 10 hours. Then the pain returns.
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Lot number: FW1331) at the age of 52 years, in left arm 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 was not reported. There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: low-grade; SARS-CoV-2 test: Negative, notes: 8 days after testing negative for COVID; Positive, notes: I took 2 at-home COVID tests using different brands and tested positive; Positive, notes: I took 2 at-home COVID tests using different brands and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including PAXLOVID given from 14Sep2022 to 24Sep2022.  No follow-up attempts are possible. No further information is expected.
5mins post vaccination pt c/o slight numbness to feft fingertips for a few seconds.  Numbness subsided.  Injection in L deltoid.  No redness or swelling noted Vitals: 87/58, 66, 24, 91% -- > 91/57, 87, 22, 100% -- > 89/56, 87, 22 -- > 19:25 89/59, 85, 20, 100% Pt c/o thirst.  Pt given orange juice and pt reports feeling better. 19:25 Instructed pt to contact MD if not feeling well.  Do not hesitate to seek ER assistance if needed.  Pt verbalized understanding. Pty stable and released from vaccination site in no distress.
Patient has had a massive change in bowel frequency since her vaccine. She used to have at least 2-3 poopy diapers a day and since the vaccine she only has one explosive diarrhea a day or every other day.
1) Itchy, painful hives all over body, esp. back, knees and underarms within 2 weeks of first dose; treated with mixture of moisturizer and steroid anti-itch cream; condition continues to this date. 2) Weight loss, joint pain and loss of muscle strength/mass after second dose (Moderna, Lot 010A21A, 3/4/21); treated with Ibuprofen, ice pack, heating pad and topical analgesic cream; condition continues to this date.
COVID toes, big toe left foot, third toe right foot, so far lasting two days at this report.
A spontaneous report was received from a 68 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced squashy neck and face, eyes dry, eye itchy and swollen arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14-Jan-2021, prior to the onset of the events squashy neck and face, eyes dry, eye itchy and swollen arm, the patient received their first of two planned doses of mRNA-1273 (lot/batch: or unknown) via an unknown route in left arm for prophylaxis of COVID-19 infection.  On 14-Jan-2021, the patient experienced squashy neck and face, eyes dry, eye itchy and swollen arm.  Patient received steroid as treatment medication.  Action taken with mRNA-1273 in response to the events squashy neck and face, eyes dry, eye itchy and swollen arm was not reported.  The outcome of the events squashy neck and face, eyes dry, eye itchy and swollen arm was not provided.  The reporter did not provide the assessment assessed the events squashy neck and face, eyes dry, eye itchy and swollen arm to study drug.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
temp elevation 105 x 2days; vomiting; severe diarrhea & dehydration; abd pain
?Covid arm? rash started below the injection site which became red and raised. Rash started small and grew in size over three days. Was hot to the touch, swollen and sore. Felt tired upon onset, lymph nodes swollen, a feeling of my entire body being swollen.  Very bad headache on day three. Treatment was three 500 mg Tylenol. ( took two 500 mg Tylenol did not bring down the pain ,took one additional 500 mg Tylenol about 45 minutes after the first dose that finally worked) Headache subsided. By day four felt fine. Rash began to fade. Today is the fourth day so nothing further to report.
The pt complained of redness, swelling, at the injection site which was 30-40 mm in size. Pt was instructed to see PMD.
This spontaneous report as received from a female pharmacist of unknown age refers to herself who was not pregnant.  The pharmacist reported that "one year ago" in August 2013, while she was preparing ZOSTAVAX (lot #, dose, route not reported) for administration to a patient, the pharmacist was accidentally sprayed with medication.  No adverse effects were reported. PQC was filled. No medical attention was sought.  Additional information has been requested.
Vaccine was diluted with sterile water instead of the recommended normal saline. No adverse effects.
VACCINE FROM A TEMPERATURE EXCURSION WAS ADMINISTERED; VACCINE WAS ADMINISTERED AT A DIFFERENT SITE; TEMPERATURE EXCURSION OF VACCINE PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 vaccine from a temperature excursion was administered, vaccine was administered at a different site, and temperature excursion of vaccine product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of vaccine product, vaccine from a temperature excursion was administered and vaccine was administered at a different site was not reported. This report was non-serious.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-NOV-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L043702 with expiration date 03-NOV-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L051124, expiration date: 14-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Client states within 2 hours after receiving her flu shot, she had pain halfway up her upper left arm and was unable to move her arm.  Client went to physician on 12/30/03 and was examined.  The physician gave the client a cortisol injection.  Client states she is now able to lift her arm but is still unable to move it from side to side.
Heart Pounding.  Irregular heartbeat.  Holter monitor showed 34% PVC's.
This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 53-year-old female patient, who had a medical history of end-stage renal disease and atrial fibrillation. The patient died (of unknown cause) (under review), five days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
Arm pain  and weakness radiating to the muscle of shoulder and shoulder blade that has lasted since receiving the vaccine.
This spontaneous report was received from medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L037554 with expiry date: 25-DEC-2017, (dose and route not reported). No adverse effects and no product quality reported. No further information provided. Additional information has been requested.
BLOOD CLOT; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. 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 blood clot. As per reporter it was reported that, "I think I have a blood clot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220515002-covid-19 vaccine ad26.cov2.s- Blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
VERY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very tired was not reported. This report was non-serious.
Patient erroneously received bivalent vaccine as 2nd dose in the primary series when he should have received monovalent vaccine
(1/26) Subq VARIVAX given Rt lower thigh. Parents notified stuff about 5 minutes after with large reddened area to Rt thigh Dr notified and seen patient 3/4 tsp BENADRYL 1 given monitored and reddened decreased to c/o BENADRYL and ban next 1-2 days Rotitq if worsen s/s
Day #1-3-- >Sore arm, edema to the site (resolved after day #3) Day #5-- >Symptoms include fatigue and increased stomach upset.  Routine labwork drawn on 2/19/21 (see results below).  Will be having labs redrawn on 3/5/21 and will see the hematology oncologist on 3/16/21.
Fever, chills, bone pain, pain down arms into hands, dizziness, nausea, headache, shot was at 11:30 am on Friday 4/2. Adverse reaction started at aprx 11pm that evening and were most severe until Sunday morning 4/4. As of Monday I still had headache and dizziness and tiredness. By Tuesday I was feeling better.
Patient was sitting and was injected with the vaccine. Mother was in the room with her. Prior to the injection the mother was asked if the patient has had vaccines in the past and if there were any problems such as anaphylaxis, seizures, passing out etc. The mother stated that she got vaccines all the time at the pediatricians office with no issue. When the  injection was complete the band aid was placed and when I do this I feel for any bumps and observe the skin. She was normal, no rise in fever either. The patient said that was a "painless" vaccine and rotated with her mom where I gave her mom the vaccine as well. With the history of having received and no issues I sent the patients to check out to receive the prescription during which the patient seemed okay. Roughly 15-20 minutes went by and then I see the mom hurrying towards me with the patient running with her as well. I instruct them to reenter the room where the patient was sat down and the mother said the patient complained of feeling dizzy and hot then fell over in the isle. I observed patient for any signs of anaphylaxis, there was none. Then the patient started to gag so I gave her the trash can to throw up in which she did. Then I asked my technician to get me a blood pressure cuff and an soaked paper tower with an ice brick along with the thermometer because the patient was burning up.  After the patient threw up she quickly felt better and we continued to monitor. I checked her blood pressure and it was 88/66. The heat was dissipated and the patient said she no longer felt dizzy and could see. We monitored for a few minutes. At this point the scare seemed to have pass. I explained to the mother that what likely occurred is that she passed out which can occur post injections. After roughly 15 minutes the patient felt better and  the mother asked if they could walk around. I said yes just stay close to make sure she is okay. The patient had energy again and when she stood up and walked around felt fine. After a few more minutes the patient said she was okay again and the mother took her home.