chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the 2nd dose of the Moderna Vaccine at 2:30pm. While eating dinner at 6pm, my sense of taste was greatly diminished. Eating normal food, such as Wonton Soup, tasted like 75% water and 25% wonton soup. Other parties confirmed it tasted normal. Was not able to taste salt well for the entire evening. Taste returned to normal the following morning.
Patient 6 y/o received wrong dose Pfizer vaccine; patient received six months to four years old Pfizer vaccine.
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 an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 12:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:21 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 80.33 years for batch number 014M20A. The age of patient was provided as 80.41 years for batch number 019B21A. Concomitant products were not provided. On 28-Feb-2021, at excursion time 09 AM, temperature was 27 and excursion time 01 PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vials were moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, at excursion time 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vials were moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-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 Fisherbrand 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.
Mother reports swelling Lt Arm from shoulder to elbow, red & hot, beginning 6/3/03
Client received a booster dose of moderna, 0.25mL prior to age requirement. Client should have received Pfizer booster.
PATIENT IS 17. UNDERAGE FOR THE VACCINE. VACCINE APPROVED FOR 18 AND ABOVE
Patient presented with cough and weakness. Patient ended up being positive for COVID and fully vaccinated, no booster
contracted Covid; he contracted Covid in between the doses; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 08Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his first dose of the Pfizer Covid Vaccine last 08Mar2021 and would be receiving his 2nd dose on 29Mar2021. However, he contracted Covid in between the doses and would come off from isolation on 28Mar2021 and would be released to work on 29Mar2021. Wanted to know if it's ok to get his second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever (101 degrees) Intense joint pain Muscle pain Increased heart rate Nausea
Guillain-Barre syndrome; Two blood clots; Pain was bad in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), RIVAROXABAN (XARELTO) and EZETIMIBE (ZETIA) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Pain was bad in legs and feet) (seriousness criterion hospitalization). On 23-Jul-2021, the patient experienced THROMBOSIS (Two blood clots) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criteria hospitalization and medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) outcome was unknown.            The patient was treated with IV immunoglobulin. The patient has been in the hospital for a week now.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received with no new information; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) 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)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) 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 WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose).    No concomitant medications were reported.  Reporter stated that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as Unknown.  It was reported Some of the patients came from another country and they do not had any way of identifying what the original series were. Date of administrations were several different days.  No treatment medications were reported.
PATIENT HAD SCAB ON VACCINATED HAND AND SPREAD ALL OVER BACK ON SHOULDER AREA AND SPREAD TO OTHER HAND AND ON FACE BROKE OUT INTO SHINGLE RASH AND PATIENT SUFFERING FROM ONE YEAR SHOWED UP AT THE PHARMACY AFTER ONE YEAR AND SYMPTOMS ERUPTED WITHIN A WEEK BUT PATIENT NOT REPORTED
This spontaneous report as received from a 71 year old female consumer reporting on herself with 5 years of psoriasis around ears, diabetes, high blood pressure and no drug reactions or allergies who on an unspecified date in September 2013 was vaccinated with ZOSTAVAZX (dose, route and lot # not provided). Concomitant therapies included FLUZONE. On an unspecified date, a day or two later in September 2013, patient stated her psoriasis started coming out all over her body described as she broke out like in measles on her stomach, under her breasts, arms, legs, back and in hair. Patient sought medical attention at physician's office on an unspecified date and was treated with an unspecified spray, topical triamcinolone, methotrexate, folic acid and twelve laser treatments since an unspecified date. A blood work was performed which was okay.The outcome of patient psoriasis started coming out all over her body described as she broke out like,e in measles on her stomach, under her breasts, arms, legs, back and in hair was reporting as recovering. Additional information has been requested.
on 9/13/21, pain at injection site, fatigue and fever of 100 degrees (experiencing this all day).
Alternating hot and cold, headaches, dizziness, extreme exhaustion, nausea
Increased heart rate to the point where he could hear it; Oxygen level dropped to mid-eighties; Blood pressure 161/91; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib), cryotherapy (cryoablation), blood pressure abnormal, and anticoagulant therapy (blood thinner). The patient was vaccinated at a clinic. Concomitant medications included metoprolol succinate, quinapril for blood pressure, dabigatran etexilate mesilate (PRADAXA), hydrochlorothiazide, zinc, colecalciferol (VITAMIN D [COLECALCIFEROL]), and krill oil. The patient previously took flu shot (INFLUENZA) in Nov2020 two months ago, and shingles shot (SHINGRIX) years ago and experienced sore arm. The patient reported having no problem until 18:30 when he felt an "increased heart rate to the point where he could hear it". He pursued saying he read his "oxygen level at 95" and "pulse at 121" with a pulse oximeter, and took his blood pressure, which was at 161/91 wilt a pulse between 128-130. He mentioned therefore going to bed and laid down, and his "oxygen level was at 85" and "pulse at 136" still using his pulse oximeter. He specified that his wife verified the pulse oximeter and after a delayed that felt like 5 minutes, she took his "oxygen level and pulse" which were at 95 and 72 respectively. He stated that "all lasted 30 minutes". As per source, "Received first COVID-19 Vaccine. Sat for 15 minutes and didn't have any problems. Last night around 6:30PM noticed a heart rate increase rapidly to the point where he could almost hear or feel it. Pulse oximeter showed pulse was 121 and an oxygen level of 94. Talked to his wife and sat down. Took blood pressure and it was 161/91. Put on pulse oximeter. Oxygen level was dropping to mid-eighties and pulse was between 135- 136. Laid down for 10-15minutes. Tried again and his oxygen level was back to 95 and pulse was 72. Whole episode lasted about 30 minutes. Was reading paperwork and talked about rapid heart rate. Had Afib, takes medication for it and had a cryoablation about eight years ago. Feels fine today. Has not had any more episodes like that and wanted to report it. Wants to know if he should contact his doctor. Wondering will he expect this again with the second dose. Could it happen again and is there anything he can do as a safety guard? Stated he could almost hear his heart beating and was checking his pulse on his neck. His heart rate returned to 71, which is low for him. Usually his heart rate is high seventies or low eighties." Clinical outcome of the events was recovered on 20Jan2021.
No additional AE details; pediatric dose of VAQTA was given to an adult patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender who was 56-year-old at the time of reporting. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in October 2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, first dose, lot #T014590, expiration date: 15-APR-2021 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product use issue). This was discovered later in electronic medical records. On an unknown date in November 2021, the patient received second dose of vaccine, which was an adult dose. No adverse events were reported (No adverse event).
VERY BIG RED AND BLACK SPOTS WITH SWELLING AND LITTLE ITCHING FOR LAST 3 DAYS AND STILL NOT GOING AWAY
After receiving both vaccines, he told mom that he "was going to faint". Diaphoretic, pale. After 20-30 secs, became responsive - sipped at juice provided. Was observed in the office for 40 mins. 6/12/14 still not feeling well - severe headache, dizzy.
Pt recv vax on 10/28/98; on 11/6/98 pt exp red spot on Lt leg vax site
2PM 29APR pt awoke from nap-cried had period of paleness & staring;t100.6 ax APAP given;no sz activity noted-sleepier than usual;came to MD office @ 4PM;t99.3 @ exam-neg;sx only lasted min
COVID PNA and hypoxia.  S/S x 2 weeks with worsening SOB at home. H/O immunotherapy for lymphoma, obesity. Steroids and sarilumab continued, + TOCI, Zinc, abx. Pt arrived on BiPap but was utltimately intubated. At time of review plan is possible trach to LTAC. Still critical in hospital 9/2.
Sore Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm (Injection Site)) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm (Injection Site)). At the time of the report, PAIN IN EXTREMITY (Sore Arm (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Developed fever and fatigue 24 hrs after vaccination. Developed facial weakness, tightness, and twitching. Bells Palsy. 01/23/07 records received and reviewed. 12/19/06-Day after vaccination developed fever and fatigue and malaise. Seen in Er received IV fluids. Couple days later developed right facial weakness, tightness and twitching. right eye facial paralysis right side. Pressure in right eye. Asymmetry of right upper and lower lips with smiling.  Neuro consult 12/20/06. Impression: Bell's Palsy. Sickle cell disease. Anemia. Could be related to the vaccination or incidental finding.
Erythema with deep muscular induration 8x6 cm around injection site on right thigh
Patient 12 weeks gestation (EDC 6/17/2018), received Varicella vaccination incorrectly instead of administration of Varicella Zoster immune globluin as post-exposure prophylaxis.
Received Engerix as 2nd Dose; Initial Report Received on 25-Jan-2022  A physician reported that a patient (age, gender, race and ethnicity unknown) received Engerix-B as a second dose.  No medical history was reported.   No concomitant medications were reported.  On an unknown date in 2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, injection site, and route unknown).   On 25-Jan-2022, 1 month after having received the first dose of HEPLISAV-B vaccination, the patient received Engerix-B as the second dose (Lot #, expiration date, NDC #, injection site, and route unknown) instead of HEPLISAV-B. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vial was punctured more than 6 hours before administration; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial that was punctured more than 6 hours before administration.    The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the unknown date, the vial used for the patient's vaccine had been punctured for more than 6 hours before administration. No treatments were administered for the event.    Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vial was punctured more than 6 hours before administration, was considered resolved.; Reporter's Comments: This report refers to a case of patient of unknown age who received the first dose of the vaccine from a  vial that had been punctured for more than 6 hours before administration of mRNA-1273 (Lot# unknown). There were no reported AEs associated with this event of "the vial used for the patient's vaccine was punctured more than 6 hours before administration."
A pharmacist reported that a 13 year old male received an injection of Tetanus Toxoid Adsorbed, Purogenated. Approximately 6 days post immunization presented to emergency room with a 4cm by 7cm area of redness at the injection site with "central clearing in the middle. On 4/19/2000, the reporter indicated that the redness was resolving.
I got all the shots but still got shingles after/suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reporter stated that got all the shots but I still got my first case of shingles after.  The patient also reported that had all my Covid shots but got Covid twice. The follow up would not possible, as no contact, details were available. Additional Supportive Information: As per source document the patient vaccination schedule was not confirm hence single shingles vaccine was captured. As per narrative due to insuffient information for start date for Covid hence which were captured in narrative.
palpitations and postural tachycardia syndrome Feb 2021.  now with short PR interval  as of May 2022 involuntary muscle twitching  developed May 2022 30 pound weight loss from January 2022-December 2022 insomnia - severe from May 2022, lessening since starting medication in September 2022
It was reported that a pt (3 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.
Ache; Burning; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site burning. On an unknown date, the outcome of the injection site pain and injection site burning were unknown.   It was unknown if the reporter considered the injection site pain and injection site burning to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The pharmacist stated that there had been complaints from the patient that the solution going in upon administration gave them a really bad ache, and that it burned. The reporter consented to follow up.  No patient demographics available at the time of reporting. The case has been linked to the case US2019AMR197121, reported by same reporter.
Severe body aches, head aches, feeling feverish and chills, tachycardia
2nd year in a row pt. has a raised, irregular-shaped red area appear at injection site approx. 2 wks after inject. given. Will disappear in about 1-2 months. No pain, itching, or tenderness. Has no allergies to eggs or neomycin.
her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine). On 04-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Evening of 2/26/14 - throat "tickled" or "itchy" and dry. Arm a little red. Given Tylenol. Mom busy and forgot to check arm Thurs 2/27/14. Child went to school. Friday 2/28/14 after school found shot area red, raised 1/2", arm "on fire" elbow to shot area below deltoid. Face and neck that lt side patchiness dots of red and hot. Throat itchy, dry, hard time swallowing, hard time breathing, rare wheeze. Gave Benadryl and went to ER. Mostly resolved by 3/3/14.
Approximately 45min after the injection, I started feeling dizziness, palpitations and racing heartbeat. Another 15min after that there was red hives that broke out on my upper chest but no where else on my body.