chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that she had chills, fatigue and a swollen red area that was the size of a baseball that was sensitive to the touch.
Patient received ZOSTAVAX 10-16-12, called today, described rash on trunk, advised pt to call MD. MD called me to confirm shingles and prescribed VALTREX 1gm.
The patient was administered a Pediatric Pfizer Vaccine instead of the adult Pfizer vaccine.  No adverse reactions reported at the time of administration
Developed hive like rash at site of flu and PENTACEL. 24 hr later fever 99 degrees - seen at clinic 9/22/12. On BENADRYL. Cleared in 2 days.
Information has been received from a female who on 14-JUN-2007 was vaccinated with ZOSTAVAX. In 2007 the patient developed shingles. No further information is available.
Patient passed away on September 3, 2020, three days after receiving her vaccines. Her husband believes her death was related to the vaccines and states she was having "all the side effects" but he would not inform us what those side effects included.
dizzy/lightheaded; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional).  A male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy/lightheaded".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247682 Same reporter and drug; similar event, different patient.
Redness and swelling, warmth, pain at injection site, followed by red splotchy areas on distal arm over next 24-36 hours.
Blood pressure plunge, pupils dilated, profuse sweating, vomiting, strong desire to 'find a place to sleep', rubbed head and eyes, dizzy, could not walk straight, all symptoms of fainting.
3? round red rash at injection site, hot to touch, hard mass at injection site 3? round
pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No allergies (medications, food and other products) reported.  Patient did not test COVID positive or diagnosed with it. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (1st booster) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concomitant products included PANTOPRAZOLE for GERD, APIXABAN (ELIQUIS), LOSARTAN, FINASTERIDE and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 04-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain) was resolving.            On the morning of 05-MAY-2022, He received the Moderna vaccine on his left arm, which was where he was experiencing the pain. He said that the pain was still somewhat there, but it never inhibited him from doing any activities. He said that the pain was improving since it first started. Outcome was very slight residual effects. Adverse event did not cause patient to seek medical care.  No treatment drug was reported.
Pt felt a little uneasy about immunizations, asking about size of needle, comparing to cortisone injection - had a bad experience - no reaction (doesn't like shots). Immediately after giving Boostrix, passed out, color pale, placed on cortet, administered NC O2 for about 20 minutes. BP 128/74, P 84. Observed for 40 minutes then released with mother. Instructed to notify Primary Care Physician over weekend with any concerns. Upon discharge pt color pink, resp easy unlabored and aware of situation.
Fever >101 degrees F x 7 days starting day after injection; lump in lower axillary region of left side (with tenderness) starting 2 days after injection and resolving 4 days after injection; stomach ache with nausea for 6 days starting day after injection; dizziness with headache for several days starting day after injection.
About 10 times a day for about 1 minute I feel tingling in my left arm, neck, left side face and left ear.  The other day for about 2 - 3 minutes I had a double vision
Patient has chronic nerve pain somewhat stable until after second vaccination   severe nerve pain getting worse by day was stable for 91/2 years only thing that has changed is never pain has increased significantly
3/19 upper left arm (site of DTaP #3) red, swollen, firm, warm - received OTC (Tylenol, Ibuprofen) and cold compress.  Not painful.  3/20 worse, swelling, temperature 99.  3/21 mostly reddened patient much better today.
Pt was admitted to hospital on or about 01/04/2003 and was Dx'd with Guilliam Barre Syndrome on or about 01/06/2003 (Confirmed by spinal tap) Discharge summary states numbness. msv
October 2021 I had mammograms that was clear, had scare on right breast. It was just a cyst. Was also having swollen lymph nodes I was so scared about it I paid for my own full body PET scan (went to oncologist) and we did diagnostic and ultra sound. It came up clear for whole body.  I had to hold off starting vaccines to make sure not cancer. Again it was clear and no cancer on PET scan. Got first vaccine in Nov. 2021 Got second in Dec. 2021 Got booster in April 2022. All shots were on left arm. All caused joint pain and unwell feeling, tired, 3rd shot caused arm swelling and a goose egg knot. Got mammograms in August 2022, showed lump in left breast. After further testing and biopsy I have breast cancer.  No family history. Got genetic testing back all 36 genetic testing came back negative. My cousin was just diagnosed last year (approx. 9 months after her vaccines started, same side, same manufacture, all shots in left arm. Same cancer. Same time frame.  Her genetic testing came back negative. (as a side note, my father (step father) has multiple myeloma, he was in remission within weeks after 2 part Pfizer, he came out of remission and now cancer treatment is not reacting, oncologist even said it should be, he has had 3 boosters. I am high risk to covid illness, my dad is high risk to covid illness, my cousin is not
Headache, Myalgia, Fever, SkinRash, chills, fatigue Narrative:
This spontaneous report as received from a other healthcare worker refers to an unknown number patients of unknown age and gender. The healthcare worker reported that less than 5 patients received (Oka-Merck) PROQUAD (0.5 ml, subcutaneously) that were exposed to temperatures of 34.8F for 5 hours. No advers effect was reported. It was unkonwn if the patient sought medical attention. At the time of report, the status of patient was unknown. This is one of several reports from the same reporter. Additional information has been requested.
The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case was reported for patient 34 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Patient developed tongue numbness, anxiety, stated that she felt her tongue was swelling up. RN and paramedic evaluated patient, VSS, tongue showed no signs of swelling, no acute signs of allergic reaction. Sat with patient for a few minutes, she calmed down and stated her tongue did not feel numb anymore. After waiting at clinic for 10 more minutes patient felt okay to go home.
Information has been received from a nurse concerning a female who in approximately May 2008, was vaccinated with a dose of GARDASIL (route and administration site not reported). Shortly after the vaccination, the patient fainted in the waiting room. Subsequently, the patient recovered from fainting. There was no injury associated with the fainting episode. The patient sought unspecified medical attention. Additional information has been requested.
red injection site; warm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm injection site) and VACCINATION SITE ERYTHEMA (red injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE WARMTH (warm injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red injection site). At the time of the report, VACCINATION SITE WARMTH (warm injection site) and VACCINATION SITE ERYTHEMA (red injection site) outcome was unknown.            No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non significant follow up - Reporter address updated.
Information has been received from a physician concerning a 69 year old female pt who on 9/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (640744/0994L). The reporter indicated that within 24 hrs (approximately 9/19/02) of vaccination with pneumococcal vaccine 23 polyvalent, the pt's arm, which had been injected, developed "extreme swelling" that extended to the elbow. It is noted the pt was again seen in the physician's office the next day (approximately 9/20/02) and the swelling had "actually progressed further down the arm." The pt was treated with a 40mg IM injection of Medrol, and an unsepcified dose of IM Benadryl. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Received vaccine 8/31/07-Started with rash, hives-took Benadryl 25 mg p.o x 3-no relief-went to ER 8/4 received Benadryl 25 mg IV, Solumedrol 125 mg IV, Pepcid 20 mg IV, Epi 0.2 mg SQ, Benadryl 25 mg IV second dose.
Symptoms - nausea, diarrhea, shivering, headache, joint soreness in hips and knees, fever, redness and swelling at injection site.  Treatment - Tylenol and sleep  Outcome - day two after injection was better,  though still had minor symptoms. Day three after injection was back to normal
Slept for several hours in the afternoon after the injection and went to bed at 7:30pm that evening.  When he woke up on 04/04/2022 at 8 am, he was able to get up and go to the bathroom, drink some fluids.  He did eat breakfast and then went back to bed.  He slept in naps with some fluid intake.  As the day progressed he could not seem to sit up in bed without falling back on the bed.  He slept more. By 3:30 pm I was very concerned when he continued with this.  He denied dizziness. I was ready to take him to the hospital thinking he might need some IV fluids.   He did not want to go. I finally helped him to the bathroom and then he moved to his recliner. He drank more fluids.  His BP was ok.  He started feeling better. He was able to walk without any problem. He was improved the next day and back to normal by Wednesday.  I don't know what to do for further vaccines now.
There have been no complaints of reaction.  TDAP given instead of DTAP letter sent to pt.
2x2.5 inch hard hot red area and pain at injection site, temperature of 100.2, mild headache, severe chills, no appetite and general weakness. Day spent on sofa or in bed. Tylenol taken. Ice to arm.  On 02/19/2020 at 0700 felt much better with the exception of injection sire. As of today the site is slowly getting better.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL lot # L013429 exp 01-JUL-2017, (route and dose were not provided). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case after 2 vaccines Moderna 4/17/21 lot# 037B21A;  Moderna 5/15/21 lot# 006C21A
fever; Headache; Stated that at night time a fever gets worst so she is wondering if she can take something for the fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 (Lot number: SL3198) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 11Jan2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 11Jan2022, outcome "recovering", described as "Headache"; CONDITION AGGRAVATED (non-serious) with onset 11Jan2022, outcome "not recovered", described as "Stated that at night time a fever gets worst so she is wondering if she can take something for the fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The body temperature was measured as 102 degree Celsius and sometimes 100 degree Celsius Stated that now it is 101.8 degree Celsius to her forehead. Stated that she noticed two hours ago and it was 99.5 degree Celsius. The reporter stated that she had the Covid 19 yesterday. Stated that it was her first dose. Stated that today she had a fever. Wanted to know if this normal. Wanted to know if can take Alka Seltzer plus for fever. Wanted to know if can take Tylenol. Stated that she was checking the papers she received after the first dose and receiving the side effects. Stated that she does not see fever as the side effects. Wanted to know if she should go to be tested. Stated that this is the first time that she had the vaccine. Unable to clarify details. Multiple attempts made to redirect caller. Stated that at night time a fever gets worst so she is wondering if she can take something for the fever. Stated that her husband got the shot about a month ago and she is taking her kids on the weekend. Stated that she just went and got it. Does not provide a physicians name. Occupation/specialty, consent to contact, address, phone number and email address not provided. The patient was treated with Excedrin just for the headache.   No follow-up attempts are possible. No further information is expected.
Leg had 8 inch by 4 inch whelp with temperature in leg, red in color.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/19/2023 GENERALIZED ANXIETY DISORDER R09.02 HYPOXIA 3/19/2023 GENERALIZED ANXIETY DISORDER
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider and hospitalized for shingles. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event shingles was determined to be medically significant.
Elevated thyroid stimulating hormone (TSH); This is a spontaneous report from a contactable consumer or other non healthcare professional. A 74 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6202) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunization at Pharmacy or drug store. Medical history included coeliac disease from 05Feb1947 and ongoing Diagnosed in 2014 , hypothyroidism from 1985 and ongoing Diagnosed in 1985, depression from 1972 and ongoing Diagnosed in 1972 , hypertension from 1992 and ongoing Diagnosed in 1992. Concomitant medication(s) included levothyroxine taken for hypothyroidism; citalopram taken for depression; estradiol for old age all from an unspecified start date and ongoing. Prior vaccinations was none. The patient experienced elevated thyroid stimulating hormone causing blood thyroid stimulating hormone increased on 08Mar2021 13:11. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone 5.340 uiu/ml on 31Dec2019, blood thyroid stimulating hormone: 4.933 uiu/ml on 17Aug2020, blood thyroid stimulating hormone 4.838 uiu/ml on 08Mar2021 and blood thyroid stimulating hormone: 8.141 uiu/ml on 14Sep2021. It was reported that, Thyroid supplement stopped working. First step was switched from generic levothyroxine to name-brand Synthroid & new bloodwork scheduled for 03Nov2021. Next step- increased dosage of Synthroid if 03Nov2021 bloodwork, showed no improvement for return of hypothyroidism. Symptoms was many. The outcome of the event was unknown.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
Pt presented in office with umbilicated lesions scattered on trunk, face, legs and few papules in diaper area. Pt did not have any fever; lesions are pruritic.
Sharp pains in my head. The pain does not last long at all, it's a quick sharp sensation, it started 3 weeks after my first injection. The pain is ongoing and is always alleviated by taking over the counter medication.  Dizziness, loss of balance. These symptoms started the day after my second dose. Those symptoms are ongoing, and I do not take anything. Neck pain located in the back and sides of the neck. The symptom started two days after my second  dose. The pain continues and I am not taking anything at this time to relieve it.  Extreme fatigue. This started hours after my second dose and continues daily.
HCP stated that a patient received half a dose , instead a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full dose) 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full dose). On 08-Dec-2021, ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient received half a dose instead of full dose.   Reporter did not allow further contact