chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 6 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171048, US2022AMR171050, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on left thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: For tolerance to the 2nd, 3rd dose refer case US2022AMR171048, US2022AMR171050 and US2022AMR171052. This was 1 of 19 linked cases, reported by same reporter It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
First dose Moderna, second dose Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer). On 30-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 18-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011979:
extreme soreness; fatigue; tachycardia; Booster; This is a spontaneous report from contactable consumer (Patient). This 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Right on 04Nov2021 12:30 at age of 36-year-old as DOSE 3 (BOOSTER), SINGLE (Batch/lot number: 3302680) for COVID-19 immunisation. Medical history included ulcerative colitis, known allergies: pollen and grass. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant drugs included fluoxetine hydrochloride (FLUOXETIN) 20mg and Ritual vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 07Apr2021 10:00 AM at age of 35-year-old Arm Right as DOSE 1, SINGLE (Batch/Lot No: ER8729) for COVID-19 immunisation, the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Right on 28Apr2021 10:00 AM at age of 36-year-old as DOSE 2, SINGLE (Batch/Lot No: EW0167) for COVID-19 immunisation. The patient received Pfizer booster shot on Thursday 04Nov2021 at approx 12:30pm. At 3:41 am the following morning 05Nov2021 the patient was woken out of sleep with a bout of tachycardia. Per smart watch, HR upon waking was 113 at 3:41 and jumped up to 139 3:42am. It remained around 120 for 5 or so minutes, then dropped to around 100. The patient was able to fall back asleep but HR remained elevated for the rest of the day (Friday 05Nov2021), always around 95-105. Other than the patient had extreme soreness (like was hit by a truck, it hurt to move body) and fatigue on 05Nov2021 03:45, which were more normal and similar to what happened last time. The tachycardia just stood out as an odd thing, so the patient figured someone should know. Since the vaccination, the patient has not been tested for COVID-19. No treatments received. Outcome of the events tachycardia, soreness and fatigue were recovered in Nov2021.
Pt recvd 3 hep B vax 11APR90,10MAY90 & 11OCT90 & was negative for hep B virus antibody.
I had a blood clot on Dec 2nd and my leg was swollen. I did go to the emergency room on Dec 11th. They did ultrasound and CT scan of my chest, which showed abnormal results. I do have a follow up appointment about that.
Body chills Fever rose to 102 with use of ibuprofen (200 mg) Fever is down to 100 this morning
Starting about 12 hours post vaccination, injection site started becoming red, tender to the touch and warm to the touch. Symptoms progressed over next 24 hours at which point pt went to see MD & was prescribed prednisone and BACTRIM DS. Pt did not have elevated temperature.
mom stated pt was very limp & legs very sore, fever, crying for long periods of time high pitch;
Patient presented to the emergency department on November 20 due to fevers, chills and progressive weakness that came on very quickly. Sepsis due to RLE cellulitis. Treated and discharged. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Congestion; Dizziness; sore throat; slight headache/her head was pounding; ringing in head headache; feeling sick; had a hard time going to sleep; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:30 (Lot Number: ER8729) as single dose for covid-19 immunisation. There were no medical history or concomitant medications. The patient previously received the first dose of BNT162B2 lot number- EM0204 on 18Mar2021 for Covid-19 immunization and experienced Sore arm. She previously received shingles shot and hurt for a long time. There were no additional vaccines administered on same date of bnt162b2.  She received the second shot on 08Apr2021 at 09:30, initially provided as 14Apr2021. She had a ringing in her head and a slight headache that she has had maybe since the time she got the shot. She blew it off as she was just working. Then she started feeling sick in Apr2021. The slight headache started from the morning she had the shot, 08Apr2021, but she went to work. The ringing in her head was annoying. She still had this and would not say it has improved. The headache and ringing in her head were together. She felt she heard it more at times. Sometimes she can ignore it and it was ok but at night, she has had a hard time going to sleep in Apr2021. It was worsening. The ringing in the head was so horrible at night because it was so quiet. She was still feeling a little sick. She then had a sore throat on 17Apr2021. The sore throat got really bad that night but she took medication for it and got better. She had a sore throat and her head was pounding and a ringing in her head that won't go away. The doctor gave her antibiotics and nose spray and cough medicine.  She didn't think anything was helping, and she wondered if it was a reaction to the shot. Her throat was still a little sore, she thought it went away but this morning 21Apr2021 she was starting feel it again and she felt a little congestion and she still has couple days of antibiotics she was taking. it was persisting. She had head pounding on 18Apr2021 morning: it was pounding like noises. While on hold the loud music was felt like pounding. This was not all the time. She had dizziness started 18Apr2021 morning as soon as she got out of bed. This was still going on occasionally, when she leans over. She had to do a lot of leaning over and therefore has not been to work in 2 weeks since getting the shot. When she straightens up, it went away. This was concerning and not normal, it's persisting. All the events did not require a visit to Emergency Room . The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
SHORTNESS OF BREATH; INJECTION SITE ITCHING; DEHYDRATION; DRUG INTOLERANCE (BODY WAS REJECTING); TIREDNESS; NUMBNESS LIPS; BODY NUMBNESS (TINGLING ALL OVER BODY); PARAESTHESIA GENERALISED; INJECTION SITE NUMBNESS; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 25-JUL-2022, the patient experienced diarrhea. On an unspecified date, the patient experienced shortness of breath, injection site itching, dehydration, drug intolerance (body was rejecting), tiredness, numbness lips, body numbness (tingling all over body), paraesthesia generalised, and injection site numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the tiredness, numbness lips, body numbness (tingling all over body), injection site itching, diarrhea, dehydration, shortness of breath, paraesthesia generalised, injection site numbness and drug intolerance (body was rejecting) was not reported. This report was non-serious.
This spontaneous report received from a pharmacy intern refers to three unspecified pediatric patients of unknown age and gender. Information on patients pertinent medical history and drug reactions/allergies were not reported. The pharmacy intern reported that three unspecified pediatric patients received adult formulation doses of RECOMBIVAX HB (lot number and expiration date not reported) on 19-JUL-2016 and 20-JUL-2016. No adverse effects were reported. No further details are given. Additional information has been requested.
Patient received Spikevax on 9/29 and that evening  started experiencing tinnitus, sore gums., headache, metallic taste and loss of taste. She went to the doctor and was prescribed and antiseptic mouthwash.
Rash on her cheek; Dizziness; Joint pain; Chills; Headaches; Soreness at injection site; Muscle aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Headaches) and INJECTION SITE PAIN (Soreness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she was tested positive for COVID-19 on 10 Nov 2020 and was hospitalized from November 10-19, 2020.) on 10-Nov-2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Headaches), INJECTION SITE PAIN (Soreness at injection site), MYALGIA (Muscle aches) and NAUSEA (Nausea). On an unknown date, the patient experienced RASH (Rash on her cheek). At the time of the report, DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Headaches), INJECTION SITE PAIN (Soreness at injection site), MYALGIA (Muscle aches), NAUSEA (Nausea) and RASH (Rash on her cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Not provided.
Patient vaccinated with 2D Moderna after presenting documentation from PCP giving authorization to administer as off label use, per CDC recommendation. No adverse reaction noted during the 30 minute post vaccination observation period.
This spontaneous report was received from a registered nurse concerning an unspecified number of patient of unknown age and gender.  The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, 12 doses of improperly stored VARIVAX Lot# M027343, expiration date 01-JUN-2018 and lot # reported M037642, expiration date 01-SEP-2018, were administered to the patients for prophylaxis. It was reported that the doses were exposed to a range of temperature of 14°F and 46°F for 2 hours and 25 minutes. It was reported that there were no previous temperature excursions and the event was detected because a data logger. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not consent for follow up attempts.; Sender's Comments: US-009507513-1702USA007065:
Rash on left upper arm, some pain.  Went to the doctor 12/14/07 and was diagnosed as having shingles.  Was put on Famciclovir for 7 days.
102.5 2-15-06 and went to urgent care. Full body rash 2-16-06 given Benadryl PO. 2-15-06 Urgent care MD stated possible viral and medication given to client. (per mom)  Child also throwing up 2-15-06.
Vaccine was reconstituted with expired Diluent; Vaccine was reconstituted with expired Diluent; No adverse effects reported; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R029514, expiration date 14-OCT-2020 for prophylaxis which was reconstituted with and expired sterile diluent (STERILE DILUENT) (lot# unknown, expiration date 28-MAY-2019) (dose, route, frequency and anatomical site were unknown). No adverse events were reported.
Woke up at 2am with fever, chills, muscle ache, joint pain and dizziness.  Fever broke around 9:30am.  The rest of the day until going to bed at approx 10pm continued with muscle ache and joint pain.
I have shingles blisters on my right ear, down to my neck and back of head with fever and chills in the first 2 days.
Breakthrough COVID-19 infection (symptomatic) diagnosed on 06/13/2021
He had a rash all over his body and rash is on and off; allergic reaction to the booster half shot; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (He had a rash all over his body and rash is on and off) and ALLERGY TO VACCINE (allergic reaction to the booster half shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 028L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Dec-2021, the patient experienced RASH (He had a rash all over his body and rash is on and off) and ALLERGY TO VACCINE (allergic reaction to the booster half shot). At the time of the report, RASH (He had a rash all over his body and rash is on and off) had not resolved and ALLERGY TO VACCINE (allergic reaction to the booster half shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient took half of booster shot. The patient had a rash all over her body and rash wason and off. No treatment information was provided.
His aunt's same symptoms following vaccination as "other HCPs are seeing other patients with the same issue"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (His aunt's same symptoms following vaccination as "other HCPs are seeing other patients with the same issue") in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (His aunt's same symptoms following vaccination as "other HCPs are seeing other patients with the same issue"). At the time of the report, VACCINATION COMPLICATION (His aunt's same symptoms following vaccination as "other HCPs are seeing other patients with the same issue") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Patient got lightheaded and dizzy about 15 minutes after vaccination. She showed syncope and lightheadedness. We laid her down and stated started to fill better. She state up and about a minute or two needed to rest again. We contacted paramedics and the arrived in 15 minutes and were able to take over from there.
While waiting at the site, my body felt like it was spazzing out and I saw blurry colored static.  It felt surreal.  It happened again within a minute. This was longer.  I had no control of my body, I was conscious the second time.  I attempted to tell myself to "focus" and try and find something with my eyes.  I couldn't; I was stuck in the state of my body shaking and unable to see anything. After the two times, I had the shakes.
Patient was given the vaccine on 8/18/2020 at 1717. On 08/19/2020 at 15:50, the patient called and talked to a nurse (MD,RN) here at facility and stated that they had a red and warm area on her arm at the injection site. Pt was instructed by the nurse to draw a line around the area and watch for changes in size, warmth, and fever. On 08/20/2020 at 10:05 AM, another nurse answered a call from this patient. Pt stated that the redness was getting bigger and is warm to the touch. Pt also had nausea, diarrhea, and a stomach ache. Nurse noted that at 11:05 the redness on the right arm at the injection site did not look infected but was warm to the touch. The redness did not spread and was not raised or swollen. Pt was offered to see the Health Aide but patient denied.
Patient given TD and Tdap at same visit. TD to right deltoid and Tdap to left deltoid. No adverse reaction noted, no fever, no rash, no pain, no streaking, no shortness of breath, no syncopal episode, no swelling at site of injection. Pt left facility in no acute distress.
arm swelling at the injection site (booster dose); possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring). At the time of the report, VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring) outcome was unknown.            No concomitant medication was reported.  It was reported that consumer was contacted by the pharmacy where Moderna booster dose was received, and the pharmacist stated the dose received came from a Moderna vial that was stored in a refrigerator without any type of temperature monitoring.  No treatment medication was reported.   This case was linked to MOD-2022-526005 (Patient Link).