chrisvoncsefalvay/vaers-outcomes huggingface dataset:
development of boils (abscessess) on body. This was not at the injection site. Started after this vaccine (#1), worsened after COVID Moderna vaccine #2 also not at injection site. Was on thighs arms
4/4: Woke up Easter Sunday with the following symptoms: sweats, chills, uncontrollable shaking, fatigue, dizziness, nausea, and shortness of breath. Went to Urgent Care, but it was closed for the holiday, so instead went to ER. See Item 19 for details. I was discharged within an hour because there was nothing seriously wrong with me, doctor wrote it off as a stomach bug and ordered me to rest and hydrate.  4/4 - 4/10: Virtually every day for this week went the exact same. I would wake up between 6-7am, feel nauseous, weak, no appetite, and shaking. Walking around my apartment would leave me utterly exhausted. I would nap from 9am-12pm, then again from 2-4pm. Ate very little, drank water and sports drinks when awake. Breathing was still shaky. Occasional diarrhea.  4/10: Although slightly less ill than the previous 6 days, I still felt weak, shaky, and exhausted. I went back to Urgent Care this time, and the doctor examined me. She noted my left ear was very inflamed and suspected an ear infection. She prescribed me a week of amoxycilin and told me to rest and eat bland foods.  4/12: After 2 days on the antibiotics, some of my symptoms cleared. I was no longer shaking or having shortness of breath, and although still tired, I did not sleep for half the day as I had the previous week. My appetite was not fully there yet, and in the mornings of this week I would wake up feeling nauseous for about 2 hours. On this day 4/12 my period also started, which is unusual. It was not due to start until around April 17th. My period is very regular and light due to being on birth control, so I consider this abnormal. The flow was also very heavy.   4/17: Heavy flow of my period slows significantly and is now just a slight pink/brown color. I only need a liner to contain it. This is also my last day of antibiotics, so I buy a probiotic supplement in the hopes that it will help settle my gut.  4/17-present (4/20): The morning nausea and lack of appetite are still present despite being off the antibiotics. Occasional discomfort in abdomen/chest. Unexplained muscle soreness in hips, legs, back, and chest. My bowel movement schedule has also completely changed. Normally I do not experience a bowel movement until late morning, after 10am. But for the past 2 weeks I have been woken up around 5:30am with a sudden urge. At the beginning of my illness it was diarrhea but now it has transitioned to slightly more solid feces. It is not really diarrhea anymore.
pt reported persistent soreness in lt arm & devel of tendonitis since flu shot;feels nurse gave shot too far back in arm;pt has been seen by MD & can not find cause for tendonitis-? flu shot only started since recv vax;
January 12, 2021: patient had a sore arm January 13, 2021: vaccination site left arm, "quarter-sized" red, hard, painful area. Patient also experienced chills, hard to move arm, fever (101) and muscle aches.  January 14, 2021: area became more "itchy" and patient began to have flu-like symptoms.  patient was referred to the ER by her PCM who then referred to back to Public Health around 8pm on January 14, 2021.  Patient was previously diagnosed with COVID-19 and it was lab confirmed.
Severe Headache; A spontaneous report was received from a Consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache.  The patient's medical history was not provided. Concomitant medications reported were antibiotics for dental surgery.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient developed severe headache.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, severe headache was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of headache, a causal relationship cannot be excluded.
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389:
Covid Vaccine dose give 5 hours past vaccine expiry time of 24 hours post initial puncture. No side effects or symptoms experience by patient. Vaccine was well kept in temperature monitored refrigerator.
pt sleeping in crib p/feeding found motionless by mom;pt cyanotic;pt picked up slapped on back no response;mom noted 2mm curd @ nasal orifice;mom aspirated small amt mucus from nose pt gasped & cried;total body profound erythematous blush
Left arm swollen twice the size as normal lethargic pain, no documentation all per mom, brought to ER, treated w/ Benadryl reported per Dr.
Shortly after the shot was administered my left arm started hurting. Nothing too bad. Later that night it became extreme. I took Ibuprofen for it and went to bed early. I had a hard time sleep because it hurt so badly. The next day I couldn't move my arm without assistance from the other arm. Thursday, 2/25/21, over night I developed a cough and woke up with a sore throat that progressively got worse as the day went on. Fatigue and body aches accompanied this as well. Friday morning, 2/26/21, my arm was 75% better, but my throat, cough, body aches, and overall fatigue were getting worse. I decided on getting a covid test before going to work that morning. I went to urgent care in and took a rapid test as well as a PCR test. Both rest resulted in negatives. Over the weekend my symptoms  were staying the same. The sore throat and cough were progressing. By Monday, 3/1/21, mid morning the Doctor I work for sent me to a walk in clinic  for another rapid and PCR covid test. Rapid came back negative and PCR is still pending. The girl assisting me suggested I report my symptoms. I haven't been since even with a minor cold since 2009. I woke up Tues. ,3/2/2021, with white pustules on my throat and very hard to swallow along with very heavy brain fog. I have not had any fever this whole time. I take my temperature multiple times a day. I am starting on a 3 day dose of a zpak today, 3/2/21.
Headache, low grade fever, myalgia localized reaction on right arm (Pneumovax, Zostavax side)
PT HAD EGG SIZE SWOLLEN AREA ON ARM JUST BELOW INJECTIN9O SITE RED & WARM TO TOUCH. PT APPLIED ICE PACK TO ARM WIT HSOME RELIEF
pre-existing tinnitus grew louder and more persistent. Has been over a week and continues today.
rash ,itching , 5 days after dose prednisone 5 days, Pepcid 5 days, antihistamine shot ,mostly cleared up. received 2nd dose 2-2-21, 7 days later itching restarted, no rash , doctor prescribed same treatment, have some minor itching.
03/12/22 presents to ED for "fevers and chills". PMHx of "hypertension hyperlipidemia"
One leg was painful to touch with no redness or external marks; patient described the pain as similar to description of pain from shingles that she had heard from friends who had shingles before. She reported started 8-12 hours after receiving the vaccine and lasted for 2 days and then went away.
Inejction site of MENACTRA local redness, swelling, pruritus approx 5 cm in circumference. No drainage.
3 hrs p/vax pt devel urticaria on torso; no resp distress;
face was swollen; tongue felt fat; This is a spontaneous report from a contactable consumer. A female patient with unknown age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown) through an unspecified route on an unspecified date as Dose 1 SINGLE for covid-19 immunization. The patient medical history included she had shellfish allergy. Concomitant medications were not reported. Reporter stated that she went last Saturday to get her first dose of the Covid vaccine at 4:15 in the afternoon and at 3 am her face was swollen, and tongue felt fat, She was afraid to go to the walk-in because she did not want to come in contact with someone who has Covid. She took Benadryl but that did not work. The patient was asked to take prednisone. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
I was ok the first day or so but then I started having ringing in my ears but it's louder in my rt. ear so I went to my dr. & was referred to an ENT dr.
Pt developed a fever and swelling on 5/22 after receiving Tdap and MENACTRA.
Patient states she developed fever, nausea, extreme left leg pain, body aches, and felt like she was going to pass out. Patient describes leg pain as extremely tender to the touch on 12/14. Patient states today on 12/15 that she only has joint pain in her left knee now, all other symptoms resolved.
At a clinic, pt was administered Menquadfi and TDAP due to parent's requesting vaccination, however, pt wasn't due for vaccine yet.
Injection site soreness (arm) during the evening, for a first dose shot received that morning.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Mar2021 (Lot number: Unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Enlarged walls of heart" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "Injection site soreness (arm) during the evening, for a first dose shot received that morning.". It was unknown if therapeutic measures were taken as a result of vaccination site pain. Additional information: Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Fever, LETHARGY, TINGLING IN LEFT ARM
Individual tested positive for COVID 11/18/20 had Second Moderna vaccine 2/1/2021. Tested positive for COVID 3/4/21
Lt upper extremity swollen, red, hot, fever 4 hrs after PREVNAR 13 IM injection: positive cellulitis/allergic reaction.
Right arm became swollen, very red, hot and painful in arm, shoulder and back.  Temperature 102.6  Tylenol and ice applied to site.
I have already passed the 42 days to receive the 2nd dose; A spontaneous report was received from a 79-years-old female consumer (patient) who received Moderna's COVID-19 vaccine (mRNA-1273) and she had already passed the 42 days to receive the 2nd dose (Inappropriate schedule of vaccine administered).  The concomitant medications reported were triamterene, pravastatin, estradiol, methocarbamol, celecoxib, tramadol, omeprazole, acebutolol, pramipexole and gabapentin .  On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient had been trying to schedule her second dose but was told by the vaccination provider that there were no available appointments until Sep 2021. The patient stated that she had already passed the 42 days window to receive the second dose.  The outcome of the event, she had already passed the 42 days to receive the 2nd dose, was unknown.  No further information was provided.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot 041L20A with no associated AEs.
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 12-FEB-2013, two of the them were vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Distal digits (finger tip digits) of fingers on both hands have reduced tactile sensory capability.  My finger tips feel numb.  Thumb is included in this numbness .   First inoculation was  25 Feb.  No lingering symptoms.  Second inoculation was  19 March.  Finger numbness seemed to appear about two days after second shot around 21 March.  Numbness still persists even after a week.   I felt this numbness was a strange development after the second shot and worth reporting.
PATIENT PRESENTED WITH FLUSHING/RED FACE AND NECK THE EVENING AFTER RECEIVING THE VACCINE.  SHE FELT THAT IT MAY HAVE BEEN A FLARE UP OF ROSACEA. ALSO, COULD HAVE BEEN A DELAYED ALLERGIC REACTION
pt recv vax; devel  inject site rxn characterized by redness,heat,soreness,and swelling from shoulder to elbow;
Patient had severe pain along "her torso to neck" with malaise, fever 101 (less than 24th duration) loss of taste sensation but returned. No rash or edema or redness at sight of injection.
Headache, fatigue - 3/15/2021-3/17/2021. Irregular menstrual cycle - period started on 3/19/2021, after only a 23 day cycle; next period started on 4/11/2021, after another 23 day cycle. Both periods were very early for me, more painful, but lighter flow. They also lasted a couple of days longer than normal.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 13 month old (also reported as age 1, units not provided) female patient (child). On 14-APR-2014 at 3:18 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
2 weeks later after both shots developed vertigo; left arm at shot site turned pinkish for about a 4-inch area with itching; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness), VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical history information provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, FOLIC ACID, ROSUVASTATIN, ROSUVASTATIN CALCIUM (CRESTOR) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchiness). On an unknown date, the patient experienced VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness) had resolved and PRURITUS (Itchiness), VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: New events were added.
PRODUCT STORAGE ERROR; VACCINE WAS ADMINISTERED TO PATIENT DIRECTLY FROM FREEZER WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 30 year old male. 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: 1822811 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported.  On 01-APR-2022, the patient experienced vaccine was administered to patient directly from freezer without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient directly from freezer without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505192, 20220504995, 20220505044, 20220505162, 20220505373 and 20220505824.
Severe mouth sores under tongue, painful, burning, couldn't speak, could eat only soft mashed potatoes, Farina, pastina, lasted at least one week. Very severe first 2 days, rinsed with prescription rinse then salt water to relieve soreness
Information has been received from a nurse, concerning a female patient (age not specified), who on an unknown date was vaccinated with the second dose of Gardasil (lot # not reported).  Subsequently the patient had a seizure.  She was seen by a neurologist, who said the seizure was because of the Gardasil.  Upon internal review, had a seizure was considered to be serious as an other important medical event.  Additional information has been requested.
febrile seizure pt became listless & lethargic then started jering motion which lasted approx 1-2 minutes; t104; pt has prior hx of febrile seizure;
Immediately after he said he was dizzy. I had him remove his mask and take some deep breaths. He did. I called for help from other nurses in the room. He had seizure activity and fell from the chair to the floor. In the process he hit his head on the table. He had his stocking hat on. The other nurses were there immediately. Talking to him, reassuring the mom, BP, pulse oximeter, ice pack, privacy curtains in place. He was offered food and drink. Other staff removed others from the room. The ambulance was called. And arrived. The ambulance assessed him. Education and instruction were given. They asked him to go to ER. He refused. They advised him to see his Doctor. The ambulance had him sign their needed paperwork. Helped him to his feet, he refused to use their cart provided. He said, I am fine. He was strongly encouraged to follow up with his Doctor. He walked out of the room with ambulance personal and his mom.
Unknown influenza vaccine: ?Influenza vaccine (inactive) 0.5 mL High-Dose?. One injection into left arm. Outcomes: coughing (<1 day), wheezing (<1 day), runny nose (<1 day), chills (several minutes), usually high perspiration  (several minutes). Patient contracted a common cold from 10/12/19-11/8/19.
lack of vaccine temperature monitoring; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients 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, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Engerix B, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Engerix B, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's comment: This case was reported by nurse. The nurse with state department of health reports there is a clinic site that had a lack of vaccine temperature monitoring data for several months.  There was no temperature data for 22 Jun 2021 to 03cFeb 2022, as well as 03 May 2022 to 19 Aug 2022.  There are partial manual logs for August 2022.  The affected vaccines are Pediarix, Kinrix, Engerix-B, Rotarix, Infanrix, and Bexsero. The nurse stated that there were vaccines administered during this timeframe, but does not know the number of vaccines administered, the dates administered, or any patient information.  The Reporter dose not have the vaccine lot numbers, expiration dates at the time of call. At the time of reporting, the vaccines have not been repeated for any of the affected patients.  The reporter consented to follow up. Additional supportive information: As vaccines were affected due to lack vaccine temperature monitoring which led to incorrect storage of drug.