chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified race received TRUMENBA for immunization at single dose on an unknown date via an unspecified route in the arm. On the same date the patient also received MENACTRA in the same arm. On unknown date the patient experienced redness, swollen, hard and painful. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 19-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Received booster vaccine on 01/13/2022. After vaccine was administered and pt was being observed she developed a rash on her left arm of the injection site and on the back. Was given Benadryl cream by the staff and observed for another 15 mins. Rash improved and she went home. Later in the day she began to have body aches, chills, and a Fever of 101, she took Tylenol and rest with fluids and side effects improved.
Presented in office 11/24/2003 with scattered red papules arms and chest.  Total of 15 papules including one which later appeared on forehead.  Papules according to mom looked fluid filled, few days later-did not ooze or scab over.  Not itchy-lasted 8-9 days.  No prescription required other than warm baths.
Itching/her shoulder started to itch like crazy/ Was itching so bad like a mosquito bite; Has a little fever; Rash/rash is hot and has a temperature in it/Rash was a week later and was weird; Itching began 25Jan2021 at night at injection site; felt like an anxiety attack; Metal taste in mouth; Funny feeling in chest; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received flu shot and experienced shoulder pain, she received first week in Oct2020 at one of the grocery stores, she doesn't remember doing that the last year or before. On 19Jan2021, the patient had metal taste in her mouth and a funny feeling in her chest that felt like an anxiety attack. The next day was fine. The patient was not anxious prior to COVID-19 Vaccine, lasted for a couple seconds and then was gone. It was minor and was not short of breath or anything.On 25Jan2021, the patient had rash and week later 26Jan2021, her shoulder started to itch like crazy. didn't look at it until the next day. Looked in mirror and noticed a rash. Has a little fever, rash was still there and can see the rash around where the point of the needle went in. The patient did not know if that was important.On 27Jan2021 took a picture of the rash and was still there. Feels there was a temperature in the rash, but it was not hurting. Stated the rash site has a fever in it. Rash looked unhappy but took a long time to look unhappy. On day of reporting, patient noticed the rash was hot and has a temperature in it. It was not big and red but was still there. Surprising that rash appeared a week later. The patient did not go through primary care to receive COVID-19 Vaccine. Lab test included mammogram, CAT scan, and testing done at the hospital. A week later rash was weird and was itching so bad like a mosquito bite and was scratching and rubbing it, didn't look in the mirror. The patient doesn't know if rash was there when it started itching. Next day was when she noticed the rash. Stated rashes can itch if they are the allergic type of reaction. Thought it was very strange. On 19Jan2021, the outcome of event anxiety attack, metal taste in her mouth and a funny feeling in her chest was recovered and outcome of other events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "body chills", "bad headache", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "body chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache".  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-202201193681 same patient, different dose/event;
Information has been received from a registered nurse concerning a 30 year old female who was 5 months pregnant who on 5/21/99 was exposed to MMR. As the pt was administering the vaccine, the child pulled away causing spray to go into the pt's eyes. The eyes were irritated immediately after the occurrence and the pt was sent to the ophthalmologist for an exam. The pt was diagnosed with chemical conjunctivitis. She was treated with sodium chloride. and lid scrub. The pt recovered. Follow-up was received which indicated the pt had no known problems. She delivered a normal infant. There was no further information.
strong seizures; strong pins and needles sensations in left side extremities; A spontaneous report was received from a pediatrician concerning herself, a 40-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced strong pins and needles sensations in left side extremities/paraesthesia and seizures.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 JAN 2021, prior to the onset of events the patient received the first of the two planned doses of mRNA-1273 (Batch Number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID 19 infection.  On 14 Jan 2021, the patient experienced strong seizures, and strong pins and needles sensations in her left side extremities, which are still mildly ongoing. She is being evaluated by a specialist. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is unknown.  The outcomes of events, paraesthesia and seizures, were considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I tested positive for Strep on 3/29/23. I had a slight sore throat and difficulty swallowing. I also had some canker sores on my tongue. I contacted a doctor and was prescribed Penicillin. This lasted for about a week but was prescribed 10 days' worth of medication. I am feeling much better now.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 10-MAY-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Sudden partial loss of hearing in right ear, followed by tinnitus starting 4 days after the vaccination. Symptoms only present in the right ear, and there is no history of tinnitus or ear problems.
2 X 2 1/2" redness and swelling at injection site, warm to the touch, itchy left upper arm. Patient took Tylenol, used cool compresses.
Pt presented as a new pt for 4 month well visit. Pt was given all 4 month vaccines on 9/12 including dtap, ipv, hep B, hib, pcv and ROTATEQ. Pt presented with sx of severe watery, mucousy diarrhea that started on 9/17. Pt had vomited x1. Mom had noted some blood in the stool. Pt visibly dehydrated. Consulted Pediatrician who suggested sending through ER. Pt chose hospital. Spoke with mom who reports pt was getting IV fluids around 4:00pm and was expected to stay. Noted today dx of Salmonella enteritis. Unable to reach mom by cell phone today to check on pt. Contacted Health dept. Was forced to leave message at state office. Message left with name, situation and return numbers. Notified local staff and admin of problem. Vaccine being held. No further given until this is confirmed and action given.
Dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Lot number: FF2589) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetics" (unspecified if ongoing). Concomitant medication(s) included: JARDIAN; LANTUS; VITAMIN C ACID; JANUVIA. Past drug history included: Sulfa, reaction(s): "Allergy"; Keflex, reaction(s): "Allergy". The following information was reported: DIZZINESS (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (Oct2021), described as "Dizziness"; ASTHENIA (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (Oct2021), described as "weakness". Therapeutic measures were not taken as a result of dizziness, asthenia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as military base. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were Jardian, januvia, lantus 10 units, vitamin C. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure/ I've had it 9 times in the last 18 months; Shingles; Fatigue; Rash; 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), shingles, fatigue and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fatigue and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had it 9 times in the last 18 months due the jabbed shedding on him/her, but found an instant cure. The patient used EMUAIDMAX ointment and rub on at first sign which was gone in a couple hours,  The patient did not did much for the fatigue but would stopped the rash in it was tracks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Treatment product EMUAIDMAX ointment was not coded due to limitation of dictionary.
Right deltoid- 6.5 x 8cm pruritic rash first noticed when he woke up this morning. Reported a small lump at site of injection immediately after admin of vaccine.
Fever, dizzy, "feels weird in her head", nausea, felt tired.  All this started only 1-2 after injection.
Patient appeared to have a fainting episode 3 minutes after receiving his COVID vaccine.  A nearby customer reported seeing a few jerking reactions and then he started to slide down in his chair.  The store director was nearby and helped him sit back up. He appeared to be OK after this happened, but the paramedics were called to be sure. The patient stated that he has a fear of needles and didn't eat anything this morning.
This spontaneous report as received from a licensed practical nurse refers to an 18 year old patient. On 25-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (Lot#, dose and route not reported) in error instead of a second dose of M-M-R II (Wistar RA 27-3). No adverse event was reported. It was not known if the patient sought medical attention. Additional information is not expected.
PATIENT REPORTED TO PHARMACY THAT SHE WAS NOT FEELING WELL, HAVING FEVER, AND HAD SOME INJECTION SITE SWELLING APPROXIMATELY 24 HOURS AFTER RECEIVING THE VACCINE. SHE CONTINUED TO RUN A FEVER AND HAVE PAIN IN HER ARM OVER THE FOLLOWING 48 HOURS. ON THE FOURTH DAY FOLLOWING THE VACCINE, SHE CAME IN TO THE PHARMACY WITH A RASH AROUND THE INJECTION, WHICH SHE DESCRIBED AS BEING WARM AND PAINFUL. SHE WAS TOLD TO GO URGENT CARE, WHICH SHE DID. THERE SHE WAS DIAGNOSED WITH CELLULITIS AND GIVEN ANTIBIOTICS.
as with first shot, my husband experienced heart palpitations after a couple minutes of receiving.  Palpitations were transitory. only lasted a few seconds. Shot 1A and 2A.  With 2A, he experienced chills, low grade fever and fatigue and sore arm.
Developed blood clot in left leg. I was also given Pneumococcal vaccine on 4/12/2021 following covid vaccine.
Little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2OA and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Little fever). At the time of the report, PYREXIA (Little fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-066273 (Patient Link).
Nausea, light headed, hot flashes, oxygen level decrease, blood pressure decrease, heart rate decrease, temperature decrease. All in cycles of 10 minutes on, a few minutes off. Was put on oxygen, sent to hospital in ambulance, and given 2 bags of fluid through an IV
This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) reported for self that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 11Mar2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she asked about the medication that her dermatologist prescribed to her after finding a skin infection at the back of her ear. She stated that she was advised to take the medication named "Doxycycline" for 10 days. However, she is concerned about the effectiveness of the vaccine since she got the 1st dose last 11Mar2021 and she is aware that she will be in the 3 weeks window before the 2nd dose on 01Apr2021. Right now, she wants to know what she can do about this so she can talk to her dermatologist and doctor at the same time. Therapeutic measures were taken because of skin infection at the back of her ear. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
itchy blisters on skin; under armpit pain; extremely weakness; fever; right arm pain and soreness; chills; skin rashes developing 24 hours after; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN ), for COVID-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "extremely weakness", "under armpit pain at same arm site", "itchy blisters on skin", "chills", "developed right arm pain and soreness ", "fever ", "skin rashes ". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose"; BLISTER (non-serious) with onset 17Dec2021, outcome "unknown", described as "itchy blisters on skin"; AXILLARY PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "under armpit pain"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "extremely weakness"; PYREXIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "right arm pain and soreness"; CHILLS (non-serious) with onset 17Dec2021, outcome "unknown", described as "chills"; RASH (non-serious) with onset 17Dec2021, outcome "unknown", described as "skin rashes developing 24 hours after".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381656 same reporter/patient/product, different dose/event.
4:00 PM the site burned and hurt. 8:00 PM very red. I put ice on it and took TYLENOL. During the night, my shoulder, arm, and neck were quite painful. My arm and neck were swollen. 3/20/16 8:00 AM - arm was red from shoulder to elbow and swollen and painful. I took TYLENOL every 4 hrs. Difficulty moving arm. 3-21-16 arm red, hurting and difficulty moving. 3-22-16 - No redness but arm was sore and tender. 3-23-16 just soreness. I have never had an adverse event from any vaccine before this and I've had the pneumonia and pneu.
Two days after vaccination the patient experienced numbness in the two outside fingers of both hands extending to the elbow, also in the toes of the right foot. Patient did not report this to providers. Symptoms did not resolve, and the patient contacted the pharmacist and reported the symptoms. The patient was told by the pharmacist to contact the provider and report these symptoms as soon as possible
Bloated when I ate food. I felt like I had something inside me and it started coming to the surface. It was a big blisters. I took photos and sent it to my doctor (girlfriend's daughter). Rash naval to back side of my back. Nasty blisters very itchy. Calamine lotion tried everything I could. I was trying antihistamine; and ibuprofen. It burned. She said it was shingles lasted 21 days. It cleared up a week before my second shot. I  had the double dose of the Shingrix vaccine that you get all at one time. About 4 or 5 months (9/2020) before this Moderna injection. September of 2020, I believe. With no side affects after it.
Patient was given the 2nd dose at less than 28 day interval ? given at 20th day. Patient stated she had some Heart Palpitations later that night, but has since resolved and not experiencing any other issues.
Tested positive for COVID-19; A spontaneous report was received from a pharmacist concerning a 31-year-old female patient, who was also the patient, who was participating in the mRNA-1273 Emergency Use Program and experienced a positive test for COVID-19.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 037K20A) in her left arm for the prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient tested positive for COVID-19 and experienced sore throat, body aches, congestion of the nose and throat, fatigue, and dizziness.    On 04 Jan 2021, the symptoms had improved.    Treatment information included Paracetamol, Acetaminophen, Vitamin C, Vitamin D, and Zinc.  Action taken for the event was not reported.  The event, positive test for COVID-19, was considered recovering/resolving.; Reporter's Comments: This case concerns a 31-year old pharmacist who experienced a positive test for COVID-19 5 days after receiving the first dose of mRNA-1273 vaccine. The causality for the event COVID-19 is assessed as unlikely, based on its known causative agent. It is likely that the patient was already infected with the virus but was asymptomatic before being administered with the mRNA-1273 vaccine.
itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacist.  A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL1284, intramuscular in left arm, on 21Dec2020 at12:30 ( at the age of 56 years old) as a  single dose for COVID-19 immunization.  Medical history included asthma, hyperlipidemia, PTSD, and seasonal allergies. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (rash), ciprofloxacin, codeine (vomiting, rash), escitalopram (dizziness, rapid heart rate). Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a hospital. There were no other vaccines within four weeks prior to the vaccination. On 21Dec2020 at 12:30, the patient experienced itchy sensation to arms, redness to chest. Rapid response was called, patient monitored. No additional intervention, no treatment provided. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination.