chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US026195 is an initial spontaneous report received from a pharmacist on 20 Dec 2013. This report refers to a 50-year-old female patient. On 22 Nov 2013, she was vaccinated with FLUVIRIN (batch number: not reported) in the arm. She reported that since vaccination, her arm had been sore and she could make limited ise of her arm. The outcome, seriousness and causality of the events were not reported.
Low titers; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional information received were as follows: The age at vaccination was not reported. The physician on the line reported that about 5 to 6 years ago, the patient received three courses (completed the series three times) of Engerix B and still had zero response, which led the patient to be therapy non-responder. No further information was provided. This case has been linked with US2019AMR117487, reported by the same reporter.       Lab Comments: On an unknown date, the patient had test for Hepatitis B antibody and found to be zero titer.
Child develop 3x3 cm warm, red, square area on L deltoid.  Negative sign illness.  Child examined 5/7/08.  Plan: TYLENOL as needed, BENADRYL 25 mg at bedtime as needed.  Recheck 2-3 days if not resolved.
pt exp onset of papular rash during weekend following MMR on 13OCT95;pt presented w/worsening rash (size of papules) & itching; initiating tx w/DPH; HCT 2.5 cream
Private office (1) DTaP immunization. When balancing our shots for the health department, they called back stating that 5 patients were given DTaP instead of Tdap. New staff was unaware that the system did not specify which shot was to be given at any certain time, or of patient age range. No adverse reactions were reported by patients, the shots were all given months ago. Discussed with the health department and they suggested to put a sticker on the boxes with age ranges to remedy the situation so it does not happen again.
Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; This is a spontaneous report from a contactable consumer (Patient reported for herself).  A 60-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206) via intramuscularly, in left arm on 10Mar2021 as dose 1, single (at the age of 60-years-old) for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 11Mar2021 the patient had allergic reaction in a way of rash, rash was all over on patient body, there was a rash on patient legs, arms and stomach and it was an itchy rash. Patient reported that she had an allergic reaction in a way of rash appeared 12 to 18 hours after the vaccine and still had the rash and it's been 9 days past the vaccine. Patient queried if rash was seeing in others and was their experience with the second dose. Patient was informed about Pfizer Medical Information and the contact was provided. Patient further queried regarding what is the time frame for the second dose. Patient was again told to contact Medical Information department for all the questions. Patient received the treatment with Benadryl for the reported events. Patient reported that the issue was still persisting and was not improved. Outcome of all the reported events was not resolved.  Follow-up attempts completed. No further information expected.
Pt experienced left arm numbness and inability to abduct left arm, pain into collbarbone area.
tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough; tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough; mental fogginess; stuffy nose; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 24Aug2022, outcome "unknown", described as "mental fogginess"; NASAL CONGESTION (non-serious) with onset 24Aug2022, outcome "unknown", described as "stuffy nose"; FATIGUE (non-serious) with onset 24Aug2022, outcome "unknown", described as "tiredness"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2022, outcome "unknown" and all described as "tested positive for Covid/Oropharyngeal Pain/Pyrexia/Cough". The patient underwent the following laboratory tests and procedures: Body temperature: (24Aug2022) 101 Fahrenheit, notes: fever of 101F; SARS-CoV-2 test: (27Aug2022) Positive, notes: My sister tested positive for Covid on 27Aug2022.  Clinical course: The reporter's sister tested positive for Covid on 27Aug2022. Her symptoms started Wednesday night (24Aug2022) as a sore throat and progressed to a fever of 101F, stuffy nose, coughing, tiredness and mental fogginess. She received two Pfizer Covid-19 vaccines and booster. She declined consent to contact but agreed to provide lot numbers at a later date.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed a bump at an injection site after receiving the vaccine. This is one of several reports from the same source.
4-5-21   vommiting ,headache  4-6-21     spine pain , headache cont ,vomiting  4-7-21   spine pain , headache cont ,vomiting reaction to morphine and oxy (anaphalactic shock ) x 2 er visits 4-8-21           spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping  Er Visit  4-9-21      spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping  4-10-21      spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping  ER  4-11-21-   4-14-21  spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping  4-14-21    spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping went to my PCP she sent me staright to hospital due to facial drooping and swelling in Face and convosiont/trimmeres. 4-22-21     spine pain , headache cont ,vomiting (min), seizures/ trimmers ,confussion/memory loss ,bladder i numb and teng in right side face and arm. facale swelling and drooping Fallow up with pcp waiting to see nerology for sezure activity  4-23-21-5-2-21      spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss . numb and teng in right side face and arm. facale swelling and drooping
Body aches, headache vomiting diarrhea, high white blood count, accelerated heartbeat
Headache, Myalgia, Arthralgia Soreness left arm, sweating, dry throat Narrative:
on 1/15/2021 this individual called in to report that on 1/14/2021 she noticed a reddened area on her left arm around the site of injection that is approximately 1"x3" in size. She reports this area is red, raised, itchy, and burning at times. She noted no other adverse symptoms until this developed.
Pain in the left side of the neck, same side as injection, has persisted since day three following second vaccination.
Arms started to itch; Fatigue; Pink rash; Hot flashes; Shaking and tremor feeling when trying to open anything or write; Flushing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FLUSHING (Flushing), PRURITUS (Arms started to itch), FATIGUE (Fatigue) and RASH (Pink rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). On 02-Feb-2021, the patient experienced FLUSHING (Flushing). On an unknown date, the patient experienced PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write). On 01-Feb-2021, HEADACHE (Headache) had resolved. On 03-Feb-2021, FLUSHING (Flushing) had resolved. At the time of the report, PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
NONE - VACCINATED A CHILD UNDER 18 WITH JANSSEN VACCINE, PATIENT LIED ABOUT AGE, DISCOVERED WHEN ENTERING INTO THE REGISTRY
Bruise with a rash around it; rash with red bumps; Chills; Headache; Vaccination site pain; mild swelling; achiness; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise with a rash around it), SWELLING (mild swelling), PAIN (achiness), RASH ERYTHEMATOUS (rash with red bumps) and CHILLS (Chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SWELLING (mild swelling), PAIN (achiness), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain). On 01-May-2021, the patient experienced RASH ERYTHEMATOUS (rash with red bumps). On an unknown date, the patient experienced CONTUSION (Bruise with a rash around it). At the time of the report, CONTUSION (Bruise with a rash around it), SWELLING (mild swelling), PAIN (achiness), RASH ERYTHEMATOUS (rash with red bumps), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021, No new information was added. On 22-Jul-2021: Follow up document received and contains significant information - New event Bruise  added.
Have been talking with doctor for a while. Had an endoscopy and Colonoscopy Dec. 6th.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 13-DEC-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA009929: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
Narrative:  Patient tested Covid positive on 1/21/21 after receiving the first Moderna dose on 1/14/21. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient's wife tested positive for Covid on 1/14/2021 and he was later brought into the ER with diarrhea on 1/21/21 and a positive COVID-19 test. Patient had comorbidities of CAD, COPD, and CHF. He was transferred to another hospital where he likely died of complications related to COVID
Patient claims she had nausea, headache, dizziness, almost fainted, was hot and cold, tiredness, and soreness at site of injection
Employee reported a lump the size of a small orange at the site of injection with swelling spreading to neck area around clavicle.
Pt has edema almost an erysipelas over the injection site, tender and hot, improved with warm packs and antibiotics.
Patient states 2 days fever with fatigue (no objective data). Received Td 8/19/05 - seen in ER 8/21/05. ER report states localized reaction to Td right deltoid. 2.5" diameter erythema.
Patient reported severe arm soreness, "hardly able" to raise arm for two days. Hives and area warm to the touch, malaise for several hours.
On the evening of 4/19/2022 I developed headache, sore throat, fatigue and low-grade fever (100.4).  These symptoms resolved by 4/22/2022.  I was on the cruise ship.  On the morning of 4/20/2022 I had a rapid Covid-19 PCR test administered by one of the ship nurses.  The result was positive and so I and my wife were quarantined to our cabin for the 5 days remaining of the cruise.  The ship physician prescribed a 5 day treatment course of molnupiravir, which I took according to directions.  I felt well, no longer had symptoms by 4/22/2022.  The cruise disembarked on 4/25/2022.  We spent the week touring until able to fly back on 5/2/2022.
Administration of Infanrix instead of Boostrix; 11 years old patient received Infanrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 16-AUG-2023, the patient received Infanrix. On 16-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Administration of Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 years old patient received Infanrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 22-SEP-2023 The reporter reported that the 11 month old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter asked if the patient had to receive Boostrix. The reporter consented to follow up.
pt recvd vax following completion of the series the pt tested neg for hepatitis B surface antibodies; No further details were provided;
COVID positive on 30Jul2022 via antigen testing; COVID positive on 30Jul2022 via antigen testing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 25Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 30Jul2022, outcome "recovering" and all described as "COVID positive on 30Jul2022 via antigen testing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
INCESSANT RINGING IN EARS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced incessant ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from incessant ringing in ears. This report was non-serious.
Liver function test abnormal. This case was reported by a pharmacist and described the occurrence of elevated liver function tests (NOS) in an adult male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). At an unspecified date prior to receipt of Twinrix, liver function tests were "normal". On an unspecified date, the patient received the first dose of Twinrix. At an unspecified time following the first administration of Twinrix, liver function tests (NOS) "went up to 150." On an unspecified date, the patient received the second dose of Twinrix. At an unspecified time following the second administration of Twinrix, liver function tests (NOS) "went up to 500." The outcome of the events in unknown. Comment: Exacerbation of elevated liver function tests and increased liver function tests were assessed as medically serious by GSK.
I have had Tinnitus since late 2017. Several days after the first Pfizer shot the intensity and volume of my Tinnitus began to slowly increase. This kept up for about 2 weeks and it has remained at the higher level since. Tinnitus is now present in the mornings, which was never the case prior to the vaccine. It used to increase in volume throughout the day. Now it's loud and present the moment that I wake up. I have been a lot more sensitive to noise in general.   I am not sure if this counts as "permanent damage" as listed below, so I will leave it unchecked.
I noticed a lump closer to my neck than my shoulder; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (Batch/Lot Number: EN6206) as DOSE 2 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The History of all previous immunization with the Pfizer vaccine First dose of the product was administered on 14Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient Received her second dosage on Saturday morning and states she has developed a lump near my neck, left, between my shoulder and her neck, closer to her neck on 14Mar2021.  It's real swollen and it's tender to the touch and it's on the same side she had her shot.  Caller wants to know if that is one of the side effects, could it possibly be one, has anyone else had one, or is it something else. Caller states she tried contacting her doctor first, but he is completely booked for the week. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
K92.2 - Acute lower GI bleeding D64.9 - Anemia Z79.01 - Anticoagulated
Large, swollen area from thigh to knee, firm, reddened and hot to touch.
6 days after vaccine date. I have enlarged, swollen and painful lymph node in my right axilla.
Patient came into clinic to receive TB test was accidentally was given Anthrax ID (.1 ml) in left arm.