chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue burns; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 15:00 (Lot number: EM9810) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Allergies to Many drugs, including B-12 and Gold, etc.; "Gold allergy" (unspecified if ongoing), notes: Allergies to Many drugs, including B-12 and Gold, etc.; "Food allergy" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "Allergy to nuts" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "tomatoes allergy" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "Sensation of pressure in eye" (unspecified if ongoing), notes: eye pressure; "Irritable bowel syndrome" (unspecified if ongoing); "Map dot fingerprint dystrophy" (unspecified if ongoing), notes: eye: map dot fingerprint distrophy (cornea not smooth); "Emphysema" (unspecified if ongoing), notes: Mild emphysema. Concomitant medication(s) included: CLARITIN [LORATADINE] taken for hypersensitivity; GELUSIL [ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE;SIMETICONE] taken for abdominal discomfort. Past drug history included: Vitamin b12, reaction(s): "Allergy to vitamin B12", notes: Allergies to Many drugs, including B-12 and Gold, etc. The following information was reported: TONGUE DISCOMFORT (non-serious) with onset 04Mar2021 14:30, outcome "not recovered", described as "tongue burns". The event "tongue burns" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tongue discomfort. Additional Information: Since the vaccination, the patient had been tested for COVID-19. On 04Mar2021 the patient experienced tongue burns. Further explained as the tongue started to bother the patient. It was stated by doctor that it was nothing but for her it was been going on for quite a while.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366681 same patient, same drug (different dose) and different event
@ 4:00 am on 8/25/21 - baby was in bed with mother asleep in her arms. Mother woke up and found baby unresponsive. Family initiated CPR & called 911. Baby was pronounced dead at the hospital.
Nasal congestion   Rhinorrhea   Acute nonintractable headache, unspecified headache type  Stay hydrated by drinking plenty of fluids.  Use tylenol or ibuprofen per manufacturer's instructions for fever or pain control.
Grandmother called @ 3:00 p.m and that  states patient having "low grade fever" with slight swelling and redness at injection site and vomiting.  Vaccine given @ 9:15 AM 11/8/13. Adverse event began @ 1:30 PM 11/08/13.
Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection
Information has been received from a consumer concerning a 19 year old female with no pertinent medical history and no drug allergies, who in August 2009, was vaccinated with the first dose of 0.5 ml GARDASIL . On an unspecified date the patient received the second 0.5 ml dose, and on 04-FEB-2010 the patient received the third dose. There was no concomitant medication. The patient felt "a pain and stinging at the injection site" after the first and second vaccination. Each time the AE "only lasted for a day or so". There were no labs or diagnostic tests performed. The patient did not receive medical attention. The patient had recovered "about a day after it started". On 04-FEB-2010 when the patient received the third dose, the needle was not properly attached to the syringe and the vaccine ran down her arm and under her blouse. She did not experience any pain or stinging when she got this vaccination. The reporter did not know how much the vaccine was injected into her daughter's arm this time. No AE was reported from this injection. Additional information has been requested.
I had a fever the day after HPV shot; feeling cold; I feel better today but still sick.
Contracted covid; Contracted covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If Covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Vestibular Neuritis. Lost my job due to vertigo, motion problems and oscillopsia. Symptoms started a week after my first Moderna shot. Received my second on April 30 and I still have balance problems, fuzzy vision and oscillopsia which has rendered me unable to work. Todays date is June 25th, 2021
shingrix vaccines with the adjuvant only; shingrix vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A healthcare provider at the doctor's office gave Shingrix vaccine with the adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They took inventory the day before the day of reporting and had Shingrix antigens was left.  They were not sure which patients received full dose and which patients received the adjuvant only. They stated that, all the patients that received Shingrix during this week would have to get revaccinated.  The doctor's office reported this to CDC.  No other information was available.  This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178136:same reporter, Shingrix US-GLAXOSMITHKLINE-US2021177375:same reporter, Shingrix
Client stated that she had had light headache, dizziness, and rash (mostly on her chest and legs) the following day after vaccination. Dizziness and H/A all gone, but the rash is still there, even though it got better. Informed us on 06/20/2005.
Pt received Moderna for dose #1 on 3/24/21, Pfizer was given for dose #2, which was "off label". Approved by provider prior to administration.
pt recv vax 29JAN97 & 9FEB97 pt devel a gen varicella-like rash consisting of blisters & 7-10 lesions;10FEB97 pt devel a low grade fever;
Within first few days of Johnson andJohnson vaccine....swollen lymph nodes, lymphedema.  2 weeks after vaccine...leg pain, bruising on legs (with no injury), peticiae rash on legs.   Now after nearly a month...still having random bruising and pain on my body (without injury), still feel very unwell, having feelings of pressure and visible swelling in neck that comes and goes, still having pain.  Yesterday a new bruise appeared on wrist with swelling, pressure, and pain.
103.1 Temperature, 24 hours of vomiting, headache, chills, dizziness
Systemic: Fainting / Unresponsive-Severe, Additional Details: The patient came to the pharmacy to receive a flu and HPV vaccine. After receiveing her HPV vaccine, patient complained of lightheadedness. I gave her a bottle of water and sat with her in the vaccine room. After about 30 seconds, patient fainted. She quickly regained consciousness and I helped her to the floor to lay down and recover. We checked her blood pressure and listened to her heart. We also gave her a glucose tablet incase her blood sugar was low since patient stated she had not eaten.
Experienced generalized aching left arm. Did not receive any medication. Aching subsided later that evening.
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right) and NIGHT SWEATS (woke up soaking wet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Allergy, Blood cholesterol abnormal and Blood pressure abnormal. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (slight headache). On 10-Feb-2021, the patient experienced TREMOR (shaking so bad), FEELING ABNORMAL (felt bad), FEELING OF RELAXATION (felt better), CHILLS (chills) and MYALGIA (arm was hurting). On 11-Feb-2021, the patient experienced MOVEMENT DISORDER (he couldn't sit up any longer), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, TREMOR (shaking so bad), MOVEMENT DISORDER (he couldn't sit up any longer), FEELING ABNORMAL (felt bad), THINKING ABNORMAL (wasn't thinking right), NIGHT SWEATS (woke up soaking wet), DYSPNOEA (shortness of breath), FEELING OF RELAXATION (felt better), PYREXIA (fever), HEADACHE (slight headache), CHILLS (chills) and MYALGIA (arm was hurting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication includes cholesterol med, blood pressure med, allergy medication. This case was linked to MOD-2021-255312. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow-up - Lot no of suspect drug was updated.
Acute NSTEMI versus myopericarditis versus COVID-19 side effect. Patient requires telemetry monitoring due to high risk for electrolyte imbalance, sudden death from myocardial injury  Follow-up cardiology recommendations for discharge planning, recommends to monitor for 24 hours while troponins are trending down.  Follow-up respiratory panel possible viral infection as a source of NSTEMI.  Replace magnesium.
non-symmetrical patch of raised and reddened skin surrounding injection site about the size of a lime. Felt and looked similar to a mosquito bite reaction, but there was no itchiness. Once noticed, it lasted about 24-36 additional hours. No other noticeable symptoms.
I developed a large hive on the vaccination site. However, it did not emerge until about a week after I had the first dose of the Moderna vaccine. I spoke to my brother-in-law who is an ER doc and he said to monitor it and if it got worse over a few day period to go to the ER. It improved about 10 days after the vaccination.
1st dose- migraine for 4 days, stomach issues (diarrhea, no appetite, upset), for 4 days, did not feel like myself all weekend. 2nd dose- migraine for 1 day, same stomach issues for 2 days.
Fever spiked to 105.9 via forehead and 103.9 orally twice, 6 hours apart. I do trust the thermometer. Cranky, sore. While I know this is a known event, the fever seemed especially high. He is currently on day 3 of fever and now dizzy with a headache. Visited pediatrician
Patient started to feel ill night of the injection and by the next morning weak and run down with the chills and sweats.
Patient fainted within 15 minutes of receiving vaccine. Patient was responsive and did not have trouble breathing. Gave patient supportive care (had patient continue to lie down, gave water, stayed with patient). Patient was able to get back up after a few minutes. Told patient to stay an additional 15 minutes as a precaution. Patient was able to leave safely afterwards.
Pt stated that she had hives on her feet and behind her ears. Also felt she had "tightening of her throat."
Right side of face droopy and paralysis of right side. Took booster on Monday morning and that night my face started to hurt but thought I was fine. The next day while trying to eat I bit my right side of my lip and my jaw would not open as far and I could not smile.
muscle aches; Pain at injection site; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 03:00 as dose 4 (booster), single (Lot number: 330368D), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering"; MYALGIA (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of myalgia, vaccination site pain, headache.  No follow-up attempts are possible. No further information is expected.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 2:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 2:55 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received vaccine past its 30 day expiry date on 11-Feb-2022 at 2:55:42 PM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was reported.
Sore arm; abdominal pain; migraine; intense body pain; joint pain; swollen ankles; 99 degree fever; fatigue; insomnia; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 13:45 at the age of 62-year-old as a dose 1, single for COVID-19 immunisation. Medical history included Post-traumatic stress disorder, fibromyalgia-in remission. The patient was allergic to yellow jackets, lactose intolerant, some anaesthesia shut the patient's bladder done. Concomitant medications included suvorexant (BELSOMRA), quetiapine fumarate (SEROQUEL), alprazolam, citalopram hydrobromide (CELEXA) and aspirin all started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 13:45, after the vaccination, the patient experienced sore arm, abdominal pain, migraine, intense body and joint pain, swollen ankles, 99-degree fever, fatigue and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The outcome of the events was recovered on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A couple of hours after the injection I got the chills aches and pain bad, temperature of 100.2. The next morning I got up with burning pain in my thigh, lower back and stomach, and my feet. Went to the doctor he thinks its Shingles gave me a prescription for valacyclovir Hcl- 1 gram tab but I don't have the red blisters.
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Jun-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
mild headache; felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm; it felt like an electric discharge; pain in my armpit; my breast, on the side that is close to my armpit, it hurts; I feel like a burning, on the same side the injection was applied; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "felt like they have pushed a ball through there, inside of me / she felt like there was a bow inside of her arm"; ELECTRIC SHOCK SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "it felt like an electric discharge"; AXILLARY PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain in my armpit"; BREAST PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "my breast, on the side that is close to my armpit, it hurts"; BURNING SENSATION (non-serious) with onset Mar2021, outcome "unknown", described as "I feel like a burning, on the same side the injection was applied". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that when the patient touch where it hurts, the pain goes away. Those are the only symptoms the patient experienced as well as a mild headache that went away with unspecified medication (the same day the vaccine was received).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm numbness and tingling; arm numbness and tingling; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP6955), via intramuscular, administered in Deltoid Left on 26Mar2021 15:09 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing iron deficiency anaemia Prior to Jun2020 and burning sensation from Oct2020 to an unknown date. The patient's concomitant medications were not reported. Patient did not take other vaccine prior to COVID-19 vaccination. After 1st Covid-19 vaccine on 26Mar2021, she developed numbness and tingling down her entire let arm which resolved within about 48 hours. The events were reported as serious (important medical event). No treatment was received for events. The outcome of the event was reported as recovered in Mar2021.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of numbness and tingling cannot be excluded.But also consider medical history of burning sensation and iron deficiency anaemia.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
This case was reported by a physician via call center representative and described the occurrence of rash in a elderly male patient who received SHINGRIX (batch number Z9RR4, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported this case through chat. The age at the vaccination was not reported. The patient developed a severe rash on the arm which he received a dose of SHINGRIX. The rash started 5 to 6 days after receiving the vaccine, which went all the way around the patient's arm from his shoulder to the elbow. The patient had no signs of anaphylaxis. The reporter did not have expiry date of the vaccine as it was given at a pharmacy and not at his office.