chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He also had Chills; He started having random cold finger tips and toes; He had pain on the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (He started having random cold finger tips and toes), CHILLS (He also had Chills) and VACCINATION SITE PAIN (He had pain on the injection site) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Hypothyroidism (About 5 years ago patient was slightly Hypothyroid).    On 09-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (He had pain on the injection site). On 10-Jan-2023, the patient experienced PERIPHERAL COLDNESS (He started having random cold finger tips and toes). On 10-Jan-2023 at 4:00 AM, the patient experienced CHILLS (He also had Chills). On 10-Jan-2023 at 6:00 AM, CHILLS (He also had Chills) had resolved. At the time of the report, PERIPHERAL COLDNESS (He started having random cold finger tips and toes) had not resolved and VACCINATION SITE PAIN (He had pain on the injection site) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   About 5 years ago doctor told patient that he was slightly Hypothyroid. He never prescribed anything for it. It did not show up on the subsequent lab works for 5 years. No concomitant medications were provided. The patient received first primary monovalent dose on 14-Apr-2021 with lot number 043B21A. Second primary monovalent dose on 12-May-2021 with Lot number 035C21A. First monovalent booster dose on 07-Jan-2022 with lot number 070H21A. Patient did not had any side effects with all three doses. On 10-Jan-2023 patient started having random cold finger tips and toes. The issue went away on 11-Jan-2023. But it came back on Feb-2023. He states that when his fingertips were cold, he measured 12F difference between the cold tip of his fingers and the base of the fingers. When fingertips were cold, there was no discoloration. The finger looks normal. In addition, he had pain on the injection site Left arm on 9-Jan-2023 and 10-Jan-2023, then it went away. After the Bivalent booster, his doctor ordered lab works on Feb-2023. Everything was normal except that he was hypothyroid. He had an appointment to visit the doctor again this week to discuss that. He was concerned about the cold fingertips and toes.  No treatment medication was provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Extreme chills that night.  Then headaches, neck aches, stomach aches, and excessive tiredness for the next 5 days as well as one more incident of extreme chills the morning of October 14, 2013, approximately 8 AM.
I had a fever, chills, a sore throat beginning the evening of the vaccination and throughout the week.
Around 5.38 pm when patient was completing his 15 mins of observation, redness and rashes was observed around injection site (left arm). patient reported itchiness at vaccine site. vital signs were within normal limits. observation was extended for 15 extra minutes. NP on site assessed the pt. PO Benadryl 50 mg  offered and administered at 5.41 pm. patient reassessed 15 minutes later. redness decreased at site. patient reported feeling less itchy and "feeling better." pt was educated about the side effects of benadryl and was advised to leave site with an escort. Pt left site around 6.05 in steady gait and stable condition.
Herpes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single, patient received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced herpes during the two doses, the patient inquired that she could take Valacyclovir without it diminishing the effect of the vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Leg swelled, was bright red and felt very warm and hard to the touch. Patient cried for 1 hour straight before falling asleep. Showed signs of siezure activity upon waking up. She now seems to tremor when waking or excited, We aren't sure it it was due to the shot, but the day of the shot was the first time the sudden jerks and tremors appeared.
Patient lost consciousness, started grunting, slight jerking of his arms and legs, and lost bladder control.  This lasted 30 - 60 seconds.  He came to and was groggy. He was pale and sweaty.  He lied down on the exam table. On call provider examined him. His  vitals and Blood glucose were obtained. He was given apple juice. Blood pressure remained low after over an hour of observation so was transported to the Emergency room by wheel chair  for ongoing observation.
pt recv vax & the next day pt exp pain & warmth @ the inj site;pain subsided gradually over the next 2 to 2.5wk;15SEP96 pt again exp rt deltoid discomfort when lifting arm over head;
Injection site pain; fatigue; low grade fever; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 15:30 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic rhinitis (severe)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "possibly some IV contrast dyes" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 15:00 , vaccine location: Right arm), administration date: 28Aug2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Injection site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "fatigue"; PYREXIA (non-serious) with onset 18Sep2021 16:30, outcome "recovered" (20Sep2021), described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced covid prior vaccination. Patient did not experienced covid tested post vaccination. Patient received medications within 2 weeks of vaccination. Patient received treatment as Acetaminophen 1000 mg for the fever.   Follow-up attempts completed. No further information is expected.
Round, raised, reddened area about the size of palm of hand with "tail" at 5o'clock. Systemic fever reported of 100.5. Seen in ER given Doxycycline. Back to ER on 9/3/2015 given clindamycin for redness extending outside of drawn border from yesterday.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 05Oct2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2023 to 08Jan2023. Clinical course: The patient experienced rebound COVID 2 days after testing negative. This was 5 days after completing my course of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe nausea and vomiting, headache, ear/neck pain, ear infection, eye infection, blisters in and around nose, eye, face, scalp, vision loss, inability to read/work 2+ days.
Arm pain; Muscle soreness around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient still experienced arm pain and muscle soreness around the injection site. The patient did not consent to follow up.
Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
Well after I received the second vaccine, a few hours later I had a fever and chills and some type of a sore throat as well. My fever was about 101 degrees and within 18-24 hours later it was all go, no fever or chills but did have a mild headache that hung around a little longer. I contacted my DR at the end of May and my other DRs and they just do not do anything really, because the pain in my shoulder just will not go away actually that is the only thing that is lingering. Even my cardiologist I have seen him and my left arm when I raise it upwards, it hurts on the shoulder and when I turn back towards my back it also hurts a lot. My DR did give me Voltaren cream and told me to get physical therapy at Stars Physical Therapy and I just started that in July. I just received physical therapy 7/23/2021, that was yesterday.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASSIL vaccine (yeast). Subsequently the patient experienced drop foot. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information is not expected.
panic attack; shaky hands right after taking the 2nd dose.; Cold hands; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program . A female patient of an unspecified age received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunisation. On 17Apr2021, the patient experienced a panic attack, cold and shaky hands right after taking the 2nd dose. Patient asked whether she needs to seek assistance due to the symptoms experienced. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Blisters & rash at injection site 2 wks after imm. given.
waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient).  A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.
On May 3rd AM experienced fatigue, by that evening had temp of 100.6. Over next 9 days temp stayed between 103.2-103.6. Joints ached, some nausea, occasionally vomiting, no appetite, continued fatigue, slight cough. Had two covid tests, first one on May 5th, second May 10th, both were negative. On May 11th went for out-patient IV fluids. On evening of Wednesday, May 12th temp was 99.8 and now had shortness of breath and increased coughing. Next day , May 13th went  for chest X-ray and diagnosed with pneumonia in my right lung. Antibiotics started that day and X-ray  in 6 weeks was clear.
it was administered after the temp excursion had occurred; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 29-DEC-2020, the patient was vaccinated with an improperly stored dose  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1687292, expiration date 25-AUG-2022 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 22.7 degrees of Fahrenheit for 35 minutes on 22-DEC-2020. Previous temperature excursion occurred on 07-DEC-2020 and the vaccine was stored at the temperature of 32.6 degrees of Fahrenheit for 30 minutes.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA001945: US-009507513-2101USA002297: US-009507513-2101USA001792: US-009507513-2101USA001777:
CELLULITIS; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Proquad for prophylaxis.   In November 2019, the patient received Kinrix and Proquad at an unknown dose and frequency. In November 2019, less than a week after receiving Kinrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Kinrix.  Additional details were provided as follows: The reporter stated that the week before the day of reporting, the patient received Kinrix and Proquad and experienced injection site cellulitis. The reporter could not comfirm, if the injection site cellulitis was due to Kinrix. It was unknown if the reporter considered the injection site cellulitis to be related to Proquad as well. This case has been linked with case US2019AMR210851, reported by same reporter.
itched; bump at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itched), VACCINATION SITE SWELLING (bump at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (itched), VACCINATION SITE SWELLING (bump at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). At the time of the report, PRURITUS (itched), VACCINATION SITE SWELLING (bump at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-074767 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074767:2nd dose case
Patient reported flushing in the face, tingling on the left side down the left arm and then began to break out into hives on their chest.  The individual also had a rapid heart rate and needed a wheel chair due to feeling slightly faint.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported. On 11-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. HCP stated that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that.
Patient came in complaining of generalized aching pain in right arm between shoulder and elbow. Presented with a large yellowish bruised area and another large area of what appears to be bleeding under the skin. The area of all bruising is approximately 8 in x 3 in.
Low grade 100.5 fever about 10 hours after vaccination. Fever went away over night. Broke out in hives all over body about 24 hours after vaccination. Have taken Benadryl twice, hives are going away.
FEVER, ACHES, DIAPHORESIS, HEADACHE, BODY ACHES, FATIGUE, MENTAL FOGGINESS, & INSOMNIA. BEGAN 13 HOURS AFTER VACCINATION AND CONTINUED STRONGLY UNTIL 3 AM 10/14/2021. MUCH STRONGER THAN SIDE EFFECTS EXPERIENCED AFTER SECOND SHOT ON 3/30/2021.
transverse myelitis p/receiving Hep B vax; admitting dx acute quadriplegia;
Questions onset of multiple sclerosis with receipt of 6 Anthrax vaccines, Hepatitis B and other vaccines prior to overseas travel. Questions genetics of MS with vaccines. Discussion with patient and review of medical records was limited to available electronic medical records (12/2005-2016) lists multiple health issues to include thrombocytopenia and erythrocytosis, lumbar radiculopathy, lumbago, Multiple Sclerosis (2005-6), BPM and more. I have no access to medical records prior to Dec 2005, specifically time periods prior to and after receipt of AVA and other vaccines in 1999-2000.
Vaccine was administer at 12:45 pm. While patient was in the observation area at approximately 12:58 pm she began to experience light-headedness, nausea, and sweating (felt warm). The pharmacist had the patient lie down and she was given juice after approximately 5 minutes of lying down. She was observed for 15 minutes while she remained in a seated position on the floor and drank juice. All symptoms resolved by 1:20 pm. She was observed for another 15 minutes and demonstrated that should could stand up without symptoms at 1:35 pm.
Pt had fever of 100-101 p/recvd DTP/OPV; during noc temp to 103 & same today; had been giving a non-ASA liquid; has not been sleeping, excessively crabby, leg in area of inject is excessively warm, red, & hard as a rock; shivering;
Mild urticaria to bilateral axilla and neck.  child given 12.5 Benadryl; symptoms resolved in 15 min.
Sore throat, nasal congestion, cough. This has happened every time I get hi-dose flu zone, this year and last year. Can we opt for regular flu vaccine instead?
Headache, NauseaVomiting, CHILLS, SWEATS Narrative:  HEADACHE X 48 HOURS