chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Earache; Upper and lower backache; Chills; Muscle pain from head to toe; Sensitive to light; Super sore arm; Pain down my right arm near the injection site; Pain down my right arm near the injection site as well as on the opposite side of arm into armpit; Fatigue; Foggy head; Random chest pains; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 16Nov2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone (NORETHINDRONE) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 25Jan2021 at 15:30 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 39-years-old); both as single dose for COVID-19 immunisation and did not have any symptoms with the first two vaccines. On 17Nov2021 at 06:00, the patient experienced headache, earache, upper and lower backache, chills, muscle pain from head to toe, was sensitive to light, had super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit. The pains continued for 48 hours (as reported). The patient also had fatigue and a foggy head and random chest pains. The patient was concerned and worried that this could be more serious. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, earache, upper and lower backache, chills, muscle pain from head to toe, sensitive to light, super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit, fatigue and a foggy head and random chest pains was resolving at the time of this report.
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown.  No follow-up activities are needed. No further information is expected.
Patient had received the vaccine for MMR and Varicella in the past/Proquad was not needed; Information has been received from a Registered nurse concerning to a 12 years old female patient. On 16-MAR-2021, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S030211, exp. date 25-MAR-2021) (rHA), 0.5 milliliter for prophylaxis, as the clinic did not have her vaccine records. On an unknown date, the clinic discovered that in the past the patient was vaccinated with measles (+) mumps (+) rubella (manufacturer unknown) and varicella (manufacturer unknown), therefore measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not needed (extra dose administered).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA003950:
Vaccine given via intramuscular route instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to an adult patient of an unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, dose, dose #, strength, frequency, lot # and expiration date were unknown) for prophylaxis, intramuscularly, not subcutaneously (subcutaneous injection formulation administered by other route). No product quality complaint (PQC) was involved.
pt recv vax; sterile abscess at site of inject; I & D of abscess, culture, ATB
Lumpiness at the site of injection; Itching at the site of injection; Redness at the site of injection; lumpiness at the site of injection; redness at the injection site; itchiness at the site of injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE MASS (lumpiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and VACCINATION SITE PRURITUS (Itching at the site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itchiness at the site of injection) and VACCINATION SITE MASS (lumpiness at the site of injection). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE PRURITUS (Itching at the site of injection) and VACCINATION SITE MASS (Lumpiness at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. In January 2021, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE MASS (lumpiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE PRURITUS (Itching at the site of injection) and VACCINATION SITE MASS (Lumpiness at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient developed redness, itchiness and lumpiness at the site of the injection that lasted for 4-5 days and then faded. Then, on the 8th day, the reaction came back and lasted for around 3 days.
2 attempts were made to administer the vaccine intradermally.  No wheals were produced with either attempt. Medical Director was consulted and order was given to administer .3ml of the vaccine subcutaneously.
Vaccine was double administered. Patient received Menactra vaccine on 5/6/22 at his pediatrician's office. Parent had signed consent for vaccine to be administered at school, this RN administered the Menactra vaccine on 5/18/22 at school. System was reviewed prior to vaccine administration on 5/18/22 and there was no documentation of dose given on 5/6/22. No adverse effects reported after dose administered on 5/18/22.
red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other healthcare professional (patient).  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on Left arm from 08Jan2021 12:45 to 08Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation.  Medical history reported as none. There were no concomitant medications. On 08Jan2021 at 18:45 (6 hours after receiving vaccine), the patient broke out in red hives, experienced chills, body aches and low fever. The outcome of the events was recovered. No treatment was given for the events. Since the vaccination, the patient has not been tested for COVID-19.
Enlarged, painful, right under arm lymphnode.  Started about 7-10 days after shot given.  Lasted 7-8 days.
had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees); had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees); experienced muscle aches; feeling very fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 10:00 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Lichen simplex chronicus" (unspecified if ongoing). Concomitant medication(s) included: JUNEL taken for contraception; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 14Jan2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 03:00 PM), administration date: 04Feb2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 13Jan2022 21:30, outcome "recovering", described as "feeling very fatigued"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 13Jan2022 22:30, outcome "recovering" and all described as "had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees)"; MYALGIA (non-serious) with onset 13Jan2022 21:30, outcome "recovering", described as "experienced muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, myalgia.  Additional details: Patient did not receive any other vaccine in four weeks. List of other medications received in two weeks include: JUNEL 1/20 for birth control and LEVOTHYROXINE 25mcg. Patient did not have covid prior vaccination. Patient did not test for covid, post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Developed low grade temp, URI, vesicle on tongue, neck in following 2 day. 6-8 more lesions back, trunk developed.
Patient received pfizer vaccine and felt upper back pain on the left side 15 minutes after administration. There was no rash, lump, bump or warm sensation around her upperback/neck area. Patient was advised to stay in the observation area an additional 15 minutes. Patient advised that she felt better but still had a little pain. She was then advised to drink plenty of water, take tylenol every 6 hours as needed and to see her PCP if the pain continues. Patient's condition was alert and oriented.
Redness and swelling at vaccination site on arm; Redness and swelling at vaccination site on arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 10:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 08:00, the patient experienced redness and swelling at vaccination site on arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site erythema and vaccination site swelling was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Hypertension; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERTENSION (Hypertension) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 002A21A) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with/tested positive for COVID-19.  It was reported as unknown if there was acute illnesses  at the time of vaccination and upto one month before.  Concurrent medical conditions included Blood pressure high since 29-Nov-2019, Hypertension since 29-Nov-2018 and Type 2 diabetes mellitus since 09-Jan-2020. Concomitant products included AMLODIPINE from 29-Nov-2019 to an unknown date, LISINOPRIL from 29-Nov-2019 to an unknown date, LOSARTAN from 24-Nov-2021 to an unknown date and METFORMIN from 09-Jan-2020 to an unknown date for an unknown indication.   On 09-Mar-2021 at 5:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021 at 1:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Nov-2021, the patient experienced HYPERTENSION (Hypertension). At the time of the report, HYPERTENSION (Hypertension) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERTENSION (Hypertension) to be not related.    Patient received third dose on 06-Dec-2021 at 13:25 pm of 0.5 dose with lot number (069F21A) in left deltoid. No treatment information was provided.  Patient did not have any adverse event including signs symptoms, clinical course  and or treatment with dates/timelines.   This case was linked to MOD-2022-503629 (Patient Link).
Pain in injection site was first effect.  The next morning body aches and fever began. Followed by Nausea and swollen and tender right arm in arm pit and severe headache.  The arm pit hurts the worse.  No outcome as of yet
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reported for 37 patients. This case is for 11th patient of 37 patients.  A 64-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9266) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. On 26Jul2021 the patient experienced tested positive for covid virus, after being fully vaccinated. Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
This case was reported in a literature article and described the occurrence of bronchiolitis in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included digeorge's syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed bronchiolitis. Serious criteria included hospitalization and GSK medically significant. The outcome of bronchiolitis was unknown. The investigator considered that there was a reasonable possibility that the bronchiolitis may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of bronchiolitis in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had DiGeorge syndrome. No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed bronchiolitis and subsequently, hospitalised. This case has been considered as serious due to hospitalisation. The treatment was unknown. The outcome of the event was not provided. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction.
Patient complaints of throat, tongue and lip numbness approximately 15 minutes after vaccine.  After a stable assessment and stable vitals signs, Benadryl 50 mg po  given with noted decreased in symptoms in 30 minutes. Patient monitored another 1 hour after issues.  Husband called to pick up patient.  Lungs clear, BP 120-130's/70-80, pulse 70-80's, res 20-24, Spo2 98-99% o room air.  Patient to call Dr.  in am, her PCP to updated her and her recommendations of further COVID vaccines.  Patient discharged home with husband, to go home. To take additional 50 mg of Benadryl this evening and if any concerns to follow up at .  Patient and husband verbalized understanding of the above instructions and treatment plan.   CNP
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 21-AUG-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. On 21-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX.
This case was reported by a physician and described a 68 year old male pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 2/4/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/23/04, the pt  received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/27/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Booster vaccine administered on 12/7. On 12/18 I began feeling intense itching  and developed a red welted rash on entire torso and groin area. Rash temporarily subsided with topical steroid ointment. I experience random  bouts of intense itching on different parts of body from scalp to soles of feet at any time. When the itching begins hives also appear and when I scratch them welt marks appear. Itching, hives , and welts will disappear writhing 15-30-60 minutes. And skin will look normal again. For 3 weeks only my face was not affected, but 3.5 weeks after the symptoms began , they then started occurring on my face and neck. As of today I am still experiencing these symptoms
rash; Pruiritis; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 18Feb2021 04:00PM (at the age of 50-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination and did not have other vaccine in four weeks. Relevant medical history included cervical cancer (1995) and bladder atony. The patient had not COVID prior vaccination and was not tested post vaccination. She had no known allergy. Concomitant medications included macrogol 3350 (PEG 3350). On 20Feb2021 10:00PM the patient had pruritus and rash anterior midsection. No treatment was received. The events were not resolved.  Information on the lot/batch number has been requested.