chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute pharyngitis; Viral syndrome; Asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 14-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Lot number: EW0181) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 19Mar2020 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Batch number: EW015), administration date: 02Jun2021, when the patient was 13-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset 23Dec2021, outcome "not recovered"; VIRAL INFECTION (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "Viral syndrome"; PHARYNGITIS (non-serious) with onset 01Mar2022, outcome "recovered" (16Mar2022), described as "Acute pharyngitis". Additional information Prior vaccinations were none. Concomitant drugs were Unknown. Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia was none. Patient age at the time of vaccination was 14 Years. Dose details: 03 Date/Time: 24Mar2022 15:08 Site and Route of injection Anatomical site of injection: Left Arm Route of administration: Intramuscular Batch number: FK9729. Comments/Narrative: Grey top Covid 0.3mI dose given after expiration (refrigeration date of 10 weeks. Accidentally went with the expiration date entered MCIR thinking it was still good after 10-week Storage. was informed that was the manufacturer expiration date and the 10-week date is still Correct There has been no side effects or concerns from patient of parents.  No follow-up attempts are possible. No further information is expected.
Shivering; fever; nausea; headache; tiredness; chest pain; tingling in fingers; swelling in hands and feet; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 06May2021 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 at 18:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 07:00, the patient experienced shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet. 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 shivering, fever, nausea, headache, tiredness, chest pain, tingling in fingers, swelling in hands and feet was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Severe nausea - day 2-7 Bronchospasm  day 2- 10 metallic taste in mouth - almost immediately to day 7 fatigue and low grade fever   day 4 hives = day 5 and 6 - took Benadryl and it controlled the hives
complete body rash - red, scaly, itchy biopsied and found to be INTERFACE DERMATITIS (SEE COMMENT)  Comment: The differential diagnosis includes pityriasis lichenoides
May 15, 2017 began not feeling well in the evening. May 16 and 17 had fever of 101.6 degrees both days, not eating well and very lethargic. May 18, 2017 no temperature. Did not go to doctor. Gave fever reducing medication at home. No NVD. Was not around anyone that was ill.
With in 1 week my father went from living in his own apartment taking care of himself, driving to his own appointments and cooking for himself to not knowing where he was - wrong city, thinking he is in a hotel instead of apartment - not knowing how to drive or fix food for him self. We had to have someone check on him every day and make him meals and just put him in a home.
feels like my testosterone is high, feel younger.; mild sore arm; now the joint pain is gone after taking the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (feels like my testosterone is high, feel younger.), PAIN IN EXTREMITY (mild sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (now the joint pain is gone after taking the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Joint pain. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (feels like my testosterone is high, feel younger.), PAIN IN EXTREMITY (mild sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (now the joint pain is gone after taking the first dose). At the time of the report, ENERGY INCREASED (feels like my testosterone is high, feel younger.) and THERAPEUTIC RESPONSE UNEXPECTED (now the joint pain is gone after taking the first dose) outcome was unknown and PAIN IN EXTREMITY (mild sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
clt stated at 1:30am on 1/7/20 she awoke with a headache.  she took a Tylenol and returned to bed.  she awoke again at 5:30 am and had nausea.  stated she vomited x 2.  came to Health department on 1/8/20 and clt was interviewed and vaers completed. encouraged clt to contact pmd and notify him of above and completion of report.
Medication administration error: Pfizer COVID-19 mRNA booster dose given to patient on 12/9/2021. MA that administered dose did not realize until later that the vial of vaccine from which she pulled the dose had been used the previous day and left out at room temperature overnight. Office manager informed patient via telephone message on 12/9/2021 that she had not received a valid booster dose and another vaccine booster dose should be administered without any need to wait (per Clinic Pharmacy Director). No further documentation in the medical record of the patient returning the phone call to scheduled another vaccine booster dose.
Large red bump developed after 1 day and has kept spreading in size with secondary sites for 7 full days. The site is warm, itchy, swollen and red. The injection site is raised and hard to the touch. The area is sore and lymph node under arm pit is also sore. 48 hours after injection, I was chilled, extremely weak, fatigued, headache and couldn't lift arm. This remained for 2 full days. Day 3 I had a sore, swollen throat. I took a non-drowsy antihistamine, which helped within 24 hours.  Pain has subsided unless injection site is hit or brushed. Mobility of arm was returned. Redness has lessened even though patches have continued to grow. Grew by roughly a centimeter per day and has finally slowed. Injection site developed a medium size bruise and area underneath still hard to the touch, itchy and red.
1 of 2 pts exp an inject site react w/in 48  hrs p/vax; pt vaxed 12JAN94 & 14JAN devel redness & swelling @ inject site (size of an apple);
This patient received immunizations on the day prior to admission. On the day of admission she was taken to the ED in status epilepticus. She was being treated for epilepsy with Zonisamide and Klonopin. The father reports epilepsy began with the first DTP. Diagnosed with carbamazepine overdose.
She got her vaccine, she first started with headaches, nausea and then vomiting.  She then had facial numbness on Saturday.  She did take Phenergren for the nausea and did help.  She went back to bed, and when she woke up Sunday still had numbness in her face, and found that her features were symmetrical and not having a stroke.  She called the advice center and they told her if it did not resolve in a couple of days that she needed to be seen.  On Monday it started to go away and Tuesday better, but has pretty much resolved.  Has occasional numbness and tingling around her eyes and her mouth as well.   They consulted the ER doctor when she called the advice center since she didn't have a way to get in, and they told her to come in if it did not get better.    She has concerns if she has to get further vaccines if it's going to be worse or some other disease process or condition.    She does have an over-active immune system.    Did take Dupixent in the past, but quit when COVID came around.
Indurated, erythematous, non tender 2" mass over Varivax site.
pt recv vax 20JUL95 & pt devel breakthrough chickenpox;the health care professional reported two other patients;they were assigned WAES 97021128 7 WAES 97021129;
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of gave FLUMIST to a child with a history of asthma was received from a health professional concerning a five-year-old female. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 13-Oct-2011, the patient with history of asthma received FLUMIST. No reactions were observed from the patient following the administration of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
MEDICAL ASSISTANT DID NOT REALIZE THAT THE VIAL SHE USED EXPIRED ON 11/27/2022 (ALMOST 30 DAYS AGO).  PATIENT WAS INFORMED.  NO UNUSUAL REACTION NOTED.
LOW ANTIBODY TITER; This spontaneous report received from a physician concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Physician reported that after patient received Janssen COVID-19 vaccine (date unspecified), on 25-JUN-2021, laboratory data included: Antibody test (NR: not provided) antibody titer levels were at 45000000000 which was low. Physician was concerned that these levels may be low and patient may need to be revaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low antibody titer. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660717-covid-19 vaccine ad26.cov2.s -Low antibody titer. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient was receiving an IVIG infusion at the time of reaction.  Patient has had infusion many times in the past with no reaction, so we are possibly attributing the reaction to her recent COVID vaccine.  Severe hives/boils from neck to knees Itching  IV methylprednisolone was administered in the home to control reaction. Her MD prescribed famotidine and loratadine to assist with relieving her symptoms.
About a month after my 2nd shot I started having issues with the range of motion on my left arm ( where the shot was administered). It has gotten progressively worse. In discussing this with medical professionals I am told it might be something called SIRVA?  Both my shots were administered by our Pharmacist. As of now I can no longer move my left arm behind me, or raise it more than shoulder height over my head without experiencing severe pain. I also have pain if I lie on it as it. It's really affecting my quality of life. I am a stage 4 renal failure patient so i have to be careful with anti-inflammatories. About all I can do to relieve the pain is tylenol, and warm heat as the seem to give me some relief.
SOB; ERTYTHEMA, INDURATION, PAIN @ RD SITE OF INJECTION WITHIN 2 HOURS OF VACCINATION.  PER REPORT OF CHILD, MOTHER APPLIED ICE PACKS TO INJECTION SITE.  ERYTHEMA (45 MM) AND INDURATION (20 MM) NOTED BY PHN TWO DAYS POST-VACCINATION; CHILD AFEBRILE.
Redness; Itching; Slightly warm at injection site; Swollen at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 04Jun2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), Gastroesophageal Reflux Disease (GERD), arthritis, asthma and COVID-19. The patient had no any known allergies. Concomitant medications included diltiazem (CARDIZEM), metoprolol (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and meloxicam (MELOXIC), all taken for unspecified indications from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 04Jun2021 at 11:30, the patient experienced redness, itching, slightly warm and swollen at injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events redness, itching, slightly warm and swollen at injection site were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Systemic: Vomiting-Mild, Additional Details: Patient vomited approximately 5 minutes after receiving her vaccination.  She stayed in the observation area for 25 minutes longer.  She did not vomit again and felt well.
Considering to give a 2nd primary dose 7 months after first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Considering to give a 2nd primary dose 7 months after first primary dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.   Reporter did not allow further contact
Brain Fog; so dang sick / really sick for three days; This is a spontaneous report from a contactable Health Care Professional. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 from Feb2021 to an unknown date; he had had COVID in Feb 2021 prior to receiving the one dose. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient had COVID prior vaccination and post vaccination, Unknown if patient had tested with covid 19. The patient's concomitant medications were not reported. On an unspecified date of 2021 the patient experienced brain fog and so dang sick and really sick for three days. The patient reports having "Brain Fog" which he experiences at times such as in the shower. He does not experience it while walking his dog or other physical activities. He relates this to having had the vaccine and COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid on an unspecified date of Feb2021. Known allergies reported for the patient as Unknown. Treatment was given for the reported events was Unknown. The outcome of event brain fog was not recovered while outcome of event so dang sick / really sick for three days was recovered on an unspecified date.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Within 10 minutes of admin - severe headache, L eye pulling/drooping. L sided facial numbness and swelling. ER admin IV SOLUMEDROL and PEPCID with no improvement. CBC/ Chem panel WNL/ MRI brain WNL. PCP visit for eval and also had neuro consult -WNL.
slept for 4 days constantly; sore arm; body aches and pain; mild fever of 100 degrees; bad headache; milder nausea; incredibily tired; didn't feel like she was going to die from this second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, PROPRANOLOL, LEVOTHYROXINE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and MAGNESIUM for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-May-2021, the patient experienced HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea), FATIGUE (incredibily tired) and THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine).   The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   On 03-May-2021, THERAPEUTIC RESPONSE UNEXPECTED (didn't feel like she was going to die from this second vaccine) had resolved. On 06-May-2021, HYPERSOMNIA (slept for 4 days constantly), PAIN IN EXTREMITY (sore arm), PAIN (body aches and pain), PYREXIA (mild fever of 100 degrees), HEADACHE (bad headache), NAUSEA (milder nausea) and FATIGUE (incredibily tired) had resolved.       This case was linked to MOD-2021-072645 (Patient Link).
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 27-JUL-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle pain; fever; shivering; feeling weak; light-headed; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ATORVASTATIN CALCIUM (received on 1st February 2023 for High cholesterol). Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT).   On 21-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 22-SEP-2023, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), fever (Verbatim: fever), shivering (Verbatim: shivering), feelings of weakness (Verbatim: feeling weak) and light headedness (Verbatim: light-headed).  The outcome of the muscle pain, fever, shivering, feelings of weakness and light headedness were not resolved.   It was unknown if the reporter considered the muscle pain, fever, shivering, feelings of weakness and light headedness to be related to Shingrix.     It was unknown if the company considered the muscle pain, fever, shivering, feelings of weakness and light headedness to be related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 The reporter consent to follow up.