chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little bit of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (The patient is usually allergic to everything).   On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced FATIGUE (A little bit of fatigue). At the time of the report, FATIGUE (A little bit of fatigue) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-406503 (Patient Link).   Reporter did not allow further contact
I had swelling and pain right arm after injection 5/4 about 17 minutes after Injection. I took 1000 mg of Tylenol for the pain On 5/4/21 On 5/5 I had a rash appear on right arm around 11:50am to 12:00pm  took Benadryl for reaction. Arm was burning and red during reaction on the right side  .
Severe weight gain despite no known cause, inflammation with pain in all joints, thyroid enlargement, changes in TSH despite no symptoms in months prior - Hashimotos was controlled
Dose number=3; Ribs hurt after getting booster shot and describe it getting hit by a car feels like; Upper back hurts too; Whenever as little as breathe ribs hurt; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 19 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number=3"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "recovering", described as "Ribs hurt after getting booster shot and describe it getting hit by a car feels like"; BACK PAIN (non-serious), outcome "recovering", described as "Upper back hurts too"; PAINFUL RESPIRATION (non-serious), outcome "recovering", described as "Whenever as little as breathe ribs hurt". Therapeutic measures were not taken as a result of musculoskeletal chest pain, back pain and painful respiration.  Additional Information: The events happened the day after getting the booster. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. On 13-AUG-2014, the patient was vaccinated with ROTATEQ lot number given as J002975, expiry: 02-AUG-2014, oral, dose unknown. It was reported that the nurse inadvertently administered an expired ROTATEQ on 13-AUG-2014. The date of expiry of the vaccine administered was reported as 02-AUG-2014. No adverse events were reported. Lot number J002975 is an invalid lot number for ROTATEQ. Additional information has been requested.
Fever between of 99 degrees starting 10hrs after vaccination, peaking at 102.1 degrees 16hrs after vaccination, then down to intermittent low fever of 99-100 until 36hrs after vaccination.  Accompanied by chills and exhaustion.  No symptoms after 48hrs.
High blood pressure; Feeling cold; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 20th May 2019, less than a day after receiving Shingrix, the patient experienced feeling cold. On 21st May 2019, the patient experienced blood pressure high. On 21st May 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the feeling cold and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of the Shingrix vaccine and she felt cold, but now she was fine. Till the date of reporting, the patients blood pressure had been high and it was180/78 mmHg. The reporter did not consented to follow up. No further details were provided
Severe pain on skin; Severe pain at joints; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine 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: EN6207) via an unspecified route of administration in the right arm on 02Apr2021 at 10:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 01:00, the patient experienced severe pain on skin and at joints. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events severe pain on skin and at joints were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
I have hives and rash on my body. I saw my dermatologist three times already -Have been give three kinds of creams for it and steroid shot but nothing has worked. It's all over my body but not on my face. It is itchy. I am getting bruising from the scratching - red spots and bruised on my thighs and pink patches all over.  I have had two charlie horses recently. I have had them before but it's been awhile.
he had a stroke; her husband can't drive; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not reported, expiration date: not reported, NDC number: not reported) via an unspecified route of administration on 02Sep2021 as Dose 1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received their second dose was unspecified. on an unspecified date,  patient experienced he had a stroke and her husband can't drive. The outcome of all the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a consumer, via company representative, referring to an unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The consumer reported that her husband (unspecified physician) mentioned that unspecified vaccines that may have been improperly stored on unspecified dates and may have been administered to unspecified patients on unspecified dates. No adverse effects were reported. Additional information is not expected, due to lack of contact details. The case was created as duplicate of case1608USA005743 that was mistakenly deleted from our database. Therefore, case # 1608USA005743 is being deleted from our flies and all the case information was consolidated in case 1610USA004920.
Face became red and flushed; Face became red and flushed; Bad taste in my mouth; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 05Mar2021 10:00 (Lot number was not reported) (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. Medical history included chronic atrial fibrillation, diabetes, contrast media allergy (CT scan dye) and penicillin allergy. Concomitant medications received within two weeks of vaccination included nuclear stress test medicine taken a day before vaccination. No other vaccine was received within four weeks of vaccination. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. On 05Mar2021 10:00, immediately after vaccine injection the patient had a bad taste in her mouth, this lasted for about 4 hours. On 05Mar2021 11:30, about 1 and 1/2 hours later after vaccine injection, her face became red and flushed, lasting about 4 hours. Later that evening she had diarrhea. The patient did not receive treatment for the events. The outcome of events dysgeusia was recovered on 05Mar2021 14:00; outcome of red face and flushed face was recovered on 05Mar2021 15:30; outcome of diarrhea was recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
COVID Breakthrough Case  Pfizer Dose 1 2/18/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6208) Moderna Dose 3 12/8/21 (018F21A) COVID Positive 12/15/21  12/15/21: This is a patient who presented to clinic today with complaints of wheezing and increasing shortness of breath, fatigue and body aches, rapid test in the clinic for COVID-19 positive, patient has significant comorbidities including COPD, coronary artery disease, heart failure with reduced ejection fraction, atrial fibrillation and hypertension.  Oxygen saturation in the low 90s in the clinic, considering patient's comorbidities I elected to admit him to the hospital for IV steroids, remdesivir and close monitoring, patient is fully vaccinated for COVID-19  12/17/21: This is a patient who presented to clinic today with complaints of wheezing and increasing shortness of breath, fatigue and body aches, rapid test in the clinic for COVID-19 positive, patient has significant comorbidities including COPD, coronary artery disease, heart failure with reduced ejection fraction, atrial fibrillation and hypertension.  Oxygen saturation in the low 90s in the clinic, considering patient's comorbidities I elected to admit him to the hospital for IV steroids, remdesivir and close monitoring, patient is fully vaccinated for COVID-19   Hospital progress:  Patient has responded well to IV steroids, remdesivir, albuterol, he is maintaining normal oxygen saturation on room air and is able to move about the room without any significant respiratory distress, he is eager to return home
Rash on face and trunk, temp 99.4 TA. Local reaction (R) leg 2 x 3 cm.
Patient presented to the pharmacy with an injection site that was hot to the touch, red/swollen, and the injection looked to be administered not in the deltoid-injection site was much lower in the bicep area.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 49-year-old female patient who received TWINRIX (batch number 53AT5, expiry date 28th November 2020) for prophylaxis. On 28th November 2018, the patient received TWINRIX (intramuscular). On 30th November 2018, 2 days after receiving TWINRIX, the patient experienced injection site swelling and injection site itching. On an unknown date, the outcome of the injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site swelling and injection site itching to be related to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on the right deltoid. On the day of reporting, the patient experienced swelling and itching at injection site. The reporting nurse was GlaxoSmithKline employee within health clinic.
Patient received an expired vaccine which got expired on 29-Apr-2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine which got expired on 29-Apr-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. It was patient's 2nd dose. The patient was fine, has not reported any side effects. The date in which the vial was initially stored in the refrigerator was reported as it came directly from freezer on 02-May-2022. The vial did not undergo any temperature excursions. No treatment medications were provided by reporter.
I received the vaccination at 9:45 am 5/6.  At approximately 4 pm, I started getting chills, aches, and a headache.  However, around 6 pm my hands started shaking violently.  When I tried to pick up a Tylenol out of my son's palm, I couldn't.  My hand was violently shaking 3-5 inches either way.  I fell asleep shortly thereafter, and when I awoke several hours later, the shaking had stopped and I just had "normal" chills.  Through the night, I had nausea and dry heaves.   24 hours after the vaccine  most side effects have subsided.  However,  I am concerned that it affected my nervous system  as I still have intermittent  pain on the back of my right hand.
Covid 19 pneumonia.  The patient initially required ICU admission and iv pressors and high flow oxygen.  The patient was later downgraded from the ICU and transferred to another unit.  The patient was recommended to transition to SNF for further rehab.  The patient completed his remdesivir and would continue decadron for a total of 10 days.
Patient reports having some nose bleeding throughout the day of vaccination after receiving vaccine and a more serious nose bleed at 2am 5-18 (day after vaccination) that required 10 minutes of pressure. Patient is on Xarelto, spoke to PCP Dr. office and MD recommended holding Xarelto the day of 2nd dose if patient wanted to receive. Patient electing to not receive second dose per patient's discretion/ decision making after speaking with his family.
STOOLS HARD/FIRM; DIARRHEA; This spontaneous report received from a patient via other manufacturer concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included polycarbophil calcium (Fibercon) for an unknown indication.  On an unspecified date, the patient experienced stools hard/firm and diarrhea (Dose number in series 1). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported and expiry: unknown) dose, frequency, and therapy date were not reported for moderate to severe ulcerative colitis.  The patient additionally received two doses of Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, intramuscular, batch number was not reported and expiry: unknown) dose was not reported (1 in 1 once), administered on an unspecified dates for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of Moderna covid-19 vaccine (Dose number in series 2). The patient received two booster doses of Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin, intramuscular, batch number was not reported and expiry: unknown) dose was not reported (1 in 1 once), administered on an unspecified dates for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of Pfizer biontech covid-19 vaccine (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from diarrhea, and the outcome of stools hard/firm was not reported. This report was non-serious.
Starting at 11pm only 6 hours after shot I began flu like symptoms. From 1am to 2am I had uncontrollable body shivers and pounding headache worst I?ve ever experienced . Had to take hot shower for 40 minutes to regulate body temp and stop shivers. Pulse had been at 114 from 1am- 4am (normally around 85). Took ibprofen for headache.. 20 hours after shot had 104.4 fever and 112 pulse - extreme headache persisting now for 30 hours - high  fever coming and going - taking Tylenol and Ibprofen? headache will not go away. Feeling flu like still 30 hours after shot.  Pulse is fluctuating between 85 and 115 depending on sleep/rest/medication. This is the worst illness I?ve ever encountered. Headache is unbearable.
No adverse effects were reported; A HCP reported an AE where a dose of improperly stored ROTATEQ was administered on 22 Jun 2022. The caller provided the patient's initials, but not their full name. No adverse effects were reported. No additional information was provided at the time; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-JUN-2022, the patient was vaccinated with improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (PROQUAD) as prophylaxis (lot number: 1837116, which was determined to be valid, with an expiration date on 24-MAR-2023) (strength, dose, route and anatomical location of administration were not provided) (product storage error). Administered dose underwent a temperature excursion of above 47 degrees Fahrenheit (F) (48.7 degrees Fahrenheit) for 11 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2207USA004409:
immunocompromised.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (her mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date at UNKNOWN SINGLE DOSE and then at unknown date via an unspecified route of administration at UNKNOWN SINGLE DOSE both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient received both doses of the Pfizer Covid vaccine and she did not have any antibodies. She stated that her mother was immunocompromised. The laboratory data included SARS-COV-2 Antibody test negative on an unknown date.  Outcome of the event was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via an other manufacturer and described the occurrence of difficulty breathing in a 67-year-old female subject who was vaccinated with Influenza vaccine, (manufacturer unspecified). Co-suspect medication included Fentanyl patch. On 5 November 2009, the subject received unspecified dose of Influenza vaccine (unknown) and also started Fentanyl at 25 mcg every three days. On 5 November 2009, less than one day after vaccination with Influenza vaccine and starting Fentanyl, the subject experienced difficulty breathing, nausea, weakness and sweating. The report stated the subject experienced difficulty breathing, nausea, weakness and sweating on 05 November 2009, the same day she started Fentanyl. The events resolved after approximately 24 hours; the subject stated she "is just fine now". Therapy with Fentanyl patch continued. On an unspecified date in November, the difficulty breathing, nausea, weakness and sweating were resolved.
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided.  No Treatment medications was provided.
Booster:    fever (101), chills, skin sensitivity, body aches, headache, muscle pain, injection site [swelling - hot- raised lump - severe pain], nausea