chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fast heart rate; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing fast heart rate and dizziness after received bnt162b2 on unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable physician. A 69-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced allergy to pneumococcal 13-val conj vaccine, urticaria and itching. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Tested Positive for Covid on June 13.  Sympoms were like sinus, head pressure, stuffy nose, Cough with clear phlegm.  No fever.
left foot swelled up, turned red and was painful, especially at achilles tendon; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 05May2021 at 13:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included tamsulosin hydrochloride (MANUFACTURER UNKNOWN) and multivitamin; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 13:00, about 24 hours after vaccination, the patient's left foot swelled up, turned red and it was painful, especially at achilles tendon. The patient could not walk with it for a few days. The swelling subsided but after 3 weeks it was still slightly swollen and red. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event achilles tendinitis and included treatment with over-the-counter advil, 18 pills over 3 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event achilles tendinitis was recovered with sequelae on  an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Pt had fever day after shot on right leg. Pt has site swelling, redness, and pain.
ER Report states:  Left upper extremity is difusely reddened, starting around glenohumeral area extending towards elbow.  Covers area of superior & lower immunization site.  Emergency doctor treated Pt. with antibiotics for cellulitis.
pt recvd vax; devel elev t of 102; dizziness, n, ha, myalgia coincident w/ recving a TYP vax;
They gave a patient the Moderna booster after the 30-day Use by Date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
5 minutes following vaccine administration, patient began "feeling funny" she walked to the waiting room where she sat down and "the room got blurry and then my hearing went out". Patient was unresponsive x 5-10 seconds. She was breathing during this episode. When she woke, she was diaphoretic and pale. We moved her to an exam room and laid her down. After 15 minutes, we attemped to sit her up, where she became pale and diaphoretic again. We then laid her down and attempted to get her up two more times where the same episode occurred again. We kept her in the clinic for 1 1/2 hours for observation and eventually wheeled her to the car. Mom was instructed to keep observing her and bring her to the ER if necessary. Mom reports today she is still a little shaky, but she is doing okay.
Immediately after she exp fatigue and pain in left shoulder. Then when she woke up full body, heart palpitations and tightness in throat causing her having trouble breathing. Her Epipen shot to relieve her pain and she followed up at the hospital. The symptoms that are lingering which happened after 1st Dose sensation of throat(uncomfortable for her to swallow) and fatigue.
poss arthus reaction; pain inj site, raised red area 5 1/2 x 4 1/2;  tx Pred & DPH; chills, t102 several days p/inj
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 24-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000862: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
After flu shot - nausea, vomiting, headaches, reaction at the site, fever, body aches. At night leg cramps - has had charley horses in past and this was worse. Fatigue since then, wheezing, tingling in feet went on for 6 weeks. Balance seemed off. Felt weak. Seems like lost strength.
Mild swelling of left deltoid area. No fever. No erythema. Tenderness. Symptoms started 24 hours after vaccine administration.
Patient reported having fever, redness, soreness at and around the injection site. Recommend tylenol for the fever and ice pack to the site to help with the redness and swelling. 2 days later pt still had fever and also decided to take benadryl with Tylenol.
MDM:  Apparent large localized reaction to moderna vaccine for Covid infection 8 days ago.  In review of the literature this has been reported elsewhere.  No evidence of cellulitis and no systemic symptoms.  At this time would have her treat this locally with some hydrocortisone and ice packing.  It is advised that she does receive her second dose as scheduled.  No evidence of anaphylaxis.
Day after vaccine 01/08 I had the normal side effects of arm soreness, some swelling, headache, body ache and fatigue. This was gone by 01/09.  On 01/14 I developed a headache and low grade temp and a scratchy throat. The morning of 01/15 I noticed the injection site was swollen with some redness, warm to the touch, feels like a hard ball, arm is hurting a little and there's off an on itching.
Red arm; 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 ERYTHEMA (Red arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red arm). At the time of the report, ERYTHEMA (Red arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.
Loss of appetite; dizziness; extreme tiredness; extreme body aches; fever; pain in both arms; chills; swelling on the left side of the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion.), administration date: 06May2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left , Vaccine Administration Time: 03:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.  The following information was reported: DECREASED APPETITE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "Loss of appetite"; DIZZINESS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "dizziness"; FATIGUE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme tiredness"; PAIN (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme body aches"; PYREXIA (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "pain in both arms"; CHILLS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "chills"; SWELLING FACE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "swelling on the left side of the face". Therapeutic measures were not taken as a result of decreased appetite, dizziness, fatigue, pain, pyrexia, pain in extremity, chills, swelling face.  Additional information: Dose 3 administration time was 05:30 PM. No other vaccine were received in four weeks and no other medications received in two weeks. No known allergies. It was unknown If covid prior vaccination or not and if tested for covid post vaccination or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two episodes of uncharacteristic nose bleeds; Two episodes of uncharacteristic nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not receive any other medication within two weeks of vaccination. The patient did not have a history of allergies to any food products or medications or others. Prior to the 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 four weeks prior to the vaccination. On 03Apr2021 at 21:00 and on 04Apr2021, the patient experienced two episodes of uncharacteristic nose bleeds. The patient did not receive any treatment for the event. The clinical outcome of the event two episodes of uncharacteristic nose bleeds was unknown at the time of this report.    No follow-up attempts are needed. No further information is expected
Fever; Arm Pain; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm Pain), CHILLS (Chills) and MYALGIA (Body Aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Arm Pain), CHILLS (Chills) and MYALGIA (Body Aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 14-Mar-2021, PYREXIA (Fever), VACCINATION SITE PAIN (Arm Pain), CHILLS (Chills) and MYALGIA (Body Aches) had resolved.            No relevant concomitant medications were reported.
On August 5th, my husband was sent to the ER after having no previous health concerns. After many days of various testing, my husband was diagnosed with liver failure. They stated he had cchirosis and would need a transplant. After many doctor visits and return hospital visits, he was placed on blood thinners and a year later given a stent. He is still on the transplant this. They sited no known reason for this rare condition besides blood clots. I am a medical professional, his care giver, wife, and possible liver donor. He is extremely fit, does not drink (much prior to this) and he is a professional swimmer. For all these things to go wrong with no reason was extremely confusing for physicians and us.  We decided to report an adverse event after a year of discussing if the vaccine could cause this. For his symptoms to come on so quickly after his second vaccine with no prior health history was baffling. We have been to hospitals all over in hope to find a solution. They recently performed a TIPS procedure but are keeping him on the transplant list for now.
1st day (2/6):  headache, sore and swollen arm, fatigue. Took exederin migraine 2nd day (2/7): headache, fatigue, all over body ache, joint pain, minor swelling in arm, sore arm, minor nausea. Took aleve, 3times throughout the day, hot bath to ease pain.  3rd day (2/8): minor headache, still a little joint pain in shoulders, arm pain, swelling is gone. Have taken 1 aleve so far this morning.
Post vax, the pt started having fever. Mom used Tylenol and fever decreased. Also, he had a lacy looking rash on his trunk, feet, legs,arms, and some on face. On 6/16, he had a fever of 104 and was taken to ER. He was dx with an ear infection and started on Amoxicillin. On 6/17 and 6/18, fever and rash continued and child cried almost all the time; did not eat or sleep well.
had a reaction to Pnaumovax/ AE realized after the call.; This spontaneous report was received from a consumer via other company and refers to an 88-year-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2019, reported as about 2 years ago, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. Also on an unknown date in 2019, the patient experienced unspecified reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and want to know if the PFIZER BIONTECH COVID-19 vaccine has any active or inactive ingredients that are present in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of this reaction was not reported.  The reporter did not provide a causal assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and adverse event.
No additional AE reported.; accidently administered VARIVAX intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 24-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W012166, expiration date: 12-APR-2024 for prophylaxis (dose and strength was not provided) administered intramuscularly instead of instead of subcutaneously (incorrect route of product administration). No additional adverse event was reported (no adverse event).
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 5:00 PM, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was provided by the reporter.  the patient did not taking any other medications/products within 2 weeks of starting COVID-19 treatment and the patient  previously receive a COVID-19 Vaccine.  Patient experienced Covid symptoms again 6 days after ending paxlovid treatment, and are still ongoing.   Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. No details on the previous 2 doses were provided. As reported, the patient had COVID symptoms 6 days after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. No details on the previous 2 doses were provided. As reported, the patient had COVID symptoms 6 days after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
About 2 weeks after the 2nd shot my l experienced paralysis in my left hand for several minutes. This occurred over a weekend and since the incident only lasted a few minutes I did not seek medical attention. On July 6, 2021 I experienced the smell of meat as a rancid smell and have to date been unable to eat meat, and the list of foods that become intolerable continues to grow including chocolate, peanut butter, onions, fried foods, coffee, crackers, chips of all kinds, cereal and corn. I also began to have a marked decline in near vision during this time. On about February 11, 2021 I experienced, for the first time ever having a moment of not knowing where I was while driving a familiar route. Since then I have had several episodes of cognitive impairment where I have struggled, sometimes for hours, to remember a simple word in conversation. Lately I have noticed a remarkable decline in memory, to the point that I am unable to recall a single detail of a trip I went on with my family the week of December 26, 2021. I cannot recall one detail of the hotel, restaurants, or any activities during that trip.
Administered the wrong brand of COVID vaccine. Dose #1 was Moderna on February 4, 2021. Dose #2 was Pfizer on March 5, 2021.  Client denied any adverse symptoms. No signs or symptoms of distress noted.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 54-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Comirnaty), at the age of 54, in left arm, on Aug 22, 2021, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medication(s) included sertraline, start date: Aug 22, 2021; and rosuvastatin. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient had pruritus (patient started itching), urticaria/hives and pain, all onset Aug 28, 2021, at 06:00, with outcome of not recovered. The events were evaluated at a physician office visit and emergency room visit. No therapeutic measures taken as a result of pruritus, urticaria and pain. Additional information: No other vaccine in four weeks. Other medications in two weeks: sertraline, rosuvastatin, Adverse event: Patient started itching and got hives. Nothing even touched this itching and pain she had. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No COVID-19 detected prior to vaccination. COVID-19 tested post vaccination. No known allergies. Other medical history: none. Follow-up attempts completed. No further information expected.