chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Muscle pain; Chills; This is a spontaneous report from a contactable consumer (healthcare medical assistant) reporting for herself.  This 39 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730, expiry date 03Jan2021) on 21Dec2020, at single dose, for COVID-19 immunization. Medical history included thyroid (no other information reported). The patient was exposing herself to patients with COVID, she worked in a health care. Concomitant medication included an unspecified thyroid medication. The patient experienced headache, muscle pain and chills on an unspecified date in Dec2020. The reporter asked if she could take like paracetamol (TYLENOL). Events outcome was unknown.
Painful Intertrigo on waist and lower abdomen/ intertrigo rash; Painful herpes outbreak all over mylower left arm and lower back; immune system was compromised; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 08Apr2021 at 11:00 (at the age of 68-year-old) at single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included herpes infection in 1975, bad back issues, high cholesterol, adhesive tape allergy. Concomitant medications included unspecified vitamins and eye drops. The patient previously took cefalexin (KEFLEX) on an unknown date and experienced constipation. The patient previously  received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 18Mar2021 at 10:30 (at the age of 68-year-old) as single dose for COVID-19 immunization; no issues after first injection. Prior to the vaccination, the patient was not 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 09Apr2021 at 20:30 (also reported as between 29-30 hours after her second shot), patient experienced very painful intertrigo on waist and lower abdomen (which she have never had) and had a painful herpes outbreak all over lower left arm and lower back. These happened at the same time. She has not had a herpes outbreak in over 30 years. She had no issues after her 1st injection and she have not heard of this occurrence happening as a side effect, but she cannot overlook the timing that both of these concurrent skin rashes happened within 28-30 hours of 2nd Pfizer shot. She went to her PCP and it was confirmed that she had a herpes outbreak and an intertrigo rash and that it's possible that her immune system was compromised somehow that caused this to occur. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of these events which included treatment with valacyclovir and ketoconazole cream. The clinical outcome of the events (very painful intertrigo on waist and lower abdomen (which she have never had)/ intertrigo rash, and had a painful herpes outbreak all over lower left arm and lower back, immune system was compromised) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presents ~ 2 weeks after primary smallpox vaccination c/o "spot" on L UE. PE demonstrates 4x3 mm pustule on L UE, ~ 5 cm proximal to primary inoculation site. Pustule is oblong in shape and comprises two well-defined confluent areas of purulent "pointing" w/o drainage or discharge. Lesion is well circumscribed w/ ~ 0.5 mm erythematous base/border surrounding central pustule. No local heat/tenderness/drainage. Diagnosis: probable secondary inoculation. Treatment: as directed for primary inoculation site.
6th cranes nerve palsy; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in upper arm on 24Mar2021 03:45 as single dose for covid-19 immunisation. Medical history included high blood pressure and cardiomegalia. Known allergies was none. None other medications in two weeks. No other vaccine in four weeks. Patient experienced 6th cranes nerve palsy. Unable to look laterally with the right eye two days following vaccine administration on 25Mar2021. Double vision on the day immediately following the covid 19 vaccine on 25Mar2021. CT scan and blood work are normal ruling out possible stroke or brain tumors. AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No Covid prior vaccination. No Covid tested post vaccination. Treatment were taken as a result of 6th cranes nerve palsy and double vision including steroid (prednisone). The event outcome for event was not recovered.  Information about lot and batch number was requested.
my child is currently 21weeks but because of the pandemic was not abpe to get Rotarix vaccine it safe to have only one dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 5-month-old female patient who received Rota (Rotarix) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient because of the pandemic was not able to get Rotarix vaccine is it safe to have only one dose and are there any risks. The reporter asked is it not recommended to get only one dose.
Information regarding PREVNAR 13 was received from a physician regarding a 3-year-old male patient (reporter's grandson) who experienced "cried for two hours" after vaccination. The patient received a dose on an unknown date in 2010. The patient experienced "cried for two hours" after vaccination in 2010. Outcome was resolved. No additional information was available at the time of this report.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: I gave the COVID vaccine to pt in her left arm.  Within 10 minutes, her mom asked me to come back there.  I came and her daughter was very sweaty and feeling very dizzy. I asked one of the techs to grab her some apple juice and an ice pack. I had one of my techs call 911.  As I said that, the daughter's mom  started to pass out on me but I caught her.  She passed out for less than a minute and then she was feeling better.  I put ice packs on mom too. Paramedics took over
Patient received expired vaccine as it was marked for a frozen expiration date rather than a refrigerator storage
Patient noticed redness/swelling at and around injection site the morning of 6-1-16. As of 6-2-16 the area has spread to roughly 7 inches surrounding injection site. Patient reports itching but no pain. The area was swollen as well.
Delayed onset of menustration in next cycle after second shot (+10 days); first time in adulthood that menstruation  has been late more than 24 hours
L08.9 Local infection of the skin and sq tissue  TX cephalexin 500mg TID (15 Qty)
The evening after the shot I had a headache and what I thought was a fever. I laid in bed and had the chills. I had an uneasy feeling and was worried about it. I had severe vomiting and diarrhea. My stomach kept rolling for several hours. Once my stomach started hurting it just exploded I had the worse gas in me. I couldn't belch or anything. I almost went to the doctor but I didn't because it was a vaccine. I thought it would take some time to get over. I have to get all my wood ready for winter and now when I go to do something I get out of breath easily but now I also fall asleep during the day when I sleep at night. I had a sharp pain up my left elbow down to the wrist as well. I was hoping I wasn't having another heart attack. It has been going on for a while now. If I prop my arm on the rest of a chair, after a while it starts. I got pain in my knee as well and I haven't fallen or anything like that.
Caller boyfriend received the vaccine and then had some dental work done.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "Caller boyfriend received the vaccine and then had some dental work done".  Additional Information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller boyfriend received the vaccine and then had some dental work done. She was wondering what her boyfriend could take for his pain since they were told by the vaccination site that he couldnt take Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling arm; Redness and swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and swelling arm) and VACCINATION SITE SWELLING (Redness and swelling arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided.
throbbing pain in the arm; heavy and sleepy arm; pain at the injection site similar to the pain experienced two or three days after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose). At the time of the report, PAIN IN EXTREMITY (throbbing pain in the arm), LIMB DISCOMFORT (heavy and sleepy arm) and VACCINATION SITE PAIN (pain at the injection site similar to the pain experienced two or three days after receiving the second dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Shingrix - the 2 doses only 1 month apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix - the 2 doses only 1 month apart).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was a Pharmacist Clinical Service Manager. The reporter inquired that if the vaccine was viable with the 1-month interval or if they need to re-vaccinate. The reporter had a pharmacist administer Shingrix, the 2 doses only 1 month apart; the reporter know in the package insert it stated this could be done if they were immunosuppressed or would be immunosuppressed and need a shorter period of time, however this was just a standard non-immunocompromised patient, so the reporter just wanted to ensure this was ok and the patient was protected. Just a normal patient and was given 1 month apart. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
October 27, 2010 severe back pain behind left shoulder blade. Excruciating pain in back for 3 days. October 30, 2010 experienced numbness in right leg, then spread to torso, left leg, 2 right fingers. Patient gait ataxia, leg parethesias, pain, some urinary symptoms shortly after receiving the flu vaccine. He was treated with a couple of courses of steroids. He was suspected to have parainfectious myelitis. His symptoms are improving.
Information has been received from a nurse referring to a patient of unknown age and gender. On 02-JUN-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed Chronic Urticaria approximately 8-11 days after the booster shot. Allergist had recommended taking Zyrtec for 2 months (starting Dec 6th). As of 2/4/2022, I am still symptomatic for chronic urticaria.
fatigue for 5 days; The initial case was missing the following minimum criteria: of an adverse event. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0142; Expiration Date: Mar2021) via an unspecified route of administration, administered in arm left on 27Jan2021 15:45 (at the age of 66-year-old) at dose 1, single for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing sinus disorder. Concomitant medication simvastatin via an unspecified route of administration from an unspecified date (Lot Number: 866082) and ongoing, at 20 mg, daily (For Example, 20 Mg Once a Day, 10 Mg Twice a Day), Date Started (Or Best estimated Period): 7 years ago for cholesterol; cetirizine hydrochloride (ZIRTEK), via an unspecified route of administration from an unspecified date (Lot Number: 843130) and ongoing, at 10 mg, daily (For Example,20 Mg Once a Day,10 Mg Twice a Day) Date Started (Or Best estimated Period): 2 years ago for sinus. On an unspecified date in 2021 the patient experienced fatigue for 5 days. Patient did not visited to emergency room. Reporter just had her 1st dose today. Reporter is asking if it is okay to take her everyday medication like Simvastatin and Zirtek. Outcome of the event was reported as resolved on an unspecified date in 2021.   Information about Lot/Batch has been requested.  Follow-up (24Feb2021): This is a follow-up spontaneous report received from a contactable Consumer. This 66-year-old female consumer (patient) reported in response to non-HCP letter sent that included the following: Patient date of birth, age and age at vaccination 66-year, relevant Medical History cholesterol, sinus added. bnt162b2 details and concomitant medication details added. Event changed to fatigue for 5 days and clinical information was updated.   No follow-up attempts are possible. No further information is expected.
A few hours after vaccination, patient developed fevers up to 101.5 and seizure episodes.  Parent described as irregular eye movements and foaming at the mouth.  One episode on same day of vaccinations and one approximately 24 hours after vaccinations.  Child was evaluated at the emergency department and then admitted to the hospital.  Work up done (below) and determined there was no other cause to her seizure like movements except perhaps vaccination reaction as all other tests were negative.  Since discharge from hospital, parents have observed patient to continue to have intermittent tongue thrust like movements or lip smacking episodes.  Fever resolved prior to hospital discharge.
Muscle aches; Tired; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and tired was not reported. This report was non-serious.
had inmmediate tachycardia; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (had immediate tachycardia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included Synthroid  for Hashimoto's tiroiditis, estradiol  for hormone replacement therapy and Lunesta  for sleep for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced TACHYCARDIA (had inmmediate tachycardia). On 22-Feb-2021, TACHYCARDIA (had inmmediate tachycardia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
almost exactly 48 hours after second vaccination, I developed a rash all over my chest, stomach and back.
Patient given Pneumovax approximately 2:46 pm on Monday 5/19/08. By evening patient stated her Rt arm began getting sore and swollen. Came to clinic with c/o pain 2-3 on scale of 1-10. Rt arm swollen hot to touch and slight red. Patient seen by physician and given ice packs to apply to arm.
Approximately 3 hours after injection patient developed a large hard bump at injection site and whole upper left arm was painful, pain in injected arm lasted about 3 days.  Day after injection patient noticed having an upset stomach which lasted 2 days.  Also day after injection patient notice increase fatigue, to the point of not being able to be out of bed for more than 3-4 hrs all day.  This increased fatigue lasted for 5 days post injection.  Day 5 after injection patient noticed swollen lymph nodes  near collar bone and in underarm on the left side, same side as injection.  These swollen lymph nodes are still present and painful today which is 8 days past receiving vaccination.
This spontaneous case reported by a consumer, describes the occurrence of allergy to vaccine (allergic) and fatigue (just a little tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A) for COVID-19 immunization. No medical history reported. On Jan 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 18, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 21, 2021, patient experienced allergy to vaccine (allergic) and fatigue (just a little tired). On Jan 22, 2021, allergy to vaccine (allergic) and fatigue (just a little tired) resolved. mRNA-1273 (Moderna COVID-19 vaccine), unknown, and mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: dosing remained unchanged. No concomitant medication or treatment information provided. This case linked to MOD-2021-233289 (patient link).
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989: