chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: patient recieved both shingrix and pfizer booster in the right arm. immediately after administration, patient became unresponsive (silent, eyes still open, unresponsive to our calls), lasting for about 1 minute. Patient then requested a trash bin and proceeded to vomit. Patient's condition returned to normal and he refused our offer to call for additional medical assistance.
see attached note Both legs swollen, red and hot-entire legs Called Mom to get update on pt re: vaccine reaction. Mom states he got 2 mo shots on 8/28. Had given infant Tylenol (dye-free cherry) @ 0630 and 1100 that day. Vaccines were given between 1430-1500. Within a few hrs-thighs started swelling, red and hot to touch. Redness and swelling spread down both legs. Also noted bruising unrelated to injection sites. Went to medical center in pm. He stayed a few hrs for observation. Redness and swelling resolved on its own. No other prob. Mom continued infant Tylenol through the night. Will report to VAERS
Localized urticarial rash (4 x 4 cm) on (L) bicep w/ site of IPV injection approximately 3-4 days after vaccine. No other vaccines given (L) bicep (DTap given (R) bicep). No tx necessary.
Patient have been administered vaccine while the temperature excursion; Patient have been administered vaccine while the temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion). On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered vaccine while the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered vaccine while the temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The healthcare professional (HCP) reported an excursion about a month ago. The HCP also mentioned that the excursion duration was 7 hours instead 5min (previously stated) and the patient had been administered from these vaccines.  The vaccine was stored in refrigerator at the time of the excursion. The lot number and expiration date was reported as 046L21A and 06-Jul-2022 in source document. The maximum temperature reached was reported as 64°F. The vials were returned to the refrigerator No vaccine state change was reported. The vials were unpunctured at the time of excursions. The frequency was reported as times per.  Treatment information was not provided.
Had ?typical? reaction on the day of the vaccine then body aches the following day. On Thursday 3/18 late in the night started feeling collarbone pain on Friday 3/19  pain for increasing worse and a large lump formed.  Consulted a family meme we who is a Chiropractor and he informed me to seek medical attention because of the injection. I came to the hospital because my doctor was closed.
Large red circle just below injection site. Outside edge of circle was bright red. The site was swollen and warm to the touch. Pediatrician advised cold compress and Benadryl. Side effect continues to be there 3 days later.
January saturday 23rd woke up lt arm itched, upper arm 2x3 inches was red by muscle area, called dr. and left message. 24th morning red had expanded, called dr. again and left message. 25th area grew again 3x4 upper left arm to shoulder. Called dr. again, came in for appt. Went to Dr. it was looked at and picture taken, thought it might be cellulitis, prescribed Cephalexin 500mg. 1 3 times a day. Drew an outline on arm.1/26/21 redness expanded and growing. Has taken Cephalexin, hydrocortisone, thyroid medication, sinus migraine medicine on 1/26/21. Doesn't hurt but has hotness intermittent. Took Ibuprofen before bed on Friday evening.
With each vaccination I have received thus far (4), my whole arm turns red as a tomato, swells up and is painfully sore for approximately 1 week. The actual lump stays with me for up to 2 months.
Info has been received from a physician concerning a 37 year old female with a history of natural varicella as a child and no other medical history, allergies or medication use whose son was vaccinated on 1/26/06 with a dose of varicella virus vaccine live. When the child was vaccinated, his arm got scratched and the mother, who was 12 weeks pregnant, was exposed to the vaccine. Although the child did not break out in a rash, the mother broke out  in "herpes zoster", shingles" on 1/28/06. Unspecified medical attention was sought. No diagnostic lab tests were performed. A product quality complaint was not involved. Additional info has been requested.
This case was reported by a physician and described the occurrence of rash in a 32 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  Concurrent medication included Clonazepam.  On 03/16/2004, the patient received the first dose of Twinrix (lot HAB016; incomplete lot number).  On 05/25/2004, the patient received the second dose of Twinrix (lot HAB306B6).  This represents an interval of 10 weeks between the first and second dose of Twinrix, rather than the recommended interval of one month.  Approximately 13 days after the administration of the second dose of Twinrix, on 06/07/2004, the patient experienced a rash.  The patient was treated with diphenhydramine hydrochloride and topical caladryl.  The outcome of the rash is unknown.  The immunization series with Twinrix was discontinued.  The reporting physician considered the events to possibly be related to vaccination with Twinrix.
about nine days after injection my upper left arm started to itch and be sensitive and got progressively more red and raised
Premature contractions; Patient received first dose on 30Apr2021 and second dose received on 14May2021.; Patient received first dose on 30Apr2021 and second dose received on 14May2021.; Patient was received vaccine during pregnancy; This is a spontaneous report from a contactable nurse (patient, reported herself). This 34-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in left arm, on 14May2021 at 12:00, as a single dose for COVID-19 immunisation and also received anti-D immunoglobulin (RHOGAM, formulation; unknown) via an unspecified route of administration, in left arm on 14May2021, as a single dose for immunisation; both were received at hospital. Patient's medical history included pregnancy. Patient had no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO), minerals nos, vitamins nos (PRENATAL VITAMINS), omeprazole and diphenhydramine hydrochloride (UNISOM) within two weeks of vaccination. Patient at Gestational period was 29 weeks at the time of report. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in left arm, on 30Apr2021 at 10:45 AM, as a single dose for COVID-19 immunisation. Patient received first dose on 30Apr2021, and second dose received on 14May2021. Patient did not receive any other vaccine in four weeks of vaccine. Patient was not diagnosed with COVID-19 prior to vaccine. The patient has not been tested for COVID-19, since vaccination. Patient was received vaccine during pregnancy. On 15May2021 (2 days after receiving 2nd dose of vaccine) at 10:00 AM, patient had Premature contractions; resulted in (Doctor or other healthcare professional office/clinic visit) and treatment (Medication to stop contractions) received. Outcome of the event Premature contractions was recovering and for other events was unknown.
p/approx 2 mins pt c/o warm flush in face & tightening both jaws, sl difficult breathing; BP 120/80, pulse 68/radial/reg, strong, called 911; exp sl nausea; 911 canc @ pt's request;
Rash on upper thigh. Red and raised warm to touch.  Per chuck speed pt given 1 tsp Benedryl.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored dose of GARDASIL (lot # J006850, expiration date 31-MAR-2016; lot # K008931, expiration date 04-MAR-2017) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Systemic: Pallor-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Mild, Additional Details: moderately diaphoretic
A 39 year old male patient with a history of back pain and previous eye injury received an intramuscular left deltoid injection of DECAVAC (lot number U2332BA) on 30 October 2008. Several days post vaccination, the patient reported pain at the injection site of the left deltoid, pain in the left arm and shoulder. There was not any redness or swelling noted during the doctor's visit. The patient had positive range of motion and was able to perform his job. The patient's symptoms persisted over ten days. The patient was not recovered at the time of the report. Follow-up information was received from a health care professional on 04 December 2008. It was clarified that DECAVAC was administered to the right deltoid and that pain in the right shoulder developed two days after vaccination. It was further clarified that the pain was not in the deltoid, but rather around the socket. The patient reported that sit bothered him when he tried to throw a ball to his children. The patient had no fever or chills and no mass appreciated in the deltoid. At the time of the report, the pain had continued for six weeks. Outcome was reported to be unknown and the patient was still being evaluated. Documents held by sender. None.
I am experiencing symptoms similar to that when I had Covid in October,2020.  My head is aching, sinuses aching and ears aching. I?m extremely tired but the pain keeps me from sleeping much.
SWELLING, REDNESS, WARMTH TO THE AREA OF INJECTION AND SURROUNDING TISSUE. STARTED 12 HOURS AFTER PNEUMOVAX VACCINES. PATIENT TREATED WITH WORM COMPRESS AND MOTRIN.
"the patient currently has negative titers"; This spontaneous report was received from a physician referring to an adult male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unspecified date approximately in 1999 (reported as "twenty years ago as an infant"), the patient was vaccinated with the full series of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose, route, lot# and expiration date were not provided) for prophylaxis.         On an unspecified date in 2019 (reported as "currently"), the patient has negative titers (hepatitis B antibody negative).  At the time of the report, the outcome of the event hepatitis B antibody negative was unknown. On an unspecified date, the patient was re-vaccinated with another dose of hepatitis b vaccine (recombinant)(manufacturer unknown) because the patient's girlfriend is a carrier of the Hepatitis B virus."  The causal relationship between hepatitis B antibody negative and hepatitis b vaccine (recombinant)(manufacturer unknown) was not provided.
Pt went into acute respiratory distress after the ppsv 23 vaccine was given. Patient given EPIPEN x 2. BENADRYL 50 mg IM injection.
30 hours after administration of vaccine seen in office for screaming for 10 hours. No local reaction noted. No fever breathing difficulty noted.
Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
temperature excursion for vaccines that were administered to patient after excursion occurred; This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number lot number S038698; expiration date 01-DEC-2021, as prophylaxis.    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of -10.2 degree Celsius (°C) for a period of 1 hour and 53 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2008USA014869: US-009507513-2008USA014803:AE Case # 01697191
My daughter tipped backwards from a standing position, with a straight body, striking her head on the floor. She stands well and has never fallen this way before. She fell in a similar way from a sitting position, with a stiff body and legs up in the air, when she had her first flu shot a month ago.
Bruising at the injection site.  Big red circle appeared on day 7 accompanied with itching at the injection site.  Symptoms have continued for 2 days.
The pt experienced a 33 x 33 mm induration, redness, swelling, warmth and painful to touch at anterior lateral aspect of left thigh. About 6 mm blisters on induration. One centrally located appearing to be the injection site. Follow up states the area appears less red today.
Nausea; Loose stools; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 16Mar2021 09:15AM at the age of 65-years-old at 2nd dose single dose for COVID-19 immunization. Medical history included fractures at wrist from 23Jan2021, and hematuria/nephrolith from 01Jan2021 and ongoing. The historic vaccine was bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, lot/batch number unknown) intramuscularly in left deltoid on 23Feb2021 03:15 PM at the age of 65-years-old at 1st dose single dose for COVID-19 immunization and experienced sore arm, queasiness in stomach 18 hours later, and loose stool. Concomitant medications were none. The patient did not take any relevant test. Prior vaccinations within 4 weeks were reported as none. The patient experienced nausea on 17Mar2021 15:00, and loose stools on 17Mar2021. The Seriousness criteria was reported as not serious. No treatment received. The outcome of events was recovered.   Information on the Lot/Batch number has been requested.
due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022; patient received 0.25 dose and not a full second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022), ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022) and ACCIDENTAL UNDERDOSE (patient received 0.25 dose and not a full second dose).    No concomitant medication information was reported. No treatment medication information was reported.  The first primary dose was given on 28Oc2021, upon reviewing the states data base, the patient received 0.25 dose and not a full second dose. HCP contacted the administering pharmacy and was told that due to interval between 1st and 2nd primary doses, they administered 0.25 Moderna monovalent booster on 20May2022 instead of 2nd primary dose. HCP was seeking guidance as what she was told did not seem correct.
PARESTECIA BOTH ARM AND FEET. SOB,DIZZINES AND CHEST PAIN. LABIAL CYANOSIS.
Severe pain radiating from neck on side of injection, down into arm and to hand.; Blood pressure elevated; Movement of hand or arm causessevere pain; Nausea; Dizziness; minor visible swelling; Redness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome, minor non-rheumatoid arthritis. The patient previously received acetylsalicylic acid (ASPIRIN), on an unspecified date for an unknown indication and experienced drug allergy (also reported as Aspirin family allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), paracetamol (TYLENOL) and zolpidem tartrate (AMBIEN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 20:00, the patient experienced severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure is elevated. Any movement of hand or arm causes severe pain, nausea, and dizziness due to pain. Some minor visible swelling and redness at injection site. No fever, some general body aches and on same day, the patient underwent test for blood pressure and the result was elevated. The events did not result in doctor or other healthcare professional office/clinic, 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 severe pain radiating from neck on side of injection, down into arm and to hand, blood pressure elevated, movement of hand or arm causes severe pain, nausea, dizziness, minor visible swelling, redness at injection site and general body aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Started on Aug. 11 at 3:00a.m.  Woke up with plugged up head and terrible headache.  Took a home Covid test and tested positive for Covid.  Called pulmonologist  that morning and he wanted me on Paxlovid. I called my doctor and she called in a prescription for Paxlovid.  Started it on the 12th of August.   I did a home rest every other day and they were positive until Aug. 16 when it was negative. I tested negative every other day for 8 days.  My symptoms were an extremely congested head and a headache. I also had chills but no fever. Sore muscles and joints and a sore throat. I never did get a cough. Was able to work in yard and do the usual things I have to do. Rested as much as possible.