chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe reactions requiring a week in the hospital; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves Adult of unknown gender patient who experienced severe reactions requiring a week in the hospital, while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Covid-19 Vaccine for Immunisation.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date(latency: unknown) , the patient reported he/she had three flu shots  each resulting in severe reactions requiring a week in the hospital (vaccination complication) same with the covid shots. Doctor says no more ever. The patient was hospitalized for this event during 7 days. (seriousness criteria: hospitalization during 7 days).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event severe reactions requiring a week in the hospital.; Sender's Comments: Sanofi company comment dated 24-Jan-2022: This case involves Adult of unknown gender patient who experienced severe reactions requiring a week in the hospital ,while receiving vaccine Influenza vaccine.(unknown manufacture). However, patient's medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Further information regarding previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Information has been received from a nurse practitioner concerning her 13 year old white son with no known medical history or allergies who on 21-FEB-1996 was vaccinated with a dose of Varivax. The lot number was unknown but it was reported that the patient received the same lot as his female sibling (WAES # 0605USA00191). On 11-APR-2006, the patient experienced full blown breakthrough varicella with 100 lesions and a fever of 100 to 101 degrees Fahrenheit. Unspecified medical attention was sought and he was treated with acyclovir. Subsequently, the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested. The nurse also reported that her three other children had similar events after therapy with Varivax (WAES number 0605USA00089, 0605USA00191, and 0605USA00017).
Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye; can not sleep; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (High blood pressure) and Diabetes. Concomitant products included METFORMIN for an unknown indication.   In July 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 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) (seriousness criterion medically significant) and INSOMNIA (can not sleep). The patient was treated with PREDNISONE on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency and VALACICLOVIR on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) and INSOMNIA (can not sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included statins, high blood pressure medication and another diabetes oral medication. Treatment medications also included some eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime.  Patient reported that he went to the ER yesterday as he wanted to rule out a stroke. There he was diagnosed with Bell's Palsy. He reported that he could not eat, could not drink, could not smile and could not close his left eye.  Company comment: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
hives size of golf balls- swells all joints  - gives stomach issues - worst pain ever for all
On 09/22/2022 around 10:00pm I had chills that night. 09/23/2022 Extreme fatigue and lack of appetite along with lack of energy through out the whole course. 09/25/2022 cough and sore throat. 09/25/2022-09/27/2022 one episode one per day. On 09/26/2022 I was positive for COVID-19  and strap throat. 09/26/2022 the nurse prescription azithromycin 250mg 2 pills first day and 1 pill 4 more day. I took the last one today 09/30/2022. Am still recovering. I still have a lingering cough.
Red, raised, tender and hot area on right thigh where she received vaccinations 3/31/2014.  Fever for 2 days up to 102 F.  Limping some on that leg.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female who was vaccinated with an 0.5 ml dose of HPV VACCINE and QUADRACEL (batch number C54978A and expiration date 17-JUL-2020) via intramuscular route in the arm on 28-SEP-2018 instead of HPV VACCINE. Concomitant medications included MENACTRA and FLUZONE for Immunisation. Also patient received first dose of ADACEL. The patient's medical history was not reported. It was an actual medication error due to wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Dose 2 given 4/2/21.  Patient admitted to Hospital with breakthrough covid19 illness, acute respiratory failure, partial lung collapse
a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (a patient accidentally received a booster dose at a local pharmacy for his first dose of the Moderna COVID-19 Primary Series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient fainted immediately after the HPV and influenza vaccines. Patient was given juice and crackers with peanut butter and sat in the office for 20 minutes. After the patient no longer was dizzy he left the office in good condition.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (knee pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (knee pain). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-091996 (Patient Link).
Tightness in chest; This is a spontaneous report from a contactable healthcare professional (patient) received via database. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 08Mar2021 at 10:15 AM (Lot Number: EN6201) (at the age of 25 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included birth control use. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken as birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tightness in chest on 08Mar2021. The patient has not taken any treatment for the event. The patient recovered from tightness in chest on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Pt c/o swelling in her arm pit, very tender, warm to touch and swollen.  Dr. stated most likely Axillary lymphadenopathy.  Pt reports some improvement today 9/30/21. vaccine given 9/25/21.  Pt did not c/o any reaction with 1st dose Moderna.  She was instructed to be seen by PCP in the next week if reaction does not continue to improve.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On unknown dates the patients were vaccinated with doses of GARDASIL (lot #, expiration date, dose and route unspecified) that were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738, expiration date 14-AUG-2017; Lot# K026666, expiration date 22-OCT-2016 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose, frequency and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness and swelling at injection site pain through shoulder, arm, 50 mm x 50ml L deltoid.
1 day post receiving vaccine, laying down to go to sleep left leg from knee down to foot went completely numb out of nowhere.  Also experienced tongue numbness.  Treatment and tests are still ongoing, and 2 weeks later the numbers is still present.
The administering nurse tried to administer the frozen vax into the patients arm and had to pull out the needle, warmed the vax in his hand, and re-administered it. The medical technologist was not able to administer all of it since some of the vax was still frozen. On May 26, 1999, the pt experienced pain in the left shoulder. Follow-up was received from a woman from a MD's office. The pt was also concerned that the vax was reconstituted longer than 30 minutes and refrozen.
fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101 degrees Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-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 14-Mar-2021, the patient experienced PYREXIA (fever of 101 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (fever of 101 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 101 (High) 101 degrees F usual temperature is 97.6 degrees F.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.
Systemic: Extreme pain in upper right leg-Severe, Additional Details: sudden upper right leg pain came on today. Doesn't remember straining her leg. Sent to urgent care for evaluation for possible rare blood clot. Pt called and said tests came back negative for blood clot. Told to rest, elevate, and ice leg.
pt recvd vax APR93 & exp sore throat; No further details were provided;
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. 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) (Unknown) was unknown.       No concomitant medication and treatment informations were provided.
Pt developed localized cellulitis at administration area (left deltoid) of varicella and Hep-B vaccines.
side of the injection was itch; side of the injection was red; side of injection was hard; Pimples in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples in the left arm), VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O37KZOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced ACNE (Pimples in the left arm). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard). On 01-Jan-2021, ACNE (Pimples in the left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event included an unknown topical cream and ibuprofen.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child received a bivalent COVID immunization at vaccine clinic. The dose received was not correct and may not adequately protect against COVID.  No adverse effects were reported at this time.
Patient had blurry vision, excessive cold flashes, high blood pressure Patient was referred ASAP to ophthalmology and to neurologist. Patient is being treated by ophthalmologist and is pending for visit with neurologist
Severe hives, facial puffiness, itchy throat, body aches x?s 3 days.
Raised hot bump with a diameter of 5 inches.  At 7am 7/16/15 diameter was 8 inches.
Pt called in to hosp 11NOV91 stated rxn to flu shot; next day lt arm broke out w/superficial rash then next day other arm got rash; pt is taking DPH for itching; advised by MD to call if any further problems;
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 16-FEB-2018, the patient was vaccinated with the third dose of improperly stored PEDVAXHIB 1 DF, lot # N024569 with expiration date 07-FEB-2020, for prophylaxis (route of administration was not provided). It was reported that the vaccine was exposed to a temperature of 52 Fahrenheit degrees for 2 hours and 56 minutes. No adverse effects were reported. No previous temperature excursion was reported. A digital data logger was involved.
pt recv vax 12NOV96 & that same day pt exp prolonged irritability crankiness & crying for 8 to 10hr;sx slowly resolved over the next 12hr;
01/11/2006 Phone call from patient states cannot move her arm.   Monday night  right upper arm sore and had difficulty moving it.  No redness just muscle soreness.  Will see Dr. today.
Client reported to clinic on 11/1/2019 for second Hepatitis A vaccine. Screening questions were completed and client did not report any previous reactions to vaccines. Second dose of Hepatitis A given. After vaccine was administered, client reports she has had left ear hearing loss since the first dose was given on 4/12/2019 and asked if this was significant. She reported the symptoms began approximately two days following the vaccination and that she woke up with nausea, vomiting, severe vertigo and it sounded like "cotton was in her ears." She stated she may have had an upper respiratory infection around the same time but did not state she was diagnosed with anything. She reports hearing loss and tinnitus was reported to her primary doctor.
Given to soon after 1st dose on 7/22/22 - no adverse reactions  noted.  Parent notified
was not eating; nausea and vomiting; nausea and vomiting; excruciating pain on her left shoulder arm, elbow down to her hand; lump above her left elbow; 3 red spots on her left arm which now appear like bruises; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises), DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MexA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises) and ARTHRALGIA (excruciating pain on her left shoulder arm, elbow down to her hand). On an unknown date, the patient experienced DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting). The patient was treated with PARACETAMOL (TYNELOL) ongoing since an unknown date for Arthralgia, Mass, Nausea, Vomiting and Rash macular, at an unspecified dose and frequency. At the time of the report, MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises), DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting) and ARTHRALGIA (excruciating pain on her left shoulder arm, elbow down to her hand) outcome was unknown.        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.   Concomitant medications were not reported.
2 mins. after shots, skin from both knees up, around diaper area and halfway up middle of abd & back, turned a bright red/mottled color. Pt. given Benadryl 50mg/cc, given IM in (l) lateral thigh.
It was reported that a patient (2 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. No further information was provided from correspondence returned on 03/13/2001.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. Since 09-SEP-2014, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose and route were unknown). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.