chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 9:12 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.40 for dose administered on 02-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27,29,32,33,35,36 Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 02-MAR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
flushed; itchy rash; swollen at shot site; 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 FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot site) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot site). At the time of the report, FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient reported that the events started 2 weeks after the first dose. No treatment information was provided.  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.; Sender'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.
2 days post receiving #6 in series for Anthrax pt. developed Flu like symptoms: severe chills, fatigue, severe body aches, nausea & vomitting, low grade fever. Also c/o pruritis, swelling and discomfort @ injection site. Pt. was sent home with antipyretics and to rest. 10/2/03 she reported that she ended up in the local ER the weekend after the injection for dehydration and  tested positive for Type A Influenza.
MPV IS HIGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Mean platelet volume (NR: not provided) Normal. On 08-APR-2021, the subject experienced mpv is high. Laboratory data included: Mean platelet volume (NR: not provided) High. The action taken with covid-19 vaccine  was not applicable. The outcome of mpv is high was not reported. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Patient received 2nd dose of COVID19 Moderna Vaccine and had received a TDAP injection 8 days prior.
It was reported that a pt (2 of 13) received a Fluzone SV '00-'01 vaccination on 17Oct2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
From office note 11/14/2011: "complaining of a rash on his left arm and pain extending from his neck down his left arm down into the base of his thumb" "Left upper arm shows vesicles grouped on an erythematous base consistent with C6 dermatome." Treated with acyclovir 800 mg 5 times a day for 5 days.
looking for blood clots on her lungs/Suspected blood clot; she is having trouble breathing; caller's wife turned pale, trachea was closing; caller's wife turned pale, trachea was closing; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) through medical Information. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date, for COVID-19 immunization. The caller's wife (patient) turned pale, and trachea was closing on 10Jun2021 while she is having trouble breathing and looking for blood clots on her lungs/Suspected blood clot on an unspecified date. Caller asked million-dollar question that who was going to pay for all of these bills? his wife has had two ambulance bills, one admission to ER, his wife right now was at the hospital. 45 minutes after receiving the second dose, caller's wife turned pale, trachea was closing. Caller contacted EMS, EMS gave Epi Pen and more medications. After 6-7 hours, his wife needed to be rushed again to hospital, but the fire station was closer. Caller knocked on their door for help and they transported wife to hospital. This happened yesterday 10Jun2021. Callers Wife had two Benadryl within the last two hours today (11Jun2021). She was admitted again today to the hospital. She does not have any medical conditions. She was 36 years. They were looking for blood clots on her lungs because she was having trouble breathing. Caller asked for us to contact her back in one hour (1757 11Jun) to continue the report. She was at the hospital. The seriousness for events was hospitalization. Therapeutic measures were taken as a result events which includes EPI PEN and BENADRYL. The clinical outcome for all events was unknown.  Information about batch/Lot number has been requested.
Patient received immunizations after 6 mo. P.E. the afternoon of 11/5/12. The following day developed congestion. Reportedly had multiple sick siblings at home. The next day she suffered a seizure, reported to last approx. 5 minutes, following which she was lethargic for approx. 20 min. Was taken to ER at Hospital. Temp recorded there was 40.1 degrees C, rectally. PE, CXR & U/A all normal. Diagnosed with viral illness & febrile seizure.
Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included POTASSIUM, SIMVASTATIN and LOSARTAN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient's HCP suggested that she should get the second shot in the opposite arm. The patient was also treated with heat pad.
SWELLING ARM; RECURRENT INJECTION SITE PAIN; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced recurrent injection site pain. On 17-MAR-2021, the subject experienced injection site swelling. On an unspecified date, the subject experienced swelling arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recurrent injection site pain, injection site swelling and swelling arm was not reported. This report was non-serious.
January 16th, 9 days after the shot (January 7th) the injection area itched,  swelled, got red and developed hives.  On January 17th the injection arm was fatigued.  Hives have not spread outside the initial area.
Pt started 1 day after vaccine with diarrhea and developed blood in stool on day 2. Stool was tested previously for blood after report of single bloody stool following 2 month visit which was guiac negative.
Client received a dose of Moderna 0.25mL rather than 0.5mL for the first dose.
This spontaneous prospective pregnancy report was received from a consumer referring to her daughter, a 17 year old female patient. The patient had no history of previous pregnancies. Concurrent conditions included asthma. Concomitant therapies were not reported. On 12-APR-2012, the patient was vaccinated with the second dose of VARIVAX (lot# was not reported) 0.5 ml, subcutaneous, and subsequently, the patient learned that she was pregnant, with last menstrual period of 18-MAR-2012 and estimated date of delivery of 01-JAN-2013. Initial exposure to VARIVAX was at 3 week(s). The patient's mother stated that on an unknown date, when her daughter first got the VARIVAX, there was a red spot at the injection site that went away after two weeks. Follow up information was received from the reporting Registered Nurse on 05-AUG-2015. On 05-JAN-13, the patient delivered a male infant weighing 3495.5 gr (11.3 oz) via spontaneous vaginal delivery. The pregnancy outcome was live birth. It was stated that no abnormalities were noted and that the baby had good APGAR scores (unspecified), that the baby did well and was discharged home with his mother. It was also stated that the patient did not have herpes zoster symptoms post vaccination, and that she did not seek for medical attention. The relatedness of VARIVAX with the adverse events was not reported. Additional information is not expected.
About a year after getting injected, I experienced swelling in my left foot & bumps on left leg. After 2 years (currently), I've been experiencing blood clots in the vessels in the front of my brain for over a month now & smelling blood
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Muscular and skeletal pain below the waist; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; Fever 24 hrs; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever, at a dose of UNK UNK, q6h. On 13-Jun-2021, BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) had resolved.            Concomitant product use was not provided.
Anaphylaxis with shortness of breath, throat tightness, dizziness and wheezing with near syncope.
37 YO F PRESENTED WITH A C/O DIZZINESS, ITCHING IN ROOF OF HARD PALATE, AND THROAT SWELLING. SHE STATED THAT SWALLOWING WATER BECAME DIFFICULT AND PAINFUL.  PT THROAT SYMPTOMS CONTINUED TO PERSIST AFTER 5 MIN .  BP138/87 HR 106 O2 100% PT WAS GIVEN BENADRYL 50 MG PO  AND FRIEND WILL DRIVE HER HOME.  THE ITCHING IMPROVED. PT ALSO INSTRUCTED TO GO TO AN URGENT CARE IF SYMPTOMS WORSENED. PT ADVISED TO F/U WITH HER PCP.
I pain for a few weeks in my right shoulder and the back of my foot. The back of my foot still hurts. And my lower back and the top of my back between my shoulder blades which is starting to go away now. For 7 hours after the dose I had pain, fever and chills but that resolved within 7 hours. But the other pain stayed for a while. I went to the Doctor because it wouldn?t stop hurting. I went on 5/26/2021 for the right shoulder, right ankle pain and they did x-rays.
Injection Arm Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Mar2021 09:30 (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: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "Injection Arm Soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19.No,COVID -19 tested for post vaccination. The Pfizer US Drug safety unit recently received the attached report submitted. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: The patient in this case is my Son. He had the shot on Tuesday 23Mar2021 and I became aware of the soreness in the arm, the morning of Wednesday 24Mar2021 and reported it on Wednesday 24Mar2021 around 2 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel flu-like sx; had no focal deficit; later exp severe joint pain, which disrupted her sleep & was sent to a neurologist; 7APR94 pt devel a fever & joint pain in shoulder; also exp paresthesia; wrists were swollen;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes II" (unspecified if ongoing), notes: diabetes II; "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: TELMISARTAN; ALOGLIPTIN; REPAGLINIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expired vaccine administered to 10 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that storage condition at the time of the excursion was refrigerated storage (temp 38F to 40F). On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality was reported in vaccine state change. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each). Vial was unpunctured and no previous excursion was reported.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Patient fainted within a couple of minutes of receiving vaccine. she was nervous prior to, and woke up pretty quickly after she fainted. stated she felt okay after having her hang out for 5 minutes, color back to normal, no sweating or nausea. called grandmother later in the evening to check on her and grandmother stated that she was feeling great.
12 hours after the shot- severe fatigue, diffuse myalgias, nausea. This resolved after 24 hours with no treatment except rest.  As far as the elevated transaminases, bili, AP- no symptoms whatsoever, either when first noted in June or now.  No alcohol intake
The day after getting the HPV vaccine (5/20/13) patient developed a maculopapular rash on sun exposed areas of skin on arms and legs. The rash was mildly itchy.
lightheadedness, diarrhea, rt arm/neck pain ? red area 3-4 days p/vax;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-395956, MOD-2021-395951 (Patient Link).
Information has been received from a pharmacist student concerning a female who on an unknown date developed zoster after her husband was vaccinated with ZOSTAVAX (Oka/Merck) on 09-JUL-2008. The patient's outcome was not reported. The patient sought medical attention with a telephone call. No further information is available.