chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 06-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000862: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-0095075131907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
The staff at a Senior Living told pharmacist that the patient was due for her Moderna booster vaccine--thus, at least 6 months had past since the patient's last covid vaccine.  Then, consent was given by the patient, and the pharmacist injected 0.25 mL of Pfizer vaccine into the patient's deltoid.  Several hours later, the staff at center informed the pharmacist that the patient had actually just had her second pfizer vaccine only 2 weeks prior.  The staff consulted a physician, and has monitored for side effects all day.  As of 5:15pm on 11/5/2021 patient is feeling well and has not had any adverse reaction to the recent vaccine.
Felt like flushing on the left side of the heart; Inflammation under the left arm (injected arm); Feels Inflammation on Urethra near left kidney; Feels like pelvic pain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Felt like flushing on the left side of the heart), INFLAMMATION (Inflammation under the left arm (injected arm)), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 010M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Arthritis (for ever).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INFLAMMATION (Inflammation under the left arm (injected arm)). On 05-Nov-2021, the patient experienced FLUSHING (Felt like flushing on the left side of the heart). In November 2021, the patient experienced URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side). The patient was treated with SULFAMETHOXAZOLE;TRIMETHOPRIM at an unspecified dose and frequency. On 05-Nov-2021, INFLAMMATION (Inflammation under the left arm (injected arm)) had resolved. At the time of the report, FLUSHING (Felt like flushing on the left side of the heart), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) outcome was unknown.            No concomitant drug was reported. On 05-Nov-2021, the patient felt like flushing on the left side of the heart only one time. The patient also had Inflammation under the left arm (injected arm) for 2 days. About 3-4 days after vaccination, the patient felt Inflammation on Urethra near left kidney. The patient states, "It feels like pelvic pain on the left side." The patient visited the emergency room. Other treatment medication was reported as 3 courses of antibiotics (SMZ/TMP) and prophylaxis antifungal oral tablets.   This case was linked to MOD-2022-535880 (Patient Link).
Sore arm; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Persistent vaginal bleeding for 9 days and counting, started within 24 hours. Heavy flow, only subsided a little so far. Prior to vaccine, had not had a period in 3 months due to Mirena IUD.  Typical flow is moderate to light prior to IUD. Not pregnant. Waiting for follow-up with GYN.
Inflammation of the area under left armpit, sensation of liquid in that pocket. It cause immobilization of the arm.
During the vaccine administration the needle popped off the syringe and the contents of the syringe spilled on to the patients arm and the administrators hand. It appeared to be the majority of the vaccine that was spilled therefore another vaccine was administered to the patient. The patient was not experiencing any cutaneous reaction to the vaccine on his arm but was advised to wash the area and continue to monitor.  The administrator did have a rash develop where the vaccine came in contact with her hand, she washed with soap and water and applied hydrocortisone cream 1% and the rash resolved.
the night of vax pt spiked temp of 104f rectal; seen in MD office next day & was doing better
Initial unsolicited report received from a non-healthcare professional on 10 November 2015. Case is linked to case 2015SA182410. This case involves a (age and gender unknown) patient who was vaccinated with a dose of [route and dose series not reported] MENACTRA (batch number, expiry date were not reported) and also TRUMENBA (batch number, expiry date were not reported) both received in arm on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced severe swelling, chills, pain and itchiness. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
on 1/29/21 pt noted rt upper arm became red, warm, non tender. Redness worsened over days.
Severe headache, it was so bad I couldn't even open my eyes, could only lay down and stay in a dark room it was worse than having a Migrane.  Had an upset stomach. Aching all over.  Lasted for 2 days.
Accelerated HTN, nosebleed, blurry vision x 5 days.
fever this am 01/11/07 101 degrees, see pmd at 11a, No more fever 99 degrees
nausea; This is a spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: not reported) via an unspecified route of administration, on an unknown date in Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient mentioned that, she received the first shot of the vaccine last week and she presented nausea recently, on an unknown date in Feb2021. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe pain in the shoulder and difficulty moving the arm where shot was given. Chills and fever of 102.6, low blood pressure, fast heartbeat.
fever, 101.4, headache, body aches Used acetaminophen to reduce aches and fever.  Fever came down by evening of 10/2/20 headache stopped 10/3/2020
Fever; This is a spontaneous report from a contactable consumer or other non hcp submitted by Call Center. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: ER8731) via unknown route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unknown date the patient experienced fever. The outcome of the event was unknown.     No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant referring to a 21 month old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 31-JUL-2018, the patient was vaccinated with an expired dose of RECOMBIVAX HB (dose, route of administration and anatomical location were not reported) lot # J006511 and expiration date: 28-JAN-2016, indicated for prophylaxis. Additionally, the medical assistant was unable to confirm if the vaccine had temperature excursions prior to be administered. No adverse effects reported.
Joint pain, already had some sort of joint pain before this just amplified it a bit; Arms hurt; Arms hurt, where it was given and mine bruised up; Felt like it attack my joint in my neck specifically; When they gave me mine, mine bled; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164) via an unspecified route of administration in Deltoid Left on 22Jul2021 at 11:30 (at the age of 37 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not received any vaccination 4 weeks prior to COVID 19 Vaccine. The patient experienced joint pain, already had some sort of joint pain before this just amplified it a bit, arms hurt, where it was given and mine bruised up, felt like it attack my joint in my neck specifically, when they gave the patient, mine bled on an unspecified date on Jul2021. Reported as, the patient had received it as well yesterday the only side effect that the patient experienced was that the patient was still experiencing joint pain but that was not anything would really call about because the patient have already had some sort of joint pain before this just amplified it a bit. The patient have arms hurt, where it was given and bruised up and did not bruised up but both of our arms hurt a bit. Other medical conditions consumer stated, the patient had problems with neck, the patient had bulging disc and stuff like that so that was ongoing problem for me personally and so like the patient said the patient already had joint pain but when got that, the patient felt like it was and felt like it attacked joint in neck specifically where the patient already had the problem, so the pain was amplified. Consumer stated, no the patient not other than Ibuprofen here and there for pain and swelling from that other issue that the patient already have hurt too but when they gave the patient's bled and that never happened to the patient, it bled and it made a pump and then nthe patient woke up this morning and it was bruised and of course it was still hurts. But his just hurts". As a corrective treatment the patient did not received any medication other than Ibuprofen. the patient took Ibuprofen for try to help the pain. Therapeutic measures were taken for the event arthralgia, pain in extremity, contusion, and neck pain. The outcome of all the events were unknown.
Patient received flu shot on the morning of 10/13/14 and called our office on the evening of 10/14/14 after noting an area of erythema and induration on vaccine site. No fever or streaking but arm felt warm at time of discovery and affected arm was painful earlier in the day. She presented in the office the morning of 10/15 and her mother noted the area of erythema had gotten larger. Measured during the visit to be 9cm by 9cm and 6cm at narrowest portion. Warm to touch with no motor deficits or edema of LUE.
Patient administered under-diluted diluted dose of vaccine. Patient did not experience adverse reaction from receiving higher dose.
About 10 minutes after getting the vaccination the patient returned to the pharmacy counter to inform me she was breaking out in hives on her arms.  I observed some redness on both her arms.  I took her blood pressure which was 186/112 in the right arm and 185/111 in the left arm.  Patient had no other symptoms.  I gave patient 25mg of diphenhydramine.  She took that and left the store shortly after.  I called her later that evening and she said the hives had completely resolved and she had no other symptoms.
Left arm swelling, redness, pain worsened one to 5 days after administration with improvement after taking Benadryl.  Was evaluated by MD, thought likely hypersensitivity.  Treatment with Benadryl/Moltrin.
soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report from a contactable consumer (patient).  A 77-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL9262), via an unspecified route of administration in the right upper arm on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced soreness in right arm, numbness in right hand and tingling in right foot on 22Jan2021 with outcome of not recovered. She was schedule for the second dose on 10Feb2021.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 14-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route af administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
I had initial pain and soreness at the site which I expected. It lessened in two days.  On March  17th I went to lift my arm noticed it was sore and tight.  I looked at it and it was swollen and warm. It also had a small rash or raised area. All of this was in the arm I received my injection
Severe chills turning into uncontrollable Rigors, Headache, total body pain and fevers. Symptoms lasted 2 days
Patient called the office on 2/11/2021 and reported an occurance of shingles. She states she noticed the shingles occurance on 2/13/2021.
Pain in arm, headache, muscle aches, joint pain, fever day 2, Taking tylenol
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of VAQTA (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Speeding heart rate from the Pfizer vaccine; This is a spontaneous report from a contactable consumer. This reporter reported similar events for four patients. This is the fourth of four reports. This case is non-serious.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. When reporter did reporter's EKG, it was reported that she was the 4th person to come in with a rapid heartbeat after the vaccine. The patient experienced speeding heart rate from the pfizer vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350648 same reporter/drug, similar event, different patient
This spontaneous report was received from an unspecified reporter refers to a 10 year old (reported also as 11 year old) male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with a dose of GARDASIL (number of dose, dose, route and lot # not reported) on 08-JUN-2012. There was no concomitant medication. On 20-JUL-2012 the patient experienced swelling and pain in 1 testicle. No treatment was given for adverse event. At the time of the report patient's state was not reported. Additional information is not expected.
Red, itchy rash.  Started evening after receipt of Hep A vaccine.  Rash first noted on feet, progressed to hands, face and trunk.  Sxs improved with Benadryl and oral steroids.
Information has been received from a pharmacist concerning a 67 year old female with sleep disorder, hypertension and no drug allergies who on 09-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose and lot number unspecified). Pharmacist indicated that the injection was given intramuscularly. Concomitant therapy included NORVASC, EVISTA, CRESTOR and AMBIEN. On an unspecified date, the patient experienced redness and warmth at the injection site. On 13-SEP-2010 the patient visited the pharmacist to have the area on her arm evaluated. No laboratory diagnostics studies were performed. At the time of reporting, the patient's redness and warmth at the injection site had not recovered. Additional information has been requested.
soreness at site of reaction; Fever; fatigue; This is a spontaneous report from a contactable other HCP. A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Oct2021 at 13:00 (age at vaccination: 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation at pharmacy/ drug store. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine taken for an unspecified indication. On 23Oct2021. On the same day, patient had other vaccine same date product= flu shot. At 21:00, patient had soreness at site of reaction, fever and fatigue on 23Oct2021 at 21:00. Case assessed as non-serious by the reporter. He had not received any other vaccines within 4 weeks prior to COVID vaccination and not received other medication within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and it was unknown if tested since the vaccination. Therapeutic measures were taken as a result as a result of the event with Tylenol. The outcome of events was recovered on an unspecified in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, HYPERtension, FATIGUE Narrative:  PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.
Patient had acute onset of altered mental status - was dazed, slow to respond, weak trembling. 1 episode of emesis. He was taken to ER - was tachycardic and extremely sleepy. He was noted to have fever to 102 degrees. He was given IV fluid boluses, but remained tachycardic. Toxin screen, head CT, CXR and lab work normal. Admitted for observation x 48 hrs. He remained excessively sleepy 1st 24 hrs.