chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other refers to a 70 year old male patient. On 08-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010109, intramuscular for prophylaxis. On 08-AUG-2017, 1 day after onset of therapy the patient experienced injection site erythema. The outcome of injection site erythema was reported as not recovered/not resolved. The reporter did not assess the causality between the events and PNEUMOVAX 23.
This spontaneous report was received from a medical assistant concerning a 60-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No patients have reported any adverse events to date. It was reported that on 28 -Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range:positive 35.2F to positive 41.7F for 12 hours. The vial was thawed on 28 Jan 2022.  No treatment medication were reported.
received the Pfizer/BioNTech booster; Night sweats; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "received the Pfizer/BioNTech booster"; NIGHT SWEATS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Night sweats"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Chills". Therapeutic measures were not taken as a result of night sweats, chills.  Additional Information:  Reported Event: Middle aged female who received the Pfizer/BioNTech booster developed sweating (PT Night sweats) and chills (PT Chills) in the middle of the night. Patient recovered from the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  No Hospitalization Prolonged. Facility where the most recent COVID-19 vaccine was administered was Unknown. Serious was reported as No. Seriousness criteria Results in death, Life threatening was no. Seriousness criteria Caused/prolonged hospitalization was no. Seriousness criteria Disabling/Incapacitating was no. Seriousness criteria Congenital anomaly/birth defect was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Major pain in lower back / like someone had plunged a knife into my lower back; Couldn't walk; This case was reported by a consumer and described the occurrence of low back pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced low back pain and unable to walk. On an unknown date, the outcome of the low back pain was recovering/resolving and the outcome of the unable to walk was recovered/resolved.   It was unknown if the reporter considered the low back pain and unable to walk to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The day bofeore reporting, the patient received dose of Shingrix and in the afternoon of day of reporting suddenly had major lower back pain like someone had plunged a knife into lower back. It made the patient double over in pain and could not able to walk for at least 5 minutes. The patient almost went to hospital but the pain then started to subside. The patient still had sore in lower back but was not like earlier. The patient asked, if any known connection which might be a side effect of the shot.
PT recieved Small Pox Vaccine after screening on 14 Feb 2008 (in Conjunction w/ Anthrax Vaccine #1). Site was covered w/ tegaderm dressing and PT instructed on after care, dressing changes, and given Trifold instruction card. Recorded as "major" take on 21 Feb 08, then on 25 Feb 08 at 0721 (local time) PT reported to myself at morning sick call, c/o generally not feeling well, fatigued, and "hot soreness" to left shoulder small pox immunization site. Exam revealed @ dime sized vaccine pox plus @ 6 satellite vaccina blisters. Erythematous, indurated skin over entire area (Approx. 12cm in circum.) and positive lymphadenopathy to left axillary nodes. VS were stable at 98.9 temp (oral) BP:124/71 P:78 R:16 Po2: 98%. pox lesions were oozing at site of vaccination and satellite lesion (honey colored mix w/ purulence). Preliminary DX of Vaccina (localized w/ secondary bacterial infection. Wound cultures were obtained. Member placed on Keflex 250mg oral. PT f/u 26 Feb 08 0730 w/ reduction in erythema and induration plus all lesions were drying and no discharge. PT f/u 28 Feb 008 @0835 w/ continued resolution of symptoms.
Vaccine administered: SPIKEVAX 2023-24 (12Y UP) SYRG Administration date: 09/23/2023, Volume (ml): 0.5ml. In addition to the COVID shot I recieved the FLUCELVAX QUAD 2023-2024 SYR shot.  My arm felt soar, but not that bad. At about 3:30 PM it took a  2 mile walk.  I started feeling a bit warm.  I ate dinner and had about two glasses of wine dinner.  About 7:00 PM I statrted feeling feverish.  My temperature was 98 degrees, but I felt hot and feverish.  My knees felt inflamed and i felt dehydrated.  I drank about a pint of water and went to sleep.  I was achey and woke up about every hour.  I felt very dehydated and drank about a total of 3 pints of water throughout the night.  The next day I was back to feeling normal.
prolonged screaming began p/returning home from MD office; returned to office 4 hrs later unable to be comforted by mom, nurse or MD sl erythema a shot site;
Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder; Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date 11th December 2021) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Grade 3 reaction with swelling and redness that covered the left arm from the elbow to the shoulder. No other vaccines administered that visit. The reporter agrees to follow up.
pt woke up w/rash to both deltoid areas; the areas appears overlapping & red to both mid deltoid areas; no c/o burning or itching, no oozing noted; no other sx noted;
Info has been received from a health professional concerning a child who was vaccinated with a 0.5ml, SC, dose of varicella virus vaccine live. Subsequently, the pt experienced a full blown case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional noted that the report she gave was hearsay and that they have never had a case of breakthrough at the clinic. Additional info is not expected.
several hr p/vax pt had fever 104 & 103;pt was seen in ER 31JUL;pt still had fever, jittery & constant crying;pt had CBC, SMA20 & LP done;EEG done nl;given Phenobarb & chloral hydrate
The next day I started having flu like symptoms that went away in a few days but my head felt like I was being electrocuted which at times I can feel throughout my body. That symptom still persists to this day
"bug-bite type rash both legs-3 on leg, 1 on other leg, 1 hand & 1 arm & 1 finger swollen;"
Has a lump right below the collar bone on the left side.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Has a lump right below the collar bone on the left side.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced MASS (Has a lump right below the collar bone on the left side.). At the time of the report, MASS (Has a lump right below the collar bone on the left side.) outcome was unknown.            Concomitant medication use was unknown  Treatment information was unknown
Received Tdap on 8/28/09.  Reports the area where the vaccine was administered was red, swollen, and warm to touch all weekend.  He also complaied of pain in the area all weekend.  He was given acetaminophen.  Presented to the PHC on 8/31/09.  There was 1 1/2 X 1 1/2 induration in his left deltoid, there area was red, and warm to touch.  He also complained of pain with touch to the area.  Recommended heat to the area and continue the acetaminophen.  Returned to the PHC on 9/1/09.  The area was not as red, but induration and pain still present.  Instructed to continue with heat and acetaminophen.  Call 9/2/09 and area continues to be very painful.  He was referred to his physician for evaluation.  Will follow up with this referral.
Fever (101 F); myalgia; malaise; headache; This is a spontaneous report from a contactable physician (patient).  A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: Arm right) on 05Jan2021 07:00 at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies. It was reported that patient experienced fever (101 F), myalgia, malaise, and headache on 06Jan2021 at 07:00. It was reported that no treatment was provided for the events. It was also mentioned that prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
26JAN98 c/o sore throat & wheezy @ 930PM;28JAN98 redness on lt arm moving up shoulder to neck;29JAN98 1AM woke up itchy, welts;smaller mosquito like area on extremities;fever-felt hot;eyes & face & neck swollen;allerg react'
PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION.  PT WAS GIVEN 50MG BENADRYL.  PTS HIVES AND ITCHING STARTED TO FADE ROUGHLY 15 MINUTES AFTER BENADRYL WAS ADMINISTERED.  PT HAD NO PROBLEMS BREATHING.
3months p/vax pt lost all body hair (alopecia totalis);MFR of vax was notified;
Patient report having a "rash on the face and a tingly throat" after receiving the first vaccine. Patient was advised to wait for 30 minutes after receiving the second dose so medical personnel could monitor her. Within approximately five (5) minutes of receiving the second dose, EMT personnel reported swelling of the patient's face. There was no reported blockage of the airway by the patient. They were responsive and able to communicate with the EMT team.
Pt fainted and lips turn blue and face become pale .  Hands and body felt cold.   Pt fainted only for few seconds.  She was okay after few mins.  Pt got taken to ER by EMS.
Administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered  past the expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered  past the expiration date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was administered with the vaccine from the vial expired on 13-Oct-2021. The vial was moved to the refrigerator on 14-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
TIA - Transcient Ischemic attach; Both vaccines was administered on same day; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (at the age of 76-year-old) (Batch/Lot Number: E200187) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included glaucoma and cardiac disorder. Concomitant medication included acetylsalicylic acid (ASPIRINA); carvedilol (CARVEDILOL) and furosemide taken for an unspecified indication, start and stop date were not reported. On 04Jun2021 13:00 the patient was hospitalized for tia - transcient ischemic attach for 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Patient do not have any allergies. Patient tested positive post vaccination. Patient received treatment for adverse event as Physical Therapy. Post vaccination the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jun2021. The outcome of event was recovered and unknown for both vaccines was administered on same day.  Follow-up actions are needed. Further information has been requested.
Mother reported right arm red, swollen, tender to touch, hot, extending to chest to sternum, back-top of shoulder to clavicle, arm-down to elbow. Also reports an allergic reaction to the bandaid that was applied. "When she removed the bandaid the next day, there was a solid blister under the bandaid". She took child to MD on 4/16/03. He gave antibiotics and steroids.
The patient's mother scheduled a Pfizer booster vaccine immunization for the patient who is 15 years old. Patient arrived to pharmacy and given the Pfizer booster despite not meeting the current approved age requirement for the Pfizer booster, which is for age 16 years old and up. Patient was 9 days from turning 16 at the time of administration. Patient and patient's father did not have any problem with the vaccine. No reaction noticed. Patient's mother said her prescriber wanted her to get the booster vaccine although requirements currently do not allow for her age group to receive the booster. Patient's mother said her daughter is immunocompromised and her prescriber recommended getting the booster. Patient did not mention any immunization side effects or issues. Her accompanying parent was satisfied with the vaccine being given to her. Patient and parent left the pharmacy without any issues or complaints.
Hot Flashes, chills, increase in non-epileptic Seizures, fever 103.7, body aches, rash around injection site, extreme exhaustion, vomiting, chest pain. Symptoms lasted 3 days with exception of rash, fever and chills which lasted 8days.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-JAN-2016, it was reported that the patient received an improperly stored dose of M-M-R II, lot # L015282, exp date on 30-APR-2017). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Only 3 doses of MMR II were administered. The registered nurse also reported temperature excursion. High temperature excursion: Temperature: 14C Time frame: 11 hours. Low temperature excursion:; Temperature: 1C Time frame: 11 hours. This is one of several reports received from the same source. Additional information has been requested.
Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198) via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, hypertension, arthritis, hypothyroidism, hyperlipidemia and known allergies to bees, trees, grass, dust, pollen and dander. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 20Feb2021 at 15:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 22:00, the patient experienced body aches, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events body aches, nausea and fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient received a Moderna Booster after receiving a full series of Sinovac (WHO approved;) COVID-19 vaccination.   lot#202105048F- sinovac dose 6/10/21 lot #J202103019 - sinovac dose 1 4/30/21
Fails to respond to his name. Has poor eye contact. Appears not to hear me at times. He appears unaware of others' feelings. Prefers playing alone  retreats into his "own world".     Loss previously acquired ability to say words or sentences  Does not make eye contact when making requests  uses a singsong voice  Can't start a conversation   Performs repetitive movements, such as rocking and spinning  has specific routines or rituals  he is disturbed at the slightest change in routines or rituals  he moves constantly  he  becomes fascinated by parts of an object, like spinning wheels of a toy car  he can sometimes be sensitive to sound and touch all of started to happen 2 to 3 months after recieving his MMR shot in April of 07
Red, raised, warm area with pain and itching at injection site. Instructed to take Benadryl and return to clinic if not better.  If worsend, should report to ER.
Pt got 2nd Pfizer shot on Thur 4/29/21 in left arm. Came in today to report swelling, redness, warmth, and itching below the injection site, and axillary tenderness. Pt stated reaction started just this morning.  Pharmacist suggested Tylenol, ibuprofen and cool compress, and to report to PCP if condition worsens.
Severe headache, nausea and vomiting lasting two days. Rx. Small sips of Gator Aid, Recovered after two days.
Received  the shot at 10:30am on Wednesday 2/17/2021. At 1:29am on Thursday 2/18/2021, Arthritis  flared & had inflammation in every joint. My hands swelled to twice threir size & became stiff. Within a couple hours the pain became debilitating, it hurt move & the pain was more serve with walking. At 3:15am Friday 2/18/2021 the inflammation started coming down.  It is now 2:15pm Friday 2/19/2021, I am still having iflammation that is tolerable & the swolling in my hands has gone down ds ar
Dizziness, nausea, vomiting, dry heaves, 100.3 fever, weakness
Swelling (about a foot in length, four inches in width) at injection site; itching; very warm to touch
Patient reports on had headache the night after getting vaccine and the next day went to get up and felt weak her knees buckled.  She reports seeing a doctor and was referred to a neurologist. The neurologist did an  EMG  on 8/17/2022 and she was diagnosed with Guillian Barre . She reports some improvement on 9/2 still has leg weakness.