chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nursing assistant reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 05-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, which has been verified to valid, expiration date reported and validated as 23-JAN-2022) for prophylaxis,  that experienced a temperature excursion (product storage error). The administered dose of the vaccine experienced a temperature and time frame of -10.2 degrees Celsius, during 1 hour and 53 minutes, as recorded by data logger. No previous temperature excursion was reported.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112:
Pt recvd Hep B vax & following 1st dose became fatigued & very sick; MAR92 recvd 2nd dose of vax & again became extremely sick & fatigued; sleeps constantly, hard to dress in morning & is unable to work;
Patient had Moderna vaccine on 3/14/2021 but she wanted Pfizer and said it was her 1st Covid-19 vaccine when she came to counter. Patient was given Pfizer and we realized the error when billing the vaccine and received an insurance error. When I called the patient to verify that the insurance error was correct, she informed me that she wanted to start the series over with Pfizer because she had a 3 day flu-like reaction to the first dose of Moderna. She was scared to get her second Moderna shot because of her reaction and wanted to instead start the series over with Pfizer. I informed the patient that she is now done with the series and that she should have completed the series with Moderna.
Pruritus around injection site, erythema, swelling and warmth.  Patient's guardian was advised to monitor site for enlargement, streaking, fever, or new symptoms. Recommended cool compress.
I had a herpes sore erupt on my left arm exactly two weeks after the second dose of Pfizer Covid 19 vaccine.  I usually have this erupt about once a year after exposure to sunlight or stress, but I had not been in the sun.  I did apply acyclovir ointment to it and it is getting better.  I also developed what looks to be psoriasis on my left elbow.  Frankly, I do not know if these two incidents are related to the vaccine, but I thought that I should report it just in case others had experienced similar occurrences.  I do have a doctor's appointment scheduled later this month and I will mention it to my doctor as well.
Client called clinic on 12/30/2020 in the am requesting us to call in prescription pain medication due to having severe arm pain at the injection site. He stated he had not slept any for the last two nights. Encouraged client to see his PMD if he was in the kind of pain that required a Rx pain medication. Encouraged client to ice down his arm for pain.
At around 7pm on 12/31/2020 I started having severe shakes  and fever by around 11pm, the fever was 104. I took 6 Tylenols and 4 Advils. By around 4am on 01/01/2021, my fever had stopped. At around 5pm on 01/01/2021, I started having low grade fever again and I took 2 Advil and I'm okay now
Ringing in ears. Started to notice 2 days after. Constant hissing sound, like crickets. At first I thought it was due to Spring noise but then noticed it was constant and even at night when trying to sleep. VERY WORRIED and not sure if I should get the 2nd shot!!!!!!
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-JAN-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1560 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Got vaccine at 9:30am Headache-after Noon same day, still have it Aches- after noon, same day, still have them Low back pain- after 4pm same day, still have it Nausea- after 6pm, same day, still have it Vomiting- around 7:40pm, same day, self induced
Light bruising, swelling and soreness in both armpits. Burning rash running down on both sides starting from bottom of armpits. Left armpit and rash worst than right side. Received vaccine in left arm
On day 4 after receiving the vaccine I awoke with a sore throat. Then on day 6 after the vaccination I have a rash the circles the injection site. The rash also goes down about 5 inches below the injection site and goes around 1/2 of my upper arm.
accidentally received another dose of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number A2L45, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 20-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 20-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: accidentally received another dose of Flulaval). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter informed that a 16-year-old  received a dose of FluLaval on 21 September 2023 accidentally received another dose of this vaccine on 20 October 2023 which led to extra dose administered. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Pain in arm, bruise in breast area, nausea, headache , dizziness, chills , night sweats, then two days later patient developed muscle spasms in her back that has not gone away.
Pain in left thigh and "wouldn't walk", starting the evening of the day immunizations administered. Area noted to be red, 2-3 days later. At the time of exam (6 days after immunizations) he had red, raised margin about 4" X 6"; central area clear and non-tender.
This spontaneous report as received from a physician refers to a pediatric patient. The physician reported that the patient was vaccinated on an unspecified date with the second dose of RECOMBIVAX HB after only 24 days of receiving the first dose of vaccine (date unspecified). Additional information has been requested.
SHE PASSED OUT ABOUT 5 MINS AFTER ADMINISTERING FLU SHOT AND ALSO WETTED HER PANTS. CALLED 911
Seizure - Full clonic/tonic 1 hr 45 minutes after receiving routine immunizations - Family describes today's episode the same as in the past (same seizure activity). Ambulance called to take Pt. to hospital because she hit her head on wall at onset of seizure.  4/14/09 Received Clinic & ER medical records for 4/1/09 & 4/3/09. FINAL DX: Seizure disorder Records reveal patient experienced unwitnessed siezure in clinic lobby, hit head on wall, tonic clonic movements of arms & stiff legs x approx 15 secs.  Afterward was back to baseline of minimally responsive & nonverbal per family who also states this episode is her typical seizure.  Had been out of meds x 3 wks since arrival from out of country.  PE revealed contracted UE & LE, multi dental caries.  Tx w/meds & referred to neuro on d/c to home.
Sudden onset loud left tinnitus. Still present 5 days later.  Hearing test scheduled tomorrow.  Likely permanent according to ENT
APPETITE LOST; BURNING  DIARRHEA; NAUSEA; MUSCLE ACHE; DRY HEAVING; MEGA FLU; INSOMNIA; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dry heaving. On APR-2021, the subject experienced mega flu. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced muscle ache. On 10-APR-2021 05:11, the subject experienced burning diarrhea. On 11-APR-2021, the subject experienced appetite lost. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dry heaving, and the outcome of muscle ache, mega flu, insomnia, burning diarrhea, nausea and appetite lost was not reported. This report was non-serious.
1-15-13 VARIVAX, right arm, polio normal. MMR II DTP left arm redness, swelling, no pain.
Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0175), via an unspecified route of administration in left arm on 29Apr2021 at 15:30 (at the age of 34-years-old) at 2nd dose, single for COVID-19 immunization. Medical history included knee swelling from previous injuries. Prior to vaccination, the patient was not diagnosed with COVID-19 and she has no known allergies. Concomitant medications were reported as none. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications received within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, she has not been tested for COVID-19. The patient reported that she had knee swelling from previous injuries and the swelling has gotten so bad that she could not walk on 01May2021 at 12:00. She did not receive any treatment in response to the events. The outcome of the events was recovering. The events were reported as serious causing disability/incapacity/ permanent damage.
Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left upper arm on 02Jan2021 13:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced itching on 02Jan2021 with outcome of not recovered. The patient got the COVID vaccine on 02Jan2021 around 1 o'clock. That evening (5-6 hours after getting) the vaccine she started itching and has been itching since then. The itching is on her body, back, and stomach. She has been itching since, it comes and goes. Itching worsened. It also worsens in the evening, night, and morning. As treatment the patient took a baby loratadine (CLARITIN).
This spontaneous report as received from a nurse refers to a 6 months 11 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
The patient received her vaccination and was fine. She was home reading, drinking tea, and playing game and someone noticed that her eye was "blood red." This was approximately 90-minutes post-injection. She hadn't had any noticeable symptoms, and felt no differently. She looked in the mirror and noticed the red color, and after a bit she did notice a slight bit of itching.  The patient's injection site is reported as normal with just a bit of warmness but no redness at the moment. The injection site does not hurt, and she reports no rash, redness, or swelling anywhere else on her arm(s), face, and/or body. She reports no other symptoms other than the eye redness and slight itching.
Extremely itchy scalp/ Itching going down to behind ears; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 07:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified thyroid medication (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Apr2021 at 01:00, the patient experienced extremely itchy scalp and the itching was going down to behind ears at the time of reporting (reported as at the present time). No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely itchy scalp/ itching going down to behind ears was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
10 days after the vaccine, The very first thing was that my hands hurt and they were swollen and in the mornings I couldn't open them up. I started going to the hot tub to get them heated and it lasted for like 3 weeks and I never had anything like that before. They were really hard to move. I had to get my rings cut off my hands and I have never had swelling like that. After 3 weeks it went back to normal and I haven?t had a problem since. I don?t have high blood pressure or anything like that. Then my knees started hurting after that and they were stiff and achy and I couldn?t get my knees comfortable and I have had two knee replacements in 2013 and so they were very stiff and achy and hurt on the outside of the knees and the next thing was my hips mostly on the left side hurt and my muscles were hurting all over, especially my arm and upper thighs. Then I had a headache on July 4 and I?ve never had that before and it lasted for 14 days before I went to ER. It wasn?t like a migraine or sinuses, it was optical neuropathy headache on back side of skull, and then the back problems started. It lasted this whole time and it's just started to improve. I did have two teeth I had to have pulled out that rotted as well.
Local reaction to Varivax. Tx: Benadryl 12.5 mg/5mL 1/2 tsp po every 6 hours prn itching.
Site of joint replacement swelled for a week. By 7 days it did not support weight. 9 days is was 80% normal.
The morning after dose five I began to itch on the right side of my torso. I didn't notice anything there while I was itching but later that day, I saw the rash. It was about the size of a tennis ball. It looks likes hives. I began taking CLARITIN and BENADRYL on the weekend. I contacted my doctor on Monday morning and he stated that it could be a normal reaction after the booster. We are monitoring the rash for now. In addition, yesterday and today my blood pressure has been higher than normal. The highest has been 159/95. But I have been averaging 140/88. I am usually about 130/75.
Client starting feeling hot and needed water-became dizzy and ;light headed-B/P 98/64-pulse 68 - gave client water and crackers- after 10 minutes- B/p 118/71--71- Client started feeling better   Gave client water and crackers on discharge and encouraged to continue hydration and eating protein. Also see MD if symptoms continues
Patient had hives and a fuzzy feeling in throat beginning about 8-9pm after vaccine. Fuzzy feeling lasted 2 hours. Hives resolved by next am but has continued to have occasional hives since this date.
6/25/2023 - 6/28/2023 (3 days) Presents emergency department with abdominal pain. Incidental finding likely and therefore patient was not started on any antiviral medications as she is in asymptomatic.  EL3248 1/22/2021 EN5318 2/12/2021 301258A 11/4/2021 7/9/2022 051B22A
This spontaneous report as received from a pharmacist refers to a 50 years old female patient with no pertinent medical history, drug reactions  or allergies. The patient was taking multiple unspecified concomitant medications. On 06-SEP-2016, the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dose was not reported, lot# M024673, expiry date on 17-NOV-2017). On 07-SEP-2016, the patient experienced fever, pain at injection site, swollen arm and could not sleep at night. She could not move the arm because of the pain. The patient was treated for the events with MOTRIN and warm compress. She did not have any laboratory test performed. The patient sought medical  attention via calling the pharmacy. The outcome of the events  was reported as not recovered. Causality assessment was not provided. The reporter considered the events of pain at injection site, could not move the arm and could not sleep at night to be disabling. This is one of two reports received from the same reporter. The cases concerned similar events on the same lot# M024673 of PNEUMOVAX 23. Additional information has been requested.
Client had received 1st dose of Covid-19 as Moderna, second dose given was Pfizer by mistake.  Client is pregnant at the time of vaccination.
Symptoms began as neck pain/soreness and the progressed to back pain (from the tailbone all the way up to the neck). It later spread to whole body pain, with the sensation that all other joints (fingers, toes, knees, elbows, shoulders, jaw, etc.) were swollen and very painful.
Numbness in arm, locallized rash/hives. Given ibruprofen at clinic. Still has rash/hives a week later.
Bruise-deep purple approximately 2" by 3" circular area below injection site L arm below deltoid muscle but above elbow. Bruised area was surrounded by one inch red margin. No pain was noted. C/O swelling-none on injection. Bruises still there decreased redness.
Later the same day as receiving the second dose there was a distinct tearing feeling around the right sacroiliac joint area. No strenuous activity or unusual movement were made; simply taking a step forward. This caused intense pain in the area- this was midstep when it happened so not upon impact or initiating the movement.  Tried to just relax the rest of the evening, slept very little overnight. The next day the pain was more intense so I contacted my chiropractor,  for an adjustment. I was able to see him that evening and the adjustment did provide some relief. I followed up with another adjustment 4/5/2021 where I was made aware that they had been noticing a trend of increased neuromuscular inflammatory episodes in patients that had recently received a second COVID19 vaccine dose and subsequently advised me I should report this as an adverse event.  I will be following up with my regular appointments and any additional treatments as required/ needed.
Temperature 102 degrees, tightness in chest, headache, tiredness, dizziness. Onset 8/21/02 about 9pm mother gave Tylenol.
Case number PHHY2012US051223 is an initial literature report received on 15 Jun 2012: This report refers to a young female patient (exact age unspecified). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Within thirty minutes, the patient lost consciousness while driving, causing her to lose control of her motor vehicle. She suffered severe injuries and was hospitalized for six weeks. During that time, her gallbladder and a kidney were removed. She also suffered a colon injury, a lacerated liver, a fractured arm and multiple left foot and ankle fractures, which left her with a permanent limp. The patient sued and claimed that the loss of consciousness was from a vasovagal reaction to the vaccination. An expert witness stated this type of reaction was "not uncommon" and was a "universally recognized potential complication". The author commented that the medical staff had an obligation to observe a patient after an injection for a reasonable period of time. In this case, it was hard to imagine that a vasovagal reaction could occur so long (30 minutes) after the injection. No further information was provided.
pt recv vax; mom called clinic, stated lt elbow was swollen; no oth problems;states 21jun95 pt had fever of 101 & a little irritable;
Diarrhea; Vomiting; Aches and pain in the whole body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Aches and pain in the whole body) and VOMITING (Vomiting) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN (Aches and pain in the whole body). On 19-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 19-Jan-2021, PAIN (Aches and pain in the whole body) had resolved. On 20-Jan-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has underlying conditions and take blood pressure pills, and has high cholesterol and diabetes.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
pt came in pharmacy 2/27/23 and reported that she got severe nausea (couldn't eat or drink) for 3 days after 1st dose of Pfizer and after the 2nd dose of Pfizer, her throat closed up ( pt had to take benadryl and pepcid ac, and antinausea med, (did not go to hospital either times )