chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two vaccines underwent a temperature excursion and were bolh administered to a patient; This spontaneous report has been received from medical assistant  concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.      On 06-JUL-2020, the patient was vaccinated with with the following vaccines that underwent temperature excursion:  - Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (rHA) .5 ml, once, intramuscular, Lot # S031483,  expiration date reported as 04-APR-2021, but upon internal validation established as 07-OCT-2021 for prophylaxis.  -Varicella virus vaccine live (oka/merck)(VARIVAX) 5 ml, once, intramuscular, S028926 expiration date 16-SEP-2021 for prophylaxis.  The temperature was reporter to had been at 28.04° Fahrenheit (F) and timeframe of excursion was reported to had been  1 hour and 22 minutes.   There was digital data logger involved and  no previous temperature excursion was reported.  This is one of two  reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011777:
Lightheaded/dizzy; Could taste vaccine; Anxious; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported by reported.  Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Feb-2021 at 3:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious). The patient was treated with WATER for Dysgeusia, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheaded/dizzy) and ANXIETY (Anxious) outcome was unknown and DYSGEUSIA (Could taste vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.3 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 79 (Inconclusive) Inconclusive, 80 (Inconclusive) Inconclusive and 78 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 97 (Inconclusive) Inconclusive, 98 (Inconclusive) Inconclusive and 98 (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 36 (Inconclusive) Inconclusive and 32 (Inconclusive) Inconclusive. On an unknown date, Vital signs measurement: 139/86 (Inconclusive) Inconclusive, 119/81 (Inconclusive) Inconclusive and 120/84 (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
my tremor was not happening anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "parkinsons" (unspecified if ongoing), notes: normally takes medication to control the tremors, but it doesn't control them 100%. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Mar2021, outcome "unknown", described as "my tremor was not happening anymore".  Additional information: On Sunday afternoon the 04Mar2021, the patient received the Pfizer vaccine. The patient was 35-year-old Parkinsons patient and after receiving the vaccine about 9 hours later around 11pm I woke up and realized that my tremor was not happening anymore, the effects lasted until about 4 pm the next day. I would really like to speak with someone about the experience I had with your vaccine. Caller stated that he started experiencing tremors around 4:30-5:00 on 05Mar2021 evening. Caller stated that he normally takes medication to control the tremors, but it doesn't control them 100%.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse.  A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included levothyroxine.  The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:30 as dose 1, single (Lot number: EN6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: soy allergy" (unspecified if ongoing), notes: Known allergies: soy allergy. Concomitant medication(s) included: QVAR REDIHALER, start date: 06May2022, stop date: 15May2022. Past drug history included: Allergic to cipro antibiotic, reaction(s): "Allergy: Cipro", notes: Known allergies: Allergic to Cipro antibiotic. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: I tested still positive with Covid. Therapeutic measures were taken as a result of covid-19, vaccination failure.  No follow-up attempts are possible. No further information is expected.
Mother stated that she noted the child had rash on the right arm this morning. The child has had a virus past four days from Saturday 03/09 through 03/12. Diagnosed with cellulitis at site and treated with Augmentin 400 mgs per 12 hrs for 10 days/
Pt. received vaccine on 9/19/17 - same pt. came by our pharmacy on 1/10/18 to say that she had issues with muscle pain/weakness from the TDAP (ADACEL) vaccine from 9/19. She asked for the Lot number, expiration date and manufacturer of the vaccine on 1/10/18 which I gave to her. She was going to speak with her doctor regarding the issue with the muscle weakness after reading online that was a potential side effect of the vaccine.
I had a fever of 101 degrees. I had a sore throat, runny nose, body aches. All the flu symptoms. The next day, I felt better.
Employee reported throat was starting to swell; epinepherine was given at 9:30am.
c/oi itchy throat, itchy hands. vital  signs  monitored.  gave 50 mg  oral  suspension Benadryl.  monitored for 30 more minutes. vital  signs stable.  body itching continued. throat itching  improved.   denied lip,  throat  swelling.  has a  pcp appointment later today.
Within 2.5 hours post injection - severe itching, swelling, redness across both hands at knuckles.  Arm, shoulder and neck soreness/ache  increased overnight. About 20 hours post injection - Fever - 101.5 (my normal is 97.8);  severe chills; severe fatigue, weakness, and tiredness; unsteady; gas and bloating;  spitting up a lot of phlegm; coughing. About 40 hours post injection - Fever - 99.6;  all other symptoms improving. About 56 hours post injection - Fever -98.0; still some fatigue and warmth at injection site.
Pt went to urgent care today 9/7/2013. Pt has infection in arm - redness, swelling. Pt got shot at urgent care and prescribed cephalexin 500mg, 1 TID x 10 days.
This spontaneous report as received from an administrator refers to an 11 year old female patient. The patient had no pertinent medical history, drug reaction or allergies and concomitant therapies. On 09-MAR-2018, the patient was vaccinated with 1 injection of GARDASIL 9 (lot # N012093, expiry date: 13-JAN-2020) as part of 7th grade scheduled vaccinations. On approximately 10-MAR-2018, a day or two after receiving the vaccine, the patient developed an itchy rash on her chest, back, abdomen and legs and also complained of mild nausea. The patient returned to the office on the day of the report seeking treatment for the rash and underwent a strep screen culture, the results of which were not known. The patient was recommended treatment with unspecified doses of CLARITIN and BENADRYL to treat the rash and itching. The patient had not recovered from the events at the time of the report. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
swollen lymph nodes; Swelling under left eye; Leg pain in both legs; This is a spontaneous report from a contactable consumer(patient). A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the right arm on 15Feb2021 at 13:30 (at the age of 77-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on unspecified date as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin from unknown date and unknown if ongoing. Concomitant medication within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021, the patient experienced leg pain in both legs and still had the pain at the time of this report. On 9Mar2021, the patient experienced Swelling under left eye. On 10Mar2021 at 20:00, the patient experienced swollen lymph nodes right armpit after Shot 2. That is when she noticed and felt them. She was very concerned 10Mar2021. The patient did not receive any treatment for the events. The clinical outcome of the events Lymphadenopathy, Pain in extremity was not resolved at the time of this report while the outcome of the event swelling under left eye was resolved on 10Mar2021. No follow-up attempts are needed. No further information is expected.
pin prick rash on her trunk and face; 'possible' difficulty breathing; This case was reported by a pharmacist via and described the occurrence of painful rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced painful rash and difficulty breathing. On an unknown date, the outcome of the painful rash and difficulty breathing were unknown.   It was unknown if the reporter considered the painful rash and difficulty breathing to be related to Shingrix.  Additional details were provided as follwes: Age at vaccination was not reported. The reporter stated that, they have a patient who was reluctant to get her 2nd dose of Shingrix due to experiencing pin prick rash on her trunk and face and possible difficulty breathing 1st night after receiving 1st dose. The reporter unable to provide any additional details at time of chat, but stated that she would have additional information at another time. The reporter consented to follow up via email.
Adverse events:  -Sudden sensorineural hearing loss (SNHL) of right ear -Tinnitus  Treatment: -Prednisone 60 mg/day for 2 weeks
Patient reports that his arm was red, swollen, warm to touch for six days.  Reports his blood pressure was high and he had readings of 200/90 at times.    Patient was extremely fatigued for three days.  Patient had COVID 19 >120 days ago, was hospitalized and had heart issues at that time.    This reaction occurred after his first vaccination.
Reoccurring events of chest feeling abnormally hot. Random events of a sporadic heart rate while relaxed and at rest. Each event is unique such that I have never felt either symptom in these manners previously to getting this vaccine. The former symptom has gone away. The rapid heart rate at abnormal times is reoccurring.
I felt pain in the left lower abdomen in a small area which severely affected my sleep on the night of 12/30. Small amount of rashes were noticed in the morning of next day 12/31. The red blisters were expanding to form a horizontal belt in my left side for the coming 3 days. I visited facility in 1/4 and Dr. made the diagnosis of Shingles. While rashes appeared in my left side, my left eye upper lid felt itchy too; the lid got red and a little swell with a few small blistered. Dr. told me that what is in my eye is also shingles.  Dr. prescribed 3 days antivirals medicine Valacyclovir. While taking this medicine the symptom was getting better with less pain, rashes were turning to darker in color and not spreading. At this time, the pain on my side remains but much less severe and the rashes are getting much better.
Information has been received from physician's office concerning a 7 year old boy with no pertinent medical history who on 01-APR-2008 was vaccinated with the second dose of VARIVAX (Merck) injection (lot#: 659943/1800U). Concomitant therapy included ZOLOFT. Within four hours post vaccination, the patient experienced a "hive like reaction", tiredness, weakness. The "hive like reaction" went away. However, as of 02-APR-2008, the patient was still experiencing the tiredness and weakness. The date of the first dose was given was unknown. The patient was recovering from tiredness and weakness. The patient sought medical attention (unspecified). Additional information has been requested.
Vaccine administered 19 hours past initial puncture in multi-dose vial. Vaccine vial remained in refrigerator and was not subject to temperature changes.
I received a booster (third) shot of Moderna vaccine yesterday. Today I have a fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I received a booster (third) shot of Moderna vaccine yesterday. Today I have a fever of 101.7) 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 PYREXIA (I received a booster (third) shot of Moderna vaccine yesterday. Today I have a fever of 101.7). At the time of the report, PYREXIA (I received a booster (third) shot of Moderna vaccine yesterday. Today I have a fever of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pyrexia: 101.7 (High) Result : Patient had fever of 101.7 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
The wrong vaccine was inadvertently administered. The patient is 4 years old and the 6 month-4 years vaccine was ordered (3 mcg dose). The patient was instead given the 5-11 year dose of 10 mcg. The patient has had some vaccine injection site soreness but otherwise no other side effects from the inadvertent dosing error.
Started with rash/hives on trunk of body. Proceeded to develop the hives all over the body from neck down to feet. Gave cetirizine the first day. Gave Benadryl the second day.
Had immunizations on 11-18-08.  Came into office on 11-19-08 with rash that "looked" like insect bites all over body.  No fever.  Treated with Zyrtec.  Dx: Urticaria vs.
Adverse event NOS; This serious initial spontaneous safety report was received by Novavax on 27-DEC-2022 from a consumer via web portal.   A male of 55 year-old  was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 27-DEC-2022.  The following medical history was reported: Cerebral haemorrhage due to Physical assault (1992), Dust allergy, Food allergy and Seizure. It was also reported the individual received unspecified drugs on an unspecified date in SEP-2022.  The following concomitant medications were reported: Keppra (levetiracetam), ibuprofen and penicillin NOS.  On 27-DEC-2022, after vaccination, the individual experienced adverse event NOS (PT: Adverse event) (Serious: Disability and Life-Threatening). Adverse event details were reported as, "Looking for medical test too participate in and get paid. SARS COVID 14. Black Tar. Crack and medical test."   Treatment for the adverse event was reported as "No."  At the time of reporting, the event outcome of Adverse event was recovered with sequelae.  Lot number was not provided in the report.; Sender's Comments: This 55 year-old male experienced: Adverse event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Adverse event was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Was walking around and started to get dizzy, and blacked out fell. He woke up and thought he hit his head and yelled for help. Called an ambulance and they took to the ER. No trouble breathing.
Pt received flu and pneumo shots in left arm. Next day pt reported nausea, fever, vomiting. Day 3 had red mark on bicep, aching arm. Also developed pain and red blotch on both thighs that lasted 5 days.
Approx 8 hrs. after vaccination, patient complained of generalized muscle pains, headache, malaise, abdominal pain and was noted to have a fever of 101. Given Tyelenol, & one hr later fever was 102. Given Motrin.  Still is not feeling well.
101.9F fever onset 12 hours after second dose vaccination with associated myalgias. Lasted 8 hours
hives, fever, headache, chills, shortness of reath, anxiety, tacycardia , weez
After last vaccine was administered, client got off mothers lap and left room to join uncle in the hallway.  Uncle stated the client had fallen down.  Client then covered her eyes and said she could not see.  Mother help client back to exam room.  Client became unresponsive and pale approximately 3:50 pm, emergency medical services called, oxygen given, vitals continued to be monitored.  4:02 she opened her eyes slightly only, 4:03 emergency medical services resumed treatment.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of ROTATEQ, lot #K009900 with expiration date of 04-MAY-2016. The patient's concomitant medications were not reported. At the time of the report, the patient had no experienced any adverse event due to the vaccination. Furthermore, no product quality issue was involved. Additional information has been requested.
I was exposed to Covid 5 days after vaccine. I tested positive 10 days after vaccine. 12 days after has headache , aches, diarrhea. Got the Regeneron monoclonal antibody infusion s 1/18 and had throat swelling about 1 hour into the infusion and got benedryl.  Improved so went home then about 5 hours after the infusion. I had chest pain and chest tightness so went to the ER with concern if re action to this infusion.  Took benedryl and xopenex and that help.   I went home ER after PE and MI ruled out    Had fever a few days later so got augmentin.  The headache and aches from Covid slowly resolved.  No further chest pain.
The patient is a 52 year old female who presents with flu shot reaction. Pt came in yesterday 12/26/2013 9:30 to obtain a flu shot 10 - 12 hrs later she experienced some symptoms like ringing in both ears before going to bed waking up with both ears plugged and still ringing hard time breathing so took ADVAIR, lightheadedness and spacy, neck is stiff and with fatigue. Pt is an engineer and felt she was not able to think and had to stay home today, She describes it only as 'spacy' there is no disorientation or lapse of thought. She does have ADVAIR but it usually only needs it during allergy season. She fel like "I don't have a lot of spit' but not as if she cannot swallow The neck is stiff and muscle ache No headache She has no fever/chills Per pt she has NO allergy to eggs - in fact she used to eat so many she stopped due to her higher cholesterol She denies asthma - inhalers only for seasonal allergies Her primary symptom she would like assist with is - ringing in the ears and a feeling of ear stuffiness 10 yrs ago she had a headache and neck stiffness/nausea -extreme /chills for 4 days after the flu shot that season She swore she would never take the vaccine for influenza again The  is the first time she has taken the flu IZ since that reaction This event was not reported She did not seek ER or PCP provider.
The injection was extremely painful. The pain travelled throughout my arm down to my fingertips. My arm became numb. I was told by the nurse to move my arm around and sent me home ( she did not keep me for 15 minutes to monitor my reactions). I began to feel faint on my way home and pulled over. When I got home I noticed the vaccine was administered extremely high on my arm. Symptoms: headaches, arm pain ( both arms), Joint pain, nausea, fatigue. I have never had issues getting vaccines in the past.