chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient (age not reported), who was vaccinated with a dose of GARDASIL (dose and lot not reported). Physician stated that a patient experienced severe numbness in her arm for 2 weeks after administration of GARDASIL. This occurred 1 to 2 years ago. In follow-up, the physician stated that she had no available information concerning the patient, since she was vaccinated and treated at another office. The physician considered that severe numbness in her arm was disabling. The patient's outcome at the time of the report was unknown. Patient sought medical attention via office visit. The healthcare professional contacted during telephone call, could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is one of two reports from the same source. No further information is available.
On 11/15/13 pt received High Dose Influenza vaccine 1 hour later felt very tired, then around 6 pm throat felt tight and itchy. She had difficulty swallowing. Took aspirin and drank water after two hours she felt better but had a lingering dry cough through the next day. Also had a runny nose along with throat tightness.
FEW TEETH PULLED; ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and INFLUENZA VACCINE for Vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE). At the time of the report, TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Muscle pain and muscle tightening all over my body, fatigue, fever, chills, night sweats that lasted overnight. Muscle pain and fatigue lasted for 1 day after vaccination. Tylenol 500mg helped but I had to call out of work.
Information has been received from a licensed practical nurse reporting on two patients of unknown ages and genders. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date in May 2018 (reported as since 03-MAY-2018), the patients received an improperly stored dose of GARDASIL 9 for prophylaxis (N020353 lot number and expiration date 28-APR-2020) (anatomical location, route of administration, strength and dose were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature bellow 0 degrees Celsius (C) (-2.10 degrees C) for 20 minutes. The licensed practical nurse reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Pt recvd 2nd dose of MMR vax 6SEP91 & devel redness, warmth & 4+ edema @ inject site on arm; no further details were provided;
Tonic-clinic non-epileptic seizure during sleep. Taken to ER via ambulance. No treatment given.
Gradually developed binocular diplopia (double vision) beginning 10/10/2022 and having full field double vision by 10/12/2022. Visited optometrist on 10/13/2022 who determined no problems with the eyes themselves and suggested the cause could be neurological.  With no improvement, went to ER on 10/15/2022.  (See Item 19 for treatment.)  After testing, neurologist diagnosed idiopathic sixth cranial nerve palsy in right eye.  He projected that this would possibly clear up on its own in 3-6 months and suggested that I see a neurosurgeon-opthomologist if no improvement after 3 months.  After 2 months, the double vision has mostly cleared with only a small section in right field of vision still with double images.
Information has been received from a pharmacist referring to a 48 year old female patient who was some type of healthcare provider. The patient had no drug reactions or allergies. The patient told that on 28-JAN-2016, she might have been vaccinated with a dose of ZOSTAVAX (dose unknown, lot # reported as L027321, expiry date: 21-OCT-2016) via intradermal route instead of subcutaneous route. On an unknown date, the patient experienced induration around injection site which was a common reaction for intradermal injection (according to the patient). The other pharmacist who actually administered ZOSTAVAX to the patient stated that she was certain that she administered ZOSTAVAX via subcutaneous route. The outcome of induration around injection site and causality between induration around injection site and ZOSTAVAX were not reported. Additional information has been requested.
C/O left arm redness, burning, and whelp next day after shot given. Reports going to walk in clinic and prescribed cream 2 weeks after symptoms started. Reports site where Zoster vaccine given.
Flu-like symptoms ... achiness all over my body (particularly in my lower back and joints), 100 degree temperature, moderately severe headache. I took two 500mg Extra Strength Tylenol caplets this afternoon, but it didn't help much, so I plan to try Advil this evening before I go to bed. This is basically the same way I felt after getting the first dose in April.
This spontaneous report as received from a consumer refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. The reporter stated that he had seen a video on the website about a year ago, saying that a patient was vaccinated with a dose of GARDASIL (formulation, strength, dose, lot number and expiry date were not reported) (date of vaccination was not reported). On an unknown date, a week after vaccination (reported as a week after) the patient died. Product quality complaint (PQC) was not involved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Redness, swelling and warmth of the entire uuper right arm as well as numerous hives present. Dyaphoresis also present.
Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive; Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 25Oct2022 as dose number unknown, single (Lot number: 942381) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Feb2023, outcome "recovering" and all described as "Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient was diagnosed as COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Pt recvd vax prior to 15NOV; 25NOV exp Proximal leg weakness L>R than weakness progressing by 28NOV could no longer walk; In past 2-3 days has had paresthesias fingers-thumbs; GBS;
muscle aches and pains, low grade fever, extremely tired for 3 days. baseball sized swelling and redness around injection site.
Red swollen 71/2 x 9cm given on (R) Delt - No pain or fever.
Leg and back body pain; body aches in her legs and back area; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 11 hrs after receiving Shingrix, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were unknown.   It was unknown if the reporter considered the leg pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 20th November 2019, at 2 pm, the patient received dose of Shingrix and at about 1am at night later experienced body aches in her legs and back area. No further details were provided. The reporter did not consent to follow up.
pt recv vax; started w/ fever 105; to ER & adm; also had rash & bilateral otitis med; fever cont till 26may96;
Vaccine was administered at approx 6 pm on 9/16/13. Upon awakening at 7 AM on 9/17/13 he noticed an area of induration that measured 3" x 2". The area was reddened and warm to touch. He stated that there was some itchiness and slight tenderness on palpitation. No other sx reported.
Repeated nocturnal priaprism  lasting unknown time. Patient states every time he woke up he had an erection so he stayed awake one time and it took 40 minutes to resolve. This was the night of the 2nd vaccination. Vaccination was around 1350 4/21/2021
1815: Pt received vaccine and Grandmother with patient waved down staff and quickly reported feeling unable to breathe to EMT on site VS: BP 128/76, HR 54, O2 97%, RR 16  Pt reports not eating for a few hours. Pt given PBJ crackers and soda. Pt reports feeling better and denies chest tightness. at approximately 1820.   EMT took the pt back to a room where pt stated that she was having trouble breathing. Pt VS: BP 128/76, HR 48, SpO2 99%, RR 16. Pt stated that she was fine after her 1st dose but that today she had only eaten 2 granola bars. Pt stated that she felt like she just could not take a breath initially, but denied SOB currently at this time. No retractions or distress noted. Pt stayed under observation with EMT for ~ 20 minutes.  BP 118/68, HR 74,  SpO2 100%.   Grandmother stated that the pt has no medical hx no asthma or any lung related hx. Pt was released under legal guardian's care (grandmother) at approximately 1839. Pt ambulated steadily, denied need for further medical care. No distress noted. Vitals stable.
Information has been received from a physician concerning a female who on 27-SEP-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, approximately one to one and an a half months after receiving the first dose of GARDASIL the patient developed a headache that lasted approximately one month. The physician does not believe this adverse experience is related to the vaccine and therefore does not wish to be contacted regarding this event. It is unknown at this time whether or not the patient will receive the second and third doses. No further information was provided. Additional information is not expected.
Patient was vaccinated at 6:00pm and told to stay at the store until 6:15pm. At approximately 6:40, while sitting in her car, she passed out. She had a friend with her that either called 911 or drove her to the emergency room.
Shingles; Pain; Cold; Chest was heavy; Bad shoulder; He didn´t sleep at all; Headache; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles), PAIN (Pain), NASOPHARYNGITIS (Cold), CHEST DISCOMFORT (Chest was heavy) and MUSCULOSKELETAL DISCOMFORT (Bad shoulder) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS764SB) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 1, Batch number:- 001A21A) on 21-Feb-2021, Covid-19 vaccine (Dose 2, batch number:- 006B21A) on 21-Mar-2021, Covid-19 vaccine (Dose 3, batch number:- 031H21A) on 22-Nov-2021, Covid-19 vaccine (Dose 4, batch number:- 004M21A) on 12-May-2022, Covid-19 vaccine (Dose 5 and batch number:- - 062F22A) on 05-Oct-2022. Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine and Covid-19 vaccine.    On 02-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Aug-2023, the patient experienced HERPES ZOSTER (Shingles), PAIN (Pain), NASOPHARYNGITIS (Cold), SLEEP DISORDER (He didn´t sleep at all) and HEADACHE (Headache). 02-Aug-2023, the patient experienced CHEST DISCOMFORT (Chest was heavy) and MUSCULOSKELETAL DISCOMFORT (Bad shoulder). At the time of the report, HERPES ZOSTER (Shingles), PAIN (Pain), NASOPHARYNGITIS (Cold), CHEST DISCOMFORT (Chest was heavy), MUSCULOSKELETAL DISCOMFORT (Bad shoulder), SLEEP DISORDER (He didn´t sleep at all) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2023, SARS-CoV-2 test: Negative.         It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 02-Aug-2023, patient received a dose of co-suspect Shingles vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient felt really horrible during the night after receiving the vaccines. It was the worst night of his life. He didn´t sleep at all. He was in pain, he felt runny, like he was coming down with a cold and had a headache. He mentioned that his chest was heavy, he was breathing fine but it was painful. He also mentioned having a bad shoulder. Next morning he did a Covid-19 test and it came out negative. He mentioned a few times that he believes that this was because of the Shingles vaccine, because it hurt, but the Moderna vaccine they didn´t feel it. It was the shingles shot the one that hurt him and his wife. At the time of reporting patient was feeling much better.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735487 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735487:Wife's case
patient called the day after vaccine of 2nd dose stating their arm was swollen and the had fever and body aches. pt instructed to use ice pack and tylenol and motrin /rest and fluids/ to call dr if it got worse.
Moderna Monovalent given instead f bivalent. No adverse effects or symptoms reported by caregiver
Transient hemiparesis, rhabdomyolysis, myoclobinuria, elevated CPK reported in pt receiving FLuogen; pt exp weakness, fatigue, malaise w/o feve & transient hemiparesis; pt hospitalized w/dx rhabdomyolysis & myoglobinuria;
headache; chills; Feeling hot; Weakness; tiredness; This is a spontaneous report from a contactable consumer(Patient). A 71-year-old female received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number:EN6202) via an unspecified route of administration into arm left on 24Feb2021 as DOSE 2, SINGLE for covid-19 immunization(at an age of 71 years) The patient medical history had included A-fib (Caller initially calls this a rapid heartbeat situation, and was diagnosed about 5 months ago maybe.) and blood pressure high (Caller said this was diagnosed about 25-28 years ago). The patient concomitant medication were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number: EL9269) via an unspecified route of administration in left arm on 03Feb2021 as DOSE 1, SINGLE for covid-19 immunization and she had no problems with her first dose. On 25Feb2021, the patient had experienced tiredness, headache, felling hot, chills and weakness. Caller said her side effects are tiredness, headache, and chills. She said she doesn't have a thermometer to take her temp but she feels hot so she thinks she has a temp. She said she was also feeling weak. She said she took a Tylenol because she doesn't know what else to do, which was why she called today. She said she also drank some tea to get rid of chills. The clinical outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Had hives with itching on back, buttocks, legs and face 2 hours after vax. Patient told his mom he did not feel well. His mom gave him Benadryl 1/21/2000 & 11/22/2000. Rash was worse 11/22/2000 but had started to go away by the time seen by MD. MD's treatment was cortisone cream to rash and Benadryl.
Within 20 minutes of receiving the vaccine, I started having uncontrollable itching. My tongue and lips were tingling, my body turned bright red, I could feel my heart rate go up, I was very dizzy, had a headache that was almost as bad as migraines, I got chills, my temperature went up, and my mouth became very dry. I was treated by paramedics with benadryl and a steroid and sent to emergency room. From there, they did blood work and monitored me for 3 hours. I was still very itchy going home where I was told to take benadryl every 6 hours. It didn't help much. I didn't sleep that night at all due to itching, headache, and dry mouth. I felt like something was crawling all over me. The next day I was still very itchy, my finger tips felt like they had been burned, and my lips, tongue, and face still felt swollen. I called my doctor and was prescribed a steroid because my symptoms were persistent and I couldn't deal with the itching. Today is day 4 from the vaccine and I'm still itching and my tongue still isn't normal. I also still have the headache and my fingertips still feel like they were burned.
exposed to someone (her son) with covid symptoms; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 13Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 13Feb2021, the patient received the first dose and was scheduled to get the second dose on 06Mar2021 but on 28Feb2021 she was exposed to someone (her son) with covid symptoms. The patient took a test, but he doesn't know the results yet. He wanted to know how much protection he has from the first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Pt vax /w Fluogen developed flushing sensation, red face, c/o nausea, vomited x 2. Red raised rash covered trunk, face, & ears with splotchy rash on arms. Vomit X 2, sent to ER.
NAME/DATE OF COVID-19 VACCINATION NOT DOCUMENTED PT ADMITTED TO HOSPITAL 7/9/2021 ADMITTED TO HOSPITAL 7/9/2021 WITH SEVERE PULMONARY HYPERTENSION, N/V
Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...looks like a contact dermatitis. Left wrist Topicals not helping. Wears a watch on that wrist, but not that day.
On 11/3/15 pt received flu vaccine and soon after developed headache and achy feeling all over her body. Later in the day she developed nausea and eventually right facial numbness. At school on 11/4 she noticed that she had a red splotchy rash on the right side of her face and neck that resolved after several hours. She also developed swelling around her right eye and the pain that felt like pressure behind her right eye worsened. She noticed that some colors began looking different in her right eye and later that day developed some sensitivity to light and a feeling that the back of her tongue and right side of throat was numb. That night they were seen in an Urgent care and started on a course of steroids. She woke on the morning of day of admission with worsening light sensitivity, nausea and pressure behind her right eye. She also began having trouble opening her right eye. No fevers throughout this time and no paresthesias or weakness in any extremities. In the hospital, the patient is currently receiving a 5 day course of IV methylprednisolone and testing. Patient received seasonal influenza vaccination in 2014 and developed similar facial and ophthalmic symptoms.
Initial report received from health care professional on 23 OCTOBER 2013. A female patient (age unknown), medical history and concomitant medications were not reported, had received a dose of FUZONE (lot number unknown, route intramuscular and site of vaccination was unknown) on an unknown date. On an unknown date, after receiving vaccine, the patient experienced numbness and major pain for several hours. At the time of this report, outcome of events were unknown. Documents held by sender: None.
This spontaneous report as received from two pharmacists (one vial field representative) refers to a patient of unknown age. On 11-AUG-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 4 of several reports from same reporter. Additional information has been requested.