chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The right leg gradually became weaker causing him to drag his right leg while walking. The dragging progressed to the right leg "giving out" causing him to fall. Three days later the left leg "gave out", again causing him to fall only this time he was unable to pick himself up. The next day he used a walker to move throughout his home but was able to hold himself up enough to move a couple of feet independently. The following morning he was unable to stand independently at all. On April 5th he got an emergency appointment with his GP who sent him to the ER. After multiple diagnostic tests, he was diagnosed with Gillian Barre Syndrome and admitted.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening). At the time of the report, IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening) outcome was unknown. No concomitant medications was reported. The reporter was forced to get the vaccine to keep on job and informed that because of the messenger in the vaccine this was happening. The reporter wanted to know how to get the vaccine out of their body. No treatment drug details was reported. Reporter did not allow further contact.
This is a spontaneous report received from a contactable reporter (Nurse). A 66-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 23Mar2021 as dose 1, single (Lot number: ER2613) and on 13Apr2021 as dose 2, single (Lot number: ER8730) at the age of 64 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), on 01Oct2021 as dose 3 (booster), single (Lot number: 30145BA) for Covid-19 immunisation. The patient's relevant medical history included: "Follicular lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Thimerosal, reaction(s): "Allergy"; Lanolin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, Covid-19. The patient received Paxlovid to treated vaccination failure, Covid-19. Treatment start date: 25May2022, treatment stop date: 29May2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
At 6: 28 pm patient reported that arm felt warm. Arm was reddened and had rash. Vitals taken every 5 minutes. 50 mg IM Benadryl administered.  Observed patient for 1 hour.  No further intervention needed. Patient went home with husband.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in August 2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M043424 with expiration date on 06-JUN-2018, (dose and  route of administration were not provided) for prophylaxis. The dose of PNEUMOVAX 23 was exposed to a temperature excursion of 31 degrees Fahrenheit (°F) or colder (26°F) during a time frame of 24 hours, with unknown number of cycles, which was detected by the data logger. There was no prior temperature excursion and no adverse events, neither product quality complaints were reported.; Sender's Comments: US-009507513-1709USA007929:
Pt received 1 IM and 1 SQ shot in (R) arm, post shot arm got red, hard, swollen. Painful enough to require ER visit, treated/w IM steroid injection and possible follow up for cellulitis per ER MD.
Numbness in left side of face, unable to close left eye completely, numbness in left side of mouth.  He went to the ER and the Doctor diagnosed as Bells Palsy and prescribed medicine.  He was put on Prednisone, Valacyclovir, and Genteal Tears.
I had a very sore arm which extended all throughout my left side, down to my hip and leg. I couldn?t walk properly or lay down comfortably for several days. I knew it was just a matter of time for the vaccine to do it?s , but it caused flare ups.
New / re-onset of asthma, dyspnea and tachycardia with minimal exertion, cough (persistent for 12 weeks, starting the night Pt received the vaccine and not resolving until early/mid-June). Pt had a remote h/o asthma as a child but had not had any flare-ups since he was 12 years old. He is a never-smoker and does not have COPD.
Fever 102 on day 5, relieved with Tylenol. Continued day 6 with temp 103, relieved with Tylenol. Increased thirst, fidgety.
Covid-19 antibody test below 4; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Enzyme abnormality (Patient's past medical history included: Enzyme.). Concurrent medical conditions included Multiple sclerosis (Patient's concurrent condition included: Relapsing forms of Multiple Sclerosis.). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4). At the time of the report, SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 antibody test: <4 (Inconclusive) On 28-Apr-2021, it was reported that patient experienced: Covid Antibody test below 4..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment  was provided.
Aching; Chills; had three falls; two motor vehicle accidents; affected her right shoulder and arm; bowel movement difficulty; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo.   In October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea. On an unknown date, the outcome of the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea were unknown.   It was unknown if the reporter considered the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose Shingrix. The patient experienced the events during the period between her first and second vaccine. The reporter did not consent to follow up. The patient reported bowel movement difficulty.  The patient reported nausea that worsened in 2019, and alleviated May 2020.  The patient reported she was prescribed an antiemetic to treat nausea. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176013:same patient
short of breath to the point that I had to go to the ER, symptoms lasted for about 10 days and I still not feeling 100%, dizziness, unable to function for 10 days, only laying down make me feel better
C/O soreness and stiffness in neck on left side, nurse noted possible lymph node swelling on left side of neck
Fever 102 started 12/24. Maculopapular rash 12/26 - 12/30.
Parent requested Pfizer Monovalent  2nd dose for 5 yo patient.   Pharmacy supplied nurse with Pfizer Bivalent even though Monovalent was verbally requested.    Vial for Pfizer Monovalent and Bivalent are colored coding is identical.   Orange cap, orange border.  Pt received Pfizer Bivalent as a second dose in the primary series.
heart pain; This is a spontaneous report from a non-contactable consumer or other non healthcare professional.   A 31-years-old female patient received second dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 28Jun2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation (lot unknown reason: Not available/provided to reporter at the time of report completion). Patient did not receive any other vaccination within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had earlier received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 07Jun2021 18:30 as dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jun2021 at 07:30 the patient experienced heart pain. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event heart pain was reported as recovering.  No follow-up attempts are possible. No further information is expected.
fatiqued/fatique still lingers on; muscle aches; sore arm; last night he woke up after 4 hrs of sleep in sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatiqued/fatique still lingers on"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "last night he woke up after 4 hrs of sleep in sweat".  Additional information: Swap from FC  first time caller 77 yr. old male got first 6 days ago and since then he has been fatiqued and asking if this is normal. He also had muscle aches and sore arm immediately after the vaccine but fatique still lingers on. He states last night he woke up after 4 hrs. of sleep in sweat. Provided number and transferred to medical information, hold que. Due to hold time. Will fax to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Five days post vax, pt developed blue spells and was admitted. She underwent a full sepsis work-up, cardiac work-up and all were normal. It was possibly a vaccine related reaction.
I have pain in the armpit area that started on 3/30 in the evening; visional swelling on in the left armpit area above the breast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure/ allergies. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient also received Desloratin within 2 weeks of vaccination. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. Since 30Mar2021 17.30 (05:30 PM) evening, the patient had pain in the armpit area. The patient took Tylenol before going to bed. This morning (30Mar2021) there was visional swelling on in the left armpit area above the breast. Outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Redness around injection Swelling at injection site Injection site is warm to touch different than other areas Chills Low grade fever Body aches
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, frequency and route of administration were not reported). No adverse effects reported. Additional information has been requested.
he gave a first dose of ROTATEQ to a 4 month old; This spontaneous report has been received from a physician via a company representative concerning to a 4-month-old patient of an unknown gender.   Information concerning patient's pertinent concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 01-SEP-2020, the 4-month-old patient was administered with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) taken orally (PO) (dose, frequency, lot number and expiration date were not reported) as prophylaxis. It was stated that the physician was unable to retrieve the product vial as it was disposed on that day after immunization.
face and lip swelling and severe oral burning pain and ulcers in mouth lasting over 1 week
Irregular menstrual spotting every 2-3 weeks for a few months beginning about 2 weeks after dose 2. I have a hormonal IUD (Lileta) and typically have no menstrual bleeding at all.
07/05/2022, I started feeling bad. I went downstairs and took a test and it went to positive immediately. I called my doctor and started PAXLOVID that afternoon. I went to bed for 4 or 5 days. I was feeling better when I ran out of PAXLOVID.
Information has been received from a medical assistant concerning a 20 year old female with hypothyroidism who on 19-JUL-2007 was vaccinated with a 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658222/0927U). Concomitant therapy included SYNTHROID. On 20-JUL-2007 the patient developed swelling to her face and lips, shortness of breath, and difficulty breathing. The patient was treated in the emergency room with BENADRYL and Prednisone. Subsequently, the patient recovered. The reporting medical assistant considered swelling of the face and lips, shortness of breath, and difficulty breathing to be another important medical events. Additional information has been requested.
Dizziness; Confusion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion). At the time of the report, DIZZINESS (Dizziness) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications details was provided. No treatment drug details was included.
Vaccine administration error - pt presented to outreach event for vaccine, received dose of Pfizer vaccine.   Following the event data entry into Middle School showed patient may have received dose of Moderna on 2/8/2021.
Individual has MS and had an exaacerbation of symptoms, i.e., muscle spasms and weakness.
I am currently having severe menstrual flow; I was on the aspirin before without such a heavy flow. My current flow is almost 10x what it was.; Also I am now having frequent head aches; dose number: 2 administration date: 06Apr2021/dose number: 1 administration date: 06Apr2021; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number er8731), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot Number: ep7533) as DOSE 1, SINGLE for covid-19 immunization. No other vaccine in four weeks, and other medications in two weeks: asprin 81mg. Medical history included sinus disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took septra and experienced hypersensitivity. On 22May2021 the patient experienced i am currently having severe menstrual flow, i was on the aspirin before without such a heavy flow. my current flow is almost 10x what it was, also i am now having frequent head aches. No COVID prior vaccination, and no COVID tested post vaccination. On 06Apr2021 dose number: 2 administration date: 06apr2021/dose number: 1 administration date: 06apr2021. 06Apr2021 the outcome of event on 06Apr2021 was recovered, and other events was not recovered  Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Day after injection site was tender to touch. Second day after it was red and feverish under the site. More tender to touch and itchy.
Did okay in the first hour, no issues.   Began to get mild muscle cramps in side of face, jaw, down both sides of neck, upper left shoulder with finger and upper right foot tingling, left wrist tightness, and itching in both armpits, upper inner arms and upper back and irritability while driving home. Went to Urgent Care. All seemed to resolve except itching, muscle pain, irritability. Itching started in legs. Was given shot of Benadryl and oral Prednisone which helped. Woke up with nausea, headache, fever, abdominal pain, muscle aches, but no itchiness. No continued irritability. Feel dehydrated now. Have had fluids. Still very dry. Headache is worse. Having some trouble getting enough  fluids  in. Will keep trying and call physician next.
Anthrax vaccine given 7/28/08 presented 2 day later with a moderate size local reaction on left deltoid.  Redness & swelling & pain 7x5cm.
Hospitalized 01/24/2022; COVID-19 positive 01/24/2022; fully vaccinated plus booster   Admission Date: 1/24/2022 Discharge Date: 1/28/2022 PRESENTING PROBLEM: Acute cholecystitis [K81.0] Cholecystitis, acute [K81.0] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 82 year old female with a PMH of HTN and DM who presented to the ED on 1/25/2022 with acute cholecystitis. Of note, the patient tested positive for COVID-19 on 1/24/2022, which was managed conservatively while inpatient given her lack of supplemental oxygen requirements. Patient underwent cholecystostomy tube placement on 1/26/22, which was tolerated well. At the time of discharge, patient was tolerating po intake, voiding spontaneously and ambulating without difficulty. Discharge instructions were provided; all questions and concerns were addressed. Patient was discharged home in stable condition.
On 07/23/01, not feeling well, no specific symptoms. On 07/24/01, 9 AM, low grade fever, swelling left side parotid area. On 07/25/01, 3 AM, 101.9 fever, golf ball size swelling left parotid area, confused, and hallucinating. Taken to the ER. No meds prescribed. The doctor diagnosed mumps disease, treat symptoms. Recovering.
Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection.  Received vaccine at 9:15 AM.  She initially felt well, but about 20-30 minutes after administration began to feel dizzy.  Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration.  Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx.  However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain.   By 11:08 no longer had symptoms except for arm pain.  By 11:43 still feeling back to normal except for arm pain.
expired diluent that was administered with MMR II; This spontaneous report as received from a medical assistant, referring to a 38 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 22-AUG-200, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) lot # R031679, expiration date 01-NOV-2020, for prophylaxis (strength, dose, route and frequency were not reported), that was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot# S018821, expiration date 22-AUG-2020 (strength, dose, route, frequency and indication were not reported).
Intense itching in areas of sweating.  Arm Pits, groin, between breasts.  Lip tingling and wheezing. Itching & wheezing relieved with benadryl.  Itching continued with less severity for 36 hrs.
Pt received Pfizer covid vaccine at 1230pm at approx. 1237pm pt became nauseated and began to vomit with lightheadedness VS: 139/91, 86 ,pox 98%. Pt vomited multiple times over a 15 minute period of time. Pt alert no c/o pain m  or trouble breathing. VS: 125/84, 100, pox 99% temp 99.8. Lightheadedness and vomiting continue. 126 pm VS: 128/88,92 pox 100% Temp 100, vomiting continued with increased lightheadedness.  At 123pm 911 called, arrived at 129pm  and left with pt at 133pm .
3 days p/vax t101 fever for three days (no fever first 3 days p/vax);