chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was retrieved from the scientific literature on 15 March 2011. Verbatim from the report: "A 59-year-old man developed nausea and lightheadedness 45 minutes after receiving the 2009 H1N1 monovalent inactivated influenza vaccine intramuscular lt (0.5 mL). Concurrent medications included aspirin (325 mg/d), lisinopril (20 mg/d), furosemide (40 mg/d), spirocolactone (25 mg/d), pravastatin (40 mg/d), hydralazine (50 mg 3 times/d), isosorbide mononitrate (20 mg twice/d), ranitidine (150 mg twice/d), theophylline (200 mg twice/d), and tiotropium bromide and budesonide inhalers. The patient had received the trivalent seasonal influenza vaccine 2 months earlier without incident. The patient's wife reported rhythmic jerking of all extremities that lasted 4 minutes, associated with eye rolling, frothy oral secretions, bladder and bowel incontinence, diminished responsiveness, and confusion. The patient's mental status had resolved on arrival to the emergency room approximately 90 minutes after receiving the vaccine. Physical examination was unremarkable except for end-expiratory wheezing. Abnormal labs were elevations in alanine aminotransferase (108 U/L) and aspartate aminotransferase (121 U/L) levels. His theophylline level was subtherapeutic at 6.6 mg/dL. Electroencephalography and noncontrast computed tomography scan were normal. The authors concluded that there is a possible association between the receipt of the H1N1 influenza vaccine and new-onset seizure. According to the Naranjo adverse drug reaction probability scale, the seizure was "possible" adverse drug reaction from the vaccine. The mechanism of the association is unclear." Documents held by sender: none.
Fever 100.7, chills, body aches, weakness, fatigue, severe headache, and nausea  6am when I woke up until I went to bed for the day at 830pm
severe pain; inability to use their right arm, lack of arm function lasted until 36 hours; some tenderness of the right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain), MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) and VACCINATION SITE PAIN (some tenderness of the right arm injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A31A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN (severe pain). 19-Apr-2021, the patient experienced MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) and VACCINATION SITE PAIN (some tenderness of the right arm injection site). On 20-Apr-2021, MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) was resolving. At the time of the report, PAIN (severe pain) and VACCINATION SITE PAIN (some tenderness of the right arm injection site) outcome was unknown.            The action taken was not applicable after second dose of mRNA-1273.  Patient reported motion in both arms is slowly recovering.   No concomitant medications or treatments were reported.   This case was linked to INC.-MOD-2021-117959 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-117959:First Dose Case
This spontaneous report as received from a registered nurse refers to a 23 year old female patient with none pertinent medical history or drug reaction allergies. In 1992 the patient received the first dose of M-M-R II (Lot # not reported) (dose and route not reported) and in 1996 the patient received the second dose of M-M-R II (Lot # not reported) (dose and route not reported). There was no concomitant therapy. On 04-APR-2014 antibody titer was drawn and the patient failed to seroconvert. The patient will be vaccinated with another dose of M-M-R II. No treatment was given for the adverse event. The outcome of client failed to seroconvert and no therapeutic response was unknown. Additional information has been requested.
Patient was walking in the store, said she started feeling anxious and light headed and began to feel like she was going to pass out.  The manager came and got me and we went to her.  She was seated and I gave her water.  After about 10 minutes she said she felt better and said she wanted to leave.  I walked her to her car, helped her load her groceries in the car and she left with her sister.  An incident report was written by store management
MYALGIA, NAUSEA, COLD SWEATS, CHILLS,  HEADACHE Narrative:   Other Relevant History:
Woke up, extreme sore throat-closing, chills/sweating, dizzy, horrible H/A, body aches. Friend picked up and took to urgent care. Treated with Abx, tested for strep throat=result negative.
Sweaty, runny nose, cough and fever. The ER summary received on 2/9/04 states short of breath, croup, stridor, vomiting, otitis, wheezing and viral pneumonia.
Information has been received from a health professional concerning an 88 year old female who on 19-Oct-2005 or 20-Oct-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650649/0790P). Subsequently, the patient experienced a red raised, swollen, hot lesion with a red line down her arm. She was admitted to the hospital the day after the adverse event began. The patient's recovery status is unknown. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a 4 month old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. The patient had PENTACEL and PREVNAR as concomitant therapies administered on an unknown date. On 04-OCT-2016 the patient was vaccinated with ROTATEQ lot number M014544, expiration date 27-NOV-2017; orally (dose number were not provided). On 04-OCT-2016, 4 hours after receiving ROTATEQ, the patient developed hematochezia stools through the night and 7 episodes of diarrhea through the night. The patient received unspecified treatment for the events and lab diagnosis studies performed included a complete blood count (results were not provided). At the time of the report, on 05-OCT-2016 hematochezia and diarrhea were resolved. There was no product quality complaint involved. Upon internal review, haematochezia was considered to be medically significant. Additional information has been requested.
I had chills & Fever started at 4P-3-6-19 chills & Fever lasted until I had surg. to Rt arm-I had shooting pain from my fingers to my shoulder I had clindamycin 300mg cap- before or-after OR-back
No adverse effects reported; One expired dose of MMR II was administered to a patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 19-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(rHA) lot # M045400 with expiration date of 14-NOV-2019, intramuscularly for prophylaxis (dose was not provided).
Complex febrile seizures. Fever began 8/2/10 in evening. Measured at 7:30 am on 8/3 -> 102.5, had stiffening episodes and eye deviation. Taken to ER. Given TYLENOL and MOTRIN over next 5-6 hrs. 2nd seizure at 4:30 pm, just before next dose of TYLENOL: 60 sec. tonic clonic sz. LP (-). UA/UC (-). WBC 5.7. (T 103.2) with 59P, 9B, Bld Cx (-). CXR (-). Observed x 24 hrs in hospital. Fever gone by 8/6. No antibiotics given.
Fainting with difficulty reviving. Event lasted approximately 3 minutes and 2 ammonia packets were used with limited success. Patient reported that she was unable to hear or see during event. After initial event, patient was taken by wheelchair to room to lie down where she reported feeling hot though she was cool to the touch. It took approximately 10-15 minutes for her to recover color and feel well enough to speak with staff.
The pharmacy technician pulled the wrong product (Infanrix, DTaP) from the refrigerator to restock the pediatric emergency room refrigerators with Adacel (Tdap).  Pharmacy carries Adacel for Pediatric ED and Pediatric Inpatient.  Pharmacy carries Infanrix only for the off-site practices the hospital stock meds for.  Once discovered by nursing when requesting restock, 3 weeks had passed.  Eight patients were potentially affected.  Upon review of the charts, only one patient actually got the DTaP instead of Tdap.  The patient's parents were notified, no adverse outcome to the patient.  The physicians were writing for the drug as Tdap, DTaP and Td, the medication is not listed in the pharmacy profile or the automated dispensing machines with these designations.  We also noted that Adult physicians were still writing for Tetanus-Diphtheria (TD) for adolescent and not following the updated 2006 CDC guidelines for adolescent patients 11-18 to receive Adacel (Tdap).  Additionally during chart review, we found that the documentation was not consistently in the same place or done completely (drug name, site administered, lot number, expiration date).  And the vaccine information sheets were not routinely given to the patient.  Tdap and DTaP are currently not allowed abbreviation and the policy was bypassed.  Pharmacy segregated the two product in the pharmacy refrigerator.  Pharmacy changed the designation of the products to be consistent with the labeling on the packaging.  Pharmacy requested ED physicians to write ADACEL instead of Tdap; ED evaluating a trigger on the physician order sheet with Adacel preprinted.  Pharmacy to implement bar-coding of the automated dispensing cabinet to reduce stocking errors.  Documentation of the vaccination to be consistent and placed on the Content for immunization form with triggers for the required information and directions to provide the vaccination information sheet to be universal for the hospital and related sites.  The use of Adacel for all patients (11-64) is being evaluated by the ED leadership.  Vaccines are not emergent medications and are being evaluated pharmacy review instead of the override status the vaccines are currently in.  Education to be provided to all staff regarding the updated CDC recommendations the writing the brand name of the medication in the order.  Medication Order writing policy to be enforced regarding the abbreviations.
About 1 day after the vaccine, I started to notice a rapid heart rate.  I monitored it throughout the day and each time my heart rate was in excess of 100 beats per minute.  My normal value is around 70 beats per minute.  I continued to monitor throughout the night and into the next day (Sunday) with my heart rate maxing out at 140 beats per minute, but again, never going lower than 100 beats per minute.  At this time, I went to urgent care to make sure nothing too serious was occurring.
Received 40 mcg of Heplisav-B; Initial Report Received on 23-Aug-2021  A registered nurse ) reported that a 68 year-old female patient (race and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on the same day.   The patient was on dialysis and does not have any allergies. No other relevant medical history was reported.  No relevant concomitant medications were reported.  On 23-Aug-2021, the patient received a total of 40 mcg dose of HEPLISAV-B (Lot # 935840, expiration date 11-Sep-2022, NDC # 43528-003-05; serial number not reported). One dose of 20 mcg of HEPLISAV-B was given in the right deltoid and the other dose of 20 mcg was given in left deltoid; totaling 40 mcg of HEPLISAV-B given that day. The patient did not report any side effects.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient with history of fear of needles and anxiety experienced dizziness, nausea, and an abnormal tongue sensation ~5 minutes after receiving the vaccination. Patient denied any treatment or further follow-up (paramedics and/or ER). Vitals 148/70, HR 74.
Pfizer bivalent booster was administered 14 days ahead of recommended administration time (less than 2 months after last dose).
Patient developed a red rash in the area where the vaccine was given.  She said it itchess and it is warm to touch.
Information has been received from a female consumer who was vaccinated on an unspecified date with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced a hard, itchy two inch square at the injection site.  It was unspecified if medical attention was sought.  No outcome was reported.  This is one of several reports by the same reporter.  Additional information has been requested.
PATIENT WAS SEIZING IN THE WAITING CHAIR FOR ABOUT 30 SECONDS. PATENT STATES THAT SHE LIKE SHE "WENT TO SLEEP"
Received HPV (#2) flu vaccine 1/12/15. Woke up that night shivering, temp 100.5, c/o trouble moving hips/pain in hips, vomited x1 stayed home next day because legs felt wierd. Then full recovery next day.
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
Chills, body aches, nausea, vomiting then diarrhea continued until Monday.
Past medical history of renal transplant in 2012, secondary to history of renal cell cancer.  On immunosuppressive medications.  Chest xray shows mild opacities.  Pt increasingly confused.
The patient presented with a nickel sized welt on his right thigh where the MMR vaccine was injected 5 minutes after the immunization was administered. The physician was immediately alerted to the adverse reaction and monitored his vitals. They were normal. We had the patient and his mom stick around in the office for 20 minutes. His vitals were rechecked where they remained normal. The patient was then released and mom was informed to call the office or seek emergency care if he developed any breathing issues.
Fluzone Quadrivalent was inadvertently administered to patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316262, 2019SA316263, 2019SA316288, 2019SA316289, 2019SA316290 (same reporter).  This case involves a 85 years old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the right deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue, very painful whole arm. Painful elbow and wrist - unable to find comfortable position. Lasted 10 days.
Gave booster shot of 0.25ml however a significant amount of vaccine leaked out in between the needle and the syringe during the vaccination and in fact the syringe separated from the needle when the syringe was retracted. Therefor the patient was offered and accepted a revaccination of 0.25ml Moderna
L leg injection site is red and swollen > 2 inches. Redness is an elevated wheal. Pt c/o difficulty walking and pain at sight.
little icky; This case was reported by a consumer and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient's wife reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt little icky for a couple of days. The patient thought he had shingles again after the Pfizer shot, but they had learned that it was a common reaction and not shingles although it looked just like them but were bilateral and extremely itchy and therefore the patient would not be getting any booster. The follow-up would not possible as no contact details were available.
medical assistant administered the diluent portion only of a PENTACEL vaccine with no reported adverse event; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event ,while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 21-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (lot UJ57AAA) at a dose of 0.5ml via intramuscular route in the left thigh as prophylactic vaccination.  On 21-JAN-2022, the patient developed a non-serious event " medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event" (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported"a medical assistant administered the diluent portion only of a PENTACEL vaccine."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medical assistant administered the diluent portion only of a PENTACEL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medical assistant administered the diluent portion only of a pentacel vaccine with no reported adverse event.
?Moderna COVID?19 Vaccine EUA? About a week after my first dose (only immediate side effect, about 12 hours after shot, was stiff left arm/shoulder for about 3 days), I had the WORST genital herpes attack that I've had in literally 40 years, with extremely swollen labia, excessively "weeping" sores, intense itching and pain. The shot was the only variable in my routine health and healthcare to which I can attribute this; the herpes attack finally began to heal, but then repeated itself, not as bad as the first one. During this time I have been taking Valcyclovir and Acyclovir cream, prescribed by OB/GYN. A few days into the initial herpes attack, my hands and face swelled and broke out in a case of (probably) dermatitis (which I've had once or twice in the last 2 years), covering my arms, legs, hands, somewhat belly and back, with itchy hives which are still healing. Was prescribed by dermatologist Hydroxyzine HCL 10 MG 3x/day + Triamcinolone Acetonide lotion USP 0.025% topical ointment, which are helping to relieve itching.
After the first dose was administered at 6:15pm on the 5th of March 2021 at 10:00pm I began to feel a tingling sensation in my muscles, face and throat. (I could hardly swallow) and the pain in my left hip intensified. (Pain that I am treating with accupuncture and pain medications). I had quite recovered from the pain but after the vaccine the pain intensified once again and it attacks me at dawn. Very sharp pain.
At 1134 patient c/o  tingling to lower lip.  Pt. examined lip in mirror stating it is swollen.  This nurse noted the lips very red.  BP 148/88, P 64, R 20, SpO2 98%.  Given water to drink.  At 1146 given  25 mg oral Diphenhydramine solution for increase in swelling to lip and 'weird' feeling in throat..  At 1150 pt.'s PCP notified via [hone call by RN .  Informed of pt.'s current status & VS.  At 1150 BP 152/90, P 62, R 20, SpO2 98%.  At 1204 BP 158/80, P 62, R 20, SpO2 98%.  At 1210 BS 301. Per RN,  states Dr. requested a BS check.  At 1215 RN, notified Dr. of pt.'s current VS, BS and pt. reporting the tingling in lip has resolved but continues with 'weird' feeling in throat.  At 1220 pt. released to go home.  Instructed by Dr. to take Benadryl every 4-6 hours today, given ER precautions & has a f/u  appt. for 1/16/21.
Gardasil vaccination given on Wednesday, May 30, 2007. Patient reported general malaise and mild joint pain on Saturday, June 2, 2007. Pain became increasingly more severe from Sunday, June 3 to Monday, June 4th. I took patient back to see the doctor on Monday, June 4th and described all symptoms to doctors. Doctors cannot figure out what is wrong. Patient has normal body temperature of 97.8% and has not yet had a fever.
Patient says she had rash at injection site, general feelings of malaise for approx. 2 days, headache, and tinnitus (uncertain if tinnitus is related to receiving shingrix).
pretty strong chest pain; heart pain; some kind of back pain, behind her heart; This is a spontaneous report from contactable consumer (reporting for her daughter).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 at 10:00 AM at a single dose for COVID-19 immunization.  The patient's medical history were not reported.  Concomitant medications included unspecified bipolar medications.  The patient experienced pretty strong chest pain on 18Dec2020 at 07:00 and heart pain and some kind of back pain, behind her heart in Dec2020.  The pretty strong chest pain lasted about 10 minutes and then went away.  The outcome of pretty strong chest pain was recovered on 18Dec2020 and of some kind of back pain, behind her heart and heart pain was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.