chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received H1N1 injection. About 20-30 minutes after injection she complained of itchy nose and eyes, started sneezing. Moved to exam room. BP taken sitting, L arm 102/40. C/O feeling weak and dizzy. Laid her on exam table-c/o tightness in throat. 911 called and paramedics came, BP 114/70, P=88. Improved. Paramedics had her sit up-respiratory symptoms were resolving. Client reported feeling better. Paramedic suggested giving her BENADRYL. Client was given 25 mg tablet diphenhydramine in the office and sent home with 3 more 25 mg tablets diphenhydramine and instructed to take 1-2 tablets every 4-6 hours as needed. Client given crackers and juice as she stated she had not eaten. After 30 minutes more she left clinic.
Has slight cold and hx of asthma and feels chest tightness and dyspnea. Used ALBUTEROL Inhaler
On evening of vaccination, developed 4 x 9 cm bruising at site with 8 x 11 cm surrounding erythema / slight edema. No fever/ irritability. Benadryl po and compresses.
pain in left arm at site of vaccine-could not lift arm for about 3 days and then it disappeared hip pain in left side near joint so bad I had to use a cane to walk about. Sore to the touch. Woke up at 6:30 am to take dog out and I was fine. Went back to bed to listen to Sunday programs and the hip pain started at around 9:00 am. Its not my bed, have a expensive temperpedic mattress that is super expensive and very comfortable.
Headaches  Nauseated  Left arm pain at inject site Upset stomach  Fatigue
Pt states that she had a rapid heart rate which dissipated after a short time and has not re-occurred since. Upon follow up call on 1/31/16 pt states no re-occurrence of symptoms.
Fatigue and headache on the first day, Thursday. On second day experience extreme fatigue, heaviness in body, fever up to 103; severe body aches. Lasted Friday, Sat (some relief); then on Sunday felt normal again after sleeping and taking Motrin.
Itching at injection site approximately 1 hour after shot; developed pain 2-3 hours after injection; swelling, redness, warm to touch near injection sight; increased malaise and nausea.
Initial unsolicited case received from a pharmacist on 19 January 2015. A 67-year-old male patient, with no reported medical history and no known allergies received an injection of FLUZONE HD (lot number not reported) on 06 October 2014. On an unspecified date, the patient experienced a "reduced" heart rate, which did not come up after exertion. He had been seen by a cardiologist, and a pacemaker was inserted. Outcome was reported as not recovered. Documents held by sender: None.
Fever, H/A, S/A, pain in feet, dizzy, pt. slept 16 hours symptoms reported verbally by mother over phone 6-7-12 recommended office visit to be seen by doctor pt. refused care, follow-up call 6-8-12 pt. still refused care mom to monitor symptoms. Follow up call 6-11-12 pt. better.
12 hours after the 2nd dose, symptoms were : high temperature (near 104 degrees), extreme fatigue (slept 20 hours out of 24);  mild confusion; low pulse oxygenation (83-88 without cpap; 88-90 with cpap); extreme body aches and pain (states he hurt so bad he could hardly move); no appetite.  This all lasted 24 hours (fever and pain improved to a manageable level with intermittent tylenor and advil, alternated) and lots of hydration.  Fever returned to normal, achiness calmed to more mild, fatigue for another 24 hours.
a really bad headache; diarrhea; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), DIARRHOEA (diarrhea) and HEADACHE (a really bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESOMEPRAZOLE, CALCIUM, COLECALCIFEROL (VIT D3) and LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 20-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 23-Feb-2021, the patient experienced HEADACHE (a really bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm and Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), DIARRHOEA (diarrhea) and HEADACHE (a really bad headache) outcome was unknown.            The treatment medication was Tylenol.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-024497 (Patient Link).
Pharmacist administered the vaccine as a subcutaneous injection instead of an intramuscular injection. Circumferential redness, warmth, and firmness at about 2 inches around the injection site.  Vaccine given at 11:30AM on 8/8/23 and symptoms started around 8am 8/9/23.
Tachypnea, fever, Severe body aches lasting 18 hours intermittent tinnitus lasting 2 days.  Symptoms similar to second dose of Pfizer but more severe and lasted longer.  Tinnitus was new symptom with the 3rd dose.
Client received school required Tdap vaccine on 7/17/07 at 7 PM in Imm. clinic. She started symptoms of fever 103 at 2 AM with nausea and vomiting, body aches and stomach cramps. Client symptomatic x 3 days, fever reached 104 (F) on 2nd day. Parents took client to PMD pediatrician x 2 visits for follow-up.
c/o stomach pain & vomiting x 1 days p/vax; area lt arm-hot to touch-? of cellulitis;
Muscle Spasms; Really exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really exhausted) and MUSCLE SPASMS (Muscle Spasms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Really exhausted). On 20-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle Spasms). On 20-Feb-2021, MUSCLE SPASMS (Muscle Spasms) had resolved. At the time of the report, FATIGUE (Really exhausted) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
This is a spontaneous report received from a contactable (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states he has the 1st dose of the Pfizer COVID19 vaccine on 01Mar2021 and was supposed to go back next Monday for the 2nd dose; states his HCP just put him on an antibiotic regimen for something he just contracted, and he wants to know if there was information related to taking the antibiotic and receiving the Pfizer COVID Vaccine. He wants to know how this medication would affect the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Numerous skin blisters with water/puss around the area at injection site. Along with swollen and change in skin color dark red /black and blue at  area site is hard to touch.  Went to urgent care to check and received antibiotics to start and then topical solution after the blisters scab suggested to use topical solution.
Glaucoma; Osteoporosis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unknown, Single for covid-19 immunization. Patient relevant medical history included allergy to hair dye, Neosporin and she received Prolia (Prolia for Osteoporosis for 4 weeks ago). The patient concomitant medication(s) included metoprolol, 25mg taken for heart rate increased. On an unspecified date, the patient experienced osteoporosis, glaucoma. Therapeutic measures were taken as a result of osteoporosis, glaucoma (she is taking different medications such as Prolia for Osteoporosis (for 4 weeks ago) and Eye drops for her Glaucoma). The outcome of events was unknown.  Information related to batch/Lot no. was requested.
Suspected vaccination failure/Got a shot 1 year, got shingles next year; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot 1 year ago and got shingles the next year. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Woke up at 5am the morning after getting the booster. The sound of my heart rapidly beating in my ears woke me. My heart rate was nearly double the normal resting rate - usually it is 55-60 bpm, but on this morning it was around 115 bpm, while I was just resting in bed. Also felt terrible with aches, headache, but that was expected. It took two days for my heart rate to return to normal range. I held off on taking my medication until my heart rate returned to normal.
Pt's husband received vaccination on 4/1/03, and wife contacted reaction from vaccine on right arm on 4/9/03, and reaction tags on left arm 4/10/03.
No adverse event; Not sure if the patient received Bivalent or Monovalent Booster; This spontaneous case was reported by a nurse and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster).    No concomitant medication were reported. The reporter (nurse) mentioned that a MD recorded the lot number on the patient chart and vaccination card for a booster shot. The reporter mentioned that because of the date, she was sure that the shot was Bivalent but did not have proof. The reporter mentioned that they are not sure if this shot was bivalent or monovalent             No treatment information was provided by the reporter.
neurological issues having seizures/stroke post COVID vaccine; neurological issues having seizures/stroke post COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Neurological issues" (unspecified if ongoing), notes: Neurological issues. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" and all described as "neurological issues having seizures/stroke post COVID vaccine".  Clinical info: Please contact, to provide information/advise on the following: Patient w/neurological issues having seizures/stroke post COVID vaccine..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events seizure, cerebrovascular accident and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt recv vax on 1/11/99; 20 min post vax pt exp sneezing, rash on head & neck w/ wheezing
3 weeks after second dose of Pfizer, woke up with vertigo/dizziness. Almost fell as I left the bed. Felt ok on and off - but in the evening felt moderate vertigo multiple times.  Went to ER and physician judged either BPPV or vestibular neuritis or something similar. No prior vestibular history or tinnitus experience. It seemed to resolve after 2-3 days of meclizine. Then again on May 22, it started and continues where on adn off vertigo and dizziness persists. Meclizine is not very effective. Hoping I feel better soon. Have an appt with PCP on Friday. Feel some neck ache occasionally. and a bit of full ear
LATE/MISSED PERIOD, both shots have affected my menstrual cycle,  MANY WOMEN ARE SAYING THE SAME THING PLEASE LOOK INTO THIS!!!
Patient developed a warm, itchy rash around the injection site about 2 inches in diameter.
Janssen COVID-19 Vaccine EUA little bumps all over her forearm and it spread to her neck and face. doesn't appear to be like a rash and no open sores.
symptoms of arm pain extending from wrist up to the neck; noticed difficulty to move the arm due to pain; symptoms of chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (symptoms of arm pain extending from wrist up to the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (noticed difficulty to move the arm due to pain), CHILLS (symptoms of chills), NAUSEA (nausea) and VOMITING (vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced NECK PAIN (symptoms of arm pain extending from wrist up to the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (noticed difficulty to move the arm due to pain), CHILLS (symptoms of chills), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NECK PAIN (symptoms of arm pain extending from wrist up to the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (noticed difficulty to move the arm due to pain), CHILLS (symptoms of chills), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided .
Feeding difficulties beginning the day after 4 mos vaccines.  Associated signs and symptoms include Parents concerned with refusing to eat that began the day after her 4 month PE and shots.  She pushes bottle out of mouth with her tongue even when starving. Dr. had changed concentration of formula at PE.  The have returned to previous concentration when this began.  She has been spitting up more since this began.  ZANTAC dose was checked for new wt last week per parents.  Otherwise she is acting fine.  No fever.  No cold sx.  Having about 4 wet diapers a day.
really sore injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "really sore injection site". Additional information: When patient had his initial Pfizer vaccine, he ended up having really sore injection site, but what made it worse was that immediately after the injection, he went to work and literally loaded up 55 tons of raw gemstone (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 14 days after receiving SHINGRIX, the patient experienced burning sensation skin. In October 2018, the outcome of the burning sensation skin was recovered/resolved. It was unknown if the reporter considered the burning sensation skin to be related to SHINGRIX. Additional details were received as follows: The patient stated that he had no irritation at the injection site. About 2 weeks after the vaccination with SHINGRIX, the patient started getting a burning sensation around the waist and the right side of his navel that moved around to the right side of his back and half way up the side of his spine. There had not been any break outs or rash and he states that it feels like a really bad sunburn. The burning has resolved some but if it is touched, it is more noticeable, especially in the back. He has reported his symptoms to his doctor. Obtained permission to contact physician.
This spontaneous report as received from a health professional refers to a 16 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with a third dose of GARDASIL lot # K0089831 (expiration date 04-MAR-2016) in the left arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received. Event and narrative were updated.
numbness, tingling lt arm & shoulder w/paresthesis; dx acute inflammatory brachial neuritis by MD;
Information has been received from a registered nurse concerning a 56 year old female patient with no drug reactions or allergies and no pertinent medical history who on 11-JUN-2012, was vaccinated with a dose of PNEUMOVAX 23, 0.5mL subcutaneously (lot number 672962/0025AE, expiration date 11-OCT-2013). There was no concomitant medication. On 12-JUN-2012, the patient developed redness, pain and swelling at the injection site, as well as fever after receiving PNEUMOVAX 23. Prednisone, BENADRYL and dicloxacillin were given as a treatment for redness, pain and swelling at the injection site, as well as fever. At the time of the report the patient's outcome was not recovered. No laboratory tests were performed. The patient sought unspecified medical attention, contacted office. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 672962/0025AE in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information received from the registered nurse revealed that on 11-JUN-2012 at 10:38 A.M, the 56 year old patient with seasonal allergies, asthma, anemia, gastrooesophageal reflux disease (GERD) and anxiety was vaccinated with a dose of PNEUMOVAX 23, SQ into her right arm (lot # 672962/0025AE). There was no illness at time of vaccination. On 11-JUN-2012 at 12:30 P.M., the patient's right arm at the injection site reddened, swollen and was not hot to touch. On 12-JUN-2012, the patient felt ill with temperature of 99.5, redness and swelling spread. On 13-JUN-2012, the patient recovered from the events. Arm injection site redness, hot to touch, feeling ill and temperature of 99.5 were considered medically significant by the nurse practitioner. No manufacturing events were noted in lot investigation that are likely to be related to adverse events reviewed. Additional information is not expected.
Information has been received from a physician concerning a 6 month old patient who was vaccinated po with three doses of ROTATEQ at the scheduled intervals (dates unspecified).  The physician reported that within 24 hours of receiving the third vaccine po the patient developed a bacterial infection of the blood and was admitted to the hospital (date unspecified).  No other information was available and outcome was not reported.  Additional information has been requested.
This initial spontaneous report was received form a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 13-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
SEVERE SORENESS AND PAIN IN THE LEFT ARM, CHILLS, LOW GRADE TEMPERATURE.
dizziness, nausea, off-balance, extreme heat in body requiring clothes removal, almost diahrhea--those symptoms lasted about 90 minutes. chills and shivering--for about another hour VERY sore right arm, normal stamina reduced about 50%, general aches--all day until bedtime