chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that his arm was sore for only 1 to 1.5 days after receiving flu vaccines in past. The reporter did not consent to follow-up. This case has been linked to the case US2018216091 (SHINGRIX vaccine), reported by same reporter for same patient.
Information has been received from a certified medical assistant, concerning a 24 year old white female receptionist, who on 16-MAR-2007 was vaccinated at 4:30pm, IM in the right arm, with the first dose of Gardasil. On 19-MAR-2007, at 9:00am, the patient developed swelling under the injection site. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a certified medical assistant, concerning a 24 year old female, who on 16-MAR-2007 was vaccinated at 4:30pm, IM in the right arm, with the first dose of GARDASIL. On 19-MAR-2007, at 9:00am, the patient developed swelling under the injection site. The CMA confirmed that the patient was recovered on 23-MAR-2007. Additional information is not expected.
My daughter cried uncontrollably for 12 hours after she received the Dtap. Two days later, she came down with bronchiolitis. Within a year she started exhibiting signs of autism.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of included ADACEL or a dose of MENACTRA in the same arm. Subsequently, the patient the patient develops a tennis ball size lump at the VARIVAX (Merck) site. The nurse stated that the did not appear to occur when given in separate arm. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
VASOVAGAL SYNCOPE:  SWEATING, DIZZINESS, NAUSEA, FLUSHING, OVERHEATING
Patient received an incorrectly prepared ACTHIB vaccine. ACTHIB was prepared with MMR diluent instead of diluent packaged with ACTHIB vaccine.
injection site is swollen; Injection site prettty sore; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 13th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, the injection site was swollen and pretty sore. The patient asked for advice if could do heat , ice or just need to wait it out.
A really bad one muscle ache and pains and dizziness; A really bad one muscle ache and pains and dizziness; I really got pain in my shoulders and my upper chest; I have been out of energy; A really bad one muscle ache and pains and dizziness/ I am busy I have muscle pain all over the body like I have the flu and I don't have the flu; I really got pain in my shoulders and my upper chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN8732, NDC number, UPC number, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient received first vaccination shot about 3-4 weeks ago. Then, received second shot and got reaction to it, really bad muscle ache, pains and dizziness. The patient tried to figure out how long this going to take until it goes away. The patient was taking pain pills because of pain in shoulders and upper chest. The patient was out of energy and had muscle pain all over the body like flu and didn't had flu. The patient went to orange coast hospital, and they provided with the injection and the patient wanted them to clear up the problem. Consumer was informed about Pfizer medical information department. The outcome of events pain, dizziness, myalgia was not resolved and for all other events was unknown.  Follow-up attempts completed. No further information expected.
Pt was given Pediarix and Hep A vaccinations on 1/7/08; were given in her right thigh.  Redness and warmth to the touch began thereafter; pt re-examined on 1/9/08 and at that point, she had a normal temperature in our office and a 2-3 inch (diameter) erythematous, slightly raised, rash localized circumferentially around the injection sites.  Pt was diagnosed with Cellulitis of Leg and Immunization Reaction--told to use warm or cool compresses, Tylenol for pain.  Advised that this reaction was not uncommon with Pediarix.  Advised to follow-up with any high fever/streaking/spreading of the rash.
Patient was given the Covid vaccination, then the influenza. Immediately thereafter, patient reported feeling hot, having a strange taste in mouth, and seeing sparkles in her eyes. We had the patient lean forward and put her head between her legs. this appeared to alleviate the symptoms. We monitored the patient in the waiting area for 15 minutes, and she reported no residual symptoms. We informed the side effects to her physician.
Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessened throughout the day (I did use analgesics), but still had chills, some achiness, and a headache the day after I received my vaccine.
Awoke from nap approx. 5-6 hrs /p DT shot, cried, then for 10 min. difficult to arouse, arm & legs limp, glassy eyed, sclera injected - No fever, no seizure activity
2 DAYS AFTER t-dap INJECTION, the patient complained of redness and swelling at injection site (r deltoid) plus fever.Was started on KEFLEX 500MG PO Q 12 HRS, plus tylenol PRN. ON day 3, cellulitis less red and less swollen, but discomfort throughout  whole R arm.C/O NUMBNESS AND TINGLING: referred to ED. DX: cellulitis of R shoulder. Treatment changed to doxycycline IV x1, and po x 10 d.
Post vaccination, the patient presented with a 50x45mm reaction, resembling a +PPD. The center was red at the site of the injection. The patient's mother stated that "it increased to that size this AM." The patient complained of some itchiness and soreness at the injection site. An area on her left arm was raised. The patient was treated with Hydrocortosone and Benadryl.
Fever the night of vaccination administration noted red flat rash on palms. Fever better after 48, rash slightly better now, still burns
19APR91 thirty to 60min, episode; Infant was fussy, w/pale, bluish color; 21APR91 similiar incident repeated;
Almost fainted; This is a spontaneous report from a contactable consumer or other non hcp reported for his sister. A 25-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN) dose 1, via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported that his half-sister had a strange side effect after Pfizer he don't know when she got the Pfizer vaccine, when she got the first dose she almost fainted. The patient was hospitalized as a result of event. The reporter asked and concerned about getting the second dose of the vaccine. The outcome of the events was reported as unknown.  Information about lot/batch about number has been requested.
@1515 pt came to clinic reporting tightness to throat. Pt stated she felt throat tightness five min after being vaccinated at 0800 am.. She did not report it to the observing nurse. Pt went home, had to come back for covid test routine for work per patient.  Pt attempted to call call center, was put on hold, so she decided to come to vaccination clinic to report symptoms. Pt was awake, alert, speaking full clear sentences, breathing easy non labored, HR 86, sat 99%. No coughing, no drooling noted.  Pt transferred to ED via wheelchair accompanied by RN and Mia LVN, RN carried Anaphylaxis kit.  SBAR handoff given to RN in ED triage area.    Opened chart for RN note.
fever, Chills, muscle aches, sick at my stomach, could not eat for 2 days, headaches, runny stools all of these have lasted 3 days
This spontaneous case, initially received from other non-health professional on 30-Oct-2018, concerns a 63-year-old, adult male patient. The patient's historical conditions included tendinitis and osteoarthritis. The patient's current conditions included hyperlipidaemia, hypertension and chronic anxiety. Concomitant medications included pravastatin (dose: 20 mg), XANAX, amitriptyline, amlodipine and diltiazem for unknown indications. On 21-Sep-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: reported as left, batch number: 250795 and expiry date: 30-Apr-2019]. No adverse events were reported after administration of the vaccine. The reporter assessed this case as non-serious.
This spontaneous report as received from a nurse refers to a 15 year old patient of an unknown gender. On 17-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
This is an Initial spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable nurse reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in injection arm. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3 inch area of erythema, fever to 101.5 degrees F 24 hours after injection of ADACEL left arm.
hot to the touch; arm became sore; red injection site; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), CHILLS (bad chills), VACCINATION SITE PAIN (arm became sore) and VACCINATION SITE ERYTHEMA (red injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (bad chills). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (arm became sore) and VACCINATION SITE ERYTHEMA (red injection site). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), CHILLS (bad chills), VACCINATION SITE PAIN (arm became sore) and VACCINATION SITE ERYTHEMA (red injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported that the patient's symptoms were continuing.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI: Patient's email address has been updated.
Muscle aches, fatigue. These symptoms were minor on the day of vaccination, but became intense the morning after. The fatigue and aches dissipated 30 hours after vaccination & were gone 36 hours after vaccination.
Resident experienced chest pain the evening he received the vaccine and requested to go to the hospital as he stated his "chest is pounding".
Shivers, headache, muscle , stomachache, all started around 10 PM the day of the shot and con all night. second day the headache and back pain persist
bruising from injection on 5/9/22 on right thigh  Father came in to office 5/13/22 stating limping on left and obvious loss of motor skills - normal exam in office (patient dancing in room and running up and down the hallway fine) other than bruise which had gone down on right thigh.
premed with Benadryl 50 mg 0953 (due to reaction with first dose). vaccine received at 1046. 1049 throat thick and unable to swallow. 1050 epi pen administered by RN (monitoring people after receiving injection) and a rapid response called. Transferred to the ER. 1147 IV Benadryl 25 mg and IV methylprednisolone given. Monitored for 4 hours in the ER then released. Throat still mildly thickened at that time. Resolved by late evening.
General symptoms- Fever, headache, joint pains, muscle pains, fatigue, swollen fingers, hands, eye lids. Narrative:
Patient developed red, raised area at injection site on 5/7/2019 as observed by a friend.  By morning (upon waking), patient developed itching at the injection site.  Encouraged patient to take ibuprofen & diphenhydramine for comfort and observe symptoms.  If no improvement in 2-3 days, encouraged patient to RTC or call PCP.
It was a flu shot but I'm not sure of the brand. I broke out into hives and my face swelled up. Was given benadryl and a steroid shot.
Pt recvd MMR vax 28JAN92 & on 8FEB92 devel generalized rash & had non-tender adenopathy in the groin, axillae & the base of neck; sx described as sx of rubella;
Sunday at 6pm 6/20/21 I has sever pain in my abdomen- demobilization pain all over torso - nothing helped the pain - came on suddenly and lasted thru the night continuously -in the morning it was better - made an appointment with doctor but cancelled it because I could get in for a couple days
On 5/28/2021 I started to develop shortness of breath. It continued to worsen and I went to the hospital on 5/30/2021 and it was discovered that I had a pulmonary embolism and after additional ultrasounds 3 DVT blood clots in my right leg.
Patient (5 years old) was mistakenly given the adult covid pfizer vaccine instead of the pediatric vaccine. The mother was alerted as soon as it was discovered. At the time of follow up, the pediatrician had been consulted and no adverse events had been reported.
Menstrual cycle occurred twice in one month.  Excessive bleeding and more days than normal.  Intense cramping.
Information has been received on 24-AUG-2017 from a nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 23-AUG-2017 and 24-AUG-2017 doses of improperly stored PNEUMOVAX 23 lot # N010106, expiration 15-NOV-2018 unknown route were administered to unspecified patients for prophylaxis. No adverse effects were reported. The vaccines were stored at the temperature of 20 degrees Fahrenheit for the time frame of 24 hours. There was no previous temperature excursion. The call was not made due to a data logger. This is one of two reports received from the same reporter. Additional information has been requested.
10/20/2023 (in the evening) - Nausea, slight swelling and warmth at injection site and aching in her leg.  10/21/2023 (1 AM ED visit) - Lightheadedness, nausea, vomiting and mild tachycardia to the low 100s. Was given Zofran and a Toradol 15 mg injection.  10/22/2023 (11:30 PM ED visit) - Rash, vomiting, diarrhea, fevers, increased soreness, dysuria and urinary odor.
Angina & Tachycardia Narrative: Employee transferred to the ER for further treatment. Employee given DIPHENHYDRAMINE INJ,SOLN 25MG/0.5ML IV Now dose and METHYLPREDNISOLONE INJ,SOLN 125MG/1VIAL IVP ONCE. 12 leads EKG showed Sinus Tachycardia. No other respiratory distress reported. The employee was closely monitor in ER for couple of hours. Employee reported feeling better after pharmacological interventions. Employee's health status improved. ED Provider sent patient home in stable condition with 5-6 Steroids PO treatment.
1.  Out of concern for potential autoimmune reactions to the vaccine, I had some blood tests taken on 12/23/2020 prior to the first dose and repeated blood tests 3.5 weeks after dose 1.  My ANA test has been checked 2 times prior to vaccine and both were negative.  On 1/19/2021, 3.5 weeks after dose 1, my ANA is now positive at 1:80. 2.  On 12/30/2020, the left side of my lower lip began to fasciculate, have paresthesias that were constant from 12/30-12/31/2020.  On 1/1/2021, 2 blisters appeared in the area of the twitching.  I have not had problems with hsv on my lips in the past, so it was very odd to have this occur 2 days after vaccine.    I had concern for hsv reactivation and its association with Bell's palsy given the reports of Bell's palsy in study participants so I called my doctor, discussed my concerns, and asked for and took Valtrex  tid and Prednisone  qd for 5 days, starting on 1/2/2021.  The blisters resolved by 1/3/2021.  The fasciculations improved greatly, but I have had 2 episodes of my lower lip feeling heavy/numb for a few hours since then.
Soreness on day of injection - itchen at injection site 1/11/21 - Redness and small bump 1-11-21 - Redness and warmth increase 1-12-21 - Singular - hydrocortisone cream Employee was furthered evaluated by MD. Prescribed antibiotic. Follow up appt. scheduled 1-18-2021 with MD.
Patient received a Moderna vaccination two days past its BUD in the fridge. Moderna contacted and stated no need for revaccination. No reported adverse events from patient.
Information has been received from a physician concerning a female who was vaccinated with the three doses of GARDASIL (lot no. not reported) on 21-JAN-2009, 31-MAR-2009 and on 19-AUG-2009. The physician reported that 7 days after second dose of GARDASIL the patient developed fever, headaches and dizziness. The patient fully recovered without treatment in 2 weeks. On 19-AUG-2009, after third dose the patient developed fever of 102F, headaches and dizziness within 4-6 hours. The patient was prescribed MOTRIN and is recovering at the time of the report. Follow up information has been received from the physician which reported that the 11 years old student with no medical history, allergies or drug reaction, on 19-AUG-2009 at 20:00 hours, experienced headache, dizziness, fever of 102F and lethargy after third dose of GARDASIL (lot no. 658271/0558X) into the left arm. The patient had not recovered and was still with intermittent headaches and dizziness. The physician reported that the sibling had dizziness 10 days after a was vaccine given (unspecified). No further information is available.
Right thigh w/5x5 1/2 cm. area of erythema 1 day after VZV vaccine given S/Q 7/7/16 5:00pm. Diarrhea day after vaccine. Seen in office 7/7/16 BENADRYL 2 tsp. every 4-6 hrs to begin and hydrocortisone. Both started in office.
lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 17Mar2021, the patient experienced lost the sense of smell and taste, since second shot of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19; on 31Mar2021, the patient underwent Nasal Swab test (SARS- Cov2-test) and the result was negative. The clinical outcome of the events sense of smell and taste was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Two patients arrived in one vehicle at a drive through COVID vaccination site. Refer to separate report for other individual. In order to improve efficiency, vaccines were drawn up by one individual. A different individual administering the vaccine assumed the prefilled syringes were Moderna vaccine and administered to the patient. After the dose was administered, it was determined that Pfizer 0.3 mL was given instead of Moderna 0.5 mL.
sore at the injection site; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    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 VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant information was not provided.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MMR and TDaP given 4-17-08.  That evening, patient states arm was sore by AM, swollen, red by the following Monday.  4-21-08 arm still red, swollen, vomiting, loose stool, face red with rash, felt shortness of breath, went to see doctor.  Patient stated previous week her son had nausea, vomiting.
Two weeks after injection, arm is still warm feeling, slightly red, and a little hard in a two inch radius of injection site. Also itches some of the time.