chrisvoncsefalvay/vaers-outcomes huggingface dataset:
consumer received the first dose of Gardasil 9 vaccine at 11 yeras old and now is 14 years old and has not received a second dose of the vaccine; no additional adverse event reported; This spontaneous report was received from a pharmacist via  employee and refers to a reporter's son 14-year-old male patient. His pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On an unknown date, when the patient was 11-year-old, he was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (lot #, expiration date, exact dose, strength, route of administration and anatomical location were not reported). At the time of this report, he had not received a second dose of the vaccine yet. No additional adverse event reported.
pt recv vax; screamed non-stop x 1 hr p/ shots on 12may95 then felt asleep & was afebrile;
Hives, neurological symptoms, tingling and burning in legs and feet, vision issues in one eye and trouble walking.
Fever, severe headache, ringing in ears, profound fatigue, arm soreness. She reports symptoms for 1 week after receiving the second shot.
Has caught coronavirus recently; Has caught coronavirus recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Has caught coronavirus recently". Clinical Course: It was reported that the patient caught with coronavirus recently (end of Dec/Jan), even though her twin had not. The patients father had also caught the virus and it might be where she got the virus from. There was a strong chance was vaccinated, and unknown regarding her father. Unsure which vaccine and when received and what dosage.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004727 same reporter/drug/AE, different patient
Pt. states that after receiving the 3rd dose of Moderna 12/27/2021, started experiencing symptoms that night of loose stool, passing out x1, fatigue, nausea, "brain fog", and headache (Lasting x10 days). No noted Primary visit/communications. Symptoms have subsided.
29AUG mom reports pt had t101 @ 12noon; later rose to 103; APAP given;pt very irritable, crying all noc;not taking formula well;advised by RN to contact MD immed;pt to be seen by MD;
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was fine then felt warm and dizzy at once. Possibly moving from one chair to the next after receiving vaccine. Patient stayed in pharmacy for 45 minutes before leaving but stated that he felt fine. Will follow up with patient tomorrow.
body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body aches), HEADACHE (headache) and CHILLS (chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history not included.  Relevant concomitant products usage were not reported by the reporter.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .  On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (body aches), HEADACHE (headache) and CHILLS (chills).  On 25-Mar-2021, CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (body aches) and HEADACHE (headache) outcome was unknown.     Treatment includes Tylenol.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Menstrual changes/unpredictable periods  - periods began coming earlier each month with heavier cramping and bleeding, menstrual changes have not resolved  over the last 7 months since vaccination
Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 25-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 659962/1740U) intramuscularly. There was no concomitant medication. It was reported that on 26-JUN-2008 the patient experienced a fever and muscle aches and the symptoms resolved on approximately 30-JUN-2008. On 27-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660555/0279X). On 28-AGU-2008 the patient developed a rash on her trunk. It was reported that the rash resolved on 30-AUG-2008. The patient called health department. This is one of several cases from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.  Follow up information was received on 13-FEB-2009 from a registered nurse concerning a 15 years old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U) intramuscularly into her right deltoid.  Concomitant vaccination included a first dose of TDAP (Lot # C2889AA) intramuscularly into her left deltoid.  ON 25-JUN-2008, The patient developed high fever and muscle aches that continued for 3-5 days.  The patient did not seek medical attention.  On 27-AUG-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660585/0279X), intramuscularly into her left deltoid.  Concomitant vaccination on 27-AUG-2008 included MENACTRA (Lot # U2638AA) intramuscularly into her right deltoid.  It was reported that on 28-AUG-2008 all over rash on trunk for 3 days.  The patient did not seek medical attention.  This is one of several cases from the same source.  Additonal information has been requested.
Patient presented for initial covid vaccine.  Felt lightheaded post vaccine.  VSS.  Patient symptoms resolved within 1 hour.
Burning and tingling down arm right away. 7 hours later back ache, arm pain, burned when I touched it, 24-60 hours later burning scalp on opposite side of injection, severe back pain, burning in left shin. 2 weeks after back pain still, severe hand joint pain. 3 weeks later severe knee joint pain  swollen lymph nodes on right side on and off still.
My eyelids and the area right below my eyes starting swelling and peeling about 48 hours after my first vaccine. After about 10 days, I went to my doctor just to make sure I shouldn?t be worried about  a worse after the second dose, but he didn?t think there was much we could do except wait it out (symptoms are annoying but not debilitating). We agreed that I should get the second vaccine. I am still experiencing swelling, itching, and irritation of the area surrounding my eyes (not the eyes themselves) 16 days after my first shot. It is worst in the morning. I have had slight improvement since initial onset, but I am definitely still experiencing symptoms.
After first vaccine administration, started experiencing multiple and frequent symptoms like:  Shortness of breath, cough, sinus drainage, sinus congestion, headache, fatigue, diarrhea, wheezing, tightness in chest, heart palpitations.  went to primary care physician a few times, got tested for covid (all negative), chest xray negative.  was finally prescribed a steroid and a rescue inhaler.  these symptoms would come and go over the next 6 months.  Before vaccination, I only had seasonally allergies that were treated with OTC allergy medication as needed but not daily.  now have to take daily anti-histamine and use inhalers to keep symptoms away.  I did not return for 2nd dose.
He came in for HepB #2 on 3/31/2012. He described blisters in mouth starting 2 days after Hepatitis B #1 & lasting 5-7 days followed with water blisters on toes on 9th day after shot lasting 5-7 days. Then noted blisters (L) ear on lobe & in ear canal lasting 5-7 days again & Dr advised writer not to give HepB #2.
Client states reaction started after a "few" hours after getting the injection. Raised red rash on left arm started to spread "almost touching elbow". Client estimates the rash is around 4 inches.  Client called PCP and was told to come to the clinic for an assessment today 03/29/21.
Patient was seen for a 4 year well check. She received routine vaccinations (as above)->Patient complained of stomach pain and vomited within 20 minutes and had facial swelling.->IM dexamethasone given with BENADRYL-resolved in 3 hours.
Left arm (injection site) is still sore; Left arm (injection site) is still red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left deltoid. On 20th March 2020, the patient returned to the pharmacy and stated that her left arm (injection site) was still sore and red.  The reporter consented to follow up.
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 180 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of, M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case: 1705USA009742.
Had a mini-stroke; Lost peripheral vision in right eye; He was really tired for a day; Blood pressure seemed like it was higher than normal; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Had a mini-stroke) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure high.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced FATIGUE (He was really tired for a day). In February 2021, the patient experienced HYPERTENSION (Blood pressure seemed like it was higher than normal). On 21-Feb-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Had a mini-stroke) (seriousness criterion medically significant). 21-Feb-2021, the patient experienced BLINDNESS UNILATERAL (Lost peripheral vision in right eye). In February 2021, FATIGUE (He was really tired for a day) had resolved. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Had a mini-stroke), BLINDNESS UNILATERAL (Lost peripheral vision in right eye) and HYPERTENSION (Blood pressure seemed like it was higher than normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: high (High) high.         It was reported that patient had tiredness for a day and a half.  Patient wishes to have booster dose but in confusion if it is fine to take booster in current situation of patient.  No treatment medication was given. Company comment:This case concerns a 72-year-old, male patient with previous relevant medical history of hypertension (blood pressure high), who experienced the unexpected event of transient ischaemic attack. The event occurred 7 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up contains no new information.; Sender's Comments: This case concerns a 72-year-old, male patient with previous relevant medical history of hypertension (blood pressure high), who experienced the unexpected event of transient ischaemic attack. The event occurred 7 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Brain inflammation  ongoing  headache  that have not gotten  better. Ringing  in my ears, blurry vision,  words get jumbled.  Several days of missed work dues to head pain.
Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
patient started having L ear pain and facial pain L side; some sore throat; then decreased hearing from L ear. ON exam in office 4/14/2021 she had otitis media with L TM perforation.
Caller took the Pfizer vaccine and then contracted Covid; Caller took the Pfizer vaccine and then contracted Covid; This is a spontaneous report from a non-contactable consumer (patient) received from the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced "took the pfizer vaccine and then contracted covid" on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Immense fatigue; Arm a little sore; listless; Slept a lot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Immense fatigue), PAIN IN EXTREMITY (Arm a little sore), LISTLESS (listless) and HYPERSOMNIA (Slept a lot) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M2DA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (Immense fatigue), PAIN IN EXTREMITY (Arm a little sore), LISTLESS (listless) and HYPERSOMNIA (Slept a lot). On 22-Feb-2021, FATIGUE (Immense fatigue), PAIN IN EXTREMITY (Arm a little sore), LISTLESS (listless) and HYPERSOMNIA (Slept a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and a low dose valium
No additional Adverse effects reported; her 1st dose of MMR II vaccine was administered into her deltoid muscle; This spontaneous report as received from a female patient of unknown age, reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-MAY-2020, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status unknown), intramuscularly (instead subcutaneously), the frequency was reports as 2 shots (formulation, dose, lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
The day after vaccination the patient broke out with blisters just about 2in below the injection site and goes down the whole arm. The blisters are red. Caller went to the DR on 7/28/2021 and received a cream. If spots does not clear up patient has to go back to the Dr.
7 days after shot, hot, itchy, red, swollen rash appeared at injection site. First small, then primary patch grew to 2x4 inches the next day. Then grew to 3x5 inches by day 6. General, same rash covered arm from elbow to shoulder. Smaller, pencil eraser rash sites on forehead, trunk and thighs. Plus "overspray light rash" on both thighs. Itchiness pain level 7 or 8. I wanted to rip the skin off. Couldn't sleep. No relief from: Benedryl, Hydrocortisone, Triamcinolone, Ice. Bad headache (pain level 5 or 6) and no relief from Ibuprofen, Acetaminophen, Imitrex. Headache relief from Excedrin on day 8, but unsure if it was due to the Excedrin or the headache just run its course. No pharmacy, doctor, or the clinic that sponsored the vaccine injection wanted to see/talk with me or even report my side effect symptoms. I would not describe these symptoms as "mild" and thought they should be reported for the benefit of future users of this vaccine. If "professionals" don't want to report, "How to Report Side Effects" should have been broadly distributed/advertised...it was not.  Please change this for the future. How else will we learn about the vaccine?
This is a spontaneous report from a contactable physician. A 18-years-old male patient received TRUMENBA (Lot# M13066, Expiry Date 30Sep2016), intramuscular in the left deltoid at 0.5 ml, single on 28Dec2015 between 2:30 and 3:00 PM. The patient medical history and concomitant medications were not reported. On 29Dec2015 the patient experienced felt fluish and fever with outcome of recovered, muscle aches and large area of redness around the meningococcal group b injection site with outcome of unknown. The patient had no cough or flu symptoms. The patient underwent tuberculin test with MANTOUX (Manufacturer: Sanofi Pasteur, Lot number: C4858BA), intradermal in the left arm at 0.1 ml, single on 28Dec2015. The doctor saw the patient 30Dec2015.
Almost passed out about 6 minutes after injection 5 days later I developed a face rash - still have face rash today
8 days after my second shot I began urinating  clotted blood; that  lasted for 3 days, gradually decreasing.
Patient was given the wrong dose (30 mcg/0.3mL) for her age. No adverse events were seen. I did not recheck the dose after it was drawn up. Parents were advised of error. They were given a number to call us if any adverse events were observed.
pt recv vax 30JAN96 & was irritable when arrived-given APAP;the next morning noticed rash on both hand,which increased to both thigh leg & feet w/a few in diaper area by second morning 1FEB96
small lump, like a ball at the injection site; It is red; muscle soreness in the arm of the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (muscle soreness in the arm of the injection), VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (muscle soreness in the arm of the injection). On 02-Feb-2021, the patient experienced VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red). At the time of the report, MYALGIA (muscle soreness in the arm of the injection) had resolved and VACCINATION SITE MASS (small lump, like a ball at the injection site) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.