chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient states that after the shingles shot, he felt very sick and lousy severely for 2 days.  Ever since then he has not felt quite right, complaining of feeling woozy, off balance, and visual symptoms that do not seem to be corrected over glasses.  He does note that his daughter contracted Guillain-Barre syndrome after receiving the flu vaccine. Patient states his symptoms are persistent but do not occur every day. He has good and bad days, whereas in the beginning he had mostly bad days.  He also had associated headache and he still gets a headache from time to time now with severe back pain going from his low back to his neck.  He has got a chronic rhinitis since the vaccination as well.  He did not complain of any headaches prior to the injections.
Sore in arm. Next day hard injection sites, aches & pain, severe headache, sinus clogged up. 8/30/11 stiff neck, sick of stomach, couldn't eat. Headache getting better, taking more TYLENOL with codeine than usual to help. Used neti pot & ALLEGRA for congestion. Felt crosseyed. Today slight headache & stiff neck.
There was no adverse event. The client was given the high dose influenza vaccine instead of the standard dose. Client was notified.
*abnormal vaginal bleeding *pain in hips, knees, ankles *2 days of diarrhea *spleen pain *left side lymph node pain esp in neck area *under armpit pain with under the shoulder blade pain *numbness and tingling in hand and feet and now just tingling in finger tips
Patient received her COVID vaccine and approximately 1-2 minutes later she started to experience extreme itching and slight tongue swelling. We administered 25 mg of benadryl and evaluated the patient for 45 minutes. Patient was doing well and not experiencing any issues by the end of observation.
Petechiae on examination (day of check-up). To Hematology - admitted to hosp. Idiopathic thrombocytopenia purpura. 11/14/07-records received for DOS 10/4-10/6/07-DC DX: Thrombocytopenia. Generalized purpura times 1 day, negative hematuria, melena, epistaxis. Febrile for 2 days, diarrhea approximately 1 week. PE: purpura of mucosa. Treated with IVIG.
On the day following my second dose, I woke up with a headache around 6am (expected this may happen and took Tylenol). A little before noon my partner and I got in the car to run an errand. In the car I started to feel worse and I fainted. I was out for about 30 seconds according to my partner. I came to and had my vitals checked at an urgent care center (all vitals WNL). During this episode in the car I think I also had chills. The onslaught of symptoms in the car lasted only about an hour before resolving. I continued to have a off and on headache for the rest of the day but other symptoms resolved. By Sunday I was pretty much back to normal; any headache symptoms were pretty much resolved. I am not sure if the fainting episode was related to vaccine or not. I have had fainting episodes in the past (2-3x at dentist office and 1x at optometrist when having eye pressure checked).
Information has been received from a physician concerning a 13 (reported as 14) year old female who on 10-MAR-1997 was vaccinated with the first dose of MMR II (HSA) and on 03-JAN-1999 was vaccinated with the second dose of MMR II (HSA) (lot numbers not reported). On 24-NOV-2009 the patient experienced mumps. At the time of the report, the patient's status was unknown. Follow-up information was received which reported that on 17-NOV-2009, the patient developed mumps. On 19-NOV-2009, the patient was dizziness and afebrile and was diagnosed. The patient had right parotitis. On 19-NOV-2009, laboratory data revealed that IgM negative, IgG 0.9 and serum amylase 190. At the time of the report, the patient's status was unknown. No further information is available.
"Pt with microcephaly and seizure disorder was in bed asleep when he awoke screaming and having rhythmic movements. His eyes would roll back and his arms would extend to the side and then violently flex in toward his chest while his legs where doing the same thing. "Per guardian, pt had not had a seizure in 3 months. Diastat was given during the episode which did not seem to directly help. Family called 911 and pt was transported to ED. Abdomen with chest xrays were performed. No further treament given.
sl swelling of face night of vaccine admin. Hives the next day, increased in severity over next 2 days. Day one given Benadry, day 2 given Benadryl and Rx for steriods with relief. C/o hives and itching.
Body ache, Fever 100 degrees, Chills, Weakness, Back pain.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUL-2016 the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II 0.5 ml (lot #L003856, expiration date 02-FEB-2017,  therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 204 hours with the lowest recorded temperature of 33 Fahrenheit degree; the second time was 444 hours with the lowest recorded temperature of 34 Fahrenheit degree; the third time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree; the fourth time was 24 hours with the lowest recorded temperature of 21.7 Fahrenheit degree; the fifth time was 1192 hours with the lowest recorded temperature of 29 Fahrenheit degree; the sixth time was 24 hours with the lowest recorded temperature of 31 Fahrenheit degree; the seventh time was 96 hours with the highest recorded temperature of 48 Fahrenheit degree; the eighth time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this type of excursion for this vaccine were refrigerator (R)/ freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient).  This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot].  It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 04-JAN-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Optic neuritis 9/27/16 blurred vision Rx high dose steroids.
Left deltoid swelling, pain, erythema; hypotension with fever to 102F.
12x14 cms- erythema on right right arm with calor.  There was no induration nor tenderness.
Shingles; Unknown if patient received second dose/1st dose received on 13th February 2020; This case was reported by a other health professional and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was a pharmacy technician. The age at vaccination was not reported. The patient had received his 1st dose of Shingrix and then developed shingles (unknown time lapse, but it was more than 2 months but less than 6 months.) It was unknown if the patient received the 2nd dose, hence incomplete course of vaccination was coded for 2nd dose conservatively. The reporter did not have details of adverse event at time of call but provided email of pharmacy for collection. The reporter consented to follow-up. Note: The reporter was not aware if second dose was administered or not but considering the time interval, incomplete course of vaccination was coded conservatively.The clarification has been raised for the same.
Central nervous system demylination 7 days after flu vaccine that led to cortical blindness.  Pathology confirmed demyelination.  5/23/08 Reviewed hospital medical records of 11/13-11/26/2007. FINAL DX: ADEM secondary to flu vaccine Records reveal patient experienced blurry vision 10/18, then lost vision on right side, then bilateral vision loss x 3 days.  Saw PCP 10/23 & had head CT scan done which revealed old infarcts.  Admitted to outlying hospital for w/u which was c/w ischemic stroke, tx & d/c to home.  Was stable until 11/9/07 when again had blurry vision which progressed to vision loss, perceiving only bright light.  Returned to outlying ER & transferred to higher level of care.  Tx w/high dose steroids w/o improvement.  Surgical biopsy done which showed inflammatory white matter disease c/w demyelination.  Additional steroids given w/o improvement. D/C to home w/outpatient therapy.
Patient experienced local site reaction. After administering vaccine, the area immediately began to swell and cause hard bump/knot at the site of injection. I gave the patient Benadryl and monitored for 30 minutes. The reaction became less severe (swelling went down and knot soften).
Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a drink. When the drink did not help she was given 12.5mg of diphenhydramine at 4:57pm. It was recommended and offered for her to take 25mg of diphenhydramine but patient stated it made her too drowsy. After a few minutes, the patient stated it felt like her throat was tightening so she was given the other 12.5mg of diphenhydramine given at 5:03pm. She stated her heart was racing and her head was pounding. Her blood pressure was 164/72 and pulse 117. She stated her chest was feeling tight and at 5:11 an EpiPen was administered and call to 911.
I caught the novel coronavirus about 6 months after I received my booster dose.  I was sick with minor cold/flu-like symptoms for about 8 days. During the worst part of the sickness, I had a fever of 101.6 and body aches. This only lasted about one day. The rest of the week I felt tired and had a sore throat with a mild, but painful, cough.
My arm pit is swollen and my arm is swollen has been for the last two days. The armpit is very painful.
ASYMPTOMATIC COVID INFECTION Narrative: REEIVED COVID VACCINE FROM PHARMACY ON 12/30/20 AND 1/20/21 TESTED POSITIVE TO COVID ON 3/12/2021 AS OART IF RIYTUBE PRE-OP TESTING BEFORE SCHEDULED COLONOSCOPY . NO SYMPTOMS RELATED TO COVID, NO OTHER ADRS TO COVID VACCINE DOSCUMENTED
Difficulty breathing, wheezing, hives, afebrile.  Treatment BENADRYL P.O.
Small pox like bumps on arm, chest; very few little pox; Not very itchy; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAR-2023, the patient received Shingrix. On 03-MAR-2023, 1 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Small pox like bumps on arm, chest; very few little pox) and pruritus (Verbatim: Not very itchy). On 06-MAR-2023, the outcome of the vesicular rash was recovered/resolved (duration 3 days). The outcome of the pruritus was not reported.   It was not reported if the reporter considered the vesicular rash and pruritus to be related to Shingrix.     It was not reported if the company considered the vesicular rash and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The case was self reported by the patient. The patient received a dose of Shingrix and experienced very few little pox which was not really very itchy. The patient reported that couple on arm and one on chest and stated as a very limited small pox like bumps. On 5th March 2023 the patient received Vaginal estergen concomitantly for dryness.   The patient reported that symptoms were not treated. The reporter consented to follow up.
Following vaccination with DTaP, less than 24 hours later, child had episode of pallor, diaphoresis and hypotonic, hyporesponsive state. After brief CPR by parent, returned to normal state. EMS transported to local ED, had normal glucose and EKG.
First day showed slight swelling and tenderness.  Nine days later swelling returned  wither ed rash at ejection  site and  around neck. The  injection site appeared to have fever as well.
At 1 H post administration, the patient reported a sensation of numbness and tingling in the lips and nose.  At 2 H post administration, the patient experienced hives, and a sensation of airway obstruction which resulted in an ER visit.
Chronic tinnitus significantly increased in intensity/volume the day following the first injection--I estimate about double the volume. In both ears. After 12 days it has not subsided at all. The increase in severity is causing secondary headache, jaw clenching, sleeplessness, irritability, hearing issues.
A patient received Adacel 0.1 mL intradermally in his right arm today by mistak, no AE; A patient received Adacel 0.1 mL intradermally in his right arm today by mistake, no AE; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 47 years old male patient who received 0.1 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number :C5787AA expiration date: 01-Oct-2022), instead of 0.5 ml via intradermal route in the right arm for prophylactic vaccination by mistake on 22-Mar-2021 (incorrect route of product administration, underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TUBERCULIN PPD (TUBERSOL) via intradermally.  It was a case of actual medication error due to vaccine underdose and inappropriate route of vaccination (same day latency).  The reporter would like to know how to proceed in ensuring that the patient receives the correct dose of Adacel. When can the correct dose of Adacel be administered? How soon is Adacel effective? Separately, the patient was supposed to receive Adacel 0.5 mL IM (intramuscular) because his wife has a baby which was due in 2 to 3 weeks.  It was not reported whether the patient had any adverse event.  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.
COVID-19  I received my 2nd booster shot on 03/29/2022 and I tested positive on 05/24/2022  at 12:30PM  I didn't know that I had COVID till my  friend tested positive. My symptoms were sore throat, eat infection,  severe headache,  severe fatigue,  diarrhea, , for a day, fever (2 days). I quarantine for 10 days.  on 05/24/2022 I went to Health Care center to get the antibody therapy. I was there for 1 hours.  After i got COVID-19 now I have less energy I am the way i used to be.  I never had fatigue but after COVID i get fatigue n every day.
Got a horrible flu after taking the shot; Got a horrible flu after taking the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. The patient received Flu vaccine and experienced horrible flu. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting
VACCINE ERROR- PATIENT UNDER AGE- 17 YEARS 6 MONTHS
Information has been received from a nurse practitioner concerning a female with a history of rhabdomyosarcoma who was vaccinated IM with the second 0.5 ml dose of GARDASIL. After the vaccination, the patient developed bruising on the arm opposite the injection site and on both thighs. She also had petechiae on her pallet. The patient noted that the same symptoms also developed after dose one of the series. Unknown medical attention was sought in the office. At the time of reporting, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Systemic: Confusion-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient said she took a beta blocker (propranolol) for anxiety before coming to vaccine appointment, but subsequently fainted after administration. This was accompanied with sweating, pale face and severe nausea/vomiting.