chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vaccine was administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 28-APR-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route were not reported, lot # U026207, expiration date 24-AUG-2023 or lot # U029496, expiration date 21-SEP-2023, it was unknown which lot was administered) for prophylaxis after temperature excursion (product storage error). The vaccine was exposed to temperature at minus 9 degrees Celsius for 1 hour and 45 minutes. There was no previous temperature excursion. No additional information.
Large 5-6 inch by 5-6 inch injection site redness, warmth and swelling. Pain is limiting arm movements.
Migraines; Ball of fluid where neck and skull met; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, more than 2 years after receiving Meningococcal B vaccine, the patient experienced migraine and localized edema. On an unknown date, the outcome of the migraine was not recovered/not resolved and the outcome of the localized edema was unknown.   It was unknown if the reporter considered the migraine and localized edema to be related to Meningococcal B vaccine.     Additional Information: GSK receipt date :10 July 2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received Meningitis B vaccine  2.5 years ago had to get this for college.The consumer stated that patient had migraines for 6 months and  straight and a huge baseball sized ball of fluid where is neck and Skull met. He missed over a month of school. The patient still had migraines. Reporter warn anyone to know to not get this vaccine. Additional Supportive information: Follow up would not be possible since no contact details provided.
Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 08-Jun-2015, Hypertension since 05-Nov-2015 and Hyperlipidemia since 05-Nov-2015. Concomitant products included ROSUVASTATIN CALCIUM (ROSUVASTIN) from 05-Nov-2015 to an unknown date for Hyperlipidemia, VALSARTAN from 05-Nov-2015 to an unknown date for Hypertension, LEVOTHYROXINE from 05-Nov-2015 to an unknown date for Hypothyroidism.    On 17-Nov-2021 at 8:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was tested positive for COVID-19 in past. No treatment were reported.   This case was linked to MOD-2021-389253, MOD-2021-407640, MOD-2021-407615, MOD-2021-407628 (Patient Link).
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patients pertinent medical history, drug allergies and concomitant medications were not reported. ON an unspecified date in November of 2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml/once, subcutaneously, (lot # and expiry date unknown). The patient was administered ZOSTAVAX (0.65 ml/ once, subcutaneously, (lot# and expiry date unknown) again on 21-JUL-2016 (product use issue). No adverse effects were reported. It was also reported that therapy was continued. Additional information has been requested.
Blind spots in both eyes, started with five spots total, multiple in right eye and multiple in left eye, started out as black spots and faded after several days to grey spots, one spot in each eye remains, spots are constant and do not float.
Information has been received from a consumer concerning her 12 year old female granddaughter with no known allergies and no reported medical history who was vaccinated with a series of three shots of Gardasil. The reporter stated that her granddaughter told when she got her sot it was really painful and stung alot. No additional information was provided. The onset date was 'after each shot". Additional information has been requested.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions; Moderna Covid-19 vaccine which has undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug details were reported.  The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. The temperature excursions occurred on 4-Mar-2022, 05 Mar 2022, 07 Mar 2022, 08 Mar 2022, 09 Mar 2022 and 10 Mar 2022. Proposed desired use by date was reported to be on 16 Mar 2022. Date vial(s) moved from freezer to refrigerator is 03 Mar 2022.  No Treatment information was provided.
Measles like rash, No treatment other than symptomatic only (Benadryl or Caladryl for any itch.
pain; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PYREXIA (fever) and CHILLS (Chills) 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 historical condition was reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (pain), PYREXIA (fever) and CHILLS (Chills). At the time of the report, PAIN (pain), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Resident was given Janssen COVID vaccine this morning. DOH then discovered she had been vaccinated with a 1st dose of the Pfizer COVID vaccine 4 weeks ago outside of this facility. Resident has had no adverse reactions as a result of receiving the Janssen vaccine this morning. She will continue to be monitored closely for S/S of adverse events/reactions throughout her stay.
TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a pharmacist on 10-Jan-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX2019-091 (PVX201901-000029; female) and PVX2019-092 (PVX201901-000030, male) were created and cross-linked in the database.  This case report describes an adult female consumer who "took Vivotif with food". The consumer was receiving Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took the three doses of Vivotif with food. The doses were taken on 03-Jan-2019, 05-Jan-2019, and 07-Jan-2019 respectively.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000030:
The first symptom started approximately 2 weeks after the Tetanus shot.  Loss taste of food and tingling/numbness of tongue.  Approx 4-7 days later my fingers and toes started numbing and tingling like "pins and needles" and progressively got worse and spread into my hands and balls of my feet.  Next symptom I lost my stamina, I became weak in the legs and muscles in my body, like my body was shutting down.  I could not walk to the end of the driveway without becoming severly weak and out of breath. Also I was having some balancing problems. My quality of life went from 100% down to less than 10%. I worked in severe pain and discomfort due to the heighten sensitivity of my hands and feet.  I am an aircraft mechanic planning to work for at least another 8-10 years but wasn't sure I could make it another year 4 weeks ago, build a new house, fix anything anymore, or even enjoy fishing. I was having my wife drive. I depend on my hands for my livelihood.  About 3 weeks ago, the symptoms started reversing and getting better each week. I went to my doctor twice when things weren't getting better. I went to the neurologist today.  I am about at 85-90% back to normal.  I still have some numbness and tingling in some of my fingers and toes, but not in my whole hands or feet.  I also have my energy back.  I'm just not sure if this is permanent, but I can now live and work with this minor discomfort if I have too.  The neurologist says I more than likely had a case of Guillain-Barre Syndrome and the Tetanus is what triggered it.
Urticaria, itching, diffuse, treated with BENADRYL by mother. Symptoms lasted approximately 5 hours.
Retinal Vasculitis - both eyes.  Severe - woke up with hemorrhaging in eyes.  Improved on it's own with time.  Happened again 9 months later 1/31/22.
itching, swelling, pain, warm to the touch and expanding border.   left arm -swollen lymph nodes under arm (painful) and at inside of elbow (just swelling)
Immediately following vaccine administration, patient went to stand up but slumped forward to the floor.  She lost color and fainted for a brief moment. She immediately came to. Her mother was in the room, mom explained this has happened before during vaccinations but that was the first time it was immediate.  The prior history was not disclosed in the pre-screening questions.
Headache; Stiff neck; Fatigue; A spontaneous report was received from a consumer concerning a 72 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and felt fatigue, headache and stiff neck.  The patient's medical history was not provided. No relevant concomitant medications were reported.      01 FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On the same day, the patient experienced felt fatigued.  On 02 FEB 2021, the patient felt headache and stiff neck.  No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events  fatigue, headache and stiff neck is Unknown.  Based on MSA comment, fatigue and headache  (Listed in CCDS), stiff neck (Unlisted in CCDS)
Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; Mom called in to report her son received VARIVAX and MMR II and 3 days after receiving vaccines her son has had diarrhea for over one month, broke out in rash, bright red, dry patchy skin open and raw on neck torso and arms and chin. Consumer staters; This spontaneous report was received from Consumer and refers to an 1-year-old male patient. The patient's pertinent medical history and concomitant medications were not reported. His drug reactions/allergies included dairy.  On 06-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), injection (lot# W018836, expiration date was not reported, but upon internal validation established as 14-JUN-2024) (strength, dose, anatomical location, and route of administration were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) injection (lot# W023072, expiration date was not reported, but upon internal validation established as 05-APR-2024) (strength, dose, anatomical location, and route of administration were not provided); both were administered for prophylaxis.  On 09-MAY-2023, 3 days after received vaccines, the patient had diarrhea (conflicting information, also reported as had diarrhea for over one month), broke out in rash, bright red (rash erythematous), dry patchy skin (dry skin) open and raw on neck torso and arms and chin (skin erosion). The patient went to see pediatrician. No treatment was given for the events. Currently, the patient's diarrhea was not as severe, not gone, and rash was still present on neck, torso, arms, and under chin. At the time of report, outcome of all the events were considered as not recovered. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) were not applicable.  The causal relationship between the events and suspect vaccines was not provided. The patient's pediatrician advised the events were from the varicella virus vaccine live (oka/merck) (VARIVAX).
I experienced general muscle aches and back pain in the muscles. I had extreme muscle fatigue and muscle aches along with a fever of 102.0. I felt as though this could not just be from exercising, I had an appointment with the doctor, and she prescribed muscle relaxers Flexeril. The fever only lasted for 1 day, so I did not mention it to the doctor. The muscle relaxers did help me to completely recover from my symptoms.  I had a blood panel completed on 10/06/2022.
pt recvd vax 22NOV93 & mom reports that 3 hrs later pt had an unusual high pitched cry that lasted 1 1/2 hrs; no treatment was given & had a nl exam on 4JAN93;
swelling on her throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling on her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced PHARYNGEAL SWELLING (swelling on her throat). At the time of the report, PHARYNGEAL SWELLING (swelling on her throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient has had L leg blood clot and multiple mental co-morbity-Anemia, hypertension, heart disease, hypokalemia, liver enzyme off per MD, poor nutrition, tremors, hypothyrodism, COPD, small vessel disease of the brain
Patient developed a cerebral venous thrombosis post vaccination. Patient hospitalized and placed on coumadin for 6 months. 11/24/09 ER records received for date 4/24/09 to 4/25/09. DX: venus sinus thrombosis, mononucleosis. Pt Presented w/ left sided transverse sinus thrombosis via CT scan results. SX: HA x2wks, N&V, flu like symptoms, cervical lymphadenopathy on left side. Assessment: (+)HA, otherwise WNL. Pt started on anticoag. tx and dc following day stable.
The evening the vaccines were administered patient stated she became itchy all over her body and her body became warm, this continued every day but only at night for a few weeks. Patient said she was also very tired but that only lasted for a few days.  Patient didn't seek any treatment and symptoms resolved on their own.
This spontaneous report was received from a physician via a company representative refers to an unspecified number of patients of an unknown age. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with more than one dose of PNEUMOVAX 23. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
11-18-15 = phone call for 3 blotches on stomach. 11-20-15 = phone call for continued rash, dad wanted seen. 11-27-15 = dad reported rash for 10 days. 11-29-15 = urgent care visit. 11-30-15 - derm. visit. 11/30/2015 Patient is an 18-month-old female toddler who presents at the request of Dr. for evaluation of a rash that is red and flat. She has had this for 2 weeks. It changes shapes and itches (intermittent, mild to moderate severity). It is all over her body. She is using BENADRYL 5mg every 6 hours partially effective. She had a Hepatitis A injection on the 17th and then she broke out that evening with the rash around the injection site and then it spread. 11/29/2015 11/17/15 had shots had hives that night gradual increase, was seen by Dr, have given BENADRYL x 7 days crying at night. 12 days ago, had shots. Occurred that evening after shots. Has not seemed itchy. First noticed around area of injection (L) thigh. The noticed on abd. Now noticed face, legs, abd. About 1 week into this, skipped a day of BENADRYL, and then seemed to worsen again. Noted temp scan temp of 99.7, one day. Change in appetite since shot, nonspecific. Noticed diarrhea last week, now better. No URI symptoms. Mom thinks might be teething. No ibuprofen given. PFSH: Hep A vaccine was only thing given. 11/20/2015 Patient is in today with her father regarding a rash started on her stomach as red blotches on 11/18. It has spread. Dad isn't noticing her scratching. She received her HepA vaccine on 11/17. No other exposures that dad can think of. No runny nose, cough, wheezing, difficulty breathing, fever, diarrhea or vomiting. Eating and drinking well. Sleeping well. PGF has allergy to sulfa.
Fever, chills, lethargy, headache, and arm pain occurring 12-24 hours after vaccination.
Mom remembers onset pediatrician 07/08/2003 constant increased and decreased in # till his next well baby exam (09/22/03).  When patient referred per diagnosis and treatment of his ITP.  PH=3000 on 09/22/03.  Received Winkho increased to 8,000 stable to 1/2 late 10/03. 2nd WinRho given 10/31/2003.  Follow up MD.
Pt received Moderna Booster. His first covid shot was Johnson and Johnson vaccine. I looked through the company email and saw where it was approved but did not see that change in booster dose. I called patient on 10/29 after calling  Moderna (10/26) and received the email with all the information concerning the vaccine. Pt stated on 10/29 that he had no side effects from receiving the full dose of Moderna.
Nausea; Psoriasis aggravated; Vaccination site pain; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2020 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single and intramuscular, administration date 13Mar2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: in her early 40's. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: PSORIASIS (medically significant) with onset May2020, outcome "unknown", described as "Psoriasis aggravated"; VACCINATION SITE PAIN (non-serious) with onset 13Mar2020, outcome "unknown", described as "Vaccination site pain"; FATIGUE (non-serious) with onset 13Mar2020, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious), outcome "unknown", described as "Nausea". The action taken for adalimumab was unknown.  The reporter considered "vaccination site pain" and "fatigue" related to bnt162b2. The reporter's causality for the event(s) of worsening psoriasis with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Covid vaccine related sore arm, covid vaccine related fatigue and nausea was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Jan2022): This Follow-up report contains no new safety information.; Sender's Comments: Based on available information the events Psoriasis, Vaccination site pain, Fatigue, Nausea were assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash on body, arms and legs began on the evening of 4/30 along with a low grade temp.  On 5/2/2010 the temp spiked to 102.6 and remained high (when not treated) for 12 hours.  Fever began to come down on 5/3/2010 and on 5/4/2010 temperature was normal.
Red 2 inch x 2 inch area, warm to touch, pain when touching area.
I am experiencing severe pain in my back in flank right side near kidney. I have been to two emergency rooms and had a virtual visit and received several different pain medications that are not helping for the pain. It feels like my kidney is having spasms. I first tried alive which only helped for a couple of hours and now nothing works. 4/7 prescribed 60mg of prednisone did not work. 4/10 visited ER prescribed naproxen and flexeril and received a toradol shot 30mg did not work. 4/13 visited ER received toradol shot, diagram 5mg and tylenol 650mg did not work took these meds home and had another dose which is not helping.