chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(4/23/21) Symptoms included intermittent (R) lower leg pain.   After 3days, started myself on Aspirin which seemed to improve Sx somewhat.   Stopped the Aspirin.  Then learned of the link of J&J Vaccines to blood clots.  Called my primary physician (5/6/21) who suggested testing to r/o DVT.   (5/7) Venous ultrasound confirmed a DVT/ blood clot in (R) lower leg.  Was then sent directly to ER for further exam and initiation of anti-coagulation therapy.  Started on Eliquis starter pack:  Initially 10mg BID,  then 5mg BID.
He said he will be taking methylprednisolone and Neo/Poly/Dex eye drops; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 52 -old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "He said he will be taking methylprednisolone and Neo/Poly/Dex eye drops".  Additional information: Patient states he is scheduled to receive his second shot 24Mar2021. Patient having an eye surgery on 22Mar2021 prior to the scheduled second vaccination date and he wants to ensure none of the medications from the surgery will effect the efficacy of the second vaccine. Patient doctor has told him the medications will not interfere but he wants to make sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High fever; Headache; Vomiting; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for four patients. This is the first of four reports. A 16-year-old patient of an unspecified gender (reported as "both male and female patients affected but number of each sex is unknown") received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via intramuscular injection in arm one on an unspecified date at single dose for meningitis serogroup B vaccine and received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, injection), via intramuscular injection in arm two on the same day at an unspecified dose, single for vaccine. The patient medical history and concomitant medications were not reported. Nurse reported that 4 known patients that they had administered both meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) to experienced the same symptoms: high fever, headache and vomiting. The patients were each administered meningococcal group b rlp2086 injection in one arm and meningococcal vaccine a/c/y/w conj (dip tox) injection in the other arm at the same time. The outcome of the events was unknown (reported as "unknown other than usually resolved and cleared up in about 24 hours.").  Information about lot/batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279369 Same reporter,drug,event/Different patient;US-PFIZER INC-2020279391 Same reporter,drug,event/Different patient;US-PFIZER INC-2020279283 Same reporter,drug,event/Different patient
Sore arm; Headache; Body aches; nausea; Drug dose administration interval too short; Did not sleep well last night; This case was reported by a consumer via interactive digital media and described the occurrence of poor sleep in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 2nd June 2022, the patient received the 2nd dose of Shingrix. On 2nd June 2022, less than a day after receiving Shingrix, the patient experienced poor sleep and drug dose administration interval too short. On 3rd June 2022, the patient experienced pain in arm, headache, general body pain and nausea. On an unknown date, the outcome of the poor sleep and drug dose administration interval too short were unknown and the outcome of the pain in arm, headache, general body pain and nausea were recovering/resolving.   It was unknown if the reporter considered the poor sleep, pain in arm, headache, general body pain and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The reporter was patient's husband. The reporter stated that the first shot was 6 weeks ago. The husband reported that the patient received her 2nd dose of shingrix in the left arm.  The patient did not sleep well last night, and next morning the patient experienced sore arm, headache, body aches, and nausea.  The reporter stated that patient's symptoms were better. The patient asked if she could take Ibuprofen for side effects from her 2nd shingrix shot. Additional Supportive Information: The patient received 2nd dose 6 weeks after receiving 1st dose, earlier than the recommended standard schedule, which led to shortening of the vaccination schedule. The follow-up would not possible as no contact details were available.
Information has been received from a registered nurse concerning a 19 year old female, with no pertinent medical history or drug reactions/allergies who on 12-MAR-207 was vaccinated with Gardasil (lot# 654741/0013U). Concomitant therapy included Ortho-Tri-Cyclen. Two hours later, on 12-MAR-2007, the patient experienced nausea and vomiting. The patient self treated with Compazine. The vomiting resolved but as of 14-Mar-2007 the nausea continued. No lab testing was performed. Additional information has been requested. The registered nurse reported that 3 other patients' experiences after Gardasil administration (WAES 0703USA02859, WAES 0703USA02797, WAES703USA02840). Initial and follow up information has been received. There was no illness at the time of vaccination.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation & Research and was released.
9days after shot my arm became very soar, puffy and a red rash developed around the injection site. The red rash spread over my arm down to my elbow. It took about a week to go away.
Developed "covid arm" at the injection site which has happened before, this time it was worse and the pain spread to my armpit. I treated the rash with hydrocortisone cream, and the pain subsided in about 3-4 days.
I developed Shingles. - Pain on left side of torso front and back. lesions developed about 72 hours after the on set of pain.  Called the doctors office and as it was a Saturday, was referred to Prompt Care to confirm the diagnosis.  Given a prescription for  anti-viral medication and also told to continue use of Tylenol for pain.   I continue to improve.
Severe abdominal cramping and excessive sweating for 15-20 min followed by bowel movements. Same symptoms again in 2 hours.
On 10/4/2000, pt had high fever 105 that lasted for 5 days. Since then he has started withdrawal and  has progress into autism. He was diagnosed with autism in August 2002. Receiving ABA intemention. Follow up on 10/31/2003: "Vaccine recipient did not recover from adverse events.  Autistic behaviors - lack of eye contact, socialization ability, language delay, repetative behaviors (eg. language and hooked on numbers), digestive problems and picky eating, sensory dysfunction.  We found measel antivirus still in his body in addition to mercury due to vaccinations."
pt recv vax 20NOV96 & 27NOV96 pt exp a hive-type rash;
8/13/21 pt received 3rd dose of Moderna COVID vaccine, not authorized by protocol.   Pt complains of nausea/vomiting, headache and general  "flu-like" symptoms.  Pt called off of work 8/14 and 8/15 complaining of stated symptoms
Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
First 2 weeks so fatigued I could only lie on couch. Had nausea, tried to control with Famotidine & Hyoscyamine prescribed by Dr. Started having uncontrollable projectile vomiting morning after shot. Saw Dr in 2 weeks, said I was just having side effects from Vaccine. The extreme fatigue lasted almost 3 months - I still have days of fatigue & having projectile vomiting - have tests
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 17-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 552 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
DIARRHEA; This spontaneous report was received from mother's patient and refers to a child female. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 05-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown (strength, lot number, expiration date, and route of administration were not provided), also, on an unknown date she experienced diarrhea.   The outcome regarding this event was not provided.   The causality assessment between therapy with and the aforementioned event was not provided.
19JUN91 6PM temp 102r, fussy; 1AM temp 103, crying; 20JUN91 130PM 104 AX, throat red; 21JUN91 101r;
pain in his hand; pain in the injection site/he is still having pain in his arm where he got the vaccine; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "pain in his hand"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in the injection site/he is still having pain in his arm where he got the vaccine"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body ache".  Additional Information: Response: Read from the attached document CONS -How long side effects last (v7.0), "Side effects reported with the vaccine include:" and "Persons Aged Between 5 and 11 Years: Local reactions duration was between 1 and 2 days and systemic reactions lasted around 1 day. All cases of lymphadenopathy (swollen lymph nodes) resolved within 2 weeks".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got autoimmune things/ Extremely sick; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 14-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) outcome was unknown.            No concomitant product was reported. On 14-Nov-2021, the patient received a booster dose of Moderna COVID-19 Vaccine. No treatment information was reported.  Company Comment : This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced autoimmune disorder (was extremely sick and got autoimmune things) unspecified days after receiving a dose (reported as Booster) of mRNA-1273. The details of previous doses was not provided. There was no information provided about the patient's underlying medical conditions, concomitant medications, details of the autoimmune disorder, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced autoimmune disorder (was extremely sick and got autoimmune things) unspecified days after receiving a dose (reported as Booster) of mRNA-1273. The details of previous doses was not provided. There was no information provided about the patient's underlying medical conditions, concomitant medications, details of the autoimmune disorder, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Last night pt was making some noises like complaining (mom was eating, she thought he wanted to eat too), then when he was standing he started to collapse, was caught before he fell, eyes rolled back, didn't close but pt was not focusing or responding to his name, looks like he stopped breathing and his lips started to turn blue, mom slapped him a couple of times, he recovered and returned to normal.  Had temp of 38 when checked.  Has been fine since, did well overnight and acting normally today.
2 mo. immunizations administered and Infanrix given instead of Hep B. Rec'd 2 doses DTaP at same time. No apparent sequelae 24 hours after administration.
09/02/22 after getting ready to leave our vacation in another country, at dinner I felt a lot of tickling in my throat while at dinner. The next day I believe I had a slight stomach problem. I was not feeling too good. I thought it was something I ate, but the throat tickling was there too. The next day I was in the car after our flight, I was in a car of six, my neighbor was coughing, and a lot and I started to cough a lot too. I was just not feeling well. Finally on that Tuesday I called the doctor's office, but before on Monday I took a test and right away it turns red right away I was COVID-19 positive. I had my husband and told him to come home from work and test and, he was positive. My doctor saw me via telephone. My doctor told me that since I am diabetic, I should take PAXLOVID. The medicine was great, I felt great. The second day I had a little diarrhea, I felt much better. Every now I then I have a lingering cough. After 11 days I still tested positive. And then I had appointment with her in 2 weeks later and tested again it was negative.
Noticed small blister corner of left side of mouth, which turned in to large fever blister later that day.  On 11/10/09, noticed a second smaller area right corner of mouth.
0953 3/8/07 Mom called into office stating patient had "rash all over body" call back at 1011 appointment given 3/8/07 at 11 am. Seen by doctor reported.
several days after the vaccination, my arm was sore. I was tired. several days later my arm was still hurting and feeling swollen and itchy and hot so I go in the bathroom and I look at my arm and there's 2 large coins sized circles hooked together. they were raised up welts. my face feels puffy. my eyes feel itchy and puffy. I am taking 10 mg of Claritin daily. I am doing hot and cold compresses. my temp is low grade fever. still experiencing this reaction on 03/11/21 Doctor is going to prescribe prednisone but I do not know if I will be taking it. I am extremely tired and I find myself waking up from 4 hour naps. the arm is hot to the touch and my face feels like its on fire as well.
When raise arm above head, shooting pain down lt arm down through tricep/bicep seems to be nerve pain vs muscle pain. Arm gets limp and doesn't function.
Patient Describes unbearable and consistent pain in and around injection site that radiates all down the arm and to opposite side of back.  Pain started 2 days post injection and has continued through today with little to no relief.  patient has been prescribed Medrol dosepak which she has used for 3 days and pain not resolved.  patient denies any other injury
10 minutes after vaccination, pt experienced shortness of breath and a racing heart beat. Pt gave her own Epi-Pen  into her left thigh. Oxygen applied. Pt transported to ED. given IV fluids & symptoms resolved, discharged to home.
Arm Pain, swelling, feels cold, headache, band like swelling on arm. Reactions began the evening of the 22nd and were still present on 11/28/16 as per our conversation. She said she wen to the doctor and he told her she was allergic to it. I explained that she got FLUAD which has an adjuvant in it which she should mention to her doctor.
A pharmacist reported that a female received an injection on Influenza virus vaccine (manufacturer unknown) and subsequently experienced an anaphylactic reaction. The reporter did note that this information was "questionable" and there is no documentation of the reported event. Anaphylactic reaction is considered medically important.
Had fever of 102  the day after of injection. On day two horrible back spasms.  Difficulty standing and walking.
Aphasia; Tiredness; Headache; Nauseated; This spontaneous case was reported by an other health care professional and describes the occurrence of APHASIA (Aphasia), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced APHASIA (Aphasia). In September 2021, NAUSEA (Nauseated) had resolved. At the time of the report, APHASIA (Aphasia), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated) to be related. No further causality assessment was provided for APHASIA (Aphasia).    No concomitant medications were reported.  No treatment medications were reported.  Patient received booster dose.  The reporter assessed the event of nauseated as not reasonably possible with Humira and did not provide any causality assessment for the rest of the events with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A report has been received from physician concerning a 2 years old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. Patient had been receiving nasal FLUMIST given on 05-Sep-2012. The patient experienced Influenza A, Influenza B, and ear infection which started on 31-Dec-2012. The outcome of all the events were unknown. The reporter considered all of the events to be non-serious.
NO adverse event at the time of this report filing. Patient got 1/6th dose of the Varicella (Varivax)
Pt recv vax on 10/6/98; 1/2 hr later pt exp fever (103) dx day fever 104; tx=Tylenol &Advil; pt to E.R.; 10/7/98 pt exp sore throat.
Initially sore arm upon vaccination. Noticed body aches around 12 hours post vaccine. Headache 20 hours post vaccine Swollen right arm tender to touch. Hot to touch. 48 hours later Redness  quarter size and  swelling  with tenderness below injection site.  Ice pack applied. Arm soreness minimized.
soreness at injection site, fatigue Narrative:  By pt. report: "Covid injection received on Thursday 1/21/21. My right upper arm was very sore and stiff. I was unable to lift my right arm and I was very exhausted as well. I called in on 1/22/21 due to side effects"
Vaccine given IM Lt arm 10/5/11. Patient woke up at 0600, 5/6/11 with swelling of Lt arm that went up to her throat. She took some BENADRYL po with no relief - 10/7/11 she started feeling like her throat was swelling & saw her physician.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th November 2018, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left deltoid. The patient was presented with injection site hurt after receiving SHINGRIX. This injection site was swollen, warm to the touch, and red. The redness was spreading down to elbow. The patient described the area of the redness to be the size of two dollar coins side by side in diameter. The patient took BENADRYL on the day before reporting and on the day of reporting reported that the reaction had stabilized and was not getting worse.
left arm pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: EW0162) at the age of 62 years 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: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021, outcome "not recovered", described as "left arm pain at the injection site". Therapeutic measures were taken as a result of vaccination site pain.  additional information:she takes Tylenol and Motrin for the pain, states she does moves her arm, does water aerobics, so its not like she is keeping it still. If she does not take a tylenol or Motrin, she cannot raise arm up.  Follow-up attempts are completed. No further information is expected.