chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; headache; vomiting; Covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive), DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 02A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced COVID-19 (Covid positive). On an unknown date, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting). At the time of the report, COVID-19 (Covid positive), DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Appx 48 hours post injection I experienced moderate pain/pressure behind my right eye with visual disturbance and eye muscle pain when reading.
got sick; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, 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 a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the sickness and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose of Shingrix. The age at vaccination was not applicable for 2nd dose of Shingrix. A female patient reported that she received 1st dose of Shingrix in August 2018 and till the time of reporting not received 2nd dose, which led to incomplete course of vaccine. The patient also reported that she got sick after the first dose, but did not elaborate.  The reporter was extremely upset and not very cooperative and also stated that what she said during the call.
approx 30min p/vax flu-like sx occurred followed by a high fever-102-103, nausea, stiffness, swollen glands, very sensitive muscles/skin;couldn't touch w/o aching, h/a, sensitive to light;
injection site pain; flu-like symptoms; fev; chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, fev, chills and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, fev, chills and injection site pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fev, chills and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms that lasted for 3 days. This case is linked to the case US2020AMR034880 for the 2nd dose of the same patient. This case is linked to the case US2020AMR034881 and US2020AMR034882 husband's case.      Lab Comments: Lab test on an unknown date
A pharmacist reported that several pt's received an expired dose of Orimune between 7/5/00 and 7/31/00. The onset of unspecified adverse events occurred within the same time frame. The Orimune expired 7/1/00. As of 8/24/00 no further information was available. Additional reports will be generated.
This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow up 1 combinedly processed) concerns a 46-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804537 was cross-linked to source case: 201804533 due to same reporter.
Itchy; Red; Bumps; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Janssen COVID-19 Vaccine Taste of mental after 30 minutes with tingling on tongue.  Tongue has been numb on the tip/front since injection.  It has slightly decreased since the first day but still remains 1 week later.
Reddened area on (L) thigh. Prescribed Keflex 250/5 1 tsp po bid x 10 days.
I began having low grade fever and joint aches on pains on 09/10/21. Due to a recent brain injury, I had been having trouble with processing thought. On 09/12/21, I noticed that those symptoms getting worse for about one week. On 10/05/2021, I had a fever of 99.6 and the next day no fever but a sore throat. I took a home covid test and it was negative. Thursday, 10/07/2021, stayed home to rest. On 10/8/2021, my temp went to 102.2 and had severe neck pain for a day. By morning it had improved. 10/09/21, I developed a headache during the day. I took a second test 10/12/2021, it came back negative.
broke out in hives; tightness in chest; severe headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches). At the time of the report, URTICARIA (broke out in hives), CHEST DISCOMFORT (tightness in chest) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications included 1 anti-inflammatory and 1 steroid medicine.
Vaccine site on rt arm began to get red.. Was 3 inches in diameter by evening of 02/18/2021. This was accompanied by fever which lasted 24 hrs.  Area becoming less red today but still about 2 inches in diameter. I feel this will subside as I have had adverse reaction to a shingles shot before.
42 year old female left arm was red and inflamed as of 3/5/21. Vitals were normal. Dr's opinon was it was infected & referred to occupational health for prescription.
I was having chest pains and difficulty breathing and was coughing a lot throwing up mucus. So when this happened I went to the ER and they found my heart was pumping really hard and they did many tests and the one test they did they found I had blood clots in my lungs so they sent me by ambulance to a more high tech clinic and so I was in ICU for about 3 day till my heart pumping was under control and they also gave me water pills to help flush the liquids out of me and they also had me on a Heparin IV to help stop the clot and help break up the clot just like the water pills. When I left ICU for the next 4 days in a regular hospital room they still gave me the water pills and the IV, till it slowly got better my chest pain and breathing. the whole time I was on oxygen for my pulse being low, and I was also on a heart monitor. Now being home I have to be on a Warfarin blood thinning pill and a Enoxaparin blood thinning shot and get my INR checked all every week to make sure not to high or low.
pt recvd vax & 5 days later devel an elevated temp, chills & felt bad; pt was hospitalized the next day; treatment: blood cultures x 2 & ATB therapy;
Information has been received from a certified medical assistant concerning a 9-week-old female with no medical history or allergies who on 01-FEB-2007 was vaccinated PO with a dose of Rotateq (lot #655483/1116F. There was no concomitant therapy. The CMA reported that on 01-FEB-2007, the patient vomited during administration of the vaccine. No other symptoms were noted. Unspecified medical attention was sought, but no laboratory/diagnostic test were performed. On that same day, the patient recovered. Additional information has been requested.
Sneezing and running noses. Lower middle back ache at level 8 in a scale of 1-10. Tenderness at injection site, no swelling or redness. Patients referred to Primary Care Physician for lower back ache.
Patient in office for 4 year immunization - chicken pox - like rash over body with approximately 50-100 pox.  Most pox dry with forming scabs.  Father states he has been home caring for son with chicken pox.  Agrees to let me call him later to get more details but does not answer phone.
pt recv vax; inc T 101.5,light rash on hands,legs,breast area,diaper area;feet itching;T 103.6,red rash all over eyes;amoxil;trommethazine for ear & throat infect;dph for itching;MD states rxn to vax per mom;had Mumps 3wk ago,tx w/ atbs
Patient called Occupational Health Clinic on 2/20/07 reporting she thinks she had a reaction to the Hepatitis B injection. Has had chest pains but states they are subsiding. Patient refused to go to a doctor for assessment.
The patient had serologic testing on 05-16-2018 due to being a healtcare professional to check immunity and had no antibodies to measles or Hepatitis B; The patient had serologic testing on 05-16-2018 due to being a healtcare professional to check immunity and had no antibodies to measles or Hepatitis B; This spontaneous report was received from a nurse practicioner referring to a 44 year old female patient, who was a health care professional. The patient's concurrent conditions included hayfever and she saw a cardiologist for an unspecified reason.  The patient had no drug allergies. She was a tobacco user. The patient's medical history included coronary artery bypass graft (CABG) in 2009 secondary to a thrombosis. Concomitant therapies included lisinopril, metoprolol and aspirin.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and with unspecified hepatitis B vaccine (manufacturer unknown) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with Merck's sterile diluent (lot number and expiration date were unknown). The reporter stated that on 16-MAY-2018,due to being a healthcare professional, the patient had a serologic testing to check for immunity and had no antibodies to measles or hepatitis B (measles antibody negative and hepatitis b antibody negative). The outcome of measles antibody negative and hepatitis b antibody negative was reported as not resolved.        The causality assessment was not provided.
Local reactions at the site of injections/3 inch area erythema; This spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a patient of unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A) and expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of 3 inches in area at the site of injection, which was considered as a local reaction.  The outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case: 201804406 was cross-linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): In the narrative, "On an unspecified date after vaccination, the patient developed erythema of 3 inches in area" was changed to "On an unspecified date after vaccination, the patient developed erythema of 3 inches in area at the site of injection".; Reporter's Comments: A patient of unspecified gender and age developed injection site erythema after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to anatomical site specific reaction.
fatigue Narrative:  Patient states having several adverse reactions after the initial vaccination: *Fatigue, started day 2 - lasted for ~5x days *Localized swelling over injection area (about size of a quarter), started day 5 - lasted for about ~4x days *Rash over area of localized swelling described as pruritic, erythematous and indurated, started day 6 - lasted for ~3 days. No therapies were tried or applied. He denies other adverse effects of vaccination.
powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event; patient received a dose of ACTHIB that had been reconstituted with an expired diluent with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 15 months old female patient who experienced powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event and patient received a dose of ACTHIB that had been reconstituted with an expired diluent with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 13v (crm197) (prevnar 13) and Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 12-Dec-2022, the patient received a Dose-4 of suspect HIB (PRP/T) VACCINE(Dose-0.5mL)(Frequency-Total)(Duration-1 day)( Strength = standard)(Formulation- Powder and solvent for solution for injection)  via intramuscular route on left leg for immunization.(Powder: Lot #: UJ604AA, Expiration date: 13MAR2023 ,Diluent: Lot #: U7172AB, Expiration date: 29OCT2022)  On 12-Dec-2022 the patient developed a non-serious events powder portion of the vaccine had not expired, but the diluent expired inadvertent administration of an expired product to a patient with no reported adverse event (Expired product administered), patient received a dose of acthib that had been reconstituted with an expired diluent with no reported adverse event (product preparation error)  following the administration of HIB (PRP/T) VACCINE.(Latency- Same day)  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for both events.  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 the guidelines. 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.
NO ADVERSE REACTION EXPERIENCED. PATIENT RECEIVED JYNNEOS #2 VIA THE INCORRECT ROUTE (WAS GIVEN IM INSTEAD OF SC). FOLLOWED UP WITH PATIENT 2 DAYS AFTER AND HE REPORTED NO INCREASED REACTION OR SIDE EFFECTS.
8 days after vaccination (this evening),  my arm is itchy at the site of the injection.  An area about 4 inches in diameter is bumpy.
First day - left arm sore at injection site and mild fatigue in evening Second day - left arm sore at injection site, mild fatigue, headache, slightly sore throat, more phlegm than normal with slight post nasal drip Third day - left arm sore at injection site (less noticeably), moderate fatigue, headache, noticeably sore throat, more phlegm than normal with constant post nasal drip, tonsils swollen 2x size, difficulty swallowing, partial loss of voice in evening, low grade fever Fourth day - some soreness in left arm but much less, moderate fatigue, headache, noticeably sore throat, more phlegm than normal with constant post nasal drip, tonsils swollen 3x size with striations of white pus on both sides, difficulty swallowing, low grade fever (patient unable to work / perform normal activities) Fifth day - mild fatigue, headache, noticeably sore throat, more phlegm than normal with constant post nasal drip, tonsils swollen 2x size with striations of white pus on both sides, difficulty swallowing, low grade fever (patient unable to work / perform normal activities) Sixth day - mild fatigue, headache, noticeably sore throat, more phlegm than normal with some post nasal drip, tonsils swollen (no pus, just inflamed), some difficulty swallowing, no fever
Symptoms: And local swelling and erythema. Treatment. Cephalexin 500 mg TID.
Received Janssen vaccine 3/18/21 - on 4/1/21 (14 days later) woke up with numbness to left side of face (can't close L eye, can't raise L eyebrow, left mouth crooked with smiling, watery left eye), and possibly droopy R eye.  No diplopia, no weakness limbs (gait ok), no pain - went urgent care - transported to ER due to concerns of TIA/CVA
About two days after my vaccine,  the area under my eyes significantly puffed up. About 6 months ago I had cosmetic fillers put under my eyes and the vaccine caused a reaction
chest pain; wheezing; complaining of breathlessness; This is a spontaneous report from a contactable consumer (patient son). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The patient's concomitant medications were not reported. It was reported that recently, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 19Mar2021. That evening, the patient experienced some chest pain and she's been wheezing and complaining of some breathlessness since then. They had noticed that from that day she had been experiencing breathlessness. Of note, she had a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The caller stated he had seen the CDC guidelines that recommended waiting 90 days after infection before getting vaccinated and the interval between infection and vaccination for his mom was 96 or 97 days. He wanted to know if this is commonly reported, and what he should do next. He asked if they should take her to the urgent care or the ER. It was reported that the patient even had a negative covid19 test last week (Mar2021). Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Patient was given a second dose of the Influenza vaccine.  Had previously received a dose 10/2019
PATIENT HAD PFIZER COVID VACCINES ON Dose 1 date: 02/10/2020,  Dose 2 date: 03/03/2021, AND TESTED POSITIVE TO COVID.
This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach. On an unknown date, the outcome of the weakness of arms, general body pain, headache, abdominal pain, pain in arm and upset stomach were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the health care professional for his wife. The age at vaccination was not reported. In 2018, the patient received SHINGRIX on left deltoid. In 2018, a day or two after receiving SHINGRIX, the patient's arm almost fell off and got swollen. The patient also experienced diffuse body aching, upset stomach, headache and abdominal pain. The events were worse on the second day. The patient's arm was still swollen but no longer painful. Everything else had resolved.
5 days p/vax pt started vomiting & then henoch-schonlein purpura set in & was seen by MD;
Bit of sore throat; Coughing; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for herself a unknown age of female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on 10May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Patient was scheduled to get her second shot of Pfizer vaccine today but she was experiencing a bit of sore throat and she was coughing a little bit, but she did not have a fever on an unknown date in 2021. She also mentioned that she came from a camping this weekend and she was not sure if she had Covid because she hasn't been tested yet (consumer was not sure, hence not captured as event). She don't have a chills. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Pt was administered a booster Moderna vaccine that had been opened > 12 hours. The vial had been opened approx 24 hours but remained in stable temperature of 4-5 degrees Celsius