chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, Blood pressure abnormal and Cholesterol.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking medications for her depression, anxiety, blood pressure and cholesterol.  No treatment related information was reported.
Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot# M013636, expiration date 15-FEB-2018, intramuscular). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Rec'd vaccines on date specified; mother called LHU to report pt had a rash; LHU was notified 2-9-17; mother informed nurse that pt "had a rash all over, but pt has had same rash several times" mother instructed to notify child's MD for evaluation since this rash has occurred prior; mother said ok.
Chills; Muscle pain remote from injection site; Headache; Painful lymphadenopathy (left axilla); Administration date=19Jan2021, dose number=2/ Administration date=21Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on 19Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included atorvastatin and lisinopril. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 21Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced chills, muscle pain remote from injection site, headache, and painful lymphadenopathy (left axilla) on 20Jan2021. No treatment received for events. The outcome of the events was recovering. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
patient states she has been itching all over her body with no rash since getting the shot (4-5 days). recommended the patient take a course of Benadryl and contact us back if itching is not relieved
Pt recvd vax 7JAN92 & on 8JAN92 pt had swelling in rt arm that AM; On 9JAN92 pt had rash, bumps, & itching on rt arm also stated heart was beating fast; Went to ER that day was tx for allergic rxn to vax;
I began feeling tingling sensation in my face and then it started going numb moving slowly from injection site up the shoulder to the inner ear across the face then the nose and scalp. It?s been 2.5 hrs since my injection and it is almost to my left ear and has made my tongue and lips numb as well. No major swelling or full  dental work type numbness just  mild numbness. That?s the only side affect I?ve had so far that is abnormal for me and how I react to vaccines or flu shots.
severe flank pain 3DEC97 went to urologist IVP done results negative;4DEC97 fever 101, went to MD;5DEC97 fever 104, anorexic, n/v, severe swelling of joints, muscle weakness, unable to move legs;joint pain & swelling remain;dx rxn to hep b;
10 minutes after receiving the vaccine he passed out for 15 minutes. He was seen in the ER, evaluated, and sent home. Later that evening he had the sudden onset of weakness in his legs, soon not being able to walk. He was taken to another ER and admitted.  Follow up on 01/12/04: "The vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Muscle ache and pain in lower body, muscle weakness after minimal use, balance and reflexes in legs and body still not 100%, nausea, motion sickness, joint ache, headache."
first dose of vaccine on 02Mar2021 and then on 10Mar2021 had a positive PCR; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 08:30 (Batch/Lot Number: EN6201) at 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included oral surgery from 17Feb2021(the caller had oral surgery on 17Feb2021, she had local anesthesia, then on steroids and antibiotics which she finished. All of the medication was finished before the caller's first shot). The patient concomitant medications were not reported. The patient was calling about the covid vaccine, she received the first dose on 02Mar2021 and then on Wednesday 10Mar2021. The patient got a PCR test that resulted as positive. The patient was wondering if she should get her second dose and what she should do about this, she had her second dose scheduled on 23Mar2021. On 10Mar2021, the patient experienced first dose of vaccine on 02mar2021 and then on 10mar2021 had a positive pcr. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Mar2021. Outcome of the event was unknown.
some symptoms of a throat condition that he has often; Cold like symptoms; sinus problem; throat hoarseness; This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced some symptoms of a throat condition that he has often, cold like symptoms, sinus problem, throat hoarseness reporter asking if her husband can receive his second covid vaccine dose if about 1 week ago he started to develop some symptoms of a throat condition that he has often due for their second vaccination tomorrow, but she wonders if he will get denied. She reports that he does not have a fever but asks if there are any symptoms that would disqualify him from getting the second dose. He has had a cold which is not what she would consider a symptom. It could just be a sinus problem. She has looked at every source of information and does not see any information about preventing one from getting a second dose with this and wanted to know if it would be contraindicated. He did not get the symptom after he got the first dose. He has had this a lot of times. He has throat hoarseness occasionally. It is the same type thing. The outcome of events was unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran
devel red, swollen, tender area in rt deltoid by DTAP;resolved w/o ATB;estimated 4x3cm lesion;
Symptoms of the bell's palsey / Diagnosed with bell's palsey / mouth drooped a bit; Eye was tearing; She drooled; Headache; Was in bed / Could not get out of bed; Flu-like symptoms; Sluggish; chills; Low grade fever/fever of 101; fatigue/ tired; Pain at the injection site; Muscle aches; joint pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On 21st June 2019, less than a day after receiving Shingrix, the patient experienced fever, injection site pain and headache. On 22nd June 2019, the patient experienced chills, fatigue, muscle pain, joint pain, nausea, mobility decreased, influenza-like symptoms and sluggishness. On 1st October 2019, the patient experienced bell's palsy (serious criteria GSK medically significant), eyes tearing and drooling. The patient was treated with acyclovir and prednisone. On an unknown date, the outcome of the bell's palsy was recovering/resolving and the outcome of the chills, fever, fatigue, injection site pain, muscle pain, joint pain and nausea were resolved with sequelae and the outcome of the headache was not recovered/not resolved and the outcome of the mobility decreased, influenza-like symptoms and sluggishness were recovered/resolved and the outcome of the eyes tearing and drooling were unknown.   It was unknown if the reporter considered the bell's palsy, chills, fever, fatigue, injection site pain, muscle pain, joint pain, nausea, headache, mobility decreased, eyes tearing, drooling, influenza-like symptoms and sluggishness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that vaccine was administered 2 months ago. The patient experienced pain at the injection site that lasted a day or two. The patient had headache and low grade fever of 101 presented the evening of the day if was administered. The next day the remaining symptoms presented and lasted 3 days. On 22 June 2019, 1 day after receving Shingrix the patient experienced chills, fatigue, muscle pain, joint pain, nausea, mobility decreased, influeza-like symptoms and sluggishness, lasted about 3 days. She was in bed for 3 days. The reporter stated that by the fourth day she was much better but still not 100 percent. The night before last she started to experience symptoms of the bell's palsey. The pharmacist reports the patient experienced a side effect and was diagnosed with Bells Palsy following dose one of Shingrix. The healthcare professional (HCP) notes side effect was described as tired. The patient was diagnosed with Bells Palsy. The reporter stated that patient eye was tearing and her mouth drooped a bit and she drooled. The reporter stated that by yesterday morning the symptoms were worst and she was diagnosed with the bell's palsey. The patient was being treated with prednisone and acyclovir. The reporter was consented to follow up. The patient provided permission to contact her pharmacist for follow up.
Dose number: 3, date 30Aug2021; Dose number: 3, date 30Aug2021; sleepy; This is a spontaneous report from a contactable consumer (patient).    A 65-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number: FD8448), via an unspecified route of administration on 30Aug2021 (at the age of 65-years-old), as dose 3 (booster), single for covid-19 immunisation.  The patient medical history was not reported. The concomitant medications were reported as none. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number Unknown), via an unspecified route of administration on 10Feb2021, as dose 1, single for covid-19 immunisation and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number Unknown), via an unspecified route of administration on 20Jun2021 (at the age of 65-years-old), as dose 2, single for covid-19 immunisation. On 30Oct2021, the patient reported booster dose and off label use. On an unspecified date in 2021, the patient experienced sleepy. The outcome of the event sleepy was unknown.  No follow-up attempts are possible. No further information is expected.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 39 years old female patient who received a 0.5ml dose of MENACTRA lot U6220AA, expiration date: 30-Apr-2019 via unknown route in unknown administration site on 22-Mar-2019 and HEPATITIS A VACCINE, HEPATITIS B VACCINE lot number and expiration date not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. A patient was inadvertently received MENACTRA instead of Hepatitis A and B vaccines. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
She developed dyspnea while out of state the day after vaccine administration. She went to the ER, was observed, not felt to have anaphylaxis, administered oxygen, then released. She was told to get her second vaccine.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was reported No Treatment information was reported
This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 51-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250800, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805055) was cross-linked to the source case: 201805049 reported by the same reporter.
Pneumococcal vaccine Rt Arm-3pm injection area sore and swelling becoming severe lasting 2 days. 6:30pm-8:30pm 10/23) severe chills and shivering. 12:30am (10/24) Fever >101 Benadry and ASA taken 3:30 am coughing and chest tightness abt 10 mins. 10am (10/24) itching and blotchy 4 inch radius of injection site. Benadryl and ASA q4-6 hrs thru out ana cont taking 10/25 Pain and swelling only low grade temp.
still felt bad along with shortness of breath; received his first vaccine dose yesterday and began feeling unwell; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported) via intramuscular route of administration as a single dose in Arm Right on 31Jan2021 13:00 for covid-19 immunization. Medical history included Allergies to medications: Ace inhibitors, HHT(Hereditary hemorrhagic telangiectasia )/High Blood Pressure, Eye conditions, Parkinson's Disease. No other vaccines received within 4 weeks prior to the COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Men's Multivitamins, Amlodipine, Tamsulosin, ferosul Iron, Ropinirole, Stool Softener. On 31-JAN-2021 21:00 the patient began feeling unwell. On 01-FEB-2021 08:00 still felt bad along with shortness of breath. No treatment received for the adverse event. Outcome of events at the time of last observation was not recovered/not resolved.  Information on the Lot/Batch number has been requested.
next morning after vaccine 7am projectile endless vomiting, fever 102.0, delusional, couldn't breath, thought hours were days, had stabbing pain in between breast bone to back, gasping for air.   Thought people were with me that were not.  Talked to people that had died.  Did not and was not able to keep any medicine down or even water down. Around noon 1 advil broke fever some.  around 3 pm took a breathing treatment (rare/occasional asthma but not constant so had the machine/nebulizer medicine).  Thought I was alone.  husband was with me.   Thought it was normal so didn't go to ER but should have.  Seriously near death experience.  Couldn't walk or stand, heart rate on athletic watch lying in bed was 120 felt like heart was coming out of my chest.  Never get headaches but my head was exploding.  This lasted 10 hours.  First vaccine no affects other than sore arm!
Patient was given 0.5ML Moderna, instead of 0.25ML for booster.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 22-JUN-2015, the patients was vaccinated with PNEUMOVAX 23 1 dose, lot# reported as L04915 (route of administration and dose were not reported). On an unknown date in June 2015, reported as within 24 hours of receiving the vaccination, the patient experienced unspecified muscle and bone soreness in an unspecified site. The patient sought an unspecified medical attention. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. There is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site muscle pain, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX 2 months before the date of reporting and afterwards they had a 3 by 3 area at injection site that turned pink, had muscle pain at the injection site and also reported having itching at the injection site. All these symptoms lasted about 1 week and then went away.
Initial and non-serious report received from the patient's parent (a healthcare professional) on 20 August 2007. A 14-year-old female with no pre-existing medical conditions or allergies received subcutaneous injections of Menactra (lot number and site not reported) and Varicella (manufacturer, Lot number and site not reported) on 17 August 2007 and that same day she experienced pain and redness at the injection site. The following day, the injection site was very swollen (9x6 inches), indurated, edematous and itchy, with no drainage. The patient was afebrile. It was reported that the patient was to see a doctor. Recovery status had been reported as "not recovered". The patient was previously vaccinated with Gardasil (manufactured by Merck); Lot number and route/site not reported) on 18 July 2007. No additional information had been provided at the time of this report.
feeling run down/Fatigue; Headache; This is a spontaneous report by a contactable consumer (patient's daughter). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. The patient medical history included diabetic, feeling run down, fatigued and weak. The concomitant medication included vitamin C, Zinc and B12. The patient had undergone laboratory tests which include vitamin D levels were 9.5 and sodium level was low. On an unknown date, the patient experienced headache and fatigue/ feeling run down. It was reported that reporter wanted to know if patient would be allowed to have a vitamin B12 shot without interfering with the vaccine. On 04Apr2021, the patient was also had second dose of the Pfizer Covid-19 vaccine and wants to know how much time after she may present side effects. It was reported that patient was in hospital for the event feeling run down on an unknown date. The reporter also wants to know how long the symptoms of a headache and fatigue last. The outcome of the events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Painful and swollen gland in my neck. This began 10 days after vaccination and remains 4 days later.
UTI; This is a spontaneous report from a contactable consumer.  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration, left upper arm on 22Dec2020 12:30 at a single dose for COVID-19 immunization at a hospital. Medical history included urinary tract infection (UTI) in 2018 (2 years ago). There were no concomitant medications as the patient does not take any prescription drugs. Patient thinks her urinary tract infection (UTI) started to develop, 28-29 hours after receiving the vaccine so the onset was 23Dec2020. Patient stated the UTI came on fast and she has an appointment with an urgent care and may need antibiotics to treat the UTI. Patient was drinking a lot of fluids to try to flush the UTI out of her system. She said she doesn't feel as bad and felt like the UTI was getting better, and just woke up a short time ago. Patient also stated that she is concerned the antibiotic will mess up the vaccine, and wanted to know if she can take an antibiotic so soon after receiving the vaccine. The patient was recovering from the event.   . .
This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site warmth and injection site erythema to be probably related to SHINGRIX. Additional details were reported as follows: The reporter herself was the patient. The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced redness and swelling at the injection site which ran down all the way down to her elbow. It was warm to touch at the injection site. The symptoms lasted for about a week and a half. All questions were asked. No further details were provided.