chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a pharmacist concerning a 75 year old retired female with a history of sulfonamide allergy who on 04-JUN-2007 at approximately 14:30 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck) (Lot#657764/0584U).  There was no illness at the time of vaccination.  On 06-JUN-2007 the patient presented with irritation at the injection site which was red, hot, and swollen.  She also had a headache and a mild fever.  No lab studies were performed.  No further information was provided.  Additional information has been requested.
EVS employee stated she had itching at the bandaid site. on arm where vaccine was given.  When bandaid removed you could see a redness around the site of bandaid.  She only complained of itchiing until bandaid was removed. Later that day  she c/o of headache and took tylenol on her own. She told me next day she had a headache most of the night and body aches. All education material was given to her in spanish and she stated she read them and understood. I instructed her to go to ED or call 911 if itching and redness became worse orwas having trouble breathing or swallowing. She denied other sx at   time of observation. It was over 30 minutes. She returned to work on floor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733), on 23Apr2021 as dose 2, single (Lot number: EW0170), on 15Nov2021 as dose 3 (booster), single (Lot number: EW0191) and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. Concomitant medication(s) included: ALPRAZOLAM, start date: 05Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Indication: Treatment of COVID-19; (Sep2022) Positive, notes: Covid-19 Rebound Infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.
pt recv vax & 12hr later had gastroenteritis & flu like sx-resolved in 36hr
20 min after shot, warmth and flushing which lasted 2 min; soreness at injection site  Soreness/swelling at site continued to present- 3rd day  Redness at site started 8 hours after injection and continued to present   Beginning 17 hours after shot and continued for 18 hours(shot+35 hrs): Muscle and joint aches Lethargy  Temp maxed out 101 No headache, no chills  After 35 hrs, temp normal, aches and lethargy faded quickly; normal by 42hrs.   Soreness, swelling and redness at site continued at 68 hrs
Excessive urination; Right arm pain; This spontaneous case was reported by a patient and describes the occurrence of URINARY INCONTINENCE (Excessive urination) and PAIN IN EXTREMITY (Right arm pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZ1A) for COVID-19 vaccination.     Previously administered products included for Influenza immunization: Flu shot. Past adverse reactions to the above products included Pain in arm with Flu shot. Concurrent medical conditions included Allergy to chemicals. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URINARY INCONTINENCE (Excessive urination) and PAIN IN EXTREMITY (Right arm pain). At the time of the report, URINARY INCONTINENCE (Excessive urination) had resolved and PAIN IN EXTREMITY (Right arm pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information after first dose of vaccine was not provided.   This case was linked to MOD-2021-075102 (Patient Link).
Flu-shot injected to left arm - deltoid area shot was injected to high and into the shoulder area. One hour after injection arm was very painful and numb. Ice was applied all night, left arm is still painful as well as neck area at times.
The patient complained of feeling crummy and having fever and headache. He also said he couldn't lift his left arm where he had the injection. He had pain, swelling, redness, and heat at the injection site and below to the elbow.
LUE red, warm 1 week after injection; erythema getting worse; pain. Reported fever/chills few days ago
Pt had severe swelling, red hot rash, induration from shoulder to elbow. With a large blister developed in the middle of compound rash area
Body aches, head ache, chills for about 7 hours from 03:00 am until 11:00 am
Pt presented with covid and treated with remdesivir and methylpredniolone. Pt was discharged home.
GENERALIZED RASH/HIVES FROM HEAD TO TOE, BRITTLE HAIR AND SEVERE ITCH BENADRYL, CALADRYL, AND HYDROXYZINE HCL 25MG
Received Dtap, IPV, MMR, Varicella at 10:15 AM-erythema around neck with patchy reddness with raised papules developed at approx. 11:00 am- no dyspnea, SOB other anaphylactic Rxs - instructed sister/caregiver to administer Benedryal PO and actuate EMS if any resperatory problems developed.
severe rash on face, lighter rash on neck, hairline, stomach and back.  Itching, burning of face rash.  Headaches.  Rash has disappeared everywhere except face.  Headaches continue and face rash continues to itch and burn, has not abated at all as of 10/30/2009.  Reported to pediatrician.
Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired). At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
This spontaneous prospective pregnancy report as received from a Medical Assistant refers to a 12 years old female patient with no drug reactions/allergies. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with her first dose of GARDASIL (lot # 671006/1291AA, expiration date 12-APR-2014) on 23-APR-2012, the second dose (lot # 671994/1537AA, expiration date 21-JUN-2014) on 06-JUL-2012 and third dose (lot # H010123, expiration date 14-JAN-2013) (route of vaccination was not reported). Concomitant medications included prenatal vitamin. The patient was pregnant when she received her third dose of vaccination. The LMP and EDD were not known. The patient had sought medical attention via office visit. No treatment was given. Additional information has been requested.
Client states she had a sore achy arm at injection site later in day of injection.  Following day continued to have achy arm along with fever, chills, headache and muscle aches.  On March 2nd she awoke with erythema and swelling of Lt SupraClavicular area and left arm.  Area on chest measured 4 X5.5 cm and area on Lt deltoid area approximately 7X 4cm.  of swelling and erythema.  Left arm has limited range of motion and discomfort.  Left  anterior cervical lymph nodes palpable. Temp - 99.4 Advised to use ice to area.  Tylenol tab 2 po as needed.  May use Benadryl po as directed.  If no improvement or worsens should see PCP.  03/04/21  Call to client, states her arm and chest area are so much better after taking the Benadryl the last 2 days.  Client will call nurse tomorrow.  03/05/21  Client text nurse and reports no remaining redness or swelling.  States still has a tenderness of injection site.  Pictures sent by patient and no erythema or swelling noted.  Advised could take Benadryl before next injection if desires.
Patient got her first dose of Pfizer on 9/2/21 and got the second dose on 9/11/21, she got it too soon. No adverse reaction noted during post vaccination monitoring. Pt educated to go to the ER at any onset of respiratory problems or even if something don't fell right.
Patient is a 73 y.o. male with a complex PMH significant for Bipolar disorder, HTN, HLD, parkinsonism, PE not on anticoagulation, TBI who presented with IPH and seizures. Patient unable to provide history, but per wife she heard him making noises in bed early in the morning, she went to check on him. He was was having a generalized tonic clonic activity of his extremities and eyes rolled backwards she did not know how long this has been going and thinks it continued until he was taken by EMT. In the ED he was loaded with 1500 mg of keppra. CT head showed aright sided IPH. He has partial seizure with left arm shaking. He was given 2mg of lorazepam and that resolved.
Chills, headache, nausea and vomiting, arm swollen and sore at site.
Male, 18 months old, was given a fourth dose of IPV. Third dose was given in February 2014. Physician stated that error occurred due to new Electronic Medical Record being implemented and the proper vaccine information was not in the EMR. In addition, the nurse failed to check the paper chart to ensure that the child was receiving the correct vaccinations. Contributing factor may have been that the child recently moved to the state and his vaccinations were not all given by this practice.
Patient went to emergency room the evening of 11/4/20 with dizziness and diarrhea.
Moderna booster received 12/3/21. For my first 2 doses of Moderna, I had a range of side effects. Same is true this time (migraine, aches/pains, lethargy, etc).  However, this go around, I seem to also be feeling very mild pain in my organs, on both left and right sides. I'm fine. I'll go to a doctor if it persists for a few more days or intensifies. I assume it's related to the booster, so I'm submitting this information for data collection purposes after reading online that some people experienced "visceral pain". It seems maybe this side effect isn't listed as common, so just wanted to share.
Body aches, headache, fatigue, fever chills. Lasted 24 hours since first symptoms appeared
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that doses of vaccines GARDASIL (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial Shot (7/10/12)-arm was tender Next Day (7/11/12)- deep pain when arm is moved in any direction other than forward and onset of nausea (7/12/12)-pain and nausea continue
About 10-15 minutes after the vaccine was administered, patient began experiencing a slight swelling around her lips.  She denied any shortness of breath or difficulty breathing.  At the initial complaint of swelling, I administered approximately 75mg of oral liquid diphenhydramine.  (Pt. weighs around 80kg.)  I watched the patient for the next 30 minutes.  Within about 10 minutes of administration of diphenhydramine, the patient stated that she felt the swelling begin to come down.  About 20 minutes later, the swelling had resolved completely, and the patient denied feeling any other side effects.
I woke up feeling terrible, like I was in a haze. I went to my previously scheduled doctor's appointment. They told me I looked awful.
He rash has developed over the last couple of days and seems to be spreading particularly around her feet and ankles and hands and wrists. The lesions are blister like in nature. They have been itchy. They are in various stages of evolution. There is no obvious bite marks. There is no known bite exposures. No one else has similar rash at home. She has never had a rash like this previously. Over the last couple of days, she has had respiratory symptoms and this morning a mild cough. She is taking no medications.
Myalgia, Arthralgia & Fever Narrative:  dose 1-day 2 and 3:Pain, Redness, Chills, Muscle or body aches, fatigue or tiredness dose 2-day 1-2-arm pain/redness; day 1-2-fever fatigue  Other Relevant History:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 50U/1ml (lot # L017757, expiration date 08-APR-2018, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 360 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2013US025328 is an initial, report received from a pharmacist on 04 DEC 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: 1308401; expiry date: not reported) subcutaneously on an unspecified date as it was mistaken for Tuberculosis test. The patient immediately experienced warm, red, itching symptoms at the site of injection. The pharmacist did not have patient information to provide and stated he would try to obtain this information. Outcome of the events, seriousness and causality were not reported.
Was in ER due to severe pain in left leg arrived at 10:47 am on May 3,2021. Diagnosed as Us Ven Duplex Lower Extreme Lt. Subocclusive thrombus in mid to distal superficial femoral vein. Was put on xarelto.
This is a spontaneous report from a contactable consumer, the patient. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, in the arm right on 11Apr2021 10:00 as dose 2, single (at the age of 35-years-old) for covid-19 immunization. Medical history included blood cholesterol increased and seasonal allergy. Concomitant medications included LIPITOR, CoQ 10, and FISH OIL. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration, in the arm right on 19Mar2021 as dose 1, single (at the age of 35-years-old) for covid-19 immunization. On 01Jul2021, the patient's upper lip was not moving correctly when he speak. Patient's upper lip felt rigid and not malleable when he speaks. Patient worried this was a case of bell's palsy. The patient seeing a doctor for the first time on 24Aug to evaluate this. Therapeutic measures were not taken for the events. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. The patient visited the doctor or other healthcare professional office. The outcome of the events was not recovered.
Patient received FLUVIRIN 0.5ml on 9-1-11; he went to ER on 9-13-11 & reported itchy, red bumps & rash below shot area about 3 days after shot (approx 9-4-13); rash & bumps still present.
Raised lesion with erythema; baseball-sized area. No systemic effect 3 days later, after initial swelling.
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
expired dose of shingrix had been administered on 5/7/2021 / expired on 5/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 7th May 2021, the patient received Shingrix. On 7th May 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. On 7th May 2021 patient received Shingrix, which was expired on 5th may 2021. The reporter asked if patient needs to be revaccinated. No other patient or  vaccination details were available. The reporter consented to follow up.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degree Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
On 09/09 started w/ back pain and could not walk. Bed ridden until 09/20. Experienced muscle spasms in lower back. Unable to stand
Mom reported pt drowsy & shaky p/shots; Taken to ER, t101R No actual sz activity, eyes rolled back in head; ER findings probable vax rxn w/poss sz;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced suspected covid-19 infection. Treatment medications included: fexofenadine hydrochloride. On 20-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000177470 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Bell?s palsy on left side (onset 01/24)  T/t Valacylovir 1000 mg PO TID x 1 week and prednisone 60 mg PO Daily x 1 week.
a 44 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - dry throat, coughing, vomited x 1. Endorsed that she is very nervous with the vaccine, started having dry throat and coughing with watery eyes. Then vomited x 1 with partial digested emesis. no hematemesis per patient.    pt kept on coughing and anxious. Otherwise vital signs stable, physical exam unremarkable. Given cetirizine and albuterol inhaler 2 puffs. Improved post medications. Referred to allergy clinic and