chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient phoned with concerns about events following Shingles vaccination that she received last week 9/1307; vaccine was administered in left upper arm subcutaneously about 45 minutes later she experienced a slight headache and felt nauseated; later that evening the injection site was "red", her dull headache persisted so she took Advil and went to bed; 9/14/07 the injection site was swollen, about diameter of an egg, warm to touch and felt itchy; later that day she felt tingling and itching sensation on right side of neck; 9/15/07 stated little red bumps appeared at right side of neck that "went down to shoulder area," later that evening the bumps had spread to her upper right back, and area was tingly with mild discomfort; 9/16/07 she awakened with discomfort and itching red bumps were then little water blisters; area involved now includes her right neck, shoulder, right chest and right back; she presented to Target Minute care and was told it "looks like classic Shingles." They encouraged her to use over the counter meds for her symptoms but in view of having had the Shingles vaccination on 9/13/07 that she should call Dr this am; I notified Dr by phone and she will in turn call patient-patients home phone number; VAERS reported completed and faxed.
ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis.  Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Information has been received from a 72-year-old male consumer with allergies to glycerol, ORGANIDIN, etodolac, and MYLICON and a history of "hernia surgery a couple of years ago" who had a physical about 04-Oct-2007. On 11-OCT-2007 he was vaccinated intramuscularly with a first dose of Zostavax. There was no concomitant medication. On approximately 14-OCT-2007 "about 3 days post vaccination) the patient experienced "swollen feet, hand, tongue, lips, and finger tips". The consumer also reported that he experienced "swelling of his throat which has closed his airway flow" and that he has developed "pimples on his upper body and hairline". The consumer also experienced "cheek soreness causing them to be raw inside". He has been to the emergency room about three times and has been hospitalized for an overnight stay. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
I have a whole bunch of lymphoedema, lupus, my ANA is high, I lost weight (a lot), I vomit, I can't keep nothing down, headache, my A1C is high, leukemia, all this is showing on blood work but the bone marrow shows negative. Biopsy on one of the lympnodes. I have these bumps on my body like jelly.
Initial consumer report via article received on 26 Mar 2010: The patient was vaccinated with Influenza virus vaccine (batch no. unknown), unknown dose, on an unspecified date. The patient experienced Guillain Barre Syndrome and was unable to work for two months (date not specified). The patient was hospitalized and would undergo surgery for a cardio-vascular disorder on unspecified date. The outcomes of events were not reported.
pt was given vax 1115AM 17SEP97 & had a febrile sz 115PM;2hr p/vax t102.7;pt given APAP p/returning w/feb sz;
1. Fatigue, Fever, Lethargy (Now Recovered; Dates: 1/29/22 & 1/30/22) 2. Lymph node swelling under right armpit (Now Recovered; Dates: 1/30/22 - 2/2/22) 3. Hives all over body, except face: exacerbated by itching (Persisting: 2/1/22 - present)   Side Bar:---i have no hx of dermatographia. last incidence of hives was in the early 1990s,
No initial reaction --> 2 weeks after vaccination (3/14/13). Patient had bilateral tingling in hands and feet. Patient wast treated by neurologist, who ruled out Guillain Barre Syndrome but attributed to vaccination.
~4 hrs after: muscle spasms in back and sciatca running down R leg. ~6 hrs after: generalized body aches, extreme soreness in L arm, chills. From ~ 9pm 2/19/21 to evening of 2/20/21 - extreme body pain (9 out of 10 on scale), aches, fever, stiffness, woozy, weak, barely able to move/walk, upset stomach and diarrhea. 2/21/21 - body aches and pain decreased from level 9 to level 6/7. Very weak - legs get wobbly if stand for more than a few minutes, feel "spent" as though had just done a long bike ride, low level headache. 2/22 - current (2/25) still very tired, run down and weak. Body aches and stiffness, particularly in the legs and arms. It feels as though the reaction the vax sparked a "fibromyalgia flare".
Mental Fog; Shivering/ rigors; Exhausted; Memory loss for an hour and a half; Fever; Mild Headache; Dizziness; Felt "out of sorts"; This case was reported by a consumer via call center representative and described the occurrence of consciousness clouding in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 15th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. On 16th October 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced consciousness clouding (serious criteria GSK medically significant), shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal. On 16th October 2021, the outcome of the memory loss was recovered/resolved. On 26th October 2021, the outcome of the consciousness clouding, shivering, exhaustion, fever, headache, dizziness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the consciousness clouding, shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The reporter was the patient.   The patient received Shingrix in an unknown deltoid and also received an unknown brand of Flu vaccine the same day.   The next day after receiving Shingrix and Flu vaccine, the patient began to had shivers, exhaustion, memory loss for an hour and a half, fever, rigors, mild headache, dizziness, mental fog and he felt out of sorts.   The patient reported that, on the date of reporting, the side effects seemed to be resolved as he was feeling better.  No Lot number or expiration date for the vaccine was known. The reporter provided healthcare professional information. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), PYREXIA (fever), TASTE DISORDER (Weird Taste) and FATIGUE (Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (result in hives) and Drug allergy (sulfur allergy which result in swelling). Concomitant products included LEVOTHYROXINE, EZETIMIBE, PANTOPRAZOLE and LORAZEPAM for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (painful arm soreness), PYREXIA (fever), TASTE DISORDER (Weird Taste), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives). On 02-Mar-2021, the patient experienced RASH (rash on the other arm). On an unknown date, the patient experienced FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm soreness), RASH (rash on the other arm), SWELLING (swelling blotchy rash near the site of injection) and URTICARIA (rash look like hives) had not resolved and TASTE DISORDER (Weird Taste), FATIGUE (Tired), PAIN (Right upper arm where she got the shot is throbbing and very hard to move) and MALAISE (she felt like sheh as a GERD after the shot) outcome was unknown.            Treatment: applied heat and icing
My heart went into AFIB from 7:30-9:30. I had to go to the ER and now am on blood pressure medicine. I am 29. This has never happened before.
On the 10th I had a severe stomachache for about 4 hours. On the 11th I developed vertigo which continued through Sunday the 14th, at which time a telehealth provider prescribed meclizine. I started meclizine on the 14th and that calmed it down. I took meclizine for a few days. Hoping it's gone now and doesn't come back. Pretty sure this was related to the vaccine.
INCREASED HEART RATE; FEVER; OXYGEN SATURATION 91%; This spontaneous report received from a consumer concerned a 75 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: 202A21A expiry: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced oxygen saturation 91%. Laboratory data included: Heart rate (NR: not provided) 91 bpm, and Oxygen saturation (NR: not provided) 91 %. On 04-MAY-2021, the subject experienced increased heart rate. On 04-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.0 F, and Heart rate (NR: not provided) increased to 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate, fever and oxygen saturation 91% was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
She slept all day, she hasn't eaten, no appetite; She slept all day, she hasn't eaten, no appetite; She started vomiting, vomited 2-3 times today; Very tired; The shot hurt; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt). At the time of the report, DECREASED APPETITE (She slept all day, she hasn't eaten, no appetite), SOMNOLENCE (She slept all day, she hasn't eaten, no appetite), VOMITING (She started vomiting, vomited 2-3 times today), FATIGUE (Very tired) and VACCINATION SITE PAIN (The shot hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) 98.4F.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Developed headache (worst of her life), vomiting, posterior neck pain on 4/9/21. She was seen at a local E.R. and suspected to have a vertebral artery dissection bilaterallly based on CT angio head, neck findings and admitted/transferred to another facility. Dissection was not confirmed on a subsequent MRI. She has been treated by neurologist in follow-up for her continued headache and neck pain.
Patient had severe swelling at injection site. This developed into a rash and bleeding from the injection site after 24 hours. Patient had a high fever for 24 hours.
Pt had episode of inconsolable crying about 2 hours, post vax, followed by fever of 102F after 17:00. The fever increased to 105F, mom started drive to hospital and at that time he had a "seizure" and was taken to hospital by EMS. Temperature on arrival was 100F and asymptomatic. Discharged on Tylenol.
9/16/02 high fever (104) sore arm (rt). 9/18/02 high fever (104) sore arm and malaise. Seen in ER. 9/19/02, 9/20/02 lab done, IV antibiotics given in ER. 9/23/02 feeling better.
The night of receiving my booster, I started to experience a fever of 102, chills and body aches. I took a couple of Tylenol, ate something and went to bed. I woke up because of a massive headache. I took some more Tylenol and took a nap. I was taking aspirin, Tylenol, Ibuprofen and Naproxen. Nothing was helping this headache. It lasted for seven days and then just went away.
On 9/16 I received both DPT and pneumonia vaccines. The pneumo had a pink mark w/in 24 hours.  It soon vanished.  The DPT had a hard spot that became red, hot & itchy 5 days later.  On 9/21 it was about 3" in diameter.  By 9/22 it was almost 5". It stung & itched, it was hot, hard and bumpy.  I went back to the doctor's office, was examined, and was to return in 2 days if there was no improvement.  Within 24 hours most of the symptoms were gone.
11/29/21 pt had a positive COVID test at Hospital; she was admitted for increasing SOB and fatigue; treated with Augmentin; transferred to other hospital for further care; O2 saturation 83% on RA; given O2 supplementation; dexamethasone, ABX, remdesivir; CTA of chest revealed lymphovascular distribution of micronodules; pt's respiratory status worsened; critically ill; dependent on Vapotherm and NRB intermittently; eventually required intubation; AKI; condition worsened; pt was found without vital signs
CHILLS; FEVER; MUSCLE ACHE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 46 year old male. 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at Right Arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from nausea on 05-APR-2021, was recovering from chills, and had not recovered from fever, muscle ache, and headache. This report was non-serious.
marked sleeplessness (entire night) , moderately sore vaccination cite, tired feeling /listlessness and  unable/unwilligness to to undertake common daily activity, upset stomach (moderate, controllable diarrhea)....symptoms reported only to indicate vaccination was not without resulting symptoms....anticipate lasting a day as was the experience with dose no. 1
I feel like uncomfortable today; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had vaccine yesterday and felt like uncomfortable today. Patient would like to know if can take Advil. The outcome of the events unknown.  Limited information available on call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 12/12/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pain in my arm from the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm from the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm from the shot). At the time of the report, PAIN IN EXTREMITY (pain in my arm from the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she has sore arm after getting the Moderna COVID-19 vaccine and would like to know if she could take Aleve or Ibuprofen.
injected with Daptacel on 25Oct2019 that expired on 23Oct2019/no ae; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 9 month old male patient who received  vaccine  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 25-Oct-2019 that expired on 23-Oct-2019.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (Act-HIB) for Immunisation; and QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) for Immunisation.  On 25-Oct-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  It was confirmed no adverse event occurred.  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 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  Information on the batch number was requested.
pt states had vax 24JUN95 p/vax stated poss rxn to tetanus; yesterday was golf ball size-today area is tennis ball size; area located lt upper area sl raised, warm to touch, itching; tenderness;
Patient reported flat, red rash at injection site approx 2 days after receiving vaccination, lasting for approx 1 week.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions and drug reactions/allergies were reported. On 04-APR-2014 the patient was vaccinated with VARIVAX lot # 0414AE expire date 27-FEB-2014 dose 2, 0.5 ml, subcutaneous. No concomitant medications were reported. It was reported that the patient was administered with an expired dose (expire date 27-FEB-2014) of VARIVAX on 04-APR-2014. The reporter also noted that the patients first dose was given a long time ago on an unspecified date and this expired dose would have been the patients second dose of VARIVAX given. No adverse effect reported. The patients sought medical attention was not reported. Additional information has been requested.
patient experiencing cold-like symptoms: sore throat, cough, congestion, runny nose, sneezing. Symptoms lasted for 6 days before resolving
Minimal blood spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Minimal blood spotting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), ROSUVASTATIN for Cholesterol, GABAPENTIN for Neuropathy, NAPROXEN for Pain.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Minimal blood spotting). On 04-Mar-2021, VAGINAL HAEMORRHAGE (Minimal blood spotting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Fever, chills, headache, photophobia, swelling, tenderness in left arm