chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions or allergies who on 15-NOV-2007 was vaccinated intramuscularly with a 0.5ml dose of PEDVAXHIB (OMPC) (lot # 654072/1013F).  Concomitant therapy included DAPTACEL and FLUZONE (influenza virus split virion 3v vaccine inactivated), date received was not specified.  On 15-NOV-2007, 12 hours post vaccination, the patient developed a fever and had a febrile seizure.  The patient was taken to the emergency room and later released.  No lab diagnostic test were performed.  The patient recovered on 16-Nov-2007.  Upon internal review, the patient's febrile seizure was considered an other important medical event.  Additional information has been requested. This is in follow-up to reports previously submitted on 2/28/2008. Information has been received from a nurse concerning a 7 month old female with no pertinent medical history or drug reactions, allergies or illness at time of vaccination who on 15-NOV-2007 at 9:00am was vaccinated intramusculary in the right lower thigh with a third 0.5ml dose of Hib conj vaccine (lot # 654072/1013F). The patient was concomitantly vaccinated on the same day with DAPTACEL -lot# C2569AA given intramuscularly in the right upper thigh and FLUZONE - lot# UT2460AA intramusculary in the left thigh. On 15-NOV-2007 at 9:00pm. 12 hours post vaccine the patient developed a fever and had a febrile seizure. The patient was taken to the emergency room and later released. No lab diagnostic test were performed. The patient recovered on 16-NOV-2007. Upon internal review, the patient's febrile seizure was considered an other important medical event. No additional information is expected.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient presented to pharmacy on 8/17/2021 and stated that they developed a rash 2 days after their second vaccine and the rash on their entire body that has not gone away. The patient did not mention any other symptoms besides her rash throughout her body.
This child had redness, swelling (urticarial), tenderness, and itchiness on left thigh 12 cm x 15 cm.
Intense chills; Fever; Skin hypersensitivity; Intense inflammation; Nausea; Loss of appetite; Intense fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no allergies to food, medication or other products. On 25Apr2021 at 19:00, the patient experienced intense chills, fever, skin hypersensitivity lasting 8 hours, along with intense inflammation lasting 14-18 hours, 4 hours of nausea, 48-hour loss of appetite and 3-4 days intense fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea was resolved on 25Apr2021 at 23:00 and the events chills, pyrexia and skin hypersensitivity were resolved on 26Apr2021 at 03:00. The outcome of the event intense inflammation was recovered on 26Apr2021 and loss of appetite was recovered on 27Apr2021 at 19:00 and for event intense fatigue was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
This spontaneous reprot was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On an unspecified dates, an unspecified number of patients received improperly stored M-M-R II lot# J010601, exp. date 30-AUG-2015, lot# K024035, exp. date 26-NOV-2016, (dose, frequency and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
felt like a tingly nerve pain; had tightening of upper back and neck muscles; Sharp pain was experienced from back up the neck up to head.; Sharp pain was experienced from back up the neck up to head.; Muscle pain was unbearable for entire body for a few hours; Sharp pain was experienced from back up the neck up to head/Severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine for Allergies: CODEINE. The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient did not had Covid prior vaccination and was tested for covid post vaccination. The following information was reported: MYALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Muscle pain was unbearable for entire body for a few hours"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset Nov2021, outcome "recovered with sequelae" and all described as "Sharp pain was experienced from back up the neck up to head."; HEADACHE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Sharp pain was experienced from back up the neck up to head/Severe headache"; NEURALGIA (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "felt like a tingly nerve pain"; MUSCLE TIGHTNESS (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "had tightening of upper back and neck muscles". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after both the initial and 2nd dose the following occurred: 12hours from receiving vaccine shot, had tightening of upper back and neck muscles. Muscle pain was unbearable for entire body for a few hours. Sharp pain was experienced from back up the neck up to head. This lasted for 7 days. Severe headache lingered for 2 weeks. The headache experiences was abnormal. Usually I feel pressure or pounding headaches, this however felt like a tingly nerve pain. It was reported that the patient recovered with lasting effects. 2 months after receiving last dose, I then also got the virus and it was a severe to mild case. The patient underwent Nasal swab test post vaccination twice on unspecified dates in Feb2022 and the result was Positive and Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with fever, chills, lethargy, headache and nausea around 0900 on 1/28/21. By 1500 I had severe nausea which resulted in vomiting (water and dry heaving) with a small amount of blood (small clots) with first time vomiting. Then at 1700 I could barely move with severe body aches and headache. Attempted to drink some water and eat soup, but intestines burned too much. Slept from 0800 on 1/28/21 through till 0830 on 1/29/21 with very minimal waking. Only left my bed to throw up one time and use the restroom one time. Took Tylenol around the clock. Upon waking on 1/29/21 noticed a petechiae type rash on both sides of my face, sore throat and mild headache (took tylenol). 1/30/21 no symptoms and facial rash slowly disappearing.
This spontaneous report as received from a nurse assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored VARIVAX (lot # L044526, Expiry date: 09-NOV-2017) for prophylaxis (dosing details were not reported). Concomitant therapies included sterile diluent. Temperature was reported as 6°F to 14°F (5.5°F) for 6 Hours 20 Minutes and -58°F to 5°F (1.5°F) for 5 Hours 15 Minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports from to the same reporter. Sender's Comments: US-009507513-1708USA009406.
Extreme high blood pressure caused traumatic bleeding nose off and on for 3 days turning into an ER visit by ambulance on the 4th day.   Blood pressure meds adjusted. Followed by cauterized nose.
pt exp abdo cramping & nausea, & diarrhea p/2nd dose of vax lasting 1 day;
Information has been received from a physician concerning a female patient who on an unspecified date received the full GARDASIL series (Lot #, expire date not reported), 120 mcg, intramuscularly. Physician mentioned that the patient was diagnosed with CIN3 syndrome. Physician indicated that patient was not sexually active. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Began itching and swelling at site and then down and up my arm.  Increased enough that I took a  Benadryl on Friday, 1/22, to try to stop it.  It continued the next day, so I started taking Benadryl and Pepcid, and finally yesterday (Monday, 1/25, I  took 2 Benadryl and 2 Pepcid at the same time and then a Benadryl last night.  It is much better now, so I have taken only 1 Benadryl with 1 Pepcid at midday, today.
Felt pain in my whole body. Especially in both my arms. Extreme nausea and some vomiting last night. Can?t do anything. Have a fever. Thought I would be getting better but  just laying in bed having awful pains.
Patient had swelling of her lips 17 hours after vaccination.  She also had fever and headache.
Phoned pharmacy day after receiving vaccination to report aggravation of bursitis and immobility of left arm.
6/3/16 pm c/o shortness of breath upon standing. 6/4/16 c/o fatigue and muscle hurting. 6/5/16 woke up with urticarial lesions trunk and extremities. Seen at urgent care - given SOLU-MEDROL injection and oral steroids x 5 days.
In the very early morning (around 3:00am) the day after my vaccine, I started to have intense pain in the armpit of the vaccinated arm. There was swelling, and it was very painful to move my arm or apply pressure to it. Around this same time, I also began to feel feverish. I had chills and body aches and felt very fatigued. These symptoms lasted for almost 48 hours after they initially began. The pain in my armpit is still present, 96 hours after the vaccination, though it is significantly less. I was able to move my arm again about 72 hours after the vaccination.
Rash from head to toe. It appeared 1-2 wk post vaccination. Likely to MMR.
When I caught COVID-19 I had a slight sore throat. On 7/13/2022 I spoke to the doctor and she prescribed me with paxlovid. I had a low grade fever for 2 days, and I had the sniffles. The fever had went away. Then on the 2nd day of taking paxlovid the sore throat went away. I thought I was better until 7/22/2022. I had snidffles and a sore throat again. I had a rebound of Covid-19. I had a dry cough too. The fever didn't come back. I had those symptoms until yesterday or this morning. On Monday I felt my lower back ache. By the end of the day I had put heat on it, and I had horrible back pain. That lasted until yesterday. Today I feel much better. The rebound of COVID-19 lasted for about a week. I had a much stronger head cold the 2nd time around. I took Advil and Aleve.   2 and a half days.
on 12/22/2020 pt received vaccine and reports that apx 3 hours later apx 15:02 started having arm soreness, headache, runny nose, fatigue, chest tightness, wheezing, and "feeling out of sorts". pt reports that symptoms have been intermittent since beginning. Today 12/31/2020 is the first day she has only had headache. Denies any treatment or medications taken/received.
Hives; Chickenpox blisters; Chickenpox blisters; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hives, chickenpox and blister. On an unknown date, the outcome of the hives, chickenpox and blister were unknown.   It was unknown if the reporter considered the hives, chickenpox and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter reported that patient had shingles vaccination and broke out in hives and chicken pox blisters. The physician said that patient was one in 10,000. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot# M039202, expiry date 11-MAR-2018) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
p/vax pt T104, chills, body was achy;took ASA for temp;went to clinic for further treatment;
After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she developed swelling in her tongue and took bendardyl (50 mg). Epinephrine was at bedside but not given. Reaction subsided. Vital signs were unremarkable. Physical exam was normal except for tongue swelling.
Fever, chills and headache starting at 6PM (7 hours after the shot) and lasting for about 6 hours.  Ibuprofen did not help.  The headache lingered (but was not as bad) for the next 36 hours
Patient presented to clinic on 07/23/2012 with 5 days of chest pain and shortness of breath after receiving the smallpox vaccination on 07/11/2012.
pregnancy; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained of injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
At a public clinic, patient and mother registered and consented to a Moderna Bivalent Vaccine. Prior to vaccination, patient's mother confirmed the child would be receiving Bivalent Moderna dose. After administration, RN asked for patient's vaccine card in order to update and patients mother stated, "This is her first dose". RN immediately informed MD. Patient's mother made aware that the child will need to receive Primary Series. Patient had no adverse reaction.
body aches; Headache; Fatigue; fever is 101.2; This is a spontaneous report received from a contactable consumer or other non-health care professional (Husband) reporting on behalf of a Patient (Wife). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date are not provided), via an unspecified route of administration on 06Apr2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. The reporter was calling about the Pfizer covid vaccine, he was calling on behalf of his wife. The patient had the second dose of the vaccine on 06Apr2021 at 1:00 pm. The patient was 48 years old and was never ever sick, she has a strong immune system. That day on 07Apr2021, the patient had body aches, a headache, fatigue, and her fever was 101.2. The reporter was looking at the website and saw that a fever of around 100 degrees would be expected, but is this normal or common to have a fever greater than that? The patient underwent lab tests and procedures which included Fever (Body temperature): 101.2 degrees Fahrenheit fever on 07Apr2021. Reporter seriousness for body aches, Headache, Fatigue and fever is 101.2 was Unspecified. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Pt recvd vax 22OCT92 & devel erythematous rash w/edema around neck, t104, weakness, sore throat, h/a, loss of appetite, tiredness, joint pain, constipation, myalgia, malaise, n/v;
Two days after receiving my second dose of the Moderna COVID-19 vaccine, I started a light mentrual period. It has now lasted 20 straight days. I take birth control and should not have a period this lengthy or outside of the sugar pills. No other changes to my health or environment has happened during this time.
Diagnosed with Blood clots in my left leg; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Diagnosed with Blood clots in my left leg) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Diagnosed with Blood clots in my left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with Blood clots in my left leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had the booster dose in November and was recently diagnosed with Blood clots in the left leg. Company Comment: This is a spontaneous case concerning patient ok unknown age and gender with no medical history reported, who experienced the unexpected serious AESI Thrombosis (reported as Blood clots in my left leg). The event occurred at an unknown day after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.    Treatment information was not provided.   This case was linked to MOD-2022-450463 (Patient Link). Sender's Comments: This is a spontaneous case concerning patient ok unknown age and gender with no medical history reported, who experienced the unexpected serious AESI Thrombosis (reported as Blood clots in my left leg). The event occurred at an unknown day after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
was on the hospital on April; This case was reported by a consumer via patient support programs and described the occurrence of hospitalization in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   The reporter considered the hospitalization to be unrelated to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. This report was submitted via the online direct entry reporting system. Reporter was the patient herself. Patient history was not provided. Batch number and expiry date was not provided. The patient was called for the assistance on Shingrix and she mentioned that she was on the hospital on April. Dates for hospitalization was not provided. Reporter was unable to gather more information. Reporter called the patient and her number did not take unknown numbers. Reporter consented to follow-up.
Since getting the vaccine, my body can not regulate temperature. I get hot  (with sweating) out of no where then I?ll get cold and then hot all within the matter of minutes. I have lost a lot of weight without exercise. I profusely sweat in my sleep at night to the point I have to change clothes and sheets. This never happened before.  When I eat I immediately get stomach pain that stops me from eating for 5-10 min then at times I can continue eating and other times I can not
Severe body rash, head to legs with body inflamation Applied topical triamcinolone After rash subsided,  my body started peeling