chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a temperature excursion for multiple vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 08-OCT-2020, the patient was vaccinated with an improperly stored temperature excursion hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022; dose and route were not reported) for prophylaxis (product storage error). Product was supported with temperature stability data.   The administered dose of the vaccine experienced a temperature excursion 50 Fahrenheit (F) for 9 hours time frame. There was no previous temperature excursion. The digital data logger was involved. There was no adverse effect reported. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Woke up at 044 with temp of 100, nausea, vomiting and diarrhea and fatigue.  GI symptoms have improved.
Serious swelling in the arm around the shot area. The swell is more than an egg. The selling is red. It starts approximately 12 days later after the shot.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W02; No additional AE; This spontaneous report has been received from nurse referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On an unknown date, the was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W025274 that had been verified to be a valid lot number with expiration date 10-AUG-2024, administered for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of 24.4 F for 5 hours 51 minutes 0 seconds. No additional adverse event reported and there was no a previous temperature excursion.
Patient was given COVID vaccine shot #1 on 1/4/2021. As of 1/8/2021 he was prohibited from donating blood due to a hemoglobin of 12.8. 2 weeks later he presented to donate again on 1/26/2021 and his hemoglobin had dropped to 7.8 without evidence of bleeding. He was subsequently admitted to hospital on 1/29/2021 - where he was found to be severely leukopenic and thrombocytopenic. A bone marrow biopsy revealed a diagnosis of severe aplastic anemia. He remains hospitalized but is now at another location. This has also been reported through VAERS.
Extreme Exhaustion, headache;, and shivers.  Began about 10 hours after vaccination.  This was the second shingles vaccination.  First one was About 60 days prior.  Zero adverse effects experienced with first vaccine.
swelling, redness, itching at/around injection site - mild but onset was one week after receiving vaccine
Rash on chest 3-4 days after vaccine on 5/13.  Patient complains of itching. Rash has persisted 12 days, ongoing, but healing.
The adverse event began by being achy.  Patient had a fever of 101.0 and elevated blood pressure of 153/normal.  Patient lost appetite for a week and her energy level was low.   About two weeks after the vaccine, the patient awoke to her left arm throbbing from the shoulder to her fingertips.
Case number PHEH2014US001238 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 13-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 13 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Mom noticed rash on right lower extremity red pimple like then traveled up to arm and chest and then became faint and almost resolved.
Partial blindness in one eye/visual disturbance; This case was reported by a pharmacist via call center representative and described the occurrence of partial sight in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced partial sight. Shingrix was discontinued. On an unknown date, the outcome of the partial sight was unknown.   It was unknown if the reporter considered the partial sight to be related to Shingrix.  Additional details were provided as follows: The patient was a physician assistant. Approximately two months after receiving the Shingrix, the reporter made a routine call to the patient to schedule him to receive the second dose. The patient's wife answered the phone and told the reporter that the patient experienced visual disturbances, and partial blindness in one eye after receiving the Shingrix vaccine. The patient did seek medical assistance. Currently it was unknown if these symptoms were related to the vaccine. The patient's wife indicated that her husband had chosen not to receive the second dose of the product.  The reporter consented to follow up.
swelling in deltoid region out of the ordinary 10 cm diameter, hot, red, pt unable to move arm; rxn occurred in rt deltoid;
Swollen arm, pain, redness lasting more than 4 days.  Painful enough to use Tylenol daily and could not be touched or sleep on my left side.
I HAD MULTIPLE SYMPTOMS SUCH AS FLU LIKE SYMPTOMS, HEADACHE, DIAREAHHA AND BODY ACHE
Patient stated she felt tingling/scratchiness in throat. BP 96/65, Pulse 71 , Pulse Ox 99%. Shortly afterwards, patient stated that her throat was feeling a little more swollen but that she did not want to go to convenient care. Patient stated she was fine and she didn't want conveneint care doctor to come see her.  Patient was talking  and no dyspnea noted throughout. Kept for 30 minutes to monitor. At end of 30 minutes, patient started to itch and wanted to go to convenient care. Went to convenient care, received methylprednisolone 125 mg IM x 1 and diphenhydramine 50 mg PO x 1. Stayed for 20 minutes and reprted relief from treatment. Discharged to home.
Tested positive for COVID-19; Dizziness; Headache; Chills; Slight fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Slight fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea). On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 after 1st dose..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Dizziness; Headache; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information include no new information.
Ongoing dizziness and elevated heart rate when standing up. Multiple episodes of losing vision during light headlines. Near miss with multiple episodes of loss of consciousness.
Patient reported very painful administration at the time of inoculation and feeling like her arm is going to fall off. She has a limited range of motion and there is visible redness and swelling around injection site. Patient has not taken anything to relieve the pain; I advised taking anti-inflammatory doses of ibuprofen three times daily.
Sharp severe pain in right upper arm at injection site. Constant pain which has not resolved but has worsened and pain to lift items with her right hand or sleep on that arm. Seen 11/5/15 with cont. symptoms as above.
Vaccination site pruritus; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 30-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No further treatment information was provided.
In 2 weeks after vacination got hands and wrist joints pain,  treated with physical therapy. Simptoms came back in 5 months and got worsened by now.
Pt recv'd MMR on 12/7/99.Pt dvlped bruising & petechiae.Pt was hospitalized and recv'd IV immunoglobulin.
Pt received ProQuad vaccine on 2/22/07 - seen at office on 7/26/07 Dx varicella zoster virus, shingles. Rx for Denavir and Acyclovir 200 QID x 5 d.
Patient experienced delayed reaction from vaccine; a red, itchy, irritated rash developed approximately 2 days after receiving her booster dose of Pfizer. This reaction was about 4 to 6 inches long on patient's arm. Resolved approximately 5 days after vaccine.
Starting at 11:30 p.m. that evening after receiving the vaccine I started to feel chilled.  the chills progressed throughout the night.  My teeth were chattering for 3 hours nonstop.  I felt very hot, but did not have access to a thermometer at that time.  I experienced severe body aches and a headache.  I checked my temp the next morning at 6:30 a.m., when I felt like my fever had broke, and it was 101.6 degree.  Throughout that day (11/24/2020) my right arm was very sore.  I continued with a fever (it dropped to 99.0 by that evening), body aches, headache, and very fatigued.  The following day (12/22/2020) all symptoms were gone with the exception of a sore right arm which lasted about 5 days.  No med. tx received
Contracted covid 19 virus after receiving first dose of vaccine; Contracted covid 19 virus after receiving first dose of vaccine; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Eh9899), intramuscular in left arm on 17Dec2020 18:00 at a single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. The patient had no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). On 27Dec2020 20:00, the patient contracted covid 19 virus after receiving first dose of vaccine. The outcome of the event was recovering. The patient did not received any treatment. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. The patient had nasal swab on 31Dec2020 and had a positive result.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
Information has been received from a registered nurse (RN) through a pregnancy registry concerning a 17-year-old Hispanic female with no allergies and a history of urinary tract infection who on 06-DEC-2005 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Varivax (lot# 647534/0823P). There was no concomitant medication. Soon after the vaccination the patient was found to be pregnant. Unspecified medical attention was sought. Laboratory and diagnostic tests were performed on 10-JAN-2006: prenatal AFP - results pending, "Hep SsAg" - negative, RPR - negative, rubella screen - "reactive," hemoglobin - normal, antibody screen negative for ABO/rhogam-. It was reported that the LMP was 28-OCT-2005 and the EDD = 04-AUG-2006. At the time of the report she was well and it was reported that the physician would be doing ultrasounds for follow-up. NO further information was available. Additional information has been received from a physician. It was reported that the patient had an ultrasound on 13-DEC-2005 for size and due dates. On 22-FEB-2006 she had a standard MSAFP. There were no previous pregnancies and the patient had no local reaction, varicella symptoms or herpes symptoms post vaccination. Additional information received from a registered nurse indicated that on 25-JUL-2006 the woman had a liveborn female infant weighing 2980 41 weeks from the LMP. There were no congenital abnormalities. Complications during pregnancy included thick meconium in fluid and tight nuccal cord X 2. Apgars were 8:9. There were no complications during pregnancy. Diagnostic test during pregnancy were all normal including "afp," ultrasound, and "glucole." Medication used during pregnancy included: prenatal vitamins (5 mg PO daily) and iron (325 mg PO daily) from January 2006 through July 2006. There was no feature of congenital varicella zoster syndrome in the infant. No additional information is expected.
On 3/26/16, patient left arm felt pain, Sunday, 3/27/16, the vaccination site was red, swollen and hard. Patient placed ice-pack and took 2 TYLENOL tablets and felt better. In the afternoon, patient felt dizzy, wobbly, face was red, chills and off balance. Sunday night soaked wet with sweat. Felt better with time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2021 as dose 2, single (Lot number: EW0177), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FE3594), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Gallbladder problems" (unspecified if ongoing); "Steroids allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175979 Same reporter/patient, different drug/event (Paxlovid);
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Severe, Additional Details: Event occurred during observation period, roughly 5-10 minutes after administration.  Patient was seated and appeared close to fainting (unresponsive, head down, unsteady) which prompted closer observation when she began to have seizure.  Patient was moved to cleared floor and EMS contacted immediately; transported offsite soon after.  Her husband reported history of epilepsy with drug regimen during event.
Extreme pain at and around site within 3 hours. Difficult to use right arm, severe soreness with throbbing aching pain. Total body muscle pain at 12 hours after delivery. Unable to sleep due to uncontrollable shaking and could not lay on injection site. Nauseous, High fever, Swelling, Redness, Fatigue and lack of focus.
On 22 March, at the recommendation of Dr., I received three simultaneous inoculations at the Clinic:  Tetanus, Zostavax and Pneumovax (23).  Within a week I experienced minor nose-bleeds with strange dark-red blood.  Within a day after the nose-bleeds, about Friday, I noticed a sharp increase in the number of "floaters" in the intraocular fluid of both eyes, but particularly in the left eye.  These floaters continue to interfere with my vision. I then scheduled an examination with my ophthalmologist who confirmed that I did have a large number of floaters, but there was no reasonable treatment at this time.
Pt rec'd Menactra on 8/8. On to Dr on 9/7/05 c/o weakness and numbness in left hand and both feet. Referred to neurologist. Pt diagnosed with GBS and required hospitalization, date and duration not known by neurologist. Pt recovering at home.
Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing sensation, vibrating sensation in my body; Heart palpitation; Cold extremities; Extreme muscle weakness/could barely open my hand muscles; Fluctuating rapid heart beat/heart rate was like 130; Feels like my muscles in my face not working well, especially in my mouth; Thyroid is been out of range; Super light headed/dizzy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm 07Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection and sinusitis. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism; valaciclovir hydrochloride (VALTREX) for Epstein-Barr virus infection; and cetirizine hydrochloride (ZYRTEC ALLERGY) for sinusitis. In Apr2021, after the first dose of vaccination, the patient had neurologic symptoms; body ache; chills; extreme fatigue; tingling in the extremities/like a buzzing sensation and vibrating sensation in the body; heart palpitations; cold extremities; extreme muscle weakness that she could barely open her hand muscles, and would feel like she was going to collapse; fluctuating rapid heartbeat where heart rate was like 130; felt like the muscles in the face were not working well especially in the mouth; thyroid has been out of range; and was super light headed/dizzy. The patient had reported the events to be serious side effects (medically significant) of the vaccine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Apr2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm and on 07Jan2021 as dose 2, single (Lot number: EJ1685) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Lot number: O13FZ1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 18May2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sickle cell pain crises, started hours after vaccination, required hospitalization starting 8/27/21 and continues until present (8/31/21), and an ER visit on 8/26/21. She is likely to stay for 7 days (currently on day 5 of hospitalization) and is recovering.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient received an improperly stored dose of GARDASIL 9, lot number: N020353 (expiration date: 28-APR-2020), for prophylaxis (strength, route and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following: Temperature/Time frame:  below 32 F (30.9 F) for 6 hours 25 minutes Previous temperature excursion: 47 F to 77 F (50.7 F) for 1 hour 27 minutes No adverse effects were reported.