chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHY SCALP; PLAIN YUCKY SYMPTOMS; CRAMPS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 04-APR-2021 17:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced plain yucky symptoms. On APR-2021, the subject experienced itchy scalp. On APR-2021, the subject experienced cramps. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, cramps, headache, itchy scalp, and plain yucky symptoms. This report was non-serious.
super sleepy. Can't keep my eyes open.; sore arm at the injection site; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Apr2021 (reported as either 01Apr2021 or 02Apr2021) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "super sleepy. Can't keep my eyes open."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at the injection site".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Patient came to receive a COVID vaccine (Pfizer), the high dose flu shot was administered. She came back to the pharmacy saying that she received the wrong immunization and had brought in her paper work from home which stated that she wanted the Covid shot. She also mentioned that she received her flu shot earlier last week.
One large diarrhea and, an hour later, a single incidence of vomiting.  Also, formation of a cold sore on the left corner of his lip over the course of that day.  After the diarrhea and vomiting, energy level returned, and the child was as before with the exception of the cold sore blister which has lingered for the past week.
L leg with swelling of entire thigh, redness/flushed appearing, tight, tender to touch, swelling from upper thigh down to knee. Entire leg tight and tender to touch.
Initial report received on 17 August 2009 from a consumer. A 54-year-old female patient, who has history of allergy to latex, thimerosal, PCN and sulfa, and who has history of increased blood pressure, had received a fourth dose of IMOVAX (lot number, route, and site not reported) on an unspecified day in October 2007. Within minutes of receiving the vaccine, the patient complained of severe swelling, shortness of breath, chest pain and generalized hives. The patient self medicated with BENADRYL and the symptoms resolved 2-3 days later. Documents held by sender: None.
Patient's mother called the pharmacy at 12:44pm on 8/26/2021 reporting on behalf of patient. Patient complained of shortness of breath with any exertion and alleviated by lying/sitting down and racing heart rate after receiving first dose of Pfizer vaccination on 8/25 around the time of 2:45pm. Unknown if fever or chills were present. Mother contacting friend to monitor patient to see if symptoms exacerbate. Will take patient to emergency room if symptoms worsen.
01/10/2021- I had a headache which was followed with nausea, nausea was relived with rest but came back, next morning I had abdominal/chest pain, lasted for days, about the 12th, I started having severe backpain and I started steroids. March 24th went to ER. March 31st revisited the ER and all my tests were normal, referred to cardiologist , discharged from him on May 4th. Have been seeing Rheumatologist, seeing gastroenterologist on July 21st
Achy muscles similar to flu, severe pain in low back/could barely walk, alternating chills and hot spells, difficulty sleeping, fever dreams, shaking/trembling hands, rummy head, headache, started in the evening, took a muscle relaxer pill at 03:00am, took 2 EXCEDRIN at 07:00am, called Doctor at 08:00am, started to fell better at 09:00am, saw Doctor at 10:30am, continue to improve throughout the day.
After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known history of CAD. EMS was called for transport to hospital for urgent medical evaluation.  Per family, the patient was taken to local ED on 2/27/21. Had EKG, blood enzymes x 2 and "everything checked out" and he was discharged home. Family notes that PCP follow up arranged and patient reported anxiety.
Vaccine given 5/6/15, patient seen in clinic 5/8/15 with left arm swelling and redness and tenderness and warmth of arm. Unsure of IZ reaction per provider note. Per mom area remained as above for 20 days following vaccination.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. No information about concurrent conditions and concomitant medications were reported. The reporter stated that the patient was inadvertently administered ROTATEQ (dose not reported) route oral on 09-APR-2014, which had expired on 27-MAR-2014 and no adverse effects reported. It was also reported that vaccine administration was supported as per stability memo. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Thursday, 07/19/01, at 11:30 PM, this patient woke up unable to sleep due to difficulty breathing and wheezing. No history of allergies. He was taken tot he ER, not seen. Brought the child home, given 1 puff of Flovent inhaler at 1:30 AM. Wheezing resolved by 4 AM completely. Also complained of itchy throat at the time of onset.
It was reported that a patient (6 of 6) received a Fluzone SV 2001-2002 vaccination (administration date and site information was not provided). Sometime after the vaccination (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U200101055, U200101225, U200101226, U200101227 and U200101228.
Full body m aches began around 30 hours after injection. Around 45 hours after injection the body aches began to subside and a fever began (max 101 degrees) accompanied by a bad headache. Temperature remained elevated, but no longer over 100 after 72 hours. Headache subsided around 72 hours. Nausea was also experienced from about 30-72 hours.
Myalgia, Diarrhea Chills, fatigue, body aces, diarrhea. Pain to injection site
On 6/19/00, the pt received her 2nd IM 0.5cc dose of Engerix-B. Following dose 2, the pt experienced flu-like symptoms consisting of body aches, gland edema, fever, and runny nose. The reporter stated that these events were moderate in intensity and possibly related to Engerix-B. They resolved on 7/2/01. On an unspecified date, the vaccinee received the 3rd dose of Engerix-B and post vax, the pt experienced unspecified flu-like symptoms. As of 7/24/01, the outcome of the 2nd episode of flu-like symptoms was unknown.
This is a spontaneous report from a non-contactable nurse, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Aug2021 at 15:30 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medications included unspecified beta blocker medications for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 11Aug2021 at 01:00, the patient experienced severe joint pain in injection arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of severe joint pain in injection arm and included treatment with unspecified anti-inflammatory medicine from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe joint pain in injection arm was not resolved 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.
A child was given his first dose of the Moderna covid-19 vaccine by intramuscular injection on 20DEC2021 (lot number 030H21B, expiration date 23MAR2022, 0.25mL); Inappropriate dose of vaccine administered (0.25 mL); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child was given his first dose of the Moderna covid-19 vaccine by intramuscular injection on 20DEC2021 (lot number 030H21B, expiration date 23MAR2022, 0.25mL)) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered (0.25 mL)) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child was given his first dose of the Moderna covid-19 vaccine by intramuscular injection on 20DEC2021 (lot number 030H21B, expiration date 23MAR2022, 0.25mL)) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered (0.25 mL)). On 20-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child was given his first dose of the Moderna covid-19 vaccine by intramuscular injection on 20DEC2021 (lot number 030H21B, expiration date 23MAR2022, 0.25mL)) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered (0.25 mL)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter. The patient had no symptoms nor had any medications or treatments.
Patient received Moderna vaccine 10 days ago, pt started having redness and slight swelling at the site 2 days ago.
First dose of  Moderna given 03/12/2021. Second dose of Moderna given 04/09/2021. Patient experienced redness, pain, light sensitivity, and decreased vision in the left eye on  04/23/2021. Seen in ER. Did not require an over night stay at this facility. Diagnosis of severe uveitis/ glaucoma. Followed by visit with Eye Specialist. Treatment included steroid eye drops, atropine eye drops, and timolol eye drops.
This spontaneous report was received from a physician concerning a 2 month old patient of an unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly store dose of PEDVAX HIB 0.5 ml, first dose, intramuscularly (lot number M025194, expiration date 22-MAR-2019) for prophylaxis.  The temperature was 35°F degrees and the time frame was 10 hours (>46° F degrees but < 77° F degrees). There was no previous excursions. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested.
I started getting tinnitis about an hour after the vaccination.  I did NOT hear that tinnitis was a possible adverse effect, so I don't think this is psychological.  Since then I have had periodic bouts of tinnitis throughout the evening.
This spontaneous case, initially received from other health professional (pharmacist), on 12-Oct-2018, concerns a 44-year-old, adult male patient. On 12-Oct-2018, the patient received expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse events were reported by the patient after the vaccination. The reporter assessed the case as non-serious. This case '201804447' was linked to case '201804445' due to same reporter. Follow-up received from the pharmacist on 31-Oct-2018: The patient's date of birth and age (44 years) was added in the patient's tab. The batch number (195245) of the product was added in the product tab. The narrative and case comment were amended accordingly.
rash upper lower body diffuse same day;serum sickness;rxn NSAIDS;seen by PMD;
This spontaneous report as received from a nurse practitioner refers to unspecified number of infants(patients) of unknown age. The reporter noticed on the immunization records of an unspecified number of infants, that RECOMBIVAX HB had been given on an alternate dosing schedule. On an unspecified date, they were vaccinated with the first dose of RECOMBIVAX HB(lot number, expiry date, route and dose were not reported) at 2 months of age, the second dose at 4 months of age and the third dose at 6 months of age. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Constant shoulder pain for the last month. Gets far worse at night, when pressure is applied, and when I make certain movements. Pain radiates from top, outside of shoulder exactly where the vaccination was administered.
On 11JUL92 swollen in neck glands-swallowing caused severe pain; t99 feels fatigue; MD dx as mumps;
no treatment by parents but noted inc irritability w/episodes of crying & stiffening body occurring @ random times through day over 4 days beginning 13MAY94 thru 17MAY94; appetite poor as well;
After the first injection, I had what turned out to be a CRVO (Central Retinal Vein Inclusion) in my right eye and it took me a week to see a Eye Doctor/Retinal Specialist. The condition started to get better after the 1st dose and it continued into the 2nd dosage (became worse). The weekend of June 8th I was placed on treatment for my symptoms. Please note that I did have COVID in March of 2020 (do not know if the condition is related to contacting the virus).
BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt had a positive COVID test on 1/14/22 in nursing home where she stays; placed on isolation; ABX; comfort measures only; on O2; pneumonia; pt passed away in the nursing home
lost the use of his left shoulder; looked and acted like shingles; not able to work; This case was reported by a consumer and described the occurrence of movement disorder in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced movement disorder (serious criteria other: Lost the use of the shoulder), shingles and activities of daily living impaired. On an unknown date, the outcome of the movement disorder, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the movement disorder, shingles and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient lost the use of his left shoulder along with getting what looked and acted like shingles after receiving vaccine. The patient was now not able to work and reporter wanted to report that there can be some really bad reactions to the vaccine. The reporter would also like to know what the ingredients were, so that they can make sure that none of those ingredients were in any of the COVID vaccines. The reporter consented to follow up.
A solicited consumer report has been received. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, flu, and pulmonary secretion (described as catarrh in the chest). Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate (seki), Saline solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, flu, pulmonary secretion were related to SYNAGIS and influenza vaccine.    A solicited consumer report has been received via Abbvie. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown Influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, Flu and pulmonary secretion. Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate, Saline Solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, Flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, Flu, pulmonary secretion were related to SYNAGIS and Influenza vaccine.
Got the vaccine, had no reactions. Then on 3/8/21 woke up with a stiff neck, muscle cramps and then broke out into a rash. She went to her PCP, and it had just come out and was right where you would wear a necklace and diagnosed her with an allergy, but did not take the medicine he prescribed as she felt his diagnosis was wrong. A couple of days later it was hurting and bother her and went to a dermatologist who diagnosed her with shingles which came out on her neck and her shoulder, and typical shingles reactions with stinging, hurting, itching, etc.   Her dermatologist put you on Acyclovir, which is helping a lot, fading reaction, and help with the pain.   She does still have some sensitivity around her neck but the rash is fading. She also had pains in her ears at the same time.
21Feb91 245 pm spiked T 103.4 /w vomiting seen in ER then admit, had diarrhea orange stool & urine, c/o headache, stomachache & sore kidneys, given Ampicillian 425 mg IV q8hrs, Gentomycin 40 mg IV q8hrs-0 meds on discharge.
States felt nauseated around 4:10 pm on 12/13 and had flu-like symptoms 12/13-12/15. Feels much better today 12/16.
Mild cough after 1 week of vaccine; This is a spontaneous report from a non-contactable nurse. A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscular (anatomical location: arm right) from 17Dec2020 07:45 to 17Dec2020 07:45, single dose for covid-19 immunisation.  Medical history was reported as none. Concomitant medication included ergocalciferol (VIT D). On 23Dec2020 at 08:00, The patient experienced mild cough after 1 week of vaccine. The patient did not received any treatment for the event. Outcome of the event was recovering.    No follow up attempts are possible. No further information is expected.