chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nightmares; lack of sleep; severe loss of feeling in right arm; gets angry really quick; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M208 and 027L208) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 15-Feb-2021, the patient experienced NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches). At the time of the report, NIGHTMARE (nightmares), INSOMNIA (lack of sleep), VACCINATION SITE ANAESTHESIA (severe loss of feeling in right arm), ANGER (gets angry really quick) and HEADACHE (headaches) outcome was unknown.      Patient received 2nd shot on 15-FEB-2021 in the right arm (Lot: 024M208, Expiration date: 01JAN1900). Patient experienced loss of feeling in the right arm to where they were let go from their job. The patient also had lack of sleep, gets angry really quick, headaches and nightmares. Patient refused to give out date of birth. Patient took Ibuprofen once in a while (unknown strength and amount). Patient gave consent for safety to follow up.     No concomitant information was provided.  Treatment information included ibuprofen once in a while (unknown strength and amount).   This case was linked to MOD-2021-118014 (Patient Link).
Felt like something was stuck in throat, fever, decreased appetite, tired, rapid heart rate, and lethargic.
101 fever aches and pains .  This is probably a normal response but don't know.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
I had a low-grade fever and I felt like I had the flu. I had fatigue, and a runny nose. It was a very mild scratchy throat. I might have a cough for one day. I had body and muscle ache. When I tested positive it was several days of thinking it was the flu. I never lost my sense of taste or smell. The only other symptom I had was waking up in a sweat but had no fever when taking my temp afterwards. I called the doctor because I am coughing up mucus. He gave me a chest Xray and that all came back fine. I never had any medications; I had a splitting headache throughout all this. I still have the night sweats, there not as bad and are starting to go away. I also had strange symptoms, I have a cyst in lumber 4 and 5 area. It flared up on day and I to walk with a cane it was so bad and painful. I still have it but not as bad, it's going away.
PAIN IN ENTIRE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain in entire arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in entire arm was not reported. This report was non-serious.
PREVNAR 13 given IM Into right thigh 10/4/16, rash developed the next day at the site, increased in size, given BENADRYL, brought back to our office 10/6/16, diagnosed with Arthus reaction, given CLARITIN.
After receiving my Dose 2 Pfizer-BioNtech 04/17/2021, EW0169 around a week or two later I noticed as three or four spots diagnosed as Morphea. I at a regular doctor regarding the vitiligo and brought the skin issue to her attention and observed and determined it was Morphea. The medicine she provided did not work; however, I have not had any further outbreaks with any other vaccination at 4th Dose of vaccination. It is on my left side which the same side as the vaccination administration. No recovered since the condition is still present and has not changed.
suffering from nerve damage from shingles/ suspected vaccination failure; suffering from nerve damage from shingles; suffering from nerve damage from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selcted as an adult as per vaccine indication. The reporter stated that, received double vaccine in 2020 and had nerve damaage from shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Fever-102°F Headache Nausea, no vomiting All lasting approximately 24hrs
This spontaneous report was received from a physician via a company representative and refers to a 12 year old male patient. Concurrent conditions, medical history and allergies were not provided. On 08-MAY-2015, the patient was vaccinated with the second dose of GARDASIL, intramuscular injection, (strength, dose, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The same date, the patient experienced loss of consciousness described as passed out. The patient sought medical attention in the office, no treatment was given for the adverse event and it was unspecified if lab diagnostics studies were performed. The outcome of loss of consciousness was reported as recovered/resolved on an unspecified date in May 2015. The relatedness between loss of consciousness and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Client's mother states that her daughter had swelling on eyelids and puffiness on her face. Also that she experienced itching in her throat. Started taking oral typhoid on 6/1/15 finished on 6/8/15. Symptoms started on 6/9/15. According to mother currently client's symptoms reduced, she feels better.
a lot of itching on her right wrist and Itching started on chin then through body; Itching and welts on her face; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body), URTICARIA (Itching and welts on her face) and PAIN IN EXTREMITY (Arm is still sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body), URTICARIA (Itching and welts on her face) and PAIN IN EXTREMITY (Arm is still sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at a dose of 25 milligram. At the time of the report, PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body) and URTICARIA (Itching and welts on her face) was resolving and PAIN IN EXTREMITY (Arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.
Patient called pharmacy to report redness and swelling at site of vaccine. Advise ice and ibuprofen/tylenol and to call MD if symptoms worsened.
shingles; Itchy feeling, constant itch, it itched; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 04-Jan-2023. Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that the Shingles was not fun. The patient start getting that itchy feeling in an area on your body that hits when he/she was trying to sleep. Had that happen to patient.  The patient stated that it was a constant itch that would not go away unless you see a doctor. The patient had to did that. When the patient showed the doctor where it itched, he said shingles. The patient already had one shingles shot. If the patient would not have that shot it could had been a lot worse. The patient stated to get that shot. Better to get it than have the itch. Additional Supportive Information: Follow-up would not possible as no contact details were available.
my arms still red in that spot, feels like a knot; My face is red, nose, chin and cheeks; Arm sore and red and has a knot; arms still red in that spot, feels like a knot; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included meniere's disease. This has caused her trouble in her left ear from hearing and was probably diagnosed in 2008 or 2009. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure. On an unspecified date patient reported that her arm was still red and the spot where they gave it to her still has a knot. The patient states that her face has also been red, like her nose and cheek and chin have been red.  The arm was sore and red and had a knot. The arm was really sore the first two days but it was like it went away or she did not really see it and then the last few days she sees it a lot.  Face was red for about four or five days. The patient adds that her arm was sore, but she saw redness, not quite as bad, not as bad as it was. It is worse now than when she first got the vaccine. The patient's nose, cheek, and chin on both sides were red. Investigations: The patient states she had lab work before she got the shot, because her blood was low. Her haemoglobin was low but it was back up to 11.5 before she got the shot. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No adverse events following prior vaccinations. The events outcome was reported as unknown.  No follow-up attempts are needed. No further information is expected. .
Swelling in face, legs and short breath. Two days later blisters on feet and swelling in legs with joint pain and very short of breath. went back to Dr on Tuesday July 3. Again three weeks later, again a week later and several times since then. Referred to two more doctors and still having problems and it seems as if the Dr's want to just pass me to others. No one wants to claim and help.
This case was reported by a consumer via call center representative and described the occurrence of leg pain in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included Pravastatin. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was not recovered/not resolved. It was unknown if the reporter considered the leg pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported however it could be 67 or 68 years. The received a dose of SHINGRIX 2 months ago from the reporting date. The patient experienced leg pain about a week later which continued till the reporting time. The patient reported she had seen her doctor and was discontinued from pravastatin. The patient did not provide physician information because she was in between physician meeting at the time of report.
At night, in an out of sleep, started scratching neck. Next day, left eye was severely swollen, sac of fluid below the eye. Rash all over the neck and top chest area on both sides. Took Benadryl did not help so Friday morning went to doctor who prescribed Hydroxyzine HCL pill for itching--every 6 hours.   Does not help much either. Today getting worse both on the eye and itching area. No problems breathing and urinating fine. Swelling interferes somewhat in vision. Will check in with doctor to see if need a specialist.
30JUL97 recv vax;returned 1AUG97 for PPD reading;mom identified hot red area where DTAP given;MD saw MD & dx area as cellulitis;
Information has been received from a licensed practical nurse concerning a 76 years old male patient with cardiovascular disorder, hypertension and gout who in August 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL TABLETS, colchicine, LASIX, simvastatin (manufacturer unknown) and LIPITOR. Within the past few days the patient developed blisters in a band on the right side of his body from front to back. The patient sought medical attention through a physician. At the time of this report the patient had not recovered. Additional information has been requested.
Treatment of COVID-19/took Paxlovid for a mild COVID infection; Treatment of COVID-19/took Paxlovid for a mild COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19/took Paxlovid for a mild COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; Positive, notes: tested positive again; Negative, notes: tested negative on day 4; Negative, notes: tested negative on day 5; Negative, notes: tested negative on day 6; Negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: took Paxlovid for a mild COVID infection. Patient felt mostly better by day 3 and tested negative on day 4, 5, 6, and 7. On day 10, patient started to experience congestion, post nasal drip, and a cough along with aches and pains. This was actually worse than the original symptoms, patient took a new home antigen test and tested positive again. The outcome of the events was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
VARIVAX had a temperature excursion and was administered after the excursion occurred; This spontaneous report as received from a reporter refers to two patients of unknown age and gender. The patients' medical history, current conditions, previous drug reactions or allergies and concomitant therapies were unknown.   On 2020 the patient was vaccinated with varicella virus vaccine live (VARIVAX) (lot # S038177, expiration date 26-NOV-2021) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination unknown).      On 30-JUL-2020 the administrated varicella virus vaccine live (VARIVAX) experienced product storage error with temperature excursion: 12 F, time frame: 1 hour and 45 minutes, no previous temperature excursion as recorded by data logger. In 2020, after the excursion occurred, two patients received varicella virus vaccine live (VARIVAX) (lot # S038177, expiration date 26-NOV-2021) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination unknown).
Adverse Events: Strong pain at site, this increased for 24 hours, then slowly decreased from 24-72 hours. At about 6 days, numbness in toes and hands developed. This was followed by outbreak of multiple blisters on hands, and grouped blisters of larger size on the sides of the lower torso.
administrated with less than two months after dose one; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: Physician reported that a patient was administrated with Shingrix with less than two months after dose one. No adverse event was reported. No patient's identifiers, lot number, expiration date and vaccination date were provided. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Information has been received from a registered nurse concerning a 26 year old female with no known drug allergies and no previous medical history who on 10-APR-2008 was vaccinated with GARDASIL (lot#659964/1978U) route and site not reported. There was no concomitant medication. The nurse indicated that the patient developed a rash on 14-Apr-2008 after she was given the vaccination. The rash is on the patient's trunk and spread to her arms and feet. No further information is available from the nurse. The patient's outcome was reported as not recovered. Additional information has been requested.
SQ ANTHRAX #1 given to L deltoid became flushed + fainted c/o "had" EPIPHEN administered.  B/P 148  P 80 R 22.
Constant ringing in my ears. It gets louder and more subtle but it is constant and maddening.
Around 10/03/2021, I was feeling sinus,  head cold type feeling. I was not running a fever, I felt like this  for a couple of days. I usually get a head cold once a year. I usually get antibiotics to clear it up.  . I did a tele-heath visit and the doctor suggested a COVID-19 test. I went to get a COVID-19 test on 10/05/2021-negative I thought I was getting better. We flew out on 10/07/2021. I was wearing a mask for 10 -12 hours . I did not sleep well. I was feeling pretty rough. I called telehealth for antibiotics because I was not getting any better. It was in my chest and it was infected. The doctor called in a prescription for Amoxicillin, 7 days,  2 pills a day.   I have not gotten better, but I am not worse.
Pt developed a significant and typical Herpes Zoster Rash in the R L-3 Dermatome 2 days after the vaccination.  He had a typical course of pain and rash that cleared after about 2 weeks of rash.  started out as a vessicular rash that became more pustular.  Does not appear consistent with bacterial infection.
Bruise at the injection site. Shoulder and neck pain on side injection was given. Feels like a pinched nerve. Fatigue.
fever; Body ache; Nausea; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported for her son (patient). A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the reporter called on behalf of her son who got vaccinated on 05Apr2021 as he was experiencing fever, body ache, and nausea after getting the first dose. And also the reporter asking if her son can take Tylenol. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 15 year old female who was vaccinated with her first dose of Gardasil vaccine. After receiving the dose, the patient experienced nausea and dizziness. Subsequently, the patient recovered from nausea and dizziness. The patient sought unspecified medical attention. Additional information has been requested. Follow-up information has been received indicated that the new 15 year old patient who had supraventricular tachycardia (SVT) felt dizzy and nauseous within 1/2 hour of the vaccine that lasted approximately 3-4 hours on 27-Sep-2007. (No fever, registered on the thermometer - head felt warm though). The patient recovered on the same day. No further information is available.
Broke out in varicella rash diffusely - later shown by genotyping to be the vaccine strain. Responded well to acyclovir.