chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pain with lifting arm overhead and reaching out to pick up something and reaching across the body causing joint pain. Have done gently stretching, started taking ADVIL 400-600 mg on 10/27/17.
Local Swelling; Dyspnea; Malaise; Choking Sensation; Dysphagia; Sputum Retention; Joint Swelling; Musculoskeletal Stiffness Information has been received from a health professional concerning a 34 year old white female with allergies to dust, mites, grass and mold, and a history of heart palpitations who was vaccinated with a first and second dose of varicella virus vaccine live (Oka/Merck) on 16-JUN-2005 and 12-SEP-2005 (lot #649442/0220R, administered SC at 16:00) Concomitant vaccination given at 16:00 on 12-SEP-2005 included an intradermal dose of tuberculin purified protein derivative (TUBERSOL). There was no illness at the time of vaccination. On 13-SEP-2005, the patient developed swelling in her neck and shoulders which was not visible. She did not feel well and could not swallow or breath normally. The patient was afebrile. Unspecified medical attention was sought. The nurse reported that she was going to give the patient diphenhydramine hydrochloride (Benadryl). No laboratory diagnostic tests were performed. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that on 15-SEP-2005 at 14:00 the patient complained of feeling swollen on both sides of the neck, her throat felt sticky and she couldn't breath properly, she had to take deep breathes to get air. The patient had a body temperature of 97.8. She had a stiff neck. The patient was treated with diphenhydramine hydrochloride (Benadryl). The patient felt like her throat was closing up. She was given methylprednisolone (MEDROL) dose pack. It was reported that the patient "had no problems" after her first dose of varicella virus vaccine live (Oka/Merck) At the time of the report the patient's status was unknown. Additional information has been requested.
Initial and follow up information has been received from a consumer and a physician, concerning the consumers 12 month old ("1 year old") son with otitis media and a fever, who on 31-AUG-2007 (reported as 04-SEP-2007 by the consumer), at approximately 12:00 noon, was "by mistake" vaccinated, SC in the lower right thigh, with a dose of PNEUMOVAX 23 (Lot # 655291/0985F).  The physician noted that the vaccine that should have been administered was PREVNAR.  The mother reported she was contacted by her physician's office, and added that her son had shown no adverse reactions.  Additional information is not expected.
I received the vaccine and was instructed to wait in the clinic for 15 minutes in case of any immediate side effects. I did not have any symptoms at this time. I drove home and started to feel achy and unwell approximately 1-2 hours after injection time. By the evening, I had a fever of 103 degrees F which lasted for >24 hours. I was seen by my family physician during this time.
Pt developed chickenpox with a duration of about 7 days. Treated with Famvir 500mg X 10 days; Benadryl and Calamine.
burning pains from knees to waist;spasms shooting through hips & buttocks;necessary to take APAP q 3 hr, confined to bed 6/18/99;MD told pt had some sore of viral infect;
Information has been received from an M.S. concerning now a five year old male who on 07/03/1996 was vaccinated with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. The pt was treated with oral acyclovir. On 11/28/2000 the pt recovered from that experience. No further info is available.
Vomiting (bile) twice , diarrhoea lasting for 5 hours, severe stomach pains lasting for five hours. Not severe stomach pains on and off for 48 hours.
patient was vaccinated in the morning at a clinic at a LTCF in the left arm and then vaccinated a second time in the right arm on the floor in her room
Initial report received on 15 January 2009 from a physician. A 7-month-old female patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received on 18 December 2008 a third intramuscular right thigh injection of ACTHIB (lot number UF520AA), a intramuscular left thigh injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B198BA), and a intramuscular right thigh injection of PREVNAR (manufacturer Wyeth, lot number D126884). The patient had not received any other vaccinations within four weeks of 18 December 2008. Five days after receiving the above vaccines, the patient began having symptoms in her sleep that included gasping and body movements the parents could not describe. The frequency of these symptoms have increased, and currently the patient is hospitalized for workup. The admission date to the hospital was not provided. It was unknown what relevant diagnostic tests or laboratory data have been performed. It was not reported whether the patient has received any treatments for the serious adverse events. At the time of this report, the patient had not recovered. Documents held by sender: None.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In September 2011, the patient was inoculated with ZOSTAVAX at medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 09-OCT-2015, the patient was treated at the same medical center for a blistering vesicular outbreak that was diagnosed as herpes zoster conjunctivitis. She was prescribed gabapentin and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Information has been received from a nurse concerning a female who was vaccinated with the third dose of GARDASIL.  Subsequently the patient experienced swelling at the injection site about the size of a silver dollar.  There was no redness or itching.  The patient reported getting sunburn shortly after receiving the vaccination, after which the swelling appeared.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. There was increased redness and pain after a week. The patient reported getting sunburn shortly after receiving the vaccination, after which the swelling appeared. The patient denied a fever or streaking. Additional information has been requested.
Shortly after (2-3 weeks) after receving my bivalent booster I developed rosacea (no prior history). Then during Nov-Dec 2022 I had unexplained pain and inflammation in my joints, followed by an excema rash (Jan 2022-Feb 2023). On Jan 5 2023 I developed disequilibrium that continues until today. I've also experienced GI issues and ocular migraines during this time period. Of note: I received 5 vaccine doses in 2022: Shingles (4/8/22 and 6/4/22); COVID-19 (4/29/22 and 9/20/22); and Flu (10/5/22). Also I began having weekly migraines after my initial COVID-19 vaccine dose (12/29/20) that eventually decreased after approximately 3 months. This pattern continued following each COVID-19 vaccine dose (12/29/20, 1/27/21, 10/23/21, 4/29/22, and 9/20/22)
Information has been received from a physician concerning a 68 year old male who on 28-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 22-JUN-2010 the patient developed shingles one time within four years of receiving ZOSTAVAX (Merck). The patient was given VALTREX for treatment. The patient sought unspecified medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Almost immediately after receiving the Rabavert vaccine both ears began ringing. I asked the pharmacist if I should be concerned about it, and she said that ringing in the ears was not listed as a side effect so she let me go home. Hours later my ears had a burning sensation inside. An urgent care doctor prescribed me with a Steroid medication and I have since been seen by my E.N.T. but the ringing has not stopped. I am still experiencing tinnitus in both ears constantly.
I had a fever of 101F and this morning it was 97F; having " a little bit of muscle ache; 3 days after getting the vaccine I had bad rashes; I'm super lightheaded and spacy like I can't think.; I'm super lightheaded and spacy like I can't think.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose last week Wednesday, 19May2021 and reported having " a little bit of muscle ache, but 3 days after getting the vaccine she had bad rashes, she was super lightheaded and spacy like she can't think. Last day (25May2021), the patient had a fever of 101F and this morning (26May2021) it was 97F. The patient saw her doctor last day (25May2021) but he didn't really tell her anything. The patient was not sure what to do. It was explained to the patient that explained in studies that the side effects did appear within 7 days but the duration might vary from one person to another. Referred to HCP if symptoms persist or gets worse. Outcome of the event fever was recovering and other events was unknown.  Follow-up attempts are needed. Further information is expected.
I couldn't move my legs and body for a day. I lost movement in my fingers and hand. I had fever and chills. Headaches.
no adverse event; Vaccine was administered to patient after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after 1 day of expiry).    No concomitant medication was reported.  Patients were both male and female, none of the patients reported being pregnant or breastfeeding. No treatment information was reported.  This case contains information for patient 4 out of 8.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case
She got the vaccine, had the chills and headache, then the next day started with rash from wrist to her shoulders, which she still continues to have.  She has seen her allergist and her dermatologist and they have give her treatment for that.  With her allergist several weeks after he put her on a steroid, once a day for 3 days, which did not work.  So then she went back to him about a rash ago and she still had the rash.  He wanted to be sure as well as her dermatologist, said that he has seen the rashes associated with the vaccine, but they disappear in a month or so.  She has a rash but no itch, the first time she had an itch with no rash.  He did a  SED rate to see if there was inflammation going on with her body and there is no inflammation in her body.  They did find out that her autoimmune system is very high, which she did not have COVID virus.  In the meantime her dermatologist is going to see if he is going to get rid of it with an ointment.  Her dentist also has the same reaction but on his legs from Moderna as well.  She was given Triamcinolone ointment.  Initially the allergist said to use it twice a day, rub it in thoroughly for 2 weeks and she still has the rash.  She used this for a month, but has stopped due to it having cortisone in it.  She had never had any issues before, no surgeries, and was very healthy.  Her dermatologist and the allergies want to do a biopsy of the rash to see if anything else is going on.  She has an appointment with the allergist, but has to wait for 6 weeks after stopping the ointment, and is to see him on future date for the biopsy.   She had a black and blue area that came out on her arm a week or so later.
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No conmeds are provided  No Treatments are provided    This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548 (Patient Link).
she was not able to sleep, possibly due to nervousness; she was not able to sleep, possibly due to nervousness; This is a spontaneous report from a contactable nurse (patient's sister). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 16May2021, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she was not able to sleep, possibly due to nervousness on an unspecified date in May2021. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Left vaccine site and came back complaining of feeling "itchy".  No hives seen and no difficulty swallowing and no edema to airway or shortness of breath.  Then began dry heaving.
This spontaneous report was received from a consumer regarding herself, a female patient of unknown age. Information regarding the patient's medical history was not provided. On 07-NOV-2012 (reported as 'last Wednesday') the patient was vaccinated with ZOSTAVAX. Information regarding lot number, dose number, dose or route was not provided. No other co-suspects were reported. No concomitant medications were reported. Following the injection (On approximately 08-NOV-2012, exact date not reported) the patient experienced injection site discomfort. The patient was told to treat her discomfort at the injection site with ice and to take TYLENOL. On 08-NOV-2012 (reported as 'last night') the patient experienced an unspecified injection site reaction: the patient stated that after the treatment with ice and TYLENOL was completed, she had noticed that by the time she had come home from work, her injection site had become hard, warm red, and raised. No further information was provided. The outcome of injection site discomfort, and injection site became hard, warm, red, and raised was unknown. A reporter causality for injection site discomfort and injection site became hard, warm, red and raised was not provided for ZOSTAVAX. Additional information is not expected.
Hiberix was reconstituted with different sterile diluent for live vaccines. Per CDC,  administered dose is ineffective. We have reached out to the patient. Patient will be notified and scheduled to repeat dose.
The patient was nervous prior to vaccine and had a needle phobia. About 5 minutes post-vaccine, the patient stated he was not feeling well and feeling warm and sweaty. The pharmacy staff provided the patient with water and an ice pack. The patient stated he was feeling faint. The patient fainted for about 20 seconds and then became conscious again. The patient didn't have any injuries and didn't fall down. The patient was okay and he laid down and elevated his feet on a chair. He then stated that he has severe needle phobia and has fainted several times in the past with vaccine administration and blood draws. He had experienced this in the past. He was still slightly faint and requested that he be checked out. The EMT arrived and they took his vitals and checked him. By the time the EMT arrived, he was beginning to feel better and had sat up and drinking water. There were no further issues. The EMT stated he was good to head home. We followed up with patient and the patient was feeling good with no further issues.
Within twenty minutes if injection redness  and itching at the site. Thirty minutes gives and welts over chest abdomen neck behind ears. Eyelid swelling. 50mg Benadryl. 40mg Pepcid and 50mg prednisone given.
Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI
Swelling, itching, warmth, redness and pain at injection site approximately 48 h after administration, then followed by shortness of breath/"labored breathing".
Headache, Myalgia, NauseaVomiting, weak, achey, sweats, no fever
Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna's Booster dose 64 days after receiving the Second Moderna's dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter didn't knew the patients height, allergies, if patient had ever tested positive for Covid-19, if the patient had any acute or chronic illness and if the patient received any other vaccine within 1 month prior to Moderna. The patient was taking concomitant medication but HCP didn't had permission to provide this information. The reporter confirmed that the patient received the Booster dose in his deltoid muscle but no information on administration route was provided for primary series.  No concomitant medications were reported. No treatment details were reported.
Information has been received from a healthcare worker concerning a female who on 10-MAY-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine.  On 11-MAY-2006 the patient experienced cellulitis.  The patient was recovering.  Additional information has been requested.
PATIENT RECEIVED VACCINATIONS.  SHE THEN ASKED QUESTIONS ABOUT OTHER MEDICAL SERVICES AND NEXT APPOINTMENT.  ABOUT 5 MINUTES AFTER THE IMMUNIZATIONS SHE AROSE AND WALKED TOWARD THE WAITING ROOM.  IN THE HALLWAY, SHE WALKED INTO A WALL AND FAINTED.  CLINICIAN WAS BEHIND HER AND CAUGHT HER AND KEPT HER UPRIGHT AND WITH HER AUNTS HELP CARRIED HER TO A PADDED CHAIR AND INSTRUCTED HER TO BEND FORWARD AND PUT HER HEAD BETWEEN HER KNEES.  THE AUNT TRIED TO KEEP PATIENT'S HEAD UP.  WITH TRANSLATION AND BY CLINICIAN DEMONSTRATING, PATIENT BENT FORWARD ON THE CHAIR AND PUT HER HEAD DOWN NEAR HER KNEES.  CLINICIAN DEMONSTRATED FOR HER TO TAKE SOME DEEP BREATHS.  AFTER ABOUT 10 BREATHS CLINICIAN HELPED HER TO SIT UPRIGHT AND HAD A DRINK OF WATER BROUGHT TO HER WHICH SHE DRANK.  AFTER MONITERING HER FOR ANOTHER 5 MINUTES, CLINICIAN PUT A CHAIR NEXT TO PATIENT AND HAD HER RELATIVE SIT BY HER AND HOLD HER HAND AND WATCH HER FOR FAINTING FOR ANOTHER 15 MINUTES.  CLINICIAN CHECKED ON HER AND AFTER 15 MINUTES WITH PATIENT STATING SHE FELT FINE NOW, CLINICIAN LET HER LEAVE WITH HER RELATIVES.