chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot number and route were not reported. No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 17, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Received flu vaccine 10/2004, since that time a dull, non-descript aching and muscle heaviness lt upper arm on over shoulder, down toward left breast. Small area of out pouching on left breast nipple. Breast tissue aches most of all. Started day shot was given.
pt recv vax 21DEC95 & approx JUN96 pt was exposed to chicken pox from daughter & 2JUL96 pt exp varicella w/sx of fever, h/a, myalgia;there were greater than 50 lesions;
Left wrist was swollen, uncomfortable to use the hand and warm to touch for 2 days.  Still somewhat swollen on Monday (4th day after injection), but wrist is functional.  Don't know if it was a result of side effect from injection or not.  Please note that the original vaccination was with Moderna , with the  second dose given March 12, 2021.  Pfizer dose was a booster shot.
Received dose on 09Jan2015; invalid extra dose on 13Jan2015; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE) and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE).   On 13th January 2015, the patient received the 3rd dose of DTaP vaccine. On 13th January 2015, unknown after receiving DTaP vaccine, 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: 17-May-2022 Reporter's comments: The physician reported that she was trying to get a 7-year-old patient caught up on vaccine schedule. The patient received DTaP vaccines at 10 weeks age on 31st October 2014, at 4 months age on 9th January 2015 and again at 4 months age on 13th January 2015 and last one at 20 months age on 17th May 2016. The healthcare professional did not know which DTaP vaccines the patient received, as they were given at a different practice. The consent to follow up was given. Additional Supportive Information: The patient received 3rd dose of DTaP vaccine earlier than recommended time frame, which led to shortening of interval between vaccine doses. This case was linked with case US2022079727, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022079727:Same reporter
swelling of mucus membranes of mouth and lips  treated with intravenous steroids and antihistimines
This spontaneous report was received from a medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered single dose vials of PNEUMOVAX 23 (strength, route, lot# were not reported) which were exposed to one cycle of 1 C for 48 hours. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
Localized reaction on left arm. Sore, swollen, and mild fever. Patient started having symptoms the evening of her vaccination. She felt too bad the next day to go to church. She called into the pharmacy on Monday, and PharmD, counseled her to use a cold compress, BENADRYL, and/or TYLENOL/MOTRIN  to treat her symptoms. He said if she still felt unwell later that day to seek a physician.
pt cried for 2 1/2 hrs; inconsolable during this time; injection site puffy & reddened also;
Intense body aches and fever started 6 hours after the shot. I am still feeling the same way today 5/16/21 at 9pm
8 days after immunization developed vesicles around injection site and pruritic. Recommended Benadryl and Tylenol and to follow up if spreading.
Patient immediately expressed that he started to have a funny taste in his mouth and proceeded to vomit.  The feeling subsided after about 10 minutes of the patient waiting, but still expressed the funny taste in his mouth.  Patient later expressed that he had a metallic taste in his mouth.  The  administering pharmacist spoke with the patient later on  and suggested to increase his intake of water, but patient already started to increase his own fluids ( milk etc).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-FEB-2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms, which was then diagnosed as severe herpes zoster, or shingles. 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. Additional information has been requested.
Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 10 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
difficult to move the arm up and down; swelling at the injection site; This spontaneous report as received from a medical assistant refers to a 69-year-old male patient. This report concerns 1 patient and 1 combination product. The patient's concurrent conditions included diabetes, hypertension and latex allergy. His concomitant therapies included lisinopril (manufacturer unknown), metformin and insulin human (HUMULIN). No information about the patient's past medical history was provided. On 03-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S029542, expiration date 10-JUN-2021 (dose was not reported) for prophylaxis. On 04-MAR-2020, the patient experienced swelling at the injection site and difficulty to move the arm up and down. The patient sought for medical attention by scheduling appointment with a physician. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
tested positive for Covid; tested positive for Covid; severe headache; chills; slept poorly; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 24Mar2021 as dose 2, single (Lot number: FN6205), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FL8030), in left arm and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 20Sep2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 20Sep2022, outcome "unknown"; HEADACHE (non-serious) with onset 20Sep2022, outcome "unknown", described as "severe headache"; SLEEP DISORDER (non-serious) with onset 20Sep2022, outcome "unknown", described as "slept poorly"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: I tested positive for Covid at home on the morning of 21Sep2022; (29Sep2022) Negative, notes: On 29Sep2022 I tested negative at home and felt fine; (04Oct2022) Positive, notes: On 04Oct2022 I started coughing and had a faint positive test at home; (05Oct2022) Positive, notes: On 05Oct2022 I woke up with a headache, body aches and head and chest cold and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, headache, chills, sleep disorder, pain.  Clinical course: Product=COVID 19 Treatment, brand=Paxlovid, treatment start date=21Sep2022, treatment stop date=25Sep2022. Patient received other medication in 2 weeks include multivitamin. Patient had a severe headache and chills on the evening of 20Sep2022. Patient slept poorly and had body aches. Patient tested positive for Covid at home on the morning of 21Sep2022 and went to her FNP who confirmed the positive and prescribed Paxlovid. Patient stayed home and completed taking Paxlovid. On 29Sep2022 patient tested negative at home and felt fine. On 04Oct2022 patient started coughing and had a faint positive test at home. On 05Oct2022 patient woke up with a headache, body aches and head and chest cold and tested positive. Chest cold and cough were worse than when I first tested positive for Covid on 21Sep2022 before having Paxlovid treatment. Patient took Tylenol, Claritin-D, Promethazine. Patient had no known allergies.
Jynneos vaccine was administered intramuscularly instead of prescribed subcutaneous route; Case reference number US-BN-2022-001869 is a spontaneous case report initially received on 12-Aug-2022 from a health care professional via Bavarian Nordic and concerns a male patient of unknown age.  The patients' relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination') at an unreported dose, or anatomical site for unknown indication.   At the time of this report, it was unknown if the patient experienced any adverse events.   Additional information received from MedCommunications on 13-Aug-2022 included additional reference.; Reporter's Comments: A male patient of unknown age was vaccinated with Jynneos vaccine, administered intramuscularly which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with Jynneos vaccine, administered intramuscularly which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Pt reported "paralysis" of r arm post vaccine, states continued to 10/26/21 he reported his pain and weakness on 10/26 claiming from first shot however he received his second dose of series and states no injury from first dose. Pt was seen in office carrying his child on his right arm which he states was paralyzed
After the first shot, tiredness and lethargy started in 17-18 hrs post vaccine. Fever recorded at hone ear thermometer 20 hrs post vaccine 101.5. Lasted about 2 days. Motrin Tylenol round the click for 24 hrs. I also took Motrin right after my shot, still had moderate arm pain or soreness at the site.  After the second shot, I took Motrin with in the hour. Fever lethargy, exhaustion started within 10 hrs post vaccine. Tachycardia for an hour , severe chills and fatigue. Took Motrin and rested . Insomnia followed. Next day was similar low grade fever and extreme tiredness. 2nd day was better. 3rd day had lethargy all other symptoms resolved . Only slight soreness at infection site remains.
MEMBER STARTED HAVING ACHES AND CHILLS STARTING ON FRIDAY, 9 DEC, THEY CONTINUED FOR SEVERAL DAYS. ON 15 DEC 2010, THE MEMBER WOKE UP WITH SEVERAL PUSTULE BUMPS ON HIS NECK WITH A LARGE CLUSTER OF BUMPS UNDER HIS CHIN. MEMBER STATED THAT THE BUMPS ARE PAINFUL TO TOUCH, BUT THAT THEY DO NOT ITCH.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sinus Tachycardia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Covid prior vaccination: Yes" (unspecified if ongoing), notes: Covid prior vaccination: Yes; "autoimmune disorder" (ongoing). Concomitant medication(s) included: Humira; Sulfasalazine; Tizanidine; Alprazolam; Zyrtec [Cetirizine Hydrochloride]. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: EAR PAIN (non-serious), outcome "recovered", described as "stabbing, throbbing pain in and around my left ear". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching feet and hands began evening of administration. Received Benadryl. Went to physician next days with hives on legs and arms only. Prednisone was prescribed. Condition resolved with 24 hours of Prednisone administration.
37 year old male received injectable influenza vaccine and TDAP on 11/29. 1 day after vaccination subject developed headache and vertigo (clinical characteristics of vertigo confirmed by speaking to patient). Vertigo persisted when subject laid down and turned his head quickly to the right. Sought medical care and was diagnosed with "benign positional vertigo" and was given meclizine, which helped alleviate symptoms. The symptoms lasted for 2 weeks and has continued until present day (2/4/2011); however, patient feels much better. He still experiences vertigo now if he is "laying down and looks quickly to the right".
PATIENT CALLED PHARMACY 2 HOURS LATER AND STATED THAT SHE GOT RASH ALL OVER HER BODY AND SOME SMALL RED BUMPS ON HER FACE. PATIENT WENT TO URGENT CARE AND GOT BENADRYL INJECTION AT URGENT CARE AND ZYRTEC TO TAKE AT HOME. PATIENT IS DOING FINE NOW. THE RASH ON BODY IS DISAPPEARING GRADUALLY.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # L027733, expiration date 13-SEP-2017; lot # M018645, expiration date: 31-MAY-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of above 46 but below 77 degrees Fahrenheit for 40 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006072.
I  HAVE BEEN FEELING A LOT OF WEAKNESS AND PAIN IN THE SITE OF THE INJECTION.   SOME TIMES DIFFICULT TO LIFT LEFT HAND.
After receiving the Pfizer-BioNTech around one 1.5 hrs my stomach was loose and I got diarrhea the same day. The following day I woke up with a sore arm, chills and mild headache.
at the vaccination site it got itchy,it's like a bug bite or something; sore arm; red bump; inflammation; like a bug bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANNABIS SATIVA (CANNABIS) for an unknown indication.    On 30-Apr-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 VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ). At the time of the report, VACCINATION SITE PRURITUS (at the vaccination site it got itchy,it's like a bug bite or something), PAIN IN EXTREMITY (sore arm), ERYTHEMA (red bump), INFLAMMATION (inflammation) and VACCINATION SITE REACTION (like a bug bite   ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-224027 (Patient Link).
Caller states soon after the vaccine, she had a painful lump on her neck; Caller states soon after the vaccine, she had a painful lump on her neck; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported about herself (patient).    A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on unspecified date in Mar2021 (at the age of 48-year-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date in 2021, the patient experienced painful lump on her neck soon after the vaccine. As per reporter, patient had already received both shots of the Covid vaccine a few months ago and completed the vaccine last on unspecified date in Mar2021. Patient experienced a painful lump on her neck soon after the vaccine. Around Mar2021 or Apr2021, there had already been a lump and it won't go away, so she went to the doctor. Patient had many tests and had ruled had out everything, including a mammogram, colonoscopy, and a biopsy and all were negative for cancer, but the lump was still there. The patient reported that she wasn't bothered by the lump but instead of the pain. Patient also felt strain and pain in the arm where she got the 2nd shot. Patient reported she felt non-stop pain at back of her neck, head, shoulder blades, and the arm and was not going away. Patient had every test possible. The patient took ADVIL and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last (v3.0) from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or program. Patient questioned do other people have this, how long do they have it, was this a short term or long-term effect. Treatment was received for the events. At the time of this report, outcome of events was unknown.  Information on the lot/batch number has been requested.
Covered in a nasty rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covered in a nasty rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Covered in a nasty rash). At the time of the report, RASH (Covered in a nasty rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact