chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RPH ADMINISTERED JANSSEN'S COVID-19 VACCINE AT 10 AM AND WITHIN A FEW MINUTES, PATIENT FAINTED AND SLIPPED OFF HER CHAIR TO THE FLOOR. PATIENT CAME TO WITHIN A MINUTE AND RPH HELPED HER TO THE CHAIR, OFFERED HER WATER AND A BANANA, AND THE PATIENT DID NOT SEEM HURT. RPH MONITORED THE PATIENT'S BLLOD PRESSURE AND COLORING/ SWEATING FOR 30 MINUTES BEFORE SHE LEFT THE PHARMACY AND HER FATHER DROVE HER HOME.
About a week after the injection my right eye started getting cloudy. I went to the eye doctor and he said I had lost some peripheral vision in that eye.
COVID-19 (Moderna) 1 03/11/2021  COVID-19 (Moderna) 2 04/08/2021
This spontaneous report was received from a pharmacist regarding an approximately 58 year old female patient. No information about medical history, concurrent conditions was reported. The pharmacist reported that on 17-OCT-2014 (reported as earlier today) the patient who was vaccinated with PNEUMOVAX 23 (lot#, dose and route not reported) at another pharmacy called to report that she has developed a "golf ball sized" sore lump at the injection site. The whole arm was sore. No concomitant medications reported. The pharmacist does not know which arm was affected. No lab diagnostics studies were performed. The patient sought medical attention by contacting the pharmacy. No treatment was given for the events. There was no product quality complaint. The outcome of the events was reported as not recovered. The causality was not specified. Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; 0.25ML/3rd dose; Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14-Mar-2022. The vial did not undergo any temperature excursions. No concomitant medications was reported. No treatment medications was reported.
This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown age and gender. On 15-SEP-2014 the patients were vaccinated with RECOMBIVAX HB (therapy type, dose, route, lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved This is one of several reports received from the same reporter. Additional information has been requested.
felt lightheaded/Felt faint; Felt hot/slowly feeling warm; Headache; Chills; deep achy muscle left side leg & upper arm pain; Achy muscle pain; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR040645).   On 18th February 2020, the patient received the 2nd dose of Shingrix. On 18th February 2020, less than a day after receiving Shingrix, the patient experienced fatigue. On 19th February 2020, the patient experienced muscle pain, light-headed feeling, feeling hot, headache, chills and leg pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, feeling hot, headache, chills and leg pain were unknown and the outcome of the fatigue and light-headed feeling were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, light-headed feeling, feeling hot, headache, chills and leg pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist was retired and the patient reporting for herself. The patient received Shingrix and felt fatigue, it resolved in 4 hours.  The patient felt lightheaded, then reported slowly feeling warm, she felt hot, had to sit due to feeling faint she reported that it resolved for a short time and then progressed to fatigue and chills, that alternated. Then she stated she had a headache after a 2 hour nap, deep achy muscle left side leg & upper arm pain.  She took Tylenol. The reporter consented to follow up.
Measles rash X 1 day. Had swollen gland, all over achiness X 7 days, very cranky and fussy X 6 weeks. Temperature up to 100F X 3 days.
High fever of 102 all day since 9:00 am.  Fatigue. Shortness of breath. Dizziness..
28JAN97 pt devel pustules on forehead, chin, lower throat & rt arm;29JAN97 devel cold sore on rt lower lip;30JAN97 3x3 patch pustules x 5 or rt lower abd;27JAN97 gen pruritus lasting x 1wk;
General malaise and fatigue set in around 8pm. Around 11pm started feeling extremely tired and nauseated, arm very painful. Took tylenol and went to bed at midnight. Slept 12 hours, drank fluids and went back to bed. Missed work. Extreme fatigue continued throughout Tuesday with lots of sleeping and lack of appetite. Starting to feel a little improvement 7pm on Tuesday.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 72, unknown and R; 48, 0 and R; 48, 1 and R; 24, -1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Vaccines given 1800 5/12/03, pt fussy. Approximately 0600 5/13-pt rigid, not breathing, no cyanotic, post 30 sec spontaneoulsy took breath-ER, released. 1030am-tonic-clinic seizure x 60-70 sec.-ER, T100-LP, admit 48 hrs with IV abx. CT nl. EEG-decreased amplitude L side probably normal.
I  administered the Janssen Covid-19  Vaccine using  a syringe/needle supplied by Janssen with the Covid-19 vaccine shipment.  Upon removing the syringe from patient's arm, the needle and it's yellow/orange safety cover became detached from the syringe and remained partially in the patient's arm and partially sticking out of his arm. I used a gloved hand and grasped the safety cover at the rim and pulled it in a manner that allowed the needle to come straight out.   It appeared to me that he had received the full dose of the vaccine (the plunger had been fully depressed before I attempted to remove the syringe/needle and the syringe did not contain any remaining vaccine in the barrel.  Patient did not  do anything that indicated he was aware of what happened, but I told him about it, showed him the needle and the syringe and told him that the full dose had been administered before this happened. Patient said he thought he felt a small splash of liquid on his arm, and possibly also on his forearm.  I called Janssen Pharmaceuticals and spoke to Pharmacist. She said if the patient received at least 50% of the dose then no further action is required. If he received less than 50% of the dose then a full dose should be administered in the alternate arm.  Janssen reference #020954274.  I relayed this info in patient, he said he agreed that he received at least 50% of the dose.  He was curious if there is a way to tell if he is fully protected against Covid-19.  I advised him to check with his doctor to see if any testing can be done to determine that.
injection site pain - lasted 3 days body/muscle aches - last 3 days chills - lasted about 12 hours fever - lasted about 24 hours headache - lasted about 36 hours nausea - lasted about 12 hours fatigue - 3 days insomnia - one night
Information has been received from a health care professional concerning a 25 year old female who on 4/21/00 was vaccinated with 1 dose of varicella virus vaccine live. Subsequently, the pt learned that she was pregnant; LMP:4/12/00. Follow-up information from the health care professional reported that the pt had a spontaneous abortion. She did not know at what weeks of gestation this occurred. No further information is available. Follow up on 06/29/2001: "Adverse event onset date/time, lot # for vaccine 1 is not provided."
Client fell to the floor and on his face immediately after his vaccine. He lost consciousness for 15 seconds and stopped breathing for 5-10 seconds. He was very stiff, turned bright red, and his pupils dilated. When he woke up he was disoriented and started vomiting. 911 was called and he was transported to the hospital via ambulance.
2-3 hours post administration pt was hospitalized w/ fever and ventricular premature complex.
I got really sick sore and fever after I got the shot the same day. Cough happened maybe a week later when the fever went down. The worst part was my heart was hurting I had a palpating heart and chest discomfort which I have since been to the hospital probably 6 times.
vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022; Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 08 Apr 2022) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone any temperature excursion.   No treatment medication was provided.
Left arm pain and weakness, left side neck pain and stiffness occurred right away and haven?t gone away
Shortness of breath - difficulty breathing. Rash to (R) and (L) armpits and ankles. Rash at injection sites on (R) and (L) deltoid. Low grade fever. C/O stomach ache.
Developed typical sx of malaise and myalgia on day1 post vaccine. By Day2, developed URI sx with nasal congestion and mucous production. By Tuesday 4/12, sx were significant enough to make certain that I had not acquired COVID in order to go to work as a physician. Tested negative by PCR
Soreness in left arm at site of injection within one hour of vaccination. Soreness worsened throughout the day and persisted for 72 hours. Soreness has returned 8 days after vaccination as well as a rash at site of injection.
This spontaneous report was received from a Nurse refers to a 20 year old female patient. The patient's medical history included flu. On 02-JAN-2014 the patient was vaccinated with 3 dose of GARDASIL (dose, route and frequency were not reported). Concomitant medications included Birth control pill (manufacturer unspecified). On 04-Mar-2014, the patient experienced that her arm (no designation on whether it was the right or left arm) was red and swollen. The patient also indicated she had gone to the emergency room of the local hospital (unspecified date, hospital or location). The hospital completed a chest and arm x-rays for the patient. No diagnosis was made. No treatment given was specified from the hospital. The patient was released the same day. The mother (anonymous) of the patient also contacted the office to state the arm also had a rash and had become hardened. The mother took the patient to the pediatrician. The patient was prescribed a Z-PAK and steroids (manufacturer and dose unspecified). The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Flu like symptoms, chills, body aches, only no fever. Persisted dramatically for 24 hours then decreased other the next 24 and now are pretty well gone.
Sweating; Tired; Chills; Not sleeping very well; Uncomfortable/Feels like she's not well; Headache off and on; Arm hurt; Nausea; Fever on an off low grade; Hasn't been eating much; This is a spontaneous report received from a contactable consumer or other non hcp. A 56-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: ER8727),via an unspecified route of administration,administered in Arm Right on 29Mar2021 11:00,at the age of 56 years old,as Dose 1,single for covid-19 immunization.Medical history included type 2 diabetes mellitus from 1994 and ongoing Type 2 since 1994 , hypertension from 1994 and ongoing Since 1994 and ongoing renal disorder Since the last 2 years.Concomitant medication(s) included metformin taken for diabetes mellitus from an unspecified start date and ongoing; carvedilol taken for hypertension from an unspecified start date and ongoing.The patient experienced fever on an off low grade on Mar2021,nausea on 29Mar2021,sweating on 30Mar2021,headache off and on on 29Mar2021,arm hurt on 29Mar2021, tired on 30Mar2021,chills on 30Mar2021,not sleeping very well on 30Mar2021,uncomfortable/feels like she's not well on 30Mar2021, hasn't been eating much on Mar2021.Therapeutic measures were taken as a result of headache off and on.Treatment received was Tylenol Rapid Release 500mg take 2 every 6 hours as needed NDC/Lot/Expiry not known.The adverse event didn't result in emergency room visit and physician office visit.The outcome of the event nausea,sweating,headache chills was not recovered and pain in extremity was recovered while other event was unknown.The patient received no other vaccination within 4 weeks.  Follow-up (01Apr2021): This is a follow up-spontaneous report received from a contactable consumer. This 56-year-old female consumer (patient) reported for herself that Vaccination Facility.  No follow-up attempts are needed. No further information is expected
PATIENT RECEIVED MODERNA MONOVALENT DOSAGE INSTEAD OF BIVALENT DOSAGE. PATIENT HAD NO ADVERSE REACTION.
Patient is stating after receiving flu shot,later that night she started to experience knuckle swelling, neck pain, and pain in both of her shoulders that still has not resolved to this date. The patient would like to visit the doctor for relief but does not have medical insurance at this time and wants the company to help.
1/21/2021, 4 pm,  Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn so I got out of bed, took a couple of TUMS and sat in chair , At 6 am I went to get in bed and felt nausea and started to go to the bathroom but ended up fainting.  When I came to I started vomiting., Then my husband had to help me off the floor and get to the bathroom.  I was vomiting and had Diarrhea.  My temperature was normal.  When symptoms subsided in about a half hour time I realized my right foot, leg and knee hurt.   At  approximately 1 pm my daughter insisted that I go to the ER, where I was treated.They ran a bunch of test but did not find anything seriously wrong with me and sent me home.
Pericarditis diagnosed by cardiologist during ER visit 01/27/04 at ER.
Two teenage brothers were each vaccinated with varicella virus vaccine live. Approximately one to two weeks post vax the first brother developed at least 50 generalized lesions. About one week later the second brother broke out in greater than 50 generalized lesions.
Moderna COVID-19 Vaccine EUA I have redness, swelling, mild pain and warm to the touch, sometimes itchy at the injection site.  It has not subsided since the date of the injection.
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 2 of 9 linked cases reported by same reporter.
Swelling of left underarm and a towards breast area; suspecting this is lymph node swelling.  I've had sentinal node disection on the right side and this is on the opposite, about same place as scar from sentinal node disection, just on the other side. Started on Sunday, October 3, 2021 - I noticed swelling when I woke up, around 8:00 A.M.
Very Sore upper left arm,; Body aches; Slight fever - 99.5; General feeling of unwellness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure (HBP), and ulcerative colitis (UC). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER3783) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 20:00 the patient experienced very sore upper left arm, body aches, slight fever 99.5 and general feeling of unwell. On same day the patient underwent body temperature test and the result was 99.5 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore upper left arm, body aches, slight fever 99.5 and general feeling of unwell were recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected.
Approximately 45 minutes after receiving the injection, coworkers said she was acting "strange" and "confused" Could spell her husband's name but couldn't say it.  Was very nervous prior to getting the vaccine..trying to distract her and asked what she had for lunch and she responded 'tobasco' but she commented that 'tobasco' didn't sound right and maybe she had a brownie.  Took her BP and it was 150/90.  EMS called.
On evening of vaccine, noticed "whelps" on legs. AM of 10-22-09 whelps spread over body. Temp 99.9-took to ER-no treatment. On 10-23-09 took to PMD-ordered BENADRYL PO. On AM of 10-24-09, rash gone, no further medicine given. PMD stated rash was allergic reaction. No other sign or symptoms of adverse reaction.
Severe headache, chills, vomiting, blurry vision, stiff, weak, dehydrated.