chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site discoloration and injection site scar. The patient was treated with ARNICARE. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site warmth was recovered/resolved and the outcome of the injection site discoloration and injection site scar were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discoloration and injection site scar to be related to SHINGRIX. Addition details were provided as follows: The patient received SHINGRIX injection around 18th, 19th or 20th November 2018 in the left deltoid. The reporter stated that, by the next day she had a red mark about 3 inches wide and warm to the touch. The day after the shot the patient showed her left deltoid (4 to 6 inches below the shoulder) to her neurologist who was concerned it was a blood clot and referred her to her regular physician. The patient saw her regular physician that same day (day after receiving shot) who said it was not a blood clot but it was a reaction to the shot. The patient also showed her pharmacist who advised her to use an over-the-counter topical gel for three days called ARNICARE. The redness was now kind of scarred and the area was no longer warm to the touch but there was still a black and blue area at the injection site the size of a quarter in the shape of a heart with a white dot where the needle went in.
soreness on the arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "brain issue" (unspecified if ongoing), notes: He keeps asking me every day, because he has a brain issue,. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness on the arm"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.; my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad. ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad. ). At the time of the report, PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna..she cannot get her 2nd dose because her arm swelled so bad. ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported. Patients symptoms of COVID lasted for 11 days.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624414:Sister in law's case
Swelling, redness, warmth, edema, and itching at injection site on L deltoid. Facial flushing, nausea, and pain radiating down L arm.
horrible reaction/really bad reaction; felt she dislocated her brain; rash across the top of her forehead that looked like she was having shingles; red bumps in forehead; disoriented; lethargic; Rash over arms; heart started pumping/heart started racing really hard/heart was throbbing/heart was racing; could not breathe; did not feel good; really tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good) and PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (She had had heart surgery in 2012 to repair a hole in her heart, doctors put a patch there) in 2012. Concurrent medical conditions included Penicillin allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache) and FATIGUE (really tired). On 10-Feb-2021, the patient experienced MALAISE (did not feel good). On 11-Feb-2021, the patient experienced PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing) and DYSPNOEA (could not breathe). On an unknown date, the patient experienced ADVERSE REACTION (horrible reaction/really bad reaction), FEELING ABNORMAL (felt she dislocated her brain), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic) and RASH (Rash over arms). At the time of the report, ADVERSE REACTION (horrible reaction/really bad reaction), HEADACHE (headache), FEELING ABNORMAL (felt she dislocated her brain), MALAISE (did not feel good), PALPITATIONS (heart started pumping/heart started racing really hard/heart was throbbing/heart was racing), DYSPNOEA (could not breathe), HERPES ZOSTER (rash across the top of her forehead that looked like she was having shingles), RASH ERYTHEMATOUS (red bumps in forehead), DISORIENTATION (disoriented), LETHARGY (lethargic), FATIGUE (really tired) and RASH (Rash over arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) blood pressure was 200. On an unknown date, Heart rate: 91 (High) pulse 91.     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.   Concomitant and Treatment was not specified.
paralysis of right vocal cord--inability to speak above whisper, coughing, choking on liquids  Treatment-prednisone, antibiotics, Zertec  Still trouble with speaking after 4 and 1/2 months
Fatigue, Pharyngitis Narrative: patient experienced symptoms for 5 days after vaccination.
Info has been received from a physician concerning a 4.5 year old male who in September of 2004 was vaccinated with a dose of varicella virus vaccine live. Recently, the pt developed a mild case of chickenpox. The physician reported that the pt was recovering. No additional info was provided at the time of this report. No additional product quality complaint was involved. Additional info has been requested.
pt recv vax 10SEP97 & 10SEP97 pt devel a fever;
About 8 weeks ago I noticed a lump on the right side under my chin, and I contacted my doctor. It was during the beginning of August. It took some time to go see him, I was referred for an ultrasound which took another couple weeks to get in, and the results came back. Then I was referred to a CT scan 3 weeks ago that I don't have the results for, but I do have the ultrasound results. I don't know for sure if it has anything to do with the vaccine.
Within 12 hours I had fever, chills and a severe headache along with fatigue. The headache and fatigue have stayed with me since the injection 10 weeks ago. I have been out of work for 3 weeks due to the increasing fatigue. I am now on medication to help control that.
Felt hot and flushed. BP 130/82, P74, no respiratory sx. no wheeze. no orbital swelling.received 25 mg benadryl po. felt better in 15 minutes
periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; periods of fatigue and weakness, itchiness in the area and some irritation; itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.    Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    Concurrent medical conditions included Hypertension. Concomitant products included ALPRAZOLAM (AZOR [ALPRAZOLAM]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (periods of fatigue and weakness, itchiness in the area and some irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patients medical history was not provided by the reporter.
About 2 weeks after receiving the vaccines, the patient had severe chills, extreme tiredness, felt as if she was freezing and was trembling.  She also had shortness of breath.
This spontaneous report was received from a nurse, concerning an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reportd. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored RECOMBIVAX HB, doses were administered to patients. No adverse effects reported.  This is one (1) of three (3) reports from the same source. Additional information has been requested.
Nausea and vomiting. Was referred to the ER where fluids, benadryl, and valium were administered
1/6/22 52-year-old female who is positive for COVID-19 as of 1/3/2022, who presents to the emergency department after a syncope episode that occurred this morning.  Patient reports that she was sitting on the computer, felt a little lightheaded and had a syncope episode.  She does report that she had the top of her head.  She is on any blood thinners.  No seizure activity.  She denies any numbness or tingling.  No focal weaknesses of her upper lower extremity.  No speech changes.  No vision changes.  No gait issues.  She denies any pain of her extremities.  She does report that she has had a cough that is been ongoing since her development of Covid-19.  She reports of right upper back pain that has been persistent
Patient experienced general malaise unknown cause. Onsite EMS was called vitals BP 146/70  100% O2 room air HR 91   Patient refused evaluation/care  released against medcial advice.
Vaccination site (right deltoid) with bruising, mild swelling, and redness noted.
Rash on trunk; This case was reported by a nurse via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bedridden and dementia.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The immunocompromised female patient with history of dementia received the first dose of Shingrix about 6 months ago, and afterwards she experienced a rash on her trunk.  The reporter described the rash as "white and pink bumps, could not say whether there was a head, and she had no other symptoms or pain, and it did not spread."  The nurse practitioner treated the rash with Valtrex, but stated it could have just been a heat rash. The reporter stated she could not provide further information. The reporter did not consented to follow up.
pain at injection site, myalgia, severe headache, joint pain x 3 weeks, psoriasis flare, carpal tunnel syndrome flare, chills, menstrual spotting, ovarian cyst
Information has been received from a nurse practitioner, for the pregnancy Registry for VARIVAX (Merck), concerning a 25 year old female with a history of 3 pregnancies and 3 live births. On 10-FEB-2004 she was vaccinated with the first dose of VARIVAX (Merck) (dose and route not reported). On 03-JUL-2008 she was vaccinated with the second dose of VARIVAX (Merck) (dose and route not reported). The patient did not have any local reactions, or varicella or herpes zoster symptoms post vaccination. Subsequently it was determined that this patient was pregnant at the time of above vaccination. No adverse reactions were reported. Date of LMP was 05-MAY-2008. EDD was determined to be 09-FEB-2009 (also reported as 22-MAR-2009-the date was received by patient). Follow-up information was received via a pregnancy questionnaire. The patient's last menstrual period was reported as 05-MAY-2008 which may not be accurate. Ultrasound during pregnancy was performed on 01-SEP-2008 with normal results. On 20-MAR-2009 the patient gave birth to a liveborn normal male infant whose weight was 6 pounds 7 ounces. There was no complication during pregnancy and labor/delivery. There was no infection or illness during pregnancy. There was no concurrent medical condition. The patient was taking prenatal vitamin 1 tablet daily through out the whole pregnancy. Follow up information was received from medical records concerning a male infant. On a scheduled office visit on 01-APR-2009, it was noted the infant was unable to lift his head with in a prone position and was reported as abnormal growth and development. The overall assessment was a normal routine history and physical well-baby visit. On a scheduled office visit on 05-MAY-2009, upon examination, Mongolian spots were observed. It was also noted the baby was unable to follow midline and it was reported as an abnormal 2 month milestone. the overall assessment was a normal routine history and physical well-baby visit. Additional information is not expected.
Hives over legs, abdomen, and arms Treated with 50mg Benedryl which controlled rash and itching. Hives retuned the following morning, evening,and next day. Continue to treat with Benedryl.
This case was reported by a other health professional via call center representative and described the occurrence of cervical neuralgia in a 17-year-old female patient who received MENVEO (batch number M16073, expiry date 30th March 2018). Previously administered products included MENVEO (received 1st dose on 6th March 2012 and experienced no vaccine related adverse events that time). Concurrent medical conditions included cochlea implant (Right ear), penicillin allergy and shellfish allergy. Concomitant products included GARDASIL 9. On 14th March 2017, the patient received the 2nd dose of MENVEO (intramuscular) 1 ml. On 14th March 2017, less than a day after receiving MENVEO, the patient experienced cervical neuralgia, taste metallic, rash and extra dose administered. On an unknown date, the outcome of the cervical neuralgia was unchanged and the outcome of the taste metallic was recovering/resolving and the outcome of the rash was recovered/resolved and the outcome of the extra dose administered was unknown. The reporter considered the cervical neuralgia to be almost certainly related to MENVEO. The reporter considered the taste metallic and rash to be probably related to MENVEO. Additional details were reported as follows: On 14th March 2017, the patient received 2nd dose of MENVEO in the right deltoid. This led to administration of extra dose. At the same visit, the patient received GARDASIL 9 in the left deltoid intramuscularly. The healthcare provider stated that the patient reported metallic taste, rash, and nerve pain in neck which caused her right-sided cochlear implant to stop working. The patient visited her audiologist about 4 times since vaccination and they were unable to fix the implant. The patient still complained of nerve pain in her neck and was unable to hear out of her right ear.
1JUL-4JUL extreme fatigue;4JUL breakout of chicken pox-severe case-pox on all parts of body-approx >1000;5JUL MD visit-anti-histamine, rest, aveeno baths;11JUL return to work;14JUL a few pox still remain;
injection pain site sore, tiredness, headache, chills, nausea, feeling unwell, decreased appetite
Severe pain at injection site. Even after 1 week pt is complaining of severe pain and is unable to mover her arm without pain.
3 inch in diameter feverish hard, red raised lump. Itching.  It?s been 8 days and the spot now looks like a healing bruise
Tired; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Mar2021 at 14:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, knee replacement, hip replacement and known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication within two weeks of vaccination. On 15Mar2021 at 12:00, the patient experienced tired and body aches. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired and body aches was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
patient administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     It was unknown if the patient ever had COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (codeine) and Hypertension (Recent change in status such as improvement or worsening: none). Concomitant products included TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for an unknown indication.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion. Treatment medications were not reported.
Within 20 minutes nausea, dizzy lasted 24 hours, day 10 injection site is swollen, slightly red, itchy, sore to the touch  raised area is round and about 2" circumference
Pt experienced blurry vision to both eyes and slight headache. Onset approximately 25 minutes after receiving vaccination. Pt did not lose LOC, did not lose vision completely. No problems with gait. Alert and oriented. Episode was transient and all sx's went away after about 30 minutes.  After sx's resolved, pt refused transport to hospital for further evaluation, signing CFD refusal form stating able to drive self home.
Post vaccine varicella started breaking out 11/15/2004 with pustules, received Varivax vaccine 1/21/04.