chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weird metallic taste; Tiredness; Fever; Pateint received 1st dose on 19-sep-22 and 2nd dose on 11-sep-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of taste metallic in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th July 2022).   On 11-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). On 11-SEP-2023, less than a day after receiving Shingrix, the patient experienced taste metallic (Verbatim: Weird metallic taste), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever) and drug dose administration interval too long (Verbatim: Pateint received 1st dose on 19-sep-22 and 2nd dose on 11-sep-2023). The outcome of the taste metallic was not resolved and the outcome of the tiredness and fever were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the taste metallic, tiredness and fever to be related to Shingrix.     It was unknown if the company considered the taste metallic, tiredness and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-SEP-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and experienced fever 100 degree F and tiredness the same night and also a weird metallic taste in her mouth.  The reporter stated that the fever and tiredness went away but the metallic taste persists until today. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Had vaccines 5/1/07 DTaP in Lefth umeral area and IPV, proquad, hep A in other sites. Pt seen today by me with 10cm indurated, but not tender left humeral area. Told to do topical measures and rtc prn fever, increased pain.
approx 45min p/vax pt became very weak, pale, & SOB;c/o heart beating fast & something in throat;taken to PMD;tx reddened for breathing difficulty & ATB prescribed;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 10:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.24. Concomitant products were not provided. On 29-Apr-2021, Excursion time was 10 AM, with temperature as 33. Total doses given for the day was 201 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 19-Apr-2021 and. Vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pregnant and recieved the moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form(s) at an unspecified frequency. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       This case concerns a female subject who reported pregnancy after the first dose of  COVID-19 vaccine (mRNA-1273) .No other information was provided regarding last menstrual period , date of conception, and estimated due date.; Reporter's Comments: This case concerns a female subject who reported pregnancy after the first dose of  COVID-19 vaccine (mRNA-1273) .No other information was provided regarding last menstrual period , date of conception, and estimated due date.
My daughter broke out in hives all over her body, face, and head.  In the last week this has now happened 5 times.
10/14 2 days post vax, pt c/o redness, tenderness with swelling & fever at site R deltoid. 23x20 red hardened area just below inject site. Area inc warm to touch. 10/15 site lger but swelling/tenderness dec. 10/20 problem resolved.
Felt like I was coming down with strep throat. I had nasal drainage down the throat. Tested negative. This was a Thursday. Symptoms cleared up the next day. The following Monday, I was sick. Fell getting out of bed. Lost control of legs due to dystonia. Was incontinent with both bladder and bowels. Tested strong positive on an at home COVID-19 test. Spoke to advice nurse at doctor's office who arranged a televisit with a doctor. Doctor prescribed PAXLOVID and to treat symptomatically. Oxygen level monitored; lowest reading recalled was 68%. Had a fever, but unknown temperature. No cough, didn't lose sense of taste, maintained appetite. Regained sense of smell that had been lost due to a childhood nasal cauterization. Brain fog was very bad. These symptoms lasted 10 days initially. On the 12th day, I developed body aches. Symptoms returned for additional 12 days. Participant slept most of those 12 days. Brain fog, and fatigue, headaches lingered. Participant states they have not been themselves since COVID-19.
Lightheaded, headache, itchy rash on back. All resolved after 1.5 days except rash which decreases with Benadryl cream application.
One and a half hours after receiving Flu shot, patient broke out in an itchy rash described as small, red, raised spots that covered her whole body.  The rash lasted 5 days.  Patient called her primary physician who prescribed a 7 day Medrol-dose-pack.Patient was in no other distress and did not see the doctor or go to the ER.
On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Flucelvax QIV administered to a pregnant patient; Sore arm; This is a spontaneous case, initially reported by other non-health professional to Agency (reference number: SEQ19-06140) on 04-Nov-2019 and additional information received on the same date (being processed together), concerning a 35-year-old, pregnant female patient.   The patient's medical history was not provided.   The patient's concomitant medications were not reported.   The patient's obstetrical history included two previous pregnancies. Also, the patient had no maternal or paternal history with major congenital malformations. The patient did not have a history of offspring with congenital malformation.   The patient's last menstrual period (LMP) date was 07-Apr-2019 and estimated delivery date (EDD) was reported as 12-Jan-2019.   On 28-Oct-2019, at gestational age of 29 weeks, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper right deltoid, batch number and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza prophylaxis.  On an unspecified date, an unknown amount of time after vaccination, the patient experienced sore arm.  On an unspecified date, three days after the onset, the patient recovered from sore arm.   At gestational age of approximately 39.6 weeks, the patient gave a live birth to a female neonate, delivered vaginally. It was reported that there were no problems with the delivery.  There were no problems since, and the baby was 'fat and healthy' as reported.   The reporter did not provide causality assessment to Flucelvax QIV.   Follow up information received from other non-health professional via Agency (reference number: SEQ19-06584) on 13-Feb-2020: Patient's date of birth amended. Pregnancy outcome received. Anatomical location for vaccination added. Sore arm added as new event. Hence, classification special case with no AE was removed. Stop date added and outcome changed from not reported to recovered for vaccine exposure during pregnancy. Narrative was amended accordingly.  Company comment: It is unknown when the patient developed sore arm, therefore the temporal and causal relationship between vaccination and this adverse event was considered unassessable. Vaccine exposure during pregnancy is unrelated to Flucelvax.; Sender's Comments: It is unknown when the patient developed sore arm, therefore the temporal and causal relationship between vaccination and this adverse event was considered unassessable. Vaccine exposure during pregnancy is unrelated to Flucelvax.
Mother reported that Patient developed fever, rash on hand and feet a few days after the vaccinations and them the skin then peeling in the rash area.  Also reported Cough and runny nose.  These symptoms were report on 7/23/21.  On 7/21/21 Patient received the same vaccines and lot numbers for dose 2.  These symptoms were not reported when vaccinator asked how he had done with his first doses of vaccine. Mother called Public Health on 7/23/2021 at 10:50am to ask about these symptoms as patient has developed a fever in the past 12 hours after receiving dose 2 of Tdap and MMR .  Family does not have a thermometer.
Patient experience partial seizure activity. She was slumped over and unresponsive with right side shaking. Patient also experienced nausea/vomiting.
redness at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   On 18th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a month after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The caller was a reporting that the patient received Shingrix and experienced redness and soreness at the injection site that lasted for about 5 days and resolved.
Given an injection of >.5mL of Moderna COVID-19 vaccine; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given an injection of more than 0.5mL of Moderna Covid-19 vaccine.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the physician reported that a patient was given an injection of greater than .5mL of Moderna Covid-19 vaccine and was seeking advice on what to do.  Action taken with mRNA-1273 in response to the event was not reported.  The event given an injection of more than .5mL of Moderna Covid-19 vaccine was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.
whole chin is swelling and the rest of the face as well; Lower back pain; feel horrible; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 18Jul2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The  patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 20Jun2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation and had hyaluronic acid (MANUFACTURER UNKNOWN) filler on chin from unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had hyaluronic acid filler on chin and believed there was reaction. On 19Jul2021 at 08:00, the patient's whole chin was swelling and the rest of face as well and also had never felt lower back pain like after the second dose of Pfizer vaccine. The patient felt horrible and had chills and fever. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events whole chin was swelling and the rest of face as well, lower back pain, chills, fever and feel horrible was not recovered at the time of this report.
Within 12 to 24 hrs of MMR had rash with increasing to joints/bilateral (ankles (///)/knees/elbows); erythematous, edematous, painful according to parent's history; no fever. Rash down 80%.
redness & itching @ the site of inj lasting 2 days;determined to be mild rxn;pt refused tx & released instructed to return if not resolved;
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt reported having issues with first vaccine very similar to this , head tingling and chest heaviness and nausea within 10 min of vaccination. Gave diphenhydramine liquid at 10 min. Blood pressure normal. Pt stayed 30min for observation was ok and left with husband.
Chills; Headache; Ache; Pressure on his chest; Sweating; Pale; This is a spontaneous report from a contactable consumer.  A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included myocarditis since Nov2019 ((Name) had myocarditis in November of 2019. He recovered well. Unknown if it was COVID). The patient Concomitant medications were not reported. It was reported he received the Pfizer Vaccine on Wednesday at 5pm and on an unspecified date in 2021, he started experiencing aches, chills and headache the following day. It continued on and off on Friday. Woke up Saturday with pressure on his chest and chills, sweating and pale. He presented to the ER on Saturday 2pm. They believe it's a return of myocarditis. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse concerning two patients, both "older children" who received on an unspecified date a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, it was indicated that the two patients developed breakthrough varicella. No intervention was reported. On an unspecified date, both patients had recovered. A product quality complaint was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information form the nurse, identified a 22 month old male child, who on 03-DEC-1997 was vaccinated with the first dose of varicella virus vaccine (lot # not reported). In June 1998 he had a mild case of chickenpox. On 11-Jan-2008, at 11 years of age, he had a "full blown case" of chickenpox. It was previously reported that the child had recovered. No further details were provided.
Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of M-M-R II (lot # L004656 with expiration date 11-FEB-2017, lot # LL007216 with expiration date 03-MAR_2017, lot # L024267 with expiration date 01-JUL-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Blood tests showing elevated ANA and high titers and rheumatoid factor and excessive inflammation that has not been present for over 20 years
headaches; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and NAUSEA (Nausea). At the time of the report, HEADACHE (headaches) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-060583 (E2B Linked Report).; Sender's Comments:  MOD-2021-060583:1st Dose of vaccine
Redness at the injection site; Swelling at the injection site; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.
Vaccine administered 8:32am. At 8:36am VS BP 74/51, P 40, R18 T98. pt sitting on chair and fell on right lateral side. Pt noted with bump to right forehead. Pt A&O verbalizes feeling dizzy and nervousness. Pt diaphoretic with brief episode of seizure-like eye twitching. Pt denies any chest pain. 8:39am VS BP 90/40 P50, R18, T98 O2 Sat 98%. Lead nurse made aware. Md on call made aware. As per MD notify EMS. Orders carried out. Applied cold compress to forehead while pt sitting up. Wife  present. VS 8:42am BP 128/76, P74, R18, T96.8, O2 98%. Pt under no distress. 8:52 EMS arrived to site. Pt evaluated by EMS and offered to be taken to hospital for further evaluation. Pt refused. Advised pt of consequences for leaving AMA. Pt verbalizes understands. 9:01am pt signed AMA. Instructed pt to seek further medical assistance if signs/symptoms persist at home. Assited pt to exit site on wheelchair accompanied by wife.
patient came in several weeks after the first dose to complain of pain in her arm stating that she saw her doctor and may need to get an mri. patient came in for second dose and said she felt better but some pain was still there. has not gotten  mri yet.