chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm was numb as well as her left leg; This is a spontaneous report from a contactable consumer (spouse/husband). A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955) via an unspecified route of administration in left arm on 18Mar2021 at 15:30 (at the age of 92-year-old) as single dose for COVID-19 immunization at Medical Center Point. Medical history of the patient included bleeding in the lower part of her esophagus, inflammation, stroke [Cerebrovascular accident; about 2 years ago, either in 2018 or 2019]. Patient was recently in the hospital and she had bleeding in the lower part of her esophagus. Reportedly, it was inflammation. Reporter stated that patient was in the hospital for 7 days then she was sent to rehab for 22 days and she came home on the Friday, 12Mar2021. Patient takes some medication concomitantly (unspecified). Family Medical History Relevant to AE(s) as None. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient previously received flu shot on an unspecified date [every year] and had no reaction and shingles shot on an unspecified date and had no reaction. On 22Mar2021, the patient woke up in the morning at about 07:00 and at around 7:30 patient noticed that her left arm was numb as well as her left leg. The patient was able to move her leg in bed some and move it some, but she can't hold any weight on it. It was the same on the day of report, for the most part. Patient didn't have any reaction to the vaccine until Monday (if the numbness was connected to the shot). Reporter (patient husband) stated that patient did not visit emergency room yet but was thinking of going to ER but wanted to talk to Pfizer first to see if what his wife was experiencing was likely connected with the COVID shot or not. Relevant tests as none. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on 14th May 2018, refer case US2018GSK229696). On 24th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms (serious criteria other: serious as per reporter). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband who reported for his wife. The age at the vaccination was not reported but could be 76 years or 77 years. The patient experienced flu like symptoms. The first two days the patient stayed in the house resting. The patient was back to normal after two weeks. The patient was otherwise in good health. The side effects were much more serious with the 2nd vaccine. The reporter reported that initial reason he called GlaxoSmithKline was the lack of availability for the vaccine. This case has been linked to the case US2018GSK229696 (same patient), US2018GSK229698 and US2018190915 (husband's case).
increase in heart rate; numbness in the legs; Lethargy; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202200518190.  A 65 year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "increase in heart rate"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the legs"; LETHARGY (non-serious), outcome "unknown", described as "Lethargy"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter would like to know if increase in heart rate was a side effect and numbness in the legs. Also questioned if lethargy or fatigue would be a part. She stated she had a patient come in and was concerned. The patient received the shot "one week ago" and was saying that her heart rate was increasing and they were uncertain if these side effects could occur after one week of having had the product or if this could be caused from another source.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/19/22 presents to ED for "Dyspnea, cough, fatigue, and diarrhea". PMHx of "COPD" "remote breast cancer treatment" "rheumatoid arthritis"
Pt complains of having a stiff neck in the morning and as day went on, pain traveled to shoulder and localized at injection site. Pain and discomfort extends from upper arm to shoulder blade to neck It is a deep aching pain, also suffering of muscle spasms and twitching on arm that was vaccinated.
hungover; sleepy; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired). At the time of the report, HANGOVER (hungover), SOMNOLENCE (sleepy) and FATIGUE (Tired) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided No treatment product information was provided.
Discovered during second vaccine visit that child received a 3 mcg/0.2 ml dose instead of 10 mcg/0.2 ml dose on July 8th, 2022.  This was discovered during second vaccination, today, August 5th.  Appropriate 10mcg/0.2 ml dose given.  Instructed to return in 8 weeks for 3rd dose.
Pt reports soreness (L) deltoid at injection site. Then developed flu-like symptoms, headache, nausea and multiple emesis. The night of the injection 8/28-8/29 that continued following day. Instructed to take Tylenol. On 8/30/07 pt reports feels better, eating/drinking well.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 59-year-old male patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, pain in arm and blister. On an unknown date, the outcome of the erythema, pain in arm and blister were not recovered/not resolved. It was unknown if the reporter considered the erythema, pain in arm and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right arm. The patient reported that the redness and blisters were near the adhesive of the band aid (CURAD brand) that looked like two cigarette burns. The patient reported that he was not sure if it was from the band aid or the SHINGRIX, or a combination of both. The patient reported that he did not have any issues with band aids in the past. Also, the patient reported that he had redness three inches below the injection site. The patient planned to follow-up with his physician on an unknown date. The patient reported that he took a picture of his arm, and would be glad to email it to agency, if needed.
About three weeks after the second shot I developed a bright red rash around both ankles.   My dermatologist called this Vasculitis.  I treated it with Triamcinolon Acetonide and anti-itch creams and lotions.  Over time the rash continued to get worse and moved up my legs to above my knees.  I have seen both my dermatologist and my primary care doctors concerning the rash over the last 2 ½ months., my primary care doctor characterized the rash as Leukocytoclastic Vasculitis.  At this time the rash continues to spread with no end in sight.
one improperly stored dose VARIVAX was administered to the patient; This spontaneous report was received from the office manager referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.      On 28-SEP-2020, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S032357, expiration date 14-OCT-2021 for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The office manager reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored.    The vaccine was stored in a temperature of 6.9 degree Fahrenheit (°F)  for 11 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Immediate: weakness and blurred vision. Difficulty focusing my eyes. This lasted through the evening of July 30th.   Since the 30th, (a little over a week now) my carpal tunnel symptoms seem much more severe! I?m experiencing numbness  and tingling in my fingers and entire hands, both left and right . The right seems more intense.  I have a scheduled appointment with my rheumatologist tomorrow, August 10th for a follow up and plan to discuss this with him.
Blotchy erythema upper (L) arm with swelling from (L) shoulder to elbow eval and tx ice to area BENADRYL P.O.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments were not applicable and the event was considered to be resolved.
Left arm redness and puffiness about 2 inches by 4 inches at injection site. No pain, no other symptoms.  Did not note reaction when vaccine was administered. There was pain for 2 days after injection and it resolved.  Unsure if redness and puffiness is new or if it's been there this whole time.
After receiving 2 doses of Pfizer COVID vaccination on 6-28-21 & 7-19-21, patient became infected with COVID in September 2021 and was hospitalized due to this breakthrough infection.
Patient passed out/fainted within 5 minutes of HPV Gardasil injection. She came to with smelling salts then fainted again. Ambulance called, transported patient to local hospital.
Hospitalized (11.4.21);  COVID-19 positive (11.4.21);  fully vaccinated PLUS booster Admission Date: 11/4/2021 Discharge Date: 11/10/2021  PRESENTING PROBLEM: Patient is a 91 y.o. female with past medical history significant for dementia, chronic obstructive pulmonary disease, who was sent in from assisted living facility for complaints of cough, shortness of breath and hypoxia.  Patient has baseline dementia unable to provide much history, patient was hypoxic with oxygen saturation 87% when presented was placed on 2 L nasal cannula, labs were mostly unremarkable apart from positive COVID-19 PCR, CRP 37. See received dose of dexamethasone in the emergency department, for further evaluation and management admitted to medical floor under hospitalist service. HOSPITAL COURSE: Acute hypoxic respiratory failure Chronic obstructive pulmonary disease exacerbation COVID-19 pneumonia present on admission Treated with 5 days of Remdesivir, and 6 days of Dexamethasone 6 mg daily, she will need 4 more days of Dexamethasone Should stay in isolation until she finish Dexamethasone, 4 more days  Currently on RA  SLP: thin liquids, regular solid (cracker/cookie), dental soft, liquids via cup and straw PT: Educated daughter that if she were to return to reside in assisted living facility, PT/OT recommend 24/7 assist of 2 persons for safety during all transfers and mobility, in addition to home PT/OT. Discharged on 11/10/2021
Developed polydipsia and polyuria within a couple of days of receiving the vaccine.  Diagnosed with diabetes via elevated A1C on 5/6/2021.
death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home.
pt recv vax 3 days later c/o swelling & pain in same arm due to tetanus shot; redness & circumscribed raised area-likely to be cellulitis; tx ATB;
1) Approximately 6 hours after receiving the injection, I had burning sensations in the inner thigh of my left leg, and between the arm pit and lung area of my left side.  At the same time, there was stabbing pains that occurred under the skin surface of my left side at lung height.  Both of these subsided within an hour, but the stabbing pain reoccurred approximately 60 hours later(10/14 at 5:30 AM) for another short time.   At 4 AM on 10/12, I woke up with a headache and body aches that lasted approximately 6 hours before subsiding.  The head and body aches seem to be expected after a vaccination, so there was little concern there.  During that 6 hour time frame, I developed a feeling similar to that of a strained muscle from my right clavicle to my right jaw that has not subsided at the current time (10/14 at 9:15 PM).  Lastly, on 10/13, I woke up at 8 AM and my right middle finger PIP joint was swollen along with my index DIP joint.
Chills, nausea, diarrhea, aches & pains, tired for 24 hours.
Problems in left arm. Pain in arm and shoulder up to neck and down to elbow. Felt like numbness, arm sleep. Continue to have discomfort, sharp pain in arm, arm still feels sleep. Took extra strength Tylenol for pain.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.   The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medications were reported.
Varicella given 9-2-10. One week later site was red & swollen & three bumps appeared.
The first day I had the strangest pinpoint pain in my left hip. I have never had that in my life. I thought I had a blood clot. I did not have fever. I was very tired, so I completed a COVID-19 home test on 10/29/2022. I called the doctor who prescribed PAXLOVID but told me not to take it unless I developed more symptoms in 24 hours. I started to cough terribly, I was tired and had brain fog. I started the PAXLOVID, but I remained very sick for 6 days. I was very lethargic and coughing and I loss the sense of taste and smell and developed a metal taste. After day 7 I started to improve. I still have a cough that I have never had before, but I am so much better. I still cough every single night and I did not do that prior to COVID-19. I went back to the doctor about 2 weeks later due to the coughing. I was given cough pearls to treat the cough. I believe COVID-19 caused my acid reflux to increase in severity.
Information has been received from a licensed practical nurse, concerning a female patient in her "early 20's" with a prior history of a negative PAP test, who was vaccinated with all 3 doses of GARDASIL (lot # not provided). Following the vaccinations, the patient had a "positive" PAP test. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
injection site area was itching really bad; red splotchiness; injection site red splotchiness; feverish; injection site was firm; injection site pain; headache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad) and VACCINATION SITE RASH (red splotchiness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ETODOLAC and CANNABIDIOL, CANNABIS SATIVA SEED OIL, MEDIUM-CHAIN TRIGLYCERIDES (CBD CANNABIDIOL HANFOEL EXTRAKT) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm). At the time of the report, VACCINATION SITE PAIN (injection site pain), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE PRURITUS (injection site area was itching really bad), VACCINATION SITE RASH (red splotchiness), VACCINATION SITE ERYTHEMA (injection site red splotchiness), PYREXIA (feverish) and VACCINATION SITE SWELLING (injection site was firm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sleeplessness, blue/green/black stools. 4 days later he past away. Nurse follow up on 11/05/04 states: "No new information." Autopsy report gives COD as SIDS (03/02/2005).
It's been 10 days and my arm is still experiencing a rash (red), bruising (purple), hot, throbbing, and itching around the injection site in a circle about 7 cm in diameter.  It's very painful and itchy.
Pt called  on 5/23/21. Pt got Moderna vaccine  2nd dose on 5/21/21 at site. Pt complains of abdomen distension and excruciating pain at abdomen area onset 5/22/21. Pt reports he has history of chronic ab pain.  Advised pt to go to ED immediately and pt stated he will go.
POSSIBLE COVID-19 INFECTION; PAIN IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced pain in arm.  On 06-APR-2021, the subject experienced possible covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible covid-19 infection and pain in arm was not reported. This report was non-serious.
Swollen, painful arm at area of site (left deltoid). Had fever and chills. Saw MD in office on 10/3/02.
Tongue and lip swelling.   diphenhydramine 50mg IM given at clinic by RN
SEPTIC SHOCK, BILATERAL PNEUMONIA, DIZZINESS, REPEATED FALLS, POSSIBLE STROKE.
1/4" nickel size lump grew on top inboard of left wrist. I watched it grow from 5:00 - 5:30 PM.
Patient and parent presented to urgent care to receive the COVID-19 vaccine. Parent told registration staff patient was 12 years old, so staff registered her for a vaccination. Patient's age was not verified or caught by clinical staff. She received an adult dosage 3 months before turning 12 years old. No adverse reaction to the vaccine noted.
Case number PHEH2014US005902, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 14-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on 16 Jan 2014. No adverse event was reported following the maladministration (incorrect storage of drug).
pt recvd vax & exp arthralgia in the arm that recvd vax;