chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 68 year old female patient with previous history of frozen shoulder, hyperlipidemia, osteoarthritis and asthma. There were no drug reactions/allergies. On 03-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PROAIR, LIPITOR and PLAVIX. On 03-JUN-2014, the patient an hour and half later after receiving PNEUMOVAX 23 experienced severe pain in the same arm, and had so much pain that evening that she could not sleep and could not lift her arm up the next day, on 04-JUN-2014. The medical assistant also noted that patient received BOOSTRIX (manufacturer unspecified) in the opposite arm at the same office visit. No treatment was given for adverse event. No lab diagnostics studies were performed. The patient contacted medical office to seek medical attention. The outcome of the events was not recovered. This is one of several reports received from the same source. Additional information has been requested.
Experienced light headed was, dizziness, nausea, and tingling sensation of the tongue. Immediately notified nurses who put me on a monitor to track O2 and BP. BP elevated but within normal range. Provided apple juice to raise blood sugar and ordered to remain until symptoms passed. Symptoms resolved within 15 minutes.   Since the event have felt elevated levels of fatigue.
(L) deltoid. Symp started 11/7/08.  Redness swelling itching spread from top of shoulder down toward elbow.  Pt given Benadryl symp. resolved by 11/9/08.
pt came into clinic 23FEB95 for vax stated had febrile sz on 12JUL94; seen in ER & PMD is aware of sz; no other sx according to mom; 30MAR95 seen @ MD's ofc-treated for ear infect w/Ceclor; t40.9C;
My temperature is 99.1°F; Shivering; Arm is fairly sore; This case was reported by a consumer via interactive digital media and described the occurrence of body temperature increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021 11:45, the patient received the 2nd dose of Shingrix .5 ml. On 27th January 2021, less than a day after receiving Shingrix, the patient experienced body temperature increased, shivering and pain in arm. On an unknown date, the outcome of the body temperature increased, shivering and pain in arm were unknown.   It was unknown if the reporter considered the body temperature increased, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and the temperature was 99.1 The patient experienced shivering and arm was sore. The reporter asked might take acetaminophen to reduce the temperature.
Extreme weakness, fatigue, dizziness, severe mood changes, anxiety, low grade fever, severe headaches, chills.  1/30/09 Received PCP medical records of 1/22-1/30/2009. FINAL DX: Records reveal patient experienced weakness, dizziness, moody, decreased energy after HPV #1 & #2 given 7/10/2008 & 9/11/08.  Increased fatigue, moody, nervous, heaviness in legs, sensitive to touch, generalized aching, low grade fever, chills after HPV#3 1/20/09.  RTC 1/30 symptoms except dizziness persist & now w/tingling in back & arms.  Difficulty sleeping.  DTRs WNL.  Dx w/rhinitis & possible early sinusitis.  Tx w/nasal spray & given Rx for antibiotics if symptoms persist.
High Blood Pressure, never back to normal; Muscle Pain; Tiredness; Chills; Nausea; Vomiting; Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), HYPERTENSION (High Blood Pressure, never back to normal), MYALGIA (Muscle Pain), FATIGUE (Tiredness) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Lung disorder NOS. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Mar-2021, the patient experienced HYPERTENSION (High Blood Pressure, never back to normal). On 29-Mar-2021, MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, HYPERTENSION (High Blood Pressure, never back to normal) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 152/67 mmHg. On an unknown date, SARS-CoV-2 test: Negative.     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.
Vaccines given on 6/20/2018. Patient reported redness, pain, swelling, slight itching, on 6/21/2018. Advised patient to call her doctor and go to urgent care. Also advised to take BENADRYL, hydrocortisone cream, NSAIDs or APAP and old compress. Advised to see MD and especially if same or worsening symptoms.
Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue after first dose of Pfizer COVID vaccine. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Pt with history of pulmonary fibrosis and a stable pulmonary nodule that had not changed much in years, but then took four RNA shots from January 2021-9/2021 and it is now clear that the lung mass is lung CA and now with mets., having worsening dyspnea with exertion of walking few feet. Last June/23/2022 had the second booster Pfitzer vaccine worsening the respiratory symptoms and 2 months later she was admitted at hospital for elevated D-Dimer and worsening dyspnea and was found to have elevated troponins , and severe tricuspid regurg and pulmonary hypertension.
Measle-like rash; itchy; This is a spontaneous report received from a contactable consumer (patient).    A 49-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:30 (Lot Number: EW0162) at single dose for COVID-19 immunization.  Medical history included the patient had elevated liver enzymes until late 2020, but those have been reduced; just on the cusp of overweight/obese; intolerant of opiods/opiates (itching); allergy to Pollen; allergy to Z-pack antibiotic. The patient was not pregnant. On 27Apr2021, the patient experienced measle-like rash (fine, small, red distinct spots) on tops of hands and feet. More prevalent on feet, from just above ankles to toes. Not on soles (or palms). Rash was not up the legs or up the arms. Itchy, rough. No swelling or fever in the affected areas. The adverse events result in visit to emergency room/department or urgent care. The patient was hospitalized for the events. Treatment received for the adverse event included steroid cream prescribed and the patient was told to take Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was not recovered.
Chills, fever (100.3) , headache, nausea, body aches
indigestion; headache; muscle aches; fatigue; shivering; This case was reported by a consumer via call center representative and described the occurrence of indigestion in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2020, 6 weeks after receiving Shingrix, the patient experienced headache, muscle pain, fatigue and shivering. In December 2020, the patient experienced indigestion. On an unknown date, the outcome of the indigestion, headache, muscle pain, fatigue and shivering were recovered/resolved.   It was unknown if the reporter considered the indigestion, headache, muscle pain, fatigue and shivering to be related to Shingrix.  Additional details were reported as follows: The patient received his first dose 6 weeks ago from the day of reporting and experiencing headache, indigestion, muscle aches, fatigue and hivering.   The symptoms lasted about 36 hours. Consented to follow up.
I got an H1N1 immunization shot at my local facility at about 3:00 PM on Monday, 02-22-2010.  I started getting a headache in the back of my head about an hour later.  It became increasingly worse, and by 7:00 PM I felt so badly that I did not want my husband to talk to me, the light hurt, and all I could do was lie down and hold perfectly still in my bed in the dark for 12 hours.  My muscles started aching by 7:00 PM on 02-22-2010, especially in my shoulders and neck, my head throbbed, and I could not focus on anything.  I felt dizzy.  I began to have night sweats and bad dreams.  On 02-23-2010 I called my primary care physician.  Her office did not call me back until this morning (02-25-2010).  Her nurse told me to take Tylenol and Motrin, and if I didn't feel better, to come in and be seen.  When my headache, muscle aches, fever, and dizziness continued, I went to see Dr. who could fit me into her schedule.  She said she would not have recommended for her patients to have the H1N1 shot, and that she wouldn't take it herself, as it was tested only in a foreign country.  She said I had experienced an allergic reaction to the immunization, and she prescribed a regimen of steroids (Methylprednisolone Pak 4mg, quantity 21) over the next 6 days and told me to take Benadryl at night (50 mg.).  I had a mild fever.  I am an Online English instructor and a professional writer, and I could not focus enough to do my work since Monday afternoon (I often work nights as well as during the day).  Dr. said I should be off work through tomorrow, 02-26-2010.  I have never had such a severe reaction to a shot before.  If I had known how miserable I would feel, I never would have gotten it.  I would not recommend it to anyone.  I feel I should be recompensed for the $10 I had to co-pay as well as the 4 1/2 work days I missed ($100 per day).
small area of redness at the injection site; received the primary vaccine series dose instead of the booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose). In November 2021, VACCINATION SITE ERYTHEMA (small area of redness at the injection site) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.  0.5ml were administered instead of 0.25ml doses to patient.
Pt. was vac. 8/29/13 approximately 11:40 AM - pt noticed redness and warmth around vac. site at approx noon on 8/30. Area widened in redness and sore to touch. Pt has been using ice on the area. Approx. 2 PM on 8/31/13 pt came into pharmacy with redness and swelling approx 5" x 3". Pt was advised to continue ice and use HC 1% cream and BENADRYL 25 mg.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-386277 (Patient Link).
Rash and itching with a sense of burning all over my body, especially the areas which sweat more like arm pit, near neck, between legs, back and chest
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-MAY-2012, at a clinic, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAR-2016, the female was treated by a physician/MD at an Ophthalmology group facility, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster on the eyelid, a damaging eye condition of zoster infections of the eye. The female patient has been prescribed tobramycin-dexameth for management of her painful conditions. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the event of Persistent strain of Herpes Zoster/treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster on the eyelid, a damaging eye condition of zoster infections of the eye (Herpes zoster ophthalmicus) was determined to be medically significant. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient felt cold and HR was elevating. Appeared clammy with an obtunded look. Head dropped to chest, diaphoretic. When name called - patient responded.  No SOB or throat swelling.  HR 105-124, BP 150-160's /  60-70s.   Transferred to the ED.  ED diagnosed with vasovagal syncope. discharged without complications.
Erythematous around the injection site about 1 cm in size. Site has been firm for 5-6 days.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006124, expiration date 02-FEB-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Presented from clinic with 3-4 days of extensive rash.  There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall.
Hypersensitivity; Hives; This case was reported by a pharmacist via call center representative and described the occurrence of hypersensitivity reaction in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced hypersensitivity reaction and hives. On an unknown date, the outcome of the hypersensitivity reaction and hives were unknown.   It was unknown if the reporter considered the hypersensitivity reaction and hives to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Vaccine facility, batch number and expiry date were not reported. The patient received a Tdap vaccine when they were a child and developed a hypersensitivity reaction that included hives. The reporter could not verify the manufacturer of the vaccine. The reporter does not have any further information to provide regarding the event.
Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold; Really hurts to walk; Pins and needles; she was really cold; Feet and hands went numb; They were a little blue and purplish hasn't gotten better,[hands] turning a little blue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb), SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue), PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold) and GAIT DISTURBANCE (Really hurts to walk) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481217 and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021 at 6:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb) and SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue). On 16-Sep-2021, the patient experienced PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold) and PARAESTHESIA (Pins and needles). 16-Sep-2021, the patient experienced GAIT DISTURBANCE (Really hurts to walk). At the time of the report, FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb), SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue), PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold), GAIT DISTURBANCE (Really hurts to walk) and PARAESTHESIA (Pins and needles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
08/13/09 Non-serious, spontaneous report received from a HCP with the manufacturer regarding administration of an expired FLUMIST vaccine. DX: Medication error.  The medication error was due to the costumer not discarding the product form the previous season. The vaccine was administered shortly after the product had expired.  .  The event was considered resolved.   03/05/09 No adverse event was associated after administration of the expired vaccine.    03/31/09 Product Complaint Investigation results received.
Patient had first dose on 12/18/2020.  On 12/30/2020 received second dose.  On Registration form he checked that he had never been vaccinated with COVID before and received second dose too close to first. (12 days apart).
waxing & waning urticaria w/in 4-5 days p/vax;felt throat closing up morning of 27NO98;saw MD;30NOV worse urticaria;case discussed w/dermatologist;
No adverse event, this was an administration error. Patient was given Janssen vaccine at age 17. Patient and guardian were counseled and told that currently Janssen is only approved for age 18 and up. Patient was monitored for 15 minutes with no adverse events.
A lump the size of a large egg formed at the injection site along redness, fever, and itching at the site.  Pain from this made it hard to use my arm. All symptoms lasted 7 days and then on days 8 and 9 resolved.none
RASH STARTED @ 1.5 DAYS LATER...STARTED ON CHART ALL ACROSS/GOT WORSE AS DAY PROGRESSED ALL OVER BODY.. NOT ON LEGS PAST KNEE AND ONLY ON INSIDE OF BOTH ARMS...OTHERWISE ALL OVER BODY NOT FACE EITHER HOT AND ITCHY.. FRIDAY WENT TO URGENT CARE THEY GAVE ME STEROID METH PAK 4 MG GOT WORSE OVER WEEKEND AND WENT TO EMERGENCY ROOM MONDAY MORNING 3/8 AT @ 6 AM I WAS GETTING CHEST SPASMS IN FRONT CHEST AND BACK/MY RASH WAS THE WORST ON CHEST. HOSPITAL CHECKED OUT HEART...ALL GOOD/PLATELETS ALL GOOD I FORGOT TO MENTION EARLIER THAT I WAS ALSO ON AMOXICILLIN DUE TO A ROOT CANAL DONE DAY BEFORE VACCINE HOSPITAL GAVE ME STRONGER PREDNOZONE  PILLS TO TAKE 6 FOR 2 DAYS THEN 5 FOR 2 DAYS...ETC. SOMEWHAT LIGHTER ON DAY 2 TODAY IN RASH..STILL ALL OVER...BUT GETTING DARKER IN COLOR.
Patient called to report tingling and numbness in ear or lip area, patient was near hospital and pharmacist recommended she stop there just to get checked out and make sure there was nothing else going on.