chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was extremely tired since the time that she had taken her Spikevax vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Cardiovascular disorder (The patients carotids were partially blocked.) and Heart block (her heart was partially blocked.). Concomitant products included ESCITALOPRAM, GABAPENTIN, ALPRAZOLAM (XANAX), ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and TRAZODONE for an unknown indication.   On 27-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 27-Oct-2023, the patient experienced FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine). At the time of the report, FATIGUE (The patient was extremely tired since the time that she had taken her Spikevax vaccine) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was reported that patient receives other vaccines in the four weeks prior to COVID-19 vaccine.  It was reported that suspect vaccine lot number and expiry date was not available. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
Fever, aches, runny nose, dizzy, fatigue, lethargy, sneezing, itching eyes.
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 12-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved.            Concomitant medication use was not reported.   Treatment information was not reported.   This case was linked to MOD-2021-202143 (Patient Link).   Reporter did not allow further contact
In September of 2022, I started having trouble with bowel movement. I was advised to go to urgent care or emergency department. After an MRI and Ultrasound, it was recommended that I have a gallbladder removal. The surgeon stated I had a very large gallstone.
About 11 hrs post/vax, she experienced itchiness in L leg. Next day, rash and itchy on all extremities and trunk. Some decrease in itchiness with Benadryl. No fever, dizziness, wheezing, dysphagia or systemic illness. M-P rash and urticaria.
The next morning, I had fluttering in my chest for 2 weeks and chest pains came 10/18/2021 at 7PM . Went to ER. Muscle relax and anxiety meds. I still have the chest fluttering ,
8" x 1" erythematous area (L) upper arm. No tx needed.
Vaccines administered.    A few minutes after receiving vaccines, patient slumped over to the left and fell off exam table.  Mother picked up patient and held her in her lap.  Patient responsive, pale.  Examined by FNP.  Patient and mother stayed in office for over an hour for evaluation.  Mother given instructions on S/SX to watch for.  Mother verbalizes understanding.  Mother called a few hours later by RN.  States patient improving, feeling better.
Information has been received from a physician concerning a 28 year old male who on 11/28/01 (also reported as 11/23/01) was vaccinated with a dose of MMRII. There was no illness at the time of vaccination. On 11/28/01, later that night, the pt experienced generalized, persistent itching which was worse at night. At the time of this report, the pt had not recovered from itching. Follow-up information indicated that the pt's persistent pruritus lasted for 21 days and the pt subsequently recovered. It was reported that the pt's history was unknown, however the pt denied one. A CBC and SMA were done with normal results. No further information is available.
My flu symptoms started on 11/03/2022 in the morning around 8:00am. I had a cough, headache, chest congestions and fever. On 11/25/2022 I  went to my doctor's office who prescribe me with Tamiflu  2 times a day for  5 days. My doctor  tested me for COVID-19, Flu, and RSV.  I  tested negative for COVID-19 and RSV, but I tested positive for flu.   I Completely recovered from flu on 12/10/2022.
DTAP/IPV combination given into LT thigh on 5/20/09.  Today area is warm to touch.  Swollen, reddened approx 3" X 5" area
Found lying face down without respiration or pulse, believed to be within 5 minutes of event.  ACLS procedures unsuccessful.  Unable to get autopsy.  Believed to be heart attack secondary to COVID infection, but unconfirmed.  Relative contribution of recent vaccination unknown.
Vaccine administered 10/23/09 at 2:15P. 8A following morning(10/29/2009) got sharp stabbing pains in toes on (L) foot. 10/30/09 AM started getting sharp, burning pain down (R) rear leg.
Pt seen at clinic on 03/07/2014 for 15 mo WCC - given PENTACEL. The next day child developed fever and refused to walk. Also developed hives - was taken to ED - no tx. Attempted cath UA unsuccessful - told to RTC but came to clinic instead treated with BENADRYL.
Severe nosebleeds while asleep. No history of nosebleeds. Had to have cauterization to stop reoccurring nosebleeds.
Approximately 6 cm area of erythema in area of injection. Developed within 24 hours of injection. No treatment needed. On left arm.
Next day (6cm long - 3 1/2cm) tall bright red risen area painful and hot. Pain in arm, difficult to lift arm. Hurts to touch.
seasonal allergies; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced seasonal allergies. Patient wanted to know if she can take pseudoephedrine for the seasonal allergies. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient began to get chicken pox lesions down her leg and on her back and arm. Patient complained of itching at the site of the lesions. Lesion onset the day after vaccine given. No s/s of fever.
Fever of 101.5 rectal, refused formula, cranky overnight, warm, red, swollen area at injection site
Shortness of breath; Felt like someone was choking his throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat). On 23-Jan-2021, DYSPNOEA (Shortness of breath) and CHOKING SENSATION (Felt like someone was choking his throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.    Treatment information was not provided.
Initial unsolicited misuse report received from a pharmacist on 23 October 2015. This case involves a female patient (age was not provided) who was vaccinated with a dose of FLUZONE QIV (Batch number, dose, dose in series and site of administration were not reported) via intravenous route on an unspecified date. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient developed a hematoma. The patient required ER or doctor visit. It was an incorrect route of drug administration. Relevant diagnostic tests were not provided and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none. Follow up information received from pharmacist on 29 January 2016. Patient age was reported as approximately 25-45.
Severe aching all over body, fever of 100.3, headache, overall ill feeling.  Symptoms lasted from 5:00pm on 4/03/2021 to 6:00 pm on 4/04/2021
approx 2hr p/vax devel lethargy, limp, hypotonic, diff to arouse or startle;nursed well but had to be awakened;color OK;improved over next 24hr;@ that time was alert, fussy, nursed well, content, tone nl, head control;
COVID19 pneumonia, bilateral infiltrates, hypoxia/COVID-19 confirmed by positive COVID-19 test; COVID19 pneumonia, bilateral infiltrates, hypoxia/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician.   A 67 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 04Feb2021(at age of 66 years old) (Lot Number: EN5318), the first dose via Intramuscular route on 14Jan2021 (at age of 66 years old) (Lot Number: EL3249), both  at single dose for covid-19 immunisation .  Medical history included closed head injury, migraine headaches, nephrolithiasis, seizure disorder, HTN (as reported). No Known allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient was exposed to COVID by contact with a friend developed COVID symptoms around 24Mar2021,  and had to be hospitalized with COVID19 pneumonia, bilateral infiltrates, hypoxia.  Events resulted in Hospitalization. Still hospitalized as of the time of this writing. Remdesivir, steroids, supplemental oxygen received as treatment for the adverse events. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient been tested for COVID-19, Covid test type was Nasal Swab and tested with positive result. Outcome for events was unknown.   No follow-up attempts possible. No further information expected.; Sender's Comments: Based on known drug safety profile, the events of vaccination failure and COVID-19 pneumonia are assessed as related to the suspect vaccine BNT162B2.
Later I became nauseous; Headache; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18Jun2021 at 08:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient was allergic to amoxicillin (MANUFACTURER UNKNOWN) .Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 08:00, right after the shot, the patient experienced injection site pain and on 18Jun2021 at 10:00, later in the day (about 3 hours later), the patient became nauseous with a headache. No therapeutic measures were taken for the reported events. The clinical outcome of the event injection site pain, nauseous and headache was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
pt recvd vax & exp burning & swelling @ the inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recur; No further details were provided;
Rash around the vaccine injection site 3 inches X 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash around the vaccine injection site 3 inches X 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
This employee received vaccine on 12/31/2020 and had minor local symptoms were resolved within first week. She noticed left lymph node swollen and about 0.5 cm area swollen under left arm which gradually increased in size of 2.0 to 3.0 cm over 10 days. Narrative: She has been taking Tylenol 650 mg twice daily and saw her PCP today who recommended an ultrasound. She is awaiting for the results and recommendations receiving second dose previously scheduled on 01/28/2021.
Narrative:  Patient received three doses Pfizer COVID 19 vaccine Mar 2021/13 Jan 2022. The patient tested positive for COVID 19 on 23 Jan 2022. The patient presented to the ED with cough, dizziness, and rhabdomyolysis. The patient was admitted on 23 Jan 22 and treated with fluids, magnesium, potassium, dexamethasone. The patient was discharged on 25 Jan 2022 in stable condition.
Loss of milestones. Went from cooing, smiling, rolling to complete cessation of all sounds. Also stopped rolling and stopped interacting. After 2 weeks, slowly began to vocalize and regain motor skills. Did not seek medical attention.
Patient had no adverse reaction. He stated that he felt normal just a sore arm. Patient was advised to come to clinic if new symptoms appeared.
Description: 28 y/o Asian male who received primary SPV (left arm), Typhoid IM (left arm) and first dose AVA(right arm) on 10/24/2007. 48 hours later he experienced 'flu-like' symptoms - mild nausea without vomiting, diarrhea, malaise and fatigue. On 11/1/2007 (8 days after vaccination), he developed itching at the back of his lower legs, followed by the appearance of a few itchy non-tender red eruptions covering his legs, back and chest. By 11/2/2007 both the itching and skin eruptions worsened to involve his face, neck, scalp and arms. On 11/3/2007, he had increased itching with swelling of his eyes, lips and ears with non-tender palmar lesions as well. There were no blisters, oral lesions, fever/chills, or cardio-pulmonary symptoms. He was seen at Hospital ER 11/1/2007 and 11/3/2007, diagnosed with dermatitis and treated with antihistamines. On 11/5/2007, he was seen at Medical Center, by Allergy and Infectious Disease (12 days post vaccination), and diagnosed with allergic urticaria vs EM. On 11/6/2007, he was seen by MC Dermatology for a skin punch biopsy - results below. SM was started on Zyrtec with gradual improvement in symptoms. Symptom: Nausea w/o vomiting Start: 10/26/2007 End: 10/28/2007; Symptom: Diarrhea Start: 10/26/2007 End: 10/28/2007; Symptom: Fatigue, Malaise <60 Days Start: 10/26/2007 End: 10/28/2007; Symptom: Muscle Pain Start: 10/26/2007 End: 10/28/2007 Comment: generalized aches; Symptom: Pruritis Start: 11/01/2007 Comment: starting posterior legs, later generalized; Symptom: Lesions, wheal Start: 11/03/2007 Comment: ID: maculopapular rash; A/I: lesions, raised; Derm: papules
This spontaneous report as received from the consumer's husband refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with ZOSTAVAX (Lot #, dose, route not reported). No concomitant Medications reported. The patient's husband reported that 6 to 7 days after his wife had received the ZOSTAVAX shot she had an allergic reaction (onset date unknown). The patient's lips tingled, throbbed, and started to blister (onset date unknown). Reporter refused to provide physician in formation. Patient's outcome was unknown. Additional information has been requested.
1-2hr p/vax pt rt arm began itching in area where shot was given;the next morning when pt awoke area had began swelling;area has gradually cont to swell, itch & later devel whelp-like rash;area tender to touch;raised area approx 8cm,hot
HAIR FALLING OUT AND THINNING, CAN SEE SCALP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 31/MAR/2069) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced hair falling out and thinning, can see scalp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair falling out and thinning, can see scalp. This report was non-serious.
Numbness in pointer finger, back and arm on the right side where vaccine was administered.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO187) via an unspecified route of administration in the right arm on an unknown date in Jun2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 16May2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021, the patient experienced numbness in pointer finger, back and arm on the right side where vaccine was administered. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event numbness in pointer finger, back and arm on the right side was unknown at the time of this report.
No other adverse events reported.; Caller reports that an improperly stored dose of VARlVAX administered to patient on 25Aug2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 25-AUG-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 dose as prophylaxis (lot number U010398 which has been verified to be valid, expiration date reported and validated as 01-APR-2023) (route of administration and anatomical site of injection were not reported) (product storage error). The administered dose of the vaccine was stored at a temperature of -13.5 degrees Celsius (C) (also reported as -14 C to -10 C (-13.5 C)), during a time frame of 6 hours 39 minutes. There was no previous temperature excursion. No other adverse events were reported in the patient.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA008089:
Paitent has no reaction to the bivalent purple cap with 0.2ml for first dose
No adverse advent, Adacel given to child age 10 years 9.5 mos of age.
Started hearing ring noise in my right ear on 04.26.21 that's persisting to this day of submitting the report.  I have gone to a walkin clinic and they refered me to an ENT. They're booked until mid June. No treatment , just trying to eat clean , anti-inflammatory
Broke out with shingles; Scheduling error - more than 36 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Broke out with shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Shingles vaccine (Completed 2 doses of Shingles vaccine.). Concurrent medical conditions included Sulfonamide allergy and Seasonal allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days). On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Broke out with shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency and PREDNISONE for Shingles, at an unspecified dose and frequency. On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days) had resolved. At the time of the report, HERPES ZOSTER (Broke out with shingles) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received does not contain any significant information.
7/28 mild tenderness took an Naproxen. 7/29 had increase in swelling and more redness in the area of the injection-iced area and took Naproxen. 7/30 increased swelling, increased swelling upper arm, also noticed swelling on medial forearm took Naproxen times 3. 7/31 less redness and decreased swelling in upper arm and forearm. Still sore and painful to touch. Treatment: Alvert daily and Benadryl at bedtime and continue to ice.
Headache, chills/seizure, body aches, dizziness, over all flu type symptoms but severe. It is now the next day and I feel pretty bad but not like last night.
Vaccine date was last day of menstrual cycle. Menstruation began again 13 days early (12 days following vaccine) and is much heavier and lasting longer than any in previous 4 years (since stopping nursing 2nd child).
Left arm became extremely sore with redness all over deltoid.  I became weak nauseated with all over aches and pains and a fever and headache.
This 49 year old female received the Covid shot on 4/6 /21    and went to the ED on 5/5 /21 with the following diagnoses listed below and died on 5/5/21.