chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection received in left arm (shoulder) - a sore has developed near his arm pit about the size of a dime.  It has a scab and is red.
No adverse affect reported from patient. Clinic held Moderna vaccine at lower temp than recommended by Modera. Vaccine was held at -90 to -60 degrees Celsius. Moderna deemed vaccine viable for use
An immunocompromised patient previously received J&J, was given 0.5mL 3rd dose Moderna instead of regular booster dose of 0.25mL.
Missed 2nd dose in allocated timeframe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe) outcome was unknown.        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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (route, lot # and expiration date were not provided). On an unknown date, the patients were administered VAQTA that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. IT was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 13 year old female with no known drug allergies who on 02 August 2004, was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). On 05 February 2006, the patient developed a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
I have had a ache in my bycept for over a week/ it began a week after the vaccination.   Not real serious but I am concerned about getting the second shot next week
Hot rash, headache, nausea, diarrhea, arm pain, heat and swelling at injection site, muscle aches, fever, sore throat, dizziness
Pt started developing hot , dry throat and swollen throat.  She also became SOB.   She was given 25mg of benadryl at onset of symptoms, 5 min later her sob became worse, additional 25mg of Benadryl given for total dose 50mg.   Pt symptoms started resolving after 15 min, and S0B  resolved in 30 min.  She was given 4 tablets of Benadryl to take home with her and advised of use, she was instructed to stay with family member rest of the day, she was instructed to call 911 if SOB should return.  Pt was driven home by staff member in stable condition.
Chest pain/pressure for several hours occurring about 2-3 days after the shot.  I didn't tell anyone or seek any treatment.  I did not associate it with the vaccination at the time.  I did not had the problem before or after.
Extreme and intense hot flashes resumed within two days of receiving first vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150 and expiration date was not reported), via an unspecified route of administration, in Right Arm on 02Apr2021 08:30 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration in Left Arm on 23Apr2021 8:30 (at the age of 52-years-old), as dose 2, single for covid-19 immunisation. The patient medical history included Heart from an unknown date and unknown if ongoing. The patient concomitant medications included acetylsalicylic acid (BAYER ASPIRIN, 325 MG) by oral route of administration taken for Heart from an unspecified start date and ongoing. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Since the vaccination, the patient has not been tested for Covid-19. The patient did not received treatment for adverse events. On 03Apr2021, the patient experienced extreme and intense hot flashes resumed within two days of receiving first vaccine. The outcome of the event was not recovered.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number not reported) on or about 02-JUL-2012 at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JAN-2013, the patient was treated by a physician for a painful rash that was diagnosed as shingles. The patient was prescribed acyclovir and VICODIN to manage her severe symptoms. 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 shingles is unknown. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the product was improperly stored at -2 c for 2 hours. On 25-JUN-2014, the patients were vaccinated with ZOSTAVAX (dose, route and lot were not reported). No adverse effects reported. This is one report of two reports from the same source. Additional information has been requested.
Parents signed child up for flu shot at enrollment.  Did not tell anyone that he had been given shot on 9/29/21.  Child was given vaccine he had been signed up for due to miscommunication.  Parent informed school this AM that he had been given the shot in September.  Child has no adverse reactions to report.
Pt developed erythema and rash. Supportive care and monitor for new symptoms.  Follow up: "was not vaccinated at office."
My lymph node in the armpit of the arm I received the injection in began to swell about 24 hours after I received the injection. It stayed swollen for about 48-72 hours. I also had sever pain in my are that began about 24 hours after receiving the injection. The pain subsided about 24 hours after it started.
COVID Positive; Drug ineffective; sweating; Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 14:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administered in arm right, administration date 12Apr2021 09:00 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 22Mar2021 09:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dairy allergy" (unspecified if ongoing), notes: other medical history: dairy allergy; "known allergy: Penicillin" (unspecified if ongoing), notes: known allergy: Penicillin. Concomitant medication(s) included: LISINOPRIL; HCTZ; OMEPRAZOLE; FLONASE; ALLEGRA. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021 02:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Positive"; HYPERHIDROSIS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sweating"; COUGH (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "Cough"; RHINORRHOEA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "congestion"; CHILLS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "fever (up to 101.7)". The patient underwent the following laboratory tests and procedures: body temperature: (31Dec2021) 101.7, notes: adverse event: Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); sweating; sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of immunisation, hyperhidrosis, cough, rhinorrhoea, oropharyngeal pain, nasal congestion, chills, pyrexia.  Additional information:no other vaccine in four weeks,no COVID prior vaccination, COVID tested post vaccination  No follow-up attempts are possible. No further information is expected.
This spontaneous non-valid report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, VARIVAX, ZOSTAVAX, M-M-R II, PROQUAD (exact dose, route of administration, lot # and expiration date were not reported for any of aforementioned vaccines) and with improperly stored doses of ROTATEQ (administered orally; exact dose, lot # and expiration date were not reported). Administered vaccines were stored outside of the cardboard packaging and exposed to light for an unknown length of time. No adverse effects were reported.
Mother states child developed generalized rash, temp ~100 f, sore throat and states this is related to Dtap and Hep A vaccination 1/24/17.
first dose on October 31st 2019 / 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019, batch number 3HTSJ, expiry date 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
temperature excursion; This spontaneous report was received from a nurse (also reported as medical assistant) and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 21-JAN-2021, the patient was vaccinated with improperly stored doses of measles (+) mumps, (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, for prophylaxis, lot # S015962, expiry date 23-MAY-2021; and varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, for prophylaxis, lot # S02560, expiry date 18-AUG-2021 (formulation, concentration, dose number, route of administration, frequency for both vaccines were not reported). Digital data logger was not involved. According to the reporter, the temperature excursion was 16.7 degrees of Fahrenheit (F) for a time frame of 1 hour on 09-NOV-2020 (reported as 09-NOV-2021), with a previous temperature excursion 11.8 degrees of Fahrenheit for a time frame of 1 hour on 06-NOV-2020 (reported as 06-NOV-2021). No additional adverse event was reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA000100:
Sore arm shortly after vaccine administered.  The next day could not lift arm and had felt like I had the flu.  Could not feel my legs and when getting up legs buckled as no sensation. Lasted a couple of hours and then went away and thought might be getting Guillain-Barre syndrome.  Felt horrible for about 5 days and could use my arm after 2 days.
Large, red, painful ring (about 5 inches in diameter)  appeared near vaccination site (began on day 8 and dissipated by day 10) on dorsum of left arm Axillary pain and swelling under left arm started on day 6, continues through day 10
patient had the 1st dose last 27Mar and 2nd dose 28Jun; swelling of lips; itchy throat; This is a spontaneous report via a Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 27Mar2021 as dose 1, single for covid-19 immunisation. A pharmacist is calling on behalf of a patient who received both doses of the Pfizer Covid-19 vaccine and had allergic reactions such as swelling of lips and itchy throat after the 2nd dose. The patient will also have a colonoscopy and the doctor prescribed Gavilyte however there is a contraindication between Gavilyte and Pfizer Covid-19 vaccine. The patient had the 1st dose last 27Mar and 2nd dose 28Jun (93 days apart). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAIN IN LOWER RIGHT LEG (STARTED 6/03/2021) CLOTS FOUND VIA ULTRASOUND SCAN (6/08/2021) LOVENOX INJECTIONS FOR 7 DAYS (120MG SUBCU) ELLIQUIS RECOMMENDED FOR 3-6 MONTHS (5MG 2X/DAY ) CURRENTLY STILL UNDER TREATMENT AS OF 6/19/2021
Patient had first Pfizer Covid vaccine and began to c/o nausea. Vomited x 2. Has history of hypersensitivities and is in the care of an allergist. VSS: 149/81, 78, 16, 100%.  Gave Zyrtec 10mg po @ 9:30am, Diphenhydramine 25 mg po @ 10:05am. Patient A&Ox7, able to verbalize needs, speech clear, skin pink, denies sob, Resting with RN at bedside. 10:20am: VSS: 136/74, 16, 70. 100%, Patient vomiting small amounts of stomach acid. Voided x 1. Patient now taking Omeprazole 40mg po as she takes this every day for GERD.  10:43am: Patient feeling better, much less mucous in throat, never nasal discharge, hives, or tongue swelling. Patient has stayed relatively stable with po meds and monitoring. 10:50am: Patient much improved, sleepy, but A&OX7. No issues noted. 11:15: Patient napping, symptoms resolved. 11:30am: Woke patient who napped x 30 minutes. Looks/feels much improved. Provider okay to DC home.  Discharged home in stable condition.
I had trouble breathing, slight delirium and dizziness but was fine after 30 minutes...
Patient had localized reaction of left arm with erythema, edema, warmth, and tenderness of  anterior  and lateral side of upper left arm.
p/vax pt devel elbow pain that worsened;pain & mild tenderness to palpation lateral lt elbow;residual nodule in lt triceps area from inj is as expected following recent inj;
Patient presents to office 11 days post vaccination reporting pain in left shoulder upon palpation and when lifting arm above shoulder.  No visible redness or swelling.
Information has been received from a consumer who was just reading facebook when the consumer saw a post from a friend of hers "Just say no to GARDASIL".  The patient was vaccinated with a dose of GARDASIL on an unspecified date.  It was apparently her daughter had been very sick for two years after receiving the shot.  It was unknown if the patient sought medical attention.  At the time of the report, the patient's status was unknown.  This is one of several reports received from the same source.  No further information is available.
This spontaneous report as received from a 66 year old female consumer with sulfa drugs allergy reporting on herself. ON 30-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ACTOS, NOVOLIN, CELEBREX, NEXIUM, lithium, PROZAC, lisinopril (manufacturer unknown) and TOPAMAX. The patient reported that on 05-MAR-2014, she started experiencing mild discomfort which turned into horrible pain. The consumer reported that she went to the emergency room on 06-MAR-2014. While in hospital the patient had a CAT scan performed (results not provided) along with other tests. The patient stated that an unspecified healthcare provider in the hospital instructed her to go to her physician's office for further advice. The patient left the hospital on 06-MAR-2014 and saw her physician the same afternoon. The patient stated that her physician diagnosed her with shingles. The patient stated that her physician noticed she had a rash on her back. The patient prescribed acetaminophen, PERCOCET, morphine, DILAUDID and acyclovir. The patient stated that the rash on her back was still present and she was still experiencing severe pain. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 29-Nov-2011) concerns a male infant, who was preterm and had a medical history of RDS (respiratory distress syndrome) and lower leg amputation. His birth weight was 1.125 pounds and had one sibling (half sibling). On 20-Oct-2011 the patient received flu vaccine. On the same day he also received ROTATEQ, DTAP, HIB, and PREVNAR. Twenty-four to thirty-six hours after vaccinations the patient developed a high temp (temperature) 102 - 103 / vomiting, decreased appetite and dehyd. (dehydration). He was admitted to hospital for 2 days with ileus. Relevant diagnostic tests included obstruction series, KUB (kidneys, ureters and bladder scan) and pedi GI (pediatric gastrointestinal) evaluation. The patient took 4 to 6 days to get better. The event outcome was recovered. The reporter considered events to be serious as the events required emergency room / doctor visit, hospitalisation and medical / surgical intervention.
PT GIVEN INCORRECT BRAND/DOSE  OF COVID-19 VACCINE FOR SECOND DOSE.  ORIGINAL DOSE (FIRST DOSE) GIVEN WAS MODERNA, LOT 041L20A ON 02/02/2021 AT 1346.  CAUSE OF INCIDENT UNDER INVESTIGATION. PT C/O MILD HEADACHE FOLLOWING INCORRECT DOSE WITH NO OTHER SYMPTOMS, EASILHY RESOLVED.
Patient felt dizzy and lightheaded shortly after administration. He states that he often works himself up over medical issues. BP dropped to 86/60 at one point. EMS was called and took over situation.
Patient received flu vaccine on November 2, 2019 and phoned Regulatory Authority on 2/24/20 to c/o moderately severe pain in left shoulder after receiving flu vaccine. Denies numbness/tingling. Reports the pain interferes with ADL's. He has used OTC Ibuprofen for the pain since then, but not on a consistent basis. Unknown if he has sought evaluation for the pain.
Initial redness swelling to area of injection. Fever 101 for 32 hours then symptoms resolved. 7 days later are again began to swell and became hat and indurated. Treated at that time with Kefles and Depomedrol
12/10/21  reports no known exposures. She HAS HAD the COVID-19 vaccine series and HAS NOT HAD the FLU vaccine. She states reports she tested positive for COVID in auguyst 2020.  She reports that symptom(s) started last night. The symptoms have been worsening during the period of illness. She has treated these symptoms with advil which HAS HELPED.  Review of Systems  Constitutional: Positive for fatigue and fever. Negative for chills.  HENT: Positive for congestion (no loss of smell ), ear pain (ear pressure throbbing) and rhinorrhea. Negative for sinus pain, sneezing and sore throat.   Respiratory: Positive for cough. Negative for shortness of breath and wheezing.   Cardiovascular: Negative for chest pain.  12/10/21  Review of Systems cont. Gastrointestinal: Negative for diarrhea and vomiting.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for weakness and headaches ("not too much of a headache" ).
ANGINA, UNSPECIFIED 1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella virus vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient was hospitalized (date unspecified) for parotitis pain management. The outcome of the event was unknown. The relatedness between vaccination with measles, mumps, and rubella virus vaccine (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
ill for five days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill for five days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (ill for five days). The patient was treated with GLUCOSE, POTASSIUM CHLORIDE (INTRAVENOUS DEXTROSE AND POTASSIUM CHLORIDE) (parenteral) for Illness, at a dose of UNK dosage form. At the time of the report, ILLNESS (ill for five days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications were reported.
I had numbness of the left side of my face with a heaviness over the left eye. I was evaluated for a stroke-NEG result I had a bad headache. The numbness resolved after 10 days . I went to an Urgent Care I also followed up with my PCP who put me on a steroid taper and an antiviral.