chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 17-OCT-2013 at 13:00 the patient was administered with M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Hives; Benadryl given and hives resolved within 2 hours of Benadryl.
Give first booster instead of a third dose to an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (Give first booster instead of a third dose to an immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient did not had COVID positive test or diagnosis.
While getting vaccinated she noticed there was some dose left in the syringe; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (While getting vaccinated she noticed there was some dose left in the syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced UNDERDOSE (While getting vaccinated she noticed there was some dose left in the syringe). On 07-Apr-2021, UNDERDOSE (While getting vaccinated she noticed there was some dose left in the syringe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The patient believed that she did not get the full dose of the vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown
A few hours after receiving the MMR shot, patient started experiencing pain in the right knee that traveled down to patient's foot.  Pain then started in the left knee on the next day. Pain was very severe, 10/10.  Patient is still experiencing pain. Current pain level is a 9/10 in right leg and a 5/10 in left leg.
Patient had dizziness and severe pain in arm and neck that was radiating down spine. This started a few hours after her vaccine which occurred in the evening. She said she couldn't move and felt paralyzed. She says she guesses she fell asleep and did not wake up for like 12 hours. She said the pain continued and blurriness was in her eyes for like 4 days, She went to her doctor and he did an MRI and MRA. She had an eye exam. All were clear. She states she still has some arm soreness.
Sl temp evening following DTP poor appetite; temp inc to 105 ax Thurs 12DEC gave APAP & tepid bath; temp dec 103; t98.6 @ 1115 in clinic;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUL-2021, the subject experienced confirmed covid 19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the subject experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was non-serious. This report was associated with product quality complaint Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
pt recv vax 6APR98 & 7APR98 devel a serum sickness like rxn described as achy to the bones & feverish;
I had a severe rash, hives, and itching all over my body for 1 month following the Covid-19 Moderna BOOSTER SHOT. The rash was on my face, arms, legs, feet, hands, wrists, chest, stomach, back, buttocks, and genitals. The rash was extremely itchy and my skin felt like fire when I touched/scratched it. The rash was so bad, I could not work for 1 month. My eyes were itchy, watery, and burning - plus the rash went inside my anus at times.  I went to the Minute Clinic 3 times. I received promethazine, another pill (I forgot the name), standard Benadryl, and a shot in my buttocks (a steroid). These did nothing at all. I then went to my PCP, Dr. He prescribed me Allegra and betamethasone dipropionate 0.05% (a gel/cream). Again, these did nothing. Finally, I saw an allergist (Dr.). He prescribed me Pepcid, prednisone, zyrtec, and more levocetirizine. These pills worked very well, and the rash is almost entirely gone (like 95-99% gone now). The allergist gave me medication that worked very well. The rash was the worst 2-3 weeks after the vaccine.  (Also, I used aloe vera from a tube. This actually helped the itching and burning quite a lot, along with placing an ice pack onto my hives, which reduced the itching and swelling).
5-6 hours after 1st dose Pfizer Covid vaccine, developed tingling and prickling sensations along bilateral arms and legs.  Changing/evolving sxs over time have included waxing and waning muscle twitching, fatigue/exhaustion, subjective weakness.  Has persisted for weeks to months (6.5 months so far).
pt exp myalgia, arthralgia, low grade temp, fine lacy erythematous rash, cervical adenopathy, ? 2wk post vax;
no additional AEs; customer called in to report a temperature excursion on GARDASIL 9. Temperature above 47F. This product was administered today.; This spontaneous report was received from a medical assistant and 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 02-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # S033308, expiration date 08-APR-2022 (route of administration and anatomical location were not reported) for prophylaxis. It was stated that it was 1 time dose. Administered dose of vaccine was stored in temperature above 47 degrees Fahrenheit (reported as above 47F) for 1 hour. There was no previous temperature excursion. Digital data logger was not involved. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
some itching throughout her body and it was more intense in her face and head, in her scalp; some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet; tingling on her mouth and tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A1ZA920) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue). At the time of the report, PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was reported as antihistamines early on for itching.
Information has been received from a nurse referring to unspecified patients of unknown age. Patient's drug reaction and medical history were not reported. On an unknown date unspecified patients received improperly stored RECOMBIVAX Hb (lot # K021444 exp 17-SEP-2016; lot # K017721 exp 27-AUG-2016). The nurse also reported RECOMBIVAX HB (lot # K021444 as reported) exposed to a maximum temperature of 52.28F for cumulative time of 7 hours and 50 minutes. There were totally 28 doses were administered. Concomitant medication was not reported. At the time of the report, no adverse effects were reported. Additional information has been requested.
That evening at about 6 pm, I got up off the couch and had a sharp, shocking pain from my butt (sciatica) down my leg to my ankle. Could barely walk and was not comfortable in bed on any side. Came on all of a sudden the night of my shot.
Red papules on face, headache and body ache with itching within 18 hours of administration of MENACTRA and GARDASIL immunization.
Elevated WBC; Elevated Platelets; Elevated Absolute Lymphocytes; Felt sleepy all day; Felt bad; No hunger; hives the size of a dollar bill; felt lump on the left arm; Redness; Itchiness; Little soreness injection arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day) and FEELING ABNORMAL (Felt bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Acute myeloid leukemia (brother, sister and niece died due to Acute myeloid leukemia (AML) blast). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness injection arm). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm) and INJECTION SITE PAIN (Little soreness injection arm) outcome was unknown and ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Lymphocyte count: high (High) High. In 2021, Platelet count: high (High) High. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included Benadryl (diphenhydramine) and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Followup information was received on 30-Mar-2021 reporter details, medical history, laboratory data concomitant medication and events were captured.; Reporter'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. Further information has been requested
OFF LABEL DOSING AMOUNT; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a pharmacist concerned a 50 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received 2 doses (2 shots regimen) and first booster dose of (tozinameran) Pfizer Biontech Covid-19 vaccine, (dose number in series 1) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with Pfizer vaccine (dose number in series 1). The patient received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 0.3 ml,1 total administered on 05-JUN-2022 at deltoid for prophylactic vaccination. The drug was associated with off label use. Age at time of vaccination 50 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2022, The patient received a second booster dose of the Janssen COVID-19 vaccine, but he did not receive entirely, as it was only administered with 0.3ml which was off label dosing frequency and off label dosing amount (dose number in series 2). The reporter did not have information about the patient. It was reported that the patient had no side effect right after received the vaccine, and reporter did not have any information since the patient left the pharmacy 2 days ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing amount and off label dosing frequency was not reported. This report was non-serious.
This spontaneous report was received from a 60 year old male patient reporting on himself. Concurrent conditions included blood pressure and type 2 diabetes. On 27-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (Lot number, expiration date, dose and route were not provided). Concomitant therapies included metformin, fenofibrate and ramipril. The patient stated that he has a red spot (injection site erythema) and a rash at the injection site. The patient added that "when he fold his arms, he could feel the heat" at the injection site. The area was also a little itchy. He could not confirmed exactly when the adverse reaction began, but the patient said that today, on 29-SEP-2016, it was most noticeable. No Product quality complaint was involved. The patient did not seek medical attention, no treatment was given and no laboratory diagnostics studies were performed. At the time of reporting the patient had not recovered from of injection site pruritus, injection site warmth, injection site rash and injection site erythema. The reporter did not assessed the relatedness between ZOSTAVAX and the aforementioned events. Additional information has been requested.
This child's arm was red and warm from the shoulder to the mid arm upper side only. The grandmother is instructed to use hot packs and Tylenol.
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
I've read that what I developed is called  "COVID arm." I had a red spot about 2 inches in diameter at the injection site. It was warm and firm to the touch. It hurt a little when pressed. I first noticed it the evening of Feb. 8. It became less red the next day, but even as I write this it still feels a bit firm.
Day after shot I began cramping as if starting a period. I then started bleeding over the weekend. I stopped bleeding for two days then started back. I am on birth control and do not ever have breakthrough bleeding. I passed some clots in my urine and this time had a heavier bleed than my prior two vaccinations which I only spotted after. The booster caused a more heavy menstrual bleed with clots.
Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ketorolac tromethamine (TORADOL).  On 30-aUG-2006, the patient felt "dizzy" after the injection.  The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope").  It was reported that the patient was seeing the physician or her pain shot.  The syncope occurred after her pain injection.  The physician believed this was a vaso vagal response.  It was reported that "it was not known if the patient was that she was scheduled to receive".  The patient sought unspecified medical attention.  It was reported that "she did not her second shot yet".  On 30-AUG-2006, "a few minutes after", the patient recovered from the events.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/14/2006.  Initial and follow up information has been received from a physician concerning a 26 year old white female with no other pertinent medical history reported.  It was reported that the patient was seeing the physician for her pain shot.  On 30-AUG-2006, the patient was vaccinated intramuscularly in her right arm with a 0.5 mL dose of GARDASIL (Lot # 653650/0702F).  Subsequently, the patient felt dizzy immediately afterward.  It was reported that the patient received a concomitant injection in her right hip reported as TORADOL and she passed out after receiving that injection.  The patient developed loss of consciousness times 1 to 2 minutes, followed by diaphoresis, nausea and sedation event consistent with vaso-vagal reaction.  The patient sought unspecified medical attention.  On 30-AUG-2006, "a few minutes after", the patient had fully recovered from the events.  No further information is available.
TESTED POSITIVE FOR COVID; TESTED POSITIVE FOR COVID; bnt162b2 (BNT162B2), dose 3 on 21Aug2021; bnt162b2 (BNT162B2), dose 3 on 21Aug2021; This is a solicited report based on the information received by Pfizer (Mfr. Control Number: 21K-163-4054978-00) from a non-contactable consumer (patient).  A 50-year-old female patient received bnt162b2 (BNT162B2), dose 3 intramuscular on 21Aug2021 (Batch/Lot number was not reported, at age of 50 years old) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 vaccination; risankizumab (SKYRIZI [RISANKIZUMAB]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 28Jun2021, at unspecified dose for moderate to severe chronic plaque. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Aug2021, the patient experienced tested positive for COVID. The action taken in response to the events for risankizumab was temporarily withdrawn on 28Jun2021. The outcome of events drug ineffective and COVID-19 was not recovered. Causality for bnt162b2: The reporter's causality for the event COVID-19 virus test positive was unrelated.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relation the events of Drug ineffective, COVID-19, off label use and extra dose administered are related to the suspect product of BNT162B2