chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications was reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the second of 27 adult patients described by the reporter.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected, as no further information was available.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:40 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 66.81 for dose administered on 13-Feb-2021 and 66.90 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 37 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
ADULT CLIENT ON PEDIATRIC CONSENT. ACCORDING TO INFORMATION PREPRINTED ON CONSENT HE RECEIVED A PEDIATRIC LOT NUMBER AND DOSE
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient received the 0.2ml dose of Pfizer COVID vaccine (orange cap) instead of the 0.3ml dose of Pfizer COVID vaccine (purple cap). No adverse effects noted. Message left on guardian's phone.
Pt received 1st dose Moderna on 3/14/21, then received 2nd dose Moderna on 4/5/21 which was only a 22 day interval
Shortness of Breath, Tight Chest, Coughing & Wheezing Treatment: Prednisone Shot and 3 breathing treatments Elapsed Time: 3 hours
Information has been received from a medical assistant concerning a 4 month old patient with unknown gender. No relevant medical condition or concomitant medication was reported. On 11-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dose unknown) (route: intramuscular; Lot# and expiration date were unknown) in error. No adverse effect was reported. Additional information has been requested.
Body ache; Chills that wont stop,; Fever; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:45 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. The patient previously took sulfas (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 23:00, the patient experienced chills that would not stop, fever and  body ache. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen. The clinical outcome of the events of chills, fever and general body pain were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
missing a period after the vaccine; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (missing a period after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (missing a period after the vaccine). At the time of the report, MENSTRUATION IRREGULAR (missing a period after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Vaccine Administration Error- Patient requested Pfizer for her COVID booster, but received Moderna by accident instead. No adverse reaction. Patient concerns were addressed.
Headache, burning in left arm, swelling in left armpit and side along ribcage and left breast (no noticeable lumps), fatigue
pt recv vax & pt devel chickenpox rash 3wk post inj;
Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.
A day after flu vaccine pt noticed a rash at injection site.  She is doing ok and I instructed her to call md if symptoms gets any worse today or tomorrow.
pt recvd vax;fever 101.6, chills, n w/out v/d;HA;sxs lasted until next day;tx:apap & Motrin given;
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 10-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX lot # K020187, expiration date 27-JAN-2016 (dose and route unknown), which was improperly stored. There is no adverse event reported. Additional information has been requested.
MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; SORE ARM; FATIGUE; FEVER; HEADACHE; MUSCLE PAIN; This solicited pregnancy report received from a patient concerned a 29 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 61.22 kilograms, and height was not reported. The patient's concurrent conditions included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included docosahexaenoic acid. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced fever. On MAR-2021, the patient experienced headache. On MAR-2021, the patient experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 100.6. On 16-MAR-2021, the patient experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, muscle pain, sore arm, maternal exposure during pregnancy and fever was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, sore arm, fatigue, fever, headache, and muscle pain was related.  This report was non-serious.
c/o nausea shortly after taking her 2nd dose of vaccine.  denies headache, SOB, dizziness and other adverse reaction symptoms.   PMH includes pulmonary HTN, DM, and low saturation (hypoxia).  O2 PRN at home.  Allergy is shellfish and she had Epipen handy.  No hhives, itching or swelling of throat noted.  Pt. continuously look weak.  V/S.  BP 201/135, forearm 116/86.  manual 146/92.   BS 242mg/dl.   Ambulance was called with patient permission.  pt. transported to ED for futher evaluation.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
pt came into the office with symptoms of  left lower extremity swelling/edema.  Ultrasound was done that determined patient  is Positive for acute deep vein thrombosis of the left femoral and left popliteal veins.  Pt placed on Eliquis right away.
After 24 hours had symptoms of fever, severe body and joint aches, headache and basically had to stay in bed for a few days.  On day 3 after the shot had severe swelling and hot to touch at injection site.  On day 4 rash started and today (3/08/21) is day 10 and rash seems to be spreading to more of my arm. Tylenol was taken for fever and ice was applied to arm.
This spontaneous report as received from registered nurse refers to a female patient of unknown age (age reported as in her teen years). The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 24-OCT-2011 the patient was vaccinated with GARDASIL (route, dosage, lot# not reported). On 10-JUL-2012 the patient was vaccinated with third dose of GARDASIL which was administered at an unspecified county health department. No concomitant medications were reported. On an unknown date the patient diagnosed with encephalopathy (medically significant) after receiving her third dose of GARDASIL. It was unknown if the patient sought medical attention. The outcome of encephalopathy is unknown. It was also reported that legal issues involved-AE has sent to legal. Upon internal review the event encephalopathy was considered as serious due to medically significant. Additional information has been requested.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The patient experienced a headache (outcome unknown). Additional information: Patient stated, "I have had a headache ever since I got the second dose of Pfizer; so what do you recommend?" No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Pt inadvertently adm MMR IM instead of SC on 08NOV90; @ time of report, pt was asymptomatic;
Pimple like rash over abdomen at waist, upper back, on right side and over both thighs. Rash is very itchy. No drainage noted. She states she felt itching before rash erupted. She was seen at the occupational health center on 09/20/04 for evaluation. Advised to use Benadryl po and topical for treatment. The rash was completely healed by about the 8ht of October.
Erythema multiforme minor- rash on the face, thighs, abdomen and arms.
Complained of not feeling well, minutes later progressed to pallor, nausea, and vomiting, then developed purple fingers. Mom call EMS. EMG gave BENADRYL, systemic corticosteroid. By the time they arrived at ER then had a rash over her body. Admitted overnight for observation. Released the next day.
I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregular heartbeat. very tired most of the day. 3 days later I broke out in a rash on my arm below the injection site and around my arm.
tender raised rash with white blisters on left upper arm bellow injection area ,  apprx. 1 1/2 inch  wide x 1 inch high , no treatment at this time
Information has been received from a male concerning his 79 year old wife with osteoporosis and allergies (unspecified) and a history of transient ischemic attack ministroke who in August 2007, was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included PLAVIX and alendronate sodium. Subsequently, just the other day, the patient developed a rash or hives. It began on one side and spread to the other side. It appeared and disappeared, from one side to the other, then spread to the belly, then the small part of her back, under her breast, and now it was under her armpits. The doctor gave the patient steroids and ointment (unspecified), but she still has the rash or hives. The reporter stated that the patient's allergies have nothing related to this occurrence. The caller didn't think it was Shingles but he was unsure what it was. At the time of the report, the patient's rash or hives persisted. The patient sought medical attention with a physician office visit. No further information is available.
This spontaneous report as received from a pharmacist refers to an unknown number of  patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that as improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. IT was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 62 (also reported as 63) year old female patient. On 26-FEB-2013 the patient vaccinated subcutaneously in left arm with ZOSTAVAX (lot number H017447, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Approximately 10 days post vaccination-Pink Large itchy area on left arm at vaccine injection site, clients reports slight swollen, raised 5 inches in length. No other symptom presents. advised to follow up with PCP and report any worsening symptoms.
She got her vaccine, had an intense arm pain and feeling of fatigue for the first 24 hours, that was getting better gradually and then 48 hours was gone.  Then she started feeling more tired than normal and very quickly getting short of breath.  She dismissed this at first, but did not feel it was related to the vaccine and it has continued.  She told her husband and he is also experiencing the same thing, which he got the vaccine as well on 5/7/22.  She has not contacted her doctor for the symptoms as they are mild but are unpleasant.  She is a healthcare provider and in pretty good condition.  She was going to contact her person in charge of infectious disease where she works.
Patient fainted after given shot. Father said this has happened before last year after getting flu shot. Called 911 and the paramedics came but father declined services.
arm a little sore for about half a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm a little sore for about half a day) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm a little sore for about half a day). On 13-Feb-2021, VACCINATION SITE PAIN (arm a little sore for about half a day) had resolved.            No concomitant medications were reported.  No treatment information was provided.  Action taken with the product was not applicable.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Action taken updated as the patient took 2nd dose but had no events; 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.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.  Antibody testing completed.
Information has been received from a lawyer regarding a case in litigation concerning an adult female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In September 2015, at age 57, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Herpes zoster. The outcome of the herpes zoster is unknown. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.