chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a Moderna booster shot of 0.5ml (not 0.25ml); received a Moderna booster shot of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml). On 29-Oct-2021, INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case concerns a 50-year-old, female patient, with no known medical history, who experienced the non-serious events of incorrect dose administered and accidental overdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was given 0.5ml of Moderna vaccine instead of 0.25ml for booster dose. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50-year-old, female patient, with no known medical history, who experienced the non-serious events of incorrect dose administered and accidental overdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was given 0.5ml of Moderna vaccine instead of 0.25ml for booster dose. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (resolved), tingling in lips (resolved), numbness left side of face (continuing)
Extreme fatigue, extreme body aches, fever (102.5-100.5) and chills (the shaking from chills was not a good match with the body aches), intense headaches when coughing or bending over, delirious night. I have gone through 4 childbirths and this was worse! It has been almost 48 hours since the side effects began and I am only now starting to feel a bit better.
sz-1wk post vax (possible febrile sz);pt seen @ hosp;
Sudden chest pain with exercise - exercise daily and never had this before.  Pain increased in intensity with exercise for over a week.  Stopped exercise when pain appeared. Pain subsided within  30 - 45 minutes after stopping.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies Sesame" (unspecified if ongoing), notes: known allergies: Sesame; "known allergies seafood" (unspecified if ongoing), notes: known allergies: seafood. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound testing positive COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as Yes. Anti-viral details was reported as Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24Dec2022, Treatment stop date: 28Dec2022, Indication: Treatment of COVID-19.  Other medication in 2weeks product: Advil, Other medication in 2weeks product: Daquil, Other medication in 2weeks brand: Lexapro  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT HAD COVID-19 VACCINE ON Dose 1 date: 01/13/2021,   Dose 2 date: 02/04/2021, AND TESTED POSITIVE TO COVID-19 9/2/2021
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 15-JUL-2016, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose, dose number, strength, lot#, expiry date were not reported). No adverse reactions reported. Additional information has been requested.
Transferred to emergency dept with chest tightness, itching, resp 24-28 - acute shortness breath and pruritus Rx with BENADRYL and prednisone released from ED.
Extremely dry mouth with mild light headed within 30 minutes, arm soreness and moderate nausea after 6 hours, moderate vomiting  11 hours after receiving vaccine.  Still moderately nauseous 20 hours post vaccine admin.
Flu-like symptoms: chills, feeling feverish (though with no temperature), fatigue, body aches. GI bleeding (blood in stool) occurred one morning but then ceased
Brain fog, blacking out, memory loss, confusion, and lightheadedness. Doctor blamed fatigue, but it definitely seems like something way more serious, especially being that I get 8 + hours of sleep every night.
Severe chills, pain in skull/cranium, lower back ache, dry heaves, loss of appetite,  very tired.
Arm swollen, red, and hot, in deltoid area. Arm was also sore to touch. Started on KEFLEX.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Hives to both arms and hands, edema (facial), increased respiratory rate, fever, chills, muscle aches and pains, malaise, localized pain
2 days after I received my second dose of the vaccine I started getting a loud ringing in my ears, a severe pain in my right ear that is still vert painful, sudden loss of hearing in my right ear.
No adverse effects; the patient received a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions was provided.      On 28-JUL-2019, the patient was vaccinated for prophylaxis with varicella virus vaccine live (oka/merck) (VARIVAX) one dose, intramuscularly, (lot # S002084 and expiration date: 21-JAN-2021) (anatomical location site of administration were not provided) (incorrect route of product administration) and sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported). No adverse effects were reported.
Did not notice on VIS form that patient had answered YES to receiving Monoclonal Antibodies in last 90 days before administering vaccine.  Confirmed that patient had received Remdesivir during hospital stay in December 2021.
My daughter was exposed to Corona virus the day after the vaccine; she was tested and today they called that she is positive; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter) that: A unspecified age of female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 12Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient exposed to corona virus day after the COVID vaccine, experienced COVID symptoms and she is tested COVID-19 virus positive. Reporter stated, "My husband, myself and my daughter all received our first dose of Pfizer vaccine (unspecified vaccine) last Friday (12Mar2021), my daughter was exposed to Corona virus the day after the vaccine and she tested positive suspiciously today so her second dose is supposed to occur on 02Apr as well as my husband and I too, does she have to wait what is the protocol for that situation. On paraphrasing concern: reporter stated, "No she was exposed the next day and then she came down with symptoms on Wednesday of this week and she was tested and they called that she is positive, yes, I wanted to know if her scheduled dose that scheduled for 02Apr, if she can go or if she has to wait and how does I that affect my husband I as we live in the same house do we have to get tested before we receive our second dose? What is the protocol for that situation?" Reporter was informed about Pfizer medical information department. Reporter stated, "That's what they said when they transferred me to and I have been on hold for an hour and half, I called the main number and explained the situation and they said they had to transfer me to a medical professional. "Reporter was informed about the role of Pfizer Drug safety as here we document the experiences of our consumer with Pfizer product and permission to probe: consumer stated, "What kind of questions do you have for me? What are your questions, not right now. "Call back was done to gather further information about LOT#, however it was unsuccessful. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. Product Complaint is there. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was received from a physician on 08 July 2008.  A 19-year-old female patient received an injection of MENACTRA (lot number, route of administration, and date of administration not reported).  Three days later, she experienced swelling of her face and throat, and "felt her throat would close".  She presented to the emergency room, and was admitted to the hospital for "a few days".  No additional information was available.
This spontaneous report as received from a certified medical assistant (C.M.A) and a nurse refers to a 12 months old patient (gender unknown). On 30-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot #J0009990; expiration date: 13-AUG-2015 (also reported as 12-AUG-2015), which was improperly exposed to 10F for 3 days, exposed to 16 degrees F for 120 hours and to 5-9.6F for 360 hours, subcutaneously. No known adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Pt inadvertently received extra dose (3rd dose) of Shingrix on 3/9/22
Admitted 8/22/2021 with Covid symptoms: runny nose, fatigue, new confusion or inability to be woken.  Onset of symptoms 8/18/2021. Not in ICU or intubated.  Submitter does not have access to further details or medical records.
Began with cramping/convulsing of my left thigh, then my right and within a split second all the muscles in my body were convulsing for about 3-5 minutes.  I had a headache and small tremors following that episode.  Tylenol helped but side effects did not dissipate until the following morning 3/11  at 10AM.  Fresh air helped also.
extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 16:15 at single dose for covid-19 immunization. Medical history included MS (multiple sclerosis); kidney disease. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included glatiramer acetate (COPAXONE) from 19Jan2021, escitalopram oxalate (LEXAPRO) and antihistamine, magnesium. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme weakness and an increase in her spasticity related to MS on 20Jan2021 12:00. Since the vaccination, the patient had not been tested for COVID-19.  The events were reported non-serious. Outcome of events were recovering. No treatment was received for the events.   Information on the lot/batch number has been requested.
fever  102- 103 for 6 days  aches chills sweating intermittent diarrhea   Take Tylenol and cold compress when fever high lots of fluids  Currently 7th day just aches and diarrhea
PATIENT HAS NOW TESTED POSITIVE FOR COVID 4 DAYS AFTER RECEIVING HIS JOHNSON & JOHNSON VACCINE AND IS HAVING A DIFFICULT CLINICAL COURSE THAT IS DEVELOPING A SARS-LIKE ILLNESS.
10/27/08 - Intussusception - reduced without surgery. Bilious emesis and lethargy. Abd X-ray - suggestive of obstruction. Therapeutic enema reduced intussusception on 10/27/08. 11/4/08-records received for DOS 10/27/08-prsented with C/O lethargy and emesis, yellow tinged emesis, congestion last stool 2 days ago.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA lot number reported as M043731 and expiry date: 22-MAY-2019 and lot number: N005274 with expiry date: 03-APR-2018) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. It was not reported if there was any previous temperature excursion for VAQTA. Data logger was involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:   US-009507513-1705USA012563: US-009507513-1705USA008387: US-009507513-1705USA012562:
PAIN, SWELLING, REDNESS AT INJECTION SITE THAT APPEARED THE NEXT DAY AFTER INJECTION AND WORSENED INITIALLY, BUT RESOLVED 2-3 DAYS LATER AFTER ADMINISTRATION OF DIPHENHYDRAMINE AND ACETAMINOPHEN.
ON 6-24-2021 PATIENT NOTICED SWELLING  AND WARMTH AT INJECTION SITE ON ARM. CALLED PHARMACY. SINCE IT WAS 5 DAYS POST INJECTION SHE WAS ADVISED TO CONTACT MD . MD WAS CONTACTED AND PATIENT ADVISED TO CONME IN FOR OFFICE VISIT. AFTER EXAM IT WAS DETERMINED TO BE CELLULITIS. AN ANTIBIOTIC WAS PRESCRIBED.
Moderna Covid-19 vaccine drawn up into individual syringes at about 745pm - 8pm on 3/24/2021, vaccine was administered to patient at 10:00 am  3/25/21, outside the recommended 6 hours after vial puncture. Vaccine remained in the refrigerator from the time drawn up to administration. Vaccine was inspected there was no particulate matter or discoloration prior to administration.
Face tingling, lightheadedness. History of childhood anaphylaxis with nuts, carries epi pen and benadryl. Sx onset within 15 minutes of first dose of pfizer vaccine administration.   Tx: recline in car seat, lower extremety elevation. Pt given 25mg PO diphenhydramine upon pt request. Approximately ten minutes later pt states facial tingling and lightheadedness subsiding. Pt then had son (vaccinated at same time) drive them home.
This case was reported by a healthcare professional, the wife of the subject, and described the occurrence of antigenemia in a 45-year-old male subject who was vaccinated with Engerix-B. The subject is a hemodialysis patient. Medical history, concurrent medical conditions and concurrent medication (other than Engerix-B) was not known. On 23 February 2006, the subject received the 1st dose (primary dose) of Engerix-B (40 mcg, unknown). On 1 April 2006, the subject received a 2nd dose (booster) of  Engerix-B (20 mcg, unknown). An unknown amount of the time after receiving the booster dose of Engerix-B, the subject experienced antigenemia. A titer for the antibody to be hepatitis B surface antigen was performed following the administration of the 2nd Engerix-B dose and was positive. The reporting nurse stated that "the dialysis center should not have done blood work for his hep B status until he finished the series". At the time of reporting the events were unresolved.
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 67-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Extreme tiredness & fever of 100.9 degrees fahrenheit 24 hours after vaccine
Papular rash esp. on trunk, one small pastule on hand. Onset of rash 10/22/14, while playing outside. Itches.
Productive cough. Shortness of breath, worse with exercise and labor. Went to 2 different doctors. 1st doctor prescribed Albuterol which I learned I am allergic to.  70%resolved.
Four days afterwards, started feeling a pulling pain in my left armpit and over the next 24 hours it got worse and bigger and more painful. I took 800 mg of Ibuprofen and I needed to take it every four hours and when I treated with this it was bearable. I did it for about 4 days or so and it began to get better. Took medicine (Ibuprofen) a week though until it was better and not painful. Slowly went away. Dr was consulted for the treatment with the ibuprofen and heating pad.
CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills and tiredness was not reported. This report was non-serious.
Got the shot on April 3 and then on the 5April started to feel like i was coming down with a cold, anyway i ended up with a upper respiratory infection after going to the doctor. Doctor gave me something to help with the coughing at night. Been taking mucinex also. Even after taking all the medicines i still am not better after 12 days but slowly getting over it. I am sure it is from the shot as i have been very careful and not been going anywhere and always wear a MASK
1 day after vaccine, (L) arm started hurting -> in the morning there was swelling & redness. Here in clinic (2 days after shot) circumference of (L) arm was 22 cm & (R) arm was 18 cm. Large area of redness & swelling, nontender.
Patient said that on Sunday she had noticed a small rash around the injection site, She said it was slightly itchy and she had iced it. By today, when she had called, it had progressed to the size of a 1 cup measuring spoon. She said she did not have a rash elsewhere and did not experience any swelling or shortness of breath.
fatigue; The pain was not strong; malaise; This is a spontaneous report from a non-contactable consumer or other non-hcp. A adult patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization; 6 hours after first inoculation the patient experienced strong pain at the inoculation site. On an unspecified date the patient experienced with second inoculation the pain was not strong, but malaise and fatigue developed the next day. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319946 Same reporter, patient different dose.
Within the week after receiving 2nd vaccine right ankle/foot swollen, a few days later left leg below the knee to foot swollen. Both lasted about five days, had chills and very fatigued. All symptoms subsided after three weeks. Use warm compress and ice paks. treated my self at home.
I took 2 at at home rapid COVID-19 test and they were negative. I went to the Dr. and Tested positive for COVID-19 on 04/08/2022. At first my throat was very sore or my thyroids were inflamed. Then, I got really bad hives that went all over my body for the next 5 days. I had a fever of 101, and some nasal drip. This lasted for about 9 days total.
Patient reported not having been vaccinated against COVID-19 in the past, and was vaccinated. Upon data entry the next day, it was discovered that patient had already received 2 doses of Janssen COVID-19 vaccine - one on 5/6/21 and one on 11/18/21. No adverse events known as of 12/16/21, but a third dose of Janssen is not recommended or approved by CDC.
15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored.  Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED
Woke up extremely cold, but skin hot to touch, body very stiff and headache. these continued for several hours.  Also was very tired, so took a long nap.  Late afternoon, all but headache was totally gone, headache as gone by the next day.
pt recvd vax; pt exp fatigue & muscle pain followed by arthralgia & nodules on the finger joints; lab tests revealed elevated sedimentation;
10/22/19 PT Presented small erythema + warm @ shot area. RX for Cephalexin 7.5mL 10/23/19 F/U for Cellulitis 10/24/19 F/U for Cellulitis Resolved
Covid monitoring documentation. PT admitted 12/7/21 documented to have positive covid. PT received Moderna 4/8/21 Lot 040B21A for dose 1. Dose 2 was Moderna given on 5/6/21 Lot 048B21A.