chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient cannot sleep; feels uncomfortable; bumps on back arms / Bumps in the legs / bumps on chest; itching everywhere / Itches in the legs / itchiness out of control; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching everywhere / Itches in the legs / itchiness out of control), INSOMNIA (Patient cannot sleep), DISCOMFORT (feels uncomfortable) and RASH (bumps on back arms / Bumps in the legs / bumps on chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Major depression, Hypertension and Migraine. Concomitant products included LORAZEPAM, GABAPENTIN, METOPROLOL, LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced PRURITUS (itching everywhere / Itches in the legs / itchiness out of control) and RASH (bumps on back arms / Bumps in the legs / bumps on chest). On 22-Feb-2021, the patient experienced INSOMNIA (Patient cannot sleep) and DISCOMFORT (feels uncomfortable). At the time of the report, PRURITUS (itching everywhere / Itches in the legs / itchiness out of control), INSOMNIA (Patient cannot sleep), DISCOMFORT (feels uncomfortable) and RASH (bumps on back arms / Bumps in the legs / bumps on chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states that she doesn't know if she has chicken pox or a reaction to the vaccine. If she scratches them, they bleed.Apart from the bumps in the chest and arms, she is having itches and bumps in the legs and the itchiness is out of control, at the point that cannot sleep because feels uncomfortable.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains Significant information.Significant follow up appended to AER. Some events like discomfort, Insomnia were added
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 0.25ml of Bivalent booster instead of 0.5 ml).    Concomitant medication was not provided. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-Sep-2022 to 26-Oct-2022. Treatment information was not provided. This case is reported for 10th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494, US-MODERNATX, INC.-MOD-2022-665704 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665704:Same reporter US-MODERNATX, INC.-MOD-2022-665494:
Full body Hives started 2 days after receiving vaccine, doctor determined vaccine was the cause. Extremely itchy patches in all of the warm places on the body.  Was prescribed with an anti-itch pill and an antihistamine.
Intense vertigo; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 12:00 (Lot number: EN6207) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; CLARITINE; AMBIEN. Past drug history included: Codeine, reaction(s): "allergy". Vaccination history included: Bnt162b2 (administration time=12:00 PM, Dose number: 1, lot number=EN6203, brand=Pfizer), administration date: 09Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 01Apr2021 10:00, outcome "not recovered", described as "Intense vertigo"; PALPITATIONS (non-serious) with onset 01Apr2021 10:00, outcome "not recovered", described as "heart palpitations". The events "intense vertigo" and "heart palpitations" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of vertigo, palpitations. Additional information: The patient received the vaccine in the hospital. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccines within four weeks of the vaccination.   No follow-up attempts are possible. No further information is expected.
Extreme chills at 5:30 pm, fever about 11:30 pm, chills again at 9am on 8/28, fever at 11am 8/28. Arm extremely sore. Received 2 shots same arm. Redness at the site.
I wanted to inform you that I had a severe reaction to the second dose of Moderna that I received on Sat, Apr 17th. Throughout the night of the 17th I had the chills, headache, and bodyache. The next morning I blacked out, fell, and have a fractured shoulder. I am a petite woman, weighing 104 lbs. I do believe there is some correlation between that and the  side effects. I know of two other petite women who have had similar reactions. Luckily for them, they didnt break any bones. Please send this info back to Moderna ASAP.
On the day of vax, the pt developed hives. It was noted that the pt drank two beers that evening and he did not know if he developed the hives before or after drinking the beer. On 09/08/1999 the hives resolved.
Patient fainted approx 15-20 minutes after administration. Patient stated he has not eaten much and felt faint after seeing a small amount of blood on arm after administration.
SWOLLEN ARMPIT LYMPH NODE OF THE ARM I GOT SHOT IN; SORE ARMPIT LYMPH NODE OF THE ARM I GOT SHOT IN; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swollen armpit lymph node of the arm i got shot in. On 2021, the subject experienced sore armpit lymph node of the arm i got shot in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen armpit lymph node of the arm i got shot in and sore armpit lymph node of the arm i got shot in was not reported. This report was non-serious.
Patient in for Moderna booster 0.25ml dose. Nurse drew up and gave 0.02ml. Patient returned from waiting area and given full 0.25ml dose
Anaphylactic reaction; This is a spontaneous report from a contactable Nurse (patient). This is the second of two cases and refers to events occurred with the second dose of the vaccine.  A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL1283), on 11Jan2021 at 11:00 at single dose in Deltoid Left for COVID-19 immunization. Medical history included asthma, shellfish allergy, allergy lobster (used steroids). Patient was not pregnant.The patient's concomitant medications were not reported. Previously on 22Dec2020 at 12:30 PM patient took the first dose of the vaccine (Lot EJ1685) at single dose in Deltoid Left for COVID-19 immunization and couple of days after she had nausea and something stuck in her throat. On 11Jan2021, 5 minutes after the 2nd dose (at 11:05), the patient experienced anaphylactic reaction, that required Emergency room visit. Patient was not hospitalized and was treated with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLUMEDROL) and "Pepcid": she was prescribed 3-day course of oral prednisone and H2 antihistamine oral "Pepcid". After finished it, she felt it was coming back therefore she took diphenhydramine hydrochloride for 2 nights in a row. She did not experience any respiratory, cardiovascular, dermatological or gastrointestinal manifestation. She completely recovered in Jan2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anaphylactic reaction  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report concerning a patient of an unknown gender and age was received from a nurse. The patient's concurrent conditions and medical history were not provided. On 19-JUL-2016, the patient was inadvertently vaccinated with an expire dose (expired product administered) of PNEUMOVAX 23 lot # L001311, expiration date 06-JUL-2016 (strength, dose, and route were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Patient was given shots at 4 months old. Two hours later, he developed startle response which became more pronounced over the next few days. Admitted to hospital on 7/7/03.
Information has been received from a medical assistant referring to a 13 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 (intramuscular; dose was unknown). The reporter reported GARDASIL 9 with lot # 1043214 which was not valid for GARDASIL 9 or GARDASIL however lot # L043214 is valid for GARDASIL 9. The patient became very dizzy on the same day. He recovered after about 30 minutes and was fine on 03-AUG-2016 when they called to check on him. No treatment was given. No lab test was performed. The patient did not seek medical attention. The causality was not provided. Additional information has been requested.
Patient had a swollen red ring on arm which went towards the back of the arm.  Daughter told me she thought it looked like it was given sub-q in back of arm. She had doctor look at it.  They wanted me to report it to Vaers.  Patient came in today and showed me picture of reaction and I saw her arm today and it looks much better, but still has an irritated ring.
a patient received MMII vaccine via intramuscular route instead of subcutaneous route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 08-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (lot # T013725, expiration date 30-APR-2022, 1 dose) via intramuscular route instead of subcutaneous route for prophylaxis (incorrect route of product administration).
Patient is known to have sensitivity/allergic reactions to other medications/food/injections.   She had an EpiPen on hand at the time of the injection.   She is a nurse and is knowledgeable of her on health situation and medicines.   She had no problem with the first Moderna vaccine she had on 4/1/2021.   She sat in a chair for about 10-15 minutes after vaccination with the second dose of Moderna Covid 19.  She decided to get up and walk around the store and noticed after several minutes she started having breathing problems/heart rate increased.  She returned to the pharmacy and was observed for 20 minutes.   She did not want us to call 911.  She wanted to try to get through the reaction herself.   I offered to administer her EpiPen or told her I had Benadryl injectable too.   She wanted a dose of Benadryl and I gave her 50mg IM.   She continued to improve and walked out of the store at her own will.  Breathing and Heart rate slowed down.   I have reached out to her at home and she is doing much better.
p/vax pt T103; very fussy; over sensitive; nothing made pt happy; started twitching; lasted 20 minutes;
No actual reaction occurred.  The vial had a beyond use date 1 year after manufacture date of 10-2021, the dose was given on 10/2/2022, using the 10 week storage guideline after removal from the frozen state on 8/12/2022, which would have been 10/21/2022.
Vaccination site swelling; Vaccination site erythema; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), CHILLS (Chills) and HEADACHE (headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RAMIPRIL, METOPROLOL, ISOSORBIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, OXYBUTYNIN, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) and CLINDAMYCIN for an unknown indication.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), CHILLS (Chills) and HEADACHE (headache). On 04-Feb-2021, CHILLS (Chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            No treatment details were reported
3 hours after vaccine administration he noted onset of pain, burning and redness to upper left arm. 3 days later he went to the emergency room with worsening of left arm erythema.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications reported. Action taken with mRNA-1273 in response to events was not applicable.
Administered PREVNAR 13 IM to (L) deltoid followed by FLUZONE to (R) deltoid IM. Within 5 mins of administering meds-pt c/o (R) arm numbness. Had difficulty lifting arm up unable to squeeze with (R) hand. Also c/o (R) thigh numbness. BP increased 150/110, HR 134, BS 84, had difficulty with speech et responding, diaphoretic et confused. Squad arrived et symptoms except for (R) arm hemiplegia began to abate.
Approximately 20 minutes after receiving FLUMIST patient reported itching to right forearm. Quarter sized hives noted & c/o difficulty breathing shortness of breath, tightness in chest. No other area on body with hive. BENADRYL 50 mg given PO. Pt observed for 30 min and discharged from clinic to home.
swollen lymph nodes in my right armpit for the first vaccine swollen lymph nodes, fever, headache, achiness, lethargy for the second vaccine
This spontaneous report as received from a pharmacist via company representative refers to a 60 year old male patient. Pertinent medical history was not reported. Concomitant therapy was not reported. In 2014, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) for vaccination. Concomitant therapy was not reported. In 2014, the patient developed a sore arm, post vaccination with ZOSTAVAX. The soreness occurred at the injection site a few days after administration of the ZOSTAVAX (unspecified which arm). The soreness went away. The patient did not seek medical attention. Lab diagnostic studies were not reported. The outcome of the event was reported as recovered (2014). Additional information is not expected.
Rash on right shoulder, chest, and back. Afebrile and asymptomatic 2/20-2/23.  Digital photos examined by Infectious Disease Doctor.  Diagnosis is erythema multiforme.
FATIGUE; SLEEPING MORE THAN USUAL; This spontaneous report received from a consumer concerned an 86 year old male. 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: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced sleeping more than usual. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleeping more than usual, and fatigue on 11-APR-2021. This report was non-serious.
Moderna COVID-19 Vaccine EUA  Vaccinated Thursday 12/31/20 at 12:30pm Friday1/1/21 7:00AM- Nausea, fever 99.6-101.6, body aches, chills, fatigue, painful to use left arm, headache, racing heart beat, shortness of breath. Persisted all day.  Saturday 1/2/21 8:00AM-fatigue, headache, muscle pain in left arm.   Sunday 1/3/21 felt pretty normal all day, some fatigue, slight headache.  Monday 1/4/21 5:00AM- nausea, shortness of breath, racing heart beat, fever 99.8, fatigue, headache.  Monday 1/4/21 10:00AM- COVID test- negative
Child recieved Pentacel and Rotarix diluent mixed together orally.  None of the powder form was administered.  Patient is doing well.  Staff spoke to pt's mother of misadministration after we spoke to the CDC for guidance as to how to proceed.  Both Pentacel and Rotarix where then administered correctly per the information given to our staff by the CDC.  A separete incidenreport was filled out and sent to staff supervisor for further training and per our clinic's policy.
Allergic reaction. Severe redness and hives on chest crawling up neck. Swollen face and red eyes.
vaccinated pt admitted to inpatient facility with covid infection. No information on vaccine type, clinic, etc.
Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site). The patient was treated with NAPROXEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as: M024678 with expiration date: 08-MAY-2018, lot # reported as: M000997 with expiration date: 07-JAN-2018, lot # reported as: L044524 with expiration date: 09-NOV-2017 and lot # reported as: L043622 with expiration date: 03-NOV-2017 (doses and routes of administration were not reported) for prophylaxis. There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was any Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Lot numbers M024678, M000997, L044524 and L043622 are invalid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested. Sender's Comments: US-009507513-1611USA007720: MERCK 1611USA014218:Mfr number.
chills; body aches/malaise; body aches/malaise; headache; sore throat; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration in left arm on 06Jan2021 at a single dose for Covid-19 immunization. Medical history included asthma, thyroid nodule and known allergies to PCN (penicillin). Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. Patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via intramuscular in left arm on 16Dec2020 at 08:00 PM for Covid-19 immunization, and experienced chills, body aches/malaise, headache and sore throat on 17Dec2020 24hrs after the first dose of vaccine and also experienced diarrhea, nausea and loss of appetite on 18Dec2020 48hrs after the first dose of vaccine. In Jan2021 12hrs after the second dose of vaccine, the patient experienced chills, body aches/malaise, headache and sore throat. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
22:00: Infant was on changing table.  Had nursed well and seemed fine-no fever-suddenly became pale, limp, grunting noises, dyspnea, slight twitching.  No eye rollong, no post-ictal state, 911 called, infant recovered by time of arrival still pale.