chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 10th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
Apprx one week after vaccination, a red, itchy, mildly swollen area appeared at injection site.  About 2 inches in diameter.
Prescription from Vivotif Berna given to patient on August 3, 2004. After filling prescription, patient called on 08/19/04, stating she took 2nd pill on 08/06/04 and developed yellow/orange stools, fatigue, abdominal cramping but no fever. On 08/31/04, all symptoms resolved, after possible treatment from doctor.
Dizziness started about 6 hours later; Nausea; Post-nausea headache; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included complex regional pain syndrome/reflex sympathetic dystrophy (CRPS/RSD), COVID-19 and allergy to penicillin and sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 19Apr2021 at 16:00, about 6 hours after the vaccination, the patient experienced dizziness which increased in intensity and led to nausea and post-nausea headache. Dizziness was yet to subside and the patient was 28 hours in. The patient also experienced soreness at the injection site, as expected. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness started about 6 hours later, nausea, post-nausea headache and soreness at the injection site were not resolved at the time this report.  No follow-up attempts are needed. No further information is expected.
Severe vertigo; This is a spontaneous report from a contactable Consumer (patient). A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2 Solution for injection, Lot number:En6201, Expiration date: 03May2021), via an unspecified route of administration, administered in left arm on 05Mar2021 14:30 (age at time of vaccination 56 years) as 1 st dose single for covid-19 immunisation. Medical history included addison's disease, ankylosing spondylitis, type 2 diabetes mellitus, Decalvans, knee arthroplasty had 2 knee replacements, and Known allergies present. No other vaccine in four weeks. No covid prior vaccination. She did not tested covid post vaccination. Concomitant medications included hydrocortisone (CORTEF [HYDROCORTISONE]), metoprolol tartrate (LOPRESSOR), empagliflozin (JARDIANCE); venlafaxine hydrochloride (EFFEXOR) and Not enough (as reported).  On 07Mar2021 18:00, the patient experienced Severe vertigo 3 days after 1st dose. Spouse had same incident 5 days after her 1st dose. the patient received treatment with Meclizine. The outcome of the event is recovering.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277098 same reporter/drug/event, different patient
Patient is fully vaccinated.  COVID + 1/10/2022 at hospitalization. The patient states that he has had symptoms for the past few days with worsening shortness of breath.  He states that they tested his oxygen level with a pulse ox and was reported to be 89%. The patient denies any chest pain.  No nausea, vomiting, diarrhea.  Though, he does have some shortness of breath and cough. Elevated D dimer.  CT negative for PE. CXR: There is no radiographic evidence of acute cardiopulmonary disease within the limits of this single view obtained. Medications steriods, albuterol, asprin. Discharged home.
TIREDNESS; FEVER; SORE AT INJECTION SITE; This spontaneous report received from a patient via a Social media post concerned a male 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, batch number: Unk) dose was not reported, administered on APR-2021 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 APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, fever and sore at injection site was not reported. This report was non-serious.
received 1st dose while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant). On 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (received 1st dose while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.; Sender's Comments: This is a case of maternal exposure during pregnancy of a 27 year old Female with no associated AEs. Patient will continue to be contacted for further monitoring.
The vaccine was given at another office. I'm not actually sure what specific flu vaccine he received.  He developed swelling of entire R upper arm, it is warm to touch and has some splotchy pink macules and patches. The R arm is notably swollen and skin is taut from from shoulder to just below/distal from elbow.  He has full ROM of R elbow and normal perfusion to R forearm and hand Treated today with dexamethasone, mom was already giving ibuprofen and benadryl
pt recv vax 16JAN97 & approx 10hr post vax pt devel swelling & erythema of hands & feet, tingling in arms, h/a, n/v;presented to MD;VS nl @ that time;
Redness, pain and swelling at injection site initially. The redness spread down onto my bicep and to the inside of my arm within 24 hours. It is painful to touch and is hot. I did not have this reaction when I got the first shot, although my arm was very painful for about three days. This is the 4th day after the second shot. I have not visited my doctor about this as I do not think it is serious. I am reporting it only because it seems to be an unusual reaction to have after the second shot.
our son has a heart murmur that was not there before; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Jun2021 14:30 (Lot number: EW0198) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 14:30, Anatomical site of injection: Right deltoid, Route of administration: Intramuscular , Lot number: EW0187), administration date: 30May2021, for COVID-19 Immunization. The following information was reported: CARDIAC MURMUR (non-serious) with onset 25Aug2021, outcome "not recovered", described as "our son has a heart murmur that was not there before". The event "our son has a heart murmur that was not there before" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cardiac murmur.  Additional information: No other vaccine in four weeks. No Other medications in two weeks. No treatment ae. No covid prior vaccination. No Known allergies. No other medical history. No Prior vaccination. Relevant test was none. Has a cardiology appointment later this months.  No follow-up attempts are possible. No further information is expected.
a herpes outbreak and it is in an area where she has had outbreaks before; This spontaneous case was reported by a nurse and describes the occurrence of HERPES VIRUS INFECTION (a herpes outbreak and it is in an area where she has had outbreaks before) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight and Herpes NOS (The patient has had herpes since the 1980s but it has been a long time since she had an outbreak.) since 1980.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (a herpes outbreak and it is in an area where she has had outbreaks before). At the time of the report, HERPES VIRUS INFECTION (a herpes outbreak and it is in an area where she has had outbreaks before) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. The patient already had developed human papilloma viral infection (concurrent condition) prior to GARDASIL. Information on medical history, drug reactions/allergies and concomitant medications were not reported. The patient stated that she was vaccinated with first two doses of GARDASIL injection, unidentified Merck HPV vaccine administered (name and lot number not provided) (dose, route of administration, and expiry date were not reported) for prophylaxis in 2012 and received her last dose in 2016 (inappropriate schedule of drug administration). It was also reported that it could not be confirmed if the patient received GARDASIL 9 unidentified Merck HPV vaccine administered (name and lot number not provided) or GARDASIL unidentified Merck HPV vaccine administered (name and lot number not provided). No adverse effect was reported. No further adverse event information was provided. There was no product quality complaint (PQC) reported.
pt recv vax 5MAY97 & 19MAY97 pt devel a severe case of chickenpox consisting of over 1000 lesions;
HEADACHE; VOMITING; CHILLS; NAUSEA; STINGING AT INJECTION SITE; This spontaneous report received from a consumer concerned a female 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, batch number: Unk) dose was not reported, administered on 11-MAR-2021 04:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced stinging at injection site. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021 08:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging at injection site, vomiting, chills, and nausea on 12-MAR-2021, and had not recovered from headache. This report was non-serious.
Feels like the head is swelling; Couldn't sleep on her left side; Feeling nauseated; Headache; Pain/pulling on the left side of my neck, giving me discomfort; Left arm stiff ,seems to be spreading to the right side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side) and NAUSEA (Feeling nauseated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Stomach discomfort. Concomitant products included LOSARTAN and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy (Heating pad) for Musculoskeletal stiffness. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This case concerns a 75-year-old female with a non-serious unexpected events of musculoskeletal discomfort, musculoskeletal stiffness, head discomfort, sleep disorder and non-serious unexpected nausea and headache. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on 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.
Patient presented to the ED and was subsequently hospitalized for GI hemorrhage within 6 weeks of receiving COVID vaccination.
Patient got pale and fainted within a few minutes of receiving the vaccine.  She was feeling well after sitting for approximately 20 minutes with a cool, wet towel around neck.  No additional treatment was needed at this time
Patient presented to pharmacy day after receiving vaccination with redness/swelling about the size of the palm of a hand 6 inches below vaccination site. Rash was slightly warm to touch. Patient reported it was itchy at first but know felt a bit painful took her to see MD, where temperature and BP was normal. MD said he was not sure 100% that it was cellulitis, but treated empirically with cephalexin just to make sure all bases were covered. Followed up with patient 3 days later --> she is fine & rash is going away.
I started to get daily headaches. They slowly started to last 24/7. I was trying Motrin, and aspirin to relieve the pain. It helped, but never fully. I was given meloxicam, which is similar to aspirin. I am having a sensitivity to gluten and was told to put Cromolyn in my water, which minimizes adverse reactions to anything I'm sensitive to. As of today, I am still experiencing the headaches. I am going to try and get a CT scan of my head and have blood work done. I had an extensive neurological exam completed on 11/19/2021. The results came back normal.
I had the regular flu shot and the nurse seemed to inject me way higher than normal (I have pictures of mark). I?ve had the flue shot and Covid shots many times but this one hurt upon injection and then an hour or two later my entire arm/shoulder became incredibly stiff and painful. The major stiffness/pain lasted about 48-72 hours. Since then there has been dull pain and stiffness and noticeable weakness now for 2.5 months and not healing. I?ve had many shots in my past and have never experienced anything remotely close to this. My arm and shoulder were also 100% healthy before shot.
During mass flu clinic for adults and children an unspecified person gave "Fluarix" to a child meant for adults 18 year old and older by mistake. No known adverse events. No adverse events occured.
Within an hour of the shot in my non-dominant arm, I started to feel unusually sore. By 8 p.m. in the evening, I started to get the chills and by 9 p.m., my entire body was aching painfully. By 10 p.m., I was trembling from the chills, could barely move from the aches, and started to get dizzy. I went to bed immediately. The next day, I still felt somewhat achy, but it felt like the pain from the shot was more localized in my left shoulder and the left side of my jaw. The chills were mostly gone. I took two doses of advil (two capsules each time) during the day.  By the evening of day 2 (~36 hours after the shot), I still felt very tired and the aches were starting to come back in my left shoulder and lower back. The exhaustion continues.
CLIENT CAME IN WITH COMPLAINTS OF PAIN, REDNESS, AND AREA BEING HOT TO TOUCH. CLIENT RECEIVED THE VACCINE ON 10-7-19, CLIENT REPORTED TO EMPLOYEE HEALTH ON 10-9-19. CLIENT SENT TO CLINIC (THE WORKPLACE) FOR FURTHER EVALUATION.
was administered liquid portion not reconstituted with powder; was administered liquid portion not reconstituted with powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 2459K, expiry date 27th May 2023) for prophylaxis.   On 13th May 2022, the patient received the 1st dose of Shingrix. On 13th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-May-2022 Reporter's comment: Medical Assistant reported that the patient was administered the liquid diluent portion of Shingrix vaccine.   The liquid was not reconstituted with the powder portion of Shingrix.  This was the patient's first dose in the series.   The adjuvant was administered from lot number 2459K (expiration date 27May2023).   At the time of reporting, repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient was administered the liquid diluent portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt was ill. fell and hit face.  was disoriented.  when presented to er had progound metabolic acidoses, hyperkalemia and severe renal failure just like 3 other H1N1 and flu vac cases this winter.
A red, warm, hard 9 cm spot that  formed around the injection site.  Started on clindamycin for cellulitis.
gave second dose at day 11; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.