chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 15 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
(L) upper arm with general erythema, 6" x 4" site, and crushed lesion at puncture site, also experienced chills.
No additional adverse event; expired vaccine PROQUAD was administered; This non-valid spontaneous report refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2021, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 ml, lot # T015598, expiration date reported as 26-JAN-2021, but upon internal review astablished as 02-NOV-2021 (formulation, strength, frequency, route of administration were not reported). for prophylaxis. No adverse event was reported.  The report is non-valid due to lack of patient's identifiers.
After 24 hours of having the shot I got an uncomfortable pain in my right shoulder blade which traveled to my left arm and into my chest. I called the Dr. and explained what was happening and they told me to get to the emergency room. They gave a injection of predinisone. They released me to go home. Within 24 hours it all started over again. I went to the emeegency room at Hospital Center. They wanted me to follow-up with a nuerosurgeon.
Peeling hands and feet; Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet; Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other hcp). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 at 15:30 (Lot number: FF2593) at the age of 72 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "CREST syndrome" (unspecified if ongoing), notes: Forme fruste CREST syndrome and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: PLAQUENIL; TEMAZEPAM and ATIVAN. Past drug history included: Mint oil, reaction: "Drug allergy", notes: known allergies: mint oil. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318; Anatomical site: left arm; Route of administration: unspecified; Administration time: 11:30), administration date: 05Feb2021, when the patient was 71 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6198; Anatomical site: right arm; Route of administration: unspecified; Administration time: 11:30), administration date: 26Feb2021, when the patient was 71 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 at 15:30, outcome "unknown", described as "Dose received: 3"; SKIN EXFOLIATION (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Peeling hands and feet"; HYPOAESTHESIA (non-serious), BURNING SENSATION (non-serious) all with onset 17Nov2021, outcome "not recovered", and all described as "Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet". The events "Peeling hands and feet" and "Numbness and slight burning feeling in hands and feet. These sensations come and go, but seem to be worse lately in that the numbness/burning sensation is in my lower legs, not just my feet" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of skin exfoliation, hypoaesthesia and burning sensation.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Felt like Flu; freezing; sweating; weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like Flu), FEELING COLD (freezing), HYPERHIDROSIS (sweating) and ASTHENIA (weakness) in a female patient of an unknown age 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 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 INFLUENZA LIKE ILLNESS (Felt like Flu), FEELING COLD (freezing), HYPERHIDROSIS (sweating) and ASTHENIA (weakness). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like Flu), FEELING COLD (freezing), HYPERHIDROSIS (sweating) and ASTHENIA (weakness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No Treatment medications were provided. No Concomitant medications were reported.
Initial information has been received from a consumer concerning her daughter, a 1 year old female patient. The patient's medical history included high fever, listlessness, lethargy and abnormal restlessness after receiving multiple unspecified vaccinations according to the recommended dosing schedule, for her 2 and 4 month visits (unspecified dates in 2014). Concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), oral for "booster" (dose, dose number, lot number and expiration date were unspecified). The mother stated that, on an unknown date in August 2015, the patient experienced again high fever (pyrexia), abnormal restlessness, lethargy and listlessness. The outcome of the events was reported as recovering/resolving. The reporter considered that the events were caused by rotavirus vaccine, live, oral, pentavalent (manufacturer unknown). Additional information is not expected because the reporter details were not provided.
red arm; zone had fever; fever; red area at the injection site; tingling on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site). At the time of the report, PYREXIA (fever) and INJECTION SITE ERYTHEMA (red area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a female consumer reporting on herself, of unknown age. Medical history and concurrent conditions were not reported. On 30-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). The patient reported that she developed unspecified adverse reactions after receiving ZOSTAVAX. The outcome of the event was unkonwn. Causality was not reported. Additional information is not expected.
Fever for 2 days following first dose of RZV; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter reported adverse event from first dose to second dose specifically fever for 2 days following first dose of RZV.  The reporter asked were there any studies that provide data on adverse events from febrile fever reaction after receiving the first dose. Upon clarification regarding whether this was an adverse event or not given the form said "Confirmed no adverse event reported. The reporter confirmed and stated via email back, "The HCP said there was no adverse event.  The HCP question was based on a patient he administered RZV and had this reaction, however he explicitly said there was no adverse event when asked. This question was submitted by reporter and email was sent for clarifying information. The reporter did not consent to follow-up.
Patient called vaccine "ask a nurse" line and described having severe posterior neck pain and a severe headache 3 weeks after receiving the J&J vaccine. She was advised to go the nearest ED for further evaluation and said that her husband would drive her.
Administered a 5 days expired vaccine to patient. Patient left Clinic without any complain of any signs or symptoms. Contacted patient same day after found out patient was given an expired vaccine.  Informed and apologize of the adverse event of giving her the expired vaccine. Patient report doing fine with no concerns. Scheduled per CDC guideline to return to Clinic to re-vaccinate for her second dose of Varicella. Patient agreed with plan.
sore and spasms in muscles; the sore spread to include the shoulder blade; Sore/ the sore has now spread across; my left shoulder sore; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (sore and spasms in muscles), MUSCULOSKELETAL PAIN (the sore spread to include the shoulder blade), MYALGIA (Sore/ the sore has now spread across) and ARTHRALGIA (my left shoulder sore) 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.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In January 2022, the patient experienced MUSCLE SPASMS (sore and spasms in muscles), MUSCULOSKELETAL PAIN (the sore spread to include the shoulder blade), MYALGIA (Sore/ the sore has now spread across) and ARTHRALGIA (my left shoulder sore). At the time of the report, MUSCLE SPASMS (sore and spasms in muscles), MUSCULOSKELETAL PAIN (the sore spread to include the shoulder blade), MYALGIA (Sore/ the sore has now spread across) and ARTHRALGIA (my left shoulder sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The patient questioned if it was normal to have sore and spasms in muscles after the booster shot. Patient got the booster shot one week ago. The first two days left shoulder was sore. The second day it spread to include the shoulder blade. After several days it had now spread across.
Minor headache, body aches, chills, low grade fever, tiredness, sore arm from injection site down to my forearm, joint pain,  and elevated heart rate (110-125 pulse rate).
Vomiting; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Initial report received from healthcare professional on 24 September 2014. Follow-up information received from the pharmacist on 03 February 2015 provided the information that the patient was hospitalized; as a result, the case has been upgraded to serious. A 92-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5016AA, intramuscular and anatomical site of administration was not reported) having expiry date 29 March 2015 on 10 September 2014. It was reported that on 10 September 2014, on the same day after receiving FLUZONE HD vaccine, the patient experienced head congestion and cough. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Follow-up information for this unsolicited report was received from the pharmacist on 03 February 2015. The vaccine was administered in the left deltoid; no previous vaccines were given in 2014. According to the reporter, the patient was hospitalized for 2 days, and the event fully recovered. The event has been upgraded to serious. Documents held by sender: none.
Information has been received on 09/20/01 from a licensed visiting nurse concerning her 6 year old son who "about three years ago" was vaccinated with a dose of varicella virus vaccine live (site unknown). On 09/20/01, it was reported that he "now" has varicella-like lesions. The pt sought unspecified medical attention. FOLLOW-UP information recorded on 11/18/01 reported that the pt did not have chicken pox. It was reported that they were unable to determine what the pt had "but the clusters were too close together to be chicken pox. It was also reported that the pt's sister (WAES01092344) developed similar symptoms. No further information is expected.
Chills, body aches, joint pain, head ache, soreness in chest and back, congestion/runny nose, productive cough.  This is going on day 3
Vivid red itchy rash over whole body beginning on day 5 following injection. Has not gone away; Extreme fatigue; Low grade fevers; Chills; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN); on an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 22:00, the patient experienced extreme fatigue, low grade fevers and chills. On 17Apr2021, day 5 following injection, the patient experienced vivid red itchy rash over whole body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID. On 07Apr2021, the patient underwent Sars Cov-2 test (test type: Nasal Swab) and result was negative. The clinical outcome of the events extreme fatigue, low grade fevers, chills and vivid red itchy rash over whole body were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received all the vaccines due at the four month visit. As soon as we got home he slept a lot, when he woke up he cried a lot, kept banging his head and we noticed that from a very chatty baby he was completely silent. I inquired about the type of vaccines he received and all I received was the name but not the manufacturer or other information. His doctor knows about the side effects and we stopped vaccinating since we don?t know what or which vaccine affected him.
faint rash on chest, traveled to arms, lt face, chest hurting, runny nose;s/sx occurred day p/vax;
Patient came to ED at 1600 with right upper lip swelling and finger swelling after getting covid vaccine earlier. Angioedema of lips, initial encounter; History of allergic reaction; Lip swelling; Vaccination side effects, initial encounter. Pt has history of rheumatoid arthritis. Was treated & discharged home on 1/12/21
This spontaneous report as received from a nurse practitioner refers to a 16 years old male patient with no pertinent medical history or drug reaction and allergy. The patient was vaccinated with first dose of GARDASIL (lot number not reported) on 18-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-SEP-2012(reported as "five days after the vaccination") the patient experienced generalized hives. The patient had taken an office visit for medical attention and was treated with unspecified dose of BENADRYL. On an unspecified date, the patient was recovered. Additional information is not expected.
Day 1-after Covid 19-Moderna injection-employee experienced an extreme pounding headache, her blood pressure was elevated 161/93. Evening hours employee reported fatigue, rash to chest/back no itching, along with fever 102F  Day 2-Employee continued with fever 100.2 F and rash to chest/back no itching-taking Motrin and Tylenol  Day 3-No fever, no rash, pain to injection site and generalized body aches Day 4-No symptoms
Noticed heart palpitations on the day after vaccine (about 24 hours later). Don't remember noticing on day of vaccination.
not immune to RUBELLA; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis.  The patient wanted to know if she could get just the rubella vaccine. She refused to answer any questions regarding why just the rubella vaccine was needed. She stated that she was immune to the mumps and measles but not rubella (onset date was not provided) so needing a booster vaccine. The outcome of the event was unknown. The causality assessment between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
pt recv vax 16OCT96 & upon arising yesterday morning 17OCT96 noticed rt arm hurting & red around site;18OCT96 pt came to clinic;shot iste very warm, red area 40mm in width & length around site;instructed not to take flu shot again;
Onset of rash/hives, pruritus 2 hours, post vax. Rash on arms, chest and back. Was given Benadryl. Itching continued. Hives dissipated by time of doctor visit. Approx. 15:00, red blotches on arms. Injection site 2"-3" erythema, pruritic, no swelling. T-95; R-14; lungs-CTA; AHR-82; BP 98/62; 124 lbs. No resp. difficulties. Decadron given IM and Claritin po in office, then prn every 12 hours. Dx: dermal reaction.
received an expired dose as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) in a 66-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 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not reported.    This case was linked to MOD-2021-365005 (Patient Link).
Half dollar sized hive with itching at site of Covid 19 booster injection. Fatigue and mild body aches.
Patient had syncope episode 5 minutes after shot was given.  Did not hit head .,  Regained consciousness after less than 1 minute