chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 15-AUG-2022, second 22-AUG-2022; Every muscle in his body aches; He has  pain; feels foggy; lethargic; feels a little hot, fever; Headache; Sinus Pressure; feels a little hot; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 15-Aug-2022 Batch-ASKU).   On 22nd August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm. On 22nd August 2022, the patient experienced drug dose administration interval too short. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the myalgia, lethargy, headache and skin warm were not recovered/not resolved and the outcome of the pain, foggy feeling in head, fever and sinus pressure were recovering/resolving and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the myalgia, pain, foggy feeling in head, lethargy, fever, headache, sinus pressure and skin warm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR123585   Additional Information: GSK receipt date: 24-AUG-2022 Reporters comment: The patient received both doses at the same HCP site. The patient received the second dose and he stated that the side effects devastated to him Every muscle in his body aches, he has pain, feels foggy/lethargic, had a fever, headache, and sinus pressure. He sated he felt a little better today than yesterday, but he still felt a little hot, has a headache, and feels lethargic. He took 2 Advil, to alleviate his symptoms, but it has not helped. Reporter requested to end call before this writer was able to ask for consent to contact HCP or further information. The reporter consented to follow up. Additional Supportive information: The patient received second dose earlier than the recommended interval, which led to Drug dose administration interval too short; Sender's Comments:  US-GSK-US2022AMR123585:Same patient
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 61-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 09Oct2023 to 13Oct2023. Patient had No Known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333433 same patient, different drug/event;
blisters in the back of throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (blisters in the back of throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL BLISTERING (blisters in the back of throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL BLISTERING (blisters in the back of throat) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant and treatment information not provided.  Treatment information was not provided.  Company Comment: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second dose mRNA-1273. Event outcome 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.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of oropharyngeal blistering. Event onset 3 days after second dose mRNA-1273. Event outcome 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.
Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Left thigh swelling 5" x 4" redness and swelling. Treated with Keflex.
Patient proceeded to post vaccination area around 6:45pm. Patient complained of dizziness. Patient denied acute typical anaphylaxis symptoms and remained AAOx4. Patient escorted to post vaccination cot where he was instructed to lay in prone position. Patient complained of feeling sweaty, hot, chills, with involuntary upper body tremors. Heart rate 111, RR 22. Unable to obtain dystolic pressure due to uncontrollable shaking. Systolic 110. Patient remained able to protect his airway. AAOx4. and hives remained absent. EMS called at 7:18pm and arrived on scene at 7:26pm. Patient escorted to hospital via EMS at 7:38pm.
Information has been received from a consumer concerning her 5 year old white son with a penicillin allergy and a history of varicella exposure from his brother on 16Nov03 who on 19Jul1999 was vaccinated IM with a first dose of varicella virus vaccine live. Concomitant therapy included a first dose of IM of measles-mumps-rubella vaccine. There was no illness at the time of vaccination. On 30Nov03, at 08:00, the pt broke out in chickenpox. It was reported that there were about 150 lesions. There were no diagnostic tests or labs done. Subsequently, the pt recovered on 04Dec2003. Additional information has been requested.
Information has been received from a physician referring to a 2 year old patient of unknown gender. Information about pertinent medical history and drug reaction was not reported. On 12-MAY-2015, due to nursing error, the patient who was intended to receive VAQTA (dose, strength, frequency, route, lot# and expiration date were not reported) was vaccinated with a dose of GARDASIL (0.5 ml, strength, frequency, lot# and expiration date were not reported) intramuscularly. It was confirmed that the vaccine was not GARDASIL 9. No adverse effects were reported. Additional information is not expected since physician asked not to contacted.
Extremely cold right hand Ocurred after first COVID-19 vaccine and 3rd (booster)
My BP went up and stayed for a week to 10 days and my doctor increased lisinopril 1.25 milligrams to now its increased to 5 milligrams. Felt like had drank a lot of caffeine and I don't drink caffeine, felt hyper. I had my check on 28 Jun 2021 at 9am and eye appt 153 over 90, at home 160 over 90 BP. I called my doctor to increase, that whole week 150 over 90s. After I started taking 2.5 milligram, my Bp 130 over 80s. On Jul the 3rd I took 5 milligrams it leveled off.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry date UNKNOWN ) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient and his wife, both ended up with Covid and had mild symptoms. The patient was infected on day 3 ,of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210913172. This case was associated with Product Quality Complaint.; Sender's Comments: V0: 20210912838-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  The second vaccine was scheduled for 22-JUN-2021.  No Treatment information was reported.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications was reported.   This case was linked to MOD-2021-335070 (Patient Link).
Pt recvd 1st dose of Hep B vax on 14JUL91 & on 17JUL91 pt devel a petechial rash in lt antecubital space; Pt was seen in ER as required by hosp policy; Pt later recovered;
Pt exp sedation, chest congestion, & lt-sided pain 2 wks p/receiving flu vax; 3 days later 29OCT91 was noted to have a temp elevation; Cipro & Robitussin were given to treat the sx;
less than a wk p/vax pt devel gen hives; treated w/DPh
Admitted to hospital on 5/2/2021 due to hypoxia and ultimately intubated.  Family moved to comfort care and he died on 5/2/2021 at 10am.
became ill on 9OCT, fever 100.7, upper resp infect, stuffy/runny nose, sinus pains, cough;
Symptoms developed 4 days later- Rash on cheeks top of forearms, shins, upper arms, torso. Tiny itchy bumps (raised dots sand-paper like). Rash continues x 2wks. Treated by PP with cortisone cream.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
developed pain at injection site the next day. pain radiates from injection site. No redness, not skin break, oozing. Hurts with movements. denied other symptoms
Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medicine were reported. It was reported that on 8Oct2022, 9Oct2022 and 10Oct2022 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster were administered. Reporter was not aware of any AEs after the vaccines were given.  This case is for the 9th adult patient out of 26 adult patients. No treatment medicine were reported.
Hard, red bump around injection site, 12/17/13 around 7:00 pm. Swelling, soreness, throbbing. 12/18/13 10am same as above plus headache, tired, weak, woozy.
still got very sick 6 weeks after last boost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid"; Bnt162b2 (Dose:02, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid"; Bnt162b2 (Dose:03, My healthy dad had, 4 of your shots and still got very sick 6 weeks), for Covid-19 Immunization, reaction(s): "Covid". The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "still got very sick 6 weeks after last boost". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My healthy dad had 4 of your shots and still got very sick 6 weeks after last boost. Would have been hospitalized but hospital too full. Took Paxlovid yet remained positive for 17-18 days. He's still symptomatic. Week 4/5. It was unknown if patient took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse concerning to an unspecified patient (unknown age and gender). Medical history, concurrent conditions and concomitant therapies were not reported. On 20-JUL-2016 the patient was vaccinated with PNEUMOVAX23, lot # K009876 with expired date 19-MAR-2016. Concentration, dose, route and frequency were not provided. The nurse reported that an expired dose of properly stored PNEUMOVAX23 (lot # K009876, with expired date 19-MAR-2016, was administered to the patient on 20-JUL-2016. No adverse effects were reported. Action taken with the vaccine PNEUMOVAX23 and the patient's outcome were unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt had a recent exposure to COVID through granddaughter. Pt has a cough, generalized weakness, malaise, and shortness of breath. Pt admitted for COVID-19 infection.
Fever 102.1 at 30 hours post injection; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 23Jun2021 at 11:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included ADHD. The patient previously took augmentin (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. 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 COVID vaccine. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); all since unknown dates for unspecified indications. On 24Jun2021 at 17:30, 30 hours post vaccination, the patient experienced fever of 102.1 unspecified units. On 24Jun2021 at 17:30, the patient's body temperature was measured and the result was 102.1 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event fever 102.1 (unspecified units) at 30 hours post injection was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Blisters, 2 dime sized, 1 smaller; Occasionally itched; Shingrix and Pneumonia Vx on the same arm; This case was reported by a consumer via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On 18th August 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In September 2022, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: This case was self reported by patient. The patient received first dose of Shingrix on left arm.  The patient also received a pneumonia vaccine at the same time and in the same arm. About 2 weeks later, the patient developed 2 dime sized blisters on right arm, which occasionally itched, and had since healed over.  The patient developed a blister on left arm that was smaller than the previous blisters on left arm.  The customer could not recall which pneumonia vaccine patient received Patient provided consent to follow up with HCP The reporter consent to follow up. Additional Supportive Information: The patient received a pneumonia vaccine at the same time and in the same arm, which led to vaccine administered at inappropriate site. It was unknown if the reporter considered the blister and pruritus to be related to PNEUMONIA VACCINE.
10:15 am I  received the shot, at 7:00pm I felt difficult to swallow. I got scared so I try to drink something. In few minutes I  started to vomit, I had nausea, then called the hospital they try to take to make to the hospital but I refused it. I was on my bed for 3 days. I  started feeling better. It was very bad  thing. I never got sick before. It took completely 5 days to recover.
7/26 Fever, body aches and arm pain. Injection site is red, warm and firm a measures 4in x 5 in. She states used Advil and slept most of day. 7/27 continues with general body aches, chills and arm pain. T emp 99.4.
Dizziness. BP 159/96 (pulse 75). Lay down and felt better.
Pt stated that only with her 2nd dose she started having symptoms. Fever, chills, nausea which she was expecting. But what has her concerned is the persistent cough and SOB that has been going on since 5/26. She said that sometimes when she gets sick this happens and takes an allergy pill. So she is going to take some today and see how it helps.
difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
Patient was inadvertently given IPV #4 at 18 months of age. No complications have resulted from this error. RN listed above discovered error on 10/07/02 while completing day care forms.
29JAN93 mom states that had a reaction to vax given 13NOV92; About 45mins -1hr p/recvd vax pt went limp & pale-lips turned purple; pt listless & limp for about 5 hrs; color returned to lip p/had a bottle of formula;
I am having still after effects of, not feeling well; I am still feeling nauseous prior; some amount of light headedness like dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0172), administration date: 23Apr2021, for COVID-19 immunization, reaction(s): "I am still feeling nauseous prior", "some amount of light headedness like dizziness". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am having still after effects of, not feeling well"; NAUSEA (non-serious), outcome "unknown", described as "I am still feeling nauseous prior"; DIZZINESS (non-serious), outcome "unknown", described as "some amount of light headedness like dizziness ".  Additional information: The patient got the Pfizer shot on Friday having the second shot on Friday and the patient was having still after effects of not feeling well. The patient was still feeling nauseous prior and some amount of light headedness like dizziness and didn't know if it was normal to have this a while.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.