chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness on her left side; her left side and foot feels numb; her heart was off the charts; Feels like from her foot from the ankle down, is swollen on the left side; Felt like her throat was burning down to her chest; anaphylaxis; had a hard time breathing; could not swallow; Ungodly taste in her mouth, god awful taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp.   A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jul2021 10:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included cerebrovascular accident from 1995 to an unknown date , surgery from 1995 to an unknown date , splenectomy from an unknown date and unknown if ongoing , urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included lamotrigine (LAMOTRIGINE) taken for seizure from 2019 and ongoing; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for somnolence from an unspecified start date and ongoing; valproate semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced urticaria, heparin and experienced drug hypersensitivity, penicillin nos and experienced drug hypersensitivity, sulfamethoxazole and experienced gastrointestinal tract irritation.  The patient experienced anaphylaxis (anaphylactic reaction) (medically significant) on 02Jul2021 with outcome of not recovered , had a hard time breathing (dyspnoea) (non-serious) on 02Jul2021 with outcome of not recovered , could not swallow (dysphagia) (non-serious) on 02Jul2021 with outcome of not recovered , weakness on her left side (asthenia) (non-serious) on an unspecified date with outcome of not recovered , her left side and foot feels numb (hypoaesthesia) (non-serious) on an unspecified date with outcome of not recovered , ungodly taste in her mouth, god awful taste in her mouth (taste disorder) (non-serious) on 02Jul2021 with outcome of not recovered , had to monitor her heart because it was off the charts (cardiac disorder) (non-serious) on an unspecified date with outcome of not recovered , felt like her throat was burning down to her chest (burning sensation) (non-serious) on 02Jul2021 with outcome of not recovered , feels like from her foot from the ankle down, is swollen on the left side (peripheral swelling) (non-serious) on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of had a hard time breathing (dyspnoea) , had to monitor her heart because it was off the charts (cardiac disorder). Information on the lot/batch number has been requested.
Went to bed at 10pm a little flu-like symptoms (aches, headache, chills). By middle of night could not find a comfortable position to sleep due to exaggerated symptoms noted above. Woke up 1:30pm following day throbbing headache, racing heart rate 155bpm, chest heaviness, no fever.  Heart rate reduced over the next day to 113/112 (my resting normal is 60-75 sitting upright)- still with some chest heaviness.no headache... went to ER took bloodwork troponin and creatine normal, PCR negative, neg pregnancy, chest X-ray normal , neg for pneumonia, EKG t-wave flattening mild arrthmia- sent home with 92-89 resting HR and to follow up with cardiology echo-stress test and holter.  Following day heart rate lower to 94-92 resting HR, mild chest heaviness have a little nagging tickle in my chest that I need to cough/clear- rapid test neg?now I?m spotting (no pain) today (very strange since I did not have a period  for quite some time-months).
This is a spontaneous report from a contactable nurse and pharmacist (patient's mother) via Pfizer sales representative. This nurse and pharmacist (mother) reported for a 16 year old male patient. A 16-years-old male patient of an unspecified ethnicity received first dose of TRUMENBA (Lot# R5077, exp. 31Jul2018), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site, arm pain, overall body malaise/fatigue, chills and nausea 3-4 hours later on an unspecified date after injection, and lasting at least 12 hours. Mother gave him TYLENOL and said symptoms appeared to improve after 12 hours. The outcome was recovering.
DID NOT SKIP A DAY BETWEEN SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2855) was received from a pharmacist on 19-Nov-2019. It described a female consumer who "did not skip a day between second and third dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: It was reported that consumer did not skip a day between the second and the third dose of Vivotif. She took doses on days 1, 3, and 4.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.
Right arm sore that evening. Left arm OK. Continued to become more swollen and tender- fever 102.6 last night (Tues. night into Wed.) Today painful to lift arm, sore under arm and into neck. Looks pale and in pain. 10/30/2002 7pm Pt had an appt with MD so mom went with her and asked MD to look at her arm. She did and advised PT she was developing a cellulitis 2 degree to one of the vaccines- Gave her a Rx for an antibiotic. 11/06/2002 PC to P- Improving although her right arm is still "sore", but not tender like it was. She continued to run fever of 102 degrees until Fri. Was able to see her PMD on Fri. He concurred that she had a local reaction to a vaccine and cellulitis. As she was on an antibiotic he did not advise any additional treatment. He thought the vaccine that created the problem was Td. The antibiotic she took was Omnicef- She continued to run a low grade temperature during the early am and late pm until Sun. and has been afrebile since.
Nauseous,fever, fatigue, muscle aches, tiredness, headache, soreness in arm
Child passed out almost 15 minutes after vaccine was administered. Then child vomited a medium amt. Paramedics on site examined the child & released with parent mother approx. 30 minutes later. Child was alert & oriented x3.  Parent reports she will take child to his pcp for follow up.
Client made TC to CCHD and stated he received overseas immunizations on last Tuesday 2-26-02 On Friday 3-1-02, he experienced body aches and generalize malaise but no fever or headache. Has taken Ibuprofen off and on, but not today, Temperature not taken today but it has been normal States no egg allergy, is allergy to bakers's yeast. Drug allergies are Erythiomycin and Sulfa. RN    (?thinks) side effects of vaccines given and s/s of possible flu-like symptoms, then to client to MD.
Was sleeping woke up with  suddenly with body violently shaking, fell right back to sleep and woke up again with violent shaking, back to sleep woke up normal time 7 AM. Just felt tired the next day.
Within 4 hours I broke out in hives starting on scalp, then stomach. Next day both legs, then up stomach, include breasts. On arms. On day 3 my upper chest area, up neck and face; This is a spontaneous report received from a contactable Consumer (patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history included asthma and Guillain-Barre syndrome (in 1972). The patient had no allergies. Concomitant medication included omeprazole, cetirizine, fluticasone propionate, salmeterol (WIXELA INHUB) and montelukast sodium (SINGULAIR). The patient did not any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported that she took first dose of COVID vaccine on 19Feb2021 at 13:00 and within 4 hours (at 17:00) she broke out in hives starting on her scalp and then her stomach. Next day both legs, then up her stomach to include her breasts. On her arms and on day 3 my upper chest area up her neck and face. The patient visited the physician office. The patient received Cetirizine 4x day and Pepic 20 mg 4x day as treatment. The outcome of the event was reported as recovering.
immediately upon inj had bad taste in mouth and inside my mouth  and lips felt filmy. from there broke out in itchy rash within minutes  and my voice was crackly the pharmacist checked on me and had to wait a few extra minutes before leaving  of note the APRN i work with was there getting her injection as well and advised on the benadryl.  I have used benadryl and claritin since the injection to help with symptoms . after about an hour after the injection my lips were very red I never experienced SOB i did report to my PCP (MD) the next day and he said to continue as I was doing and to alert him if things worsened ( also note I work at my PCP office) Employee from pharmacy called to check in on me on the 23rd and advised I report the event to you and questioned if I should take dose 2 and I told him i WOULD NOT be taking another dose. since the injection i have continued to have the under the skin itchy rash and inside mouth and lips felt irritated after and i have experienced several other persistent symptoms of ha on and off,  blurry vision, facial swelling around eyes, nausea no vomiting ,decreased appetite ,fatigue ,upper gastric pain for a few days after, and felt weak in lower back, voice is crackly at times and the tip of my tongue will feel a burn\tingly feeling. AGAIN i have not had what i would call SOB I did let my PCP know today of the persistent symptoms and that I was reporting them over to you as the pharmacy directed. I did not have a formal office visit but my pcp did note the effects in my chart
Nausea starting 8pm the night of the vaccine, tiredness and chills. Day following vaccine had severe headache all day and diarrhea mid to late day.  Next day only mild headache.
Smallpox vaccine given during Coast Guard duty.  States onset fatigue, headache, muscle aching duration 3-4 days started approximately 3 or 4 days after vaccine -now resolved completely.  New onset 1.5cm patch alopecia central anterior.  Scalp since 04/17/2003, no other patches alopecia.
pt recv vax 27FEB97 & 3 days post vax pt c/o diarrhea, & joints ached all over;pt saw MD who recommended that pt not recv 3rd dose;
Suspected Vaccination failure; Had have two. That frist two didn't work/since  page is for what is shingles' and reported shot did not work; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shots and it didn't work. The patient went back to checkup, he/she was advised to get shots done again. The cost was high and patient wanted to be safe. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt recvd vax;approx 26sep95 exp itching where shot given;area was really hard;
pt recv vax & 10 days later pt exp fever for 6 days & lesions similar to chickenpox;cult of the lesions was positive;
Patient reported having fainted after receiving vaccinations or blood draws before (vasovagal response). Within 5 minutes of receiving vaccination, patient turned pale and started sweating. Patient's body and head were supported by another chair and parent holding him.  He was given a bottle of water, ice packs for his head, wet paper towel for his forehead, and a lollipop to suck on. I took his blood pressure and monitored the patient for 30 minutes. BP was 118/62 with HR 57 initially. This lasted 10 minutes, then the patient got color back in his face, was verbal the entire time, and did not want me to take his blood pressure again. He did not fall over at any point. He reported having this response to all routine vaccinations and blood draws.
"not feeling well" - weak, dizziness - syncope - went to ER, found to have sinus bradycardia in the 30-40s, hyponatremia. discharged home, stopped metoprolol.
No additional AE reported; Adult patient was administered the pediatric dose (0.5ml) of RECOMBIVAX HB; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, pediatric dose of 0.5 milliliter (Incorrect dose administered), lot #U032668, expiration date: 24-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events were reported.
I cannot do anything anymore. I used to quilt, garden, go to church, go shopping, all the many and varied things a normal person does. All I can do is sit in my recliner and read or sleep all day long. I want my life back. I've told Dr all about my health and all she does is look at me. I wish I had never had this covid booster. I wasn't given any vaccine at the time of my covid booster.
Firm pressure under the sternum after about 2-3 day of second injection. Lasted about 12 hours and went away.  No breathing issues.  Been fine since.  No return of pressure. Decided not to check with doctor.
Pt. was being monitored in ER as he reported a seizure after 2nd vaccine in ER 4 days prior which was not witnessed or reported. With screening pt at Public Health prior to 3 rd vaccine dose and his report of seizure, he was taken back to ER where vaccine was given by PH nurse. Pt observed by 2 PH nurses for 24 minutes when seizure like activity observed. ER Doctor and staff attended to pt.
Papular/postular rash two days ago, non-itchy, afebrile, varicella.
PAIN ON THE LEFT ARM AT SITE OF INJECTION FOR ONLY 2-3 HOURS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain on the left arm at site of injection for only 2-3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the left arm at site of injection for only 2-3 hours. This report was non-serious. This case, involving the same patient is linked to 20220221177.
Headache, Fever, HA, TEMP, DIZZINESS AND CHILLS Narrative:
a swollen lymph node on my collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a swollen lymph node on my collar bone) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LYMPHADENOPATHY (a swollen lymph node on my collar bone). At the time of the report, LYMPHADENOPATHY (a swollen lymph node on my collar bone) 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.
"felt like I had a vaccine"; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. The age at vaccination was not reported. After vaccination, the patient felt like she had a vaccine. The reporter declined to provide any additional details for this adverse event.
1 of 3 pts immunized from the same pnu-immune lot# who devel an adverse event;pt immunized 14NOV94;15NOV devel high fever,feeling weak,head congestion,chills,large local redness around inj site;other flu-like sx x 1 wk;recovered
Patient started having elevated blood pressure right after influenza (FLUAD) and pneumococcal conjugate (PREVNAR-13) vaccinations. Patient doubled-up on blood pressure medications about every other day for 5 to 6 days while pressure was high. Patient now feels well with minor complaints (elevated blood pressure, flushing, face getting red --- although blood pressure has been normal past few days).
Redness, swelling, & soreness at site of injection - started several hours after injection and is still present. Treating with ice and cold compresses. Headache started overnight the first night and lasted about 30 hours. Treated with Tylenol, but got no relief. Fatigue started within a couple hours of the injection and lasted about 24 hours. Chills were intermittent and started about 15 hours after injection and lasted until about 24 hours after injection. Nausea started about 15 hours after injection and lasted until about 24 hours after injection. Vomiting started about 18 hours after injection and only happened once. Low grade fever started about 15 hours after injection and lasted until about 24 hours after injection.
Mom called had vomiting 3 hours after vaccine 4:00pm - Fever 101.4 ax, questionable febrile seizure, shaking, eyes deviated to one side. Patient sent to Emergency Department.
Initial unsolicited report received from a nurse via phone on 14-SEP-2018. This case involves a 14 month patient who was vaccinated with 0.5 ml dose of DAPTACEL (batch number C5190AA, expiry date 24 April 2019), intramuscularly in left thigh on 14 Sep 2018. It was reported that, patient also received Daptacel on an unspecified date in June 2018. Concomitant medication involved Prevnar, Varicella and HIB. It was a case of actual medication error as Extra dose administered. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A (not clear)) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. Patient stated he could not take the second dose as he lost his job.
patient receiving ADACEL instead of DAPTACEL with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who had received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]  instead of daptacel with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-May-2022, the patient received a  0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (strength, formulation: unknown) (lot U6984AA and expiry date: 18-Mar-2023) (Drug Interval Dosage : Once Drug Treatment Duration) via intramuscular route in unknown administration site for prophylactic vaccination.  On 23-May-2022 (latency: same day) the patient receiving adacel instead of daptacel with no reported adverse event (wrong product administered) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient receiving adacel instead of daptacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A 10 month old female received a dose of Prevnar. On 5/1/00, the pt developed an "intermittent" tactile fever, and "severe" vomiting. Diarrhea and irritability also developed. These events continued over a 5 day period. The diarrhea, and irritability persist. This is one of two reports from this facility of an adverse experience following receipt of Prevnar.