chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right arm is killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm is killing her) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Anxiety, Aortic valve stenosis, Hypertension, Hyperlipidemia, Insomnia and Asthma. Concomitant products included ALPRAZOLAM (XANAX) for Asthma, LOSARTAN for Hypertension, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Insomnia.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (right arm is killing her). At the time of the report, VACCINATION SITE PAIN (right arm is killing her) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (right arm is killing her) to be possibly related.    Concomitant medication includes: Advair Diskus (Device-Inhaler)    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Medical history added. Event outcome and causality updated. Concomitant medications added. Reporter details added.
my body broke into raised hives with a flaming itch/it covered all of my body at different points even my fingers and the soles of my feet; my body broke into raised hives with a flaming itch; covered with a full raised rash on most of my Torso,all extremities, soles of my feet; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Mar2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included multiple environmental allergies and high blood pressure(controlled). The concomitant medication included allergy shots, losartan 50mg, ethinylestradiol, norethisterone (NECON). On 23Mar2021 at 12:00, patient felt itchy, patient was completely covered with a full raised rash on most of Torso, all extremities, soles of my feet, everything except face, over the next 48 hours body broke into raised hives with a flaming itch every 5 hours. The patient reported that, it covered all of my body at different points even my fingers and the soles of my feet (as reported). The patient received zyrtec, and Levocetirizine, one each morning and night and prednisone 20 mg 3 tablets every day for 5 days as a treatment. The event resulted in physician office visit and emergency room visit. The patient had undergone, covid-19 PCR on 25Mar2021 and result was unknown. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
I HAD PAIN IN MY BACK AND MY HAND WHERE I RECEIVED THE SHOT (WAS RED) BUT I DID NOT SUSPECT MY HAND AT FIRST BECAUSE I HAD MORE THAN ONE PAIN.I THOUGHT IT WAS ONLY MY KIDNEY INFECTION.LATER I STARTED TO HAVE A FEVER AND MEAUSRED TO ABOUT 102. I WENT TO DOCTOR TOLD HER ABOUT MY INFECTION AND MENTIONED THE VACCINE I TOOK WHICH WAS TYPHOID VACCINE (SHOT) BEFORE I TRAVEL OVERSEAS ON NOV 1ST. I TOOK ANTIBIOTIC.  AND I ALSO PUT ON MY SWALLAN HAD ALOE VERA AND ICE PACK. I WAS IN BED THURSDAY, FRIDAY AND THE WEEKEND. TODAY MY HAND FEEL ITCHY AND SWALLAN. I AM HOME TYPING THIS. TODAY IS SUNDAY THE 22ND OF JULY 2007.
administered a dose already expired; This case was reported by a nurse and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number PL9T9, expiry date 3rd September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 16th September 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 16th September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that medical assistant administered a dose of Rotarix which was already expired on 3rd September 2021, which led to expired vaccine used. The reporter consented to follow up.
8/27 - 9:30 pm: body aches and mild headache Throughout the evening - tired and unable to rest due to increasing body aches, sore muscles, increasing headache, swelling in lymph nodes under L. arm, pain/discomfort in L. breast, rib cage, and shoulder. 8/28 - discomfort described above failed to lessen. 8/29 - 6:00 am: CONCERN OF BLOODY URINE which has continued throughout the day. It is now 4:20 pm.  Symptoms described above have lessened but still persist. Sore throat is present, swelling is mainly under left arm (lymph nodes).
Began with irritation and redness around injection site. Approximately 9 pm, I noticed most of my shoulder was very red. By 10:00 pm (approximately 6 hours after injection), I noticed peeling of my skin down left arm.
On 03/23/05, right upper arm swollen and red, temperature 99 degrees and rash on body. Saw doctor for already scheduled appointment and NP noticed arm. Mother not concerned about arm until NP questioned her about shots.
Fever and chills 12 hours afterward  Severe Headache since injection  Fever up to 101 since injection,  Tylenol and IBprofin  to keep fever reduced
pt recv vax & while needle still in lt deltoid, arms straightened, eyes rolled back in head, spine arched backward;pt moved to floor & became fully conscious 10-15sec;BP 130/80, P80, R24;felt dizzy;didn't know what happened;tearful;nervous;
Adverse event information provided in this submission, is per a report received by a Public Health Department from a submitting facility. Covid-19 vaccination information is from Immunization Registry.  Pfizer 3/15/2021 lot number not available; Pfizer  4/07/2021 lot number not available;  Pfizer 12/21/21 Lot number FE3594;  Pfizer 10/19/22 Pfizer BvlntBstr 12+  Lot number: GH9697  Per note submitted from the hospital admission date 11/20/2022. ?Multiple diagnoses were considered for this patient including but not limited to pneumonia, UTI, arrhythmia, sepsis. Clinical impression appears to be most consistent with fever secondary to COVID-19 with altered menta l status and atrial fibrillation. Patient presents with subjective fevers and chills per the wife at home. Increased confusion and agitation today. Does have a history of dementia and i s normally confused. Per the wife he is essentially at his baseline but was slightly more agitated today. She noted that he felt warm at home and was shaking as though he was having chills. No temperatures measured at home. Here his lungs are clear and his urine is clean. White blood cell count is normal. Lactic acid is 1.8 and so below 2. Does not meet criteria for severe sepsis. No evidence of hypotension to suggest septic shock. Oxygenating normally. EKG shows what appears to be rate controlled atrial fibrillation which I cannot find a history of. There are no ischemic changes although he does have a more noticeable left bundle branch block on today's EKG when compared to previous. His troponin is normal. Thyroid function is normal. Electrolyte's and renal function are normal. Patient's C OVID swab did come back positive for COVID. I think this is likely the source of his fever. Given his age and risk factors and potential new A. fib I think admission for further evaluation is warranted. He is admitted in stable condition on 11/20/2022.?  No further information is known on the outcome of this patient. Please contact provider for any additional information.
7 days after i got the vaccine my left upper arm where i received the vaccine became very itchy and different shaped bumps began to form. the next day, day 8 there was an oval shaped raised, slightly hard, red rash around the area where i had the vaccine. this remains today 9 days after i received the vaccine but it looks a little bit less raise and red/hard.
with the first dose of the Covid Vaccine the patient had soreness in the legs; Really Tired; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jan2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Patient Medical continuing: yes , Patient Medical comments: verbatim: Blood pressure high; "Hypothyroidism" (ongoing), notes: Structured information(Patient episode name): Hypothyroidism, Patient Medical continuing: yes. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "with the first dose of the Covid Vaccine the patient had soreness in the legs"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "Really Tired".  Additional information: Caller stated she did not know the year for the patient's date of birth. She first states it is (year) but then states (year). This was captured as stated by the caller, (year). Family Medical History Relevant to AE(s): None. Prior Vaccinations (within 4 weeks): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse event did not result in Emergency room visit and result in physician office visit. Relevant Tests: None. Patient received second dose on 29Jan2021. Seriousness for the events was reported as not serious. Other products and investigation assessment was reported as no. Relatedness of drug to reaction(s)/event(s).Reaction assessed: First Dose: Soreness in the legs. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed: First Dose: Really Tired. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt devel knot in arm-varying in size one as large as golf ball-not going away;
Her right thigh swelled up and turned red. It was super hot to the touch and had two round circle areas around the injection site. My daughter also had diarrhea, upset stomach, nausea, fever of 101.1 and lethargic and not eating well. She complained of pain and itchiness on the area.
Pt received vaccine on 10/23/12 and has had fever and stiff neck for two days since HPV vaccine. Pt also dizzy.
This spontaneous report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored of RECOMBIVAX HB lot numbers reported as K007263 Expiry date 09-JUN-2016 and K018180 Expiry date 17-SEP-2016 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Went to work that afternoon and suddenly felt nauseated and passed all the way out (8 pm). Fell and did hit head. EMS called to scene - was checked out "ok all VS WNL". Mom stated refused to go to hospital. Stayed in bed next day with HA and nausea.
feel tired; inability to lift her arms or legs; Weak; Shaky; overall Malaise; Lethargic; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, the dose was an unknown dose. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms. On 18th November 2019, the outcome of the tiredness, mobility decreased, tremor, malaise, lethargy and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. For tolerances of 2nd dose, refer case US2019AMR230021, reported by same reporter for the same patient.
During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.
9-9-2021 upperbody aches headache and chills. 9-10  blurry vision and  upperbody aches as of today  headache is gone upper body ache persisst and vision is improving.
12:00 on 8/22/00, pt states she experienced redness, itching of face and upper body 20-30 minutes, post vax, lasting about 45 minutes. She states she also had some shortness of breath at the same time. At 14:00, talked to pt by telephone and she stated all of the above symptoms had subsided. Pt to check with physician if any of above symptoms reoccur.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 86 years old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies.   On or about 15-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for Herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: pt is receiving anothoer dose of shingrx because the dose she received on 05/102022 was not within the required temperature-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium
Medical assistant accidentally pull Pfizer pediatric dose and vaccinate patient. Patient waited 15 minutes with no adverse event. Attempted to contact patient same night but unable to get through, will continue to reach out and inform patient to be revaccinated at one of our other mobile clinics.
Diarrhea; Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Soreness in left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Soreness in left arm). At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Soreness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported
This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 DEC-2021, the patient experienced positive covid test. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine was not applicable. The outcome of positive covid test was not reported. This report was non-serious. This case, from the same reporter is linked to 20220104898.
pt recvd vax 18OCt93 had fever to 102-103 x 24 hrs; almost constant screaming; had APAP;
Client called reporting "massive" HA and sweats overnight; followed by "queasy" stomach and left-sided facial numbness. Denied numbness interfered with breathing or talking. Advised to seek medical eval. 1/25/17 Reported persistent numbness.
Diagnosed with severe case of shingles 2 1/2 weeks after second dose of Moderna.
Patient experienced cellulitis (w/o abcess) reaction after a few days after receiving the SHINGRIX vaccine. Received BACTRIM DS to treat.
The next morning after the vaccine, patient woke up with hives mostly on her trunk ,back and legs and was itchy all over.She had these symptoms until 2days ago.They did not worsen but did persist.
Patient received H1N1 vaccination on 11/6/09. Pt was 14 wks 3 days pregnant. On 12/21/09 pt started bleeding and was found to have 21 wk fetal demise an induction was done on 12/21/09 at local hospital.
Diffuse pustular rash on trunk, thigh, buttocks, fever, chills, headache, myalgias starting morning of 1 April 2013.
Rash on the right forearm; Hives on inner thighs progressed to outer thigh and hips, then belly, and on arms; Really bad itching; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration in the left arm on 30Mar2021 at 13:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included scleroderma, fibromyalgia, raynauds, pulmonary hypertension and other unspecified conditions. The patient was allergic to other unspecified medications. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received flu vaccine and experienced rashes and hives. It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 14:00, right after the vaccination, the patient experienced rash on the right forearm and then hives on her inner thighs which progressed to her outer thigh and hips, then belly and on arms. The patient also experienced really bad itching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event rash on the right forearm, hives on inner thighs progressed to outer thigh and hips, then belly and on arms and really bad itching was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt developed a very sore arm, headache and nausea 10/6/2020 which resolved on 10/7/2020
Had chills and every bone in my body hurt. Sent to bed at 10pm and woke up at 1pm the next day .Took another Tylenol and went back to bed until 9 pm. I ate and went back to bed until the next morning. Started to better in the morning.
Pt recv vax on 12/3/98; on same day pt exp chills, Rt Arm swollen at vax site; tx=ice
Vaccine may have been administered outside of the room temperature window. Janssen is good for 2 hours at room temperature.  Vial was out of the refrigerator for longer than 2 hours time.
This spontaneous report as received from a other health professional refers to a 12 year old female patient. On 01-SEP-2017 the patient was vaccinated with GARDASIL 9 lot # N019923 dose 3, intramuscular for prophylaxis. On 01-SEP-2017, 1 day after onset of therapy the patient experienced syncope. The outcome of syncope was reported as recovered/resolved.
2 days after vaccination with MMR, Varivax, Hib- Pt  developed bright red, irregularly shaped macular papular rash on torso, face, and thighs. Asymptomatic. No change with Benadryl.
redness, itchiness, bump on injection site; redness, itchiness, bump on injection site; redness, itchiness, bump on injection site; This is a spontaneous report from a contactable other Health Professional (patient). A 50-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 18Jan2021 11:15 at single dose on right arm for covid-19 immunisation. Medical history included hypertension, hyperlipidemia, history of brain tumor. Concomitant medication included levetiracetam, hydrochlorothiazide, valsartan (VALSARTAN HCTZ), atorvastatin and K [potassium]. Historical vaccine included 1st dose of bnt162b2 (Lot: EK5730) on 29Dec2020 at 11:00 on right arm for covid-19 immunisation. The patient experienced redness, itchiness, bump on injection site on 19Jan2021 at 19:30 with outcome of unknown. No treatment was received for the events.
Arm turned red, swelled, and itched like a bug bite around the injection site  that happened about 7 days after 1st shot and lasted about 72 hours .   I have three red marks remaining that look like scratched.