chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 13th of 15 reports. A patient of an unspecified gender, age and race/ethnicity received PREVNAR 13 (Lot. N4385, expiry date 31Oct2017) on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The vaccine was administered to this patient after a temperature excursion. On an unspecified date, the patient experienced severe reactions on arm. Clinical outcome was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Pain, stiffness, heat sensation in neck the day following administration, tx seen by NP in medical center EOHW, given Tylenol 325mg 2 tablets, to return to clinic if symmptoms worsen.
Pt recvd vax & devel nausea & vomited once (projectile) which also resolved;
pt broke out in hives & a rash the morning p/vax; MD recommended treating w/DPh & told mom the rash & hives could be D/T causes other than the vax given;
1) Persistent headache in left temple area.  4-5 on pain scale, only stopping for 1-3 minutes at a time. Does not significantly interfere with sleep, but does interfere with daily activities. - Eases with Tylenol 1000mg.  - No change 2) Infrequent blurred vision - No treatment - No change 3) Difficulty recalling/remembering information, including simple sentence structures. - No treatment - No change, words can be recalled given 30-60s  Have spoken with healthcare provider. Will attempt to get an appointment.
In September I started having pain in my feet, I thought it was because I do between 10-20,000 steps a day. The balls of my feet started hurting. I took a medical leave of absence. The doctor diagnosed me with peripheral neuropathy.
Redness, swelling, pain and bruisng of the left arm. Patient took Tylenol and Benadryl.
Information has been received from a female patient's father who states that in August 2007, his daughter was vaccinated with the first dose GARDASIL. In October 2007 the patient was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced joint pain, muscle pain, headache and nausea. The patient's joint pain, muscle pain, headache and nausea were ongoing. The physician was contacted, but did not know if the latter events were related to GARDASIL. The caller declined to provide any additional information. Additional information is not expected.
Patient presented to the local ED with a chief complaint of nausea and vomiting.  Patient states that she has had ongoing nausea and nonbilious, nonbloody vomiting for approximately 1 month.  Accompanied by 3-4 loose stools per day. During that same time, she has lost approximately 20 lb.  She saw Gastroenterology today as an outpatient and they recommended that she proceed to the ED because of dehydration.  She was found to be positive for COVID 19 but no symptoms were reported.    EXAMINATION PERFORMED: XR CHEST 2 VIEWS INDICATION   No evidence of acute cardiopulmonary processes
On 12/19 or 12/20, about 3 days after receiving the Moderna Booster, I noticed that that some areas of my face were numb. (It feels like it does when novocaine starts wearing off  - lesser feeling, but not completely numb). More numbness in more areas of my face as time goes on. I had the same reaction after my second dose of the Moderna Vaccine as well. It started a few days after getting the 2nd dose, got worse over time, after hitting peak numbness it started subsiding in about 14 days and completely relented after about 3 weeks. My face is still numb (number today than a couple of days ago) and hasn't started subsiding yet. Assuming that it will resolve and go back to normal within a few weeks.
tightness in her neck, jaw, ear, and face this morning/tightness in the left side of neck and jaw; tightness in her neck, jaw, ear, and face this morning/tightness in the left side of neck and jaw; arm was sore/Sore arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 74-years-old female patient received 1st Dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EM9810),  intramuscular, administered on 03Feb202110:30 as SINGLE DOSE for an unspecified indication  Medical history and concomitant medications.were not reported.  The patient experienced sore arm on 03Feb2021 and tightness in the left side of neck and jaw on 05Feb2021.The outcome of Sore arm was resolved on 03feb 2021 and tightness in left side of neck and jaw was resolved on 05 feb2021. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available.Caller mentioned seeing a number # on her vaccine record card, but she doesn't know what that is for.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sore throat from post nasal drip, headache, body aches, fatigue, sneezing, runny nose, head abd nasal congestion
No adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 28-SEP-2019, the patient received improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (lot #: S012246, expiration date: 10-FEB-2020) (strength, dose, frequency and route of administration were not provided) as prophylaxis (product storage error). The vaccines were exposed to temperature of 68 degrees Fahrenheit for 8 hours. Previous excursions was reported as 57 degrees Fahrenheit for 2 hours. The data logger was involved. No adverse effects were reported.
sight problems; double vision issue; eyelid was drooping; high blood sugar; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On Sunday, 21Feb2021, he got the second dose of Pfizer's COVID-19 vaccine, at night he started experiencing a reaction, he began having sight problems. He thought it would be temporary, so he went to bed (used slang), but on Monday he still had the double vision issue, he had problems in his vision, his eyelid was drooping, so he went to the emergency room at (Name). They determined he has double vision and right now his eyelid is completely drooped. He is very surprised after receiving the vaccine, he has low cholesterol and high blood sugar at 126, his blood pressure was 133-135. The patient underwent lab tests and procedures which included blood cholesterol: low on an unspecified date, blood glucose: 126 on an unspecified date, blood pressure measurement: 133-135 on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Flu vaccine administered about 2 PM. About 230 PM, began to have an allergic reaction (hives). Sent to ER.
Systemic itching. Doctor office visit. With antihistamine, including prescribed medications, took 48 hours to resolve.
Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series were not reported) in the arm on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date and duration following the vaccination, the patient developed sore arm with lump that was warm ('war') to touch. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. Corrective treatment was reported as 'no'.  The outcome of events was reported as unknown. List of documents held by sender: none.
Intense , persisting headache; body ache; diarrhea; fever; chills; nausea; swollen arm; Painful arm; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, starting midnight the patient experienced the events intense persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm  and painful arm.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of events intense, persisting headache, body ache, diarrhea, fever, chills, nausea, swollen arm and painful arm  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1 week after injection developed swollen upper arm at injection site, itchiness at injection site.
24 hours later felt chills, started sneezing, Nasal drip that was clear.  Nose started to swell, then strong swelling around eyes and nose.  Sinus swelling led to pressure.
Muscle pain in shoulder/ pain; Weakness in shoulder; Unable to raise arm above head; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced localized muscle pain, localized muscle weakness and mobility decreased. On an unknown date, the outcome of the localized muscle pain, localized muscle weakness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the localized muscle pain, localized muscle weakness and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced muscle pain and weakness in her shoulder that resolved in about 6 days.  The reporter also stated that she started a home improvement project this week and found that the pain and weakness had returned and she was unable to raise her arm above her head. The patient was given medical disclaimer. Referred to Professional. Spoke per PI (package insert) and content. The reporter consented to follow-up.
Patient had a home antigen test for covid, which was positive; 99.6°F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had a home antigen test for covid, which was positive) and PYREXIA (99.6°F) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PYREXIA (99.6°F). On 13-Aug-2021, the patient experienced COVID-19 (Patient had a home antigen test for covid, which was positive). At the time of the report, COVID-19 (Patient had a home antigen test for covid, which was positive) and PYREXIA (99.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 99.6 (High) 99.6 degree F.. On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) positive for covid19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided Before the vaccine was given, on 7Aug2021, the patient was tested negative for covid19. The caller wanted to know if the vaccine is less effective in this case or the effectiveness remains the same.
Narrative: 61 y/o male presented to ER on 1/2/22. Received the COVID-19 (JANSSEN), VECTOR-NR, RS* vaccine on 11/30/21 and presented to the ED on 1/2/22 with worsening LLE pain. CTA revealed pulmonary emboli, extensive aortic thrombus, L renal infarct, common iliac stenosis, CFA/SFA/profunda occlusion on the left. LE duplex 1/4 with multiple b/l DVTs. Patient also had a new thrombocytopenia with PLTs of 61 and D-dimer of 13.62. Hem/Onc was consulted and patient was transitioned from a heparin drip to an argatroban drip and received 2 doses of IVIG for possible Thrombosis with Thrombocytopenia Syndrome (TTS) related to the COVID-19 vaccine. He underwent thrombectomy of left iliac, CFA, SFA, profunda and patch angioplasty on 1/14/22 HIT panel has resulted and is positive and patient appears to meet the 5 criteria for definitive diagnosis of TTS. Definitive Diagnosis (must meet all five criteria) per Hematology: - COVID vaccine 4 to 42 days prior to symptom onset - Any venous or arterial thrombosis (often cerebral or abdominal) - Thrombocytopenia (platelet count < 150 x 109/L) - Positive PF4 "HIT" (heparin- induced thrombocytopenia) ELISA - Markedly elevated D-dimer (> 4 times upper limit of normal) Discharged on 1/19/22 on apixaban. PMH includes HTN, GERD, depression, RLS, and lung nodules
Pt had erythema, swelling and pain. This was an adverse event, not an unusual event. The pt however was very concerned but was reassured easily.
Minor left arm pain at injection site for 24h; malaise for 24h; Left supraclavicular lymphadenopathy (multiple swollen nodes); This is a spontaneous report from a contactable physician reporting for herself. A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL3246), via an unspecified route of administration on 08Jan2021 at 11:45 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) taken for birth control from an unspecified date and unspecified if ongoing (reported as taken in two weeks). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) from an unspecified date to an unspecified date for an unspecified indication and experienced allergy. On 15Jan2021 at 12:00, the patient experienced "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)". The clinical course was reported as follows: "Minor: left arm pain at injection site for 24h and malaise for 24h, left supraclavicular lymphadenopathy (multiple swollen nodes) noticed 7 days after vaccination and still present 11 days after vaccination." It was unknown whether the patient received treatment for the events. The clinical outcomes of the events "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)" were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Felt faint, hand numbness/tingling, turned pale in color, nausea 15 minutes after receiving 1st dose of Pfizer COVID vaccine. Patient put head between legs and a cold compress on neck. Took blood pressure 20 minutes, 30 minutes, and 35 minutes after vaccination. Blood pressure range 93-102/62-68. Pulse range 76-104.
anal mucosal herpes outbreak 2 days after vaccine.  she has a hx of HSV but never had outbreak in this location
2wk p/vax pt head started bobbing;it is worse @ noc & is beaming progressively worse;child had no temp post vax;child is awake & alert;no c/o neck pain/ h/a;
A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 24 November 2003. On 24 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
raised bump at injection site; itchy; sore arm for 2 to 3 days; area red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site). At the time of the report, VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 8/2 after being fully vaccinated I tested positive to COVID. I experienced SOB but no other symptoms were associated. 8/4 I had the infusion.
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included APIXABAN (ELIQUIS).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the 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.
After receiving my 2nd COVID vaccine I went I for my annual physical in May. My EKG was slightly abnormal but my doctor missed it. In June I started having SOB and palpitations. I went back in to see my doctor and the EKG was very abnormal. He referred me to a Cardiologist. I was diagnosed with Left Bundle Branch Block and an ejection fraction of 45?. Since then, I've been diagnosed with Congested Heart Failure with an ejection fraction of 30?.
This spontaneous report as received from an office manager, refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 and expiration date 20-JUL-2017) (lot # L023936 and expiration date 15-MAR-2017) (doses and administration route was not reported). The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved: Yes. This is one of several reports from the same reporter. Additional information has been requested.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 28-JUL-2016. [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Pain when the flu vaccine was given really high on my left arm then, two days couldn't move my left arm at all without screaming pain.  I still to this day cannot move my left arm to the far left without horrible pain & can't sleep on my left side at all. I can rub my arm really hard then it will relieve some of the pain.
Pt had increased crankiness and inconsolable crying lasting 24 hrs with low grade fever up to 100.7 F symptoms started approx 8PM 06/09/2004 until today. Pt well today. 6/10/04 mother reports no symptoms.
Pt stood up about 10 minutes after receiving his vaccine.  he felt dizzy and light headed and then lost consciousness for about 5 seconds.
Swollen, red, and warm to the touch. Patients PCP advised patient to take Benadryl and Motrin.