chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FDA/CDER/OSE Follow-up for FAERS Case EUA Casirivimab given to 44 patients instead of intended COVID-19 vaccine. Follow up with reporter on 04Jan2021 revealed that 44 patients, ages 77 to 97 years received casirivimab 0.5 mL intramuscularly instead of the intended Moderna COVID-19 vaccine on December 30. Of the 44 patients, 38 were vaccinated on December 31. At 48-hour follow up on Jan 1, 31 reported no adverse events. Of the 13 patients reporting an adverse event, most (n=9) reported arm soreness. The contributing factors/cause Included: Wholesaler shipping boxes for the vaccine and monoclonal antibodies look identical. Hospital was supposed to receive 216 vials of casirivimab and 216 vials of imdevimab, but received a partial shipment of casirivimab. The wholesaler sent a 2nd shipping box of casirivimab that was not expected. Staffing shortages at the hospital. Vials stored next to each other in the refrigerator. Picked up the "red top" vials and delivered them to multiple vaccination sites. Four sites received both casirivimab and Moderna COVID-19 vaccine in the same delivery, of which one site inadvertently administered the casirivimab to 44 patients instead of the intended Moderna vaccine. The Regeneron EUA products "are poorly labeled for identification having letter and numbers instead of the drug name on the vials". "Both drug vials have a red top"
Patient began feeling tingling in her arm, felt left side of face go numb.  Stated she just didn't feel right.  Then stated her throat was starting to close up and became hoarse.  EPI was administered x 1 at clinic and patient transported to ED where she was observed and discharged on Prednisone.
Initial information received on 27 September 2013 from a physician. A 52-year-old female patient whose medical history and concomitant medication were not reported, received in DTP (lot number U4646AA, Expiry date unknown). It was reported that the patient experienced significant reaction at deltoid site of injection, warmth, redness, and swelling. Patient had fever 99.3 and body aches on 27 September 2013. Itching and nausea at injection at site on 27 September 2013. Administration site reaction was not reported. List of documents held by sender: none.
After leaving drive-up site 15 minutes after injection I removed face mask as was feeling hot and prickly.  Looked in mirror and my Face was red/flushed and hot (not my forehead, but entire cheek and chin area).   Did not spread to other areas, no breathing problems.    Reaction may have actually started immediately after injection but since had to wear facemask I was unable to see my face.  It took between 60 and 90 minutes for my face to return to normal color and temperature.
5 minute tonic clonic seizure following vaccines. approx. 16 hours after vaccine, released with diagnosis of febrile seizures.
itching everywhere; bad trembles and could not stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (bad trembles and could not stop shaking) and PRURITUS (itching everywhere) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (experienced trembles and could not stop shaking).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced TREMOR (bad trembles and could not stop shaking). On an unknown date, the patient experienced PRURITUS (itching everywhere). At the time of the report, TREMOR (bad trembles and could not stop shaking) and PRURITUS (itching everywhere) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Benadryl (diphenhydramine) for the itching.; Sender'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.
Very black mood different from normal depression since directed outward. Normally I'm a mild mannered person. For two days I harrassed and bullied whoever was near. The first two days were the worst. Once the mood started to lift, I relized what was going on and was able to mitigate the situation. It took a week until all effects were gone
Narrative:  79yo male oncology pt Diagnosised with: 1. met hepatocellular carcinoma (intrahepatic mets) PD-L1 negative, MSS 2. Ph+ CML/ALL On 9/3/2021 pt's wife had phoned oncology clinic to inform pt hospitalized at (outside agency hospital) and is now hospice. Pt died at this hospital on 9/11/2021. Pt had received covid vaccines on 1/15/21 & 2/12/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Patient had fever, sick, no appetite, sore arm, red arm, arm stiff and could not move for 2 days, and 3 days after redness started migrating up arm
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EL0140), in right arm, on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIALIS, start date: 08Apr2022, stop date: 31May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negetive; positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information : Patient received other medication in 2 weeks of vaccination. Anti-viral details:Product: COVID 19 Treatment Brand: Paxlovid : Treatment start date: 31May2022,Treatment stop date: 04Jun2022.Indication: Treatment of COVID-19. Rebound of mild symptoms and COVID positive test after testing negative.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Information has been received from a physician concerning an 81 year old female who on approximately 12-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (lot# 658208/0886U). On approximately 30-OCT-2007 about two weeks later, the patient broke out in shingles. On 31-OCT-2007 the patient came to the physician's office and was diagnosed with ophthalmic zoster. "The patient was prescribed FAMVIR and was referred to an eye doctor." The outcome was unknown. There was no product quality complaint. Additional information has been requested.
pain in injection site arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 67 years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via an unspecified route of administration in the left arm on 13Mar2021 at 11:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included Type II diabetes mellitus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 13Mar2021 after 6 hours of vaccination, the patient experienced very slight pain in injection site arm. The patient did not receive any treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the pain in arm was resolved on 14Mar2021.   No follow-up attempts are needed. No further information is expected.
Could not Pee; Patient launched into a stream of explectives/ as verbally aggressive and used multiple expletives during the conversation; Patient received an unspecified HPV vaccine; Lost vision in one eye; This spontaneous report was received from a male patient reporting on himself (age unknown). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient  was vaccinated with an unspeified HPV vaccine (manufacturer unknown) (also reported as an unspecified "vaccine shot"), for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, the patient was not able to urinate (reported as "cannot pee", so he went to the hospital for medical attention, the patient mentioned that "5 days" but it was not clear if refers to  5 days hospitalized or that he received the vaccination 5 days ago.  The patien also mentioned that after vaccinatin with an uspecifed HPV vaccine, he lost the vision in one eye and as a result turned into a "Pirate".   It was also noted that during the call the patient was verbally aggresive and used multiple expletives during the conversation (Verbal aggression )   At the time of the report the patient was not recoverd from lost the vision in one eye.  The patient's outcome of "cannot pee" and Verbal aggression was unknown.  The causal relationship between the aforementioned events and  unspecified HPV vaccine was not reported.  Upon internal review, lost the vision in one eye was considered to be a medically significant event.
When I had COVID-19 I had congestion; runny nose; severe headache. The congestion lasted for 3 days and the headache lasted for 10 days. I went back to work after 10 days.
Right arm had swelling from deltoid/tricep (back) area down to elbow, redness, soreness, and heat were noted. Symptoms began to decrease (redness, swelling, pain) as of 7-12-13 after ice application and OTC BENADRYL.
Patient started feeling light-headed when sitting in observation room.  Patient laid self across chair and put feet up; staff immediately went to him and encouraged him to go to EMS room for comfort and to lay down on cot. Used wheelchair to transport. Patient given water and laid for 15 minutes and then felt better.
hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt)of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2011, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a  pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a healthcare provider for hearing loss. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   Upon internal review, deafness was determined to be medically significant.
Excessive ringing in both ears louder each day; increase in migraine headaches; disease recurrence; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medication included propranolol (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 20Feb2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced excessive ringing in both ears - louder each day. It did not go away and the patient wished there was something she could do to stop it. The patient also had an increase in migraine headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excessive ringing in both ears louder each day and increase in migraine headaches were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received on 03/14/01, from a health professional concerning a 30 year old female who in March 2001 was vaccinate with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Concomitant therapy included hormonal contraceptives (unspecified).  It was reported on 14 Mar 2001 that several days ago, 6-8 days post vaccination, the patient developed a small lesion on her left wrist.  The patient sought medical attention.  Follow up information was received from the same nurse pravtitioner who indicated that the patient's rash was not due to MMRII(MSD) (lot number not reported). The patient's rash recuurred and a diagnosis of Tinea was made. The reporter indicated the patient's symptoms were not related to MMRII (MSD). Additional information is not expected
SkinRash chills Narrative:  macular rash over the trunk anterior chest, abdomen, back and both arms
Local swelling within 24-30 hour time frame, swollen to size of about 4 inches wide but barely raised, red. Went to ER - given cephalexin, prednisone 60mg qd x 5 d, & SOLU-MEDROL; returned 10/27 & red diffuse papules & given prednisone again.
Temp of 100 R-allergic type rxn over entire face & body; pt presented to MD office; allergic dermatitis;
Onset of itching, numbness, swelling, rash face, neck, arms after receiving H1N1 vaccine. Seen in the ED. IV BENADRYL.
the patient "had an abnormal PAP test on an unspecified date in 2018, that was positive for HPV" / the patient "has had unspecified frequent retesting, and is still positive for HPV".; pseudo brain tumor diagnosed by MRI in 2017; This spontaneous report was received from patient's mother referring to her 22-year-old daughter.  The patient's concurrent conditions and medical history were not reported. The patient did not have concomitant therapies, drug reactions or allergies.  On an unspecified date in approximately 2010 (reported as when patient was 13-year-old), she was vaccinated with 3 dose series of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot # and expiration dates were not reported) for prevention of Human Papilloma Virus (HPV).         On an unspecified date in 2017, the patient was diagnosed through magnetic resonance imaging (MRI) with pseudo brain tumor (idiopathic intracranial hypertension) which was treated with high dose steroids (unspecified). On an unspecified date in 2018, the patient had an abnormal Papanicolaou Smear (PAP) test, that was positive for HPV (papilloma viral infection). The patient had unspecified frequent retesting, that was still positive for HPV. It was reported that the patient received treatment for the event, and that she sougth medical attention. At the reporting time, the outcome for idiopathic intracranial hypertension was unknown while for papilloma viral infection was reported as not recovered.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review idiopathic intracranial hypertension was considered to be a medically significant event.
swelling lymph node underarm; painful lymph node; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via mylan.  This case involves a 56 years old female patient who experienced swelling lymph node  of underarm (lymphadenopathy) and painful lymph node (lymph node pain), while she received vaccine YELLOW FEVER VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious swelling lymph node underarm (lymphadenopathy) and painful lymph node (lymph node pain) (Unknown latency) following the administration of YELLOW FEVER VACCINE.  Lab data was not reported.  Final diagnosis was lymphadenopathy and lymph node pain.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for lymphadenopathy and lymph node pain.  There will be no information available on the batch number for this case.
Patient received MENACTRA vaccine on 7/28/2010. Patient had seizure episode on 8/4/2010 leading to hospitalization
Patient experienced lethargy, signficant rash on arm around injection site. In addition, patient reported potentially unrelated side effects of slight episodes of anxiety and shortness of breath when walking up and down the stairs. This occurred not immediately after the vaccine, but between 1 and 3 days after administration. Side effects dissipated after this time frame.
had experienced fatigue; stiffness in the injected arm; loss of appetite; FEVERISH; NAUSEA; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, limbs stiffness, decreased appetite, fever and nausea. On an unknown date, the outcome of the fatigue, limbs stiffness, decreased appetite, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fatigue, limbs stiffness, decreased appetite, fever and nausea to be related to Shingrix.  Additional details were reported as follows: The patient was a neighbor of the reporter. The age at the vaccination was not reported. The patient received Shingrix and experinced fatigue, nausea, feverish, loss of appetite and stiffness in the injected arm. The Symptoms lasted a week. Reporter did not consent to follow up. This case has been linked with case US2020077689, reported by same reporter.
Information has been received from a physician concerning a 12-month-old female who was vaccinated with a dose of Varivax. Subsequently the patient developed fever. Subsequently, the patient recovered. Medical attention was sought. There was no product quality complaint involved. It was reported that this patient had a similar experience after vaccination with Proquad (WAES0704USA02190). Additional information has been requested.
This donor previously took Tetanus injections February 2001 and experienced a "deep throbbing pain" bilaterally in arms and shoulders. Did not associate this occurence with injection. He began to have same signs and symptoms after the injections on 06/25/01. The patient states that pain would alternate b/w arms lasting at 15 minutes. Pain is ongoing.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was mentioned in the report that the vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  Treatment details were not reported by the reporter.
Rash on legs and abdomen. BENADRYL given. Rash gone within 45 minutes.
Day after rabies #3, received, joint pain lasting 5 days generalized rash, pain esp. R knee, lasting 2 weeks. Edema of R knee, rash on lower extremities, lasting 2 days. Dr's office visit. ANA and Mono tests done both returned mildly positive (client states) no treatment. Waited on further vaccines.
Rash: starting lower posterior torso, progress to full posterior and anterior trunk > progressing to tightness in throat and chest (1830hrs ER intervention of Benadryl and steroid at this time reversed symptoms).
Arm is swelling a little bit; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore). At the time of the report, PERIPHERAL SWELLING (Arm is swelling a little bit) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.