chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt devel severe myalgias & fatigue 2hr post vax ;later devel severe h/a, abd pain & diarrhea-feels sick inside;sx persisted for 3 days are not improving;
itchy all over her body; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Mar2021 14:30 (Batch/lot number unknown), at age 46 years old, as dose 1, single, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included diabetes and asthma both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included unspecified other medication taken in two weeks. The patient did not receive other vaccine in four weeks. On 03Mar2021 14:45, 15 minutes after the vaccination (also reported as "within 10 minutes of getting the vaccine"), the patient was itchy all over her body. Treatment for the event included an unspecified antihistamine. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAr-2013 to 01-ARP-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 13 year old female patient who on 01-APR-2013 (at 10:31 AM) was vaccinated in left arm with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and PAIN (Pain). At the time of the report, COVID-19 (COVID-19) and PAIN (Pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Event outcome updated. New event added.
Kidney function changes; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (Kidney function changes) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Mantle cell lymphoma.    Concurrent medical conditions included Mantle cell lymphoma.   On 23-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL IMPAIRMENT (Kidney function changes) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function changes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment-This spontaneous case concerns an elderly  male patient of unspecified age with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Renal impairment(AESI) on unknown dates after a dose (dose number not specified) of mRNA-1273 vaccine.. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.  The reporter's causality for Imbruvica for the event(s) of KIDNEY FUNCTION CHANGES was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: This spontaneous case concerns an elderly  male patient of unspecified age with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Renal impairment(AESI) on unknown dates after a dose (dose number not specified) of mRNA-1273 vaccine.. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Swelling of thigh, erythema, fever to site, area 3cm above injection site to just above knee. Benadryl PO/ cool compresses. No systemic symptoms
MILD CHILLS FOR SEVERAL HOURS.  SEVERE RASH ALL OVER THE BODY.  BUMPS, REDNESS & ITCHING. SEEN AT PRIMARY PHYSICIANS OFFICE BY NURSE PRACTITIONER, GIVEN AN INJECTION AND RX FOR METHYLPREDNISOLONE 4mg DOSEPK, CLOBETASOL 0.05% CREAM AND EPINEPRINE 1.3MG AUTO-INJECT.  ALSO TAKE CLARATIN AND PEPCID.
5 to 6 days of 102-104 fever, pain to back and stomach, flu-like body aches, hallucinations, chills, vomiting, severe dehydration, impact to liver and kidneys (including infection)
Mother brought child in today for a routine check up and stated slightly over 48 hours after last vaccines given (2000) he had fever to 105 and went to emergency room and did not notify me.
This spontaneous report as received from a healthcare worker refers to a 86 year old male patient with allergy (allopurinol), high cholesterol, and "thyroid" who is also a physician. In approximately June 2013, about a month ago, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, (lot number # H017759, expiration date 04-JULY-2014, route not specified). Concomitant therapies included SYNTHROID and LIPITOR. In approximately June 2013 also reported next day after receiving PNEUMOVAX 23 the patient developed muscle pain, redness and swelling at the injection site. The reported stated that symptoms lasted about three days and by the fourth day after receiving PNEUMOVAX 23 the patient was completely recovered. None of lab diagnostics studies was performed. There was no treatment given for the adverse events. The outcome of the events was reported as recovered/resolved in approximately June 2013. Relatedness between therapy with PNEUMOVAX 23 and events was not reported. This is one of several reports from the same source (report from the same reporter - MARRS # 1307USA002299). Additional information has been requested.
7/27/04 @ 12:50 pm, patient was given MMR vaccine SQ x 1 in her left arm. Approximately, 3 to 4 minutes later, she complained of feeling lightheaded and began to faint.  She was pale and diaphoretic but never lost consciousness.  She was unable to talk for about 1 minute.  She maintained respirations and a pulse: VS HR=76-78, BP=110/70, O2 Sat=98%RA at 12:55pm / HR=96-110, BP=110/62, O2Sat=98%RA at 12:59pm. EMS was called. By the time of their arrival at approx. 1:00pm, she was alert and oriented and able to walk to the gurney without incident.
Otitis externa, bacterial infection of neck- treated with Ciprodex suspension / mupirocin topical / hydrocortisone topical for 7 days Fever, leukocytosis, lymph node abscess, lymphadenitis - clindamycin and ceftriaxone through IV for 5 days. Keflex oral started for 10 days total. Incision/drainage of lymph node abscess Ezcema/rash on face.
On accident grabbed the wrong vaccine. Until entering lot number in the computer realized it was the wrong vaccine. GARDASIL given instead of KINRIX.
Information has been received from a health professional concerning a 3 year old pt who was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast), a 2nd dose of Haemophilus B conjugate vaccine, Prevnar, DPT and poliovirus vaccine. Subsequently, a few hours post vax, the pt experienced a seizure. The pt's outcome was reported as unknown. The pt's seizure was considered to be an "Other Important Medical Event" by the reporter. No further information is available.
4x6cm indurated area w/some soreness;got as large as 7cm x 12cm, resolved on 10OCT97;
pt who was hospitalized was administered 2 doses of rubella vax & devel neg titer;No further details were provided;
within 45 min developed allergic rxn symptoms - throat closing and facial swelling, paresthesia.  Over the following days after vaccine, pt developed muscle weakness, leg stiffness w./ trouble ambulating and chest pains.  Using cane to walk at times.  Has been on disability since vaccine.
The patient currently has no issues to report. The patient was requesting to get the 2nd dose of his Shingrix and the pharmacist did not verify that it had been the appropriate 2 months since the first dose. The patient received a 2nd dose of shingrix just 17 days after receiving the first dose of shingrix.
has been feeling anxious/very very anxious; has some discomfort in the chest; t's more like a strain, like when you lift something heavy and it strains you in the chest, in the muscle; has some discomfort in the throat; acid reflux; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (has been feeling anxious/very very anxious), CHEST DISCOMFORT (has some discomfort in the chest), MUSCLE STRAIN (t's more like a strain, like when you lift something heavy and it strains you in the chest, in the muscle), OROPHARYNGEAL DISCOMFORT (has some discomfort in the throat) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), DULAGLUTIDE (TRULICITY), DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVOTHYROXINE, LOSARTAN, TRAMADOL and TRAZODONE for an unknown indication.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced ANXIETY (has been feeling anxious/very very anxious), CHEST DISCOMFORT (has some discomfort in the chest), MUSCLE STRAIN (t's more like a strain, like when you lift something heavy and it strains you in the chest, in the muscle), OROPHARYNGEAL DISCOMFORT (has some discomfort in the throat), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and HEADACHE (headaches). At the time of the report, ANXIETY (has been feeling anxious/very very anxious), CHEST DISCOMFORT (has some discomfort in the chest), MUSCLE STRAIN (t's more like a strain, like when you lift something heavy and it strains you in the chest, in the muscle), OROPHARYNGEAL DISCOMFORT (has some discomfort in the throat), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and HEADACHE (headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment details were provided by reporter.
Three weeks after her first dose, my daughter started to develop nausea, vomiting, rash all over and fever that lasted 8 days.
Patient completed pfizer series and chose to use moderna booster.  48 hours post vaccination patient began to feel very lethargic, had shortness of breath, anxiety, chest pain, and a sense of impending doom.  patient was treated at a medical center and then by cardiologist.  cardiologist started patient on medications to manage heart/chest pain issues.  patient stated by friday October 29,2021 was starting to feel better.
vomiting, fever to 101, diarrhea within hours of receiving rotavirus vaccine, was seen on 1/8/21 and again on 1/12/21 still with symptoms
Soreness in the injection side; Got pointy pain in the first two fingers of her hand; Pressure on her left side of her chest; Hurt when breath; Pain in the leg when walk and stand; Pain on the joints of her hands; Felt itching in left arm and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Felt itching in left arm and hands), PAIN IN EXTREMITY (Got pointy pain in the first two fingers of her hand), CHEST DISCOMFORT (Pressure on her left side of her chest), DYSPNOEA (Hurt when breath) and PAIN IN EXTREMITY (Pain in the leg when walk and stand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (Felt itching in left arm and hands). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Got pointy pain in the first two fingers of her hand), CHEST DISCOMFORT (Pressure on her left side of her chest), DYSPNOEA (Hurt when breath), PAIN IN EXTREMITY (Pain in the leg when walk and stand) and ARTHRALGIA (Pain on the joints of her hands). On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness in the injection side). At the time of the report, PRURITUS (Felt itching in left arm and hands), PAIN IN EXTREMITY (Got pointy pain in the first two fingers of her hand), CHEST DISCOMFORT (Pressure on her left side of her chest), DYSPNOEA (Hurt when breath), PAIN IN EXTREMITY (Pain in the leg when walk and stand), ARTHRALGIA (Pain on the joints of her hands) and INJECTION SITE PAIN (Soreness in the injection side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient developed bilateral hand swelling, limited range of motion. Mildly warm, erythematous, sausage shaped fingers.
CHIEF COMPLAINT:   pt c/o cough congestion that started 3 days ago   HISTORY OF PRESENT ILLNESS:     60-year-old female with a history of Down syndrome, group home resident presenting for the evaluation of shortness of breath.  The patient reports 3 days of cough and shortness of breath.  Her symptoms have been progressive.  EMS does report that Covid has been present in the patient's care facility.  She denies chest pain.  Her cough is productive.  She denies nausea vomiting or diarrhea.  No fevers.
Unexplainable syncope x2, 40 min apart. Fractured arm due to fall.  Also positive Covid test after receiving vaccine. No symptoms.
got the 1st dose and experienced pain; A spontaneous report was received from a consumer concerning a 61-year-old, female patient, experienced injection site pain.  The patient's medical history, was not  provided by the reporter, included allergy was not reported,  Concomitant medications reported were not included.  On 09FEB2021, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch  number: 026A21A) route of administration not provided for prophylaxis of COVID-19 infection.     Patient received the first dose on 09FEB2021 and experienced injection site pain that started 3 hours after the vaccine administration and lasted 2 days and he received the second dose on 11MAR2021 at 8 am and started experiencing pain around 4-5pm and he couldnt sleep all night due to excruciating pain. The pain subseeded up to 2 days after the second dose, lab data were not provided.Treatment for the events included ibuprofen and acetaminophen medication.  Action taken with mRNA-1273 in response to the event was not applicable.  The out come of the event was not recovered or not resolved.; 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. Further information has been requested
The patient had soreness at injection sight on the night of 9/27/10.  She did not feel well the next day and stayed home from work.  She went to see her doctor 9/29/10 because she still did not feel well and had redness and swelling spreading from injection site.  The doctor prescribed cephalexin.
Soreness in left arm; Chills overnight; Fatigue; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 32-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 as single dose (at the age of 32-years-old) for COVID-19 immunisation. The medical history of the patient was reported as none. Concomitant medication included doxycycline (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 12:00, the patient experienced soreness in left arm, chills overnight, fatigue, muscle aches, headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, chills, fatigue, muscle aches, headache were resolving.  No follow-up attempts are needed. No further information is expected.
Initial report received from other health care professional on 23 Dec 2009: This patient was vaccinated with FLUVIRIN 0.5 ml, intramuscular, on 17 Dec 2009 in the morning. Later on in the same day, on 17 Dec 2009, patient experienced flu-like symptoms, including fever, chills, and muscle pain. Symptoms had not completely subsided to date. The outcome of events were reported as condition unchanged.
Information has been received from a 70 year old female consumer who about two years ago, in approximately 2008 was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that within the past 6 months she developed shingles on abdomen and right rib cage with itching. The patient recently was diagnosed with small cell cancer. At the time of the report, the patient had not recovered. The patient was seen by the physician. Upon internal review small cell cancer was considered to be an other important medical event. Additional information has been requested.
pt appeared pale & quiet a few seconds p/receiving DPT; was sucking pacifier w/easy resp; appeared sleepy;
Within 5 minutes of getting the Moderna COVID-19 vaccine patient C/O tongue feeling fat. She was brought back into the clinic room. B/P 118/74/ O2 Sats 99% & HR 84 beats per minute. She was given cool water to drink. Provided with Benadryl 25mg PO @ 2:52pm.  At 3:00pm client reports that tongue feels normal and pressure around teeth has resolved.  Client to follow up with PCP if needed.  Client left clinic @ 3:02 pm.  RN notified APRN.
Developed pain in arm approximately 1-1/2 to 2 hours after injection which became severe after several hours. Approximately five hours after injection, developed headache, sinus pain and congestion, joint pain, muscle aches and contractions, chills, fever 103°, loss of taste, gout flare-up, and fatigue.  Symptoms persisted for approximately 36 hours. Self-treated with tylenol, OTC nasal decongestant, ice (for arm pain) and lots of water and sleep.
She got 4 different vaccines at her 4yo check up. 2 in each thigh. When we bathed her that night we noticed the injection site on one leg very red and raised into about a 3in wide hive. We didn't medicate and sent her to bed. The next day she was covered from head to toe in small hives. Have one dose (5ml) of BENADRYL. Day 3 she is covered in massive hives head to toe. We called her doctor who said it was ?probably from cedar pollen in the air? and advised to administer BENADRYL and to take her to ER if her breathing got difficult. Obviously we weren't satisfied with that answer so we brought her to Emergency Room. She was treated for and obvious reaction to one or more of the 4 vaccinations by a 3rd dose of BENADRYL and a prescription steroid. Hives went away for about 6hrs and came back much fewer however triple the size and redness of the previous day. We are now on day 4.