chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blind; Blood clot; This is a solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-058583), license party for apixaban.  This 74-year-old male patient was involved in a patient support program. The patient (patient ID: redacted) received APIXABAN. The report describes a case of BLINDNESS (Blind) and THROMBOSIS (Blood clot). Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced BLINDNESS (seriousness criterion medically significant) and THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN (Unknown) was unknown. At the time of the report, BLINDNESS and THROMBOSIS outcome was unknown. The patient stated that he was legally blind and that he developed a blood clot after receiving the Pfizer Covid19 vaccine. For APIXABAN(Unknown), the reporter did not provide any causality assessments. This case was received from a consumer via research group. Patient received apixaban for unknown indication. Follow up cannot be performed as no further information available.  The reporter's assessment of the causal relationship of the events with suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: BMS Medical Evaluation Comment: This patient had blindness and thrombosis while on therapy with apixaban. Based on the nature of the event blindness is considered not related to apixaban therapy. Underlying thromboembolic risk as ascertained by the use of apixaban is a significant factor that likely predisposed the patient to develop thrombosis. Concurrent administration of Covid 19 vaccine is an additional risk factor that could have contributed to thrombosis. The event of blindness is likely an intercurrent condition and is not related with BNT162B2 use. The causal association cannot be excluded between the reported event of thrombosis and BNT162B2 use.  The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
I experienced dizziness, nausea, and headache about an hour after my third Gardasil injection.  My left arm was sore and swollen.  I had all these symptoms, but much less severe after the first and second injections.  I contacted my doctor's office after the third and they instructed me to come in if I felt it were an emergency or take OTC medication for the pain and swelling and see if the symptoms resided.  I took 600 mg of ibuprofen which helped mildly with the pain. The dizziness and nausea were gone within 24 hours.  My arm continued to be sore to the touch and difficult to move for about 14 days post injection; longer than I have ever experienced after a vaccination.
No adverse effects; the administration of one dose of an expired vaccine, GARDASIL 9 (Lot # R024264 / Expiration Date:10/29/2019) to one patient on 11/5/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.      On 05-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength and route of administration not reported; lot # R024264 and expiration date 29-OCT-2019) for prophylaxis (expired product administered). No adverse effects was reported for the patient by the nurse.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-MAR-2011, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, concentration, lot# and expiration date were not provided) for the long term prevention of shingles and zoster-related conditions by a healthcare provider in a clinic. On an unknown date, the patient suffered following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. Pt was treated by a healthcare provider. Outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Severe headache (doesn't go away with Tylonol or Advil). Sore, swollen arm.
Within the hour I had quite a bit of pain at the injection site.; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient stated that, "I received my first dose of your COVID-19 vaccine on 23Dec2020. Within the hour I had quite a bit of pain at the injection site. Not even thinking, I applied heat. Now I am worried I may have messed up the vaccine. The heat was not applied for very long but could I have messed up this very important privilege." Therapeutic measures were taken as a result of event. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
From initial information received at manufac on 16/Apr/2003, it was reported that a 4 month old female infant received second doses of ACTHIB, lot number UA812AA, given in the left thigh and Tripedia, lot number U0853BA, given in the right thigh on 09/Apr/2003. Pt's parent called 2 days later on 11/Apr/2003, complaining of pt having a drooping mouth. On 12/Apr/2003, pt went to doctor's office and complained of right arm and right leg hemiparesis. Pt was referred to a neurologist and was diagnosed with Hemiparesis. Pt was given a CAT scan- results were normal. Reportedly, the adverse reactions are "now completely resolved, date resolved not mentioned." No other vaccinations were reported within 4 weeks of this date. The follow up received on 4/28/03 reported by a physician stated that ACTHIB and TRIPEDIA were given IM, in the morning of 4/9/03. Reportedly, the pt has a history of gastroesophageal reflux disease an dis currently taking Zantac. At the ER, the pt had a head CT, which was normal. The pt was diagnosed with right hemiparesis and symptoms almost completely resolved in a week. No seizures or fever were reported.  Follow up on 07/10/2003: "Reported by a physician, that ACTHIB & TRIPEDIA were given IM in the morning of 04/09/2003.  Reportedly, the patient has a history of gastroesophageal reflux disease and is currently taking Zantac.  At the ER, the patient had a head Ct which was normal.  The patient was diagnosed with right hemiparesis and symptoms almost completely resolved in a week.  No seizures or fever were reported.  From additional information received on 07/01/2003, through telephone contact with the reporting physician, it was reported that the patient was followed up by a neurologist and has completely recovered without sequelae.  No further information is available, therefore, this case is considered closed."
After diaper change, patient began to gasp like he could not catch his breath (per mother).  The episode lasted 3-4 minutes.  She denies loss of consciousness, change in color, or tone.  He remained responsive during the episode.  She brought him to the ED for evaluation.  I am the ED physician who saw him.  His physical exam and vital signs were normal.  CXR and abdominal XRay normal (no signs of inhaled/ingested foreign body).  ECG normal with exception of prolonged QTc.  This was discussed with our cardiology service and patient was deemed safe for discharge to home.
This spontaneous report as received from a physician refers to a 12 and a half years old male patient with wheezing. The patient did not have known allergies. On 11-DEC-2001, the patient received the first dose of VARIVAX (Merck) (Lot # not reported) (0.5ml, subcutaneous) and the second dose of VARIVAX (Merck) (Lot # not reported) (0.5ml, subcutaneous) was administered on 28-APR-2008. There was no concomitant medications. On 21-JUL-2013, the patient experienced a rash and then vesicles appeared with pain and the patient sought medical attention, was diagnosed with shingles at an unspecified medical clinic, the patient was not admitted to the hospital. At the time of the report the patient's outcome was unknown. It was reported that therapy with VARIVAX (Merck) was not discontinued. Additional information has been requested.
Information has been received from a woman in a doctor's office concerning a female pt with no documented allergies or pertinent medical hx who on 17OCT2003 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. The reporter indicated that the pt developed a localized rxn to the vaccination. The pt experienced redness and inflammation at the injection site. The pt also developed a swollen tongue. The pt was treated in the office with oxygen and monitoring. the pt recovered within 30 minutes and was then sent home. The pt has been fine since then. It was noted within 30 minutes and was then sent home. The pt has been fine since then. It was noted that prescription drug was not required. A product quality complaint was not involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. The reporter also indicated that three other pts experienced redness and inflammation at the injection site after therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Had immunizations earlier in the day in our office. Had seizure at midnight. No fever noted before seizure. Had temp of 102 during the seizure.
Patient describes pain in right arm w/ swelling at injection site and feels hard. Pain radiates up shoulder and neck.
Right arm pain x 3 weeks, which eventually radiated up to the Right side of the neck approximately 3 weeks after the vaccination.  Also developed nausea and fatigue approximately 6 weeks after vaccination.  Required ibuprofen to be able to move neck.  Diagnosed with AML on 12/2/2015.  2 days after start of chemotherapy, all symptoms resolved.
Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.
left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "unknown", described as "left arm soreness".  Additional information: The left arm soreness came on fairly immediately after the vaccine injection. She has a titanium in right arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; it itches on the body; like red spots; swollen/sometimes it goes and sometimes it comes; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (it itches on the body), RASH PRURITIC (like red spots) and SWELLING (swollen/sometimes it goes and sometimes it comes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MENSTRUAL DISORDER (menstruation problems/With the menstruation the problems appeared after 15 day from the second dose). 2021, the patient experienced PRURITUS (it itches on the body), RASH PRURITIC (like red spots) and SWELLING (swollen/sometimes it goes and sometimes it comes). At the time of the report, MENSTRUAL DISORDER (menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (it itches on the body), RASH PRURITIC (like red spots) and SWELLING (swollen/sometimes it goes and sometimes it comes) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Reporter stated the village where I live a lot of people is suffering this.   This case was linked to MOD-2021-413613, MOD-2021-413614, MOD-2021-413615 (Patient Link).
According to his medical file documentation while observing pt post immunization, pt had episode of tonic-clonic convulsion. Pt no LOC, no incontinence, no post ictal period. Pt A&O x3. C/o residual h/a. Denies dizziness, visual disturbance, ab pain. On re-examination no facial deficits. A/P post immunization reaction. Will continued for further symptoms. TYLENOL for headache. If condition worsens may 9-11.
I received the 2nd dose of COVID vaccine on 4/9/2021 at 8:15 am, and around 7pm began developing 4 levels of increasingly strong side effects: 1) 7:30 8pm  fatigue and mild fever w/ flushed face, esp. eyes/lips; mild headache starting. 2) 8:30 more feverish/achy w/ uncontrollable strong shakes (tight jaw) when rose to use the restroom; also strong headache with "fiery" sensation on face; 3) 9:00 severe headache and fatigue; inside entire head felt swollen and extra pressure behind eyes. 4) Interrupted sleep/crazy dreams waking every 20  30 minutes; 2-3 AM developed nausea; 3AM took Advil and slept until 5:30 am. Saturday awoke fine -just tired.
pt recv vax 19NOV97 & 21NOV97 late afternoon pt was c/o pain & itching rt arm where Td was given;upon observation mom states had some swelling of entire upper arm to elbow w/red raised rash;area warm to touch & itched;
Have shingles and had all tha vaccines/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have shingles and had all tha vaccines/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received all the shingles vaccines and experienced shingles. The patient stated that the vaccine did not work. The patient received treatment but it was did not work. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
6 hours after shot, broke into big hives on face. Took Zyrtec and Claritin and went away in 30 mins. Some itchiness on body but not hives.
My vision degraded. There was a twinkle or sparkle in my vision. I went back to pharmacy and checked my blood pressure. It was high. I have never had a high blood pressure reading. I spoke with the Pharmacist. She said this was a normal reaction and not to be worried. When I checked the manufacturer website it did not mention anything about high blood pressure as a possible side effect. After about an hour my vision was okay. I checked my blood pressure 4 hours later and it was normal.
This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Caller stated that no side effects have been reported from the patient and had not mentioned whether it was his first or second dose. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. This case was linked to MOD-2021-293191, MOD-2021-293335.
Patient states she has a sore arm and fatigue.  The side effects have continued for at least a month.
TESTED POSITIVE FOR COVID ON          2-2-22                                , DECEASED ON   3-6-22
Pt recvd vax JAN92 & devel was neg for Hep B surface antibodies; No further details were provided;
Arm pain/soreness began about 8 hours after receiving vaccine, lasted for three days- was at it's worst morning after. Slight swelling and knot at injection site also occurred day after vaccine. Headache began morning after receiving vaccine, was off an on for three days. Lightheaded/fuzziness began two days after vaccine, lasted for 12 hours. Symptoms treated with ibuprofen and cold pack for arm.
Pt received FLUMIST H1N1 on 11/20/09 at 7 PM. That evening started having some difficulty breathing that worsened on 11/21. Seen 11/21/09 at ER for respiratory distress. Rx'd as asthmatic. Hospitalized until 11/23/09. 12/02/09 and 12/08/09. Discharge summary, ED and hospital records received for DOS 11/22/09-11/23/09. Pt. presented with respiratory distress and  wheezing which began on 11/21 after receiving vaccination.  Also reported multiple episodes of vomiting.   Symptoms worsened upon awakening and was brought to ED. Treated with nebulizers and  oxygen administration to keep saturations in mid 90's. Admitted to hospital for respiratory management, IV steroids, continued nebulizer treatments, and Tamiflu. Improved and stable at discharge. DC DX: resolved wheezing; history of eczema, suspected allergies
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information:Patient was immunocompromised and told immunologist for the first that  had a reaction to the Pfizer covid. The previous dose felt like everyone else didn't have anything but a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed Ulcerative Colitis shortly after getting the vaccine.  I was defecating blood and lost 50 pounds in the span of a month.
A little discomfort; This spontaneous case was received on 30-Nov-2022 from Communications (reference number: SEQW22-06149) and concerned a female patient of unspecified age. At the time of this report, the patient was 74-year-old.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced a little discomfort.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.   This case is linked to the case 202208649 (the same patient).  Company comment: A female patient was vaccinated with influenza vaccine, on an unknown date. An unknown amount of time following vaccination, patient complained of discomfort. Considering limited information provided, and unclear temporal relationship, causality of the suspect vaccine is unassessable.; Sender's Comments: A female patient was vaccinated with influenza vaccine, on an unknown date. An unknown amount of time following vaccination, patient complained of discomfort. Considering limited information provided, and unclear temporal relationship, causality of the suspect vaccine is unassessable.