chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist refers to a female patient of unknown age. On 13-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
BRADYCARDIA; BROKEN CAPILLARIES; VARICOSE VEINS; SHORTNESS OF BREATH; LUNG ISSUES / PROBLEM WITH THE LUNGS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative via social media concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced health problems that she never had before and the doctors could not diagnose anything. A couple of weeks after she had the Johnson and Johnson vaccine, she developed broken capillaries and varicose veins. It was quick to come on and extreme. Then she had extreme fatigue and shortness of breath. One Doctor said it was bradycardia the other one said it was a problem with the lungs (lung issues) but lung doctor said her lungs were fine. Doctors did not know what it was. She want her healthy life back. Doctors were afraid to get involved was what she thought. They act uncomfortable and politely go to another discussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the broken capillaries, varicose veins, extreme fatigue, shortness of breath, bradycardia and lung issues / problem with the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220246253-covid-19 vaccine ad26.cov2.s-bradycardia. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe headaches every day; Muscle spasms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 17:00 (Lot number: Fa7404) at the age of 36 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Factor V" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 29Jul2021, outcome "not recovered", described as "Severe headaches every day"; MUSCLE SPASMS (non-serious) with onset 29Jul2021, outcome "not recovered", described as "Muscle spasms". The events "severe headaches every day" and "muscle spasms" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, muscle spasms.  Additional information: No covid prior to vaccination not tested for covid post vaccination. No known allergies. No other vaccines in four weeks.  No follow-up attempts are possible. No further information is expected.
Pain in injection arm; muscle ache in arm; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 16:45 (Lot number: Fh8920) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 25Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. Concomitant medication(s) included: ORTHO TRI-CYCLEN LO. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep6955), administration date: 24Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Oct2021, outcome "recovering", described as "Pain in injection arm"; MYALGIA (non-serious) with onset 25Oct2021, outcome "recovering", described as "muscle ache in arm". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: No other vaccine in four weeks, other medications in two weeks: Ortho tricyclen lo, no covid prior vaccination, no covid tested post vaccination and no known allergies. Query: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: Thank you, The first awareness date was onset of the event which was the night of 25Oct2021.
1st - swelling of muscle injected in to size of 1/2 tennis ball, pain when moving arm.  Called drs office was told it was probably an allergic reaction.  Later rash on neck, chest, arms and face - took 2 Benadryls didn't help, then throat started closing went to ER.
swelling in her legs bilaterally; difficulty swallowing; shortness of breath; rash in legs bilaterally; chills; fever; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, LOSARTAN, VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient mentioned that she went for urgent care and she was given some medications.
Rash all over chest, back, on arms, legs, face, lips and scalp. Spots were red in color and would have blisters that would come up and pop. Spots would burn and body felt like it was on fire. They would scab over. Spots were and are sore to the touch. A knot came up on the right side of neck at the base of hair line.  Steroid shots, Antibiotics and ointment was used as treatment.
hot to touch; hot to touch; red face; gets hot and then cold; face gets red and flushed; fever/feverish; chills; swelling injection site/swollen; flu like symptoms; ache joints; lethargy; tired; low energy; The injection site red; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received Shingrix. On 13th October 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness and energy decreased. On 14th October 2019, the patient experienced red face, feeling hot and cold and facial flushing. In October 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced feeling hot and injection site warmth. On an unknown date, the outcome of the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day she developed fever, chills, swelling at the injection site, flu like symptoms, ache joints, lethargy, low energy and felt tired. At the time of reporting she went to work and her face would get red and flushed, she experiences a hot and then a cold feeling off and on. She reports that she was still feverish but has not taken her temperature.  The people had told her that she was burning up after touching her.  The injection site, left arm, was still red, swollen and hot to touch.  The reporter did not consent to follow up. The caller reported that she did not had a treating physician.
Narrative: 78yo male with history of severe aortic stenosis, CLL stage 3 cancer, chronic anemia, heart failure, Afib, Osteomyelitis of pubic symphysis and inferior pubic rami, CAD, COPD, Hx of L MCA stroke in 2020 with residual right sided weakness,PAD s/p bilateral iliac stenting,Lung nodule, Chronic Pain/neuropathy, and Prostate cancer s/p radiation with complicating recto-urethral fistula received covid vaccines on 2/26/2021 & 3/26/2021. Pt was discharged to nursing facility on 5/29/2021. Pt died at facility on 6/5/2021. Prior to death social workers were attempting to place pt in hospice care. Death likely not related to covid vaccinations.
Less than 0.5ml administered, significant amount leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received a Shingrix second dose less than 0.5 ml. The amount of liquid that leaked out was significant. Final reconstituted volume of Shingrix less than the recommended dose. The reporter gave consent to follow up by email. Additional Supportive Information: The patient received less than recommended dose of Shingrix, which led to accidental underdose.
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (route and lot # not reported) 4 days earlier than the prescribed dosing schedule. No adverse effect was reported. Additional information is not expected.
I got tested positive a week after the vaccine; This is a spontaneous report from a non-contactable consumer (patient).   A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a week after the vaccination, the patient got tested positive for COVID-19. It was reported that the patient was supposed to get next vaccine on tomorrow (31Mar2021, next day of this report). The patient was asking whether to received next vaccine or not. The event was reports as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Local site reaction and then 4-5 vesicles on body.  No other infection.  reported to VAERS at parent's request.  Otherwise well.
Shortly after I got my shot within 2 hours it started with body aches, fever 101, headaches, chest tightness for about 4 days. I was taking Tylenol, magnesium, zinc, vitamin c, and was using nebulizer. It felt like I had covid all over again. In beginning of June, I had trouble breathing, my breathing been of since my vaccines. I was rushed to Hospital after I went to Urgent Care, I had a blood clot in my leg and a blood clot in my lung with lung damage. They put me on oxygen, ran test, Heparin drip, antibiotics, Lovenox injections. I went home after 2 days with nursing services for 6 to 8 weeks. I was bed ridden with oxygen, I still have oxygen. I have been off blood thinners for a month and I have to be retested to see if i can go completely off of them or be put back on them.
Day one-approximately five hours after vaccination swelling-upper right arm from shoulder to elbow-approximately the size of a football-slight rash at site-severe pain and restricted movement of arm. Pt took 2 aspirin for pain prior to bedtime. No relief. Pt believes she ran high fever during night because in morning believed she had been hallucinating throughout night. Day two-pain, swelling, rash and restricted movement of arm persists. Nurse at physicians office advised (over phone) tylenol and icing swollen arm. Pain and rash subside, swelling does not. Day 3-AM pt pain free, has full movement of arm. Swelling remains. Pt stops tylenol and icing. Approximately 48 hours after vaccination pt feels severe restriction around right elbow. Swelling has now extended from right shoulder to a point midway between right elbow and right wrist. Pt also feel swelling in right ring finger and numbness in right little finger. Swelling and numbness also in right upper lip. Rash from right arm pit extending throughout swollen area. Pt visits doctor who states it is an allergic reaction to vaccine. Temperature 99.3. Prescribed #21 methylpredisolone dosepak, 4mg. and antihistamine (pt took Allegra D120mg) 2x per day. Day 4-all symptoms subside except for swelling which remains through day 6.
URTICARIA; RESPIRATORY DISTRESS  Narrative:  A 43yo female with historical ADR of respiratory distress and urticarial from an influenza vaccine Type of Influenza vaccine, manufacturer, date and place of vaccination were not specified by the reporting nurse. Unable to find Influenza vaccination history on the patient's Immunization record and unable to access immunization record
itchy, red, rashy, swollen Hard to touch pharmacist suggested ice, Benadryl Dr contacted he will contact pt & also suggested ice & Benadryl
A few days after the vaccine, patient had a (non-febrile) tonic/clonic seizure, during which he became unresponsive/unconscious for 2-3 minutes, with twitching, and change in color (blueish). He was transported to the hospital via ambulance, during which he regained consciousness, and remained in a post-ictal state for about 30-40 minutes. The hospital did not perform any imaging or bloodwork, other than a blood sugar. Patient saw a neurologist later that week. Patient went on to develop daily seizure activity, and was diagnosed with Epilepsy, via EEG in January. At this time he is on 2 anti-convulsant medications to control his Grand mal seizures, and Myoclonic jerks.
Nausea and lightheadedness began about 20 minutes after administration. Lightheadedness abated after about 1 hour, nausea intensified and persisted, abated after about 26 hours. Fatigue  began about 2 hours after administration. Fatigue abated after 24 hours. Severe headache (migraine) began about 2 hours after administration, still persists at 28 hours mark. Injection site tenderness, swelling and redness (2-inch diameter, bright red)  noted about 8 hours after administration,  tenderness persists, redness beginning to abate  at 28 hours.
My left arm, from injection site in the upper arm to the wrist in the lower arm, has ached since the injection. The more I work/exercise that arm, the more it aches.
Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and co-worker). This is the first of two reports. A 61-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: unknown), intramuscular, on 06Jan2021 13:30 at a single dose on left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was also reported that she received the vaccine at a military facility. There were no additional vaccines administered on same date of bnt162b2. Medical history included high blood pressure diagnosed about a month ago (Dec2020) and ongoing, and glaucoma from an unspecified date (diagnosed when she was 15 years old) and ongoing. Concomitant medications included losartan (Manufacturer: Lupin, 50 mg tablet) for high blood pressure, venlafaxine ER (Manufacturer: Aurobindo, 150 mg Prolonged-release capsule) as anti-depressant, latanoprost (Manufacturer: Sandoz, 0.005 %) for glaucoma, and brimonidine tartrate, timolol maleate (COMBIGAN, Manufacturer: Allergan) for glaucoma; all were from unspecified dates and ongoing. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9699), intramuscular, on 19Dec2020 at a single dose on left arm for COVID-19 immunization; there was no adverse event following this vaccination. The patient experienced headache on 06Jan2021 at 11:45 am (As reported, pending clarification). The patient reported that she did not have anything with the first dose. She got the second dose of the Pfizer Covid Vaccine on 06Jan2021 at 13:30. She started getting headache at 11:45 am (as reported) but she didn't think much of it. On 07Jan2021, she had a headache and she took two Tylenol and then went to sleep. She woke up around midnight that night and her headache got a little bit worse, so she took two Tylenol again and fell asleep. In the morning of 08Jan2021, around 2:30 am her headache got worse and worse, and she took three Tylenol. Her headache was still there but it was not enough to go to the emergency room or anything. She panicked on Thursday (07Jan2021) since her headache was still there; her headache was still lingering but it was going away. Her headache pain was at 7 out of 10 on an unspecified date. She stated that she was supposed to work at the time of report, but she called out of work due to her headache. Therapeutic measures were taken as a result of the headache and included treatment with Tylenol 500 mg (lot number: DFE3060A, expiration date: Apr2022). The adverse event did not require a visit to Emergency Room or Physician office. Outcome of the event was recovering.
Onset headaches and constitutional sx post vaccine day #7 with gradual escalation in arthralgia, mostly cervical region - associated with fever to 100.4, ocular pain with normal visual acuity. <20 papulopustular lesion on face, trunk, extremities, marked axillary, not generalized, lymphadenopathy.  05/15/2007 TC from reporter MD in Japan. Wanted to clarify pt's status to VAERS.  MD reports pt did have a rxn to Smallpox (less than 20 lesions and constitution sx.- H/A, fever, tender axillary lymphadenopathy, myalgias) however, the subsequent hospitalization was likely unnecessary per MD.  Facility did not have ability to do an LP for dx of H/A symptoms, so pt was transported and hospitalized.  Hospitalization was due to spinal H/A 2' to LP and development of "Redman Syndrome" due to rapid infusion of abx (Vanc, Gent, and Ceftrax). MD reports pt has fully recovered.  MD will try to get records or will write a case summary and submit. 05/22/2007 Case summary received from MD/reporter in lieu of medical records which will be difficult to obtain as they are in a Japanese facility. Submitted as "Other Correspondence" for scanning.
Pt vaccinated with DTP experienced erythema blotchy rash rear site of immunization.
Fever, NauseaVomiting, fatigue, numbness and tingling right arm and leg.
On 01/23/2022, I woke up in the middle of the night with a fever (99.8) and felt crummy. I felt like I had the flu and was achy. I took ibuprofen and went back to sleep. When I woke up in the morning, the fever was gone but I had a "screaming" headache. I went a took a COVID test at the fire station and it was negative. I still felt achy, feverish and fatigued, which lasted the rest of the day. The headache pretty much went away mid-afternoon with only some pressure remaining. The next morning I woke up and felt almost normal and took another COVID test which was negative. Then, I went to my PCP on (01/25/2022) and got the dual flu test/Covid test and was negative for the flu but positive for COVID (which was only 2 hours after my previous negative COVID test). The fever resolved on Wednesday. I still have some head congestion to this day and some fatigue; however, it improves daily.