chrisvoncsefalvay/vaers-outcomes huggingface dataset:
46 year old healthy female, clot within 48 hours, resulting in stroke. No history of cardiovascualr or stroke issues, no family history, etc.
Initial misuse case was received from a health care professional on 25 OCT 2013.  Cases were received on 21 March 2014 at GPV. A 24 year old patient whose demographic details, medical history and concomitant medication was not reported received a does of FLUZONE ID on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received vaccine in incorrect age. Laboratory investigation were not reporter. No adverse event was reported. List of documents held by sender were none.
Patient developed 3 inch circumference erythema swelling and itching of left upper arm. It appears injection was not given in deltoid muscle, as the injection site was 3 inches above elbow (vaccine was given at Walmart )
Pretty bad stomach pain, that comes in persistent waves while standing, makes "me" unable to go to work; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Oct2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Sep2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 07:00, the patient experienced pretty bad stomach pain, that comes in persistent waves while standing and made him unable to go to work. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pretty bad stomach pain, that comes in persistent waves while standing and made him unable to go to work was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. given  vaccines. Pt. sitting on exam table. Advised to wait in room while I finish documentation, and I would be back to discharge them. Once back to the nurses station heard pt. grandfather yelling help. Provider and I entered the room and found grandfather holding pt. up. States that she fainted and fell off bed. He caught her, but her chin hit the floor.
Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, vision going black like I was going to pass out, it passed in about 5-10minutes of laying down; also had metallic taste in mouth the rest of that day. Thursday I just felt red, itchy, swollen L arm due to vaccination site. Friday morning my bottom lip was severely swollen with numbness and tingling. It went down by the next day and after taking Benadryl. I have not had an allergic reaction to anything in my life before. Was instructed to not get second vaccine as I may have a more increased reaction to it.
Large localized area of erythema near injection site.  Appears to be local allergic reaction.
Following the administration of seasonal flumist, Gardasil, and PPD Mantoux test, patient became faint, pale, shaky, and incontinent. She did not lose consciousness or fall. Patient assisted to lie down with feet elevated, drink two juice boxes, cool rags placed on forehead and neck. Within 2 minutes, patient returned to normal color, and no longer was faint or dizzy. Paitient instructed to sit in chair and remain seated for 15 minutes prior to leaving clinic. Upon leaving clinic, patient continued to be free of dizziness or faintness, and kept normal coloring.
Patient received under diluted dose of Covid 5-11 vaccine. No adverse effect reported by parent.
This case was reported by a healthcare professional and described the occurrence of itchy skin rash both forearms in a 40-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 20 March 2012 at 08:50 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm and experienced vaccine underdose. The indicated adult dose for HAVRIX is 1 ml and the subject was only administered 0.5 ml. On 20 March 2012, 10 minutes after vaccination with HAVRIX, the subject experienced itchy skin rash both forearms (rash that was itchy on the lower part of both arms). The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE and BENADRYL. The events improved after 15 minutes of administration of EPINEPHRINE and BENADRYL. No other events were noted. It was additionally noted that the actual injection site had no reaction at all. It was unknown if the subject had experienced any adverse events following previous vaccinations. The lot number was reported as AHAVB4938A from the reporter; however, based on safety lot number review, the lot number was corrected at initial entry to AHAVB493BA.
This spontaneous report as received from a physician via company representative refers to three unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On 24-JUN-2015 the three patients were vaccinated with an unspecified dose of GARDASIL 9 (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant medications were unspecified. The three patients reported that, on the same day, they experienced a tingling sensation in their arm as the vaccine was being administered. The three patients also stated that the arm that received the injection felt numb and also experienced soreness at the injection site following the administration of GARDASIL 9 on 24-JUN-2015. The three patients were called by the physician's office on 25-JUN-2015 and stated that they no longer experienced the injection site hypoaesthesia and paraesthesia, only the injection site pain. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as the reporter did not wish further contact.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was inoculated with ZOSTAVAX on or about 17-OCT-2014 at a pharmacy for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX (onset not further specified), the patient developed an intermittent, sharp throbbing pain on the left side of her face. Thereafter, she was diagnosed with trigeminal neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Since receiving the Pneumovax vaccine in her right arm, the patient's right arm has been red, swollen, and painful, from her elbow to her shoulder. She states she has edema pooling around her elbow and her arm is in a lot of pain. She had a Fluzone HD in her left arm with no reaction.
On 4/21/03 given Hib and DTaP in R thigh developed redness and warmth at injection site on 4/22/03. Treatment-Keflex 250/5 2.8ml PO q8h (tid) x 7-10 days.
Pt's right thigh and leg indurated with height of 12 mm X 14mm to the side.
Covid-19 Moderna Shot 3 given on 3 December 2021 with reaction on 13 December 2021. The reaction included full body urticaria and respiratory distress. Patient presented to the emergency department for care. He was given a short course of steroids and antihistamines. The short course of steroids led to improvement in respiratory symptoms but his urticaria remained. Outpatient follow up led to use of fexofenadine 180 mg taken as three pills daily. He was also prescribed albuterol sulfate 90 mcg taken as needed for respiratory difficulty. An EpiPen was prescribed for emergencies if needed. The fexofenadine was managing his symptoms adequately with a reduction in severity of his rash. However, the patient tried to decrease his fexofenadine down from 3 pills daily to two and later to one pill but each time he has tried to decrease dosing his rash has recurred. He was referred to allergy and immunology for assessment and allergy testing. Allergy and Immunology continued with antihistamine use but no additional medications have been used. He has had continued symptoms for 8 weeks as of 2/8/2022. He was recently referred to Dermatology for additional evaluation and management.
Systemic rash on face, torso, arms, legs, plantar surface of hands/feet.
Pt stated nausea 18 hours after receiving the vaccination that culminated in an emetic episode. Pt is still recovering from the nausea, but stated that his symptoms have not exacerbated since throwing up at 05:45.
fever; chills; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male consumer received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the right arm on 18Feb2021 at 08:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin 10 mg, finasteride 5mg, and aspirin [acetylsalicylic acid] 81 mg, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EL9262) in the left arm on 28Jan2021 at 14:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on the night of the second injection, also reported as 19Feb2021 at 00:15, he developed fever and chills. The next morning, he had a fever of 101.4 and took 1300 mg of acetaminophen. The rest of the day his temperature averaged 99.7. The next morning his temperature was 97.7 and he felt much better. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of fever and chills were recovered in Feb2021. It was also reported that since vaccination, the patient had not been tested for COVID-19.
light headed/dizzy; a little confused sometimes; monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round; monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jan2022 10:30 (Lot number: FJ5682) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bipolar 2" (unspecified if ongoing); "depression" (unspecified if ongoing); "GAD" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "allergies to Avocado" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included: LAMICTAL. The following information was reported: POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 17Jan2022, outcome "recovering" and all described as "monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round"; DIZZINESS (non-serious), outcome "not recovered", described as "light headed/dizzy"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "a little confused sometimes". The patient reported that monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round. The second round was 3 days ago, and she was still light headed, dizzy, and a little confused sometimes. Therapeutic measures were not taken as a result of polymenorrhoea, heavy menstrual bleeding, dizziness, confusional state. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Wednesday morning after vaccination, felt achy. Then late morning experienced facial swelling, swollen glands in neck, skin on face red and tender-to-touch. Swelling so severe could not breathe out of her nose or see.
At 10 minutes post-vaccination, patient had noted a dry, scratchy feeling in her throat and asked if I (mom) had brought a water bottle with us (I had not).  At 20 minutes post-vaccination, patient began feeling her throat tightening, tongue swelling, and stated that her lips/mouth/tongue had a tingling sensation. At this point she was taken to the nurse/paramedic to be monitored with EKG, pulse oximetry, and given a bottle of water to drink. After 30 minutes of monitoring, the nurse/paramedic asked patient if her symptoms were improving and if she felt well enough to go home.  She said that her symptoms were not gone, but improving, so she was told to sign a waiver/refusal of care form and released. However, at 11 hours post vaccination (1:30 AM), the symptoms returned (tongue swelling, throat tightening, tingling sensation in and around her mouth).  I administered Benadryl (2 tablets), monitored for 30 minutes, and symptoms improved.   No further symptoms after that point.
Fever, chills, body aches, headache, nausea, fatigue. Symptoms lasted 24-48 hours. All symptoms were gone by 48 hours.  Treated with ibuprofen and bed rest.
Information has been received from a registered nurse concerning an 80 year old female with a history of tetanus.  On 17-OCT-2006, the patient was vaccinated intramuscularly in the right deltoid with the second dose of Pneumovax 23 (Lot# 651399/0486F).  At the time of the vaccination, the patient was noted to have redness of arm.  On 19-OCT-2006, the patient was seen in the emergency room (ER) with right forearm redness which he felt to be an allergic reaction to Pneumovax 23.  The patient was treated with steroid dosing and CEFALEXIN.  On 20-OCT-2006, the patient was seen in an office visit and her arm was feeling better with a little more redness.  It was reported that the patient was recommended not to receive the Pneumovax 23 again.  It was reported that the symptoms resolved.  At the time of this report, the patient had recovered from the events (date unknown).  It was reported that on 23-NOV-1999, the patient was vaccinated with the first dose of Pneumovax 23.  Additional information has been requested.
Vaccination failure; shingles; shingles pain/painful rash; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and etanercept (Enbrel) for rheumatoid arthritis.   Previously administered products included Enbrel with an associated reaction of herpes zoster. Concurrent medical conditions included rheumatoid arthritis.   In April 2018, the patient received the 1st dose of Shingrix (intramuscular). In May 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started Enbrel at an unknown dose and frequency. In May 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In January 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: It was reported that prior to getting Shingrix she developed shingles while taking Enbrel. The patient stopped taking Enbrel and waited sometime after shingles resolved before getting Shingrix. The patient received 1st dose dose of Shingrix in April 2018 and the 2nd dose of Shingrix in May 2018, only one month later, which led to shortening of vaccination schedule.  About one month after the 2nd dose of Shingrix, she restarted Enbrel. She developed shingles in January 2019 and had 2 to 3 cases since then and currently had shingles.  She stated each time she started taking Enbrel, she developed shingles.  She had seen her primary care physician, an emergency room doctor, her rheumatologist, an infections disease doctor and an after hours doctor about the cases of shingles she had experienced.  At least twice the provider she saw stated that she did not have shingles and a blood tests was performed which came back positive for shingles. Several of the providers never looked at her back, where she was experiencing the shingles pain, while declaring she didn't have shingles. Since it was on her back she could not see if she had a rash. For her most recent case of shingles she saw the after hours doctor, who actually looked at her back, and stated she did have shingles. The reporter considered shingles and painful rash to be related to Shingrix and Shingrix. The reporter consented to follow up.
anaphylactic reaction started 15 minutes after the injection, with blotchy skin, throat irritation and cannot swallow own saliva. EpiPen administered immediately with improvement.
Experienced arm soreness after 1st dose; This is a spontaneous report from a patient via Pfizer-sponsored program. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from an unknown date in 2013 to an unknown date (she had a breast cancer and had a lump, and everything removed). The patient's concomitant medications were not reported. The patient experienced arm soreness (caller stated that it was like someone took their knuckle, the middle finger knuckle and hit you right where the injection was, also when she lifts her arm in the air it would hurt, not bad just that you can tell that there was something there) in after first dose few weeks ago of Pfizer-BioNTech COVID-19 vaccine on 29Jan2021, caller stated that she took a couple of TYLENOL's and she was ok. She wanted to know what she should expect with second dose. The event was reported as non-serious. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Pt recvd 4 doses of Engerix-B & had mild blurred vison p/2nd & 3rd doses but did not report this; 8MAR92 devel double vision for distance both horizontal & vertical & episodic diplopia;
pt recv vax 26SEP96 & on 24APR97 pt devel vax & recovered;
This was after second covid vaccine-rash on arms legs and stomach doctors have tried many treatments nothing has worked; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 12:00 PM at age of 63-year-old as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes and heart stent. No known allergies. No covid prior vaccination. Concomitant medications included apixaban (ELIQUIS), empagliflozin (JARDIANCE), metformin, and clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This was after second covid vaccine on 16Apr2021 08:00 AM, rash on arms legs and stomach doctors have tried many treatments nothing has worked. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, has the patient had not been tested for COVID-19. Different prescription creams and prednisone received. Outcome of the event was not recovered.  Information about batch/lot number has been requested.
Redness and swelling at both vaccine site started 2 days after vaccination. 9 days later started having vomiting, diarrhea, and macular rash on trunk.
The evening of the vaccine, the patient experienced severe muscle pain and an inability to move left arm. This continued until the next morning when she notified the provider.
If I scratch my arm blood pools under the skin of both forearms ? even now. Bloodwork is ?normal? except for low stored iron.  Some random bruising  Long term pain in the arm of the Injection site
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 17:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
lt leg swelled immediately p/recvd inject; swelling remained for 2 days; also had fever that lasted for 4 days; dx w/ear infection;
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-JUN-2018, the patient was vaccinated with VARIVAX (strength and dosage schedule were not reported) intramuscularly, for prophylaxis (lot number: N014369, expiration date: 21-JUN-2018) which was reconstituted with sterile diluent (lot number: N014365, expiration date: 11-OCT-2019). No side effects were reported.
This spontaneous report as received from a registered nurse via a company representative refers to a 7 year old female patient. On 17-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that the vial was expired by 2 months. Right after the expired vaccine was administered that day, 17-MAR-2014, the child was given another dose of PNEUMOVAX 23 that was not expired. There were no adverse effects reported at that time. There were no laboratory studies performed. Additional information has been requested.
Rash on face, scalp, arms and abdomen that started 7/28/05.