chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; passed out twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (Pfizer employee, reported for niece of reporter).  A 43 year-old female patient received bnt162b2 (BNT162B2, Brand: Pfizer), administration date 28Nov2021 (Batch/Lot number: unknown; Lot unknown reason: Not available/provided to reporter at the time of report completion) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2; brand: Pfizer; lot unknown; lot unknown reason: Not available/provided to reporter at the time of report completion), for covid 19 immunization; Bnt162b2 (Dose Number: 1; brand: Pfizer; lot unknown; lot unknown reason: Not available/provided to reporter at the time of report completion), for covid 19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "passed out twice". The event "passed out twice" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of loss of consciousness. The reporter received an email from sister-in law that a very healthy niece who received her third dose of the Pfizer Covid shot the day before reporting day, passed out twice and was now at the ER in [State name]. 30 years ago her twin brother received a shot (it may have been a rubella shot), was paralyzed for a short time and still had some side effects. The reporter did not remember the name of the condition that he had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown.  Information on the lot/batch number has been requested.
Information has been received from an office manager concerning a 15 month old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number 656572/0115U). It was reported that after receiving the vaccine the patient developed varicella like lesions, less than 50 on the trunk and legs. A lot check has been initiated. Follow up information was received from a health care professional requesting a lot check on varicella virus vaccine live (Oka/Merck) (lot number 656572/0115U). This is one report from the same source. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
lesions on  legs/ lesions on arms and neck/ skin issues; has scars that are awful; these marks that are gray in color and all over his arms and going up his neck too; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient AIC is 5.7 to 5.9 for the past three years, takes insulin) since 2016.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too). At the time of the report, SKIN LESION (lesions on  legs/ lesions on arms and neck/ skin issues), SCAR (has scars that are awful) and SKIN DISCOLOURATION (these marks that are gray in color and all over his arms and going up his neck too) had not resolved.            No concomitant medications were reported  The patient stated that he's been to the emergency room 4 times for skin issues and still not going away  For treatment the patient had tried 4 different cream and nothing was helping.They don't itch.   This case was linked to MOD-2021-009530 (Patient Link).
Started to feel like my breath was being taken away at times for a few days (started a few days prior to 1/2/2021. Also, I felt like my heart was racing and having heart palpitations. On 1/2/2021, I noticed a inflamed rash over the injection site. It was slightly warm to to the touch and slightly sore. The rash had a red line around it with red spot inside the circle. The rash was gone by the morning on 1/3/2021.
Left ankle swelled up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Left ankle swelled up) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SWELLING (Left ankle swelled up). On 22-Apr-2021, SWELLING (Left ankle swelled up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-273091, MOD-2021-273091 (Patient Link).
swollen posterior cervical nodes 2-3D p/vax & still swollen;fever 103.6 next day x3D;leg pain pt would not walk, was carried w/in nl range of rxn;occurred 1-2d later & cont;2&3 occured that evening, APAP didn't help lasted 2-3 days;
shingles; Information has been received regarding a case in litigation from a lawyer and refers to a currently 88-years-old patient of unknown gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date was not provided) by a pharmacist (as prescribed by a healthcare professional) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of shingles was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Pt received vaccine Wednesday night. Mom first noted ran last night as red arm/very itchy. No change today 5-6 cm by 4cm cm erythematous swollen left arm, around Flu shot site. No tenderness to touch.
Information has been received from a registered pharmacist concerning an actually 78 year old female patient with hypertension, allergy to LEVAQUIN, cephalexin and sulfonamides who on 01-JUL-2005 was vaccinated with the second dose of PNEUMOVAX 23 (Lot# and expiration date not reported). Concomitant therapy included ZOLOFT. Pharmacist reported that the patient experienced left arm swelling after administration of her second dose of PNEUMOVAX 23. The patient sought medical attention through an office visit. It was reported that the patient was treated with unspecified medication by doctor. At the time of reporting the patient had recovered on an unspecified date. Follow-up information was received indicating that there were no records. No further information is available.
Information has been received from a office manager concerning a 14 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 660387/1967U). On 27-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (Lot number 660553/0070X) and on 24-NOV-2008 with the third dose of GARDASIL (Lot number 661764/0650X). In September 2008, the patient complained of tiredness. The patient was cultured and was positive for mononucleosis. In January 2009, the patient began to felt awful and really bad. The patient had some laboratories taken and her blood work came back as: WBC-2, platelet-150, and no leukemia. The patient was hospitalized for one week. She had since been released from the hospital. Additional information has been requested.
Myalgia, Fever, Swollen,red, and tenderness at injection site, sweaty Narrative:
pt to hospital with increasing weakness and difficulty ambulating; was scheduled to have left 3rd toe amputated on 1/4/22 but tested positive for COVID; not in any respiratory distress; doesn't need O2 initially; started on steroids and antibiotics; eventually became hypoxic; AHRF requiring 10L O2; septic shock; transferred to ICU; placed on BiPAP; eventually required intubation; suffered A Fib with RVR; cardiac arrest; family made decision to make pt DNR/DNI; withdrew care and pt died in the hospital
Swelling; Redness; Joint pain; Couldn't put pressure on her left heel; All night kept me awake; Tingling in both arms and hands; Numbness in both arms and hands; lost appetite; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in both arms and hands), HYPOAESTHESIA (Numbness in both arms and hands), PAIN IN EXTREMITY (Couldn't put pressure on her left heel), SLEEP DISORDER (All night kept me awake) and DECREASED APPETITE (lost appetite) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Carotid artery occlusion (carotid artery blockage in the neck), Cholesterol high, Blood pressure high and Polio. Concurrent medical conditions included Hypothyroidism and Glaucoma.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite). On 17-Apr-2021, the patient experienced PARAESTHESIA (Tingling in both arms and hands), HYPOAESTHESIA (Numbness in both arms and hands) and SLEEP DISORDER (All night kept me awake). On 18-Apr-2021, the patient experienced PAIN IN EXTREMITY (Couldn't put pressure on her left heel). On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness) and ARTHRALGIA (Joint pain). On 18-Apr-2021, PARAESTHESIA (Tingling in both arms and hands), HYPOAESTHESIA (Numbness in both arms and hands), PAIN IN EXTREMITY (Couldn't put pressure on her left heel) and SLEEP DISORDER (All night kept me awake) had resolved. At the time of the report, DECREASED APPETITE (lost appetite) and ARTHRALGIA (Joint pain) had resolved and SWELLING (Swelling) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she takes medication for all the medical conditions she is having but did not provide any further information.  Treatment information was not provided.   This case was linked to MOD-2021-148785 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient details, new event (loss of appetite) and vaccination date was updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Patient presented to the ED on 4/11/2021 and was subsequently hospitalized for pneumonia and pulmonary edema. Patient presented to the ED on 6/4/2021 and was subsequently hospitalized for third degree heart block. These visits are within 6 weeks of receiving COVID vaccination.
pt woke up 24AUG93 @ 5AM w/muscle cramping in legs, arches of feet, back & neck; neck was stiff; pt went to sports practice-though not feeling well; stomach muscles tight; had h/a, hands were weak; t101.5 & chills;
Received flu vaccine at around 11:15 am. Started having difficulty breathing, poor color. Was given 0.3 mL Epinephrine @ 11:51 am. B/P 142/78 P - 90. She appeared to improve slightly; was taken to E.R. for further eval
Nausea and headache mild beginning 5 hours after vaccine. Then in middle of night, moderate nausea, chills, fever, moderate muscle and body aches and moderate headache. These moderate issues continued throughout day after vaccine. Motrin and Tylenol helped a lot.
After the vaccine I had the expected: arm tenderness, headache, sore throat, body aches.  Then on the 18th in the middle of the night I felt twitches in my chest and discomfort and tightness. It felt to me similar to my pulmonary embolism. I had some twitching going up the right side of my neck too.  I do feel congestion, which is creating me becoming out of breath doing normal activities. I kept thinking: Should I go to the hospital?   It?s day 5 since the booster. I?m going to get a covid test just in case. I?ve never reported information such as this, but am interested to see if people who have had a PE are having similar reactions to the booster.
-C/O of tingling sensation near left cheek/left mouth; vaccine given at 1:08pm adv rxn occurred at 1:38pm; Moderna 008B21A
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number B4277, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number BA975, expiry date unknown) for prophylaxis.   On 20th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 4 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171174   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving 1st dose of Pediarix, 1st dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: US-GSK-US2022AMR148961:
received her first dose of MENACTRA when she was 10 years and 8 months old, the patient received a second dose of MENACTRA when she was 14 years and 7 months old, with no reported adverse event.; received her first dose of MENACTRA when she was 10 years and 8 months old, the patient received a second dose of MENACTRA when she was 14 years and 7 months old, with no reported adverse event.; Initial information received on 02-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old female patient who received her first dose of meningococcal a-c-y-w135 (d conj) vaccine [MENACTRA] when she was 10 years and 8 months old, the patient received a second dose of menactra when she was 14 years and 7 months old, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Meningococcal a-c-y-w135 (d conj) vaccine ( Strength, dose, formulation, lot number and expiry number: not reported) via unknown route in unknown administration site and on an unknown dates 1 other doses were administered for suspect meningococcal a-c-y-w135 (d conj) vaccine ( Strength, dose, formulation, lot number and expiry number: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient received her first dose of menactra when she was 10 years and 8 months old, the patient received a second dose of menactra when she was 14 years and 7 months old, with no reported adverse event (Drug use in unapproved age group)  (Drug use for unapproved schedule) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event Drug use in unapproved age group and Drug use for unapproved schedule.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt is fully vaccinated with Pfizer as of 1/2021.  Pt reports covid symptom onset of congestion, cough, sore throat, runny nose and headache starting 8/27/21. Tested covid positive with PCR NP swab on 8/30/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 14:00 as dose 1, single (Lot number: en5318), in right arm, on 01Mar2021 as dose 2, single (Lot number: fn6200), in right arm, on 27Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 30145ba), in right arm and on 22Jul2022 as dose 4 (booster), single (Lot number: fj4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type II" (unspecified if ongoing), notes: Other medical history: Diabetes type II. The patient's concomitant medications were not reported. Past drug history included: Ciproflaxin, reaction(s): "Known allergies: Ciproflaxin", notes: Known allergies: Ciproflaxin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive; (10Feb2023) Negative; (14Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
New onset of significant sinus arrythmia palpitations became significant on 4/14/22 after #4 vaccine of 4/8/21.   Onset 4/13.  Sx severe enough to trigger urgent care evaluation.  Very symptomatic irregular heart beat found to be sinus arrythmia.  Condition was easily noticed on EKG's and physical exams on 4/14/22 pm and 4/15/22 am.  D-Dimer elevation of 1.82 (<0.52).  This triggered a CT angiogram which was normal.  Sx resolved after 4/15/22.  Holter was essentially normal 4/22-4/24/22.
No additional AE reported; during administration of  MMR II dose, patient moved her leg and she only received about half the dose; This spontaneous report was received from a medical assistant student and refers to a 2-year-old female patient.   The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 28-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) subcutaneous injection, 0.5 ml, lot # U017524, expiration date: 03-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstituted with a sterile diluent (Inappropriate age at vaccine administration). During administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) dose, the patient moved her leg and she only received about half the dose (Accidental underdose). Agent confirmed there was nothing wrong with the product. No additional AE reported.   This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000351:
fever; irritability; constant crying for 3 days (frantic crying) leg not straight, but bent; loss of appetite, loss of sleep;