chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 544 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom reports immun recvd 12noon & rxn started 2PM "non stop" high pitched screaming, crying x 7 hrs; very irritable that night; dad held pt most of night-only way consoled; t103 ax; redness, tenderness, swelling @ inject site, knot @ site;
Painful swelling of lymph nodes on left side. Armpit feels like it?s on fire from the inside, ache radiating down my left arm and into my thumb, burning and inner itching on outside area of left breast. No treatment due to not having a PCP.
Patient Fainted 2 minutes after vaccine. He was sitting in chair and fell (caught by family) and woke up instantly. As I arrived, 10 seconds after fall, his eyes were open but he could not see anything. He was able to state his name, date of birth, and where he was, just couldnt see. "Everything is all black." After closing eyes for 30 seconds, opened and he could see, but everything was green. Vision color was back to 100% after 20 minutes but still blurry. Patient BP was normal. Sweating.
Case number PHEH2011US01743 is an initial spontaneous report received from a nurse on 04 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenCWY liquid conjugate component of Menveo vaccine intramuscularly on an undetermined date. No other adverse reaction was reported.
Pt C/O scratchy throat, facial and scalp itching and cold sensation extending down face neck shoulder to back area
second has not been administered; Covid-19; This case was reported by a pharmacist and described the occurrence of coronavirus infection in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 14th November 2020, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the coronavirus infection and social problem were unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose. The patient missed to receive the second dose of Shingrix at appropriate time, probably due to pandemic. It should have received until December 2019. Additionally, the patient was recently diagnosed with Covid-19. The reporter consented to follow up.
The whole room got dimmer after receiving the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 130B21A and 001B21) for COVID-19 vaccination.     The patient's past medical history included Migraine (She has migraine 10 years back.). Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, LOSARTAN, DILTIAZEM, CETIRIZINE HYDROCHLORIDE (ZYRTEC), FLUTICASONE PROPIONATE (FLONASE), SALBUTAMOL SULFATE (ALBUTEROL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MAGNESIUM, IRON (IRON Supplement) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine). In April 2021, VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Additional information received on 04 June 2021 in which patient initials updated. On 30-Jun-2021: Significant Follow-up document received on 30 June 2021 with patient's current medical condition reported.
I was eating dinner then I felt hurt in my vulva felt very sore I did see my doctor which they mentioned this could be a chronic issue for the treatment they just increased my asteroid compound
Pain at the Rt Upper Arm Immediately post Flu vaccine. Pain scale peak at 8/10, currently 4/10 after two 16 days. Rt upper arm intermittent shooting pain with Rt posterior form arm pulsating pain developed on day 3rd after the immunization (1/15/21), worse pain at 9/10 at  the beginning, now 4/10. No numbness in the area, muscle strength was not affected.
Woke up on the middle of the night extremely dizzy  this interrupted her sleep; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep) and PAIN IN EXTREMITY (Sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Feb-2021, the patient experienced DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep). On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 17-Feb-2021, DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Fever 2-3 hrs p/immun; Next day hives 3MAY91; blisters agitated; DPH & topical cream given;
Fever, chills, nausea, vomiting, dizziness, generalized ache for 24 hours.  Tylenol, Zoran, Pepcid
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 2/24/21 and 3/22/21. Presented to ED after being discharged 48 hrs prior for COVID PNA. Admitted for c/o worsening malaise and weakness with acute hypoxemic respiratory failure 2/2 superimposed PNA. Developed a completely opacified L hemithorax on CXR and on CT noticed to have a large effusion and/or necrotic lung post radiation, possibly a developing abscess. Transitioned to comfort care; expired 9/19/22. Tx'd w/zosyn, methylprednisolone, doxycycline, and ceftriaxone.
After receiving 1st dose, he had little soreness, pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm). At the time of the report, PAIN IN EXTREMITY (After receiving 1st dose, he had little soreness, pain in right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-296101 (Patient Link).
Symptoms began Saturday afternoon:  fatigue, nausea, headache, chills, muscles ache. Diarrhea began on Sunday around 3pm
Blood clot on his left leg, from his groin to his ankle/still having the blood clot; A spontaneous report was received from a consumer concerning an 80-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and had blood clot on his left leg, from his groin to his ankle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039KZ014) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Jan 2021, approximately two weeks prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient reported having a medically significant event, blood clot on his left leg, from his groin to his ankle and is still having it. The patient taking medication for it.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the event had blood clot on his left leg, from his groin to his ankle was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This is a spontaneous report received from contactable reporters (Nurses) from medical information team. An 11-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 2 (orange cap), 0.2 ml single (Lot number: FL8095) intramuscular, in left deltoid for COVID-19 immunisation. The patient's relevant medical history included: "Seasonal allergic rhinitis", start date: 12May2014 (ongoing); "Parental concern with child(s) weight", start date: 19Feb2021 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 26May2022, outcome "unknown" and all described as "0.2mL undiluted pediatric dose"; PYREXIA (non-serious) with onset 27May2022, outcome "recovered" (28May2022), described as "fever"; HEADACHE (non-serious) with onset 27May2022, outcome "recovered" (28May2022); NAUSEA (non-serious) with onset 27May2022, outcome "recovered" (28May2022); VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 27May2022, outcome "recovered" (28May2022) and all described as "pain and swelling at injection site". The events "0.2ml undiluted pediatric dose", "nausea", "pain and swelling at injection site", "headache" and "fever" required emergency room visit. Therapeutic measures were taken as a result of overdose, product preparation error, nausea, vaccination site pain, vaccination site swelling, headache, pyrexia. The reporter considered "0.2ml undiluted pediatric dose", "nausea", "pain and swelling at injection site", "headache" and "fever" not related to BNT162b2. Additional information: On 08Aug2022, a reporter elaborated that the medication error occurred during preparation/administration. It involved diluent not being added to vaccination due to human error. The patient had increased side effects including nausea, pain and swelling at insertion site, headache, and fever. The patient was seen in the emergency room on 27May2022 and was administered Zofran and ibuprofen. No additional follow-up nor relevant test was conducted and the patient was discharged on the same day (27May2022). The patient fully recovered on 28May2022. The patient had no prior vaccinations within 4 weeks. No follow up attempts are needed. No further information is expected. Follow-up (08Jul2022): Follow-up attempts are completed. No further information is expected. Follow-up (08Aug2022): This is a spontaneous follow-up report from a contactable Nurse. Updated information included: new reporter, patient information, relevant medical history, suspect product details (dosing regimen, vaccination facility), reaction data (event onset date, causality assessment, emergency room visit, treatment received), new events (nausea, vaccination site pain, vaccination site swelling, headache, pyrexia), clinical course details.; Sender's Comments: Reported events are probably associated to the overdose use of the suspect drug BNT162b2 and are therefore not related. Case to be re-assessed upon receipt of new information.
Site: Pain at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too Low, Additional Details: upon administration vaccine squirted out of syringe instead of entering patient, leur lock of the syringe was faulty, prior to administration leurlock was tightened, pt was revaccinated with a quarter of the 0..5 ml dose.
Information has been received from a licensed practical nurse concerning a 67 year old male with no drug allergies who on 26-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin, ZANTAC, INDERAL LA, GLUCOPHAGE, lisinopril, ASTELIN, NIXIUM, FLONASE and PEPCID. "Within 10 days of vaccination", in approximately July 2008, the patient developed an "itching, burning" rash on both arms and legs, trunk and groin. The patient went to see a physician. No laboratory diagnostics studies were performed. The patient had been treated with triamcinolone and hydroxyzine. At the time of report, the patient was recovering. Additional information has been requested.
Headache, Sedation, NauseaVomiting, Swelling @ injection site, Chills Narrative:
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning.  26 minutes later the symptoms are followed by cold sweats.  She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing.  Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis.  Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication.  Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems.   Patient did not receive any additional therapy in the ED.  She was observed for 2 hours in the ED and was subsequently discharged home.
COVID breakthrough case; COVID breakthrough case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162B2 (BNT162B2), intramuscular, administered in arm right, administration date 15Oct2021 09:00 (Lot number: EW0217) at the age of 52 years as dose 3 (booster), single; intramuscular, administered in arm left, administration date 16Feb2021 09:00 (Lot number: EN5318) at the age of 51 years as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 10:00 (Lot number: EN5318) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ADVIL [IBUPROFEN]. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no history of COVID-19 prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022 12:00, outcome "recovering" and all described as "COVID breakthrough case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2022) negative, notes: Nasal Swab; (14Jan2022) negative, notes: Nasal Swab; (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
The evening after her second COVID shot, the patient experienced a 10-minute seizure where she was unable to move or uncurl her fists. Afterwards, she began to loosen-up, hyperventilate and then passed out twice. After this, she lost vision for 5 minutes. Then she became very hot with profuse sweating, ringing ears and dizziness. She then got cold sweats and chills for about 30 minutes. After this, she still had some tension in her calves. It took another 30 minutes before she was able to walk again. She took some Tylenol for the pain. Later, when she took her temperature, it was normal. She has been tired and resting since the incident but has not had any more seizures.
Felt dizzy following shot. Developed tremors of arms and legs. (BP 166/97, P 117) Bright red flush on face and neck. BP rose to 200/100, throat was dry and she couldn't swallow well. 911 was called. Oxygen applied by 911 EMS personnel, IV started. Arms and legs flaccid, patient was unable to move them. No respiratory distress. In ER for 2 hours given vistaril.
acute kidney renal failure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "acute kidney renal failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24OCT95 1PM terrible h/a;aching all over; went home from school on 24OCt; did not work 25OCT95; pain started in lt arm & spread;joints in legs & feet hurt;fever on 25OCT95; called PMD;feel like run over by truck;
difficulty breathing; Rapid heart rate; chest tightness; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: EW0196) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose single, solution for injection, lot number=EW0167, vaccine location=Right arm), administration date: 27Aug2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "difficulty breathing"; HEART RATE INCREASED (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "chest tightness"; PAIN (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "pain". The events "difficulty breathing", "rapid heart rate", "chest tightness" and "pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased, chest discomfort, pain.  Additional Information: Facility type vaccine physician's office/urgent care. The patient has no reported allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Left arm pain, swelling at sight of injection, dizziness, passed out,bump on head
Reddish raised bump on wrist/ Reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 12May2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not aware of the known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 21Apr2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 14May2021 (Friday night), the patient noticed a reddish raised bump on wrist. On 15May2021 (Saturday morning), the patient had multiple reddish bumps on the wrist area and that evening noticed the reddish bumps appearing on stomach. On Saturday night, the patient had break out on elbow area with many bumps on both arms at that point. On 16May2021 (Sunday morning), the patient had bumps all over arms, legs, back, stomach, chest and all over body with many areas complete raised red area (bumps combined together). On Sunday evening, the patient started taking prednisone. On 17May2021 (Monday evening), the bumps started reducing and by Wednesday into Thursday were pretty much gone. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported event which included treatment with prednisone (MANUFACTURER UNKNOWN) 20 mg, one every 10-12 hours. The clinical outcome of the event reddish raised bump on wrist/ reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area was resolved on an unknown date in May2021.