chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No aditional adverse effect reported; patient recieved expired PROQUAD; This spontaneous report has been received from a licensed practical nurse concerning to a patient of an unknown age and gender. Information concerning patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 22-SEP-2020, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHa) (PROQUAD) (lot # S008574, expiration date 16-SEP-2020) (dosage regimen and route of administration were not reported) as prophylaxis. No additional adverse effect was reported.
Pt.'s mom brought pt. to clinic room when another child's name was called.  I (RN) was not aware that I had the wrong child. I did ask mom if her child's name was pronounced and she was here for one year immunization and mom said yes. Mom answered screening questions appropriately, immunizations were discussed, and VIS was presented for wach Imm. Imms were given as noted above and mom was given immunization record. Mom was them escorted to lobby where she signed in for appt and staff noticed she had immunization record in another child's name. Mom was notified that the MMR, Varivax, and Hep A vaccines that pt. received were not age appropriate and that they need to be repeated after 1st birthday. Pt.'s pediatrician was notified and our health department medical director was notified. Mom was advised to contact pt.'s doctor and out health department if she was concerned that pt. was experiencing any side effects.
not being able to swallow or talk; fingers have been swollen and numb; fingers have been swollen and numb; Her toes can't bend- only bend half way; It feels like I have extra skin, like socks on my feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 50's received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHAGIA (medically significant) with onset 2021, outcome "unknown", described as "not being able to swallow or talk"; PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "fingers have been swollen and numb"; LIMB INJURY (non-serious) with onset 2021, outcome "unknown", described as "Her toes can't bend- only bend half way"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "It feels like I have extra skin, like socks on my feet". The event "not being able to swallow or talk" was evaluated at the physician office visit.  Clinical information: She has a CNA on the line who received first dose of the Pfizer BioNtech COVID 19 vaccine in Apr2021, and second in May2021. She has been out of town. Since she got the vaccine, her fingers have been swollen and numb. She can only bend her toes halfway. She said it feels like she has extra skin on her feet like she has socks on her feet. While out of town in (withheld), she could not swallow or talk and was seen by a doctor in (withheld). She did not say what they told her. She has spoken to her Pharmacy and they said they have had similar complaints from other patients. She declined specific age but said she was in her 50's. Agent provided answer to her questions and said her symptoms were not reported and referred her back to her primary care provider. Caller disconnected prior to transfer.  No further details provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shingrix 50MCH inj: next day fever 100.5 for 24hours...headache, weakness, stomach pain (bloating and cramping)...these affects lasted 4 days...Very weak and headache the four days...
She specified she gets achy back; gets achy back specially during rainy temperatures; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as SINDLE DOSE for covid-19 immunisation. Medical history included accident years ago. Concomitant medications included tramadol taken for back issues resulting from an accident years ago, start and stop date were not reported; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for headache, migraine, she has been having for her whole life, start and stop date were not reported. The patient specified she got achy back specially during rainy temperatures in Apr2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a 5 month old patient. On 04-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ (dose and route not provided, lot number # reported as L039638, expiration date 23-AUG-2017). No adverse effects were reported. Additional information is not expected as the nurse did not wish to be contacted.
Rash for 1 day, mild itching, raised blanching papules of different shape and size, all over her body.
Cataract Surgery; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4254354-00 (Agency).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150525). The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CATARACT (hospitalization, medically significant) with onset Mar2021, outcome "recovered", described as "Cataract Surgery". The action taken for upadacitinib was dosage permanently withdrawn. Causality for Rinvoq (Upadacitinib). The reporter's causality for the event(s) of Cataract Surgery was not provided. Agency's opinion is that there is no reasonable possibility that the events of Cataract Surgery. Pfizer Biontech Covid-19 Vaccine Tozinameran causality as per reporter not reported.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Cataract and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Immediate numbness of arm, Immediate hot flashes with blurred vision, increased heart rate, possible drop in blood pressure, Immediate nausea, Immediate fatigue. All within 5 minutes of injection.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The nurse reported that the patient received three doses of GARDASIL 9 outside of recommended dosing interval. On 04-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L014198, route and expiration date were not reported). The second dose of GARDASIL 9 (lot # L045700, expiration date 22-FEB-2018, route unknown) was administered on 24-MAY-2016. The third dose of GARDASIL 9 (lot # L045700, expiration date 22-FEB-2018, route unknown) was administered on 28-JUN-2016. No adverse effects were reported. Additional information has been requested.
Full body hives, 35min after administration. Reported feeling extremely uncomfortable. No Resp/pulm involvement, vitals normal on exam. Evaluated by onsite EMS, did not require or accept medication treatment. Able to ambulate after 60min of observation and leave with co-worker. Given guidance for monitoring, and precautions for calling EMS/going to ED.
Febrile to 102.3, tachycardia to 140's, malaise and lethargy. Resolved after 24 hours.
Swollen (L) neck lymph nodes - then (L) ear ache and sore throat on (L) only. Worsening until seen by Dr., 11-3-08, @ 6 pm. Dx. Pharyngeal cellulitis. Started Z-pack. Back to Dr., 11-5-08, 11 AM; general malaise, extreme fatigue, continued sore throat, back pain, frequent urination.
Pain in left hand. Pain subsided, then came back. Numbness in left hand. Swelling and stiffness in left hand.
Lacking energy/lethargic, vomiting x5 48 hours after immunization; no treatment.
Left arm pain at rest and with movement; headache; full body myalgias; sore throat; This is a spontaneous report from a contactable physician (patient).  A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231 expiration date unknown), intramuscular in left arm on 12Jan2021 at 08:00  at a single dose for COVID-19 immunization.  Medical historywas reported as none. The patient had no known allergies. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 22Dec2020 at 12:30 PM for COVID-19 immunization. The patient has not had COVID prior to vaccination. The patient had no other vaccines within four weeks. On 13Jan2021 at 14:00, the patient experienced left arm pain at rest and with movement, headache, full body myalgias, and sore throat.  Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.
I started to itch on my neck and scalp on 12/14/2021, by the end of my shift I was getting a rash on my chest and hives all over my body. I called emergency virtual visit in my primary care on MyChart (I got my vaccine at my job, but I seek primary care somewhere else. Dr. is my primary care doctor) and they prescribed me a medrol pack and told me to take Benadryl. I took Benadryl, Claritin, and Zyrtec. Zyrtec worked the best for me to take the itching and hives away so I continued with that. I started to get chest tightness, shortness of breath, and itchy throat and I went to the hospital and the ER doctor said I was stable, fortunately. The hives eventually subsided after a day or two, I can?t remember how long exactly, but I stood with dermatographia and itching and redness in random areas. The dermatographia has persisted until this day, but is improving gradually with time. I hope it completely goes away eventually. I?m not anti vax at all, but I do think this reaction was caused by the booster shot as I found a group of thousands of people with similar symptoms to mine in varying severity online. I had cleaned my house up and down as I was having trouble identifying what could have caused my symptoms since the reaction was so delayed until I came across this group. It started to make more sense, but I?m not sure if you guys would even believe me.
No adverse reaction to patient noted. Vaccine administered over 12 hrs after vial was punctured.
The day after the first shot I was tired and had extreme pain in the arm where I was injected. The pain in my arm lasted 4 days.  Since the following week after the first injection, I have shortness of breath when doing physical activity.   The day after the second shot, I had a headache, nausea, extreme pain in the arm where I was injected, and I was extremely tired.  Today (09/25/2021) at 4:30 am, I noticed extreme swelling in the lower left side of my face and lips. This is still occurring, along with pain at the side of the injection.
The first couple days exp pain at injection site. After next days having pain around the left shoulder for about 3 weeks. I seen my PCP and Neurologist stated it might been nerve pain was prescribed Gabapentin.
First of two vaccine injections received roughly 3-4 weeks ago. Onset of severe dyspnea on exertion 5 days ago. Echocardiogram demonstrates severe global hypokinesis with an estimated ejection fraction of 15%. No antecedent history of dyspnea, drug use, angina or heart disease. No prior physical limitations. Relation of new onset/newly diagnosed cardiomyopathy to vaccine is unknown. Investigation and clarification of particulars (including which vaccine, date of injection, etc.) to follow. This communication prompted by ECHO review.
Arm was sore at the injection site, but around bed time (~10pm) it became so sore I described it as feeling as though I was stabbed in the arm with a knife, or hit with a bullet it was so painful. Around the same time, my body temperature became so cold I had to layer clothes. Normally I sleep in shorts and a t-shirt, but I put on sweat pants, a sweat shirt and socks, sleeping under two blankets, and I was still shivering. The next day this coldness continued, and I added another layer on top and a knit hat. I felt tired apart from the poor sleep, and a little nauseous at times. My appetite was reduced. I finally took my temperature in the afternoon on Nov 23 and it was 99.8. This elevated temperature continued until Nov 24 when I returned to normal.
Patient complained of diarrhea, extremely tired, stabbing pain on right side under the breast, nerve pain. She couldn't go into work on Monday and then went into work on Tuesday but had to leave within 3 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 07Apr2021 as dose 2, single (Lot number: ER8737) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 032H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: ADHD. The patient did not had any known allergies. Concomitant medication(s) included: SERTRALINE, start date: 01Jan1999; ADDERALL, start date: 01Jan1999. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; HCP administer the vaccine to patient, after the expiration on the 5Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     The patient had no allergies (medications,food and other products). The patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and never had COVID-19 positive test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 15-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The adverse effect did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalization). The patient did not experience a similar event in the past. On 31-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was unknown.   This case was linked to MOD-2022-613364 (Patient Link).
Patient developed severe left arm pain at injection site limiting his range of motion, he was unable to sleep well that night due to significant pain.  He noted mild swelling at the site, but denied bruising, erythema, discharge, or pustule.  He denied SOB or fever.  The following afternoon he took OTC Aleve with some relief and improvement in symptoms.
1.  Slightly dizzy/light-headed, lasted until evening.  Had to be careful not to tilt head back or sense of dizziness increased.  Fine the following day  2. Sore arm, lasted a couple of days.  Hard to tell exactly, because of:  3. Sore shoulder (seemed to set off bursitis) which lasted several days.
Administered \some vaccine that were expired a week ago. It was kept in the fridge.; Patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered \some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022.  Patient was administered with second booster dose.  No treatment information was provided.   This case was linked to MOD-2022-543481 (Patient Link).
Left arm edema - redness - erythema, warm to touch, itching. Noted at site where PNEUMOVAX was given.
Information has been received from a pharm D. concerning a 59 year old female who in approximately 2006 "about 2 years ago" was vaccinated with PNEUMOVAX vaccine. After receiving the vaccine the patient experienced swelling of entire arm. On unknown date the patient recovered. No further information is available.
Left arm began itching at injection site. Increased redness down arm and toward inner arm, warm to touch. Verbalized took Tylenol. Verbalized redness has decreased on outside of arm but remains same on inside, as well as itching and warmth.
soreness in injection arm, stomach felt sick the next morning for a couple hours, possible headache from it
This report is submitted per patient request. Pts report. 9/29/09 11:40 pm pt awoke shivering, felt extremely cold. Neuropathy worse in hands & feet, queasy, gi upset & belching. (No fever). Status on 10/7/09 symptoms improved.
Fever (101) started at 1:22 AM 3/31/2021 and did not break until about mid morning.  Also had severe headache until approximately 9 PM 3/31/2021.  Pain in joints (especially in both hips) until approximately 6 PM 3/31/2021.  Nausea and light headed until 4/1/2021 morning.  Very tired (slept all day on 3/31/2021).
Stomach Pain, Nausea, Diarhhea, Hot Flashes and Cold Chills.  No Fever.
A report was received from a health care professional on 11/19/03 concerning a 37 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Information has been received from a female who on 29-NOV-2006 was vaccinated with Gardasil. At the time of reporting, the patient had not yet received her second dose of Gardasil due to hip replacement surgery. Additional information has been requested. Upon internal review, hip replacement surgery was considered to be an other important medical event.
Rash on both arms and knees/Skin rash post-vaccination; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on both arms and knees/Skin rash post-vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rash on both arms and knees/Skin rash post-vaccination). At the time of the report, RASH (Rash on both arms and knees/Skin rash post-vaccination) outcome was unknown.        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.   This case was linked to MOD-2021-027273, MOD-2021-027363, MOD-2021-020109, MOD-2021-028798, MOD-2021-027379, MOD-2021-027398 (Patient Link).
Family informed me that 4 days after the COVID vaccine was given, the patient had an episode of bloody stool (noted BRBPR (bright red blood per rectum) with blood clot in the pamper). No fever, no symptoms of pain, no N/V/D. Otherwise, normal po /play. No sick contacts. Of note, sibling that received the COVID shot on the same day had same symptom.
Full course approximately 12 hours, from 10 am to 10 pm: moderate to severe body aches over entire body and limbs, moderate headache, mild nausea. Severe fatigue causing inability to stay awake for 15 out of 22 hours.