chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired PENTACEL being given to 3 patients with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received via Representative (Employee).  This case involves 3 patients of unspecified demographics who experienced expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] being given to 3 patients 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, 3 patients received expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at dose 0.5 ml once at (unknown: strength, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.    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.
I started having headaches the evening I received the vaccine. I woke up the next morning  with a headache and dizzy. I went to the doctor and had blood work done. My results showed my Ferrous level were low and I was prescribed Ferrous sulfate.
stomach pain; Blotchy; rosacea; stomachache; fever; nausea; chills; swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), PERIPHERAL SWELLING (swollen arm) and ABDOMINAL PAIN UPPER (stomach pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 07-Mar-2021, the patient experienced RASH MACULAR (Blotchy) and ROSACEA (rosacea). On 23-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form and IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Mar-2021, PERIPHERAL SWELLING (swollen arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), RASH MACULAR (Blotchy), ROSACEA (rosacea), ABDOMINAL PAIN UPPER (stomach pain), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.1 (High) The patient body temperature was 101.1.         Concomitant medication included omegas.  Further treatment information was not provided.  The patient also reported that her both arms were swollen after the both shots. and mentioned that people called it as COVID arm.   This case was linked to MOD-2021-163463 (Patient Link).
Severe lingering headache, shoulder and back pain, abdominal pain, nausea, early menstrual period. Started 8/13/2021. All symptoms except for headache subsided by 8/17/2021. Dull headache and back pain still persistent. Took ibuprofen and calcium carbonate, frequent fluid intake, and rest.
Patient received the vaccine which had been shipped more than 2 days/ No AE; Initial information and additional information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to case 2019SA241338 and 2019SA243238 (same reporter).  This case involves a 39 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number UJ211AA expiry date 30-JUN-2020 not reported via intramuscular route in the left deltoid on 27-Aug-2019 the vaccine that was shipped more than 2 days.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no Side Effects.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Documents held by sender: none.
Left arm swelling and pain. Red rash overlying the swelling. Muscle inflammation. Improving when seen in clinic.
She had redness, swelling, and a nurse at the local health center thought maybe a cellulitis.
numbness an tingly feeling in both her hands, arms, legs and feet; numbness an tingly feeling in both her hands, arms, legs and feet; Left side of body had most pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Myalgia, Numbness of extremities and Tingling of extremity, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain) had not resolved.            Concomitant medications included birth control pills.
Fever, chills, fatigue, headache, ringing in ears, ache at injection site.
injection site swelling; minor pain; This case was reported by a consumer and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling and pain. On an unknown date, the outcome of the injection site swelling and pain were unknown.   It was unknown if the reporter considered the injection site swelling and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine at the end of this September 2021. The patient experienced injection site swelling and minor pain. The case has been linked with the case US2021AMR232228 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232228:Same reporter
3 days after second SHINGRIX patient had exacerbation of Asthma Symptom. Patient presented to me on 08/26/18 with Asthma Symptoms. Called patient 8/27/18 to see how they were feeling and Patient said now having issues with hives. Advised to call Doctor.
Patient describes ringing in the ear for the first five days and then dizziness upon change in position or abrupt movement of head that continues to this date. He also is off balance when standing.
uncomfortable & itchy all noc;woke up w/generalized hives & swollen lip;recovered in 2 days p/treatment w/Pred;pt recvd prev series in a clinical study of monkey kidney vaccine in 1984 & poss booster in 1985
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Transgender female-to-male" (unspecified if ongoing), notes: Transgender female-to-male; "Trigeminal neuralgia" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL oral, start date: 19Nov2021; BUSPIRONE oral, start date: 01Mar2021; BUPROPIONE SANDOZ oral; TESTOSTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), 9 days after the suspect product(s) administration, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (02Jun2022) Positive, notes: Rapid antigen and PCR positive; (02Jun2022) Positive, notes: Rapid antigen and PCR positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Vaccine and other medication received in 2weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
11/4/03: Mother states child c/o slight itching and reddness at sight of injection 11/5/03: Mother called the Health Dept. around 6 p.m. to report that injection site is size of golf ball with reddness and defined borders. Child c/o increased in itching. Told by Health Dept. to take child to ER. Mother states ER MD gave child Benadryl and Ibuprofen and called it allergic reaction.  11/6/03 Mother states child is better and attended school today.
Information has been received from a health professional concerning a 78 year old male on 02-JUN-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  Subsequently, the patient experienced a sore and red arm.  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  The physician requested an investigation into the lot number.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released.  Additional information is not expected.
A 17-month-old male patient, with no concurrent illnesses, or pre-existing medical conditions, had received a intramuscular left thigh dose of DAPTACEL (lot number C2797AA), and a intramuscular left thigh dose of IPOL (lot number A0273) on 08 January 2008.  The following day, the patient developed redness and swelling well below the injection site on the left thigh.  The child was also limping.  The reporting physician stated the vaccines were reported as being administered intramuscularly, but could have been administered subcutaneously based on the symptoms.  The patient required a physician visit, and was re-evaluated by a physician on 10 January 2008 and noted to be already improving.  There were no diagnostic tests or laboratory data performed.  The recovery status of the patient was reported as recovered.
pt states that itching and soreness started within a day, and 3 days later it began to swell and get red.  it is 1 week later and the arm is still red, and sore but not as red as it was, and it's not itching like it was
pain; reduced the range of motion of her left arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (reported as 20Jan2021) at 05:15 PM (Lot Number: EL3302) as dose 1, single, via an unspecified route of administration, administered in left arm on an unspecified date (reported as 20Jan2021) (Lot Number: EM9810) as dose 2, single for COVID-19 immunization. Age at vaccination was unspecified, non-pregnant at time of vaccination. Medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine; colecalciferol (VIT D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 12:00 AM the patient was still experiencing pain which reduced the range of motion of her left arm. Seriousness criteria was reported as disabling/incapacitating. The events resulted in disability or permanent damage. No treatment was received. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
"I woke up shivering, cold at 0200. I had no pain; just cold and sweating. My breathing was normal. I waited for a little bit and called my doctor. He told me to go to urgent care but they were closed so he said to go to the emergency room. They monitored me for an hour and put in an IV of normal saline. I felt better.  They did not give me any medications. They recommended I take ibuprofen when I got home.  They took my temperature but I don't know what it was. In the morning I feel body ache, so I took ibuprofen. After that I felt fine, but then I started shivering again, cold, clammy. I never had any pain. I did repeat ibuprofen after I took my temperature in my arm pit and it read 98. I fell asleep. Then on Sunday I was better than Saturday but not quite all right. I stayed home from work on Monday. I didn't take any ibuprofen after Saturday. I went to my primary on Monday for something else and discussed reaction with her. She said I was fine. I want to get the next dose in the series in a month. I'll be fine.
tested positive after first dose was given; tested positive after first dose was given; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the first of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-2021058678 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE
Systemic: Fainting / Unresponsive-Severe, Additional Details: upon exiting vaccination room pt fell forward. it is unknown if she fainted or tripped, mom was standing behind her and was unsure as well. pt bumped head and had a welt on her upper right eyebrow, also her nose began to bleed. ice pack was given/applied to head/eye, paper towel given to stop nose bleed. also water/starburst given. 911 was called. dispatchers came and quetsioned if she felt dizzy when she left room to which pt responded no, ambulance took pt.
Approx. 3hrs after the vaccine shot, I started to get GBS symptoms starting with my feet becoming numb and a few hours later in the night, it progressed to my lower legs and by the next day on 8/21/21(12-24 hrs after the shot) I had also heavy leg weakness, increased numbness on lower body, right hip pain and dull numb feeling of my head. On 8/22/21, I had worsening GBS symptoms - stomach, chest, lower back, arms, hands, head, legs & feet numbness, more weakness, fatigue and nausea. All of the same symptoms I had with prior GBS experience. Over the next several weeks, the GBS symptoms have fluctuated increasing and decreasing in severity.  Also had occassional ankle popping sounds when walking & small short duration muscle tremors in my right upper thigh area.  On a few occasions I felt as though I need to go to the ER for GBS treatment but was able to get through the worse episodes.  Over time for the 3 months since I had the vaccine shot the GBS symptoms have gradually began to decrease in intensity.  Although some symptons are still present such as numb feet and head issues and occasional other body areas, the overall symptoms have lessened at this point after 3 months.  Based on my reaction to the 1st vaccine dose, I and my doctors agree that I should not get the 2nd dose.  I am sending this to you as the CDC website indicates that it is okay for persons with GBS to get the COVID-19 vaccine but no mention of these potential reactions. I checked the box for "Life threatening illness" as GBS is a serious condition that can quickly become life threatening should the symptoms accelerate quickly which could cause paralysis and death.  I did not feel that I was approaching that point but the possibility was still present due to the unpredictable nature of GBS.
Per patient: " I received my 2nd vaccine on  Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow.  I developed body aches as well as a headache and arm soreness.  I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021.  I called the health department to let you know. "
Rash (erythematous, itchy) over injection site that started 1 week after injection.
6/4 67-year-old female history of type 2 diabetes, hypertension, metastatic colon cancer presents with altered mental status.
Felt funny and legs quit working and she couldn't walk. Went to ER. The ER doctor couldn't find anything and she still couldn't walk so they told her it was a bad reaction to the booster.
Hay fever; Runny nose; Sore throat; Tired; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Developed fever less than 24 hours after vaccination. Fever resolved on 01/21/2021 @ time of office visit. He was having symptoms at time of office visit. The symptoms were chills, headache, nausea,lack of appetite,light headiness,congestion & dizziness.
I got shingles from the vaccine/Suspected vaccination failure; I got shingles from the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got shingles from the shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.