chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt and husband talked to our pharmacy manager as said they had swelling of the lips as well as tingling of the throat and lips.  Also had red eyes.  Pt did contact MD, but unknown if went in of just called.  Still not sure if related to shot.
25 mins after receiving synagis 75mg pt developed reddish-pink lesions over trunk, back, legs. Pt also rec'd Prevnar. No lesions. One hr after receiving vaccines.
Pfizer-BioNTech COVID-19 Vaccine EUA. Provider preparing vaccine diluted it using a smaller volume of diluent (1.5mL) than recommended (1.8mL).  She injected 0.3 mL as indicated.  Pt. was observed for 15 minutes and reported no adverse reaction.  Consultation with Pfizer Safety Reporting revealed that this volume dilution would produce a concentration within the therapeutic range.
72 hours of body aches, fatigue,  uncontrollable chills, fever and night sweats.  Got vaccine 8am and symptoms appeared at 4am next morning.
Cried for app. 7 hrs following first set of immunization. Then periodically for next few hours.
15 minutes after injection BP 151/104, dizziness, off balance, numbness and tingling to bilateral legs and arms, blurry vision right eye. 7/31/21: same, but with expressive aphasia/difficulty concentrating, intermittent chest pressure symptoms of numbness and tingling to extremities, blurry vision right eye, off balance, extremity heaviness remain as of today.
injection was not given properly in the deltoid and that it was given down, wrong way of administration; Arm started bleeding; A spontaneous report (United States) was received, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) reported that the injection not given properly in the deltoid (it was given down, wrong way of administration)/incorrect route of product administration and she experienced bleeding of that arm/vaccination site haemorrhage.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (LOT# 031020A) intramuscularly for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient reported that the injection was not given properly in the deltoid (it was given down/ wrong way of administration), and her arm started bleeding.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The event, injection was not given properly in the deltoid (it was given down/ wrong way of administration), was considered resolved on 03 Feb 2021. The outcome of the event, arm bleeding (at vaccination site), was not reported.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  Also, based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site hemorrhage, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse via a company representative refers to a 12 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (dose, route of administration,  lot # and expiration date were not reported). The patient experienced two sports related concussion after beginning the GARDASIL series. The first one in October 2014 and the second one in December 2014 just two weeks prior to receiving his final dose of GARDASIL. On an unknown date (reported as immediately following administration of his third and final dose of GARDASIL, the patient experienced seizure. It was reported that the registered nurse just finished administering the vaccine and was getting ready to withdraw the needle (it was still imbedded in the patient's arm) and the patient "fell off the needle" and had a seizure. The mother caught the patient. An unspecified physician came in to assess the situation and determined the patient did not require an Emergency Room visit. The nurse stated that she believed that the patient was holding his breath and had some sort of vasovagal. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Upon internal review the adverse event of seizure was considered to be medically significant. Additional information has been requested.
headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "COVID exposure", start date: Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1st dose sore arm lasted one day; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (1st dose sore arm lasted one day) in a 32-year-old male patient who received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine)  on 06 Jan 2021 for COVID-19 vaccination.     No Medical History information was reported.  Concomitant medication of was not treatment.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) via Intramuscular route of administration(batch no. 025L20A). On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (1st dose sore arm lasted one day). On 06-Jan-2021, PAIN IN EXTREMITY (1st dose sore arm lasted one day) had resolved.      The treatment medication included-Meclizine 25mg Ativan 1mg (only one time) Sertraline 25mg  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was linked to MOD-2021-022173 (Patient Link).; Sender'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 spontaneous report as received from a physician refers to a 73 year old (age at the time of the report) female patient with diabetes, gastroparesis, hypertension and gastritis and no drug reactions/allergies who on an unknown date was hospitalized due to Gastroparesis. On 16-APR-2013, while in the hospital, the patient was vaccinated intramuscularly in the deltoid muscle on her right arm with 0.5 mL of PNEUMOVAX23 (lot # H014653, expiration date on 19-APR-2014) as a routine hospital vaccination. Concomitant therapies included LOVENOX, ERYTHROMYCIN, MIRALAX, NIFEDIPINE, TYLENOL, ZOFRAN, PHENERGAN  and TEMAZEPAM. After receiving the PNEUMOVAX23, the patient experienced pain and a rash at the injection site, AE onset date was reported as 17-APR-2013. The physician stated that less than 24 hours later, the rash doubled in size and was measuring 2.5 by 4 to 5 centimeters. The rash was blanchable, erythematous and her right upper extremity was warm. The physician reported that the patient had a good pulse, good right arm motion, there was no pus or collection and no systemic fever. No treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The causal relationship between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Daptacel was administered to an 11 year old patient; patient was administered Daptacel instead of Adacel; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C5307AA via intramuscular route in the right deltoid) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 13-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. This would have been dose 6 in the series.  It was unknown if the patient had any adverse event.  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. List of document held by sender: none.
Patient noticed bruising and swelling in the evening of 3/29/18. In the evening of 3/30/18 patient experienced more swelling and redness. In the morning of 3/31/18 patient observed more swelling and the area was warm to the touch. The arm was very sore and tender when touched.
This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, fibromyalgia and sickness. On an unknown date, the outcome of the influenza-like symptoms and fibromyalgia were unknown and the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fibromyalgia and sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's daughter. The age at the vaccination was not reported. The reporter stated that the people were getting flu like symptoms from the flu shot. Sometimes these symptoms were much worse. The reported stated that her mother (patient) got sick with flu like symptoms, all at the same time, after they got their shots. At the time of reporting, the patient had been diagnosed with fibromyalgia. The reporter stated that Flu shots were not properly tested and well known not to be effective and these flu like symptoms were contagious. The patient was sick the longest and never fully recovered. The reporter did not believe this was a coincidence. This case is 1 of the 3 linked cases reported by the same reporter.
Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath
The pt developed swollen, red right deltoid area starting on 04/02/2002. When seen in office on 04/04/2002, the pt had normal exam except for right deltoid (indurated area of 2" across with 1.5-2" x 4" erythema).
Welted hives running down left arm (non vaccinated arm) Spotted hives on calves and shins Blotchy hives on neck and chest
GAVE PATIENT COVID 19 VACINE BIVALENT WHEN SHE GOT ONE ON 11/18/2022
Patient developed increase in size of lt mid bicep with redness, tenderness, and firm area of edema noticable on the day following the administration of the vaccines which increased in size and intensity over the next 2 days.  Patient returned to clinic on 5-2-08 for doctor consult regarding reaction.  Advised tylenol, benadryl, and ice for swelling and discomfort.
inbitially 0.125  and later recieived correct dose 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04D21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline diabetes. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) from 10-Dec-2021 to an unknown date for an unknown indication.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25). On 19-Dec-2021, OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.
uncomfortable rash covering thigh; severe shivers; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. On 4th May 2022, less than a day after receiving Shingrix, the patient experienced shivers. On 7th May 2022, the patient experienced rash. On an unknown date, the outcome of the shivers was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shivers and rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 07-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient. The patient had the Shingrix vaccine Wednesday morning.  The patient experienced severe shivers all Wednesday night.  At the time of reporting, the patient now had an uncomfortable rash covering his/her left thigh. Additional Supportive Information: The follow up would not possible as no contact details were available.
Vaccine inadvertently administered into the shoulder (instead of the deltoid) too high. Immediate pain with shoulder movement especially internal rotation and abduction. Better for a few hours then increasingly worse/very limited ROM x 72 hrs. Some improvement now at approximately 6 days. Seems to be gradually getting better.
Currently 35 weeks +1 pregnant at time of second shot. Woke up 12 hours after shot with extreme chills that caused my whole body to shake and teeth were chattering. I felt like I was out of my body and couldn?t use the bathroom because my body was shaking so hard. I have never felt that cold in my life. Then I was under double blankets with a heating pad and started sweating and soaked through everything I was wearing but couldn?t have my skin touch the air with intense shaking. Fever was around 100 the entire night and into the next day when it continued to fluctuate between 99.5 and 100. Couldn?t sleep, muscles felt like they were on fire and arm joints hurt. Slight headache, sore throat and very nauseous. Heartburn was worse it?s ever been in pregnancy. Was hard to get out of bed and walk around. Felt slightly better by 5pm but could only eat something small and then went right to sleep. Woke up next morning and most adverse symptoms were gone aside from moderate fatigue. Also have been having pretty intense lower stomach cramps for 48 hours post vaccination. Arm pain was also intense near injection site and felt groin lymph node pain on side of injection.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received when the patient was 60 years old). On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient claimed that the SHINGRIX shot was the worst shot she had received in her life. The patient claimed that she experienced arm pain and she could not lift her arm above her head. The patient was tired and felt sick with flu symptoms and she could not do anything for a day or two but it took a full week to resolve. The reporter did not consent to follow up.
Chest pain in middle of night on 7/16. Was achy and had some pain but thought it was normal side effects.  She starting having a more difficult time sleeping unless she was sitting up. The pain continued through Sat 7/20 but it was being relieved with ice and Tylenol.  On 7/20 she went to the ER b/c she started having trouble breathing.  Testing was done and pt had an elevated ddimer and a chest angio was done.  The results showed plural effusion and pericardial effusion.  She has an apt with a cardiologist in 2 days.  No hx of cardiac events
AFIB/flutter; threw up; Threw up and saying that her heart was racing/have bouts of palpitations/heart rate was out of control; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 22 years on 28Apr2021 (lot number: EN6199) as single dose for covid-19 immunisation. Medical history included extreme immune system, described that patient was 3 weeks post term (as reported) and had issues when she was born, she was adopted and when all the kids would get sick she would always get the sickest; had seizures that only lasted about 2 years (not ongoing) when she was a baby. Family medical history relevant to AE was none. Concomitant medications were none. No vaccines administered on same date or within four weeks prior to the first administration date of the suspect vaccine. The patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 via an unspecified route of administration, administered in arm right at age of 22 years on 07Apr2021 (Lot no: : EN6205) for covid-19 immunisation, few days later she felt something and thought it was anxiety. On 15May2021, 8:30 in the morning patient threw up and was saying that her heart was racing, so she got their finger monitor, and heart rate was out of control so they took her to the emergency room. They tried to get her heart rate down with medications and sent her to an electro physicist, and the rest was history. The only reason attributed this to the vaccine was because this occurred 17 days after her second shot and patient was has been an athlete her whole life, has been in great shape with no heart problems. They captured flutter on the EKG, and saw AFIB when she was under, on 15May2021. Patient ended up having to have cardiac surgery (for AFIB) on 16Jun2021 13:00 in hospital from 16Jun2021 to 17Jun2021. Patient was doing really well, they had to do an ablation. Patient will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. Saw the cardiologist, patient may have bouts of palpitations, but has had nothing since 3 days after the surgery (19Jun2021). The outcome of the events palpitations was recovered on 19Jun2021, other events was recovering.  Follow-up actions are needed. Further information has been requested.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Case number PHEH2014US023526 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 21 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: A12014 and expiry date: Sep 2014), on 08 Nov 2014. No adverse event was reported following this administration error.
Hard, painful lump at injection site larger than the size of a quarter. Lump is still present as of today, over a week and a half later. Redness has lessened.
accidental administration of Ipol intradermally instead of Tubersol; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26 years old female patient who was vaccinated with a 0.5 ml dose of vaccine IPV (VERO) [IPOL] (lot N1K93 and Exp. Date 18-Nov-2019) instead of TUBERCULIN TEST [TUBERSOL] via intradermal route in unknown administration site on 04-Jun-2019.  The patient did not received any concomitant medications and medical history not reported.  It was an actual medication error case due to wrong vaccine administered.  It was unknown whether the patient experienced any adverse event post vaccination.  No corrective treatment received.  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.  List of documents held by sender: none.
chills; headache; tired; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced chills, headache, tired. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case meets criteria for vaccine breakthrough review. Patient had SOB, no other COVID SxS.  Presented for low hgb/iron deficiency anemia.
11/16/05 3AM, Muscles in arm and chest tightening up and into chest - breathing hurt chest to back. Could not take a deep breath without excruciating pain. To ER. Admitted for 2 days. Cardiac work up; no cardiac problems. Muscle were like rocks.
itching, swelling of lt arm (opposite of inj site), wheezes, SOB tx meds;
I had given Tdap, then HPV, 30 seconds after pt, had seizure like symptoms, boarded up lasting 45 seconds, upon coming out of it pt was real confused.