chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a reaction of spider/mosquito like bites; Swelling on the left arm, which is the same arm where he received the injection; Red "patchy areas" and itchiness on his leg; Red "patchy areas" and itchiness on his leg; Red "patchy areas" and itchiness on his leg; This is a spontaneous report from a contactable consumer (patient mother) or other non hcp. A 22-years-old male patient (reporters son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 11Jun2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in June2021, the patient developed a reaction of spider/mosquito like bites and swelling on the left arm, which is the same arm where he received the injection. He also has red patchy areas and itchiness on his leg. According to the caller, its all on his left side. Caller would like to know if these symptoms have been reported with the Pfizer BioNTech COVID-19 vaccine. The Outcome of events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 20-JAN-2014, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 23-OCT-2014, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # K004204 exp 12-JAN-2017) intramuscularly. No adverse effects were reported. Additional information has been requested.
Patient with bronchospasm, coughing, shortness of breath. Treated with Epi-pen, Solu-medrol, Benadryl, Pepcid and Duoneb in the clinic. Then transferred to hospital for higher level of care via EMS. Patient stabilized in the clinic. Monitored for a few hours in the ER and release in stable condition.
CHIEF COMPLAINT:   Has been having URI symptoms. congestion. some SOB has copd Sore throat. Was @ walkin 12/16 dx viral infection given Abo. No better today Sat low. Upon ems arrival 90% RA Lungs diminished on R Nauseated, given zofran PTA Mid sternal pain CP 3days   HISTORY OF PRESENT ILLNESS:     Has been having URI symptoms congestion shortness of breath and sore throat was at the walk-in on 1216 diagnosed with viral infection not feeling better low O2 sat 90% and also having midsternal chest pain for the past 3 days.  No tearing station the neck chest abdomen pelvis.  No arm pain.  No headache.  No abdominal pain.  No fever or chills.  No other complaints.
Patient was administered the Tdap vaccine instead of the DTaP that was supposed to be given as age appropriate.
Patient with 2 COVID vaccines who admitted to hospital with positive COVID test.  Asymptomatic for COVID other than weakness leading to fall.  Provider d/c note:  "93-year-old female who originally presented to Community Hospital yesterday, on 7/25/22, after she fell at home. The patient cannot recall the events that led to her fall, but states that she no ooze (sic) that she fell at home.  The patient apparently called for a neighbor, who then alerted EMS, and brought the patient.  Upon initial evaluation, she was complaining of pain in her right chest.  As is detailed below, radiologic workup revealed for right-sided rib fractures and small pneumothorax   She was observed closely with pain management and incentive spirometry.  Her pneumothorax improved with observation and pain was controlled. Xrays showed fractures of R.2nd-5th ribs.  Transfer to skilled nursing was advised, and COVID screening was positive, despite being asymptomatic.  This delayed her transfer additional 10 days, before she was accepted for transfer.  There are no interval events.  Initial sodium 136 dropped to 129, without improvement upon discharge.  Initial potassium 3.5 dropped to 2.8, but improved to 4.3 with replacement."
My daughter fainted and had seizure like movement. She has never done this following a vaccination. It really scared me and was very unusual for this to happen to her. She is not afraid of shots.
Throat swelling, tongue tingling  Narrative: Code 99 called to the second floor auditorium where this simply  received her second coronavirus vaccine. Approximate 10 minutes later she  developed tightness around her neck and her tongue started to swell. No chest pain  or shortness of breath. No rash. Didn't have a problem with her first vaccine.  Epinephrine 0.3 mg 1M and Benadryl 50 mg 1M given. The patient started to feel  better. Tip of the tongue was slightly swollen and red. Patient spoke in normal  sentences. No stridor. Appears well and resting completely in the wheelchair.  Brought to the emergency department for further evaluation and observation. ED  provider note: 62 yo FEMALE w/ Wo multiple medication allergies p/w possible  allergic reaction. Pt recieved her second covid vaccination today @ approxately  1330 and reports nearly inmediate onset of sensation of "like a pill is stuck in  your flu-oat" and feeling like her throat was swelling. Then states that she  developed an abnormal sensation on the tip of her tongue described as tingling and  swelling. Denies any n/v, abdominal pain, sob or difficulty breathing. Pt received  0.3 mg of 1M epi as well as 50 mg of 1M benadryl. Pt observed in ED for 6hrs,She  was given steroids and Pepcid in the ER. She has an EpiPen at home due to an  allergy to bee stings. I told her that while a recurrence of her reaction is  she should pay close attention to any new or worsening symptoms and return to the  ER immediately for chest pain, shortness of breath, oral swelling, GI symptoms, or  any other new symptoms she develops that she is concerned about. She expressed  understanding of this plan. She was given a short course of steroids and  instructions for scheduled Benadryl for the next 24 hours.   Other Relevant History.
Patient's husband notifies the pharmacy on the morning of May 19, 2021 that his wife was vaccinated yesterday 5/18/21 and had a seizure this morning. In addition, he notifies that his wife is not taking the LYRICA as his doctor had prescribed, it must be once a day, yesterday she did not take it because the patient decided to take it every other day. Patient would visit her doctor today.
Patient is a 72 year old female with PMH hypothyroid, COPD on home O2, anxiety, HTN, depression and GERD who presents to the ED for weakness and lethargy. Patient is A&O to person only. History is obtained from the record. As per the record, the patient's husband reports that the patient typically sleeps 10-12 hours but over the past few days the pateitn has been sleeping 23 out of 24 hours a day. The husband reports that her oxygen level was 88% on oxygen, he increased it and her saturation improved to 90%. The husband reports that he recently had a head cold. The patient's husband called Doctor and was told to send patient to the ED. At present, patient is arousable to verbal stimuli and denies chest pain and shortness of breath.
Came with a moderateheadache; Repeated nausea; vomiting from 7 am to 4 pm, could not hold anything down; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ep7534) and expiry date included 31Jun2021, via an unspecified route of administration to left arm on 17Mar2021 at 16:00 (at the age of 62-year-old), as single dose for COVID-19 immunisation. Medical history includes paroxysmal atrial fibrillation (episodic) and unknown if ongoing. Concomitant medications include pravastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and flecainide (MANUFACTURER UNKNOWN) for an unspecified indication since an unknown date. The patient had no known allergies to foods, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 07:00 (as reported 08: 00), the patient experienced repeated nausea and vomiting from 7 am to 4 pm, could not hold anything down and came with a moderate headache at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 20Mar2021 (since the vaccination) which included nasal swab test (SARS-COV-2) and the test result was negative. Therapeutic measures were not taken as a result of the events nausea, vomiting and headache. The clinical outcomes of events nausea, vomiting and headache were recovered in 20Mar2021 at 16:00 and on an unknown date in Mar2021 respectively.  No follow-up attempts are possible. No further information is expected.
3/30-C/o headaches, sinus congestion, injection site pain, nausea & lightheadedness beginning last night. Took ibuprofen with minimal results. Denies SOB, chest pain or difficulty breathing. 3/31-Spoke with pt to follow up with her symptoms. She said that she is doing much better, about 75% back to normal. She still has nasal congestion and drainage. I told her to call back if she had any other concerns for us to document. She thanked me for my call and I wished her a good day.
4 hrs after flu shot - wheezing, coughing, red eyes. 9 hrs after flu shot - All symptoms of the flu including fever of 100.8 - stuffiness in nose and sinuses - restless night. 22 hrs after flu shot - no symptoms - back to normal health.
inadvertently administered an expired Pediarix (exp:4/4/22) dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 67-day-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-APR-2022 Reporter's Comment: The reporter was clinical coordinator. The reporter called in to inquire that should the patient be revaccinated as they inadvertently administered an expired Pediarix dose to a patient. The reporter declined follow-up from safety team. Additional Supportive Information: The patient received Pediarix, which was expired on 4th April 2022, which led to expired vaccine used.
Fever, sore throat, ear ache, cough, runny nose, sneezing, no energy, body Aches, headache, watery eyes
lymph nodes got swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes got swollen) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced LYMPHADENOPATHY (lymph nodes got swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes got swollen) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
1st Booster: Date: 23Aug2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Booster: Date: 23Aug2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (allergy to sea food), Allergy to antibiotic (allergy to tetracycline) and Allergy to allopathic drugs (allergic to another medicine also (antibiotic) but she cannot remember the name.).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Booster: Date: 23Aug2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Booster: Date: 23Aug2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant/regular medication: Lot of medications. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-504324 (Patient Link).
6/14/2021-6/17/2021 1.  Spots on body, itchy.  (ER 6/15/21 am - Hives, not poison ivy) 2.  Both hands hurt, swollen, red, very painful, hard to bend fingers or hold things.  Left hand worst. 3.  Feet swollen, left heal hurt for a while 4.  Both wrists hurt, left wrist worst. 5.  Red swollen streak down spine.  Swollen 1/2" or more raised off spine.   6.  Left face swollen.  Right jaw hurts so bad that it was hard to open mouth. *** Took benedryl 25mg every 6 hours, zrytec twice daily, continue normal pepcid pill.  Everything cleared up 6/18/21 7am.  Showed daily pictures to Dr. at follow up ER appt on 6/18/21.
Ordered the wrong vaccine type, but patient needed DTaP and IPV. Patient was 17 months old. No adverse reactions were noted. Immediately called guardian, and left a voicemail to have guardian return the phone call. Immediately told supervisor as well of event.
Information has been received from a health professional concerning a patient who on 01-DEC-2006 was vaccinated with a first 2 ml oral dose of Rotateq (human-bovine). On 02-DEC-2006 the patient was vaccinated with a second 2 ml oral dose of Rotateq (human-bovine). No adverse experience was related to this event. No other information was provided. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 18-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On 28th June 2018, 1 days after receiving BEXSERO the patient experienced vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful. On an unknown date, the outcome of the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful were unknown. It was unknown if the reporter considered the vomiting, feeling unwell, headache, light headedness, feelings of weakness and feels awful to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO on right deltoid. The patient vomited 4 times in one day but it subsided at evening on the day before the reporting date. The patient felt weak like she had been run over. The patient had no fever or diarrhea.
Narrative: Patient is a 75-year-old male, was scheduled for his first COVID-19 vaccine on 2/6/21 at 10:45 AM. He received the MOderna vaccine (lot: 013M20A) in the right deltoid muscle. The patient remained in the facility for 15 minutes post-vaccine administration. On 2/7/21, the patient visited the Hospital with complaints of lower extremity weakness (unable to stand) and dehydration. After receiving IV fluids and a complete work-up, the patient was discharged. The patient reported that the symptoms subsided the next day. He cancelled his second COVID-19 appointment at this tie. A neurology visit on 3/15/21 ruled out other disease states such as Guillain Barre Syndrome. On 3/18/21, the patient agreed to schedule his second COVID-19 vaccine in the community. It is unknown if the patient followed through with this request.
Itching all over body, face and ass; Feeling drowsy because of medication; Rash all over the body and on face going down; Little congested in throat; Extremely bad headache; Anaphylactic shock; Trouble in breathing; Face swollen; A spontaneous report was received from a consumer concerning a 50-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, feeling little congested in her throat.   The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.   On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in left hand for prophylaxis of COVID-19 infection.   On 25 Mar 2021, after 15 to 20 minutes after vaccination she got anaphylactic shock. Her pharmacist noticed that her face was swelling, she was trouble in breathing. Pharmacist gave her diphenhydramine and inject her epinephrine pen in her right thigh and send her to hospital. In the ambulance they gave her diphenhydramine through IM and she got discharged from hospital on 25 Mar 2021 in night.  On 26 Mar 2021 she woke up with extremely bad headache, itching all over body, face and ass and feeling drowsy because of medication, rash all over the body and on face going down, she was feeling little congested in her throat.  Treatment for the events included epinephrine, diphenhydramine, prednisolone, and famotidine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, and feeling little congested in her throat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
She was doing fine till when I called her in the morning on 04/11/2021 to check how she was doing that she stated that her entire body hurts and that she had a fever and felt chills overnight just as myself and my son did. She stays on campus so I was not able to get her temperature. She said she could not get out of bed and that her legs were very week. She complained about body aches for at least 2 days. We all had bad headaches as well.
the diluent for the product was expired with no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient who was reported with diluent for the product was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2022, the patient received suspect standard hib (prp/t) vaccine powder and solvent for solution for injection at a dose of 0.5 ml once (lot UJ594AA, expiry date - 30-Jan-2023) (diluent - Lot Number:U7171AB, Expiration Date: 26-Oct-2022) via intramuscular route in unknown administration site for Immunization.  On 31-Oct-2022 the patient reported a non-serious event of the diluent for the product was expired with no reported adverse event (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Rash began developing as a few spots and by the next day entire stomach was covered in red spots/ bumps. They began to lessen toward the end of the next day.
Assessment -52-year-old woman with persistent upper arm pain and tenderness in the area of a shingles vaccination July 2022 currently without any acute surgical indication and no sign of any sprain strain tear or fracture.  Her symptoms and exam and tenderness are consistent with a persistent injection reaction and postinjection pain with tender point or trigger point in the area without any defect or mass. Plan - I recommended activity modification, avoiding direct pressure, heat, stretching, ice, topical medication, oral medication, consideration for physical therapy.  She was informed that pain and tenderness in the area could persist for up to a year.  Trial of diclofenac.  3/2/2023  1:10 PM
Injection site haemorrhage; Injection site reaction; Injection site pain; Felt very ill; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site hemorrhage in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DUPILUMAB (DUPIXENT) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of DUPIXENT (subcutaneous) 300 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Injection site haemorrhage), injection site reaction (Verbatim: Injection site reaction), injection site pain (Verbatim: Injection site pain) and illness (Verbatim: Felt very ill). The action taken with DUPIXENT was unknown. The outcome of the injection site hemorrhage, injection site reaction, injection site pain and illness were resolved.   It was unknown if the reporter considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter was a patient. The reporter reported that she had a most recent injection and had little mark where needle went in, pain at injection site, felt very ill after receiving second dose of Shingrix and also had little amount of blood at the injection site while being treated with Dupilumb (Dupixent) and Varicella zoster vaccine and with the use of Dupixent single dose pre filled pen. Dupixent had been identified with device issue. The patient past medical history, vaccination, medical treatment, family history were not provided. It was not reported if the patient received a corrective treatment for all event. At the time of reporting all events were recovered. It was unknown if the reporter considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Dupixent. It was unknown if the company considered the injection site hemorrhage, injection site reaction, injection site pain and illness to be related to Dupixent. The reporter requested to consent the follow up.