chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered GARDASIL 9; The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered GARDASIL 9; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 21-APR-2016, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiry date, site and route of administration were not provided) for prophylaxis. The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Wrong product administered, Extra dose administered). Per the patients immunization record, he had already received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 21-APR-2016, 23-JUN-2016, and 08-NOV-2016. The 4th dose was administered 29-AUG-2022 during a visit for a physical examination. No additional adverse event was reported.
Breakthrough case admission after 3 vaccines  Moderna 1/14/21 lot# 01J20A;  Moderna 2/1/21 lot# 013M20A;  Moderna 12/3/21 lot# 066H21A;
started to experience some mild PVCs (premature ventricular contractions); This case was reported by a consumer via call center representative and described the occurrence of premature ventricular contractions in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included premature ventricular contractions (one and a half years ago the patient had an incident of PVC).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced premature ventricular contractions. On an unknown date, the outcome of the premature ventricular contractions was unknown.   It was unknown if the reporter considered the premature ventricular contractions to be related to Shingrix.  Additional details were provided as follows: The patient stated that one and a half years before receiving the Shingrix vaccine she had an incident of premature ventricular contractions but her doctor ruled out any abnormalities with her heart. The patient received the dose of the Shingrix vaccine in her left deltoid muscle.  After being injected with the vaccine the patient started to experience some mild PVCs (premature ventricular contractions) but on 17th February 2020 her PVCs were so intense that she had to go to the Emergency room.
fever 101 for 36 hours swollen and pain in my arm SHINGLES ON PART OF MY BODY.
Vasovagal Syncope - Per patient was feeling a little dizzy after the 15 minute wait time.  Stepped outside and it was hot and humid and walked a few steps and thought she was going to faint.  Got to the car and fainted.  Husband was with her and came in to get help.  Nurse helped her in via wheel chair brought her to a room and observed her.  Took approximately 60 minutes before she felt better to leave.  She also stated she had not eaten anything yet in the day.  Nurse gave her some apple juice while under observation.
Neck stiffened up. Swollen lump in collar bone. Pain in shoulder radiated down arm. Pain in elbow. Weakening of hand. Swollen knuckles.
Patient is a 92 year old male, past medical history of  CHB s/p PPM ICD, dementia, chronic CHF, CAD, hypertension presents to the ER with progressive weakness and cough for the past 2 weeks.  Family reports that he has been having a couple day history of diarrhea with poor appetite.  No further episodes of diarrhea in the ER.  Patient denies any pain but feels generally weak but not short of breath.  Multiple family members have tested positive recently for COVID-19.  He was vaccinated x2 for COVID-19 in February/March 2021.    Patient is require supplement her O2 however has not had signs of inflammatory worsening.  Chest x-ray repeat on 08/06/2021 shows bilateral lower lobe lung infiltration.  Oxygenation is 2 L on nasal cannula which is keeping a 95 percent sat unfortunately dropped to 86 percent on room air. Ferritin levels 2000 wondered 16, CRP is 0.35, procalcitonin 0.04 and he is otherwise stable for home care.  Discussed this with patient's daughters 1 of whom is a physician to other 1 is his caregiver who he lives with however she also has COVID-19 although does not have pneumonia and is physically fit for caregiving
The needle must not have been secured properly to the syringe, because when the plunger was depressed to inject the immunization, only some of the immunization went in the patient's arm, and the remainder squirted out of the side of the leurlok. The entire dose of the vaccination was not given.
The patient states a couple days after his second Covid Pfizer vaccination he started to experience pain inside his arm. He has a bruise next to where the vaccination was given. He has limited range of motion in the left arm.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 15-MAY-2018, the patient was vaccinated with M-M-R II lot # M017348 and expiration date on 06-APR-2018 for (dose and route of administration were not reported) prophylaxis. Concomitant therapies included sterile diluent (MRK). The reporter specified that, the expired dose was inadvertently administered and that the vaccine was properly stored. No adverse effect were reported.
Upper back muscle pains; Sore arm; A spontaneous report was received from a consumer concerning a female patient of 71-years-old,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, upper back muscle pains.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the event(s) sore arm, upper back muscle pains.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), sore arm, upper back muscle pains was unknown.
Lethargy; I have a hard time getting her out of bed /she seems knocked out; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01SM264) for COVID-19 vaccination.     The patient's past medical history included Dementia.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out). At the time of the report, LETHARGY (Lethargy) and FATIGUE (I have a hard time getting her out of bed /she seems knocked out) had not resolved.            Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I had a fever, chills, fatigue and nausea. I woke up with a fever and chills about 12 hours after receiving the vaccine.  I took Advil for symptoms that lasted about  3 days.
Patient presented for his first vaccine dose. He later stated he felt a sensation of something moving through his arm after vaccine administered, then states he felt some increased anxiety, followed by cold sweats, and then lost consciousness.  He was noted to be unresponsive, initially with brief period of apnea, and was unresponsive to sternal rub by vaccine administration staff.  He was placed into a reclined position in the driver seat of his vehicle. He regained consciousness within a minute, and was normally responsive but with pale color noted to face and chest, diaphoresis, and thready pulse with bradycardia, HR 43.  Difficult to auscultate HR and breath sounds clear but shallow. EMS responded promptly and assisted with evaluation, with initial BP 80/50, SpO2 97%.  Patient became less responsive and started to lose consciousness again, but responded to questioning, then lost consciousness again. His feet were placed on the dashboard to elevate them, and he quickly regained consciousness, pulse improved to HR 86, and repeat BP after a few minutes was 140/76. Oxygen saturations briefly dipped to 90% then rebounded to 100%. He improved quickly, was normally responsive and able to drink orange juice. He had pale clammy skin on the face, neck and hands, and some facial flushing.  Patient was monitored for several minutes, had improvement in symptoms, and refused transport by stretcher to the ambulance. He was able to walk to the passenger side of his vehicle and was driven out of the vaccination facility and further monitored. Blood glucose noted to be 96, EKG normal with sinus rhythm, no acute ST or T wave changes or other acute abnormality.   Patient was offered transport to the hospital for further evaluation, but he declined. Symptoms resolved completely, he was monitored for resolution of symptoms. He reported prior similar symptoms after a hand laceration at work and after a dental visit. Risks discussed, prevention measures for second dose discussed. Encouraged follow up with PCP given recurrent vasovagal syncope. No signs of allergy noted.
Received DTaP #4, Hep A #2 and Flu vaccine on 10/11/11. Febrile seizure occurred on 10/12/11.
Swelling, warmth and redness at site of injection. Hives on both forearms with pruritus. Responsive to Benadryl.
expired dose of FluLaval QIV to pregnant female patient; expired dose of FluLaval QIV on 25Sep2025 to pregnant female patient; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number CA52L, expiry date 30-JUN-2023) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 25-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: expired dose of FluLaval QIV on 25Sep2025 to pregnant female patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: expired dose of FluLaval QIV to pregnant female patient).  The outcome of the expired vaccine used and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (FluLaval Quadrivalent 2022-2023 season): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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: 25-Sept-2023 The case was reported by Obstetrics and gynecology office supervisor.   The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. This is 2 of 2 linked patient report reported by the same reporter. A medical assistant administered an expired dose of FluLaval QIV  to pregnant patient, which led to expired vaccine used and vaccine exposure during pregnancy.; Sender's Comments:  US-GSK-US2023131819:Same reporter, different patient
Fever, rash, joint sitffness, hives allergic rxn 1 day p/vax; rx w/Pred p/1day rx of DPH;
Patient was supposed to receive the Bivalent vaccine and instead received the Monovalent years and up.
The following day I had soreness in my left shoulder. Then two days after that the 11th I had a really bad headache. The following day I started feeling like my equilibrium was out of balance. I can not even walk a straight line. The headache and soreness in my shoulder went away but I am still experiencing equilibrium issues.  This is making it hard for me to walk. It feels I have been on ship. I called in to my ARNP this morning; She and I are waiting on a return call from her.
Engerix, patient was supposed to get meningococcal; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old male patient who received HBV (Engerix B) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd May 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 23-MAY-2022 Reporter's Comments: The medical assistant reported that they inadvertently administered Engerix on the day of reporting to a patient.  The reporter stated the patient did not need it and was supposed to get the unknown brand meningococcal. The reporter confirmed patient was not received the Engerix series in the past.  The reporter did not consent to follow-up. Additional Supportive Information: The patient inadvertently administered Engerix and was supposed to get the unknown brand meningococcal, which led to wrong vaccine administered.
I received a flu shot around 9:45am on 10/30/20, around 4:30am on 10/31/20 I woke up and felt my lips were swollen. I went to the gym and wore a mask during the work out. When I took off the mask around 6:30  the left side of my face was red with bumps, looked like hives. When I got home I noticed it all over my neck, chest and arms. I took three benedryls throughout the day and it helped a little. The next morning on 11/1/20 my eye lips and under the eyes were swollen.  It took a full day for it to umswell.
Within 12 hrs of receiving vaccine pt became lethargic. Didn't really nurse. Difficult to arouse. Decreased urine output.
She got her vaccine, she got it on her left shoulder, and the person who administered it said that he hit either a vein or an artery.  She had shoulder/bicep pain since she got the vaccine.  Then she noticed that it got more acute after day #4, and there was a bump about 1" down from the injection.  Since then it took 2 1/2 weeks for the bruise to go away, and felt that it was muscle damage from the needle itself.  Now her bicep is still tender to the touch, and it's been over a month, and has constant pain in that bicep.    She did not have any adverse reactions with the first three other than fever and normal reactions.  This is the first time that the person who administered it said they may have done something wrong, and having a reaction and the severe bruising and pain.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: pt is at nursing facility and after the flu, overnight the pt developed rash on her limbs and the at the injection site it is red and hot to the touch. Pt is being seen at dermatologist office.
patient was in clinic lobby, ready to exit and began to feel faint. There was an employee near door where patient was attempting to exit and patient voiced she felt dizzy, as employee tried to help patient to sit in a chair, the patient began to fall backwards. No injury to patient as employee was able to hold patient by right arm and patient did not suffer hard impact on ground. Patient brought back to laboratory area via wheelchair, patient was very pale and clammy stating she felt dizzy and nauseated. Attempt to take blood pressure at 8:38am unsuccessful. Patient taken to examination room via wheelchair to lay on exam bed with knees bent. Serial blood pressures taken laying down ranging from 88/53mmHg to 89/58mmHg with pulse range at 57 to 65. Patient color returned, patient voiced feeling a little better and assisted to sitting position at 8:55am, serial blood pressures taken in sitting position, ranges 87/58mmHg to 90/62mmHg. Patient given water at this time, continues to feel improvement. Standing blood pressure ranges from 84/61mmHg to 88/59mmHg. Patient states she was feeling a "little weak" prior to entering clinic and also voiced that she generally feels dizzy when she experiences pain. Patient left clinic at 9:09am with spouse who accompanied her. Spouse was driving personal vehicle.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of HPV vaccine (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported) and a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). It was reported that the patient went back to the physician office the same day of vaccination for an unspecified reason. The next day (date unspecified), the patient died. Cause of death was not reported. The causality between the suspect vaccines and the patient's death was not reported. Upon internal review the event was considered to be medically significant. This is one of several reports received from the same source. Additional information is not expected as there was no contact details provided.
Patient came in with her mother to get a meningitis and Tdap vaccine.  Our new form has all vaccines listed for patient to circle which they are here to receive.  The immunization was processed as a fluarix instead of meningitis/Tdap.  Pharmacist checked label printed and administered the patient a fluarix instead of menveo/boostrix which is what the parent wanted.  After the flu shot was administered the mother asked which immunization her daughter received and that is when the error was found.  The mother was very upset, she did not want her daughter to receive a flu shot.  She did report that the daughter developed a fever that was brought down by OTC fever reducers. She did bring her daughter back on 11/2/20 for the menveo and boostrix immunizations.
Have been subscribed an antibiotic for an issue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue). At the time of the report, VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Redness; Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   On 20th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema and pain in arm. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced redness and a sore arm after dose one of Shingrix. The patient came to the pharmacy and showed the redness and it had already begun to fade and the current status was unknown. Health care professional noted that she had a picture she could send if safety required it and asked to request during follow-up if photo was required.  The reporter did not provide address details.  The reporter consented to follow up. No additional information was provided.
it was rpt from MD ofc concerning a pt who was vax & subsequently pt exp an unspecified adverse event. was seen in MD ofc on 10mar or 11mar99. no further info avail
Patient currently inpatient at 8 days. Patient is a 69 y.o. male with history of intraventricular hemorrhage due to AVM s/p repair, type 2 diabetes mellitus, hypertension, hyperlipidemia and depression who presents today with shortness of breath.  He was vaccinated for COVID-19 in February and March 2021.  No booster.  His daughter contracted COVID-19 on Christmas, and was quarantining/isolating in their home.  He believes that he avoided all contact with her following her diagnosis, but he states that he began to develop symptoms 15 days ago.  He reports decreased oral intake, cough, nausea with vomiting and fever.  As the cough persisted, he began to produce more sputum. Fever and generalized weakness persisted.  Over the last week, he has felt more short of breath.  His daughter and spouse have been urging him to be seen for the last week, but he has refused.  Over the last 24 hours, his spouse and daughter noted that he couldn't move or walk without feeling markedly short of breath, so insisted he come to the ED.  He has been taking over-the-counter cough and cold medicine at home with minimal relief.  He does admit to worsening headache over the last few months.  His daughter is quite concerned about this, given his history of AVM, which was discovered around 12 years ago and treated by Neurosurgery.   In the ED, he was febrile up to 38.8° C, tachypneic and tachycardic.  Venous blood gas showed pH of 7.52, pCO2 38 pO2 <20.  Labs showed CRP 296.8, lactic acid 3.2-- >1.2-- >1.3, procalcitonin 0.22, WBC count 10.5, BUN 22, Cr 0.87.  COVID-19 testing positive.  He was markedly hypoxemic in the emergency department, and placed on high-flow nasal cannula with FiO2 0.80, flow rate 35 L. he was given 1 g of Tylenol, 2 L of IV fluids and 6 mg of Decadron.
Rec'd shingles shot - 2/12/07 - Shingles pain started on 7/23/07 followed by severe rash on left arm, shoulder and upper back. To date, pain and itch still occurs - left arm and hand are weak.
March 3 I became very ill. Lethargic and had flu-like symptoms. Over time began having neurological symptoms including short term memory loss and numbess and tingling in the cheeks as well as shakey arm and hand on right arm only.  Symptoms on face started and right and have moved over to the left side of the face. Continued memory issues off and  on. Memory issues include getting lost while driving and inability to spell. Basic confusion at times. Again these symptoms come and go on a daily basis.