chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient).    No concomitant medications were reported. No treatment medications were reported.
Started having trouble breathing shortly after the Pfizer Booster Shot in November 2021.  Had a chest X-ray November/December 2021 Hospitalised after being taken extremely ill/struggling to breathe. Massive blood clot on lungs.
Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens; Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:30 as dose 4 (booster), single (Lot number: GL0446) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 10Nov2022 as dose number unknown, single (Lot number: 942395), in left arm for immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Prior carpal tunnel release in both hands." (unspecified if ongoing). The patient had no allergy. Concomitant medication(s) included: ADDERALL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The patient had no covid prior vaccination. The patient didn't have covid tested post vaccination.  The following information was reported: NEUROPATHY PERIPHERAL (medically significant), SENSORY LOSS (non-serious) all with onset 12Nov2022, outcome "recovered with sequelae" and all described as "Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens". Therapeutic measures were not taken as a result of neuropathy peripheral, sensory loss.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.
NO TASTE; SORE ARM; FEVER; CHILLS; This spontaneous report received from a parent concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 2021, the subject experienced chills. On 03-APR-2021, the subject experienced no taste. On 03-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills on 2021, and fever on 03-APR-2021, and had not recovered from no taste. This report was non-serious.
Her voice was a little rasped which may have been allergies; Her voice was a little rasped which may have been allergies; Felt bad; Hives on her left wrist, which was the arm of the vaccine; Feel a little stressed at the vaccination site due to poor safety precautions; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 61-year-old female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 07Jun2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history included allergies to trees, cats, and several foods. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10May2021 as 1st dose, single dose for COVID-19 immunization. Patient received her first Pfizer Covid 19 Vaccine on 10May2021. She took the second Pfizer Covid-19 Vaccine on 07Jun2021. On an unspecified date in Jun2021, her voice was a little rasped which may have been allergies. Within one hour of receiving the vaccine she felt bad and experienced hives on her left wrist, which was the arm of the vaccine. She reports eating a hamburger prior to her appointment yesterday (07Jun2021). Voiced she was not allergic to anything on the burger. She did feel a little stressed at the vaccination site due to poor safety precautions. She was not sure if the hives came from stress or not. Patient asked if hives have been reported. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Information has been received from a physician concerning a 15 year old male patient with AUGMENTIN allergy and a history of tonsillectomy who on 05-OCT-2010, was vaccinated with the first dose of GARDASIL (lot # 0787Z, expiration date: 03-NOV-2011), intramuscularly and on 12-APR-2011, was vaccinated with the second dose of GARDASIL, (lot number and dose not reported), intramuscular. There was no concomitant medication. On 08-NOV-2010, the patient experienced sinus infection. BIAXIN 500 mg by mouth every 12 hours for 14 days, AFRIN, "salt water gargle", and TYLENOL for fever were given for the treatment of the adverse event. No lab diagnostics were performed. The patient sought medical attention office visit. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a 44 years old female patient with asthma, amoxicillin allergy, sulfa allergy and tretinoin allergy who on 13-NOV-2012 was vaccinated with dose 1, 0.5 ml of PNEUMOVAX 23 intramuscularly in the gluteus maximus, right side (lot number H012650, expiration date 27-FEB-2014). No other co-suspects were reported. Concomitant medications included: albuterol (manufacturer unknown). The nurse practitioner reported that the patient developed an injection site reaction described as cellulitis. The reaction site was described as tender swollen, erythematous area at the injection site 3 by 4 inches that was accompanied by generalized fever and chills. The exact development of the event was unspecified, but on 16-NOV-2012 the patient contacted the office and the nurse noted that the patient had a slight limp from the swelling and cellulitis. It was also reported that the patient could not walk right due to the limp. No laboratory tests were performed. The patient sought medical attention and had received Z-PAK as treatment. At the time of the report, it was unknown if the patient had recovered from the events. The relatedness for cellulitis, slight limp and could not walk was unknown for PNEUMOVAX 23. The nurse practitioner considered the event of could not walk right to be significant disability or incapacity and cellulitis to be life threatening. This is one of several reports received from the same source (other MARRS number 1212USA005195 and 1212USA005209). Additional information has been requested.
Pt called on 8/29/21. Reported fever and muscle pain that started at night of vaccination - she took Tylenol
Localized reaction at site, (erythema), shortness of breath. Pt presented days after vaccine occurred and has Asthma Hx.
Severe vertigo within 24-hours of injection.  Treated for benign paroxysmal positional vertigo (BPPV) in the emergency room on 03/25.  Seen by ENT on 03/31, who diagnosed condition as vestibular neuronitis, not BPPV.  Diagnosis was confirmed with a caloric reflex test on 04/16.  Participated in monthly vestibular rehabilitation for six months post diagnosis.
Patient is a 74 y.o. male patient of CNP with history of hypertension, hyperlipidemia, BPH s/p prostate cancer, hypothyroidism, Lewy body dementia presented with severe confusion found to be COVID-positive and febrile.  Confusion likely metabolic encephalopathy due to acute viral infection.  Completed course of remdesivir and received a course of Decadron with improvement of respiratory symptoms.  To be discharged to SNF.   Acute metabolic encephalopathy suspect due to COVID-19 Virus Infection with viral pneumonia  Febrile 102.1 on admission Date of onset of symptoms: unclear though believed to be about a week ago Symptoms present on admission: severe confusion and mental decline, severe weakness, and frequent falls Initially on room air however became hypoxic shortly after admission Date of covid positive test: 12/16/2022 Vaccination status: vaccinated Imaging: Chest x-ray mild right basilar atelectasis CT head - no acute intracranial abnormality; CT cervical spine - no injury Oxygen requirements on admission: None Current oxygen requirements: RA with sats 93-94%. 96% on 2 L. Requires oxygen at night Medical therapy: completed remdesivir, IV Lasix 20 mg daily x3 for dry lung strategy. Patient received 7 days of decadron. He has been having progressive worsening confusion. Will discontinue steroids, should that be contributing to his confusion.  Consultants following: infectious disease Completed 5 days of abx Anticipated special isolation end date:12/26/2022  CT angiogram of the lungs was done which ruled out any pulmonary embolism     Acute hypoxic respiratory failure - secondary to covid - improving with decreased oxygen requirements   Lewy body dementia with anxiety Hard of hearing Patient uses hearing aids  Rns informed of communication barrier Per daughter, patient's memory is usually sharp and his dementia Continue Zoloft and Exelon Worsened due to underlying COVID infection.   Frequent falls S/p scalp trauma Patient with fall 12/14 prompting ER eval and again with repeat fall earlier today Usually ambulates with use of a walker and able to participate with PT Currently at assisted living for ST and PT which he usually is able to participate with  PT/OT, speech consulted   Hyponatremia due to dehydration and possibly due to  Diarrhea: Resolved Anemia, chronic OSA not on CPAP  HTN, essential Hyperlipidemia Hypothyroidism:Continue atorvastatin, levothyroxine, metoprolol  BPH s/p prostate cancer Continue tamsulosin PSA screening MRI brain given sudden onset confusion which is normal
p/vax pt passed out & had sz;this is according to teacher;child was taken to MD;had an episode of hyperventilation;
Patient received PNEUMOVAX 23. Administering pharmacist administered in lower tricep area. Unknown if it was IM or SQ admin. After approx. 4 hours pt. noticed extreme redness, swelling and pain. Injection area and approx six inches below. Injection area was hot to touch. *Note-called Merck 9/12/16 to report case #00187376.
Patient, patient's father, and patient's sister came into store for a vaccine. Technician asked patient's father if the patient was over the age of 12 and the father stated that she was. Technician also asked the sister how old she was and was informed the sister was 20.  On the Consent form, the father also put 12 as the patient's age. The date of birth was left blank, but was not noticed by pharmacy staff. Both the father and daughter received their vaccine. Later, as the pharmacy tried to process the vaccination, the missing date of birth was found and a technician called the number provided for the patient's date of birth. The sister answered the phone and gave the patient's date of birth.  After realizing the patient is under the age limit for the vaccine, the phone number was called again to alert them to the need of waiting till the patient is 12 for the second dose, and that a VAERS report would be filed. The patient's sister said that she is 12, and asked the patient, who also said she was 12, however, they still provided the same date of birth.
got sick; she got little bit cough and begin Flu; she got little bit cough and begin Flu; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got sick and was not able to get the 2nd dose on time. She plans to take it in August. She was supposed to get her second dose but she got little bit cough and she got to begin Flu or something she didn't care, now trying to get her second dose vaccine. I wanted to know if the event dose she is planning for second dose in Aug2021, my question is, if I needs to restart whole process or just need to take the second dose. She is asking if that would be okay or should she repeat the 1st dose. The outcome of the events illness, cough, influenza was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Patient received by error 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose recieved on an unknown date).   On 30th March 2022, the patient received the 3rd dose of Shingrix. On 30th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comment: The patient received Shingrix third dose by error. The consent to follow up was given. No information available on patient´s details and lot number of the vaccine. Additional Supportive Information: The patient received 3rd dose of Shingrix in error which led to, extra dose administered.
Rash/lesion (L) arm. Doxycycline (given by another facility).
Patient received his second dose of Pfizer today (10/20/2021). Minutes after administration and counseling, patient returned back to pharmacy window to report numbness to the right side of his face from the top of his forehead down to the bottom of his jaw.  Patient was counseled to continue to sit for further observation. After 30 minutes, there were no other progression of side effects.  Patient reported that the area of numbness had not spread, no numbness/weakness in arm. Patient was able to carry on conversation with me with no signs of confusion or slurred speech.   Blood pressure was taken and was 126/70. He reported some tension headache and pressure under his jaw and back of his head.   Patient is a store associate working a shift tonight. Asked him to check back with the pharmacy again before 9pm and to let us know if he develops any other side effects/symptoms.
Large warty growth at injection sites; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 12:00 (Lot number: EN3248) at the age of 74 years as dose 1, single and administered in arm left, administration date 09Mar2021 12:00 (Lot number: EN6199) as dose 2, single for covid-19 immunization. Relevant medical history included: "Vascular dementia" (unspecified if ongoing), notes: vacular dementia; "Cerebral amyloid angiopathy" (unspecified if ongoing), notes: CAA; "Acute intermittent porphyria" (unspecified if ongoing), notes: AIP (Acute Intermittent Porphyria). The patient took concomitant medications. Past drug history included: Bacitracin, reaction(s): "Drug allergy", notes: Known allergies: Bacitracin antibiotic. The following information was reported: SKIN PAPILLOMA (non-serious) with onset Mar2021, outcome "not recovered", described as "Large warty growth at injection sites". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin papilloma.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
I am 59 years old and I am post menopausal and had cramping, was having a menstrual period and by the end of the day it was gone. I telephoned my gynecologist and the office nurse called me back and relayed my information to her. I told her my menstrual period was gone in one day. I have recovered from my adverse event.
Approximately 2 hours after injection, severe nausea, diaphoretic, hand trembling, heart palpitations, difficulty reading print and typing (using keyboard) difficulty focusing, dizziness, tachycardia, lightheadedness, lasted approximately 3-4 days.
I submitted a first report w adverse reactions already; this is a follow up report w additional symptoms: Shortly after I submitted first report, I experienced additional symptoms which included profuse sweating from approx 3:00am-8:00am, 10/2/2021, day after vaccination, drenched/soaking wet in sweat, all throughout the early morning, and what felt like a low grade fever throughout the day, 10/2/2021. As well as continued left arm, shoulder blade, shoulder, and up through the left side of neck pain/soreness/muscle discomfort, on side injection was received.
This was the first time I received the HEP B vaccine as an adult. I had received this vaccine series a total of 3 times as an adults, and was told each time vaccine didn't take but was safe to have again. After each time I had this vaccine all symptoms I had after first vaccine increased and new symptoms emerged leading to a diagnosis of Multiple Sclerosis (MS) a about 2years that was so progressed that I needed immediate infusion to try and reverse effects. Symptoms I started having after first vaccine: Migraines with dizziness with right facial hand and arm numbness that accompanied the migraine. These symptoms got worse after I received my second series in 2004 at clinic. I had a MRI of head that showed spots, they thought I might have MS. I was started a MS medication and the was told later that I didn't I had my 3rd Hep B series maybe 3 years about which increased symptoms to syncope, vertigo severe migraines and the my confirmed Dx of MS
15 minutes after vaccine administration, pruritis to throat and upper chest. No shortness of breathing, urticaria, edema.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  Subsequently, the patient recovered from syncope.  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  At the time of the report the outcome was unknown.  Additional information is not expected.
Swelling of left forefingers, itchy red rash on back of hand. Took oral benedryl on onset of symptoms. Symptoms resolving
patient states the technician immunizing was removing the needle as injecting and gave the shot into the sq instead of in the muscle.
No additional AE; HCP calling to report that an expired dose of PROQUAD was administered to a patient on 14JUL2022.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.    On 14-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection,(strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number T030944 has been verified to be a valid lot number with expiration date on 09-MAR-2022, and was reconstituted with sterile diluent (MRK) (strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided), lot number T020661has been verified to be a valid lot number with expiration date on 24-DEC-2022, both administered as prophylaxis. No additional adverse event was provided.   Concomitant therapie included sterile diluent (MERCK STERILE DILUENT) Lot #T020661 (had been verified to be a valid number; expiration date 24-DEC-2022, and upon internal validation established as the same date) for prophylaxis.
Dry red patches at the bridge of the nose and above the eye lid, at the tip of the nose, inside the elbows, and on the thighs. Also my scalp got very inflamed with the same dry skin patches and some hair loss. I take the Flurbiprofen for osteoarthritis in my hands and noticed that when I took it, only used when needed, it started to alleviate the condition and when I didn't take it, it would come back. So I started taking the full dose daily, 1 pill twice a day. It has not completely alleviated the problem but has dramatically improved it. So this has been going on since End of September and continues but appears to be going away. My plan is to continue to take the Flurbiprofen until it does. It looks about 90% gone as of today, progress is very slow.
This spontaneous report was received from a pharmacist via poison control center(PC) referring to a 30 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAR-2018 the patient was vaccinated with GARDASIL 9 for unknown indication (dosing details, lot/batch# and expiry date not reported). The patient was falling outside of the Food and Drug Administration (FDA) approved age-group for GARDASIL 9 administration, so this was an off-label use of the vaccination. It was unknown if the patient had experienced an adverse reaction from the vaccination. Outcome of the event was unknown.