chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional adverse events reported; patient received V AXELIS plus PEDV AXHIB today in error; received VAXELIS plus PEDVAXHIB today in error / PREVNAR was intended to be given instead of PEDVAXHIB / this was a general human error; This spontaneous report was received from a certified medical assistant and refers to a 2-month-old patient of an unknow gender. No information regarding the patient's medical history or concurrent condition was provided. Her concomitant medications included Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  On 22-NOV-2021, the patient received diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) lot # U7124AA was confirmed to be valid, expiration date 13-JUL-2024, 1 dose (exact dose, route and site of administration were not reported) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # T042015 was confirmed to be valid, expiration date 23-JUL-2023, 1 dose (exact dose, route and site of administration were not reported) both for prophylaxis, reported as in error. Pneumococcal vaccine conj 7v (crm197) (PREVNAR) was intended to be given instead of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and there was nothing regarding packaging that caused this error. It was reported as a general human error (wrong product administered, accidental overdose). No further information was provided. No additional adverse events were reported.
headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administration error, patient was ordered and documented to have Hepatitis B but after administering nurse documented giving Hepatitis B, she potentially pulled Hepatitis A-adult. After reviewing inventory report and administration transactions, patient was determined to be one of two patients having had a vaccine administration error.
felt a sting when the needle went in to her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; The liquid in the vial squirted out as the nurse was giving it to her and it ran down her arm; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular in the right arm, on 19Feb2021 10:00 (Lot number: EL9267; Expiration date: 31May2021), at age 76 years old, as dose 1, single, for COVID-19 immunisation, at a public health department. The patient has no medical history and concomitant medications. The patient received her first dose of the Pfizer COVID-19 vaccine on Friday, 19Feb2021 10:00. She stated that the liquid in the vial squirted out as the nurse was giving it to her, and it ran down her arm. She stated that the nurse asked someone to report it, but the nurse told the patient just to come back for her second dose stating it should cover you. She reported that the nurse said, well that doesn't seem right, and then the nurse said, well that was fast. When the caller looked at her arm, the liquid was running down her arm. The nurse said it squirted out at her, so the patient has no idea how much she vaccine got. The patient wanted to know if it was safe to get the second dose if you did not receive the first dose and if it is important to get two full doses. Also, the patient felt a sting when the needle went in her arm. She felt the needle go in but felt nothing after that. The events did not require emergency room and physician's office visits. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Felt lightheaded; couldn't sleep for exactly 12 hours; headachy; very tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Felt lightheaded), INSOMNIA (couldn't sleep for exactly 12 hours), HEADACHE (headachy) and FATIGUE (very tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt lightheaded), INSOMNIA (couldn't sleep for exactly 12 hours), HEADACHE (headachy) and FATIGUE (very tired). At the time of the report, DIZZINESS (Felt lightheaded), INSOMNIA (couldn't sleep for exactly 12 hours), HEADACHE (headachy) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Rash, hives started on next day after immunization given, responded to BENADRYL. Reports gets hives with all immunizations.
Arm swollen, has a visible raised area, hurts to raise the arm, tender and aching enough to lose sleep.  Treatment recommendations by her physician was to take some Advil and call the pharmacy. Treatment recommendations by the pharmacy was to add cold packs throughout the day, monitor and call physician/urgent care for visit if not better.
Pt had a very small, barely noticeable tick. After the vaccine, it became more apparent. By day 10 she was a slave to the movements of the tick. It had ramped up as was happening every few minutes. By day 14 it began to diminish. It has been almost 2 years since the vaccination. The tick is not constant, but it is very noticeable. It happens 5-8x throughout the day. On occasion there is an accompanying scream, but not always. More of an uncontrollable, jerky movement.
fever of 104.4, chills, headache, body aches, nausea, fatigue ..  treated with ibuprofen
Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored M-M-R II (lot#, expiration, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001263:  US-009507513-1703USA001265: US-009507513-1703USA001264:
Nausea-PHENERGAN. HA-ibuprofen. Chills-TYLENOL.
Patient started with dizziness and fainted/fell to the ground, patient was warm and sweating, BP, temp and glucose levels was taken, patient sat up on the ground and ice pack was applied to her neck, pt got back up and sat on the chair and symptoms started getting worst, patient started sweating more and was not responding to questions being asked, finally patient was able to respond and wanted us to call 911. EMT came and continued monitoring patient and they said her tests came back normal so she felt comfortable to go home.
3/22/21- Raging headache, extreme chills. 4/9/21- Left foot swelled up like a grapefruit,  was worried about blood clot when I saw them on 4/10/21.
Information has been received from a licensed practical nurse concerning an 8 year old female with no known medical history or allergies who on 14-MAY-1999 was vaccinated with a 0.5 mL SC dose of Varivax (lot # 630027/0312J). There was no concomitant medication. On 05-OCT-2006 the patient developed a fever which lasted until 06-OCT-2006. On 07-OCT-2007 the patient developed a rash with multiple papules. The patient was treated with an oatmeal bath. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0610USA07126) had a similar experienced after vaccination with Varivax. Additional information has been requested.
Patient calling with c/o rash on chest that he noticed after shingles shot. Rash.
Smallpox vaccination on 9/12/2015. On 11/27/2015 she still had eschar -- decreasing in size from the previous week. Otherwise normal take and asymptomatic after 2 weeks post vaccine.
Sudden severe dizziness with severe vision changes and vomiting within about 20 minutes after injection. I called 911 and quickly felt better, so did not go to hospital, but light headedness remained for almost 2 weeks. Not sure if it is completely gone. I do have a fear of needles and get dizzy from them, but have never experienced anything as severe or terrifying  as this.
Headache within 2 hrs of vaccine, tylenol taken 4hrs post vaccination with relief
Head jerking to left <24 hours after administration of vaccines. 4/18/08-records received-visit  1/22/08-C/O sore throat DX: pharyngitis with headache nausea posterior adenopathy. 2/8/0/-C/O very tired. 3/24/08-left ear pain aftrer swimming. 3/25/08-shaking at school, first head started to jerk then body shaking. Left frontal head tenderness. Mild jerking motion noted negative on sensory or strength differences.  3/27/08-no further twitching.
Fever, chills, headache, nausea, vomiting  starting @22 hours after injection
Eyrthema and swelling around site of shots on left arm - 2 x 2 cm induration 2.5 x 3.5 cm - mother  Rx possible infection.
I had my vaccination on 09/08/2022. On 02/19/2023 I had a cough that was getting worse. I tested COVID-19 positive on 02/20/2023. I called my doctor on 02/20/2023 and was informed to go to urgent care as I was out of the state. I went to a local urgent care in which I was prescribed PAXLOVID 02/21/2023. I feel the medication helped my cough. On 02/25/2023 I tested COVID-19 negative but I was still very weak with stomach problems. I came back home on 03/01/2023 and had 3 negative COVID-19 tests. I still had terrible fatigue and pain in my shoulder and elbow. I felt like my body was telling me my body is not right. I went to my orthopedist on 03/12/2023. They are unsure if it is lingering from COVID-19. I have started physical therapy to help my pain and energy levels.
VERY SICK; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Symptoms: On May 14 (chills, fever (temp 102), severe body aches, headaches), On May 15 (chills, body aches, lethargic), On May 16 (no sense of taste, lethargic, mild body aches), On May 17 (no sense of taste, lethargic)  Sense of taste still hasn't returned.   Treatment: drank lots of water, bedrest
In ability to breathe well even after taking meds.  A form of Interstitial lung disease.
No adverse events known. Patient said he got BAM treatment for COVID-19 less than 90 days before their vaccination date. Staff did not notice and gave the vaccine.
severe headache, vomiting, diarrhea requiring ambulance transport to ER and hospitalization
I received the vaccine at 2:30 in the afternoon. At around 5:30 pm, I experienced soreness in my arm at site of injection and down my arm. At about 10:00 pm. I started having flu like symptoms - aching, headache, chills. The symptoms got worse as time went on - developed a 102 temperature, severe headache and pain in my neck, vomiting and nausea. I went back to my physicians office at 9:00 am the next morning (04/03/2019). They gave me an injection for the nausea. I went home and slept the remainder of the day only being able to drink small amounts of fluid. On 04/04/2019 I felt better, but still stayed in bed all day with fatigue and overall not feeling well. All symptoms were gone by 04/05/2019.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve replacement" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN 81; VITAMIN D [VITAMIN D NOS]; WARFARIN. The following information was reported: FATIGUE (non-serious) with onset 28Jan2021, outcome "recovered" (29Jan2021), described as "A little tired the first shot". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient had no drug allergy. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient felt a little tired after the first shot. No reaction after the other three. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201049304 same patient, different event and different dose;
Dry mouth; Always thirsty; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and THIRST (Always thirsty) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported. No concomitant medication reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth) and THIRST (Always thirsty). At the time of the report, DRY MOUTH (Dry mouth) and THIRST (Always thirsty) outcome was unknown.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Progressively over next few hours, not immediately, patient developed very sore throat. Went to Emergency Dept. Found to have throat constriction thought to be from anaphylactic reaction.
After administration, the patient became dizzy, shaky and sweaty. Her eyes were slowly closing and opening. I had her parent get juice and a candy bar while I monitored her. She stayed seated for at least 30 minutes and felt better after eating and drinking. She left with her parents after she felt better.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol 2 tablets was taken as treatment for headache.  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.   Reporter did not allow further contact; 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.
Small fiber neuropathy; worsening neuropathy; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; This is a spontaneous report from a contactable physician. A 64-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported treating for small fiber neuropathy. Subsequently after the vaccine she had experienced increased pain and numbness over her body. This had been ongoing for six plus weeks. Patient had taken a 72-hour 5-day course of Ibuprofen, with no benefit. She had a skin biopsy to check for worsening neuropathy. Test results were pending at this time. The patient was asked to complete the biopsy prior to the vaccine; however, she was reluctant about coming out during the Pandemic. It was stated that there may be a possibility of a 5-day Medrol dose pack. Caller asked if there were reports of individuals with similar diagnosis who had experienced the same symptoms, if so, were there any treatment recommendations. Physician voiced he has had a couple patients with the same diagnosis that had been vaccinated report worsening symptoms also. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Improper storage of product in use; This spontaneous report was received from a nurse practitioner, referring to a 22-month-old male patient at the time of vaccination (also reported 2-year-old). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 17-AUG-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). It was reported that the call was due to data logger. It was reported, the patient would be repeated with new vaccine stock.; Sender's Comments:  US-009507513-2108USA006311:
Greatly exacerbated post polio syndrome. Pain (bursitis and tendonitis) in lt arm. Fatigue - such that couldn't get out of bed in a.m. in bed most of day (extremely unusual - tho' typically takes 2 naps/day). No treatment. Back to baseline by 4th day (in terms of 'outcome').
Patient had 2nd dose of vaccine- she had J&J first on 3/12/21 and then had Moderna in December 2021. She had a screening mammogram in April 2022 that showed a new mass, new from her last mammogram one year prior. Biopsy revealed cancer.
pt recv flu vax 23OCT95 & that day,pt exp atropine-like sx & a dry mouth;No further details known as of the date of this report;
No additional adverse events reported; administration of a pediatric dose of VAQTA to a 20 year old male; administration of a pediatric dose of VAQTA to a 20 year old male; This spontaneous report as received from a nurse and refers to a 20-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 16-AUG-2021, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # U013969 was confirmed to be valid, expiration date 06-FEB-2023, 0.5 milliliter (route of administration, anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Patient reports heart racing, pulse 122, BP 179/94 at 9:48, 104, 160/95 at 9:58, 90, 145/84 at 10:08.   Relaxation techniques started, symptom began to improve
Redness ,itching ,sore ,skin hard  and bumpy arm swollen and hot
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called.  Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived  and assumed care, transferring patient to a higher level of care.
Patient received her first COVID vaccine on 3.3.22. Reports that 48 hours after vaccination, she had swelling of her lips and cheeks (history of dermal fillers) as well as ear swelling on one side. Lips and cheeks have improved significantly. Ear lobe still remains slightly swollen. No ShOB, hives, or difficulty breathing reported.
Patient was given 0.25mcg of Moderna Bivalent Booster. Patient was to receive 0.5mcg.  Wrong dose was given to patient.
Inital COVID-19 doses amdinistered at 17 years of age on 03/25/2021. Second dose administered at 17 years of age on 04/20/2021.
Patient called the pharmacy on 8/26/20 and stated that she had a reaction to the Shingrix vaccine that she received. She stated that she immediately felt pain and discomfort and that she complained to the pharmacist at that time. Patient is reporting that she developed a rash on her left side, near her breast that evening and she is experiencing pain and swelling around the injection site and in the right arm. She went to her physician and was prescribed lidocaine 5% patch to help with the pain.
Patient presented with a swollen and red arm. They had some arm pain and itching around the injection site.
I was fine on the day of the shot and fine during the following day 1/17 but became dizzy during the night and the morning of 1/18.  I felt better on Tuesday, 1/19 but awoke on Wednesday 1/20 feeling dizzy again and still am at this point.
I26.99 ACUTE PULMONARY EMBOLISM 4/7/2022 ASTROCYTOMA, BRAIN HIGH GRADE, UNSPECIFIED SITE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2022 ASTROCYTOMA, BRAIN HIGH GRADE, UNSPECIFIED SITE I26.99 ACUTE PULMONARY EMBOLISM 4/7/2022 GLIOBLASTOMA MULTIFORME, BRAIN, UNSPECIFIED SITE    MALAISE AND FATIGUE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2022 GLIOBLASTOMA MULTIFORME, BRAIN, UNSPECIFIED SITE    MALAISE AND FATIGUE
T99, runny nose, cold 7MAY91 dx bronchitis-temp @ 103.9R, pharnygitis; Seen @ ER: