chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unsure if there was any vaccine in the syringe; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (unsure if there was any vaccine in the syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (unsure if there was any vaccine in the syringe). At the time of the report, UNDERDOSE (unsure if there was any vaccine in the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
4 hours after recieving vaccine, patient had vomiting, chills and a low grade fever. His wife was worried due to his current cancer diagnosis and took him to the ER. They gave him anti-emetics and fluids, kept him for a couple hours but not overnight. He said he had a similar reaction to a flu shot forty years ago, but his oncologist wanted him to get one now and patient was comfortable trying it again.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-NOV-2017 and 21-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 28-APR-2019; lot# N020353 and expiration date 28-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Information has been received from a medical assistant referring to an unspecified patients of unknown age and gender. On unknown dates, since 01-OCT-2015, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date 27-AUG-2016; lot # K014548, expiration date 27-AUG-2016, dose unknown) that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
Initial report received from a healthcare professional on 03 September 2013. A 28-year-old female patient had received intramuscular first dose of ADACEL (lot number: C4432AB, expiry date: 18 October 2016, site of administration was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 01 February 2013 and the estimated date of delivery was 08 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient did had experienced any adverse event. List of documents held by the sender: none.
left sided axillary lymphadenopathy after 2nd dose (given in left arm) Narrative:
This case was reported by a consumer via call center representative and described the occurrence of pain upon movement in a 70-year-old female patient who received BOOSTRIX for prophylaxis. The patient's past medical history included mastectomy. On 12th July 2018, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 13th July 2018, 1 days after receiving BOOSTRIX, the patient experienced injection site pain and injection site swelling. On 19th July 2018, the patient experienced pain upon movement. On an unknown date, the outcome of the pain upon movement was not recovered/not resolved and the outcome of the injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the pain upon movement, injection site pain and injection site swelling to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX on the left arm. Seven days after receiving BOOSTRIX, the patient experienced arm pain with movement. The patient had denied permission to contact their physician.
Intermittent Abdominal cramping on 23rd and 24th. Diarrhea on 25th at night. I?m usual sensitive like this to some antibiotics. Feels similar.
Initial information received from a healthcare professional on 10 April 2014. A male patient (no other information was provided) whose medical history and concomitant medications was not reported had received dose of DTaP, MMR, IPV, Varicella vaccine (batch number, expiration date, route and site of vaccination was not reported) on an unspecified date six years ago. The patient does not have any illness at the of vaccination and preexisting physician diagnosed allergies, birth defect, medical conditions was unknown. It was also reported that the patient was tested for an allergy to pork gelatin. It was reported that patient had an adverse event six years ago on an unspecified date. The detail of laboratory investigation and corrective treatment was not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Patient lst consciousness approx 1 min. Helped into wheel chair, once in exam room, she lost consciousness again, with a tremor noted, eyes rolled back and unresponsive for approx 30- 40 seconds. Heart rate dropped, diaphoretic, PCP present. Assisted x 2 to exam table. O2 via n/c at 3 liters with juice given. EKG per PCP showed bradycardia otherwise normal. Patient able to return home after approx 30 min. Patient called by staff and reported no other events, she did state however that she felt drained and not like herself.
Patient came in on 7/30/03 AM L Deltoid area very swollen, red, tende and warm to touch.  Says child has complained of high fever that are relieved by Tylenol but return.  Referred to clinic for provider visit. 7/30/03 AM. NKA allergies- no previous history of adverse reactions.
Atrial Fibrillation, Ventricular Tachycardia,  Atrial Flutter.  Onset day after vaccination and experience episodes ranging from 1 - 25 minutes daily.
Uncontrollable vomiting/diarrhea for 10+ hours, went to ER and was given minimal relief. Severe body aches, continued chills, fever started day 2 after 2nd dose and emergency room visit.  I am still not well!
Left observation area post-vaccination and returned to the clinic area approx. 20 min after injection. Felt hot, had headache, and was shaky. VS WNL, administered IM Benadryl 25 mg and kept in observation for approx. 45 min.
VERY HIGH FEVER OF 103., HEADACHE, BODY ACHES, VOMITING LEG PAIN
This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) at left arm on 11Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history included high blood pressure. Patient is not pregnant. Other medications in two weeks included Amlodipine besylate and lisinopril and "altor". No other vaccine in four weeks. Patient used had known allergies to tetracycline. Patient experienced diarrhea on day 2, 3, 4 start on 12Jan2021. No treatment received for the events. Outcome of the event was unknown. No covid prior vaccination. No covid tested post vaccination.
pt called on 12/5/20. stated there was retina detachment after each vaccination (once in august once in november)
Palpitations started several hours (~6hrs) after injection, intermittent throughout the days, exacerbated by eating, persisted approximately 8months and now are very few and far between though still happening very rarely. Also developed significant tender axillary adenopathy that lasted approximately 4 weeks.
Patient has pain in Left upper in area of vaccination when arm is elevated. This pain continues since vaccination was administered 10/2/10 til 10/28/10.
left leg deepvein thrombosis; blood clot; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 12Feb2021 19:30 (7:30 pm) as single dose for COVID-19 immunization in a hospital. Medical history included high blood pressure and high cholesterol both from an unknown date. No known allergies. The patient took an unspecified medication. No other vaccines in four weeks. No COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (lot number: EL9261) on 22Jan2021 07:15 am on the right arm for COVID-19 immunization. On 25Feb2021 21:00 (9:00 pm), the patient experienced left leg deep vein thrombosis and blood clot which required a visit to the emergency room and subsequent hospital admission. The patient was given Eliquis as treatment. The patient was tested for COVID-19 post vaccination via nasal swab on 08Apr2021 with a negative result. The outcome of the events was reported as recovering.
Dizzy, nauseous, headache, body aches, fatigue, black tary stools., diaphoretic, near syncope
Nurse telephoned by legal guardian several hours after child received MENACTRA vaccine - report symptoms of general malaise, headache, weakness and shortness of breath. Advised that could be moderate to severe reaction to MENACTRA Vax and directed to go to ER for eval/tx
Pt rcv'd doses 1 & 2 of Lymerix on 10/12 & 11/23/99. Following 2nd dose, pt exp loss of vision in 1 eye, asymmetrical hearing loss, severe tinnitus. Tinnitus is resolving. Current status of pt is unknown.
Initial misuse report received from health care professional on 16 Oct 2013. This case is linked to case number 2014SA044360. A 3.5 year old patient had received 0.25 ml dose of FLUZONE instead of 0.5 ml on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Pt states that he having severe arthritis attacks in his joints.  Pt said the pain is in one joint and with move to another joint which seemingly happens about every 24 hours.  He has not had this pain in his elbows or his feet but it has been everywhere else including his jaw.   It is beginning to happen in multiple joints at the same time.  Pt is using 800 mg Ibuprofen every 8 hours.  His PCP did blood work on him and then referred him to a rheumatologist due to his symptoms but they refused to schedule him an apt since his blood work was normal.  Pt is supposed to have his 2nd dose on 3/4/2021 but is worried about getting it and will try to get in to see his doctor again today.
01/18/22 presents to EC ED for "right stump wound infection". PMHx of "PAD s/p arm vein femorotibial reconstruction with subsequent reocclusion necessitating a BKA c/b difficulty healing requiring multiple debridements"
Patient received booster dose of Pfizer vaccine. It was not noticed that he was under 16 until time of billing, post giving the vaccine. It has been 6 months since dose 2 but patient is 14 years and 8 months.
Received vaccine booster (second booster, 4th shot total) on 11/17/22. On 1/26/23, started feeling ill with terrible headache and scratchy throat. Thought it was allergies or head cold. Had trouble sleeping overnight. Right nostril completely clogged. Got up 1/27/23 morning with worst headache of my life, clogged then very runny nose so hard to breathe through nose but could breathe fine through mouth, scratchy throat, fever at 100.8F, racing heartbeat. Self-tested for Covid-19 with FlowFlex test which was positive. Contacted INOVA Urgent care to see if I could get Paxlovid prescription to lessen symptoms. Paxlovid taken for 5 day treatment and symptoms lessened considerably. Fever went from 101 down to normal 98.6. I never lost sense of taste or smell. The Paxlovid didn't taste great though. Then several days after Paxlovid treatment finished (2/1/23), I had a rebound of symptoms on 2/6/23. Symptoms stayed mostly in my nose and throat. Some coughing, more sneezing, runny nose, scratchy throat, Headache did not return. Breathing was fine throughout. I did not feel anything weird in my chest or lungs. All fine there. Finally think I'm mostly over the symptoms on 2/17/23.
Information has been received from an approximately 28 year old female consumer with no past medical history and a sulfa allergy, and photosensitivity who in approximately 1991 was vaccinated with hep b vaccine recombinant and experienced large hives from her nipples to her knees. It was reported that concomitant medication at the time of this report 10/23/2001 included Synthroid. Unspecified medical attention was sought. No further info was provided. Additional info has been requested.
Started with a bright red rash and very severe itching which started with face and neck eventually going all the way to my toes over 10 days. I was told after getting flu shot by the county nurse that I would have problems with this vaccine due to it having a preservative in it. My local doctor was giving out at Expo in town.
No adverse effects were reported in the patient; a 15 month old patient received a dose of MMR II on 7/5/2019 at his 15 month check up. It was later discovered that the patient had aslo received a dose of MMR II at the 12 month checkup; This spontaneous report was received from a medical assistant referring to a 15 month old male patient. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported) at his 15 month checkup. Then it was later discovered that the patient also received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at the 12 month visit as well in approximately April 2019 (inappropriate schedule of product administration). No adverse effects were reported in the patient.
Burning, stinging at injection site, egg sized raised area, painful and warm to the touch.
red, itchy welts; Red raised itchy welts on same arm; Red raised itchy welts on same arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red, itchy welts), ERYTHEMA (Red raised itchy welts on same arm) and PRURITUS (Red raised itchy welts on same arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced URTICARIA (red, itchy welts), ERYTHEMA (Red raised itchy welts on same arm) and PRURITUS (Red raised itchy welts on same arm). At the time of the report, URTICARIA (red, itchy welts), ERYTHEMA (Red raised itchy welts on same arm) and PRURITUS (Red raised itchy welts on same arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Major narrative update
Swollen, red, warm thigh-approx. 7 by 4 inches in size.
Pt. bled. Small circumference bump rose. Swelling became worse. Applied ice pack. Patient there is no pain.
injection site is very, very warm at the site; she has gotten nauseous twice; is feeling dizzy; This spontaneous report was received from a consumer, referring to their mother, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in October 2021 (also reported as less than 12 hours ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection and influenza vaccine (manufacturer unknown) injection (strengths, vaccination schemes, anatomical sites of vaccinations, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis.  On an unspecified day October 2021, the injection site was very, very warm (vaccination site warmth), also she had gotten nauseous twice (nausea) and was feeling dizzy (dizziness).  The outcome of vaccination site warmth, dizziness and nausea was not reported. The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was reported as related. The causal relationship between the events and influenza vaccine (manufacturer unknown) was not reported.
INCREASED BLOOD PRESSURE; ARM WEAK; SEVERE RINGING; MASSIVE HEADACHE; ARM NUMB; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced increased blood pressure, arm weak, severe ringing, massive headache, and arm numb. Laboratory data included: Blood pressure (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased blood pressure, arm weak, severe ringing, massive headache, and arm numb on DEC-2021. This report was non-serious.
Extreme Flushing of face when active at all. Appears sunburned on face.; Sunburned on face; Headache daily that worsens throughout day.; Nausea; irritability; This is a spontaneous report from a contactable consumer (reported for herself). A 40-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:15 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included impaired gastric emptying, schizophrenia, bipolar disorder, post-traumatic stress disorder and drug hypersensitivity (sulfa allergy), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 did not receive any other medications within 2 weeks of vaccination. The patient previously received geodon (ZIPRASIDONE MESILATE) and experienced drug hypersensitivity and paxil (PIROXICAM) and experienced drug hypersensitivity. On 31Jul2021 at 16:30, the patient experienced extreme Flushing of face when active at all. Appears sunburned on face. Headache daily that worsens throughout day. Nausea and irritability. The reporter stated the events result in Doctor's or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events included treatment with ibuprofen and appointment with her PCP (Primary Care Physician). The outcome of the events was not resolved.  This follow-up is being submitted to notify theta the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approximately one quarter of vaccine given, followed by full dose in same arm; Vaccine Underdose; Syringe came off while injecting this patient; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No new information was provided.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # unknown with no associated AEs.
Injury via needle on palm of hand; Accidental occupational exposure to product; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a female patient who administered Rabies NVS (RabAvert) for prophylaxis to the patient.   On 12th August 2019, the patient received RabAvert. On 12th August 2019, immediately after receiving RabAvert, the patient experienced needle injury, accidental occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the needle injury, accidental occupational exposure to product and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle injury to be related to RabAvert.  Additional details were received as follows: The age vaccination was not applicable for this report. The reporter stated that, the nurse was handling the Rabavert vaccine, and while disposing the needle in sharps container the needle flew back out and poked her in the palm surface of her hand. No further details were provided.