chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced a lump just above her collar bone on the same side she received the injection; Caller states she originally thought it could be swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced she experienced a lump just above her collar bone on the same side she received the injection, caller states she originally thought it could be swollen lymph nodes. Caller states the lump has remained about the same since Friday. Caller states she saw her primary care doctor, but the doctor did not know what it was and "had never seen this before." Caller states she went to the hospital today and the providers at the hospital also told her they had never seen this before. Caller states she originally thought it could be swollen lymph nodes. The outcomes of events were not recovered.   The Lot number for BNT162b2 was not provided and will be requested during follow up.
Feels like neuropathy; Pain in arm that shoots down; Arm feels dead; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 12th November 2021, 1 days after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), pain in arm and numbness of upper extremities. On an unknown date, the outcome of the neuropathy, pain in arm and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself, who was a health care professional (physician). The patient received his second dose of Shingrix in his right arm and started experiencing pain in his right arm that shoots down the arm beginning the day after the injection.  The patient stated that that the pain felt like neuropathy and his arm felt dead.  Till the time of reporting, this sensation and pain were still unresolved, four weeks following the injection. Reporter could not provide the lot and expiration date of the Shingrix vaccine. The reporter consented to follow up.
Suspected vaccination failure; My brother got vacc and still got shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got vaccination and still got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) 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 EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about patient 14 out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Move difficulty in mobilization/ambulation; swelling of hands bilaterally; more difficulty breathing; soreness at injection site; is taking now pain meds and alkaselzer; improving; client's daughter also reporting adverse effects.
Left arm/deltoid swelling, enlarged axiillary lymph node, dizziness, n/v, fever, cold sweats
fell down/fell down at home again/fell down twice; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down/fell down at home again/fell down twice) in an 80-year-old female patient 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) 1 dosage form. On an unknown date, the patient experienced FALL (fell down/fell down at home again/fell down twice). At the time of the report, FALL (fell down/fell down at home again/fell down twice) outcome was unknown.     No concomitant medications was reported. The reporter states that, the patient fell down. The patient had to go to the hospital. Then on the way back from hospital, patient fell down at home again. Patient also took the last booster. No treatment medications was reported.   Reporter did not allow further contact
patient was given the liquid portion of Pentacel only/ No AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 25 months old female patient who received only liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (fourth dose 0.5 mL, lot number : UJ259AAA, expiry date- 14-May-2021) via intramuscular route in left thigh for prophylactic vaccination on 14-May-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (product preparation issue).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever 102.9  Chills Body aches Headache Symptoms lasted 48 hours. Not helped by Tylenol. Relief achieved by Advil.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 2/14/2023 UNSPECIFIED ATRIAL FLUTTER
Approximately the next day after my booster shot I experienced the following symptoms: Difficulty breathing (cannot breathe), Chest pain, High blood pressure. I went to the ER and they took my blood pressure and did some blood work,  IV line (Blood vials), Chest X-Ray (showed spots on both lungs - especially the right side). After doing all those tests I got discharged eventually - I started to feel better. It took a few days for the chest pain to subside and the breathing difficulty took 1 week to subside and the blood pressure took a month - until I got my normal pressure back.
Information has been received from a health professional, a nurse, concerning a 74 yr old female who on 22Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). On 23Nov04 the pt experienced super swollen site reaction that was red and pink down to the elbow. Also reported that two other pt's (WAES No0411USA04075 and 0411USA03975) experienced the same super swollen site reaction that were red and pink down to the elbow onset date was 24Nov04 and 22Nov04, respectively. No further information is available.
Approx. 10 minutes after vaccination, patient developed rash and itchiness around left deltoid and upper left arm.  Patient did not difficulty breathing or shortness of breath, reaction local to vaccine site.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. The patient's current condition, drug allergic reactions and medical history were unknown. On 10-MAR-2015 the patient was inadvertently vaccinated with PNEUMOVAX 23, (dose number, lot number and expiry date unknown) which expired on 06-MAR-2015 intramuscularly. This was supported. No adverse effects were reported. The outcome of event was unknown. No further information provided. Additional information has been requested.
15 minutes after the shot got really dizzy and felt like she was going to pass out. She went to the ER and spent the night. She vomited in the ER.
When it was administered it hurt a lot; some vaccine spewed out on my arm; some vaccine spewed out on my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown(booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "When it was administered it hurt a lot"; UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "some vaccine spewed out on my arm".  Additional Information: The patient (reporter) received the newest booster and had terrible side effects and when it was administered it hurt a LOT. When the young man pulled the shot out some vaccine spewed out on my arm.  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.
Patient stated that their throat was swelling and that they were having difficulty breathing.  The patient was given one dose of epinephrine 0.3 mg in the outer right thigh and 911/ems was called.  They arrived within 10 minutes and took over care of the patient.
Received vaccine 7:30 PM Monday, began feeling tinging in lower lip Tuesday, did not notice any symptoms Wednesday, Thursday 11:00   AM noticed drooping left side of face, couldn't smile on left side, eye drooping, difficult to close left eye.  Transported to ER by ambulance at 11:30 AM. Diagnosed with Bell's Palsy.  Released from ER to home.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, route, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sick for 48 hours afterward with flu-like symptoms (headache, nausea, fever, aches, chills, fatigue). Developed persistent cough and chest pain a month later and was treated with prednisone and an inhaler
PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 66 yo female with PMH of IDDM2, chronic diastolic heart failure, mild intermittent asthma, OSA and essential HTN who presented to the ED due to generalized fatigue and dyspnea. She reported symptoms started 2 weeks prior to presentation and was treated with Azithromycin prescribed by urgent care without any improvement.    In the ED, patient tested positive for COVID-19 with CTA thorax demonstrating finding consistent with COVID-19 PNA. Her pro-calcitonin was unremarkable and she was without leukocytosis. She was requiring 2 liters via NC at time of admission due to hypoxia. She was started on Decadron with admission to the medicine service   She was able to wean off oxygen soon after admission and was able to maintain oxygen saturation >88% with ambulation on room air. She was started on higher dose of insulin (Lantus 50 units daily) by the admitting team than compared to her home Lantus dose of 30 units HS. Patient was offered monitoring overnight to ensure no hypoglycemic events given >20% increase in her home insulin dose, but requested discharge.   She and her daughter were provided instructions on monitoring blood glucose closely over next 24 hours and provided signs/symptoms of hypoglycemia. She was recommended to increase her home Lantus to 36 units HS while on Decadron and decrease back to her home dose with completion of steroids.   She was discharged in stable condition and discharge instructions provided. Transition to home with COVID was arranged prior to discharge.
I had a routine health screening and I had my blood drawn and also the platelets, and that is when they noticed the levels were low, I tested at 50,000 per UL. After that I went to a specialist, and they wanted to stabilize my platelets so they gave me prednisolone. Still doing more testing at this time. The steroids are helping but it is better than it was.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SORENESS IN THE INJECTION ARM; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mildly obese, and allergy to citrus. Patient had no known medical conditions. The patient experienced drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 08-JUN-2021, the patient experienced soreness in the injection arm and tiny headache. On 06-AUG-2021, the patient experienced sinus irritation. Patient thought it could be due to seasonal allergies. Out of caution patient performed a COVID-19 test, result was positive (suspected covid-19 and suspected clinical vaccination failure). It was reported that patient received the result on 11-AUG-2021 morning at 05:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, soreness in the injection arm and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210822665-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
On Thurs night 16MAY91 started developing inc temp-went to ER Sat night 18MAY91 fever of 106F-seen by Md-states caused fr MMR vax recvd 8MAY91; No rash has developed;
H1N1 given 1/21/10. Pt came to health dept at noon on 1/22/10 c/o R sided numbness, chest pain and HA - was referred to ER. Reports symptoms started last night.
L deltoid inject site from vax reddened, raised area approx 5 cm with ecchymosis at inject site. Resolved on own.
Patient in the office for 11 year well visit. Received MENACTRA and TDaP vaccines. Child walked out of the exam room and into the waiting room to leave the office and told mom she didn't feel well. Mom stating that she turned around as patient was starting to feel weak. Mom lowered her to the ground so she didn't fall and hit her head. Mom stating that child never blacked out but was very dizzy. Did pick her up and put her in a chair in the waiting room and this is when I got upfront to check her. Child looked very pale and C/O dizziness. Otherwise ok. Pt denies falling and hitting her head. Acting well. Alert and oriented. Dr carried pt back to an exam room where we had her lay down for a little while. She was given cool cloths and water to drink. Patient felt better almost immediately but we had family wait 10 mins to make sure she was ok. Mom to F/U with any changes/concerns.
He felt really tired for couple of days; This spontaneous case was reported by an other caregiver and describes the occurrence of FATIGUE (He felt really tired for couple of days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (He felt really tired for couple of days). At the time of the report, FATIGUE (He felt really tired for couple of days) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. No lab Data  This all for 1st Dose   This case was linked to MOD-2021-168108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Details aboutv2nd dose adverse events On 14-Jun-2021: Non significant follow up
Fever, chills, body aches, fatigue, headache, arm swelling at injection site
Soreness at injection site; tired; dizzy; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose on 6th August 2019, refer case US2019AMR191400).   On 14th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, dizziness, chills and headache. Rechallenge with Shingrix was positive. On 15th October 2019, the outcome of the injection site pain, tiredness, dizziness, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, dizziness, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experience arm soreness on left arm and also had injection site pain, tiredness, dizziness, chills and headache. The reporter consented to follow up. This case linked with US2019190817, reported by same reporter.
approx 15min p/vax pt became dizzy, nauseous, diaphoretic, fainted-fell-hit head on wall (forehead) & floor (occiput);pt regaining consciousness c/o numbness/tingling/dizziness;rescue squad notified-tx on scene & released;
Patient stated that she experienced chills, shoulder pain, and chest tightness for 2 days after the administration.
extreme nerve pain  in lower spine/back while sitting.; left leg became extremely weak and could not lift it; spinal nerve compression; This is a spontaneous report from a non-contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration on 28Apr2021 at 10:00 (at the age of 56-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included autoimmune disorder, chronic kidney disease stage 2 (CKD2), anemia, peanut allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number ER8734) on 05Apr2021 as a single dose for COVID-19 immunization. The patient previously received penicillin and prochlorperazine (COMPAZINE) from unknown dates for  unknown indications and experienced allergy. On the third day after the shot (01May2021) at 07:00 the patient experienced extreme nerve pain in lower spine/back while sitting. It got worse over several days and the left leg became extremely weak. She could not lift it. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited urgent care as a result of the events and was diagnosed with spinal nerve compression of unknown cause. The patient received treatment with an anti-inflammatory shot, prednisone, and pain reliever. The outcome of spinal nerve compression of unknown cause was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
DOSE#1:  SLIGHT LOSS OF TASTE IN THE ROOF OF MY MOUTH FOR A COUPLE OF DAYS  DOSE#2:  TOOK 1000MG OF TYLENOL PRIOR TO DOSE GIVEN AT 16:00 ON 02.22.21  NO ISSUES UNTIL ON 02.23.21 AT 17:00 BEGIN TO HAVE SUDDEN CHILLS, SLIGHT DIZZY, TOOK TYLENOL AGAIN AT THAT TIME,  CHILLS CONTINUED ALL THROUGH THE NITE, TEMP AT 98.5 WOKE VERY FATIGUED AND SLUGGISH THE NEXT DAY>>>RETURNED TO BASELINE ON 02.24.21  AT 19:00
Permanent change in tasting foods: everything tastes hot, spicy. Even ketchup! Cannot eat any actual spicy food at all now, because it severely burns my tongue, whereas I could before I received the vaccine.