chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Other pulmonary embolism without acute cor pulmonale Pneumonia, unspecified organism Acute kidney failure, unspecified Pulmonary embolism  Acute renal failure (ARF)
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  The patient did not provide the Pfizer medication.  The patient had COVID-19 infection.   Reporter did not allow further contact
PATIENT RECEIVED FLU VACCINE AND LOST BALANCE/FELT DIZZIY WHILE STEPPING OUT OF PATIENT CARE ROOM. PATIENT HIT HIS HEAD ON WALL AND PHARMACIST WITH AID OF MOTHER WALKED PATIENT OVER TO A CHAIR AND PROVIDED WATER AND ICE PACK. AFTER A FEW MINUTES PATIENT AND MOTHER LEFT AND PATIENT WAS FEELING BETTER BUT STULL A LITTLE LIGHT HEADED. FOLLOWED UP WITH PATIENT 2 HOURS LATERS AND MOTHER REPORTED PATIENT WAS DOING BETTER AND RESTING AT HOME NOW. ALSO CONTACTED DOCTOR OFFICE AND INFORMED THEM OF ADVERSE EVENT THAT OCCURRED
I developed a previously never experienced constipation, with soft, not impacted stool. I'm a physician of Internal Medicine and would equate this w/ something of an atonic colon. I self-administered two separate Fleets Childrens rectal suppositories w/o response, then repeated digital disimpaction every hour or so, for the next 12-16 hours. Began Miralax powder the evening of January 16, 2021 around 7PM and repeated full doses at bedtime, again at approximately 4AM on January 17, 2021 and a fourth full dose at 8AM. The Miralax finally resulted in a more liquid stool that morning around 10AM, w/ relief of the generalized abdominal discomfort
dizziness; fever of 103; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMARIN; ESTRADIOL. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever of 103"; NAUSEA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller also noted AE experienced from the PfizerCovid19 vaccine: really uncomfortable reactions. With the second one she had fever of 103, dizziness, nausea, also with the booster, same reaction, but not as bad, she was still sick for 3 days. She is a senior citizen, and she was a wreck thinking of taking booster. She stated she had reported this experience to Pfizer before. Caller asked about receiving the new booster dose of the Pfizer Covid19 vaccine, Bivalent, gray cap and how many doses are recommended and what it is covering. She wanted to know about reports of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few minutes after receiving vaccine, L eye had some visual disturbances, guest quoted seeing "wavy lines and mirage". Was assessed by RNs. Guest denied blurry vision, diplopia. Denied any headache or dizziness, Guest reported having experienced visual disturbances previously.  The visual changes resolved at 15 minutes.
pt recv vax; noticed edema in area of inject; hot to touch; area now inflamed; edematous; seen by MD; pt improving;
Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 12Apr2021 as dose 2, single (Lot number: EP6955) at the age of 43 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09May2022, outcome "unknown", COVID-19 (medically significant) with onset 09May2022, outcome "recovered" (2022) and all described as "Patient tested positive for COVID".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) positive.  Therapeutic measures were not taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient tested positive for COVID on 09May2022. Prior to vaccination, the patient was not diagnosed with COVID-19.
She got her vaccine, she had no reaction other than a sore arm.  She was busy and doing stuff all day long, got home around 8:00 or so and then started to get severe stomach ache, and feeling that it may have been something she ate.  She then had vomiting, and went in to bed, really didn't sleep but felt that it would pass.  In the middle of the night she had vomiting again, 2 times of diarrhea and now is feeling much better.  Had flu-like symptoms, and feels kind of wiped out.    She had a pneumococcal vaccine 14 years ago and had a similar reaction to this, but not quite as severe.  She believes it was the pneumovax.
Patient was admitted to observation level of care on 7-9 with increased confusion and weakness. Patient noted to have tested positive for covid on 7-9.
Information has been received from a physician concerning a male patient who was vaccinated with PNEUMOVAX 23 (Lot # not provided), 0.5ml. After patient received PNEUMOVAX 23, he experienced blood clots at the injection site. The patient was admitted to the hospital for unknown amount of time. This is one of two reports from the same source. Additional information has been requested.
Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approximately 13 hours after vaccination and all resolved after almost 68 hours except for the muscle aches and fatigue.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 56-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Patient was seen at Hospital for seizure, fall and head injury.  Subsequent workup following transfer to another hospital revealed L frontal lobe parenchymal hematoma with overlying subarachnoid hemorrhage, no underlying aneurysm or vascular malformation.  He had MRI with and without contrast revealing partial occlusion and thrombus of the superior sagittal sinus with adjacent hemorrhage and edema.  Treated with heparin, transitioned to coumadin.
RAISED, RED, ANGRY, ITCHY RASH TO THE LEFT SIDE OF NECK, BEHIND LEFT EAR,  AND GOING UP ONTO LEFT SIDE OF LOWER JAW.
This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a adult female healthcare professional who intended to vaccinate a patient with SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional who was pregnant, suffered a needle stick while preparing a dose of SHINGRIX for administration. The healthcare professional declined to provide any further information including address.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017 at 13:21, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
14:55 patient states she felt eye swelling, trouble swallowing, and numbness in throat. Vitals taken 99% on Room air and lung sounds clear patient heart rate elevated at 107. contacted charge nurse to contact Dr. patient taken to gurney and 2 Liters Nasal Canula applied. Per Dr. order, patient given Claritin 10 mg Tab oral and Benadryl 25 mg Intramuscular. At 15:30 patient states feeling much better. able to drink water, no numbness in throat no tongue or eye swelling. no signs of distress. per Dr. ok for patient to be discharged home. patient able to call son to pick up patient. patient placed in wheelchair. Vitals stable on RA 98% blood pressure 109/80 heart rate 99.  No signs of distress. Breathing equal and unlabored. aoxo4. patient able to go home with son.
Within 24 hrs, onset of truncal itch, hyperesthesia, dysesthesias, bilat trunk, non-dermatomal pattern. Also significant fatigue and hyperhydrosis.  This has persisted to this day.  Night sweats and itch are worsening.
This spontaneous report received from a registered nurse, via company representative, refers to a 14 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Fatigue; Feeling Lathargic; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and LETHARGY (Feeling Lathargic) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Fatigue) and LETHARGY (Feeling Lathargic). At the time of the report, FATIGUE (Fatigue) and LETHARGY (Feeling Lathargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs included No treatment drugs included
Patient was immunized for flu and pneumovax 23 on 10-13.  The arm in which she had the pneumovax 23 (by 10-15) when she woke up in the am had hot, raised, red, swollen patches around the area where it was given.  She also stated she has pain in her shoulder and underarm area.  Flu shot was given in right arm, but it did not have the same reaction.  Pt. did not mention getting or wanting any medical attention...
Information has been received from a nurse and her 79 year old mother (the patient) who had a history of shingles on July 2008 with the rash localized to the buttocks and peritoneal area. The patient's daughter reported that the patient, on 20-NOV-2008, was vaccinated with a dose of ZOSTAVAX possible via IM in the left arm near the shoulder area. Concomitant therapy included TENORMIN, COUDMADIN, VYTORIN and CELEBREX. Right away after vaccination (20-NOV-2008) the patient started experienced pain, tingling, and numbness in her left arm extended to the wrist and fingers. That same night the patient could not sleep by resting on the left side. It felt like "the left side went to sleep". The next day she woke up and her fingers, knuckles and wrists on both sides were swollen and painful. The pain is believed to be joint pain, accompanied with stiffness and swelling. At bed time, the hands got hot and the pain increases. The symptoms had persisted for 1 week and 4 days. The pain intensity is the same as day 1 but the swelling had decreased from scale of 10 to 7 or 8. On 24-NOV-2008, the patient went to see a physician assistant who prescribed NEURONTIN (strength unspecified) and BENADRYL (manufacturer unspecified) however that did not help and the patient is still experiencing the pain. He patient was diagnosed with ZOSTAVAX inflammatory response. Follow up information received from a nurse on concerning her 79 year old mother, with knee osteoarthritis, atrial fibrillation and paroxysmal atrial tachycardia and a history of pulmonary toxicity in December 2005, who on 20-NOV-2008 was vaccinated with ZOSTAVAX (Lot# 662969/1206X). Concomitant therapy included atenolol. COUMADIN, VYTORIN, CELEBREX, aspirin and THYROXIN. On 20-NOV-2008 during the night of vaccination left side, left arm and hand went to sleep, and left ring and middle finger numb. When the patient woke up next morning, on 21-NOV-2008, the patient's fingers, knuckles and wrists of both hands were swollen, stiff and painful. The symptoms persisted for 4 days (24-NOV-2008) the patient called the office doctor and was prescribed with NEURONTIN (100 mg) and BENADRYL (25 mg) which did not relieve the symptoms. The patient called again 4 days later (28-NOV-2008) and was prescribed a prednisone dose pack which alleviated the symptoms except for the persistent numbness of left arm, left ring and middle fingers when the patient lied on the left side or holding arm up to talk to the phone or read a book. The nurse considered the persistent numbness of left arm, left ring and middle fingers and the swelling, stiffness and pain of the fingers, knuckles and wrists to be disabling. No additional information is expected.
3/22/04 child noted with lesion (white pustule 5 mm diameter) infect with no drainage 1-2 mm below left eyebrows. Client noted signs/symptoms began 3/19/04 with itchiness & redness.
Two months after my second Covid vaccine I started experiencing very heavy periods. Every cycle has lasted on average 2 weeks long of bleeding along with passing blood clots.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 at 11:00 as dose 2, single (Lot number: EN6201), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 19May2022 at 14:00 as dose 4 (booster), single (Lot number: FM992) at the age of 84 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: If vaccine received reported as Yes. Other medication in 2weeks reported as No. Patient received anti-viral treatment started from 11Jul2022 to stop date 16Jul2022 for Treatment of COVID-19 via oral Administrator route.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Signs and symptoms: extreme fatigue (sleeping 15-20 hours/day), migraine headaches, nausea, vomiting, diarrhea, shortness of breath, chest pain, dizziness, increased frequency and intensity of heart palpitations and near syncopal episodes. Time Course: Began 2 days after vaccine was administered and has not ceased yet as of this submission. Some symptoms have decreased in intensity/frequency but are still present daily.
Started with chills, then fever up to 100.6 and body aches for about 40 hours. Pain in arm of injection, and swollen lymph nodes and pain in armpit. Severe headache and nausea for about 24 hours.
Patient received DTaP#5 and Hep A #1 in (R) lateral thigh on 08 Jan 07, using 25g 5/8in needles; two staff and Father needed to subdue patient and complete injections. Father noted bruising and redness at DTaP injection site the morning of 09 Jan 07. Patient was returned to clinic 10 Jan 07 when injection site became increasingly inflamed, itchy and warm to touch. Patient was afebrile with a reddened, warm area 6cmx5cm, extending from inferior / lateral edge of injection site outward. No hx of adverse reaction to any previous vaccinations. ** Patient received other vaccinations FIVE weeks prior (01Dec06) at parents' request that immunizations be divided: Varicella#2 (L) thigh, MMR#2 (L) thigh, and Influenza#4 (R) thigh. Patient was experiencing a viral URI at that time. ** Miralax has been discontinued due to diarrhea and "cold-like symptoms". Benadryl is for PRN emergency use secondary to food allergies. Zyrtec for chronic allergic rhinitis. ** Patient is of adoption, no birth or biological family hx available.
Pain and itch of (L) shoulder after (immed.) vaccination. Pt seen with 5cm x 4cm sl warmth, pink and induration.
Swelling at the injection site and pain in the arm started on day 2 or 3 after the shot.  The pain became so intense I was not able to sleep one night.  The pain and swelling completely subsided by day 5. On day 8 I received 45g of Immunoglobulin (Gammagard) and 20mg of solu-medrol through a port in my chest on the right side.  6 hours after infusion the COVID19 injection site became itchy.  It proceeded to become red, swollen, tender, and hot to the touch.  The swelling, warmth, and tenderness has subsided.  It is day 14 now and there is still some redness.  It did not become as painful as the initial reaction.  My doctor is recommending I not get the 2nd shot.
Contact Dermatitis in left eye; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: ew0185), via an unspecified route of administration in her left arm on 23Apr2021 (at the age of 55-years) at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes spironolactone (MANUFACTURER UNKNOWN), sottopelle and progesterin (MANUFACTURER UNKNOWN), all for unknown indications. On 14May2021, at 12:00 (at the age of 56-years), the patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: Unknown), via an unspecified route of administration in her left arm as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient received the most recent COVID-19 vaccine at pharmacy or drug Store. The patient was diagnosed with COVID-19 prior to vaccination on an unknown date. The patient was not tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced contact dermatitis in her left eye. The patient experienced contact dermatitis in left eye after both vaccines. The patient received an ointment for the event contact dermatitis in left eye. The clinical outcome of the event contact dermatitis in left eye was resolved on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.
Approximately,12 hours after the shot,I had uncontrollable shaking of my arms, pain at the injection site, chills,headache.