chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the way out of the office, pt was checking out and stated she felt dizzy and passed out. Patient hit her head on the floor and was unconscious for about 30 seconds. She was monitored in the office and then sent for stat head CT, pt complained of LA pain and numbness with swelling. Pt was referred to neurology.
From initial information received on 09JUN2003 from a health care professional regarding an adverse event occurring in the USA it was reported that a 16 year old female patient received IMOVAX RABIES, lot number PMW0046, administered intra-muscularly in the right arm and her second dose of JE-VAX, administered intra-muscularly in the left arm on 22MAY2003. Eight days later, on 30MAY2003, the patient developed generalized hives and felt a choking sensation. She did not have any laryngeal edema. She was given Benadryl orally as treatment. The recovery status of this patient is currently unknown.
I've been sick 8 days, excruciating, awful; head pounding; difficulty breathing; neck pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), NECK PAIN (neck pain), ILLNESS (I've been sick 8 days, excruciating, awful) and HEADACHE (head pounding) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), NECK PAIN (neck pain) and HEADACHE (head pounding). On an unknown date, the patient experienced ILLNESS (I've been sick 8 days, excruciating, awful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Feb-2021, DYSPNOEA (difficulty breathing) and HEADACHE (head pounding) had resolved. At the time of the report, NECK PAIN (neck pain) and ILLNESS (I've been sick 8 days, excruciating, awful) outcome was unknown.        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.
Felt like hit with something Tuesday late afternoon(2/2) and took Advil, at 1 am (2/3) started shivering uncontrollably, temp 98.4 (normal 97.4), at 2am took Advil 400 mg.  In morning started shivering again, took Advil, got COVID test at 3:40 pm (PCR test- Negative), felt not great, but not that bad.  Through night on Wednesday pain struck all over, especially knees, back.  I felt joint and muscle pain and felt extremely weak.  Couldn't roll over in bed, couldn't stand up or sit down without major struggle, had to use my arms and struggle to get up and felt a lot of pain.  Even my teeth hurt.  I was taking 600 mg. of Advil every six hours.  At around 5 hours, the shivering would start.  Continuation pg doesn't work
Booster dose given 12/10/2021, was not due until 1/2/2022
Generalized red rash started on upper body and spread to lower limbs. BENADRYL 25mg 4 times per day for next 2 days. Urticaria resolved over 30 minutes while at office.
At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 pt became pale and diaphoretic, so EMT lifted her from chair, she then lost consciousness for approximately 30 seconds.  Pt was placed on floor in trendelenburg position with her feet elevated on a chair.  When she regained consciousness she did not recall being placed on the floor and stated she "blacked out" and was still dizzy.  At 1138 EMT called 911.  At 1145 EMT recorded the following vitals: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care of pt. At 1150 paramedics took the following vitals: BP 70/50, HR 54, and blood glucose 95, and from these indications decided to start and IV and admininster a 500cc bolus. Pt O2 sat was 100% but she was placed on 2L O2 NC for comfort. At 1205 paramedics transported pt to Hospital for further evaluation.
hypertensive flushed experiencing tachycardia gave Benadryl and her hypertension medication still monitoring
Sharp pain and aching over entire body, weakness, all joints in pain, headache, swollen lymph node by left jaw
Softball-sized red area to left upper thigh. Itchy, swollen, tender.
A non-serious spontaneous report of 16-month-old got FluMist was recevied from a nurse concerning a male. On 23-Oct-2009, the patient received a sing dose of FluMist. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information was received on 04-JUN-2010 and incorporated into the narrative: no adverse event occurred.
This spontaneous report was received from a pharmacist and refers 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 02-FEB-2017 at 12:59, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. 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-009507513-1704USA000391: 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-009507513-1704USA000440: 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
tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms; Left sided numbness on her face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms) and HYPOAESTHESIA (Left sided numbness on her face) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms). In March 2021, the patient experienced HYPOAESTHESIA (Left sided numbness on her face). At the time of the report, PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms) and HYPOAESTHESIA (Left sided numbness on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Patient updated new events .
She got her vaccine, she started feeling itchy on the sides of both ribs and her chest.  It started subtle but then it started getting really red, under her arms, parts of her back, mostly her upper torso and the back of her upper legs.  She is still having the reaction, not as severe as it was, but saw her dermatologist and was put on oral steroids for 14 days.  It subsides some, and has been on all types of cream.  She also went to UC at first and they treated her for shingles, which she told her it was all over it was not that.  They then said it was scabies but then it was not that as well.  They put her on Promethazone and they put her on different creams, etc.  Had a biopsy that said it was medication done and that it was affiliated with the COVID vaccine.  She had another set of biopsies done 2 weeks ago and could have been due to medication/vaccine or insects.  She had a lot of blood work done that she is waiting to see what they show including Lyme and other diseases.  Since she has been diagnosed with RA she seems like her body has gone haywire.    She is still under treatment but is still having the reactions to her upper torso and back of her legs, not as red and looks more like a measle outbreak.  She did itch it which made it worse and also had sores on her head as well.  Not on her legs, but mainly upper torso.   It was not on her hands or lower arms, necks, breasts and upper arms were bad, as well as her stomach, but not female areas, but did have a spot on her rectal area.    She has had dental work to get ready for dentures and they put her to sleep to remove her teeth and she had a flare after that anesthesia.    Last week when she went to the dermatologist she discontinued her Pravastatin as it said it could flare up.    She is very nervous with this, and is scared to get the booster and is scared due to the other variences of these.
Primary varicella rash vesicles and scabbed lesions greater than 40 across body (arms/legs/chest/back).
Information has been received from a nurse concerning an 18 year old female with a positive seizure history who on 29-AUG-2007 was vaccinated with a dose of Gardasil (LOT# 657622/0388U). Three to four minutes after administration, the patient developed a seizure. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
No additional AEs; HCP calling  to report a temperature excursion. Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant referred to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapies were not reported.  On 23-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, administered for prophylaxis (lot # W02294 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiry date was reported as 13-JUL-2024; strength, anatomical location and route of administration were not provided). The vaccine underwent temperature excursions of 6.9 Fahrenheit Celsius (F) for 15 minutes (product storage error). The previous temperature excursion as follow: 7.1 F for 30 minutes and 11.6 F for 1 hour. No additional adverse event (AE) was reported (no adverse event).
Rash, on and off fever, lightheaded disoriented, hard to breathe.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 29-MAY-2014 the patient was being vaccinated with (Oka/Merck) VARIVAX, subcutaneously, dose number, dosage, site of administration, lot# and expiry date not reported. It was reported that the patient grabbed the syringe of (Oka/Merck) VARIVAX while it was being administered and the reporting nurse was unsure of how much (Oka/Merck) VARIVAX the patient received. No adverse effect was reported. The outcome of the events was unknown.   Follow up information received from the nurse referred to the 4 and a half years old female patient with one sibiling and no illness at time of vaccination. There were no allergies or medical conditions. On 14-MAY-2014, the patient was vaccinated with fifth dose of DTaP (dose and lot# unknown) IM. On 29-MAY-2014 at 06:54 PM, the patient was vaccinated with fifth dose of IPV (dose unknown, lot#J1561) IM in right arm and second dose of (Oka/Merck) VARIVAX, SQ (lot#J013733, expiration date 30-OCT-2015) in left arm.   While administering the vaccine on 29-MAY-2014, the patient grabbed the syringe and did not receive full dos of vaccine. No relevant diagnostic tests and laboratory data were performed. The outcome of patient grabbed the syringe and did not receive full dose of vaccine was reported as recovered on 29-MAY-2014. On 17-JUL-2014, the patient received another dose of (Oka/Merck) VARIVAX (dose, route and lot# unknown). Additional information is not expected since all follow ups requested to complete the case were received.
3/20 - 3/22 - jaw, neck, shoulder pain and stiffness 3/21- through present date - hip and thigh pain/stiffness 3/23-3/25- severe jaw/neck pain and stiffness 3/27-4/1 - elbow and below tenderness/pain 4/1 through present date - shoulder/upper arm pain and tenderness 4/4 - 4/8 - chest pain/breastbone pain when breathing, moving, and to touch.  ER visit for this side effect in the AM on 4/5 bc later that day was my 2nd vaccine and I wanted to verify nothing serious was happening prior to the admin of the vaccine.  Not being able to take ibuprofen after the vaccine really exacerbated the pain and inflammation, making it much worse.  I took Advil early on 4/6 which did alleviate the inflammation and reduced the pain significantly. 4/14 - went to the urgent care ctr for treatment of symptoms, was told this type of side effect starting around 2 weeks after 1st vaccination has been common in patients coming to the urgent care ctr.  Got an anti-inflammatory shot and a steroid shot to reduce my symptoms.
C/O FATIGUE AND FLU-LIKE SX'S W EXCESS MUCUS (CLEAR) AND LOW GRADE TEMP. HAD SAME SX'S FIRST DOSE AND DID NOT DISCLOSE TO STAFF UNTIL NOW.
within 2 weeks of vaccination, red bump developed...continued to grow/raise. Now, TEN months later, there is a 11x8 millimeter round raised bump - appears to be scar tissue (thick).  A few months following vaccination, he was seen by both a naturopath and opthamologist.  Both agreed something odd was going on - specifically impacting his autonomic nervous system - trouble focusing his eyes after reading - taking up to 1 min to come into focus, heart rate randomly racing and blood work showed liver enzymes were outside of normal ranges.
This medically confirmed spontaneous report (initial receipt 09-Jan-2013) concerns a 54 year old male patient with a medical history of Type II DM (diabetes mellitus), hyperlipidemia and renal calculi. Concomitant medications included fish oil, nicotinic acid, glipizide, cetirizine, acetylsalicylic acid, metformin, ramipril, and gemfibrozil. On 04-Oct-2012, the patient received AFLURIA (batch P59007). On 01-Jan-2013, the patient developed possible pneumonia, bronchitis and influenza like illness with symptoms of sore throat, fever, chills, productive cough, sinus headache, fatigue and body aches. The patient had an office visit to the physician on 08-Jan-2013 and the patient was seen by the physician on 08-Jan-2013. The physician diagnosed bronchitis with possible pneumonia. The patient was treated with doxycycline BID for 10 days. The event outcome was not yet recovered. Reporter's comments: The reporter considered events to be non serious.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous (as per prescribing information recommendation). No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached: 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
I am pregnant and I took the vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and I took the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Fever over 104, dec during day, inc at night lasted 3 days; Used APAP q4hrs as directed plus other fever reducing methods; ER MD said cont same;
Heart palpitations, no pain, palpitations would not stop, my heart was 125 BPM. Basically that was something that happened to me that was new and it would not stop and it went until November 2022. I had shock treatment to the heart in the hospital but that did not work, a month later I had an ablation that got my heart rate under control.
6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
No adverse event; a dose of PROQUAD was given to a patient after a TE; This spontaneous report was received from a Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W029554, expiry date 14-MAR-2024, 0.5 milligram once as prophylaxis (route of administration was not provided) and sterile diluent lot# W030845, expiry date 17-JUL-2025.  It was reported that the vaccine was administered after a temperature excursion of -14.3C for 15 minutes (product storage error). There was no previous temperature excursion. No Further AE details reported.
Increased pain same day of shot, following day pain worse, difficulty moving left shoulder, to MD 10/21/2016- stated  influenza vaccine injection to bursae, vs. deltoid. Given cortisone injection 10/21/2016.
began with headache and chills during the night and the next day continued headache, chills, tired, loose stool decreased appetite.  The second day after injection was better but not normal and the third, fourth, fifth, and sixth days were mainly headaches with minor chills.  The most persistent event has been waking with headaches each morning.   Goody's  headache powder helped but then they returned.   Sixth day just felt tired along with the headache.  Normal appetite has not returned.
Nurse reported that a patient received 2 doses of PROQUAD shorter than recommended.  The first dose of PROQUAD was given on 8/7/2023 and second dose was given on 8/22/2023.  No additional AEs were reported. No further information provided.  No PQC.; No additional AEs were reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 07-AUG-2023, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w035472 and expiration date 06-MAY-2024 for prophylaxis (exact dose, route and site of administration were not provided). On 22-AUG-2023, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w035472 and expiration date 06-MAY-2024 for prophylaxis (exact dose, route and site of administration were not provided) (inappropriate schedule of product administration and no adverse event).
COVID-19 VACCINE DOSE #2 WAS GIVEN EARLY, 15 DAYS AFTER THE FIRST INJECTION.  DOSE #1 GIVEN ON 9-13-2021- INFO. LISTED ABOVE IN ITEM 17 DOSE #2 GIVEN ON 09-28-2021- PFIZER-BIONTECH, LOT# 30135BA IM, LEFT ARM
STINGING TONGUE 45 MINUTES AFTER INJECTION; CLIENT STATED SHE WAITED 45 MINUTES AFTER VACCINE ADMINISTRATION THEN DROVE HOME, ON THE WAY HOME SHE EXPERIENCED RACING HEART, STRATCHY THROAT, DIZZINESS, AND METALLIC TASTE IN MOUTH; SHE WENT STRAIGHT TO DR OFFICE WHO ADVISED SHE RETURN HOME AND TAKE BENADRYL. SHE STATES SHE TOOK BENADRYL EVERY 8 HOURS AND THE ADVERSE EFFECTS LASTED 4 DAYS, TODAY WAS DAY 5 AND SHE IS FELLING BETTER, ALSO EXPERIENCED A SWOLLEN ARM AND COULD NOT SLEEP IN HER BED AND A LARGE BRUISE ON HER ARM.