chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker referred to a 74 years old female patient with allergy to gluten and wheat, allergy to penicillin and codeine. The patient's medical history included diabetes, hypothyroidism, hyperlipidemia and celiac disease. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot # not reported) on 29-AUG-2012. Concomitant therapy included ARMOUR THYROID TABLETS, omega-3 marine triglycerides, kelp and multivitamins. The reporter stated that "five minutes ago," the patient received a dose of PNEUMOVAX23 and "was having a reaction right now." The patient's injection site was currently swelling and had already become "the size of a golf ball." The reporter stated that in addition to swelling, the injection site became red and warm. The patient also developed facial flushing and nausea. The caller stated that "911" was called and the patient was transported to Hospital (patient admitted) by the emergency squad. At the time of reporting, the outcome of the adverse events was reported as not recovered. Additional information has been requested.
Nausea and dizziness 4/14 - 4/17. Sudden hearing loss and tinnitus in right ear on 4/17 (no prior tinnitus and previously only mild hearing loss in both ears).
At 5:16pm the patient received 0.2mL of the Pediatric Pfizer vaccine. At 5:20pm the patient lost consciousness. The father grabbed the patient as he was falling to the ground and gently laid him on the ground. The father carried the patient to the cot. The patient reported feeling dizzy and nauseous. The patient denied any pain. The head of the bed was elevated. The patient denied any trouble breathing. At 5:24pm the patient's BP was 90/62 and HR was 110. At 5:24pm the patient vomited. At 5:24pm EMS was called. At 5:29pm the patient reported that he no longer felt dizzy. The patient was asked if he was itchy anywhere and he reported that his back was itchy. The back was assessed and hives were present across his back. The patient's parents reported that the patient has a history of breaking out in hives. The patient reported that his back was itchy before receiving the vaccine. At 5:31pm BP was 102/72 and RR 13. The fire department arrived at 5:35pm and assumed care of the patient. At 5:40pm  BP was 118/77, HR 74, and O2 Sat 95%. At 5:41pm paramedics arrived on site and assumed care of the patient. At 5:43pm the patient was transported by the paramedics to the emergency room.
shingle shots were awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and it was awful. Follow-up would not be possible as no contact details available. For tolerance of 2nd dose refer case US2021AMR202800.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202800:same patient same reporter
Leg cramps/pain from knees down to palm of both feet.; Pain in muscle, bone and nerve; Tingling at bottom of feet; Feet were cold could not warm them; Small pain in arms; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient,  A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP9655) via an unspecified route of administration in the arm left on 30Mar2021 at 19:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease or hypothyroidism and food allergy (gluten and soy). Concomitant medications included nitrofurantoin (MANUFACTURER UNKNOWN) started from an unknown date for an unknown indication. 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 vaccines within four weeks prior to the vaccination. On 01Apr2021 at 00:00, the patient experienced leg cramps/pain from knees down to palm of both feet, pain in muscle, bone and nerve, tingling at bottom of feet, feet cold could not warm, small pain in arms, fatigue and joint pain. The patient has reported that ER dr. cleared him of deep vein thrombosis, could feel small pangs in my arms, turned into fatigue and joint pain and then after 4 days it has gone at the time of reporting. It was  started after 72 hours. The event resulted in emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the event pain in legs, pain, feeling cold, pain in extremity, paresthesia, fatigue and joint pains was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
maternal exposure during pregnancy; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021. The most recent information was received on 25-Mar-2021 and was forwarded to Moderna on an unknown date.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (27JAN2016-Live, Full-term Birth 29JAN2018-Live, Full-term Birth). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 06-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred on an unknown date.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Ultrasound foetal: normal normal.         Treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Internal review on 25JUN2021 resulted in updates to pregnancy details.
Flu symptoms; high fever, coughing, nausea, etc.  Resulted in 2 Trips to ER.  Negative rapid test was received an hour before the vaccine due to exposure. A positive PCR COVID test was administered and a positive result was received 1 week after the vaccine.
flu like symptoms; nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain; she got nocturnal limb pain in her legs, arms, and buttocks; developed low grade fever; aches and pains/ nocturnal myalgia; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia) 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 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia). The patient was treated with PARACETAMOL (TYLENOL) on 19-Sep-2021 for Pain, at a dose of 1300 milligram and OXYCODONE on 19-Sep-2021 for Pain, at a dose of 5 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks) and PYREXIA (developed low grade fever) outcome was unknown and MYALGIA (aches and pains/ nocturnal myalgia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  The nocturnal pain stopped in the day time but at night she was disturbed with pain Tylenol together with Oxycodone,gave her sleep relief, event low grade fever lasted for one week noted.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Event (nocturnal myalgia) outcome updated.
Headache, Myalgia, HEADACHE, MIGRAINE, NAUSEA, BODYACHES Narrative:
For the first two weeks, there was only mild headache and fatigue.  But on day 12 (or 13) following the shot, my husband had severe abdominal pain and black, tarry poop.  He passed out on the toilet in the middle of the night and hit his head, woke up in a puddle of blood (from hitting his head) . He was severely lightheaded, short of breath, could not walk.  He had to crawl back to bed.  He continued to have severe  lightheadedness, shortness of breath, muscle aches, abdominal pain, and also ringing in his ears.  He called me early Saturday morning and told me what happened and that he called out from work.  (We do not live together. He is 280 miles away because of his job.) That man has called out sick only one time since I've met him in 1998; so when he told me he did not go to work, I knew it had to be really bad.  I drove up there ASAP the same day, and I took the pulse oximeter with me.  His oxygen levels were all over the place.  They were usually better (like high 70s to low 80s) while he was lying down.  When he would sit up or stand up, the number would plummet, reading so low I thought he was going to die. One time his finger was so cold that it took me 4 tries to get a reading.  It read at 55, but I realize that might be because his finger was too cold.
Patient called just before closing and said she had received her shingles vaccine at our pharmacy a few days ago. She said starting yesterday, a day after receiving the vaccine, that she had what she described as hives all over her body. She said that you couldn't see them but she could feel them all over and they itched. She said she was having no other symptoms. I instructed her to take BENADRYL for the itching and to keep an eye on it. Doctors offices are closed for the weekend but I told her if she starts having more severe symptoms (ex: difficulty breathing, etc) that she needs to get in and get checked out right away. We will also check back in with her and see how she is doing.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In December 2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician's assistant at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
in the NICU for respiratory support; preterm delivery after 2nd covid vaccine; first dose on 19Dec2020; This is a spontaneous report from a contactable physician (parent). This physician reported information for both mother and baby. This is the baby report.  A fetal male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 19Dec2020 (lot number: EL0140) and second dose on 08Jan2021; both transplacental as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The mother had a preterm delivery after second COVID vaccine. The patient (2-day old at the time of the report) was in the NICU for respiratory support; no infection and was breastfeeding well. The patient had no malformation/anomalies diagnosed. The reporter considered the events to be non-serious. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded based on temporal association. Case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-2021015910 same drug, different event and patient
The patient was admitted to the ICU 7/25/2021, with low B/P, severe weakness, Pneumonia and loss of appetite. She tested Positive for COVID. She is fully Vaccinated, with Moderna 3/4/21, and 4/7/2021. She has been moved to a regular COVID room, out of ICU, but is still very weak, and not able to answer interview. I have attempted to contact her husband, and sent a text message. She was seen in a doctor's office 7/24/2021, and diagnosed with COVID, and continued to get worse. Her Isolation will be extended through 8/13/2021, unless changed upon discharge.
Severe pain in the same arm where vaccine was given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in the same arm where vaccine was given) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain in the same arm where vaccine was given). At the time of the report, VACCINATION SITE PAIN (Severe pain in the same arm where vaccine was given) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported.    This case was linked to MOD-2021-098906 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up was received on 30-apr-2021 and contains no new information.
elevated titer; generalized rash; sores in mouth; body aches; low grade temperature; This case was reported by a physician via call center representative and described the occurrence of viral titer increased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced viral titer increased, generalized rash, sores mouth, general body pain and slight temperature. On an unknown date, the outcome of the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature were unknown.   It was unknown if the reporter considered the viral titer increased, generalized rash, sores mouth, general body pain and slight temperature to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Batch number was not reported. The patient received both doses of Shingrix vaccine on time. The patient presented high titers. The patient expereinced rash, sores in mouth, low grade fever and body pain.      Lab Comments: On an unknown date serolgy test was performed.
Complained of aches, pains, sore arm for many hours after vaccination.  Took ibuprofen the day of vaccination and the day after vaccination to manage symptoms.
Started with major fatigue and muscle aches. Two days later I started running a fever with random mild headaches. I then started having facial congestion and a sore throat, and developed a cough and feeling of aches in the chest. I tested for COVID and was negative. On August 14 I lost my taste (I had not completely gained my taste after being sick last year) As of today (August 20)  I am still having a fever, one of my tonsils is swollen, I am still congested, and am still experiencing fatigue and muscle aches, along with a cough and a sore chest. I have been tested for COVID three times and every time was negative.
10/31/06 1530, Employee received FLULAVAL vaccine left deltoid.  11/01/06 1000, Employee woke up with redness and swelling at injection site.  11/02/2006 Employee states arm looks much worse, came in for evaluation.  Measured 50 cm X 50 cm redness, swelling and warmth at injection site.  Continued to monitor, employee states completely resolved 11/05/06. (OMIC) Per 60 day report: Total recovery. No file needed & she did not get the flu. No treatment required.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA007705: US-009507513-1705USA007709.
Fever 103, chills, nausea lasting 3-4 hrs. Returned to clinic for re-check, seemed well. Phone follow up next day - well.
Follow up information received from the reported on 27-Feb-2004, provided further clarification of the event and treatment plan. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a physician regarding a 46-year-old male patient who experienced "mild" swelling of the right side of his face, lips, right periorbital swelling, mild "pink eye" and slightly swollen ear canals on 10-Dec-2003, within a "few hours" post immunization of Flumist.... Medical History: The patient's concurrent illness includes seasonal allergy (hay fever). Product Details: Indications for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant Therapy: Concomitant therapy included Paxil (paroxetine hydrochloride). Event Details: About 12 hours post immunization, on 10-Dec-2003, the patient experienced "mild" right facial and lip swelling (swelling face), "mild" right periorbital swelling (eye swelling), "pink eye" (conjuctivitis allergic), and "slightly" swollen ear canals (auricular swelling). The physician assessed the event as an "allergic reaction to Flumist." (hypersensitivity). The patient was treated with cool compresses and prescribed Benadryl 50 mg initially and ten 25 mg every 6 hours PRN; along with Naphcon A ophthalmic solution and Zyrtec 10 mg QD. The physician also noted gentamycin ophthalmic solution. The reporter stated that the symptoms resolved in 36 hours.
Presented on 9/14 to ER with anginal chest pain lasting 30 minutes (substernal pressure, radiating to L neck, arm) which self-resolved.  On admission, patient was treated with 36 hours of heparin drip d/t suspected ACS (later discontinued). Later treated with 4mg IV Mg2+  for relative hypomagnesemia (1.3), and 2L LR for orthostatic hypotension.   Labs/imaging revealed cardiac stress (troponinemia) in absence of obstructive coronary artery disease on cardiac cath, and "non-ischemic focal myocardial fibrosis" on MRI. Over the course of the hospitalization, anginal chest pain did not recur,  and troponin trended back to within normal range. Patient was discharged with a low-dose beta-blocker (metoprolol XL 12.5 QD) in addition to optimized stain (atorvastatin rather than simvastatin) and optimized alpha-blocker (tamsulosin rather than alfuzosin).  Per Cardiology consult: "Etiology of myocarditis is unclear, he has somewhat focal LGE. No HF,  normotensive, no heart block. DDx is broad including sarcoid, viral infection and COVID vaccination (got three doses)."
Patient is a 12-year-old female who presents with rash, back pain, and pain with deep breaths following her COVID-19 shot today.  Patient has a history of having COVID-19 in September 2020.  Mom states she is a long-haul her and has had migraines and developed POTS following having COVID-19.  She is currently in enrolled in a study and has been seen and followed up there for the symptoms.  It was recommended that she obtain a COVID-19 vaccine.  Today she got her second vaccine and within 10 minutes she began having headache and then developed a generalized red rash with facial swelling about an hour later.  Mom gave 25 mg of Benadryl and rash seemed to improve.  Patient was complaining of pain to her mid back.  She stated she had worsening pain when she took a deep breath.  She denies any frontal chest pain.  No shortness of breath.  She did not take any Motrin or Tylenol at home.  Mom states she also got a rash with COVID-19 shot.  Patient denies any vomiting.  No diarrhea.  No cough.  No difficulty breathing just pain when she takes a deep breath.  No drooling.  No difficulty swallowing.