chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't fall asleep; Felt very unwell; Fever; Nauseousness; Chills; Feeling pain in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever) and NAUSEA (Nauseousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fatty liver and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Feeling pain in her right arm). On 23-Mar-2021, the patient experienced INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-054422, MOD-2021-054422 (Patient Link).
11/19/23: Pt presented to the ED with complaints of right thigh pain, swelling and redness that began on 11/17/23, and complaints of dyspnea on exertion that began on the morning of 11/19/23 while the patient was on his morning run. The patient received the COVID-19 Pfizer Comirnaty Vaccine on 11/9/23. This was the pt's 5th or 6th dose of the COVID-19 vaccine per his report. He was diagnosed with  bilateral pulmonary emboli and DVT of the right leg on 11/19/23 and admitted for a heparin drip. Of note the patient has no PMH for chronic conditions, he is on no prescription, OTC or herbal medications at home. No prior history of clots, or clotting disorders.
Initial unsolicited report received from a Physician via other company (Pfizer, 2016078594) on 18-Feb-2016. This case involves a (age unknown) female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed allergies. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
The pt experienced 3 red spots, one the size of a quarter and 2 the size of dimes, 2 to 3 inches below the injection site on the left arm and the pneumonia vax. Not itchy or painful, flat not raised.
pins and needles sensation from left mid-upper arm to fingers (rated 3/10) that began the morning after receiving her 2nd dose of COVID-19 vaccination (Pfizer). intermittent aching at dorsal side of right forearm just distal to elbow and at radial aspect of right wrist rated 5/10 on pain scale. Denies any limitations in ROM or weakness. intermittent tingling in left upper thigh anterolateral and anterior shin just distal to knee. No treatment will follow up to be evaluated in 1 week from 10/18/2021
27 hrs post administration of pediarix 3 3/4 hours of screaming-admitted to hospital with petechiae on both lower extremities-septic workup negative-baby returned to normal post the 3 3/4 hour crying spell-developed blood streaked stool 3 d later apparently unrelated-seemed to be an intolerance to something in mom's breast milk.
8/17/2010 3:00 PM Pain - Applied Ice and took 800 Mg. Ibuprofen. 4:00 PM Redness; 5:00 PM  Extreme Heat, pain, stiffness & increased redness; 7:00 800 Mg. Ibuprofen. 2:00 AM 800 Mg. Ibuprofen 8/18/2010 Continued 800 Mg. Ibuprofen every 4 hours. 5:00 PM three blue marks under bicep. Sniffing. Difficulty breathing requiring rescue Asthma Inhaler. 8/19/2010 Fever, chills, continued paid and redness. Went to Urgent Care at 5 PM. Was given a shot and Rx for MethylPREDNISolone 4MG Dspk 21. Told to take Benadryl. 8/23 Feeling better. Continuing Medications as prescribed. Slight redness and slight  itching at sight. 8/24 Recovered
45-year-old male comes into the emergency department via EMS. The patient started to feel bad approximately 2 days ago where he had chills and generalized fatigue. He got a flu vaccine yesterday and his symptoms got progressively worse. He is complaining of fatigue, weakness, difficulty sleeping, chills, congestion, abdominal bloating. He slept overnight and woke up this morning. The patient went to work and when he came back home he laid down on the couch and tried to relax. His daughter looked over at him and told his wife that the patient was no longer breathing. The wife at that point time looked at her husband and saw that he was having a seizure and called EMS. She does not know exactly how long the seizure la
pt recv vax 30SEP97 & 10hr p/vax pt exp chills for a duration of three hr & myalgia;
Fever (104); aches, chills, and other flu-like symptoms (moderate). Lasted approximately 10 hours, starting about 8 hours after injection
Left arm is red and hot, painful. Can move arm, elbow and shoulder easily. Advised to call if she gets worse, runs a fever or unable to move extremity.
Muscle pain, headache, neck ache, very tired, arm that the shot was administered was very tender
Dizziness, Sedation, Fever, NauseaVomiting, diaphoresis Narrative:
Pt attributes Guillain Barre symptoms to Influenza vaccine provided at medical center. He was hospitalized 11/7/10 at hospital then subsequently at hospital with MI.
Patient presented with history of 9 day worsening symptoms. Patient experienced productive cough, headache, runny nose,  and nausea. Patient required up to 5L of nasal cannula. Patient received dexamethasone 6 mg IV once.
patient received full dose of vaccine (syringe was drawn up to proper dose and injected) without any spillage or missed dose. after plunger was fully emptied into patient's arm, the needle of the syringe detached from the barrel (during the process of pulling the needle out of the arm). patient had no reaction, just reporting this to be on file
patient c/o itching at back of neck and chest. Benadryl 25 mg PO given
17 year old was sent to our clinic and told we give Pfizer.  When she was told it was Moderna, neither her or her mother said that she   was 17 and the registrar did not realize that she was only 17 so she was given a shot of moderna.  She was monitored for any side effects.  There were none
This spontaneous report as received from a nurse refers to an 8 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
I was fine for the hours after the shot and then later in the day when I looked at phone messages I had such a brain fog that I did not know who the people were that I had been in contact with regarding a specific issue.  Basically people I had been working with for months on a situation did not register at that moment and I could not recall their names or faces.  For the rest of the night I would look at a piece of paper with their names on and I could not recall them.  It scared me and my wife so much for the rest of the night.  I woke up the next morning and had total recall so I did not report it to my dr.
I had an unusual reaction, my lips swelled up after I received the vaccination. I received the shot about 9:30 am. It started about 5:00 pm to the next morning and subsided. I also had more common symptoms as well headache aches and pains and diarrhea.
On Christmas day 2022, late in the day, I started feeling very fatigued with a scratchy throat. My eyes also felt very small and puffy. The next morning, I had a head congestion, fever and sore throat. As the day progressed, it moved to my chest. I tested positive for COVID-19 with a home test. I realized I also had brain fog as if everything was in slow motion. I sent a message to my doctor. I began taking the antiviral on the 27th and by Thursday I began feeling better. The following Monday, I tested negative. I feel like I am completely recovered but my brain fog lasted another 10 days.
pt seen 30NOV95 & was told by mom that pt cried for 4hrs w/o consolation p/last DTP 29SEP95;
1st dose 12Oct2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Administered 1st dose of Shingrix on 12th October 2021, batch number:Z4427 and expiry date: 31-Jan-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter and patient did not go back for 2nd dose of Shingrix.  The patient was now requesting the 2nd dose of Shingrix and 2nd dose had not yet been administered. Adverse event contained all reported information.  The reporter gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
12:15 pm infant was vaccinated and cried, then he had two episodes of intense breath holding and EMS had to be called. Infant became pale, lethargic, had to be stimulated.
Started with numbness on right side of face on 2/3/21.  Numbness continued and subsequently went to ER, at approximately 10:30 AM.  After receiving  an EKG, a chest X-Ray, and a CT of the head, I was informed that I had developed Bell's Palsy.  I was then seen by Dr., Neurology who also confirmed.  I was then admitted to the hospital for observation and another CT of the head 24 hours after the first.  I was given Acyclovir 200mg and Prednisone 10mg. during my hospital stay and prescribed after discharge at approximately 5 PM on 2/5/21.  as of the date of this report, still experiencing same symptoms
A currently 60 year old male pt was diagnosed with bladder cancer, for which he was treated in 1998 with two cycles of six weekly instillation of Oncotice. At the end of his first cycle in 1998 he presented with joint pain and was diagnosed with polymyalgia rheumatica. Oncotice treatment was continued. The pt received prednisone for about a year and his symptoms subsided. In Feb 2006 he was diagnosed with a bladder cancer recurrence and Oncotice treatment (10% dose) was initiated in April 2006. After the third instillation he presented with symptoms of polymyalgia rheumatica and hives. Oncotice treatment was continued.
no additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old female patient. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 30-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W017343, expiration date: 13-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  On 01-DEC-2022, the administered dose of the vaccine experienced a temperature excursion (product storage error). The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175:
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 31-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours highest recorded temperature). The vaccine status was reported and "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several reports received from the same reporter. Additional information has been requested.
all across her lip and cheek, she has a dark red, round bruise; looks like a bruise that has been healing; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (all across her lip and cheek, she has a dark red, round bruise) and IMPAIRED HEALING (looks like a bruise that has been healing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Lip augmentation (fillers in lips and cheeks.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (all across her lip and cheek, she has a dark red, round bruise) and IMPAIRED HEALING (looks like a bruise that has been healing). At the time of the report, CONTUSION (all across her lip and cheek, she has a dark red, round bruise) was resolving and IMPAIRED HEALING (looks like a bruise that has been healing) had not resolved. 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.   Concomitant product used were not provided by the reporter.   Treatment medication were not reported by the reporter.
I have severe breast soreness throughout the month. I cannot even lay face down it hurts so much. I am not pregnant. I also don?t bleed much anymore during my period. Everything was normal until I got the vaccine.this is not due to stress. My period was always normal until the vaccine. After the second dose my period was dark and clotted and very light. I continue to have the same symptoms 5 months later.
Felt as tho I could not get a good breath. Heart was flopping around like crazy. So scared I couldn't move. Lasted 2 hrs or longer. Just laid still and seemed to be out of it. Heart still acts up at times but seems to be getting some better. Was like I was dying??
Cough, congestion, fatigue, fever  treated with TAMIFLU 12-29-17 - 12-31-17.
No additional AE reported; Healthcare provider reports administration of an expired dose of MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with an 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), lot #T013724, expiration date: 21-APR-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (Expired product administered).  It was reported that the vaccine was stored within the recommended storage range until date of administration and was not involved in a temperature excursion. No additional adverse event was reported.
8 cm x 5 cm erythematous, edematous area on (L) thigh area started 2/8/13.
He felt dizzy and passed out for about a minute. Paramedics observed him for an hour, checked BP and pulse frequently. He said he has a history of syncope after any injection or needle stick. He was escorted out to his ride, said he's fine.
Information has been received from a registered pharmacist concerning a 6 year old female patient with a history of chronic constipation and no drug reactions who on an unspecified date, was vaccinated with a dose of VARIVAX (Merck) (lot# not reported, subcutaneous, 0.5ml) and a dose of MMRII (lot# and route not reported) in bilateral thighs.  On an unspecified date, the patient developed thigh pain after the injections.  The patient had no rash and no fever.  On 14-SEP-2009 the patient developed a urinary tract infection and was placed on therapy with antibiotics.  On 21-SEP-2009 the patient developed "shaking, soiled her pants and screaming with leg pain".  The patient was taken to emergency room and CT scans were performed.  The patient was diagnosed with constipation and was transferred to another hospital.  In the emergency room an enema and digital stimulation was attempted for disimpaction and was unsuccessful.  On 22-SEP-2009 the patient was then admitted around 2 a.m. to be disimpacted under sedation later today.  Due to the patient's complaint of thigh pain a CK level was drawn at 5:25 a.m. on 22-SEP-2009.  The results were elevated at 432 (normal range for the hospital 20-160).  Blood work was performed with no results reported.  The patient's thighs were nontender to palpation during assessment.  At the time of this report, the patient had not recovered.  Additional information has been requested.
chills, fever, headache, muscle pain, fatigue, diarrhea - time course of approximately 12 hours
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 43-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included breast cancer. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 43-year-old patient with medical history of breast cancer, who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms.  Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
sharp pain where the vaccine was provided a couple of times; numbness and tingling on my arm; numbness and tingling on my arm; can not do certain movements; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 16Apr2021 at 15:30 (Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history was none. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient was not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 on left arm on 18Mar2021 at 16:00 (Lot Number: ER2613) as single dose for COVID-19 immunization. The patient experienced sharp pain where the vaccine was provided a couple of times and numbness and tingling on arm and cannot do certain movements on 16Apr2021. The adverse event results in doctor or other healthcare professional office/clinic visit. The patient received ultrasound of left arm. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician, via company representative, referring to a 20 year old female patient. The patient's medical history included chronic regional pain syndrome. The patient's drug reactions/allergies and concomitant medications were not reported. On 24-AUG-2012, the patient was vaccinated with the first dose GARDASIL for prophylaxis (dose, route, lot # and expiration date were not reported). It was reported that on the same date the patient was concomitantly vaccinated with meningococcal vaccine (unspecified). On an unknown date, the patient experienced seizures, epilepsy and an unspecified type of psychological and neurological symptoms. At the time of reporting the outcome of the events was unknown. A product quality complaint was not involved. The causality assessment between the events and GARDASIL was not provided. Upon internal review, seizures and epilepsy were determined to be medically significant events. Additional information has been requested.
This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of Oral, ROTATEQ lot # K016263, expiration date: 26-JUN-2016. No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a consumer, refers to the daughter of her sister's friend who was a currently grown adult female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (strength, dose, route of administration, lot number and expiration date were unknown). There were no concomitant therapies reported. The patient had an outbreak of varicella after receiving the vaccine years ago, on an unknown date. The patient also reported that, on unspecified dates, she had had "shingles" numerous times in the years after receiving it. The outcome of varicella and shingles was unknown. The causality between VARIVAX and varicella and shingles was not provided. Additional information has been requested.