chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 66 year old female patient reporting on herself. The patient's concurrent conditions included unspecified allergy and drug reactions or allergies to myacins and zinc eye drops. On 01-JUN-2016, the patient was vaccinated with a dose PNEUMOVAX 23 injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided. Concomitant medication included ARMOUR THYROID tablets. On 01-JUN-2016, after the patient received the injection, she rotated her arm to circulate the vaccine. The patient explained, that she could only lift her arm one third of a normal rotation for the first 24 hours after injection. The patient further explained, that she experienced nausea, a rash at the injection site down to the elbow, diarrhea and severe pain after receiving PNEUMOVAX 23, on 01-JUN-2016. The patient tried to get medical attention, but the physician's office could not fit her in for an appointment. When the symptoms did not resolve, the patient called the physician's office again at an unspecified time and the "on-call" physician told her to use an unspecified dose of BENADRYL. She took the BENADRYL for five days. The patient stated it took her 10 days to "feel human again". At the time of the report, the patient still had dark circles under her eyes and did not "feel 100 percent" (details were unspecified). She also stated, that at the time of the report, it was almost two weeks later and she still was not perky. The outcome of dark circles under eyes and feeling abnormal was reported as not recovered/not resolved. The outcome of the other events was not provided. Causality assessment was not reported. Additional information has been requested.
A few hours after receiving the first dose, I started with a mild headache and very sore arm. The headache and sore arm worsened and then around 9pm I started with horrible chills and body aches. My symptoms continued onto the next day, including intermittent nausea and extreme fatigue. I had to leave work early on Wednesday 1/20/21, called out of work on 1/21/21. My symptoms were gone by mid day of 1/21/21 except my fatigue and headache lingered until 1/22/21. I took extra strength Tylenol throughout the days.
Patient was seen in office for hives on face (chin, cheeks only). Dr thought possible contact dermatitis. Pt has been in since 4/27/01 for her 4 months series and received Pneumococcal #2 without problems.
Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the second dose of the Pfizer vaccine and a week later felt a sort of hot feeling in my head similar to that ballon sensation when first coming down with the flu but nowhere near as intense. The dizziness was worst on March 10th then slowly resolved itself over the next few weeks. It was mild to moderate in intensity, I could feel a continuation of movement after turning my head sideways, it felt like the head was still going. Strange. I was still able to go to work but the effect was noticable. The only variables in my life recently were beginning Humira on Feb 2nd 2021 and getting the series of Pfizer Covid vaccines on Feb 19 and March 12. I did notify my gasteroenterologist because at first I assumed it was the Humira. He said that is not a side effect. On further research I have seen a lot of people reporting vertigo several weeks out after the Covid shots as if the antibody formation produces and inflammatory response in the ear in some patients. Unknown the symptoms are related to the shot or not. I had one outbreak of Meniere's Disease in 2006 and has not recurred. Perhaps the vaccine can cause a recurrance?
AFTER PATIENT GOT VACCINE, PATIENT WAITED FOR 15 MINUTES. PT STATED EXPRESSING SHAKINESS, GLITTERY, AND ABOUT FAINT. I RAISED HER LEGS UP AND GAVE HER ORANGE JUICE, PT RESTED HER HEAD AGAINST THE WALL. WITHING 15 MINUTES, PT WAS BACK TO NORMAL.
Initial report received on 16 Dec 2010: This patient (centre number 08, patient number 080013) was enrolled in study V72_29.  Study medication was commenced on 21 Oct 2010 at 16:45 hrs and on 21 Nov 2010 at 11:16 hrs.  On 13 Dec 2010, the patient presented with abdominal pain, vomiting and feeling feverish.  The patient was hospitalized on 15 Dec 2010.  The patient received treatment with morphine.  The ultra sound scan of the patient was performed.  At the time of reporting, the patient's condition was persisting.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow-up received prior to circulation of the initial on 21 Dec 2010: The investigator did not provide any final diagnosis.  The ultrasound scan of the patient was normal.  At the time of reporting the patients condition was improving.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow up received on 21 Jan 2011: The patient had similar previous episodes prior to enrollment in the study although none required hospital admission.  The onset date of vomiting and feeling feverish was 15 Dec 2010.  The pain persisted and the general practitioner (GP) was called for a home visit who diagnosed irritable bowel syndrome due to gluten intolerance.  No diagnosis was given on discharge from hospital but there was a possible diagnosis of endometriosis.  Treatment was with Oramorph and codeine.  The patient completely recovered from vomiting and feeling feverish by 16 Dec 2010.  The abdominal pain continued niggling and completely resolved by 18 Jan 2011.  In the absence of investigator's causality assessment, agency has processed the event 'irritable bowel syndrome due to gluten intolerance' as suspected for reporting purposes.  Follow up received on 01 Feb 2011: The investigator confirmed that the onset date of the irritable bowel syndrome due to gluten intolerance was 17 Jan 2011.  The investigator also stated that the provisional diagnosis of irritable bowel syndrome due to gluten intolerance was made on 17 Jan 2011 (after the study vaccination) but the symptoms proceeded the study vaccination.  At the time of this report, the irritable bowel syndrome due to gluten intolerance was improving.  The investigator assessed the irritable bowel syndrome and gluten intolerance as non serious events and not suspected to be related to the study vaccine.  The investigator stated that endometriosis was not a confirmed diagnosis but was assessed to be non serious and not suspected to be related to the study vaccine.
Awoke next day with itching, facial swelling. Tx: Benadryl by MD's at hospital.
Onset of SVT, resolving after 10 day; worsening of hypertension; first occurrence of shingles (herpes zoster recurrence)
intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead; given another Pfizer Covid-19 bivalent booster instead; shortness of breath; chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive influenza vaccine (INFLUENZA VACCINE). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BIVALENT), SINGLE), administration date: 2022, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "given another Pfizer Covid-19 bivalent booster instead"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown".  Additional information: Caller states he already received the Pfizer BioNTech Covid-19 bivalent vaccine 7 weeks ago. He intended to get a flu shot yesterday but was inadvertently given another Pfizer Covid-19 bivalent booster instead. Caller states he is now experiencing shortness of breath and chest discomfort and is concerned about possible cardiac side effects from the vaccine. Caller states he only experienced a sore arm with the first few doses he received. Caller asking if cardiac side effects are known to occur after receiving bivalent doses too close together or if they occur more often in people who have experienced cardiac side effects in the past. The consumer reported experiencing a sore arm after the first four injections of the Pfizer COVID-19 vaccine. The consumer reported getting 5 injections total of the Pfizer covid-19 vaccine, with the 4th and 5th doses being the bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300013130 same patient, events after different doses of the vaccine;US-PFIZER INC-202300013129 same patient, events after different doses of the vaccine;US-PFIZER INC-202300013128 same patient, events after different doses of the vaccine;
Information has been received from a registered nurse concerning a female patient who in approximately 2009 " about a year ago" was vaccinated with a 0.5 ml first dose of GARDASIL injection (Lot #: not reported). The patient had an allergic reaction to GARDASIL. The registered nurse stated that the patient's mother was also a nurse who took care of the reaction and so the patient did not seek medical treatment. The patient decided to discontinue GARDASIL series. At the time of the report, the patient's outcome was unknown. No further information is available.
inadvertent administration is reported in pt who recvd 1 dose of fluogen vax instead of Epogen on 7OCT93; pt was asymptomatic p/receiving the fluogen subsequent ot dialysis;
Extreme chills, uncontrollable for long periods.   My entire body would shake uncontrollably.  Lasted nearly 4 hours.  Slight, but manageable, chills proceeded for another 12 hours.  Fever, headache, nausea lasted 24 hours.  Took tylenol to treat the headache and fever.  Pepto bismol to treat the nausea
Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is on report of several from the same source.
It was reported that the pt right leg was swollen, red and very painful, he would scream every time you moved him or he moved his leg. He was given tylenol and told me to rub myoflex on his leg for the pain. Seen same day as injection. Dx: allergic reaction.
First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.
Information has been received from a medical assistant regarding a 12 month old female who received her 4th dose of Prevnar (pneumococcal 7-valent conjugte vaccine) on 07-OCT-2003, and experienced a "cellulitis type event" , including redness, swelling and warmth at the injection site. Two days post immunization, the child experienced a "cellulitis type event" and an injection site reaction on her thigh characterized by redness, swelling and feeling "warm to the touch". Treatment included Benedryl (dephenhydramine) and ice. As of the date of this report, the caller had heard nothing back form the parent, and assumed the event was resolving. No additional information was available at the time of this report.
headaches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and denosumab (PROLIA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included cancer. The patient concomitant medication was not reported. On an unspecified date patient got Prolia injection last time with first dose and had headaches, neck and shoulder pain. Patient had cancer and goes for her regular CAT scan. Patient wants to know: the CAT scan gives contrast, will that cause an interaction. The patient underwent lab tests and procedures which included computerised tomogram and the result was unknown. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information expected.
dizziness; tchiness on the area of the injection; bump on the injection site; Nausea; Fatigue; redness and soreness at the injection site; redness and soreness at the injection site; skin rash on her left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE RASH (skin rash on her left shoulder), VACCINATION SITE PRURITUS (tchiness on the area of the injection), VACCINATION SITE PAIN (redness and soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness and soreness at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE RASH (skin rash on her left shoulder), VACCINATION SITE PAIN (redness and soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness and soreness at the injection site). On 19-May-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). On 24-May-2021, the patient experienced VACCINATION SITE PRURITUS (tchiness on the area of the injection) and VACCINATION SITE SWELLING (bump on the injection site). On an unknown date, the patient experienced DIZZINESS (dizziness). On 21-May-2021, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, DIZZINESS (dizziness), VACCINATION SITE RASH (skin rash on her left shoulder), VACCINATION SITE PRURITUS (tchiness on the area of the injection), VACCINATION SITE PAIN (redness and soreness at the injection site), VACCINATION SITE ERYTHEMA (redness and soreness at the injection site) and VACCINATION SITE SWELLING (bump on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Pain and tightness in chest w/ coughing, tiredness, 05/14/2021 ongoing Ice and OTC Ibuprofen for treatment.
same as the first....for 3-4 days after i suffered from intense musculoskeletal pain all over my body that made it difficult to move.
pt developed a large CVA -5 hours after getting the vaccine dose; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Feb2022 08:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant) with onset 24Feb2022 12:00, outcome "not recovered", described as "pt developed a large CVA -5 hours after getting the vaccine dose". The event "pt developed a large cva -5 hours after getting the vaccine dose" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical summary: Patient underwent CVA treatment. It was unknown whether the patient took other vaccine in four weeks. It was unknown whether patient had covid prior vaccination. The patient was not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event cerebrovascular accident and the suspect drug BNT162B2 cannot be excluded.  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.
Between 101.3 and 103.3 degrees Farenheit temperature for 48 hours.
on 1/16 notice a pruritic red bump on the first knuckle of the 3rd finger on my right hand, later that night noticed one at the base of my left thumb, this morning noticed 3 red bumps on the outer aspect of each elbow and one or two on the outer aspect of each upper arm at the deltoid, all bumps are pruritic to some degree  no bumps noted anywhere else on my body as of yet and no other reaction thus far other than the normal soreness at the injection site the first 72 hours
Developed swollen, red upper left arm, some hardness and itching. Redness spread to upper elbow. Advised ice, Advil, Cortaid, Benadryl PRN.
Initial report received 21 October 2009 from a consumer, who is also the patient. A 38-year-old female patient with no past medical history had received a left deltoid intramuscular injection of FLUZONE on 19 October 2009 AM and two hours later, she developed left neck pain and left shoulder pain. Two hours after that, she developed chills, body aches, nausea. On 20 October 2009, she developed sweating and fever (temperature not reported). The patient had no concurrent illness and she had not been taking any concomitant medications. Corrective treatments consisted of TYLENOL. At the time of the report on 21 October 2009, the patient's temperature was normal, her body aches were better; however sweating persisted. No additional information was provided. Documents held by sender: None.
numbness and pins and needles on her right foot and arm; left arm started going numb; numbness in the left part of her foot, throughout the day it spread to her leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness in the left part of her foot, throughout the day it spread to her leg), HYPOAESTHESIA (left arm started going numb) and PARAESTHESIA (numbness and pins and needles on her right foot and arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A121A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included Birth Control (CONTRACEPTIVES) for Birth control, TOPIRAMATE for Migraine.    On 06-Mar-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in the left part of her foot, throughout the day it spread to her leg). On 10-Mar-2021, the patient experienced HYPOAESTHESIA (left arm started going numb). On 11-Mar-2021, the patient experienced PARAESTHESIA (numbness and pins and needles on her right foot and arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in the left part of her foot, throughout the day it spread to her leg), HYPOAESTHESIA (left arm started going numb) and PARAESTHESIA (numbness and pins and needles on her right foot and arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Computerised tomogram: normal (normal) normal. On 10-Mar-2021, Electrocardiogram: normal (normal) normal. On 10-Mar-2021, Magnetic resonance imaging: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to urgent care on 08MAR2021 due to spreading numbness on the left side and was told it was a normal side effect and to rest and take OTC ibuprofen. On 10MAR2021 the patient went to the ER due to numbness in arm and all tests were normal.  No additional treatment information was provided.
an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; Initial information was received on 07-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 3 months old male patient and reporter reported that an expired diluent was used to reconstitute HIB (PRP/T) vaccine [ACT-HIB] and administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Dec-2022, an expired diluent (lot number: U7178AA; Expiry date: 30-Nov-2022) was used to reconstitute 0.5 ml of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot UJ635AA, expiry date for product: 27-Jan-2023) via intramuscular route in the right leg for immunization and administered to a patient with no adverse event (expired product administered) and (product preparation error) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
spoke with the patient in regards a feeling she has a sensation or feeling on the side of her ankle. she is not sure if its from the vaccine or not , she also explained she donated blood plasma on Friday , and she was dehydrated. told the patient to seek medical attention ASAP or go to Er. spoke with her  doctor, team and she said she will call her today , to schedule her to come in this evening for a check up. patient confirmed dr called her to be seen this evening
Low grade temperature, rash on arms/chest, injection site red swollen and warm to touch.
Headache, chills, night sweats, body aches, slight fever.  Lasted from Tuesday at 11:00 pm to Thursday early morning 5:00am.