chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual bleeding  (after no period in8 years due to continuous cycling); Aches/pain; Abdominal pain; Migraine; Fever; Chills; Nausea; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient was allergic to latex, egg protein and casein. Concomitant medications included buspirone hydrochloride (BUSPAR), oral contraceptives nos (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN); all from unknown dates for unknown indications. 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 06Apr2021 at 09:00, the patient experienced menstrual bleeding (after no period in 8 years due to continuous cycling), aches/pain, abdominal pain, migraine, fever, chills, nausea and confusion. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events menstrual bleeding, aches/pain, abdominal pain, migraine, fever, chills, nausea and confusion were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
t102, rt groin lymphodenopathy & pain; non productive cough; no fluctuant 1 cm erythematous over inject site;
Left arm reddened warm deltoid upper arm. 10/30/03 at 9 AM noticed 4" x 2" area.
Patient stated that two days after receiving first dose of Pfizer vaccine a pustule rash started on bilateral forearms. Rash was extremely itchy and painful. Pustules erupted  and drained spontaneously. Healing rash still lingering on left arm (21 days later). No medications taken. No History of allergy. Referred patient to PCP for referral for allergist before receiving second Pfizer dose.
This spontaneous retrospective pregnancy report as received from a physician, for GARDASIL and VARIVAX (Merck), two Pregnancy Registry products, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On 01-NOV-1996, patient was vaccinated with first dose of VARVIAX (Merck) (Lot #, exp date, dose/frequency, route and duration were unspecified). On 04-AUG-2009, patient was vaccinated with first dose of GARDASIL (Lot #, exp date, dose/frequency, route and duration were unspecified). Unspecified Pregnancy test was performed in January of 2013 with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 25-FEB-2013, the patient was vaccinated with second dose of GARDASIL (Lot # reported as 0131AE, exp date, dose/frequency, route and duration were unspecified) and second dose of VARIVAX (Merck) (Lot # H006538, exp date, dose/frequency, route and duration were unspecified) while pregnancy. Concomitant therapies included INFANRIX, HAVRIX and MENACTRA all were administered on 25-FEB-2013. Initial exposure to GARDASIL was at 12 week(s). No adverse event reported. Patient had sought medical attention via office contacting. Blood tests including a CBC, Iron level and STD test were performed with no result provided. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Pt received injection, "the morning of 11-15-13, by that evening the area was swollen, red and painful." Pt went to ER, but did not receive treatment, for the local reaction.
For two days afterwards I experienced a low grade fever, chills, aches, fatigue. These are common. But my blood pressure spiked 16 points diastolic and 10 points systolic. My blood pressure was averaging 120/70 until I took the vaccine. Now my readings are much higher: 136/81; 140/86;137/79/135/81/132/86/133/83. I am taking the maximum dosage of BP medications, but to no avail.
Fever, (tested after ibuprofen = 100.5F), severe chills, flu like symptoms- muscle aches and joint pain. At injection site, red, hard, warm to touch about 5-6 cm.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: Pt stated that she was nervous that she would \"pass out from vaccine\", recommended she stay 30 min instead of 15 min for monitoring. Has hx of anxiety d/o & panic attacks (3x/month). Stated she felt dizzy after getting vaccine and she contributed it to that. Gave 12oz OJ, 1 protein pack (nuts & chocolate berries) and water. Only had ramen noodle soup today & was dehydrated. Checked in after 30 minutes, felt fine and was back to normal.
Elevated blood pressure, Encephalopathy, Lumbago, Transient global amnesia
Unspecified Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecified Adverse event) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecified Adverse event) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (Unspecified Adverse event) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
It first started as a cold a week after the vaccination, I get yearly allergies so I though it was my allergies or maybe a cold, I did not get fever or any other symptom.  I was seen by my provided a few weeks later and she said I had bronchitis. I was given medication to treat the bronchitis, I was also given the albuterol treatment to help with my breathing. I have been feeling a bit better after the medicine. I have a recheck appointment on January 17 and  on  February 21 I see a pneumologist.
Patient received first Moderna vaccine in sequence and about 10 minutes after passed out or lost conciousness for a few seconds.
redness and swelling appeared at the injection site; pain in the muscle at the injection site; pain extended into the shoulder; swelling appeared at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis.   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site muscle pain and shoulder pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site muscle pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site muscle pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and reported redness and swelling appeared at the injection site that resolved.   A few weeks later in February, the events returned and the new event of pain in the muscle at the injection site presented and pain extended into the shoulder.  The patient was treated with medications but could not remember what they were.   The patient mentioned taking an antibiotic for bronchitis and the arm pain resolved.   In June the pain returned and it comes and goes and treated it with Aleve. The reporter consented to follow up.
Pt received both doses of Moderna COVID-19 vaccination, on 2/25/2021 and 3/25/2021.  Admitted to hospital 7/4/2021 after a fall at home unrelated to vaccination.  Fall resulted in a hip fracture.  Pt tested positive for COVID-19 as part of routine admission testing, but did not appear to have any COVID symptoms.
This spontaneous report as received from a 59 year old female consumer reporting on herself with blood pressure and thyroid and no drug reactions or allergies who last Monday on 25-NOV-2013, was vaccinated in the left arm with a dose of ZOSTAVAX (route and lot number not reported). Concomitant therapies included Diovan, Synthroid and estrogens, conjugated, Prempro. The consumer reported that a noon for the next day on 26-NOV-2013, she developed reactions. She said that the vaccine injection site, which was on the left arm, itched and was red with soreness. Later in the same day following the injection, she noticed tenderness in the right side of her jaw along with shooting pain in her right eye. The consumer self-medicated with prescription Locoid cream. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown.
accidental administration of expired FLUZONE HIGH DOSE vaccine by an HCP with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA419905(CLUSTER) and 2022SA420369(CLUSTER).  This case involves a 65 years old female patient who had accidental administration of expired fluzone high dose vaccine by an health care professional(hcp) with no reported adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( lot UJ748AA and expiration date: 30-Jun-2022) at a dose of 0.7ml once  via intramuscular route in the left deltoid for immunization.  On 06-Oct-2022(latency: same day), the patient had accidental administration of expired fluzone high dose vaccine by an hcp with no reported adverse event (expired product administered) .   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
10 days after the booster my entire body was covered in hives after seeming the allergist, dermatologist and rheumatologist they diagnosed me with dermographia
Headache immediately on injection and persists after 24 hours despite aspirin, neck ache started several hours after injection and persists after 24 hours, diarrhea started several hours after injection and lasted overnight, uncontrollable shaking with cold extremities in bed at night - got into a hot shower but shaking started again when I got out of the shower, pain at injection site that started at once and has gotten worse - injection is hot and painful after 24 hours, whole body aching (feels like flu) started a few hours after injection and is better after 17 hours. Left side of body is worse than right side - had shot in left arm.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 13-JAN-2014 the patient was vaccinated with expired ZOSTAVAX lot # H013944, .65 ml, subcutaneous. No adverse event was reported. The outcome of administered an expired dose of ZOSTAVAX is unknown. Additional information has been requested.
Initial misuse report received from a health care professional on 20 September 2013 and on 21 March 2014 at GPV. A patient of unknown age and gender had received FLUZONE and receiver another FLUZONE High Dose on an unknown date. No adverse event was reported. The list of documents held by sender: none
pt recvd vax;had chilly sensation,mild body malaise following day;22nov94 feeling numbness on upper lip w/ mild difficulty in swallowing;got worse next day;unable to swallow solid food;to MD 28nov;tx reglan syrup; referred to ENT
Almost immediately after receiving the vaccination, my daughter felt lightheaded, knelt down and then passed out. Her eyes rolled in the back of her head, and she shuttered.  She came to within a few minutes.  She was confused at first as to what was going on and where she was.  After about 5-10 minutes, she recovered and seemed fine.
Several pts at this site exp fever,chills & fainting following receipt of Typhoid vaccine w/this lot #. Reporter unable to specify # of pts exp this event.
This spontaneous non-valid report was received from internet from a consumer, who was reporting on her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot # and expiry date were not reported). M-M-R II vaccination had adverse reaction to the reporter's daughter, she was autistic. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Blood pressure skyrocketed from 100/50 normally to 179/110; Dizziness/Dizzy; Vision was blurry; Headaches; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B211A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for Prophylaxis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) (seriousness criterion medically significant). In April 2021, the patient experienced DIZZINESS (Dizziness/Dizzy), VISION BLURRED (Vision was blurry) and HEADACHE (Headaches). The patient was treated with LOSARTAN POTASSIUM for Blood pressure high, at a dose of 50 mg twice a day. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) had not resolved, DIZZINESS (Dizziness/Dizzy) outcome was unknown and VISION BLURRED (Vision was blurry) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 179/110 (High) skyrocketed from 100/50 normally to 179/110 and after sometimes it was  down to 167/106. On 02-Apr-2021, Computerised tomogram: negative (Negative) Negative. On 02-Apr-2021, Magnetic resonance imaging: negative (Negative) Negative.         Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-213201 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
diarrhea; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Feb2021 (today), the patient had experienced diarrhea upon waking up. Second dose was due 21Feb2021 (today) and reporter was worried about having patient take the second dose. The outcome of the event was unknown.
Very sick; felt knee problems; feeling clammy; hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), ARTHRALGIA (felt knee problems), COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ARTHRALGIA (felt knee problems), COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes). On 01-Apr-2021, the patient experienced ILLNESS (Very sick). On 04-Mar-2021, ARTHRALGIA (felt knee problems) had resolved. On 01-Apr-2021, ILLNESS (Very sick) had resolved. At the time of the report, COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant therapies or drug reactions/allergies was provided. On an unknown date, the patient was vaccinated by a medical assistant with a dose of VARIVAX 0.5 ml, probably intramuscularly instead of subcutaneously (dose number, anatomical location, lot number and expiration date were not reported), for prophylaxis. It was reported that it could not be verified which size of needle was used to administer the vaccine, however no adverse events were reported. No product quality complaint was involved. Follow up information has been received from the registered nurse on 31-MAR-2017. The nurse reported that the patient developed "a localized reaction at the injection site" on 05-MAR-2017, which was treated with BENADRYL. Subsequently, on an unspecified date in March 2017 (reported as "took 2 to 3 weeks to resolve"), the patient recovered from the event. The causality assessment between VARIVAX and injection site reaction was not provided. Additional information has been requested.
mild fever cold sweats severe headaches nausea bad shaking dizziness severe fatigue achy joints severe pain at injection site loss of energy loss of appetite diarrheafelt just like covid 19 symptons lasted approx. 2.5 days
sense of smell different; Aches all over the body; taste different; vomiting; nausea; Terrible HA; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided by reporter. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR Form received on 28-APR-2021 Contains no new information
I experienced migraines that lasted 3 days after my shot and also pain in my arm.
Initial report received from a healthcare professional on 08 May 2013. A 28-year-old female patient had received an intramuscular 0.5ml dose of ADACEL (Lot number: U4612AA, Exp. date: 20-Sep-2015) in right deltoid on 08 May 2013. The patient was pregnant at the time of vaccination. The date of last menstrual period was 27 September 2012 and the expected date of delivery was 04 July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 08 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Initial report received on 22/Sep/2006 from the patient. A 68 year old female patient had received an intramuscular, left arm, fifth dose injection of Imovax Rabies, lot number unknown, on 07/Sep/2006. The patient had experienced a "bat exposure." No information was reported regarding testing of the animal. Two days post vaccination, the patient experienced pain in her left arm and shoulder. Per the reporter, the event did not require examination by a physician. Other medications included extra-strength Tylenol and coumadin. Past medical history was reported as torn rotator cuff. At the time of this report, the patient had not recovered. This patient had experienced a separate event of pain and weakness in her right arm following dose four that is described in case 2006-02510.
On 11/10/00, pt was vaccinated in the left arm with a 2nd dose of pneumococcal vaccine 23 polyvalent. It was noted that the pt received a 1st dose in Dec/1996. On 11/10/00, pt also received influenza virus vaccine (Fluzone). It was reported that the pt had previously received influenza virus vaccine 5 or 6 times. On 11/11/00, the pt reported that she developed cellulitis. Follow-up information from a health professional reported that the pt had redness and swelling of left arm which began on 11/11/00. The pt was treated with Keflex, 250mg for 5 days. The reporter considered the left arm redness and swelling to be "Important Medical Events". Subsequently, the pt recovered. Two additional pts had a similar experience following exposure to pneumococcal vaccine 23 polyvalent 1531J.
pt recv vax & pt devel swelling & redness of eyes, consistent w/conjunctivitis;pt was referred to ophthalmologist who felt that pt conjunctivitis was secondary to varicella vaccine;
Developed asthma Difficulty breathing Constant flow of mucus down throat Glands in throat periodically swell to a concerning level Fatigue Brain Fog  Memory Loss Dizziness/Light headedness
Flu Shot - little redness at injection site. Sore muscle. PNEUMOVAX 23- extreme soreness, redness rash like with whelps, swelling from top shoulder to elbow. Feverish in rash area. Cold packs did not help, or hot compresses. Itchy in spots.