chrisvoncsefalvay/vaers-outcomes huggingface dataset:
D-DIMER NUMBERS ELEVATED; EXTREMELY HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced d-dimer numbers elevated. On APR-2021, the subject experienced extremely high blood pressure. Laboratory data included: Blood pressure (NR: not provided) Extremely high, and Fibrin D dimer (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from d-dimer numbers elevated, and extremely high blood pressure. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
SOB 15 minutes after receiving vaccine 140/73 BP o2 95% 66 pulse
Severe imbalance/dizziness started 3 days after second dose. It is now 7 days since it started, and seems to be abating a bit. Fatigue comes and goes, as well as mild nausea. I had headache, muscle aches, fatigue with the first dose, but no dizziness. Just had dizziness with the second dose to the point I had to hold onto walls, furniture, etc. to not fall down.  There is quite a bit of similar experiences online. I am guessing that these symptoms are more common than CDC is reporting for fear that it will prevent people from having the vaccine. These symptoms should be made more public so others are aware. I hope these symptoms go away at some point soon.
This spontaneous report as received from a registered nurse refers to unknown number of patients with age and gender. On unknown dates the patients were vaccinated with ROTATEQ lot # K007243, route was default as oral, (expiration date, strength, dosage, frequency were unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
pain at the injection site; body aches; joint pain; muscle pain; had a reaction to the covid shot; black ring like around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), PAIN (body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and VACCINATION SITE REACTION (had a reaction to the covid shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OXCARBAZEPINE (TRILEPTAL), BUSPIRONE, METFORMIN, LEVOTHYROXINE, LISINOPRIL, DEXLANSOPRAZOLE (DEXILANT), PRAVASTATIN, TRAMADOL, RISPERIDONE, HYDROXYZINE HCL, MELATONIN, IRON, ASPIRIN [ACETYLSALICYLIC ACID] and CAFFEINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), PAIN (body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain), VACCINATION SITE REACTION (had a reaction to the covid shot) and VACCINATION SITE DISCOLOURATION (black ring like around the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site), PAIN (body aches), ARTHRALGIA (joint pain), MYALGIA (muscle pain), VACCINATION SITE REACTION (had a reaction to the covid shot) and VACCINATION SITE DISCOLOURATION (black ring like around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   QUALITY-SAFETY EVALUATION OF PTC: https://ilssafety1f.quintiles.com/img/CF/zoom.gif
Internal bleeding episodes; This spontaneous case was reported by a consumer and describes the occurrence of INTERNAL HAEMORRHAGE (Internal bleeding episodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal bleeding episodes) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Internal bleeding episodes) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  The reporter mentioned that the event occurred several weeks after receiving the second dose of the Moderna COVID vaccination.  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.
Still hurts on the second day after the vaccine but not swollen.; Right hand was swollen and hard to make a fist.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8735) via an unspecified route of administration in the right arm on 20Apr2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included prasugrel (MANUFACTURER UNKNOWN), acetylsalicylic acid, ascorbic acid (ASPIRIN), bupropion hydrochloride (WELLBUTRIN) and chlortalidone (MANUFACTURER UNKNOWN); all for unknown indication and start date. The patient had no allergies to food, medication or other products. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 30Mar2021 at 11:30 as a single dose for COVID-19 immunisation. The patient got shot on the right arm and on the next day, on 21Apr2021 at 08:00, her right hand was swollen and hard to make a fist. Still hurt on the second day after the vaccine but not swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right hand was swollen and hard to make a fist and still hurt on the second day after the vaccine but not swollen was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure; Shingles; My upper arm was covered in a rash; Felt like someone had struck me with a baseball bat; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, rash and feeling abnormal were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and feeling abnormal to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had both doses of Shingrix the second dose administered in April 2019. The patient upper arm was covered in a rash the next day and felt like someone had struck me with a baseball bat. The patient stated that most aggravating part was that she had two outbreaks of shingles since then. The patient just one of the unfortunate 10 percent and there was nothing else to be done. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for herpes zoster was unknown. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation and time to onset for herpes zoster was unknown.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 17-year-old male patient of an unspecified race/ethnicity received TRUMENBA, first dose, via an unspecified route of administration on  27Feb2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on 27Feb2017 horrible headache very soon after vaccination, and fever of 100. Both events were non-serious. Everything resolved within a few hours and he was able to go to school the next day. The outcome of horrible headache and fever of 100 was recovered on 27Feb2017. The patient also had a ppd test given on 27Feb17, the same day as the first dose of meningococcal group b rlp2086. The patient and the parents are very nervous to get the second dose. The information on the batch/lot number has been requested.
This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (pain in the tailbone), NECK PAIN (pain in the neck), NEURALGIA (nerve pain), HYPOKINESIA (She had to spend a lot of time in bed, because she could not move that much) and ELECTRIC SHOCK SENSATION (after a while it affected the whole body and muscles, like electrical shocks on the lower and upper body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had no allergies to medications, food and other products. The patient's past medical history included COVID-19 in December 2020. Previously administered products included for Drug use for unknown indication: Johnson & Johnson vaccine (1st dose) on 02-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine. Concurrent medical conditions included Lung cancer since 2019. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Chemotherapy. On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced BONE PAIN (pain in the tailbone), NECK PAIN (pain in the neck), NEURALGIA (nerve pain), HYPOKINESIA (She had to spend a lot of time in bed, because she could not move that much), ELECTRIC SHOCK SENSATION (after a while it affected the whole body and muscles, like electrical shocks on the lower and upper body), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not sit or stand too long because it causes muscle sore), HEADACHE (headache) and MYALGIA (muscle pain/causes muscle sore). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, BONE PAIN (pain in the tailbone), NECK PAIN (pain in the neck), NEURALGIA (nerve pain), HYPOKINESIA (She had to spend a lot of time in bed, because she could not move that much), ELECTRIC SHOCK SENSATION (after a while it affected the whole body and muscles, like electrical shocks on the lower and upper body), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Patient could not sit or stand too long because it causes muscle sore), HEADACHE (headache) and MYALGIA (muscle pain/causes muscle sore) was resolving.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: Positive. On an unknown date, Computerised tomogram: could not find anything abnormal. On an unknown date, Magnetic resonance imaging: could not find anything abnormal. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  The patient did not experience any symptoms after getting 1st booster dose. The patient did not experience a similar event in the past. The patient visited few doctors and treatment given for symptoms was a muscle relaxer, Motrin, but it did not work, Gabapentin, that helped a little bit. Reporter did not allow further contact.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), second lasting for 8 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and third lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Flublok was administered to pediatric patient, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA420021(CLUSTER), 2022SA419213(CLUSTER) and 2022SA420025(CLUSTER).  This case involves a 7 years old male patient who was administered flublok, with no reported adverse event, after receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE( lot QFAA223 and expiration date: 30-Jun-2023) at a dose of 0.5ml once via intramuscular route in the left deltoid for immunization.  On 10-Oct-2022 (latency: same day), the patient was administered flublok  with no reported adverse event (product administered to patient of inappropriate age) following the administration.   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.
fever of 102 F; nausea really bad; sore arm; throwing up; upset stomach; In Bed for couple of days; body aches across shoulder and neck; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea really bad) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea really bad). At the time of the report, NAUSEA (nausea really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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.   Reporter did not allow further contact; 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.
Shortly after the shot was given the patient came back to the pharmacy because she started feeling dizzy and nauseous. The patient had redness and flushing of the face. She also exhibited symptoms of gassiness such as flatulence and burping. I asked the patient if it was okay for me to administer an EPI-PEN but she repeatedly denied the offer even after telling her the importance of it. I then insisted that the patient sit down for a few minutes and I grabbed a water bottle for her to drink. Every 5 minutes, I checked on the patient for continuous updates and she stated she felt better after drinking the water. She sat down for approximately 15 minutes before leaving the store and I walked her out to ensure everything was okay.
Approximately 24 hours after the immunizations pt began running a fever 100 degrees, reduced appetite. Left arm (deltoid) swollen, red, hot about the size of a lemon 4 1/2 x 3 inches. Tx: Tylenol and cold compresses.
14MAR96 pt was brought in for 2nd series of vax upon review prior to vax mom stated p/last vax pt cried & was cranky for 3 days & had a very large goose egg size swelling on area where pt recv shot;2nd series w/held pt referred to pvt MD;
Cutaneous peeling of skin on bottom of feet mostly on heel.  Pt denies callused skin on feet prior to this.  Noticed 2-3 days ago.  Also. he noticed burning right index finger a few days after receiving  injection.  It now has flaky peeling skin only to that finger.   He states he noticed burning the a bit painful.  States it felt better to walk.  Now he is having the multi-layer continued skin peeling.  Advised keeping the feet moistened, Xyzal, and Tylenol.
No additional adverse effects reported; pharmacist reports improperly stored PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 04-MAR-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial for injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; and lot number R031812 has been verified to be valid, expiration date reported and validated as 26-SEP-2020) (product storage error). No additional adverse effects reported.  The temperature excursion reporter was: 70 degrees Fahrenheit for 24 hours. No previous temperature excursions. A data logger was used.
Pt started breaking out in rash and itching, took benadryl. On 1/11/03 early am taken to ER with shortness of breath,increased rash and itching, given benadryl and decadron IM, relieved temporarily. On 1/12/03 to ER with more rash (all over body) & itching given larger dose of benadryl and decadron, taking Zyrtec & Tagamet PO. Rash better on 1/14/03 Mom states. ER MD states related to Hep B.
Patient reports approx 48 hours after 2nd dose of Moderna COVID 19 vaccine  nausea/vomiting,  fatigue, headache.  Pt has had ongoing symptoms of extreme fatigue, headache, feels like her heart "flutters".  Pt began experiencing intermittent shortness of breath which began approx 2-3 weeks ago.  Pt reports seen by Primary 3-5 times since 2nd vaccine and concerns. Pt reports  had routine bloodwork, and everything has come back normal.  Pt reports has been seen by endocrinologist for evaluation and all testing and bloodwork has also been normal
Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102.1 - had temperature all weekend and tried to bring it down with Tylenol. Went to work on Monday, Jan. 4, and was sent right home after taking a COVID test (result was negative).  Follow up with my Doctor on Thursday, the 7th, and had another COVID test was a positive result. Friday, the 8th, my family went to clinic to test and so I tested again that day and my result was negative for that test. My symptoms were body aches, headaches, lost sense of taste and smell and fatigue. These lasted 5-6 days.
Cellulitis to L arm, treated with KEFLEX on 9/6/18.
Mother called Public Health Clinic 2 days after child received vaccine stating "child's left leg is red and swollen" started last night, mom didn't have an exact time as to when symptoms started. Mom couldn't describe the size of the swelling but stated "its just really swollen"
Patient was given the 3 vaccines intramuscularly, she was then given the PPD. A couple minutes after that she asked if she was supposed to feel dizzy, then she passed out onto the floor from the chair. In the midst of me catching her as she was leaning off the chair she hit her head on the arm rest. Patient regained consciousness after about 7-10 seconds, we left her on the floor for a minute or two. Dr. came in and checked on her. We then helped her to lay on the bed. She began to feel nauseous, she was given an Emesis bag, then started vomiting. She was given water and an ice pack for her head because she complained of a headache where she hit her head. We called her parents to come drive her home, mom arrived about an hour and a half later to get her. Patient felt better, but still was a little nauseous. Dr. spoke to both the patient and her mother before they left.
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included clogging in ear, sleep issues, and sinus drainage, and concurrent conditions included little nasal drainage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced unexpected therapeutic benefit. On 13-MAY-2021, Laboratory data included: X-ray (NR: not provided) Sinuses are all clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Numbness to face with tingling. Improving over time but still present on 11/1/21
headache- sore throat- chills- productive cough- shortness of breath- body aches- ear pain- sinus congestion- nasal congestion- swollen glands- wheezing- sneezing starting 10/26/21
Patient passed out.  Mother stated he gets panic attacks every time he has a needle stick.  Patient was fine shortly after.
Partial numbness from hip to toes; both legs. Several blood tests, MRIs, spinal tap. Acupuncture and detox treatment. Eye, visual evoke test- MS tests.