chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Intestinal cramps; Kidney pain; Fatigue; Loose stool; Pain at injection site; Malaise; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included depression, adhd, raynaud's syndrome and patulous eustachian tube. The patient did not have any known allergies. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), lisdexamfetamine mesilate (VYVANSE), iron (MANUFACTURER UNKNOWN) 65 mg, ascorbic acid, pyridoxine hydrochloride, biotin, tocopheryl acetate, folic acid, thiamine hydrochloride, cyanocobalamin, riboflavin, choline bitartrate, inositol, nicotinamide, calcium pantothenate, glutamic acid, bioflavonoids nos, methyl hesperidin (B 100) and tyrosine (L-TYROSIN) 750 mg; all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 17:00, the patient experienced nausea, intestinal cramps, kidney pain, fatigue, loose stool, pain at injection site and malaise. Therapeutic measures were taken as a result of nausea, intestinal cramps, kidney pain, fatigue, loose stool, pain at injection site and malaise which included self-treatment with motrin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events nausea, intestinal cramps, kidney pain, fatigue, loose stool, pain at injection site and malaise were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15.  Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.
Severe body/joint aches and fatigue, chills, headache, abdominal pain/distension
8 hrs post injection to 48 hours post-injection- Extreme fatigue 12 hrs post injection until 42 hours post-injection:  Joint and muscle pain (entire body, focused primarily in torso, legs, and joints), periods of extreme body sweating and hot flashes
severe lymphadenopathy left clavicular large nodule about an inch protruding. More large nodes picked up on CT scan and ulstrasound.scans and work up done at Hospital and CT report said suspicious for cancer. Ultrasound doctor  decided against biopsy and diagnosed that it was a severe COVID19 vaccine reaction since the nodes were found three days after vaccination, same side of body as vaccine was given, the left side.
This is a spontaneous report from a contactable consumer reported for her daughter. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on 10Jan2017 at 0.5ml single in Left Arm for meningococcal immunisation. On an unspecified date in Jan2017 received the 3rd dose of MMR in Left Arm. Medical history included ongoing Allergy to Penicillin and 'Cycline' drugs. Have known of allergy to Penicillin since she was a toddler. Concomitant medication included ethinyl estradiol, norgestimate. In the past received MMR with no adverse effect. The patient experienced chills on 10Jan2017 with outcome of recovered, and feeling tired on 10Jan2017 with outcome of not recovered.
26 CAUCASIAN F WITH NO KNOWN PMHx. PT C/O WEAKNESS, PULSATIONS IN HER RIGHT PARIETAL HEAD REGION, AND A NON-PRURITUS URTICARIA ON HER MID CHEST, RT ARM AND BACK OF RIGHT SHOULDER  POST VACCINATION. PT DENIED CHEST PAIN, SOB, OR PARESTHESIAS IN UPPER OR LOWER LIMBS.  VS @ 2:38 PM BP 130/87 HR 85 PT APPEARED IN NO ACUTE DISTRESS WITH NORMAL BREATHING. ERYTHEMATOUS URTICARIA PRESENT ON RT BRACHIAL AND SCAPULAR REGIONS. PT WAS GIVEN PO BENADRYL 25MG AND GATORADE. SHE WAS EDUCATED ON THE RASH AND SIDE EFFECTS OF BENADRYL FOR WHICH SHE VERBALIZED UNDERSTANDING. PT WAS STABLE TO LEAVE THE OBSERVATION SITE WITH RELATIVE DRIVING. PT WAS ALSO INSTRUCTED TO F/U WITH HER PCP.
client approached the EMT station complaining of neck pain. Client was alert and tracking with her eyes and appeared to be in mild discomfort. Client had a chief complaint of left side, anterior neck pain. Client stated that approximately five minutes into the observation, she began to experience neck pain and denied any history of severe injury or surgery to the site. This is the client's first dose of the Pfizer vaccine. Client states that she has a secondary history of seizures for which she takes lamotrigine for daily. Client stated she was allergic to ibuprofen. Assessment revealed 8/10 pain on the anterior of the left side of the client's neck that was non radiating. She described the pain as a "pinch and burn" that began abruptly. Client was negative for swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Client's vaccine was on the left deltoid and negative for pain upon palpation and intact. Client's airway, breathing and circulation were intact. Client was alert and oriented to person, place, date and event. Client's initial vitals at 1240 were blood pressure 108/74, pulse 86, respirations 16, 99% O2 saturation, Breathing at 16, Eyes equal and reactive to light, Lung sounds clear bilaterally, and skins were normal throughout her body. Client denied this complaint resembling any type of aura for her seizures. Client agreed to stay for the additional 30-minute observation. Water was given. Vitals were taken every 5mins for 30mins. Patient felt better and pain went down to 3/10. Patient refused to stay for the remaining of observation and emergency precautions were given and recommended to follow up with PCP and register for Vsafe. She left site in no distress.
Extremely tired immediately after, about a week after I started having fainting/ syncope problems. It got so bad that I was fainting once a day sometimes more. It lasted for about 3 years and I can finally say I have had no more episodes this year. I saw a few doctors, they checked my heart, my brain to rule out seizures, a lot of testing and nobody figured out why it was happening.
Neck pain; back pain; muscle ache; severe nausea; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (severe nausea), MYALGIA (muscle ache), NECK PAIN (Neck pain) and BACK PAIN (back pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication, SALBUTAMOL (ALBUTEROL HFA), ATORVASTATIN CALCIUM (LIPITOR), CARBAMAZEPINE (TEGRETOL), FISH OIL, GABAPENTIN, TRAMADOL, QUETIAPINE FUMARATE (SEROQUEL) and ONDANSETRON (ZOFRAN MELT).    On 08-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 NAUSEA (severe nausea). On 11-Mar-2021, the patient experienced MYALGIA (muscle ache). On an unknown date, the patient experienced NECK PAIN (Neck pain) and BACK PAIN (back pain). At the time of the report, NAUSEA (severe nausea), MYALGIA (muscle ache), NECK PAIN (Neck pain) and BACK PAIN (back pain) outcome was unknown. Not Provided      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.
irritated sinuses; night sweats; drippy nose; sore throat; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever). At the time of the report, SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremities)-Medium, Systemic: Allergic: Rash Generalized-Medium.
Tightness in chest; This case was reported by a consumer via interactive digital media and described the occurrence of chest tightness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th December 2022, the patient received Shingles vaccine. On 5th December 2022, less than a day after receiving Shingles vaccine, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was not recovered/not resolved.   It was unknown if the reporter considered the chest tightness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: This case was reported by the patient's wife interactive digital media. The patient's wife stated that the patient got a shingles shot about 3 hours ago The patient was feeling a tightness in chest.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Knot in injection site and massive headache. Was treated with Toradol and antibiotics due to ear infection
her left arm hurt; feeling of hot flash and cold flash; headache; lightheadedness; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 25th February 2020 03:00, the patient received the 1st dose of Bexsero. On 25th February 2020 04:00, 1 hr after receiving Bexsero, the patient experienced pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea. On 26th February 2020 02:00, the outcome of the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling hot and cold, headache, light headedness, vomiting and diarrhea to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in her left arm around 3 pm and around 4 pm started to had diarrhea, vomiting, lightheadedness, headache, feeling of hot flash and cold flash and her left arm hurt and by around 2 am the next day all the adverse events had resolved. The reporter consented to follow up.
MOC called and reported that child had mild temperature, moderate red rash all over body.  Today no more fever but rash persists.
Nurse reports an improperly stored PROQUAD that was administered.; No other AE reported; Information has been received from a nurse, concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T003833 and expiration date of 01-AUG-2021 (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -9 Celsius degrees to 8 Celsius degrees  (-4.12 Celsius degrees) for 30 minutes. No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved.
Came down with flu symptoms 24 hrs - was sick for 1 week - Flu like symptoms.
Pain fever. Pt received PNEUMOVAX at about 12:30 yesterday afternoon. About 7 hours after getting vaccine, pt started to feel myalgic. Woke at 2:45 am with pain to right side of sternum. Pain radiated down and across diaphragm and down back. Pt took TYLENOL before bedtime and again at 2:45 when waking. Pain resolved after 30-45 minutes and pt was able to return to sleep. Pt slept in semi fowlers to decrease pain. No shortness of breath. Pt stated she never had this type of pain before. Rated pain last night a 8-9 (1-10 scale) and now a 2-3 (1-10 scale). Soreness at injection site. Fever 100.4 last night. Low grade fever today. Pt feels confident that reaction was due vaccine and is now resolving.
Presented to ER on 10/30/2019 with worsening shortness of breath. Chest xray revealed a spontaneous pneumothorax on the left side. Since the initial spontaneous pneumothorax, he has had 3 more all on the left side, 2 of which have resulted in surgeries to try and fix. Just discharged from the hospital for the 4th one with a chest tube left in place due to being high risk to have another surgery at this point
Patient had clinically recovered from hypotension and syncope so she was scheduled for discharge. In accordance with hospital policy, patient was offered an influenza vaccine prior to discharge. Approximately 10-15 minutes after receiving the vaccine, patient was being assisted to the bathroom when she lost consciousness, fell backwards, hit her head on the wall, and fell to the floor. The patient became pulseless with agonal breathing. CPR was initiated, an IV was reinserted, and a non-rebreather w/ surgical mask was placed. ROSC was achieved after 20-25 minutes. During the code, the patient received epinephrine x 4, cardioversion x 4, and bicarb x 2. She was intubated and transferred to the ICU where she underwent targeted temperature management. She ultimately sustained end organ damage requiring her to become dialysis dependent. Hospital course was further complicated by a massive GI bleed and infection. Patient ultimately died on 11/12/2020
Chest pain, headache, fever, nausea, joint pain, muscle pain and weakness.
Possibly inadvertently injected with empty syringe with J&J vaccine and vanish point syringe
A non-serious spontaneous report of administration of H1N1 to a 58-year-old female patient has been received from a pharmacist concerning a 57-year-old female. The patient did not have any medical history and was not taking any concomitant medications. On 13-Oct-2009, the patient received H1N1, Intranasal, for an unknown indication. Since the vaccination the patient has remained healthy and well. She never developed any adverse symptoms or flu-like illness. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 16-Dec-2009 and incorporated into the narrative: date of birth (age), medical history and concomitant medications and current health status of the patient. Also received information on name and contact number of the vaccine administrator.
area around vax site swollen, warm to touch & painful; inject given 7JUL93, swelling began 8JUL93 & warmth & pain present 9JUL93;
Red, irritated & itchy area L/deltoid after receiving Td on 5/27/99. Some erythema & induration. Suspect allergic rxn vs cellulitis. Treated with E-mycin.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 18-JUN-2012 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 18-JAN-2017, the patient was treated by a physician of a medical group he was in for a painful, blistering rash that was diagnosed as shingles. The male patient has been prescribed tramadol and acyclovir to manage his discomfort and symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Child had "tremors", post vax. Saw MD who felt tremors were caused by DTAP given. I am unable to reach child's mother X 2 and has not returned my call.
vial undergo temperature excursions; The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022; No adverse event; erroneously vaccinated with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Oct-2022 and was administered on 11-Nov-2022).    No concomitant medications were reported. It was reported that the patient was administered dose after 30 days use by date which was 9 days past expiry date. The vial was kept in refrigerator on 03-Oct-2022 and the (BUD) refrigeration date was 02-Nov-2022. The size of the vial was 2.5 ml. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681156:
angioedema within 15' : tongue swelling, difficulty talking, increased BP :  transferred to ED & tx with H1, H2  with sx resolution . Observed 6 hrs and d/c to home
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Started with swollen, hot areas of shots and fever. Baby Tylenol was administered for fever and pain. Very cranky, wouldn't sleep well. Over the next couple of months he went from speaking sentences to just "Mama", "Dada" and "uh-oh", quit potty training, quit sleeping well at night, quit eating most of the foods he ate normally. He would learn new words and then drop the other words he knew. We have done speech therapy.
The same night of the third dose I had vertigo and it was really bad and I contacted my doctor and she ran and MRI and gave me medicine.
Aprox 30 hours after third dose (booster), I developed a large, hard, bump, red in color and warm to the touch, approx 2-3 inches in diameter, on the upper arm underneath the injection site (not in lymph node under arm).
3/19/2021 appt 3 hrs after injection Symptoms include strong feeling of horrific flu symptoms coupled with fatigue, inability to speak loudly and clearly, inability to move coupled with dizziness and nausea. Symptoms lasted approximately 20 minutes. Symptoms left as quickly as they came on and did not repeat. Felt fine. Felt fine after day one.