chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, was initially received on 02-Nov-2017 from other-health professional, concerns a 49-year-old adult female patient. Historical condition included hypertension which occurred and resolved on an unspecified date. Concomitant medication included EXFORGE for an unknown indication. On 26-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195229 and expiry date: May-2018). On 30-Oct-2017, the patient was presented to physician with itching, joint swelling, and lip swelling. On the same day, the patient was prescribed CLARITIN (1 tablet AM) and BENADRYL HS (1 tablet bedtime). On 31-Oct-2017, the patient was prescribed MEDROL (1 tablet per day) dose pack. The physician recommended, the patient should not receive any additional flu vaccine. The outcome of the events was not reported. The reporter considered this case as non-serious. Non-significant follow-up received on 29-NOV-2017: Updated dosage regimen and frequency of treatment drugs. The narrative was amended accordingly. Significant case correction received 02-NOV-2017: The case comment was (changed from not related to related) corrected.
Dx: fall, elevated troponin, acute kidney injury, COVID (10/15/2021).  Treatment: medical management including aspirin, statin and metoprolol. IV Decadron.  Daily asprin.  Discharged to skilled nursing facility.
Starting on the 18th, I noticed the area was suddenly itchy and when I looked at it, there was a large red oval area surrounding the injection site with raised welts.  Without any treatment until that evening, the itchiness faded and the welts went away.  Hydrocortisone was applied in the later evening.  On the 19th, the area is still red and covers a large part of the upper arm with some slight itching occasionally
Medication Administration, Leakage: Patient?s identity was confirmed, consent obtained, and screening performed. Injection was placed appropriately in the deltoid without resistance, however a more than half of appropriate dose lost. Dose re-administered in right deltoid without issue. VAERS report submitted by medical lead.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EN6202) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "IBS-D/Irritable bowel syndrome with Diarrhoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovered" (19Jun2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (19Jun2023) Negative. Therapeutic measures: Paxlovid as COVID-19 treatment from 12Jun2023 to 17Jun2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257324 same patient, different drug and event;
Dizzy; felt sick for 2 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (felt sick for 2 days) and DIZZINESS (Dizzy) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick for 2 days) and DIZZINESS (Dizzy). At the time of the report, MALAISE (felt sick for 2 days) had resolved and DIZZINESS (Dizzy) outcome was unknown.            No concomitant medication was reported.    It was reported that, patient in his 40's. The patient felt sick for 2 days and was dizzy after receiving fourth dose of Moderna bivalent vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-666036 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666036:(MOD22-028046 (father case)
Patient reported "COVID Arm" for 3 days after the vaccine.  She reported this to the pharmacy on 6/9/21.   She said that she experienced redness, swelling, and had trouble moving her arm.
Redness swelling pain left upper arm - site of flu injection. Also increased shortness of breath, wheezing.
This spontaneous report as received from a pharmacy technician concerning a currently 41 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
16 days after vaccination I experienced an acute attack of vestibular neuritis resulting in a three day hospitalization and ongoing vestibular balance therapy.  The connection between the Pfizer bi-valent vaccine and subsequent vestibular neuritis was mentioned by by vestibular therapist so I therefore wanted to report the possible connection.
Patient received the 2nd dose of Moderna 19 days after first dose., Patent did not had any side effects.
Syncopal Episode; hit her head; Malaise; Felt weird; Feeling a little flat; She "passed out"; Syncope; This is a spontaneous report from a contactable consumer (patient).  An unspecified year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported, Expiration date: Unknown), via an unspecified route of administration in the left arm on 01Apr2021, as a 1ST DOSE, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patent stated that on an unspecified date (9 days later) in Apr2021, she had a syncopal episode while she got up to go to the bathroom and passed out in the morning after waking. She hit her head and ended up in the hospital. She had undergone blood work and said because this event was 9 days after the vaccine, it was probably not related to the vaccine. The patient has been feeling a little flat since the first shot. She experienced syncope, malaise, felt weird, Syncopal Episode, Feeling a little flat. Patient was just feeling the general malaise since the first shot. Patient had a syncope, day nine after the first shot The outcome of all the events were Unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Patient presented to clinic for Pfizer booster; after booster administered patient reported she actually received Moderna vaccine 2 dose series, and not Pfizer.
8 days after my first injection, there appeared a red patch at the injection site downwards the size of my hand.  It itched but there is no sign of a bug bite.  Everyday it slightly lightens up.
That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips.  Temp 102.6 overnight..  On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
urticaria-onset 13MAR96 MMR w/diluent given 6MAR96;rx cecritan,tarac,Pred
Client seen at clinic 48 hours after immunization. Right thigh reaction noted by parent within 29 hours. Reaction noted is 5.5"x5" inflamed area right thigh.
Employee experienced dizziness upon waking the morning after the vaccine. She had some muscle weakness, headache, and fatigue throughout the morning.
Tuesday night, I went to bed with some symptoms. I didn't feel well so I took a Benadryl to help me sleep and felt like I had a cold. I also took some Tylenol as well. The next morning my throat was sore and it felt like a worse cold. My daughter took me to urgent care immediately because of the sore throat. Just felt like I had a very severe cold with a sore throat. At urgent care, I was prescribed Paxlovid.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.  Patient's year of birth was reported .
I felt great before the vaccine; then two hours after receiving it, I started to sweat, feel nauseated with vomiting, dizzy, aching, sore throat, cough and low grade temp.  It has continued for 5 days.
vaccination site erythema; vaccination site pruritus; sweating; neck pain; weght gain; appetite lost; fatigue; lymphadenopathy cervical; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Chronic lymphocytic leukemia in 2013, Blood pressure high, Diabetes, High cholesterol, Heartburn, Stroke and Alcohol use. Concurrent medical conditions included Drug allergy (Tetracycline,penicillin). Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for Cardiovascular disorder NOS, METFORMIN for Diabetes, PANTOPRAZOLE SODIUM for Heartburn, ATORVASTATIN for High cholesterol, ALLOPURINOL for Kidney disorder, TETRACYCLINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
redness around the injection site; swollen around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), SPIRONOLACTONE, METOPROLOL SUCCINATE (TOPROL) and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen around the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include: allergy reliefs called top care
Client came to clinic on this date. Had redness, slight swelling, some warmth to the touch and ecchemosis down his entire right arm and into the wrist, especially on the interior aspect of his forearm.
1 week following flu vaccine started to feel tingling numbness in toes/fingertips. LE weakness which is progressively worsening over past 4 weeks, increased reflexes. Medical records state Hypertonia, pain. msv
Pt received ZOSTAVAX injection 12/30/13 SQ right arm. Pt noticed local skin reaction (rash, swelling, and itching) at injection site when showering 12/31/13 at 9 PM. Reported rash at 10:15 AM on 1/1/14. Pt told to use hydrocortisone cream and report worsening of symptoms, signs.
S/P small pox vaccine X 9 days, swelling redness, tenderness, local induration, L arm with supraclavicular shoulder reaction, cellulitis. Cipro 500mg #6 bid, follow up 2 days.
Pt was awake & screaming every 1/2 hrs during the afternoon; Refused feedings, moaning, went limp, vomited x 2, got very pale & convuls x 1; Seen in ER @ 845PM; t100; No tx required, sent home; T101.2 @ 5AM 19JUN;
Arm became very sore less than 12 hours after vaccination; Sore injection site, raised inflamed bump at injection site, res circular rash encompassing and surrounding injection sight; extreme soreness in injected arm (not just when touching injection site)
Sweating really bad; Light headed, "off center"; Feeling tired, really tired; Vomited 3 times; Heart started racing; Aches in arms and legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Heart started racing), PAIN IN EXTREMITY (Aches in arms and legs), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center") and FATIGUE (Feeling tired, really tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concomitant products included OXYCODONE for Pain, BISOPROLOL FUMARATE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Aches in arms and legs). On 20-Apr-2021, the patient experienced TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times) outcome was unknown and PAIN IN EXTREMITY (Aches in arms and legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: normal (normal) Normal. On 20-Apr-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included unspecified ophthalmic antibiotics post-cataract surgery.
vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------  TRANSIENT CEREBRAL ISCHEMIA 3/7/2022 TRANSIENT CEREBRAL ISCHEMIA
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 08-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
about 11 hr p/vax devel a fever up to 102;entire upper arm became red & warm;saw family MD 11SEP & started on ATB;
Within 3 hours or receiving tetanus shot,  I couldn't move my left arm to the right across my body or above my chest and was in extreme pain.  When I called the doctor's office and spoke with the nurse assistant who administered the shot, she said it was because I tensed up and it would be sore for a few days. Over the next few days the pain continued to worsen, unable to sleep through the night, can't do normal activities,  movement is restricted in that arm above my chest, across my body and to the left. Sought treatment at Urgent Care on 8/24 which stated injection sight which is still bruised was way to high on the shoulder and administered into the joint or nerve causing a frozen shoulder.
Pt did not disclose had already received 1st dose of vaccine on 1/20/2021
At 5:00pm on 02/12/2021 evening after receiving 2nd dose reports hands were bright red no other symptoms noted at that time. Later on in the evening on 02/12/2021 began to experience a increasingly sore arm. Reports waking up on Saturday 02/13/2021 with a headache, chills, sweats, body aches, and fatigue. Reports sleeping a large portion of the day on Saturday. The symptoms started to subside at 9:00pm on 02/13/2021 and when woke up at 8:30 on 02/14/2021 reports symptoms were gone.
Information has been received from a physician assistance concerning a 15 year old female who on 01-APR-2008 was vaccinated with a dose of GARDASIL.  Concomitant therapy included DTAP.  The patient passed out in the office after the vaccination and recovered after a short interval.  No treatment was required.  Medical attention was sought in the office.  The patient was seen in the office because she had been experiencing some dizziness.  The PA thought it might be low blood sugar.  No product quality complaint was involved. Followup information reeived from a nurse indicated that the patient has fainted on other occasions such as having blood drawn. The physician assistant does not believe that this was related to the Gardisil. Followup information received from a nurse indicated that the patient became weak and nauseated after shot of Gardisil, however the patient dis this when lab was drwan as well. The patient laid down for a few minutes and was fine. The office and mother did not think this was an adverse reaction to the vaccine. Additional information has been requested.
Patient presented to the clinic on 11/30/2021  stating that she needed a dose of covid-19 vaccine.  She did not state that she had had 3  previous doses of Pfizer's covid-19 vaccine on 3/23/2021, 4/13/2021,11/9/2021.  0.30 ml of Pfizer's Covid-19 vaccine was administered for a total of four doses. This patient was not immunocompromised.
Began getting right calf cramps intermittently which evolved to constant cramp by October.  Then two months of menstrual beeding and ER admission for DVT.  I had never had menorrhagia or blood clot before.
Hives and itching all over body. Joint swelling and pain occured also, tylenol did not help with the pain. Localized swelling and pain at the injection site.
Headache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Kidney stones (Hospitalized. Recovered 14-Jan-2021; also reported at the beginning of February 2021, his kidney stones were removed) from 28-Dec-2020 to February 2021 and Stent placement (Stent placed to remove the kidney stones.  Stent was removed on 11-Jan-2021) on 11-Jan-2021. Previously administered products included for Kidney stones: Keflex from 28-Dec-2020 to 06-Jan-2021. Past adverse reactions to the above products included No adverse reaction with Keflex. Concurrent medical conditions included Kidney stones (Recurring issues with kidney stones), Non-tobacco user, Abstains from alcohol, Attention deficit disorder, Asperger's syndrome, Scoliosis, Obsessive-compulsive disorder and Crohn's disease (Moderate to severe). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit disorder.   On 08-Aug-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain in arm) had not resolved and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, X-ray: kidney stones (abnormal) Showed that he had 2 kidney stones..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain in arm) to be possibly related. No further causality assessment was provided for HEADACHE (Headache).    Treatment of the events were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 24-MAY-2021 contains no new information. On 01-Jun-2021: Follow up report received on 01-JUN-2021 included additional events.