chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60yr old male (documented allergies:  erythromycin (diarrhea) and penicillin (rash)) with unknown PMH presented for COVID-19 vaccine on 4/7/21.  Of note, patient reported previously lightheadedness/dizziness after blood draw or injection.  Patient declined to be reclined for administration.  RN administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1425.  Shortly after, patient reported feeling lightheaded and requested to be reclined.  Patient alert and oriented, other symptoms denied including hives, shortness of breath, or throat swelling.  BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline).  After resting in reclined position for ~5min, patient r BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline).  After resting in reclined position for ~5min, patient reported feeling better.  BP upon sitting was 161/92, MAP 115, HR 85, 97% RA.  Patient endorsed being back at baseline.  Patient discharged in stable condition with no other issues.
Arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2022AMR094578).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094578   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had arm hurt both times much worse and longer than the Covid shots. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094578:Same reporter
Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear.   @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation.  at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.
This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns a 69 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported. Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Adverse reaction to the Shingles vaccination. vaccine card does not show the brand or manufacture of the vaccinations given. Right arm was sore. about 1 hour after injection stated with chills, and physically shaking as if very cold/freezing cold, very anxious to get warm, fell asleep (about 4 hours), no urine or defection for 12 hours even after drinking plenty of fluids upon waking. Arm swelled from injection to elbow and skin was very taught(swelling increase for 2 days), used ice packs to help reduce swelling (didn't work). Inside of arm was very red, hot to touch. Felt dizzy for about 2 days after injection. Arm is still sore 9/10/2022, sore to raise arm. Can feel lumps in the muscles above the elbow on the inside of the arm.
On December 18 I'm start having a very bad rush and itch; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (On December 18 I'm start having a very bad rush and itch) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced RASH PRURITIC (On December 18 I'm start having a very bad rush and itch). At the time of the report, RASH PRURITIC (On December 18 I'm start having a very bad rush and itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   Reporter did not allow further contact
Pain on the injection site such that movement hurts such as changing clothes, driving or cooking.  Took ibuprofen extra strength last night and put heating pad to alleviate the pain but the pain is still there.  It is difficult to move the arm, every movement involving the arm hurts.
This spontaneous report was received from a nurse via a company representative referred to unspecified patients of unknown age and gender. On an unknown date unspecified patients were vaccinated with ZOSTAVAX (Lot # unspecified) (dose, route and indication unspecified). The reporter stated that the physician's practice, was "seeing more cases in which patients were complaining that ZOSTAVAX elicited headaches" on unspecified dates. Action taken and outcome of the event was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this reported. Additional information will be provided if available. Additional information has been requested.
EAR PAIN; EAR SQUEALING; SHARP PAIN ON NOSE; THROBBING PAIN BEHIND EYES; DRY MOUTH; SWOLLEN THROAT; DIZZINESS; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced ear pain. On 25-MAR-2021, the subject experienced ear squealing. On 25-MAR-2021, the subject experienced sharp pain on nose. On 25-MAR-2021, the subject experienced throbbing pain behind eyes. On 25-MAR-2021, the subject experienced dry mouth. On 25-MAR-2021, the subject experienced swollen throat. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain, ear squealing, sharp pain on nose, throbbing pain behind eyes, dry mouth, swollen throat, dizziness, and body aches. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via unspecified route of administration on the left arm on 17March2021 at 11:00 hours as a single dose for COVID-19 immunisation. Medical history included ptds, anxiety disorder, hashimotos thyroiditis, sleep apnea and pcos. Concomitant medications included metformine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), levo (MANUFACTURER UNKNOWN), prazosin (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN). The patient had allergies to nuts. Prior to 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 4 weeks prior to the COVID vaccine. On 18March2021 at 07:00 hours, the patient experienced vomiting and diarrhea. The patient did not receive any treatment for the adverse events. The clinical outcome of the events vomiting and diarrhea was recovering.    Information about lot number cannot be obtained. No further information is expected.
Severe headache 11/24/19, Aleve 2 tablets, mild headache 11/25/19 Aleve 1 tablet,  11/26/19 aware of double vision . saw regular ophthalmologist 11/27/19 for problem check due to sudden onset of double vision.  Spoke with family physician & both concluded I should be examined by neuro  ophthalmologist.  First appoint due to holiday was 12/3/19.  Diagnosis made during that visit of 6th nerve palsy
Left ear hearing loss; Vertigo; Nausea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 16Oct2021 11:30 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE (at the age of 61 years) for covid-19 immunisation. Medical history included ongoing diabetes and ongoing hypertension. Concomitant medications included influenza vaccine (FLU VACCINE VII); lisinopril (LISINOPRIL); and metformin (METFORMIN), all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 on 01Mar2021 (Lot: EL-3247) and second dose on 24Mar2021 (lot: EP-6955) for Covid-19 immunisation. The patient experienced left ear hearing loss, vertigo and nausea on 19Oct2021 07:30. The patient was hospitalized from Oct2021 to Oct2021 due to the events. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI): unknown results in 2021, and  sars-cov-2 test via nasal swab: negative on 21Oct2021. Therapeutic measures were taken as a result of the events (treatment reported as IV, MRI, sofran etc). It was also reported that the events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected. Information about batch/lot already obtained.
Menstrual cycle delayed 7 days. My menstrual cycle is normally on time. My lips have been dry/cracked/peeling since the vaccination.
flu like sx x 7 day, chills, fever, joints attacked/painful, no strength especially knees, wrist, hand-pain moves from one joint to another;Annual follow-up dated 10/10/00 states that symptoms progressed into Wegeners Granulamatosis.
no adverse effect; the 44 year old patient received one pediatric dose of VAQTA; This spontaneous report was received from a health professional (nurse prescriber) refers to a 44 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 31-MAY-2019, the patient was vaccinated with one pediatric dose of hepatitis a vaccine, inactivated (VAQTA)(strength: 25/0.5) at a dose of 0.5 milliliter once via intramuscular route for prophylaxis (incorrect dose administered) (Lot # expiry date was not specified). No adverse effect reported. No PQC involved. The outcome of incorrect dose administered, and no adverse event was unknown.
Patient received the booster dose of the Janssen COVID vaccine (lot 1855194) and the Fluarix influenza vaccine (lot 7557A) at approximately 1625. At 1655, patient reported to Paramedic and PHN feeling like her throat was swelling and dysphagia. PHN noted patient no use of accessory muscles or difficulty speaking. Vital signs: blood pressure 142/86, O2 99%, pulse 86, respirations 16. Patient reported allergy to PEG causing hives and throat tightness for which she takes oral Benadryl with good effect. Medical condition includes arthritis. Patient takes Truvy weight loss supplement. PHN offered Benadryl IM, patient consented. PHN administered Benadryl 50mg IM at 1656. PHN educated on remaining for 30min monitoring from time of medication administration, to follow up with provider, and ER precautions. Patient called sister to arrange for transportation. At 1700, patient reported improved dysphagia and able to drink water provided by site with no difficulty. At 1703, vital signs: blood pressure 136/72, O2 99%, pulse 84, respirations 14. At 1708, vital signs: blood pressure 136/78, respirations 16, O2 99%, pulse 82. Patient reported blurry lights. Patient moved unassisted to zero-gravity chair with no difficulty and placed supine closely monitored by PHN. At 1720, vital signs: blood pressure 128/84, respirations 14, O2 99%, pulse 76. Patient reported all symptoms had resolved and starting to feel drowsy due to Benadryl. Patient's sister arrived at site. Patient left walking with steady gait at 1746 accompanied by sister to drive her home.
Vasovagal syncope- twice, oral fluids, juice remain supine Trendelenberg.  She was treated in our facility.
Information has been received from a physician concerning a female patient who was vaccinated with 0.65 ml dose of ZOSTER vaccine and after receiving the vaccine developed a case of shingles. Eventually the patient experienced herpetic neuralgia. The patient sought medical attention. At the time of reporting. the patient had not recovered. This is one case of two cases received from the same source. Additional information has been requested.
No reported adverse event. Two Jannsen Covid-19 vaccine doses given in 1 month period
Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed and she experienced tachycardia for several minutes. Pulse was not checked. She then became extremely pale, light headed, and sick for 10-15 minutes. Chest was heavy in the evening from 8-9 pm so she took an antacid and went to bed. She woke up at 11pm, but body was still sleeping and she couldn't move. She has never experienced this before. Arm was very sore, but has improved. Has also been taking ibuprofen and Tylenol for body aches.
PATIENT RECEIVED MODERNA AND FLU VACCINES. REPORTED WHAT SOUNDS LIKE AN ANXIETY ATTACK, FELT DIZZY AND SAID THROAT FELT SORE AND FELT WEIRD TO BREATH. PATIENT FULLY CONSCIOUS, ALERT, AND RESPONDING. NO ISSUES WITH VACCINES OR SEVERE ALLERGIES REQUIRING EPI PENS IN THE PAST. NO HISTORY OF ASTHMA OR BREATHING DISEASE. NO ISSUES WITH DIFFICULTY BREATHING WHILE AT PHARMACY THAT WOULD REQUIRE USE OF EPI PEN. PATIENT REQUESTED EMS CALLED.
No additional AE; reports that a pediatric dose ofRECOMBIV AX HB was administered to an adult patient; This spontaneous report was received from a nurse and refers to an adult patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On 27-JUL-2021, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), 0.5 milliliter (route was not provided), lot# was reported as T018888, expiration date 03-NOV-2022,  for prophylaxis.
3 days after my first dose of the Pfizer vaccination I had a moderate/severe genital herpes outbreak. I was diagnosed with genital herpes 17 years ago and have not had an outbreak since the first time. I am not currently taking any medications related to genital herpes or anything else. I have no treatment to report and the outbreak ran its course lasting 2 weeks.
Patient came in to receive her 1st dose of Moderna. Patient was screened by an vaccinated by one of our nurses. Patient states having an anxiety attack after receiving her dose. Patient reports feeling dizzy.  Another nurse came over to assist the patient. Patient then started wheezing. Patient reports having asthma, but neither her nor her mother brought her rescue inhaler. A Code Blue was called and Dr. came to the vaccine clinic. Dr. evaluated the patient and recommended that the patient be observed for 20 more minutes. Dr. then headed next door and prescribed the patient an Albuterol inhaler to be filled at our pharmacy next door so they would have one with them (Rx# 6101288 Ventolin Inhaler [Albuterol Sulfate]). Dr. came back with generic Albuterol and the patient inhaled 2 puffs. Patient felt fine after the 20 minute waiting period and went home.
Patient accidentally given Pfizer vaccine for second dose instead of Moderna. No adverse events/reactions have been reported by the patient.
Shooting pain down (L) arm; arm red and sore. ADVIL, cool compress.
1030 shot Administered 1130 sleepiness 1230 jaw tightening 1300 neck sore 1630 neck, along spine, lower back sore 1855 body aches 2045 nausea/ chills/ fever/ headache/ rapid heart rate over 100bpm 2045-0700 rapid heart rate/ fever over 100
Patient given flu shot on 1/12/2022 and had already had one for this season on 11/1/2021
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself.  This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
1st shot: no immediate reaction. Racing heart that night. No illness reported, 11 days later I had a small red spot at injection site that was hard and hot to touch but went away on its own in about 1 week. 2nd shot: I had the vaccine on Friday, Feb. 5, 2021 at 5:05p.m. and had immediate reactions. That night I had a racing heart (which I had with the first vaccine)The next morning, Saturday the 6th, I woke up very sick. Symptoms included total body aches, pounding head, loss of appetite, racing heart, general flu like symptoms. I noticed a large red knot/rash on my arm at injection site. By Sunday the 7th, the symptoms had subsided mostly but the knot/rash was larger. Sunday night the knot/rash was even larger, hard and hot to the touch, the redness has darkened. I went to urgent care and they said it was not an infection since I had no pain (just uncomfortable and slightly itchy) they thought it was an allergic reaction and gave me steroids. Monday the 8th (today) the red rash/knot is less dark and hard but larger/wider in size. I had dizziness, lethargy, racing heart and loss of appetite.  I have not worked since Friday the 5th.
7-26-12 patient had awaken with a red itchy $.50 piece size area at injection site. Advised BENADRYL and ice to area. Mother called again on 7-27-12 and Dr. said to continue current treatment until size decreases. Mother contacted 7-30-12 and she said there was only slight redness at this time.
2nd dose blood clots calves of the legs, after a trip, it hurts and went to the doctor and on meds and clots disappeared. I knew I had the blood clots. My calves on both legs started hurting after 2 days after the vaccine. Took a trip and the pain was worst. I went to doctor and 27 Apr 2021 Ultrasound. On medication - Eliquis. The doctor asked for PT to stay on this meds for an extended period.
Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection location soreness and pain. Cannot sleep at night. I thought to call 911.
red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot; Itching around the ankle; Very red spots on the leg, upper arm, upper foot, on top of the toe area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, 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 RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) (topical) for Itching, at a dose of 0.5 %. At the time of the report, RASH MACULAR (red blotches on the calf of the left leg, then closer to the knee,bigger one in her upper left arm, then on top of the right foot), PRURITUS (Itching around the ankle) and ERYTHEMA (Very red spots on the leg, upper arm, upper foot, on top of the toe area) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.