chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events.  No follow-up attempts are possible. No further information was provided.
9/24 ER visit w/ c/o shoulder injury, bruise over (L) deltoid site of injection, has hematoma. 9/29 Return to ER w/ chills, persistent arm pain. 9/30 pt called MD office - shaking, chills. Advised to go to ER CBC and ESR repeated, decreased ROM, pain and swelling (L) shoulder. Discharged to see Ortho MD today (later in day) ER MD spoke to Ortho surgeon. Sent home. Returned on 10/5 to Ortho surg and admitted to hospital w septic arthritis. I and D x 2.
Patient developed hives all over legs, where vaccine was administered ((L) leg) but spread to both. Mild hives on face. Cried for 30 minutes. Waited in office x 45 mins. monitored, prescribed BENADRYL to take home by the time he left, hives were gone.
Employee states that approximately 2 hours after receiving the vaccine started to have nausea followed by headache, numbness/tingling to extremities, and body aches. Employee states that the symptoms lasted approximately 1 week.   Also reports going to the ED the following day for the symptoms.
4 & 5DEC pt felt lethargic, ill, T101;6DEC red raised rash appeared on arms, legs, stomach, face;rash burned, itched & @ times painful, fever cont;5DEC evening earache occurred MD notified;APAP & DPH given 7DEC;8DEC rash, warm
10mins post vaccination, pt reports "I feel my blood pressure go down".  Pt also reports dizziness. Vitals: 19:40 138/81, 88, 18, 100%-- > 19:45 129/89, 84, 18, 100%. An ammonia inhalation was used and the pt was provided water and juice.  Pt recovered quickly indicating that he was feeling better/asymptomatic.  Pt stable and released from the vaccination site.  Pt walked out of vax site, refused wheelchair.
The patient experienced pain in the arm, a fever, red blotches on dorsal aspect of the arm. The patient was treated with Tylenol with codeine, Demerol, and Benadryl.
LMP 2/10/2021. Estimated due date 11/17/2021. Received vaccine on 3/23/2021. During initial prenatal visit  4/1/2021 there was no reported heartbeat and baby was measuring later than calculated based on LMP.  On next appointment 4/8/2021 heartbeat was found and baby was estimated to be due on 11/21/2021. On follow up appointment 4/15/2021 baby no longer had heartbeat based on measurement was due 11/21/2021.  Doctor noted a missed miscarriage on 4/15/2021. On appointment 4/19/2021 still no heartbeat and no growth. D&C took place 4/21/2021.
Received 3 doses in total; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA468A, expiry date 31st March 2022) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date). Concomitant products included Men ACWY-CRM NVS (Menveo).   On 31st August 2021, the patient received the 3rd dose of Menveo. On 31st August 2021, unknown after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient received a booster dose of Menveo on 8th August 2021 and by mistake received another dose on 31st August 2021, 3 doses in total, which led to extra dose administered. The reporter consented to follow up.
This case was reported by a physician via call center representative and described the occurrence of papular rash in a 4-year-old female patient who received KINRIX (batch number A75B7, expiry date 3rd September 2016). Co-suspect products included MMR (batch number K007974, expiry date 3rd June 2016) and VARIVAX (batch number K002036, expiry date 10th February 2016). On 8th January 2015, the patient received KINRIX .5 ml, MMR and VARIVAX. On 8th January 2015, immediately after receiving KINRIX, the patient experienced papular rash. On an unknown date, 2 days after receiving KINRIX, the patient experienced eye swelling and giant urticaria (serious criteria GSK medically significant). On an unknown date, the outcome of the papular rash, eye swelling and giant urticaria were not recovered/not resolved. It was unknown if the reporter considered the papular rash, eye swelling and giant urticaria to be related to KINRIX. Additional information received: Patient experienced papular rash in the buttock area and in the leg area. The patient's giant urticaria was everywhere. Physician recommended patient to go to emergency room.
Pt was given expired vaccine in error.  Moderna expiration date was 08/31/2021 and was administered on 10/18/2021 in error.  Pt was notified of error and reports only side effect from vaccine was a sore arm for 1-2 days. Nurse notified Moderna of error as well. Pt desires to RTC on 11/5/2021 and repeat initial Moderna dose to replace expired dose.
Pt recv vax on 8/2/95; on 12/12/99 pt exp zoster of rt arm & hand w/ pain, fever, headache, malaise
Red rash and swelling around the injection site as well as itching. A couple, myself being one, had a rash on their entire arm.
My 11 year old daughter received the HPV vaccine yesterday. She almost fainted after the shot and has had dizzy spells since the shot. I know that fainting and dizziness are common side effects, I just wanted to let you know for your data.
Pt called stating had developed swelling and redness that was warm to the touch. Hives and itching from shoulder to elbow in the vaccinated arm 8 days after (12/30/15). Pt was instructed to take BENADRYL.
Patient received Pfizer vaccine and was standing with parents during his suggested 15 minute wait time. During this time, parents noted that he "passed out" but they caught him. He then gained consciousness immediately and sat down to be monitored by pharmacists on duty. His vitals were checked immediately. O2 saturation was 97-99. Blood pressure 138/83mmHg with HR of 81. Patient had trouble breathing for 2 minutes. O2 saturation did not change. After 2 minutes, he breathing improved and patient was calm.
pt recv vax & 1mo post vax pt exp malaise, fatigue, enlarged liver & abd pain;MD was required;pt was found to have poss case of hep A;reporting RN stated that MD in question misdiagnosed the pt;pt was told that +HAV Igm r/t vax;
1 wk after vaccine, bilateral knees, ankles and foot pain lasting 1 wk. Pain worsened and she developed swelling of lower legs with rash lasting 1 wk. Unable to walk -> ED.
The first night: Chills, area of injection swelling, and entire body aches. The second day: area of injection a swelling and entire body aches. The third day: area of injection swelling. The fourth day: area of injection swelling.
red, hard knot in arm at injection site since waking the morning after; extreme sore muscles and fatigue all day 4/18
She was born August 22nd, 2008, perfectly healthy, an easy, happy, delicate baby girl.  She did not receive any Hep B vaccines.  However, at two and four months she received all other vaccines according to the CDC's schedule.  Looking back, I see the downward spiral, but did not know what to look at the time. For this, I am extremely ashamed to admit, being that I have a medical degree.  Her 2 month vaccinations were given 10/22/08.  She was initially excessively sleepy, at 5 days she was irritable and refused to eat, within the first week her tongue began involuntarily protruding, at 5-6 weeks I believe she suffered a seizure which I did not recognize at the time as being that, she would also have frequent episodes of high pitched screaming.  After the 4 month vaccines (12/23/08), similar things took place, however, there was not a seizure episode that I can recall.  But she continued to become less interactive (would not respond to a loud blender 2 feet from her, sit quietly in bath chair for an hour, not react to play with siblings), bloated, allergy and infectious symptoms (but never spiked a high fever).  I did give her tylenol the first two days after both sets of vaccinations because of the high fevers both my boys spiked with their vaccinations. Patient took a bottle at 6am, was awake til 945a, took another bottle, fell asleep in her papazon swing supine, nothing over her head, she made no sounds, picked her up to change her 45 ming later, and she was lifeless. Autopsy found nothing, unknown/undetermined. I am looking to find the appropriate person to review it and do further testing as indicated.
a patient only received ACT-HIB portion and missed diluent (Dtap/IPV) portion of Pentacel/No AE; Initial information was received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.   This case involves a 3 years-old male patient who received only ACT-HIB portion and missed diluent (DTAP/IPV) [diphtheria, tetanus, acellular pertussis / Poliomyelitis vaccine(Inactivated)] portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: unknown, dosing details: fourth dose and expiry date 23-Apr-2021) via intramuscular route in the left deltoid on 09-Sep-2020 for prophylactic vaccination (product preparation issue).  For ACT-HIB vial batch number and expiry date was reported (lot UJ229AA and expiry date 21-Apr-2023) and not reported for DTaP/IPV portion.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to inappropriate reconstitution technique (latency was on same day).  It was also reported that they wanted to purchase the diluent or 0.4 percent NaCl (Sodium chloride) to mix with the powder that is left of the Pentacel dose and diluent in the Pentacel was the Dtap/IPV portion.  At the time of reporting, no adverse event reported.  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 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.
Numbness in little finger of arm of injection after 2nd dose; Tingling in little finger of arm of injection after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd dose). At the time of the report, HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) had not resolved and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd dose) outcome was unknown.            No concomitant medications reported. Treatment information not provided.
Very Sore arm, Bad headache, Muscle Soreness, especially in right hip and right shoulder.  Arm better in the morning after, but headache lingers.  Muscle pain a little less by 11:00 a.m.
bursitis; Developed severe pain in right shoulder approx 7 days after 1st vaccine/joint pain in hands, knuckles, toe joints in both feet, ankle joint pain in both feet; This is a spontaneous report from a non-contactable other healthcare professional (patient).   A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 05Mar2021 at 12:00 (Batch/Lot Number: ER8733) (age at vaccination 44-year-old) as dose 1, single for covid-19 immunisation at Health Clinic/ Administration facility. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient developed severe pain in right shoulder approx 7 days after 1st vaccine. Went to ER and diagnosed with bursitis. Have no history of arthritis or autoimmune disorders before the vaccine. Then, the patient developed joint pain in hands, knuckles, toe joints in both feet, ankle joint pain in both feet after 1-2 weeks after 1st vaccine. Progressed and joint pain worsened over the next weeks. Shoulder joints began with pain. Had blood work done last week and I have high indicators for Rheumatoid Arthritis on 13Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment included medications for the events. The outcome of the events was not recovered. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8733) as dose 2, single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
After dose 2 / diagnosed with Shingles; 1st dose in Nov 2019 / due to Covid-19, 2nd dose on Sep 2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   In September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles and social problem were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix 1st dose in November 2019 and due to Covid-19, 2nd dose was administered on September 2020 (no exact date was provided). After receiving dose 2, patient was diagnosed with Shingles. The reporter consented to follow up.
pt recvd vax & approx 2 months p/vax & exp liver disease & was hospitalized; administration dates of prev doses;
Chills, headache, body aches, and fatigue.  Started at 4am the day following shot.
Missed two days of work; Pain; Slight fever of 100°F; Right foot had a gout attack; Felt sick; Right foot hurts really bad/Right foot hurts like crazy; Could not sleep; Sweat like crazy; Messed them up; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep) and HYPERHIDROSIS (Sweat like crazy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout (Gout once 6 years ago and since then the patient had to modify his diet.) in 2015.    On 02-Sep-2021 at 1:26 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Messed them up). On 03-Sep-2021, the patient experienced GOUT (Right foot had a gout attack), ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work) and PAIN (Pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, HYPERHIDROSIS (Sweat like crazy) and PYREXIA (Slight fever of 100°F) had resolved. At the time of the report, GOUT (Right foot had a gout attack) was resolving and ILLNESS (Felt sick), PAIN IN EXTREMITY (Right foot hurts really bad/Right foot hurts like crazy), INSOMNIA (Could not sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Missed two days of work), FEELING ABNORMAL (Messed them up) and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 100 (High) Had a slight fever of 100 degree Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Additional information received included patient demographic details, suspect vaccine details, reported adverse event outcome and causality.
This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of ROTATEQ that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins.  Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006922: US-009507513-1707USA006923: US-009507513-1707USA006335:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: IRREGULAR HEART BEATS. PATIENT REFUSED TO HAVE US CALL PARAMEDICS. WIFE IS TAKING HIM HOME. WE DID SUGGEST FOR HIM TO GO TO THE HOSPITAL AND PROVIDED THE ADDRESS OF THE CLOSEST HOSPITAL BUT PATIENT REFUSED.
Within 15 minutes of administration, patient began to experience dizziness, shooting left arm pain, and felt like she was about to faint.  Patient was instructed to lay down on floor.  After assisting patient to the floor with  legs elevated, she was observed to have blanching of lips.  Check injection site to see if there was any swelling.  None noted.  Continued to observe patient for 5 minutes while asking questions to ensure that  there was no airway constriction.  After patient was able to sit up, she was offered water to drink.  Patient admitted to having not eaten anything today.  When patient felt well enough to walk she was escorted out by her mother.  It was revealed during conversation that patient has an extreme needle anxiety.
This spontaneous report as received from a female register nurse reporting on her self, a female patient of unknown age. On 21-AUG-2012, the patient was vaccinated intramuscular with PNEUMOVAX 23 dose and lot: unknown. Other suspect therapies included on 21-AUG-2012, intramuscular ZOSTAVAX (dose lot: unknown). The consumer stated that on 21-AUG-2012, she received ZOSTAVAX and PNEUMOVAX 23 intramuscularly in the same arm. On 22-AUG-2012, the patient developed a red, raised, itchy area that is 3 inches in diameter around the injection site. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. The patient's outcome for red, raised, itchy area that is 3 inches in diameter around the injection site was unknown. Additional information has been requested.
1230PM c/o face, neck, & arm hurting; swelling around ear & jaw, t99-100; 11PM took to ER seen by MD t103 given APAP; dx parotitis;
her husband may have had some aggravation agitation and irritation; her husband may have had some aggravation agitation and irritation; he had soreness around the injection sight; angered; upset; Frightened; he was worried about getting sleep for work; he was worried about getting sleep for work; soreness/mildly sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EW0150) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGITATION (non-serious), IRRITABILITY (non-serious), outcome "unknown" and all described as "her husband may have had some aggravation agitation and irritation"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "he had soreness around the injection sight"; ANGER (non-serious), outcome "unknown", described as "angered"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "upset"; FEAR (non-serious), outcome "unknown", described as "Frightened"; ANXIETY (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "he was worried about getting sleep for work"; PAIN (non-serious), outcome "unknown", described as "soreness/mildly sore".  Additional information: Reporter states they got the first vaccine, both her and her husband at 9 am Wednesday, she confirms 07Apr2021. She states her husband may have had some aggravation agitation and irritation that maybe related because he received the same vaccination. She does not know if his was physical but he had soreness around the injection sight. Could have been experiencing something similar and was angered, upset, and frightened and didn't mention it. She does not really know. She states that she isn't really sure about the aggravation and irritation, but that it began when they were having to go to the hospital because of her symptoms and he was worried about getting sleep for work the next day. It was around 12:30 AM that night after the injection was given at 9 that day. The soreness began the same day, she does not think it is still going on he has not complained about it. It may be mildly sore.   No follow-up attempts are possible. No further information is expected.