chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Four surgeries.). Concurrent medical conditions included Hypertension, Hypothyroidism, Penicillin allergy and Allergy to antibiotic (Allergic to levaquin). Concomitant products included CARVEDILOL and LEVOTHYROXINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment for the event was not reported.   This case was linked to MOD-2021-054468 (Patient Link).
2 days after flu vaccine painful swollen area at site of injection right arm. Resolved after 4 days. At midnight 10/31/03 experienced severe shaking (unable to pour water without spilling) as if cold yet tops of arms and legs warm. Shaking resolved only after 3 hours and returning to bed with extra blankets. Awoke with severe headache, nerves sensitive, no energy and still feels this way at 9:45 AM at time of call.
About 17 hours after receiving the vaccination, I had vertigo. I woke up at 4:30 AM half an hour before my usual wake-up time, and the room was spinning and I had a headache. I had nausea at the time.  I was unsteady for about 30-60 minutes, until I took Dramamine, which resolved the issue that day.   Then about 24 hours after I received the vaccination, I developed chills and fatigue ( I didn't check by temp).  I have been having vertigo daily and a headache upon waking up in the morning (today is  5 days post vaccination), and today, this was associated with an episode of emesis  without nausea or abdominal pain.  I did not have these issues previously.
Pt is a 21-year-old female who presents as a rapid response from the:  Vaccination clinic. Patient reports that she received her covid vaccine and then  sat in the chair while sitting in the chair waiting out her observation. She  started to feel lightheaded, noted stars, noted everything started to go black  and then slumped over in her chair. According to the nurse/pharmacist that was  there they were able to catch her and slowly side or down so there was no head  injury. She was brought immediately to the emergency room. She reports that she still is feeling dizzy and lightheaded. She denies any chest pain or shortness of breath No feeling of chest tightness or throat tightness No feeling of swelling or throat closing No swelling to her lips or face No rash, urticarial or hives
she has experienced alterations to her menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, DOSE 1; SINGLE), for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "she has experienced alterations to her menstrual cycle". The event "she has experienced alterations to her menstrual cycle" required physician office visit.  Additional information: Reporter's daughter (14yo) received the 2nd dose of the COVID vaccine late July and she has experienced alterations to her menstrual cycle (it gets lighter but it doesn't go away. Pediatrician mentioned that the vaccine was causing this types of alterations in some people. I need to receive information on this regard. I would like to know if this side effect will go away and when.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Muscle  atrophy of upper left arm ( deltoid muscle) in place of two vaccinations Moderna ( 01/14 and 02/11/2021). Noticed 3 months ago, getting bigger and deeper. Atrophy is deep about 7-8 mm, and big as 3 x2 cm. Very visible. No pain , but occasionally mild burning sensation.
Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort
patient with complaints of ulnar nerve neuropathy - patient with tingling of the entire left hand and pain difficulty with gripping.  cold sensation.
States arm hurt - stinging at site within 3 hours of vaccinations. Continued to worsen in pain, noticed pinkish color at site. Progressively got worse over next 5 days at which time client went to local ER - given pill to swallow and script for Benadryl. Called us on 12/1 and interviewed on 12/2. Arm improved as of today.
Initial report received from a health care professional on 10 February 2012. A female patient (age not reported) received an injection of DIPHTHERIA AND TETANUS TOXOIDS (manufacturer and lot number not reported) on an unknown date 17-years-ago and an unspecified amount of time later, stopped breathing. No additional information was available. The outcome was not reported. Documents held by sender: None.
Fluid shift developed under nerve cluster in high part of left shoulder, neck. Lots of pain. Increased BP. Hospitalization. Arm sling.
2 days after shots given, symptoms reported by patient at site of injection: red, painful, tenderness and sensitive tissue at underarm areas.
A lump appeared shortly after the vaccination was given and remained for six weeks.  After this time the lump started to decline and pain in the arm started.  This pain ran all the way down my arm to my fingers from the injection site.  At times the pain is unbearable and requires that I take Tylenol and put on a Lidocaine 1% patch.
During a review of the Health Dept. internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Janssen COVID-19 Vaccine EUA  Rash all over the body. Burning sensation we skin is pinched or moved.
Sore muscle at injection site from time of injection thru 01-07-2021 Congested sinuses  morning of 01-06-2021 thru present (01-12-2021) Sore throat  morning of 01-06-2021 thru 01-07-2021 Fatigue 01-06-2021 Sore joints 01-06-2021 thru 01-07-2021
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 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6201), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FE3184), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunization. The patient's relevant medical history included: "restless leg syndrome" (unspecified if ongoing); "Known allergies: yes - sulfa drugs" (unspecified if ongoing), notes: Known allergies: yes - sulfa drugs; "Known allergies: shrimp" (unspecified if ongoing), notes: Known allergies: shrimp; "Known allergies: yes - kiwi fruit" (unspecified if ongoing), notes: Known allergies: yes - kiwi fruit; "Known allergies: yes - hazelnuts" (unspecified if ongoing), notes: Known allergies: yes - hazelnuts; "Known allergies: yes - gluten" (unspecified if ongoing), notes: Known allergies: yes - gluten. Concomitant medication(s) included: PRAMIPEXOLE, start date: 01Jan2005, stop date: Feb2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 4 months 23 days 6 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
SMALL BALLS IN SKULL AND SCALP/ BLOOD CLOTS/HEADACHE (8-9/10); NOSE BLEED; FEELING UNWELL; FEVER; HEADACHE (3/10); This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes for three years and was on pill medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20GA21A, and expiry: UNKNOWN) 1 total dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the patient has not felt well since vaccination and had fever that broke within days. The patient experienced constant headache on a pain scale of 3 out 10 and was taking analgesics for three months but headache got worsened and never got better. On 19-OCT-2021 and 20-OCT-2021, the patient had nose bleed and visited emergency room on 21-OCT-2021. On 21-OCT-2021, the patient had severe headache on forehead with a pain scale of 8-9 out of 10. On the same day, the patient got Computerised tomogram which showed small blood balls in skull and scalp. The ER doctors referred the patient to neurology center, where he got admitted and had tomography done along with other exams. Chiropractors monitored the patient for stroke which was ruled out. The patient developed neck pressure at hospital but doctors disregarded and explained it was a part of symptoms and did not treat it. The doctors wanted the patient to have chiropractor check and will go to primary care tonight. The patient was hospitalized for four days and discharged on 24-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 21-OCT-2021, and fever, and had not recovered from feeling unwell, small balls in skull and scalp/ blood clots/headache (8-9/10), and headache (3/10). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211052851-COVID-19 VACCINE AD26.COV2.S- Small balls in skull and scalp/ blood clots/headache (8-9/10), Nose bleed . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Small raised rashes appeared about 1 week after the vaccine. Size about 3mm in diameter, red edges, top of rash skin tone color. Rashes did not itch, and resolved in about 2 weeks. There were about 5 rashes in total, on arms.
Patient was given 2 doses of Pfizer and a Fluarix in error - should have only received Pfizer and Fluarix.    Patient stated no adverse effects when I called on 11/15/21.  He stated his reaction was similar to the reaction for first 2 doses of Pfizer.
Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023; No adverse event; a bivalent dose was administered which was beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a bivalent dose was administered which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, 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 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a bivalent dose was administered which was beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a bivalent dose was administered which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) 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 (a bivalent dose was administered which was beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023).    No concomitant medications were reported. Date vial was initially stored in the refrigerator: 13-Jan-2023 No treatment medications were reported.
Information has been received from a nurse referring to multiple unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot number and expiration were: L026407/15-JUL-2017, L008272/11-MAR-2017, L016124/06-MAY-2017). No adverse effects reported. The temperature excursion was 6.8 degree Fahrenheit for 45 minutes. There was no previous temperature excursion. This report was for data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Had body aches, sore arm and fatigue the night of vaccine. Woke up following morning and had 100.5 fever, sweats, body aches and fatigue. These lasted all day and were the worst that night. Temp was 101.6 before bed on Thursday after taking 600mg ibuprofen an hour beforehand.  Throughout sleeping I had the sweats and woke up soaking wet and freezing. Side effects have lessened today and fever is down to 99.7 .  Still feeling fatigued. Bpdy aches and sweats have lessened.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 33-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included 1st dose of hepatitis B vaccine recombinant (manufacturer unspecified) given on an unspecified date. Concurrent vaccination included influenza vaccine 2011-12 season (manufacturer unspecified) given on 14 November 2011. On 14 November 2011 the subject received 2nd dose of hepatitis B vaccine administered as ENGERIX B at 1.0 ml in the left deltoid. On 14 November 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site pain. At the of reporting the event was improved. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
Red splotchy rash from neck to tailbone and also from chest to waist, not raised but warm to the touch and intermittently itchy. Discovered at 5:30pm on 1/21, front rash has diminished as of 8am 1/22 but is still present. No fever
the coach for the basketball team at got two doses of the Pfizer Covid 19 and tested positive for Covid 19; the coach for the basketball team got two doses of the Pfizer Covid 19 and tested positive for Covid 19; This is a spontaneous report from a contactable other hcp. A 64-years-old male patient received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE covid-19 immunisation. Medical history included dizziness (subsided) from an unknown date and unknown if ongoing on in unspecified date in Oct 2020 stroke and bleeding on the brain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took warfarin for blood clotting disorder. The patient previously took rabies vaccine on an unspecified date in Jul 2020, for rabies immunisation and experienced arms and legs were wea (subsided) and hypersensitivity/ eczema psoriasis. The patient experienced the coach for the basketball team got two doses of the Pfizer covid 19 and tested positive for covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date got two doses of the Pfizer Covid 19 and tested positive for Covid 19 and international normalised ratio: 3,5 on an unspecified date still threw a clot. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2.
Pt was seen on 6/25/03 for well child exam. At that time pt was given DTaP in right thigh. Seen again on 6/27/03 for cellulitis and immunization reaction to DTaP. Had a 24.5 cm x 16.5 cm warm and pink area where shot was given.
This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a certified medical assistant concerning a 19 year old female with a mold allergy who on 13-Dec-2006 was vaccinated IM into the left deltoid with a 0.5 ml dose of Gardasil vaccine (yeast) (lot# 654540/0800F). Concomitant therapy included Advair, Allegra, montelukast sodium, Ortho-Tri-Cyclen Lo and Lexapro. Illness at the time of vaccination included a cold. On 13-Dec-2006 the patient experienced a fever of 101.4 degrees F, head pain, neck pain and swollen glands. Her fever decreased to 99.1 degrees F. On 14-Dec-2006, she called the office to report these events. The patient was seen in the office and was diagnosed with sinusitis and the doctor said it was not related to the vaccine. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Information has been received on 03-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 27-AUG-2014, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about July 2015, the patient was treated at an urgent care for shingles.As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
I was fine the first and second day. On Sunday morning I was in pain. I had body aches. I could not do anything. I went to the emergency room that morning because I was not feeling well. They did a Covid test, which came back negative. They gave me a shot of steroids for the pain. They did not prescribe any medications. I had the second shot on 08/10/2021 and I just had a swollen arm for about a week.
On January 26 2021, I got my second vaccine and My harm was sore. when I got home I just take Tylenol before I went to sleep. On January 27, I wake up with a little of body pain , but I came to work, then about 08.30 I start having chills and by body start hurting a little bit more, by 0930 the symptoms start getting worse, I start chills, feverish feeling and my body aches. seems the symptoms was getting worse , so I went home and take more Tylenol and rest.
Nonbloody diarrhea for 2 weeks Labs ordered - Ova & parasite, Yersinia culture, Rotavirus antigen, C Difficile real Time PCR, Giardia Ag, Stool culture, Immunochemical Fecal occult Blood diagnostic
Since I had the tetanus injection, I have had pain in my shoulder.  I have limited range and numbness/weakness, which is often severe.
PT PRESENTED WITH CLASSIC ANAPHYLAXIS SYMPTOMS I.E. RESPIRATORY DISTRESS, HIVES, DIZZINESS, TACHYCARDIA AFTER RECEIVING ADACEL TDAP SHOT IN LEFT ARM AT 0746 ON 25 JULY 08. PT WAS TREATED WITH T1-2 CAP PO Q6H P, BENADRYL INJECTION INTO THIGH, 1TAB PO BID F STOMACH NR
Acute swelling is legs IgE reaction0.02ml and 48 hour delay hypersensitivity was positive.
symptoms: cold sweats, headache, dizziness, light-headed, chills, body aches, drowsiness time course: 24 hrs.
injection but did not reconstitute medicine first/only gave the "diluent"; injection but did not reconstitute medicine first/only gave the "diluent"; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA438A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This age at vaccination was not reported for this case. The nurse reported that a medical assistant administered a patient with Menveo injection but did not reconstitute the medicine first and only gave the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with US2021160396, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160396:Same reporter
Patient received first dose Moderna vaccine on  3/31/2021. Approximately two weeks after receiving the first Moderna vaccine patient states he started to have pain in the lower leg which was not normal. Pain increased to a point that patient seeked care and was evaluated for a blood clot which he was told was "negative" as no clot was initially found. On 4/28/2021 Patient presented to pharmacy to receive second dose. Pharmacist asked how patient tolerated first dose to which he replied he had no issues, so the second dose was administered. AFTER the second dose, patient did state he was seen by a CNP for leg pain but a clot was ruled out. Approximately 3 weeks after the second dose of Moderna vaccine the patients leg pain increased to a point that he presented to the local ER and it was determined at that visit that he did indeed have a large blood clot in the leg and a second smaller clot in the upper thigh. He was sent home on Eliquis. He subsequently presented to another ER approximately one week later for uncontrolled leg pain due to massive size of blood clot in leg. At this point, patient is at home recovering.