chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flutterings in my chest periodically; Right arm injection site pain; This is a spontaneous report from a contactable other HCP. A 29-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 08Oct2021 at 08:30 (Batch/Lot Number: FF2589) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included obesity, known allergies: raw fruits and known allergies: vegetables. The patient received initial dose of BNT162B2 on 17Sep2021 (Dose number: 1, Lot number: FF2588, Administration time: 08:30 AM, location: Right arm) and reported Muscle/body aches from the bottom of my ribcage to the base of my neck and Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest. Concomitant medication included dextroamphetamine hydrochloride (DEXTROAMPHETAMINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sodium benzoate and experienced drug hypersensitivity (Known allergies: sodium benzoate). The patient experienced fluttering in my chest periodically and right arm injection site pain on unspecified dates. The patient reported Right arm injection site pain was present to date of 2nd dose/ 3 weeks and I experience fluttering in my chest periodically which were not present prior to receiving this vaccine. No treatments was received for the events. Outcome of the events was recovered with sequelae.; Sender's Comments: Based on the available information,. the contributory role of the suspect product BNT162B2 (BNT162B2) to reported Cardiac flutter is possibly related. Case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202101346039 same patient/reporter/drug, different dose/Event
Patient developed severe itching, redness and warmth as well as mild urticaria at site of vaccine administration - deltoid area of left upper arm approximately 10 x 16 cm also itching up thigh with no rash.
Information has been received from a healthcare worker concerning a currently 23 year old male patient whose mother was a non-responder to Hepatitis B vaccination (unspecified). On 17-AUG-1995, 09-OCT-1995 and on 27-AUG-1996, the patient was vaccinated with the first, second and third doses of RECOMBIVAX HB (manufacturer unspecified). Subsequently, on an unspecified date, the patient tested negative for Hepatitis B antibodies after these first series. Then, the patient was vaccinated with the second series which consisted of 3 pediatric doses of RECOMBIVAX HB, two each, to total 1.0 mL solution on the following dates: 20-AUG-2010 (Lot # 0438Y) thimerosal free, 10-JUN-2010 (Lot # 0438Y) thimerosal free and 20-OCT-2010 (Lot # 666188/1491Y) thimerosal free, respectively. The patient had not been tested for Hepatitis antibody titers after this second series. At the time of the report the patient's outcome was not specified. The patient sought unspecified medical attention. Additional information has been requested.
I received the vaccine on 1/21/21. On 1/28/21 I noticed some itching in the area, though I did not check it. On 1/29/21 the itching became more persistent. When I looked at my arm, I had a red, slightly raised oblong rash encircling the injection site.
presented to ED the evening of 1/3/2020 with fever of 101.6. Diagnosed with a simple Febrile seizure
C/o tingling, redness, itching in neck, jaw, facial area when she returned home. States is allergic to latex. All supplies latex free. Took 1 Bendaryl & symptoms subsided.
Constant headache, fatigue, brain fog, dizziness, orthostatic intolerance, anorexia, poor sleep. Diagnosed with POTS Feb 19, 2015.
swelling on his arm; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Sanofi (manufacturer report number 2021SA156335). A 27-year-old male patient received BNT162B2 (COMIRNATY, Lot unknown, second dose) solution for injection intramuscular in May2021 (at the age of 27-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included efmoroctocog alfa (ELOCTATE) at 4536 iU via intravascular route and 4500 iU. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Apr2021 and caused a bleed to the left arm and arm was still sore at site. The patient received Pfizer Covid Vaccine in the second week in May2021; he said he sustained some swelling on his arm on 22May2021 and he infused (efmoroctocog alfa) twice after to treat the swelling. The outcome of the event swelling on his arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have never had any type of heart palpitation before.  I have also never had any heart trouble nor high blood pressure or anything of the sort.   The only sort of health condition I have is some varicose veins from prior pregnancies.     But about 3 days after the vaccine I was sitting on the floor and suddenly my heart started going crazy.  It was beating way faster than if i had suddenly over exerted.   I have never felt it beat so fast before.    I looked down and my whole chest was vibrating.   It felt like a lump was in my throat.  It was pretty scary.    I don:t know what the rate got up to.  It took me awhile to find something to measure it with and it had calmed down some by then but it still registered 140 bpm.  My rate is usually around 75bpm and I was doing nothing but just sitting on the floor when it happened.   It only lasted a few minutes, but my left arm ached a few more days and my heart seemed like it was beating stronger than normal for about 2 weeks (but when I checked it pulse rate and pressure were normal).   That was the only time it happened.  Otherwise i just had a sore arm and a headache for about 2 days.
Covid arm - itchy red rash developed on day 8 following vaccination. Swollen around the injection site. Still slightly itchy and red 5 days after showing up.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II [lot # K009192, Exp. date 27-JUN-2016] subcutaneously; dose, dose number and anatomical location were not provided. No adverse effects were reported. A product quality complaint was not involved. The outcome of product use issue was unknown. Additional information has been requested.
Reported by gdmom-primary (sole) caregiver; cold & cough since 10SEP; 14SEP vomiting, fever but no reading; 15SEP hive-like (welts) on neck, ears, abd, legs; itching; ear swelling & hot; 17SEP adm to hosp;
UPPER LEFT THIGH FELT LIKE HE HAD PULLED OR STRAINED A MUSCLE; REDDISH RASH ON THE CHEST AND BACK; HORRIBLE HIVES OUTBREAK (MASSIVE PATCHES OF HIVES ON YOUR STOMACH, BACK, ARMS, KNEES, UPPER THIGHS, HEAD, NECK, HANDS, FEET, RING FINGER IS SWOLLEN, PALM OF BOTH HANDS); This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, egg allergies, seasonal allergies, and eczema. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced reddish rash on the chest and back. On 08-AUG-2021, the patient experienced horrible hives outbreak (massive patches of hives on your stomach, back, arms, knees, upper thighs, head, neck, hands, feet, ring finger is swollen, palm of both hands). On 29-AUG-2021, the patient experienced upper left thigh felt like he had pulled or strained a muscle. On SEP-2021, treatment medications included: methylprednisolone. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) normal. Additional treatment medications (dates unspecified) included: famotidine, cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible hives outbreak (massive patches of hives on your stomach, back, arms, knees, upper thighs, head, neck, hands, feet, ring finger is swollen, palm of both hands), and reddish rash on the chest and back, and the outcome of upper left thigh felt like he had pulled or strained a muscle was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
pt presented to ER in full arrest p/a nap 19MAY98 1 day p/vax;
patient received expired dose of Daptacel, no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 15 months old female patient who received an 0.5 mL fourth dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 03-FEB-2020.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that child received expired dose of Daptacel. Medication expired on 30Jan2020.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
On the evening of the getting vaccine, I had developed a fever and body ache. Symptoms are similar to having the flu. Symptoms got better the following day
Arm has a red big blotch about 4 inches tall and 6 inches wide/Started small quickly grew to 4inch by 6inch patch; Itching; Redness and swelling on left upper arm site of injection; Redness and swelling on left upper arm site of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Arm has a red big blotch about 4 inches tall and 6 inches wide/Started small quickly grew to 4inch by 6inch patch), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness and swelling on left upper arm site of injection) and VACCINATION SITE SWELLING (Redness and swelling on left upper arm site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, GERD and Vitamin D deficiency. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, LEVOTHYROXINE and LIOTHYRONINE for Hypothyroidism, VITAMIN D2 for Vitamin D deficiency, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH MACULAR (Arm has a red big blotch about 4 inches tall and 6 inches wide/Started small quickly grew to 4inch by 6inch patch), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness and swelling on left upper arm site of injection) and VACCINATION SITE SWELLING (Redness and swelling on left upper arm site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (topical) for Adverse event, at a dose of 1 dosage form and BACITRACIN, POLYMYXIN B SULFATE (POLYSPORIN [BACITRACIN;POLYMYXIN B SULFATE]) (topical) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Arm has a red big blotch about 4 inches tall and 6 inches wide/Started small quickly grew to 4inch by 6inch patch), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness and swelling on left upper arm site of injection) and VACCINATION SITE SWELLING (Redness and swelling on left upper arm site of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.           Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Major update in Narrative, Med.History, Action Taken, Con.Meds, Treatment, Events &  Event Assessment  Treatment included Benadryl- A and polysporin.
Starting on Monday evening employee starting feeling tired. Beginning Tuesday morning employee woke up and had "black spots" in vision and also felt lightheaded. Took Tylenol around 8:00am Tuesday morning and had a fever of 100.8 degrees Fahrenheit. Employee states Fever went away around noon on Tuesday. Body aches and headache throughout the day and symptoms continuing until Wednesday morning. Throbbing ache at site of injection. Injection site also swollen and red, warm to the touch.
Myalgia, Fever, chills, breast sensitivity Narrative: 1/19 recieved vaccine 1/20/21 T 100.6 myalgia chill. Went home for the day
Received TDAP in rt upper arm, area very hot, hard, extensive pain and swelling with bruising. Diarrhea started 9/22/2012.
Information has been received from a licensed practical nurse referring to 15 patients of unknown age and gender. No concurrent or historical conditions were reported. The nurse reported that the 15 patients received improperly stored M-M-R II (lot number, dose, frequency and route were not reported) on an unspecified day. Information regarding concomitant medication was not reported. No adverse effects were reported. It was unspecified if the patients sought any medical attention. Additional information has been requested.
Patient was administered a vaccine which was kept in the freezer longer than the 2  week recommended time.
I had no side effects after the first dose. After the second, I ran temperatures up to 102 F, body aches, fatigue, malaise, decreased appetite, headaches for three days. The headaches persisted as well as the fatigue for over two weeks.
Fever of 103 unable to bring down. Change in level of consciousness. 9-19-18 seen in office and level of consciousness much improved.
Engerix B vaccines experienced a freezing temperature excursions; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix B vaccines experienced a freezing temperature excursions). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2023 The nurse reported that Engerix B vaccines experienced a freezing temperature excursions that occurred between 20 September 2023 and 05 October 2023. She believed that there were probably three doses administered after the freezing excursion, which led to incorrect storage of drug. But she had not yet performed an audit so did not have any patient information or dates of administration. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Within 10 minutes developed headache, near syncope, blurred vision, Later that day chest pain, shortness of breath improved over 3 days 2.5-3 weeks later peppery/burning sensation  left side of body, left neck pain and headache  Swelling left upper palate
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-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 VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-344139.
Nausea/diarrhea started soon after.  Later chills, fever of 102, headache, extreme fatigue.  This lasted through the night and into the next day.
nauseous; could not eat nor drink; threw up; dry heaves; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. Medical history included Covid and pneumonia (previously) and had an antibody infusion. The patient's concomitant medications were not reported. The patient received the first dose on 17Mar2021. On 18Mar2021, she experienced side effects that lasted for 2 days. She said she could not get out of bed, felt nauseous, had dry heaves, threw up, and could not eat nor drink. She said she previously had COVID and pneumonia and had an antibody infusion. She wants to know if that was a factor that led her to have these side effects. The patient was told that there is no information whether her history with COVID, and the antibody infusion she received caused the side effects to occur, and to contact her healthcare provider if the side effects continue to bother her. The events resolved on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
2/5/2021:  Bells Palsy 2/11/2021:  Bruising appeared bilaterally on upper chest.  Lump on left side below clavicle.  Pain stated at injection site and bruising appeared.  2/12/2021:  Going to Hospital ER to have blood work and CT scan to rule out thrombocytopenia.
Patient received a pneumonia vaccination subcutaneous on 10/31/10. Patient returned today (11/3/10) and reported arm is sore. Pt's right arm is reddened from 1/2 inch above elbow to 1/2 inch below top of arm. Also she got 2 welps about the size of a dime on arm.
Beyond feeling completely flu-like symptoms x10  I felt overwhelming depressed. No, I felt despair. I have never felt that hopeless just days after vas was onset.. alleviated some, mostly. But today I received dose 2. I?m scared. I can?t take despair a second round. It will be a too.
Pt was evaluated 6 days post/vax & had no rash at that time. Per mother, pt developed rash 4 hrs post/vax (urticarial?).
10/29/21 around 8 pm, started with headache, chills, fever, hurt everywhere, very dry, eyes itched, jaws hurt, neck glands hurt, felt painful to take a deep breath, very weak.  10/30/21 morning had still aches and pains, headache, fever.  Wanted ice water and ate some Ritz crackers and soup for dinner.  These issues continued throughout the day.  On 10/31/21 still had headache, most other symptoms were gone, was able to eat and drink more normally.  still weak throughout the day, walking to the bathroom took everything out of me.  At about 2 p.m., headache disappeared.    11/01/21, woke up with headache, but was better by noonish, felt better, able to do more around the house; however, it was too much, as due to my other health issues, I have more soreness, but issues from the vaccine, I believe, are gone.
Reaction site of injection, red, swollen, cries when touched. Benadryl and Tylenol.
48 hours, post vax, pt had muscle spasms for about 30 minutes. 2-3 days later, had another episode of spasms X 2. 2 months later, muscle feels "weaker" not able to use arm in the same way since injection. Had an injury (very deep wound) in the same arm (barbed wire pierced arm), 2 days before shot. It is an aching pain a of the time and it never seems to go away now.  Had an active life-style before "shot". Pt was referred to the MD of his choice.
Client received pediatric Pfizer dose at age of 13 instead of 12+. Pfizer dose from RN. Client vaccinated at time of second dose with appropriate dose and family and client deny any adverse reaction to pediatric Pfizer dosage.  Coaching on safety measures done with RN.
Patient received flu shot 10/8/15 and reported "cold shaking chills" with full body tremors after receiving flu shot same day. Reports full body shaking tremors started 9:30 or 10:00pm and lasted 45-60 minutes. This is discussed with Dr. Symptoms persisted on and off until 5:00am, tremors described "like a seizure", RN.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (unknown if pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for COVID-19 immunisation; COVID-19 vaccine (manufacturer unknown), 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: "hypothyroid" (unspecified if ongoing); "oral cancer 2013", start date: 2013 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; FLOVENT; SINGULAIR; XYZAL; FLONASE ALLERGY RELIEF; PEPCID AC; OMEPRAZOLE. Past drug history included: Lortab, reaction(s): "Known allergies: lortab". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) positive, notes: Rebound Covid. The patient received Paxlovid from 09Aug2022 to 13Aug2022 for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.