chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breakthrough Covid infection; breakthrough Covid infection; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Oct2021 (Batch/Lot number: unknown) as dose 3 (booster),single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 01Jan2021, for COVID-19 immunisation; Bnt162b2 (Dose number:2, after receiving Pfizer primary series and booster. Vaccines received 01Jan2021, 11Feb2021, and 09Oct2021.), administration date: 11Feb2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough Covid infection"; IMMUNISATION (medically significant) with onset 09Oct2021, outcome "unknown", described as "booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt stated when he was leaving pharmacy he felt a little light headed, so after he developed chest pain and difficulty breathing.  Overnight patient experienced a neurological pain in throughout his back from top to bottom.  The following morning the chest pain continued, and pt began gasping for air, at which point he called 911.  In ER pt received oxygen and morphine, was released after 5 hours with instructions to follow up with cardiologist for stress test.
For the seven days immediately after the second COVID 19 vaccine shot on 5/18/2021, I felt great fatigue and general flu symptoms, including feverish spells of night sweats sever body aches. I also experienced a constant tension stomach ache starting two days after the shot and lasting for five full days. The most significant problem started on 6/15/2021, when the two lymph nodes in my right neck started to swell. By the evening of 6/17/2021, the pain and discomfort was bad enough that I went to Urgent Care. The doctor examined my nodes, throat, ears, and sinuses; he said he could not find anything wrong, but that the nodes situation was odd. He told me to monitor the situation take Tylenol. On 6/25/2021, I saw my Primary Care doctor. She was worried and prescribed Augmentin for seven days. The seven day course of Augmentin did nothing. By 7/2/2021, the nodes had only further enlarged and hardened to where I was in great pain (frequent sharp pains all around the nodes, which were very tender to the touch). I saw Dr. that morning; she ordered me to the Emergency Department. I checked in at the hospital; the doctors ordered a CT scan, which indicated sever inflammation and necrotic tissue of the two neck right side lymph nodes, as well as inflammation of the left neck side lymph node. The ED doctors scheduled an appointment for me with an ENT doctor, on 7/7/2021. Dr. examined me and determined the area needed to be biopsied. He prescribed Hydrocodone 5mg for the searing and unrelenting pain. The biopsy surgery took place on 7/13/2021. Dr. continued the Hydrocodone at 10mg for pain following the surgery. Dr.  received the pathology report on 7/23/2021 and has referred me to an Infectious Disease doctor for further review. I am recovering from the surgical wound, but otherwise, the remaining lymph nodes have not lessened or healed. They remain hardened and painful in my neck.
Started with mild pain at the injection site. As the evening progressed so did the pain to a medium level. When I went to bed I developed chills and uncontrollable shivering for about 1 to 2 minutes. I remained extremely chilled throughout the night despite a heating blanket and several thick blankets over me. I developed a severe headache that lasted until the next day. My joints were extremely painful as well. I didn?t sleep much.
FREEZING FOR ABOUT 2 HOURS THEN SWEATED FOR ABOUT2 HOURS....BAD HEADACHE AND NAUSEA...AND VERY TIRED LASTED ABOUT 24 HOURS TOTAL
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 12:00 in the afternoon, the reporter gave a double dose of FluMist to a 41 year old female pt whose medical history was not reported. The reporter stated the pt had no adverse events. No further information is available.
RT ARM 16X11CM LOCAL REACTION.  VACCINE GIVEN ON AUGUST 14TH, SYMPTOMS OF ITCHING AND SWELLING BEGAN THE EVENING OF 14TH OF AUGUST.
pt recvd vax 25APR91 & 19APR93 MD dx the pt w/mumps; No further details were provided;
Severe Swelling, pain, itching left arm, 1 week after vaccine, itching and swelling better within 3-4 days , some pain remains at injection sight.
Monovalent covid vaccine administered as bivalent, pt. notified and advised to repeat bivalent booster => 2 months
Monomorphous erythematous papules to (L) side of body. Unilateral thoracic exanthema of childhood. As well as fever of 101-102 degrees.
Uncontrollable diarrhea for 15+ days, turns into constipation.
Patient was sitting after receiving the vaccine. The patient had a hairy arm and the inject safe bandage had come up from the skin on one side. The injection site had some bleeding and the patient looked over and passed out at the sight of blood about 5 minutes after receiving the vaccine. The pharmacist went over and rolled the patient over and he regained consciousness immediately. After talking to the patient to make sure they were alert and ok they had patient slowly sit up and eventually sit in a chair. Paramedics also came and patient denied going with them to the ER. The patient remained sitting until they had his girl friend pick him up.
Evening of vaccine date client had tactile fever, body aches, pain and swelling at site of injection. Fever and body pain continued for three days, after which client gradually began to feel better.
red arm, swollen lymph gland right arm,  golf ball size, warm to touch, started 2 days after administration,  subsided 4 days after start date.  patient stated he experienced a burning sensation in lower abdomen area, kidney area.
7 days after my first vaccine my arm got swollen, a little tender and itchy.  I had the typical sore arm immediately after the injection for about 48 hours and it went away.
severe fatigue; headache; joint pain; nausea; vomiting; chills; sweats; low grade temp 100; This is a spontaneous report from a contactable other healthcare professional (patient).   A 47-year-old adult female patient (Non pregnant) received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration at left arm, on 20Feb2021 at 06:30 PM (age at vaccination: 47 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes controlled high blood pressure. Patient was allergy to Cephalosporin and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication included Amlodipine 5mg daily. 24 hours after getting vaccine, On 21Feb2021 05:30 PM, the patient had experienced severe fatigue, headache, joint pain, nausea and vomiting, chills, sweats and low grade temp 100-symptoms still present. On 02Mar2021, the patient had laboratory investigations on nasal swab rapid test and nasal swab PCR which test results negative. On 04Mar2021, the patient had nasal swab rapid test and nasal swab PCR test result negative. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient had shooting pain up from her shoulder to her neck, very severe headache and patient experienced auditory musical sound that kept playing over that only patient could hear that others could not hear.
On 01 Apr 08 he was vaccinated with Hep A # 2, and TdaP. He denied any immediate problems with vaccination. Approx a couple of weeks later he started to develop lesions on his body and was diagnosed by a  dermatologist as having leukocytoclastic vasculitis. Records of this visit are not available. Since that time he has had recurrent lesions with subsequent evaluations by allergy, dermatology, and rheumatology. His current diagnosis is chronic, cutaneous, ANCA negative, small vessel vasculitis associated with mildly low C3 level, without signs of systemic involvement. Other that an influenza vaccine in Oct 08, without worsening of symptoms, he was received no other immunizations.
On 4-15-2021 about 3 1/2 hours after vaccine I had a pins and needles sensation in my right neck and shoulder, this continued then on 4-16-2021 I was woken from sleeping by pain in both legs and feet along with an electric feeling radiating down my legs. I slept on and off that night after taking advil. I woke in the late morning and as I was getting out of bed I couldn't walk normal with balance and stability issues no vertigo or dizziness. I was extremely fatigued that day with walking instabality and balance problems ever since.In March of  2022 I started slurring words which has continued to this day along with other symptoms.
Mild to severe nausea, on and off, from around 7/25 until 8/18. No other symptoms (no fever, no diarrhea, etc - only nausea).
pt claimed neg hx of vax reaction in past; NKA; c/o t103.9 po 6 hrs p/vax adm; c/o body aches, nausea, tiredness; no rash or swelling; had crying jag next morning several hrs; then fever broke & felt well;
PROBLEMS IN BOWEL AREA; BODY ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced problems in bowel area. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, problems in bowel area and fatigue was not reported. This report was non-serious.
CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and fatigue was not reported. This report was non-serious.
Pt did not seroconvert p/ 3 doses of Engerix-B  vax.
Initial unsolicited report received from a consumer via nurse on 31-Jan-2017. This case involves a female patient (age not reported), who was vaccinated with a dose of DIPHTHERIA AND TETANUS (batch number, expiry date, dose, route and dose in series not reported) on an unknown date. Patient had a medical history of multiple sclerosis for which patient was taking AUBAGIO orally since 29-Dec-2016 as concomitant medication. On an unspecified date after the vaccination, patient had developed cellulitis on left side and tennis elbow on right side. Lab test was not reported. Corrective treatment included ten day course of antibiotics which was completed by patient. Outcome of the events was reported as unknown. Upon internal review the case was considered as serious because of important medical events: cellulitis on left side and tennis elbow on right side. Documents held by sender: none. Sender's Comments: This case concerns an unknown age female with history of multiple sclerosis (MS) was on AUBAGIO, who received DIPHTHERIA AND TETANUS TOXOIDS and experienced cellulitis on left side and tennis elbow on right side. Time to onset is unknown. However details regarding relevant medical history, prior vaccination history and its tolerance, patient demographics, diameter of the cellulitis are needed for complete assessment of the case.
Patient previously received 1 dose of Pfizer vaccine (2/10/2021-lot EM9809). Facility spoke to prescriber since the Pfizer dose was not available for the resident. Prescriber advised them to administer the Moderna vaccine as the second dose.
Pt recv vax on 8/26/97; in 9/97 pt exp headaches, vomiting & loose stools.
possibly recieved a third singrix injection; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th April 2019) and Shingrix (received 2nd dose on 12th August 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. In January 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. After getting the first 2 doses, the patient seemed to had possibly received a 3rd dose of Shingrix from another pharmacy which led to extra dose administered and had not noticed any issues till the time of reporting.
left eye started to puff up; left eye blurry; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN AND POLYMYXIN B SULF & DEXAMETH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIORBITAL SWELLING (left eye started to puff up) and VISION BLURRED (left eye blurry) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-034778 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded MOD-2021-034778:Case for 2nd dose of vaccine
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1130 with symptom onset at 1135. Pt reported numbness in arm and shoulder of injected site (left), which progressed to the tip of her tongue and lips with a tingling sensation. Benadryl 25mg PO administered at 1155. Symptoms resolved after further observation.
heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 33 years old and unknown gender patient who experienced heart problems while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation and expiry date was unknown) via unknown route in unknown administration site.  On an unknown date the patient developed a serious event "heart problems "(cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported" 33-year-old had to be replaced in a game due to heart problems Separate case has been created for each patient It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart problems).  At time of reporting, the outcome was Unknown for the event heart problems.; Sender's Comments: Sanofi company comment dated 08-Feb-2022: This case involves a 33 years old and unknown gender patient who experienced heart problems while receiving vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored VAQTA (0.5 ml, lot # was reported as K010195, expiration date was reported as 15-JAN-2016, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
immed p/vax pt c/o nausea while walking to waiting room; pt states could not see & felt weak & sat on the floor; 2 mins later was fine; BP 110/70;
10 minutes after receiving the vaccine, I looked at the clock and remembered thinking "Wow.  I'm really tired." I also remembered I only have 5 minutes left to sit here. The last thing I remember is someone tapping on me and shouting asking if I was okay. I had been unresponsive for about 30 seconds. A lady that was watching me said my eyes went shut and my chin hit my chest as I was talking to her. They called an ambulance and my initial blood pressure was 70/40. I was transported to the ER and was given IV fluids. They did bloodwork but nothing showed anything. The doctors don't know why the vaccine dropped my blood pressure and caused me to be unresponsive. Ever since the vaccine I have battled with extreme tiredness.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 13-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012733 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Dizziness, muffled/hissing  sound in ears, heart palpitations
This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.
Swollen armpit (lymph nodes) in right arm (received shot in right arm). Noticed 36 hours after covid booster.  Large swollen area - about the size of tennis ball in armpit. Tender. Swollen area has not decreased.