chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Oct2021 13:15 (Lot number: FE3590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), administered in arm right, administration date 09Oct2021 (Lot number: 312834) as dose 1, single. Relevant medical history included: "Barrets" (unspecified if ongoing), notes: Barrets; "COPD" (unspecified if ongoing); "HBP" (unspecified if ongoing); "HDL" (unspecified if ongoing); "Melonoma of nose" (unspecified if ongoing), notes: Melonoma of nose; "Melignant Carcinoid Tumor lung" (unspecified if ongoing), notes: Melignant Carcinoid Tumor lung; "Diabetes 2" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Augmentine, reaction(s): "Known allergies: Augmentine", notes: Known allergies: Augmentine. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 01Feb2021, for Covid-19 immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 2, Batch/Lot No: En6202, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Oct2021 01:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "achy"; HEADACHE (non-serious) with onset 10Oct2021 01:00, outcome "recovered with sequelae", described as "headache; pain in back of head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, pyrexia, chills, pain, headache.Additional information: No, the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Yes, patient received other medications the patient received within 2 weeks of vaccination. Yes, prior to vaccination, patient diagnosed with COVID-19. No, Since the vaccination, has the patient been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Lost in Daydream (Mental Fog); Lost in Daydream (Mental Fog); Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Change in taste of familiar foods; This is a spontaneous report from a non-contactable nurse (patient). A 39-years-old female patient received bnt162b2 (BNT162B2) (not pregnant), dose 2 administered in Arm Left on 10Sep2021 08:30 (Batch/Lot number was not reported) at age of 39-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic.The patient medical history and the concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received bnt162b2 dose 1 administered in Arm Left on 20Aug2021 13:00 at age of 39-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Lump in left armpit that gradually sent pain and lump into left breast, Change in taste of familiar foods, Lost in Daydream (Mental Fog) on 10Sep2021. The outcome was Resolved with Sequel in Sep2021. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Covid test post vaccination (Nasal Swab): Negative.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Lost in Daydream (Mental Fog) and the administration of the suspect, BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
Information has been received from a registered nurse concerning an 11 year old female who on 02-OCT-1997 was vaccinated SC with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) ( lot number: 622625/0085E). Concomitant therapy included Pediarix, measles-mumps-rubella vaccine (MDS) and Hib conj vaccine (unspecified carrier). On 26-FEB-2008, the patient developed a general rash of 50-500 lesions and a temperature of 103.3. The patient was diagnosed with chickenpox. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought through a phone call. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information from the registered nurse provided no additional information. Additional information is not expected.
Broke out in large red bump outside around armpit on left side. Lasted about 4 days. Treated with Hydrocortisone cream.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Severe, Systemic: Weakness-Mild
Right upper arm 15 by 20 cm erythematous area to elbow, no induration to observe.  Call if it does not resolve.
This spontaneous report as received from a pharmacist refers to her husband approximately 40 years of age who was also a physician with hypertension, type 2 diabetes and hypothyroidism. On an unknown date in 1992(reported as in early 1992), the patient was vaccinated with a first dose of RECOMBIVAX HB(Lot number, expiry date, route and dose were not reported). Concomitant therapies included COREG, DIOVAN, HCTZ, metformin, JANUVIA, LIPITOR, SYNTHROID and CYTOMEL. On an unknown date in 1992(reported as fall of 1992), the patient had his titer's drawn for Hepatitis B which were negative and the treatment was two more doses of RECOMBIVAX HB(Lot number, expiry date and dose were not reported)which were given intradermally. Again, on unspecified dates, her husband's titer's were negative each of which were followed up with one more dose of RECOMBIVAX HB(Lot number, expiry dater, route and dose were not reported). The patient had sought medical attention for the events (details unspecified). Approximately on an unknown date in 1992, the initially occurred negative titers was resolved and on an unspecified date, the negative titers which occurred for the second time was resolved. Additional information is not expected.
Intramuscular route was administered as other (subcutaneous); Injection site was 3&1/2" above her elbow in the back of her arm; A spontaneous report was received from a type concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was 3 and 1/2 above her elbow in the back of her arm(injection site swelling) and incorrect route of product administration via subcutaneous route.  The patient's medical history was not provided. Concomitant medications was not reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: 032L20A) subcutaneously in left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced injection site was 3 and 1/2 above her elbow in the back of her arm and administered subcutaneously.  No treatment details was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of injection site was 3 and 1/2  above her elbowin the back of her arm was unknown and intramuscular route administered as other (subcutaneous) was recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with reported event of injection site swelling.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown 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 an unknown date, 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 an unknown date, the patient experienced PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No relevant concomitant medications were reported. No treatment medication reported.  This case was for the 16th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:  CASE
Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 3 (BOOSTER), Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 23Sep2023 tp 27Sep2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19 and suspect product.
NO ADVERSE REACTYIKON WHATSOEVER!!  Exp date of vaccine was 03/19/2022
Breakthrough case admission after 4 vaccines Pfizer 1/22/21 Lot# EL3248;  Pfizer 2/12/21 Lot# EM9810;  Pfizer 11/17/21 Lot# FF2590;  Pfizer 5/21/22 Lot # FP4554
After receiving the first dose of SHINGRIX, the patient developed a mild case of shingles above her right eye approximately 1 month after immunization. The patient was evaluated by her doctor and was given Valtrex. The patient is still having symptoms of the shingles today on 5/27/18.
9-6-10 at 1530 called triage & spoke to nurse regarding pain, redness and swelling at site of DTAP. Adv ER 9-6-10 at 1821 went to hospital ER  (L) thigh 6 cm x 5 cm upper lateral portion of erythema. Induration 2 cm x 2 cm. Dx: skin infection, localized reaction to vaccine. Put on cephalexin 250mg 9/9 called office to update 9/17 pt well.
PT MAY NOT HAVE RECEIVED IMMUNIZATION UPON INITIAL INJECTION. SYRINGE MAY HAVE BEEN EMPTY. TO ENSURE PT TRULY RECEIVED IMMUNZATION, THE VACCINE WAS READMINISTERED IN OTHER ARM.
"wasn't feeling well after the vaccination"; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 'wasn't feeling well after the vaccination'/feeling abnormal.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced 'wasn't feeling well after the vaccination'/feeling abnormal.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of 'wasn't feeling well after the vaccination'/feeling abnormal was unknown.
Patient received a Janssen shot on 7/1/21 around 9:45 AM. After the shot, he stood in the line for the pharmacy and he said he suddenly feels very light headed and almost fainted after getting a shot. I provided a water and told him to get rested on the chair and check up on him every 5 minutes to make sure he is alright. He said he had allergic (anaphylaxis) reaction  in the past and he said he usually does not get vaccinated yearly (flu etc) and the most recent vaccine that he received was the tetanus shot in 4-6 years ago. He said he feels fine (no rash/no more cold sweat) after resting about 20 minutes on the chair and told him to stay around 10 more minutes. Before he left the pharmacy(30 minutes after the shot), I told him if he feels any allergic reaction coming through, go to nearest emergency room/hospital.
tested positive greater than 14 days after fully vacinated tested positive greater than 14 days after fully vacinated
18 HOURS POST VACCINATION HAD CHILLS AND BODY ACHES FOR APPROXIMATELY 24 HOURS.
7/26 - LA slightly red around inj site of Tdap since then - lacy rash 4" around site w/ small 1" area many 4" down arm (+) itch pain - 5 saw MD 2/28/12 (+) local reaction.
Swollen lips, itchy throat, hives.  Received treatment in ER as he had already left our office.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.            No concomitant and treatment medications were provided  Caller was a liver transplant recipient.  He wanted to know the timing of when he should get the 3rd dose booster.  The caller also stated everyone else in the house has had COVID and agent assumed they have had the vaccinations.      The caller stated he also has another daughter who tested positive for COVID after receiving both doses of the Moderna vaccine.   Reporter did not allow further contact
NAUSEA, BODY ACHES, MALAISE, REDNESS, SWELLING  AND PAIN IN SIDE OF REACTION.
Immediately after administration of Tdap, experienced left neck stiffness and tightness that lasted for 4 days. Gradually less stiff/tight over time. Continues intermittent "tightness" with neck rotation to the left side. Also stated "bulls eye" rash noted on left neck the day after vaccine administration.
Acute non occlusive thrombus of common femoral and iliac vein in left leg
Recurring pain around left eye. Probably sinus pain or migraine rather than true eye pain. Maybe be related to the walk to and from the clinic, exposure to strobe lights en route, etc.
Mild headache, nausea, low grade fever, and severe injection site swelling and redness.
ground level fall - admit for ORIF, had preop +COVID, 3L O2, denies SOB or other COVID symptoms. hgb 5.4 - blood transfusion; transfer to rehab; no meds given for Covid
I began having headaches in March that I can recall.  They began as mild occasional headaches that I described as waves and/or stabs of pain all over my head, unlike any headache I've ever had.  These headaches progressively worsened to the point of being debilitating  and with associated numbness, fatigue, and exhaustion.  In May I saw my PCP and eventually had 2 Emergency Room visits for unbearable pain and a 7 day Inpatient stay for pain control and full neurological evaluation.   Eventually my neurologist prescribed a tapering dose of prednisone which thus far seems to be successful.
MILD COLD LIKE SYMPTOMS. MILD SORE THROAT, FATIGUR, MILD MUSCLE ACHES, MILD CONGESTION
patient received the Havrix that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's Comments: The health care professional reported that a dose of Havrix was given to the patient and it was already expired. No reactions reported.  The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up by email. Additional supportive information: The patient received Havrix dose which was already expired, which led to expired vaccine used.
Initial information received on 31/Aug/2006 from a company representative.  This information was reported in the context of a litigation case, and the initial information was reported by a health care professional. A 31 year old male patient received a second dose of Imovax Rabies, lot number W1275 (invalid lot number) on 14/Apr/2004, as part of post-exposure prophylaxis following a bat bite on the patient's left middle finger. It was not reported whether the bat was tested for rabies. On 19/Apr/2004, the patient reported that he had been experiencing "jaw chattering" since receiving the dose on 14/Apr/2006. There was no mention of the patient being treated for the symptoms. It was not reported whether the patient continued with the rabies series or whether he recovered from the event. This patient experienced a previous adverse event of "shakes" following the administration of the first dose of Imovax Rabies which is reported in case 2006-02315.
On 11/05/2021, the day after receiving my vaccine, I would get dizzy when I would stand up. If I sat down, it would stop but when I stood up, I would get dizzy and felt like I would pass out. I attempted to go to work on the third day after my vaccine but had to come home from work. The dizziness lasted for around a full week.
IT STARTED OUT WITH A SORE THROAT & NOW HE HAS A RUNNY NOSE & CONGESTION I TOOK HIM TO DR & HE TESTED POSITIVE FOR COVID 01/08/2022
-Severe headache, that caused blurred and blacked out vision whenever head was moved. Also included stabbing pain in ears as well as behind eyes. -severe diarrhea and nausea. Diarrhea and stomach cramps occured after anything was eaten or drunk (besides water) for 48 hours -fever between 101 and 102.3 for nearly 48 hours after vaccine.
Ongoing episodes of cold sweats, dizziness , fatigue ever since getting my 2 dose
Patient received the vaccine and about 10 min or so waiting in the chair she approached the counter saying she felt itchy all over her body and dizzy. She was provided with liquid Benadryl 25 mg at 4:50 PM and observed she continue with the itchiness so I gave her a second dose 25 mg at 5:17 PM. After a few minutes she started to feel better, itchiness and dizziness disappeared. Advice patient to go to hospital if symptoms come back or get worse.
Experienced shortness of breath upon minimal exertion 24 hours after having receieved the vaccine. Called MD 72 hours vaccine received - MD advised hospital ER. Admitted with pulmonary embolism and deep vein thrombosis. Remains short of breath and is on 4L of oxygen. Receiving anti-coagulants.
12 hrs after receiving vaccine, fever 101, chills, muscle aches, nausea, fatigue, dizziness. 2 days later developed cellulitis in right arm, swelling, erythema, tender, swollen, streaks. Took Cipro herself to relieved symptoms x 3 days.
Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.
myocarditis and pericarditis Afib  pericardial window  cardioversion