chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination failure; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 at 14:00 as dose 2, single (Lot number: EN6207), in right arm and on 07Sep2021 at 14:00 as dose 3 (booster), single (Lot number: EW0179), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Sep2022 at 13:15 as dose 4 (booster), single (Lot number: A57162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "lung cancer" (unspecified if ongoing); "missing lower lobe of left lung" (not ongoing); "known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT HFA, start date: 04Oct1999; SINGULAIR, start date: 02May2000; VENTOLIN [SALBUTAMOL], start date: 01Dec2000; CBD OEL, start date: 14Mar2017. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022 at 13:15, outcome "not recovered"; VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid (Lot number: GF7893) from 22Mar2023 to 03Apr2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300143827 same patient, different drug/events;
Cold, clammy, loss of vision brief period.  Pale, decreased pulse, decreased blood pressure.
Slight stomach nausea around Noon that Sunday(01/08/2023) & pooped Twice(Highly Irregular, usually Every Other Day); Stronger Stomach nausea Monday(01/09/2023, Day3 After Booster) Morning, nausea Begins to Subside After 2pm, No Other side effects so far
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes and post herpetic neuralgia (but the patient never had episode of Shingles.). Concomitant products included gabapentin. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, nerve pain, tingling of extremity, numbness of upper extremities and skin lesion. On 11th July 2018, the patient experienced skin plaque and erythema of extremities. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the nerve pain, tingling of extremity, numbness of upper extremities, skin plaque and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the shingles, nerve pain, tingling of extremity, numbness of upper extremities, skin plaque, erythema of extremities and skin lesion to be related to SHINGRIX. Additional details were received as follows: The patient was seen by pain Neurologist for potential Shingles outbreak in the past with continued (Postherpetic neuralgia) PHN. The patient reported either PHN or possible diabetic nerve pain in the area of T 7 to T 8 that ran from back to front, this pain was present before receiving a dose of SHINGRIX vaccine. The patient received the SHINGRIX vaccine in the left arm. About 4 or 5 days after SHINGRIX vaccination, the patient noted nerve pain on the opposite side of her left side of injection. Later the patient reported that 4 days after a dose of SHINGRIX vaccine, she woke up in the middle of the night with terrible stinging under her skin, skin lesions. The patient noted, the pain took her breath away at times, it was a sharp pain and more of a stinging than a dull pain. It started on her right side, under her arm area, close to her breast area. In the morning of reporting day, the patient woke up to find a dime size, raised thickened plaque feeling, red area that was just below her shoulder but still on her arm and toward the underarm area. It was bumpy in appearance. The patient was referred to physician and she planned to discuss with her pain management and Primary Care Provider (PCP). The patient called back and reported that she was seen by the internal medicine physician. The physician confirmed that the patient had a case of shingles. The patient was unsure if the events was related to SHINGRIX vaccine or not. The patient provided contact details of the physician.
Dizziness; fatigue; difficulty breathing; arm pain; swelling at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 17May2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 14:00, the patient experienced dizziness, fatigue, difficulty breathing, arm pain, swelling at injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness, fatigue, difficulty breathing, arm pain, swelling at injection site was not recovered.  No follow-up attempts are needed. No further information is expected.
Highly irregular menstrual cycle early June very heavy bleeding. Since then my period has not come at all and is several months late. I am not pregnant. I have never had any irregularity in menstrual cycle.  We use natural family planning as birth control and are now unable. This has very negatively affected my family,
A few days after the vax, I started getting redness and pain in my right eye. I've had uveitis before so I recognized the symptoms, so I called my doctor who recommended I take prednisone eye drops and it cleared up quickly.
This is a spontaneous report from a contactable consumer through a non-clinical study program (marketing program no available), and then from a contactable other hcp. A 80 years old female consumer received PREVNAR 13, via an unspecified route of administration, in left arm, at 0.5 ml single, on an unspecified date about 2 weeks before the report. Ongoing medical history included blood pressure high and cholesterol high for about 2 years. Concomitant medications included oral ATACAND at 32 mg once a day, oral Baby Aspirin at 81 mg once a day, oral CRESTOR 5 mg once a day and oral hydrochlorothiazide 12 mg once a day. She did not receive any other vaccine on the same dale along with the suspect vaccine, she denied receiving any other vaccine within 4 weeks prior to the date she received the suspect vaccine. The consumer experienced on unknown date quick rash/reddish rash at site that moved to elbow (maybe a day after receiving the vaccine) which she said was ok but on an unspecified date at night she was waking up in the middle of the night, had pain in right and left wrist, pain in part of arm/tenderness and pain in left arm where shot given, pain in back, pain in neck and shoulders, some time it affected joints, right knee pain (that woke her up last night). The consumer stated she had experienced this maybe a couple of times a week. Consumer described her pain as like a toothache. Consumer said she did inform her doctors office of the rash and other symptoms and said she was told that it was normal, that some people got it and some did not and that the rash came with the shot. Consumer said that her husband got the vaccine too and did not get a rash. Consumer said the rash went away after 3 to 4 days. The consumer was not recovered from pain in right and left wrist, in shoulder, back, neck and knee. The outcome of the other reported events was unknown. The other hcp did not confirm occurrence of the events reported by the patient, and said that the patient did not provide information to him/her regarding the reported adverse events. Follow-up (20Nov2014): New information from the same contactable consumer includes: patient age, gender and ethnicity, vaccination details, medical history, concomitant medications, additional events and outcomes. Follow-up (09Dec2014): New information received from a contactable other HCP includes: the reporter did not confirm occurrence of the events reported by the patient. Follow-up attempts completed. No further information expected.
Information has been received from a certified medical assistant concerning 3 females infants patients who between 15-OCT-2014 and 27-OCT-2014 were vaccinated with improperly stored dose of ROTATEQ, oral (lot # K005397, expiration date 29-FEB-2016) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/28/2022 HEART FAILURE W REDUCED LVEF 31-40%, UNSPECIFIED ACUITY
Attempt to give COVID booster and it got mixed up with the JYNNEOS. No adverse outcome, but wrong vaccine given. Person will return for their COVID booster.
9NOV91 cough & fever seen by MD dx laryngitis-rx Amoxicillin; 13NOV much imporved getting better; 27DEC91 recovered;
large Hives w/in 24 degrees - treated w/BENADRYL - hives have continued to appear for 3 days - always treated with BENADRY
Patient presented to ER on 2/2/08 with vomiting, bloody diarrhea; had Abdominal U/S which showed intussusception which was followed by a barium enema which showed resolution of intussusception, still in hospital as of today 2/4/2008. 2/22/08-records received for DOS 2/3-2/4/08-Gastroenteritis with hematochezia resolved intussusception. C/O diarrhea 2/2/08, watery stools. Vomiting and blood noted in stool. Fussy.
Injection site reaction reported as "red spot," muscle aches, joint pain, and fatigue.
Strong chills/shaking, body aches, head aching turned into a migraine with nausea.
Swollen, red, warm to the touch and it itches. Right anterior thigh, 4cm x 6cm erythematous macule, superiorly the border has 1.5 x 2 cm indurated area with central injection mark.
Hives that come and go all over my body. The hives itch and make my joints swell. There is discoloration (purple color) around some of the hives
patient described injection site becoming red the evening after immunization. The next day (today) patient stated a sore goose egg that's red and hot to the touch. I recommended the patient contact her PCP for further guidance and possible treatment.
Parent had sent in consent for flu shot to be given on 11/3/22.  Found out after Patient had flu shot already this season on 9/24/22. Lot Number UT7701KA
Pt went to ER for evaluation of painful swollen arms where immunizations were given. No fever no chills. Diagnosis in ER - acute allergic reaction vs. cellulitis.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two shelters.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Beginning on May 27th, I started experiencing extreme dizziness. When it would happen, I had no warning that it was going to happen. A couple of times, I passed out briefly. As time went on, the dizzy spells progressively became worse. On June 19th, I had an awful headache for most of the day. I sat down in my chair and asked my sister to take my bp. My first take was 200/100 and my second reading 198/98. While doing that, I lost consciousness. She told me to open my eyes and asked me what I see. I couldn't see anything, everything was black. My husband and sister were going to take me to the hospital, but I started to have a full body tremor. They called an ambulance for me and they took me to the Hospital. While I was there, they performed multiple EKG's, 24 hour urine, multiple blood tests, an EEG, MRI, MRA, CT scan and I had a heart monitor. All tests came back within normal limits. I was there for 2 1/2 days. I was sent home and followed up with my PCP, cardiologist and ENT. My doctor had me stop taking metoprolol and start taking losartan 25 mg/day and night. I started feeling a bit better. I was still having dizzy spells and my bp was in different ranges. July 19th, my sister was over and she noticed that I wasn't feeling well. I was having another bad headache. I took a shower and got into my chair and all of a sudden I felt like I had blinders on and could only see grey. I told her that I didn't feel well. They called for a ambulance again. My bp was 202/110. By the time the ambulance got to the house it was 198/110. The EMT's couldn't get a pressure cuff on my arm to get another reading. I went back to the Hospital and I was in observation for 1 1/2 days. They only drew blood during this visit and performed one EKG. They told me that they didn't feel any reason to perform the same tests as before because I was there a month prior. Since I have been home, I have been monitoring my bp as requested. I am now taking losartan in the morning 25mg and metoprolol 25mg at night, along with all of my other medications. I saw a neurologist and she labeled (her clinical opinion) the two hospital visits and TIA (Trans Ischemic Attack) due to high blood pressure urgency.
Initial information received from other manufacturer (service request number 1-7348370174) on 10 June 2013. The information was originally reported by a non-healthcare professional (patient parent). A male patient, whose initials, age, medical history and concomitant medications were not reported, had received a dose of DAPTACEL and IPOL (lot number, dose number, route and site of vaccination were not reported for both vaccine), both on 29 May 2013. On 31 May 2013 at night, the patient experienced red, swollen hard area about 2 inches in diameter around injection site. Corrective treatment and laboratory data was not reported. At the time of this report the outcome of events was not reported. List of documents held by sender: none.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was hospitalized on 3/8/21 at hospital for a severe COPD exacerbation. In February 2021 he was diagnosed with lung cancer that could not be treated surgically. On 3/29/21 he was admitted to hospital with his second MI in 5 months. He later passed away there on 4/6/21. Other comorbidities include COPD requiring oxygen, MI, HTN, HLD, smoking, polysubstance abuse, homelessness.
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA VACCINE; PATIENT WAS RE-VACCINATED ON 10/7 AND STAFF WERE TRAINED ON PROPER DOSING AND ADMINISTRATION.
stroke; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Very limited information regarding this event has been provided at this time. No further information is expected at this time; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time
By night soreness at site of injection began and has not gone away yet. By 6/19 arm started itching, extremely hot and red rash on arm. By then, arm more sore than ever - it hurt to touch it. Sprayed hydrogen peroxide and took away itching. By next day, redness was moving location in arm. Called nurse line who recommended doctor visit. Went to doctor who prescribed sulfamethoxazde/trimethoprim and hydrocortisone cream. Red is gone; arm still sore on places. Still not sure if infection or allergic reaction to meds.
Patient states next day when waking up he was very dizzy, lightheaded  for 15 min per day. this has been continuing till this date of submission of form
Rapid onset ascending muscle weakness in legs, tingling, numbness presumed to be Guillain Barre by physician and neurologist
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: blurred vision, became hot and sweaty, had not eaten and is diabetic. he felt his blood sugar might have been low. he was  feeling generally unwell and concerned enough to ask me to call the rescue.
10 days after receiving the Moderna dose 1, I woke up to a swollen, red arm where the shot was.
This spontaneous report as received from a physician refers to a 32 days old patient. The patient was vaccinated with the first dose of oral ROTATEQ (lot number, route, dose not reported) on 27-AUG-2012, 10 days before 6 weeks old. No other co-suspects or concomitant medications were reported. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information has been requested.
Severe joint pain throughout entire body and lethargy that lasted 24 hours. Minimal injection site soreness
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
First episode of symptoms included nausea, vomiting, weight loss, fever, headaches, falling, weakness, fatigue, altered level of consciousness and difficulty speaking, writing and walking, etc. Symptoms would wax and wane. Treatment included ORAP for difficulty speaking - "Tourette syndrome" and Verapamil for cluster headache.
Our infant received the roto vaccine - by mouth - along with her other 2 month vaccinations - injections-.  She had blood in her stool and extreme discomfort for the next 3 days.  It seems the roto vaccine caused the painful and bloody stool.
I woke up and felt good there was no post nasal drip or congestion, do not know if the vaccine is helping my allergies; dose 1, 04May2022; dose 2, 04May2022; dose 3, 04May2022;; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 10:45 as dose 4 (booster), single (Lot number: FL3197) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "congestion" (unspecified if ongoing), notes: congestion; "Postnasal drip" (unspecified if ongoing), notes: post nasal drip; "Penicillin allergy" (unspecified if ongoing), notes: allergies Penicillin; "allergies" (unspecified if ongoing), notes: was having post nasal drip and congestion prior to my vaccine due to allergies. Concomitant medication(s) included: METFORMIN; LISINOPRIL; CRESTOR; BENADRYL; AZELASTINE. Vaccination history included: Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EL3247,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 1,, other vaccine same date vaccine location: Left arm), for Covid-19 Immunization; Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EL3247,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 2,, other vaccine same date vaccine location: Left arm,), for Covid-19 immunization; Bnt162b2 (other vaccine same date product: Pfizer,, other vaccine same date lot number: EW0217,, other vaccine same date vaccine date: 04May2022,, other vaccine same date dose number: 3,, other vaccine same date vaccine location: Left arm,), for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04May2022, outcome "unknown", described as "dose 1, 04May2022; dose 2, 04May2022; dose 3, 04May2022;"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05May2022 at 06:30, outcome "unknown", described as "I woke up and felt good there was no post nasal drip or congestion, do not know if the vaccine is helping my allergies". Therapeutic measures were not taken as a result of therapeutic response unexpected.
pt recv vax 9MAY96 10AM;by 4AM devel fever of 105;parents gave motrin & APAP;not fussy or crying, teething, cold sx, sniffles & cough x 1 wk;examined by MD day 2 fussy, t102, day 3 t100-101, fussy;
Injection was high on the right shoulder, vaccine apparently injected in and/or around the subacromial bursa. Right shoulder pain starting ~5 hours after the injection on 4/2. Pt came in to clinic 4/5 with right shoulder pain. Injection mark visible high on the  right shoulder, about midline, well above the deltoid. Pain at superolateral right shoulder. ROM quite limited d/t pain.  IM ketorolac in clinic. Rx: meloxicam and hydrocodone/acetaminophen, ice packs, sling, compression sleeve.
On January 21st I woke up at 3:00 am with a small rash on my left arm, where I received the vaccine. I put an ointment and took Allegra 24 hour to treat reaction. On January 22, 2021 I woke up with two more spots on my arm so I went to go see my doctor and I was given a shot at the clinic and also prescribed an ointment and oral medication (I do not have them with me at this time). On the evening of January 22 , my arm (near the shoulder area) swelled and got red. It is a hot and burning sensation on the area of reaction with redness and swelling. At this time, most of the swelling and redness went down,  but I am still dealing a mild burning sensation and mild swelling. I will still taking the 24 hour Allegra along with the oral medication and ointment I was prescribed yesterday.