chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Had the shot and still got them / mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and got mild case shingles. The patient went right to physician.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Blotchy red rash, puffiness to face and lips, without oral swelling or trouble breathing. Went to ER on 09/20/2018 and given one dose of steroid (there though more likely viral reaction). Rash worsened over next 24 hours so went to hospital 09/21/2018 and felt more likely delayed MMR vaccine response, given antihistamine cetirizine/ranitidine, particularly given similar responses in past for father and father's family to MMR vaccines (though they have completed them).
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 24 month old female patient who received a third dose on an unspecified date and subsequently, developed invasive pneumococcal disease. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date, the patient received a third dose of Prevnar. In Jun 2005, the patient developed invasive pneumococcal disease (pneumococcal infection) (drug ineffective). A culture was performed (date unspecified) identifying the causative organism as Streptococcus pneumoniae, serotype 19A. The patients outcome is unknown. Culture results streptococcus Pneumonia, serotype 19A was done on an unspecified date. No additional information was available at the time of this report.
3AM: Severe dizziness, fainted while  sitting down. All day 02/16: Low energy, very tired, feeling weak. Nausea at times, low appetite. Dizzy at times.
Severe chills, Fever up to 102, arm soreness, fatigue, mental fog,  headache. Tylenol taken every 4-6 hours for 24 hours. Fever gone at 24 hours and other symptoms improved over next 24 to 48 hours.
Dizziness; disorientation; body aches; switching between feeling too hot and too cold; headache; nausea; arm pain; extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15May2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included escitalopram oxalate (LEXAPRO) 20 mg, daily and testosterone phenylpropionate (TESTOSTERONE) 25 mg, weekly, both from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 hours (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15May2021 at 21:00 hours the patient experienced dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea and extreme tiredness. No therapeutic measures were taken a s a result of the adverse 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 event dizziness, disorientation, body aches, switching between feeling too hot and too cold, headache, nausea, pain and extreme tiredness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Tingling in fingers and toes. Weakness in hands, loss of balance eventually paralyzed from waist down (temporary). Inability to swallow.
has been left diplegic in a wheelchair since the Pfizer vaccine was given to him; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient has been left diplegic in a wheelchair since the Pfizer vaccine was given to him. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Patient received Td-111 on 3/29/04 in left arm. No other vaccinations were administered at the same time. The patient could not recall receiving Td in the past. On 4/2/04 patient called doctors office complaining of fever (101.7 F), achiness, chills, swelling at injection site, and swelling in joints. The doctors note says that the reactions began 2-4 days after the Td shot. On 4/9/04, patient called doctors office again complaining of hives and being sore in muscles and joints. On 4/12/04 doctor saw the patient in the office, left arm finger and wrist were red and hot to touch, still feeling really achy. There was noticeable swelling of both hands and patient had a slight temperature (99.1 F). The hives were gone. Doctor prescribed Medrol dose pack, Tagamet 400mg and Zantac. The patient was told to revisit doctor if necessary. Follow up on 4/14/04. The doctor agreed to contact the manufacturer if patient returns for follow up visit. No further information was received.
MENVEO vaccine was not mixed with diluent. Patient only received diluent intramuscularly. Contacted patient to return for vaccine.
Right side face drooping, seen in ED Dx Bells Palsy. Prednisone 20 mg PO BID vaccine given 10/2/13. Onset sxs 10/18/13.
A report from a physician concerns a 13 year old female patient. Relevant history, concurrent diseases and concomitant drugs were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an outside pharmacy, so the doctor doesn't have information on lot number. Patient passed away on 16-Dec-2014. Patient was positive for influenza A. The parents requested an autopsy, and the preliminary report states following Diagnosis: 1. Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from the lungs. Physician said that once they receive the final autopsy report they will notify our office. The patient died from the congestive hemorrhagic lungs on 16-Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was performed. The reporter considered the congestive hemorrhagic lungs to be serious by the criterion of death and other events to be serious by the life threatening criterion.
This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a 49-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE with an associated reaction of respiratory tract congestion (received in 2017, for adverse event refer case US2018GSK196442). Concurrent medical conditions included drug allergy (thimerosal). On 17th September 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In September 2018, 5 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever. Rechallenge with FLULAVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the respiratory tract congestion, cough and nasal congestion were not recovered/not resolved and the outcome of the dizziness, chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the respiratory tract congestion, cough, dizziness, chills, general body pain, nasal congestion and fever to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QIV and it was a prefilled syringe. The patient experienced chest congestion. The patient had denied permission to contact their physician.
Same day bruising and pain around injection site. Then at night time developed a large, red, hot spot below injection site (about an inch and half away from injection site). Also inlammed a little.
pt reported breaking out w/herpes zoster, lt buttock 3 days p/vax
Myalgias, pain, swelling, and redness at the site of vaccination and extending down the arm; fever to 103.6. Resolved over - 4 days.
Patient came in on 6/7/22 to receive her first booster shot and notified me that she had elevated D-dimer (when she had her regular scheduled blood work, which happened to be 14 days after the 1st covid shot and 13 days after the second). She did not experience a clot but wanted to inform me of the elevation. She did discuss the results with her Hematologist, who recommended that she still get the booster. No adverse events occurred other than the d-dimer elevation. No treatment was necessary. patient received 1st dose at pharmacy as listed second dose was 11-09-2021 at my store lot: fh8020 im in right arm  had fluzone hd on 10/30/2021 lot: uj773aa im
This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
All-over body hives/ some hives on her thigh, and they spread throughout her body; Had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh; Felt hot and took temp and had no fever; Nauseous and sickly feeling; Nauseous and sickly feeling; Soreness; Sore and stiffness in muscles; Sore and stiffness in muscles; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer (Patient). A 67-years-old female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), dose 1 intramuscular, administered in Arm Left on 22Jan2021 09:00 as single dose for covid-19 immunisation. Medical history included allergies, compromised immune status, She takes regular prescriptions for blood pressure , respiratory illness, Genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, She was taking Chemo 5 1/2 years ago but not any more, for breast cancer, high blood pressure, which was prior to getting vaccine; she could not take Taxotere and a CyL one, She later corrected to state it was one Paclitaxel and Docetaxel, she does not have a lot or expiration for either, her body had a severe reaction to them; chronic kidney disease that was diagnosed 3-4 months ago, regular flu vaccine- she gets sick, nausea, lightheaded, warm and want to throw up. The patient family medical history included diabetes, blood pressure, heart issues. Prior to vaccination the patient did not receive any other vaccines within 4 weeks. No additional Vaccines administered on same date of the Pfizer Suspect. The patient's concomitant medications were not reported.  The patient had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh on 28Jan2021 08:30, all-over body hives/ Hives on whole body including stomach, arms, thighs on 28Jan2021 22:30, soreness, sore and stiffness in muscles on 22Jan2021 09:30, felt hot and took temp and had no fever on 26Jan2021, nauseous and sickly feeling on 26Jan2021. It was reported that after first shot she was fine at first and just had a little soreness. Yesterday, she developed 2 bumps on inside of her thigh. She thought she got bit by a spider. Last night, she noticed her stomach, arms, thighs and whole body had hives. Maybe they turned into hives. The ones on her thighs are now hives. Her whole body is broken out with hives and these bumps. She would like to know if she can still have symptoms from that much time frame after the first injection. The events did not resulted in emergency room visit. The outcome of the events soreness, sore and stiff muscles, Felt hot and took temp and had no fever, Nauseous and sickly feeling were recovering and the outcome of 3 bumps on inside of thigh, hives on whole body including stomach, arms, thighs were not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning herself (a 24 year old female) with migraine who received the first two doses of GARDASIL already and noticed increased incidents of headaches and migraines after getting the first dose. She was diagnosed with migraines before starting the GARDASIL, however she experienced more often since starting the therapy. At the time of reporting the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Determined she had a mild stroke yesterday, March 21. Had slurred speech, could not form words, couldn't cook. Symptoms actually started on March 17th, one week after having the vaccine. She is currently hospitalized at hospital where she received her vaccination.
Lt arm induration about 2 CM in diameters erythematous tender to palpation. 2 days after vaccination for 2 days and resolved, given Motrin alternation with Tylenol and compresses.
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (non-pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# EW0170), intramuscularly, in left arm, on Apr 17, 2021, at 02:15, single dose, for COVID-19 immunization. The patient's medical history included arthritis, factor 5, endometriosis and fibromyalgia. Allergies to remicade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Humira. The patient received other medications within 2 weeks of vaccination. On Apr 19, 2021, patient had facial swelling, nodule formation and tenderness on left-side of face along cheekbone at the site of filller injections. Adverse event resulted in physician office visit. The treatment included prednisone 5mg for all the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. The patient has not recovered from the events. No follow-up attempts possible. No further information expected.
Administered 2nd Moderna vaccine, leaked around needle. Patient did not receive dose. Needle was intact, did not dislodge. Patient was informed, no adverse reactions. Per administration nurse running Senior center, 2nd dose given due to loss of first vaccine materials. Monitored and observed x 30 minutes.
Patient called 1/17/18 to report that she experienced what she believed was "nerve pain" in her right arm the afternoon after I gave her her immunization (1/15/18 ~10:20 AM). She said it started w/ her upper arm on left & that she couldn't lift her arm, but that she wouldn't describe it as sore. Then she said in the evening the pain traveled to her neck and shoulder, then down her left side of her back & her lower left arm. Tuesday she stated she felt a little better but thought she also felt pain on her right side and that she couldn't get comfortable lying down on either side. She called the pharmacy on 1/17/18 at 1:40 PM to report these symptoms and I asked if she could come by the pharmacy for me to check the administration site and/or see her doctor and she said she would try. She stated at the time of the phone call on Wed 1/17 that the pain had reduced significantly and that just her left upper arm was bothering her. I told her I was available here until 8 PM on both 1/17 & 1/18 but she has not returned, so I am moving forward with the report and will follow up with her when I return to work 1/22/18. She stated she wasn't sure if she had a reaction to the vaccine itself or if the pain was from the administration site itself.
Allergic reaction to immz (Dtap or IPV). Lt with 15x15cm area erythema, 5x5 induration, apply ice pt per providers notes, Rx: Atarax, Tylenol.
12-minutes after vaccination, the patient reported feeling lightheaded and dizzy. Patient was noted to be anxious and hypertensive. EMS managed care on-site and patient refused transport to hospital. Noted to be feeling improved prior to leaving facility.
Just 2 days after the vaccine, I started to have the inflammation in my mouth and around the tongue area. I thought to have vaccine related effects so neglect them. Though after first shot, this issue was not major. When I went to take my second shot in October, I informed to the nurse about this issue. However, I took my second shot and after that the nightmare started. Just 2-3 days after the vaccine, I started to have more issue in my mouth. My cheeks started to rub against my teeth, my tongue surface from top become white and skin of inner side of cheeks started to rip off. I informed to my PCP and he suggested me to take Zyrtec/Benadryl (Anti-histamine). Though Zyrtec didnot worked for me so I started Benadry which gave me relief for only 1 days. I took Benadryl for almost 2 weeks but it didnot helped me. I tried to inform to my PCP about this through message and tried to take his appointment but his calendar was full and never got his response (which was totally unprofessional). Though from the same hospital, I got the call from a nurse who talked with me and suggested to try to take appointment and continue with Benadryl. Since I was scared a lot for these issue and I started to look for another provider who can see me in-person. During this time, my symptoms got worse and tip of my tongue started to show sensitivity which makes me more nervous.  Luckily I got the appointment of other PCP and she suggested me to take me gluco-corticoid and other medicine but they also gave me relief for only 2-3 days.  Now, my symptoms have become worse and now quarter of my tongue is having sensitivity including the "burning sense" in my mouth all 24h hours.
NO ADVERSE REACTION OCCURED. PT IMMUNOCOMPROMISED REQUESTED 3RD DOSE BUT WAS GIVEN BOOSTER 0.25ML DOSE OF MONDERNA INSTEAD. PATIENT WANTED FULL DOSE AND IS NOW NOT SURE WHAT TO GET.
suffered from several outbreaks / also between 5-6days after this shot.; On Jul 2019 / received / first dose / today /is asking if/ can get the second; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (suffered from several outbreaks before getting Shingrix first dose).   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Between 5 to 6 days after receiving firs dose Shingrix, the patient suffered from outbreak of Shingles. For this situation her physician did not authorized to complete the series but today this patient was asking if she can get the second dose. Till the date of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 4th of five reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Numbness of left hand fingers; stiffness started 15 minutes after vaccine. BP readings: 141/90 (pulse 86), and 148/89 (pulse, 84). 100% O2 sat.
sick, headache, body aches, fatigue.  Sunday better.  Monday sore throat, chest congestion, pimples in side of mouth and nose, constant mucous.  Something wrong with chest.  Can't eat solid food.  Clearing throat.  Speaking in full sentences.  Fees like it is hard to get air in.  "something is there that needs to come out".  Mild dizziness. No appetite.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420040-00.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159928), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRULICITY, start date: May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26May2022, outcome "unknown", COVID-19 (medically significant) with onset 26May2022, outcome "recovering" and all described as "COVID".  The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID and the suspect drug BNT162B2 cannot be excluded.