chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Shingles after dose two; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 91-year-old female patient who received Herpes zoster (Shingrix) (batch number B334Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number EY93J, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer and shingles.   On 17th July 2018, the patient received the 1st dose of Shingrix. On 22nd October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingrix was positive. 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 Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced shingles after the 1st and 2nd dose of Shingrix. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012493:Same reporter.
fevers; chills; sweating buckets; joints were aching; felt like he had dirt in his eyes; flu like symptoms; sweating profusely; felt drained; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729, patient was 59-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 04:10 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, seasonal asthma, covid-19 virus from Dec2020 to unknown and had to quarantine for 2 weeks at Christmas time last year. There were no concomitant medications. Historical vaccine included received tetanus vaccine last year for immunization. Reported that patient received the Covid 19 vaccine, waited and left the facility. He had no problems. Patient went to bed last night, and he started getting fevers and chills throughout the night with others events. His wife told him to call and report it. Probably around midnight last night patient got up to go to the bathroom and he noticed he had been sweating profusely and had the chills. A day after vaccination in morning he felt drained. Once he got up this morning and took a shower that seemed to help. This reminds him of having a 24 hour bug or flu. He was totally not expecting it. He does feel improved. He feels better than he did. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Administered Vaccines on same date with the Pfizer vaccine considered as suspect. The patient had not received any vaccine prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 07Apr2021, the patient experienced fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely, on an unspecified date in Apr2021, the patient experienced felt drained. No AE(s) require a visit to emergency room and physician office. The outcome of event (felt drained) was unknown, and the outcomes of events (fevers, chills, sweating buckets, joints were aching, felt like he had dirt in his eyes, flu like symptoms, sweating profusely) were recovering.  No follow-up attempts are needed. No further information is expected.
Patient was walking back to observation area and fell on his right side. He bumped his knee with a small scratch and small bump on right chin. B/P  90/54, MAP 64 HR 90 Pulse Ox 98%.  When nurse got to him he was disoriented and diaphoretic and could not walk and was pale.  Transferred to gurney with feet up.  Cleaned scrap on knee and put ice on chin.  Mom was present with other siblings.  Was orientated to time and place at 10:30.  BP 97/59 67 pulse.  Patient was very nervous prior to getting vaccine.  Stated I didn't mean to see my sister get her shot- but when I opened my eyes I saw her getting the needle.  Said he remember seeing "spots" right when he came out of bay.   Patient monitored for 30 minutes, then had him sit at side of bed.  Then had patient stand for a few minutes with no issues.  Nurse escorted patient and family out with no difficulty.  Was feeling well at discharge 10:50
She suffered pain that started on her left ear and radiated to her cheek and brow and developed a rash on her left eyelid. She was diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 10-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered pain that started on her left ear and radiated to her cheek and brow and developed a rash on her left eyelid. She was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, she has not recovered from herpes zoster. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered a disabling event by the reporter.
Pain radiating way beyond injection site to armpit, chest, under arm, shoulder joint, etc.  Now, at 29 hrs. later the pain continues and is very severe.  Tylenol and immobilization provide minimal relief.  This is far from "normal" pain at the injection site.
At first had symptoms that are common including mild fever, chills, headache , etc.. then experienced extreme vomiting which required a prescription from her pediatrician to control so she could keep liquids down. Vomited about 10 times in a few hours then managed to stop after the medication was administered.  She is a petite person and it took a long time after the vomiting stopped to get her fully hydrated and able to urinate properly
Pt started to appear pale upon injection of 4th and final immunization. She reported feeling nauseous, and was very quiet. Pt was escorted to the bathroom with staff members and parent where she became weak and more pale. Pt did not fall or lose consciousness. She was sat on a chair against a wall with staff members and parent and was given ice pack to hold against base of neck. Pt sat for about 10 minutes before stating she was starting to feel better. Upon questioning, she confirmed that she was very nervous to receive the vaccines today.
has an ear infection currently; fluid in the ear; sneezing badly; nose got bloody; This is a spontaneous report received from a contactable other hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an ear infection currently and fluid in the ear. In Mar2021 she was sneezing badly, and her nose got bloody. She wanted to know if she can take stool softener after getting vaccine. She had an ear infection currently/fluid in the ear that was a recurring issue and was happening before she got the first dose of the Pfizer Covid 19 vaccine. She states it was not due to the vaccine. She was using a prescribed topical ear drop however she may possibly have to take oral amoxicillin. The pharmacist told her that it would not be a good idea to take antibiotic two weeks prior or post vaccine administration. Her doctor did not feel it was an issue. She wanted to know if she takes amoxicillin and get the second dose of the vaccine. On 12Mar2021, she was prescribed amoxicillin by her Doctor because her Doctor wanted to take the fluid out in her ears. But a pharmacist told her that she should not take the amoxicillin because she already took the 1st dose. She did not take the amoxicillin because her Doctor told to take that when they see an infection after they take the fluid out. She mentioned as well that last 13Mar2021 she woke up sneezing very bad that her nose got bloody. Escalating this because the caller was sneezing badly after she got the 1st dose. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache every day since second shot-that's now 4 months; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache every day since second shot-that's now 4 months) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache every day since second shot-that's now 4 months). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 25-Aug-2021, HEADACHE (Headache every day since second shot-that's now 4 months) had not resolved.            Incomplete information provided regarding the concomitant drugs was provided.
mark on her arm at injection site; Weakness; Dizziness; injection site is big; (mark) is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness), INJECTION SITE SWELLING (injection site is big) and INJECTION SITE ERYTHEMA ((mark) is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness), INJECTION SITE SWELLING (injection site is big) and INJECTION SITE ERYTHEMA ((mark) is red). At the time of the report, INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness) and INJECTION SITE SWELLING (injection site is big) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications are provided.  No treatment information reported.
pt recv vax 12FEB96 & 26MAR96 & devel a skin rash on the inj side @ lt buttock & thigh;5JUN96 pt presented to MD;pruritic rash was described as a small bumpy pink raised rash & pt dx w/post inflammatory erythema;
Afew hours after receiving the inoculation, I was extremely sleepy.   I was sleeping at my job, and my boss had me go home early.  I went to work the next day, however I was feeling weird, my sense of smell and taste were off, as the day continued I started having a headache, body aches, and general malaise.  I went home early, again from work.  But when I arrived to my residence I was having severe chills despite my efforts to try to keep myself warm.  The chills lasted for more than 24hrs, preventing me from sleeping, my body aches were getting worse, my eyes were extremely red, and I did not feel like eating.  Near the end of the day, the chills became sweats, and I was trying to balance between being hot and clammy, to chills.  The next day I paid a visit to my primary care doctor.  I was tested for covid - which was negative, I was tested for the flu - which was negative, and my lungs were clear so there was no reason for my doctor to believe I have a pneumonia.
Narrative: Yesterday, he received the first dose of Moderna COVID-19 vaccine. Last night he started having myalgias and fatigue. He slept for hours last night. This morning upon awakening, his generalized myalgia were so severe that he felt he could not get out of bed. Today, his left arm is so sore and painful that he can't lift his left arm about shoulder level. He has not had measured fever, chills, N/V/D, runny nose, sore throat, cough, dyspnea or abdominal pain. No change in his senses of taste or smell.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 11-JUL-2018, the patient was vaccinated with and expired dose of M-M-R II lot # M027637, expiry date: 02-JUN-2018, therapy type rHA, for prophylaxis. Concomitant therapies included sterile diluent. The patient experienced no adverse event.
Exactly 2 weeks after receiving the vaccine, I started feeling extremely dizzy 24/7. Since then, I have had no relief in this symptom. Any time I eat anything at all, I feel intense pressure in my sinuses area, my head, behind my ears, and become very dizzy. I often stumble due to the dizziness and have to close my eyes most of the day. It has been very debilitating. I am unable to work, and everyday tasks are very challenging.
Pt received flu and pneumonia vaccines at approx 1:00/pm. On 10/15/09 received phone call from husband at 8:10/am on 10/16. Stated wife began to have fever and chills at approx 6:30/pm on 10/15/09. temp 102.5, experienced weakness took ASA for symptoms still experiencing weakness temp 100.5. Will see PMD.
Same day of injection, that night, reddish skin changes appeared, next day induration of skin of the thigh area appeared, with mottling of the skin, an area of about 2x2 inches. It keeps growing induration. No pain, no fever, no decreased activity reported. Today I found on right lateral thigh, about middle third aspect, an induration area, very hard, non tender, of about 3.5 x 3.5 cm with erythematous skin change, and a mottled area of skin with mild soft induration of 10 x 12 cm roundish, not tender, not warm, not fluctuant. This corresponds to the IPV injection site.
1/11/22  51 yr/o male patient that presents to the office today with c/o congestion and sore throat.     HPI Patient reports symptoms started Saturday with sore throat, then progressed to congestion.  He has been taking mucinex for the last few days and he does feel he is improving.  Review of Systems  Constitutional: Negative for chills and fever.  HENT: Positive for congestion and sore throat.   Respiratory: Negative for cough, shortness of breath and wheezing.
approx 9 days p/vax pt devel rash over the arms & legs; pt had fever (low grade)
On 6/2/21, patient c/o decreased range of motion and pain about 3-4 days after receiving 2nd dose of Moderna.  Office visits on 6/4/21 and 6/10/21 for bursitis with Celebrex 200 mg capsules prescribed once daily on 6/4 and twice daily as needed on 6/10.
MASSIVE HEART ATTACK; BLOOD CLOT IN DAMAGED APEX; This spontaneous report received from a consumer (wife) via a company representative through social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have heart problem prior vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-DEC-2021, the patient experienced massive heart attack, and blood clot in damaged apex. It was reported as "Bless your wife. My husband had a massive heart attack after the vaccine still with us but lots of damage and still has a blood clot in damaged Apex. This was December 7, 2021. No prior heart problems ever". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in damaged apex, and the outcome of massive heart attack was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221139543.  It was determined that 20221139543 was a duplicate of this case. All relevant information regarding Manufacturer Report Number 20221139543 will be submitted under 20221139393.; Sender's Comments: V0: 20221139393-massive heart attack. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221139393- blood clot in damaged Apex. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
pt had a positive COVID test on 8/10/22, 8/31/22, and 9/12/22; pt was brought from Center with low BP, slow speech, poor oral intake; pt has been missing HD due to weakness; at Center they did administer dexamethasone; at hospital, pt given inhalers, O2 supplementation; pt septic; CT of chest/abdomen/pelvis showed signs consistent with metastatic disease; did give empirical ABX; transitioned to hospice and pt passed away in the hospital
Patient became unresponsive and fainted for several minutes within a few minutes of receiving meningitis and hpv vaccines. She continued to complain of a spacey/ dizzy feeling for several hours as well as pain at the injection site.
Chills, Fever (101F), body aches, nausea, sensitivity to touch, fatigue.
R deltoid swelling, noticed when awaking on 02/14/2020. Given Ibuprofen with significant improvement in symptoms.
Bumps on the skin, itchiness, swelling of the face, hands and joints.
VERY DIZZY; BAD REACTION; This spontaneous report received from a patient via a company representative concerned a 69 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, first dose administered on 01-APR-2021 and second dose on an unspecified date in 2021 for prophylactic vaccination (dose number in series 1).  On an unspecified date, the patient experienced foggy eyed in the left eye/was seeing double some days, when used hands a lot of pain and when used wrists a lot of pain (dose series 1). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The outcome for foggy eyed in the left eye/was seeing double some days, when used hands a lot of pain and when used wrists a lot of pain was unknown.   The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in  series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.   On an unspecified date in 2021, after getting the booster shot, the patient was very dizzy and was having bad reaction (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported.  The outcome of the very dizzy and bad reaction was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211050535.
pt recv vax 21MAR97 & about 4hr p/that had episode of persistent crying for almost 24hr
About 3 or 4 days after vaccination administration the patients mouth became covered and lips covered with cold sores/canker sores.
Large reddened area at site of vaccination, 150mm x 150mm, rechecked area 1 day after 120mm x 100mm with MOTRIN/cool compresses.
10 week obstetric patient - EDC 5-12-10 c/o headache evening of day FLUZONE administered woke up 1-130 AM 1 episode of vomiting, AM of 10-14-09 Patient noted rash on upper abdomen rash worsened over abdomen. Patient seen in office 10-16-09. Physician noted macular rash improved as of this date - 10-19-09 but still with rash. 10/30/09 Medical records received for dates 10/16/09 to 10/23/09. DX: macular erythematous rash on upper abdomen. Possible SE flu vax. Presented with c/o rash on abdomen, itching after getting flu vax on 10/13/09. Pt stated woke up same night vomiting, HA, and then the rash appeared on abdomen. pt. is pregnant. Assessment: erythematous rash on upper abdomen, FHR(+). 10/23/09 Pt called OB stated rash resolved. No further action.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 09-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Fever chills, fatigue, swollen lymph nodes (L) and (R)- neck, arm pits Narrative: