chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got it and had shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got it and had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient's friend via interactive digital media. The reporter stated that the shingles shot did not always keep you from getting shingles.  The patient got shingles vaccine and had shingles twice after it.  The reporter further stated that another pharma money maker. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
My son was born a healthy 7lb baby boy with no underlying issues. On his 2nd day of life he quickly became ill and died within hours of being sent to the NICU. He was given Hep B vaccine the day before. Autopsy and WES test were all normal.
I received my Covid-19 vaccine on 07/29/2022. On 01/15/2023 I started to have a bad cough. I reached out to urgent care and was tested negative for Covid-19. I was prescribed Amoxicillin for 5-10  days .
Patient appears with redness underneath injection site and tender to the touch. Size of redness is about 6-7 inches in diameter. Patient also states she experiences nausea. It has been 2 days since injection and redness is still there. Patient states that this has happened last year as well when she got her Fluzone HD. She had never had any reaction when she got the Fluzone Quadrivalent.
It caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit; It wasnot a normal cycle; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle). On 25-Aug-2021, INTERMENSTRUAL BLEEDING (it caused me to bleed unusually/Patient was due for her menstrual cycle on 03Sep2021, started to bleed a couple of days after first shot, around 21Aug2021/it was not a normal spotting, just a little bit) and MENSTRUAL DISORDER (it wasn't a normal cycle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. Treatment to the events not reported. Patient was due for her menstrual cycle on 03-Sep-2021, but that never happened, she is still not in menopause. Patient schedule second dose on 16-sep-2021.
Vials which undergone temperature excursion might have been administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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 PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients). At the time of the report, PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included adalimumab (Humira). On 4th June 2018 11:00, the patient received the 1st dose of SHINGRIX. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On 11th June 2018, the patient experienced injection site warmth and injection site itching. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site warmth, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site warmth, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in her upper left arm. The patient reported that she experienced soreness and redness at the injection site. On the reporting day, after 7 days of vaccination the redness had spread and it was large and warm to the touch as well as itchy.
Fever with T > 100F lasting 48hrs total, central 24hrs had 102F < T < 103F. Temperature measured via in ear sensor.
The pt experienced persistent crying for more than 3 hours which began within 24 hours of vax. The pt was evaluated at the hospital. It was thought to be related to the DTaP vaccine.
Patient oxygen saturation dropped that night after the vaccination, husband brought patient to the ER that same night and was released. But patient oxygen saturation dropped again Friday morning down to 60% and he brought patient back to the ER.
Headache, side body pain, kidney and liver pain, rib pain, abdominal pain, dehydration, arm pain, ear pain, weight loss, chest pain, dizziness, heart racing, numbness in face, emotional, depression, tired all the time, throat feels like its swollen, vomiting.
While receiving MENACTRA, pt experienced near syncope, then sat up, alert and responsive - pt monitored for 20-30 min after injection. No complications noted thereafter.
Raynaud phenomenon, right hand, noted about 12 hours after vaccination (overnight), relieved by warming hand in shower. Gradually lessened in intensity and frequency over the course of a week and then stopped with no recurrence over the following year, to date. Received Pfizer as "booster" in November 2021. Photographs available. By Raynaud phenomenon, I mean cold, numb fingertips, appearing pale, while other parts of affected hand appeared purple. No previous history of Raynaud or other vascular, immunological, or inflammatory diseases. I am a physician, but I'm reporting this as a patient.
Patient reports feeling hot, rash noted to chest, taken to ER @ 0836 where she was treated and released without any further incident.
Swollen lymph nodes, chest pains, dizziness, faint feeling, heart rate elevated, itchy skin, headache, nausea, sweating.
Started with sore arm  on the first dat, follwed by chills in second day.  After 3 days, bloating, stomach and heavy palpitations started. Heavy palpitation with chest discomfort, body weakness and shivering still present even after 10 days.
101 fever for two days, on and off followed by vomiting within 24 hours. By 2/12/15, daily diarrhea for 4+ days.
This non-valid social media spontaneous report as received from an unspecified reporter refers to unspecified number of children patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that, parents who injected their children with GARDASIL were murdering and maiming them (onset date unknown). The outcome of adverse event was fatal. Upon internal review the event of murdering and maiming was considered to be disabling. This is one of several reports received from the same reporter. Additional information is not expected as no reporter's contact details were provided.
Patient is a 74 y.o. female patient of PRIVATE, MD with history of hypertension, hyperlipidemia, COPD, brain aneurysm, cervical cancer, degenerative disc disease with lumbar radicular pain presented to Doctors Hospital with worsening shortness of breath.   Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms: 1/4/2023- 3 days prior to admission  Symptoms present on admission: Shortness of breath cough yellow phlegm production malaise Date of covid positive test: 1/7/2023 Vaccination status: vaccinated Imaging: CTPA?No evidence for acute pulmonary embolism.  Mild bilateral perihilar airway wall thickening reflect sequela of infectious or inflammatory bronchiolitis.  No focal lobar lung consolidation.  Multiple mildly prominent bilateral hilar lymph nodes measuring up to 1 cm thick at the right hilum, likely reactive or inflammatory etiology. Cardiomegaly with extensive left and right coronary artery calcifications.  Extensive bilateral upper lobe centrilobular emphysema. Moderate bilateral peripheral upper and lower lung interstitial lung disease. Heavy atherosclerotic calcifications at the celiac and superior mesenteric arteries origin Oxygen requirements on admission: 4 L Current oxygen requirements: RA however desats down to 74% on rest after 2 passes to door 1/11. Takes some time to recover back to 85-91%. Will give another day to finish 5 day remdesivir course. On 2L NC 1/12, no significant desats with ambulation  Medical therapy: Decadron and remdesivir started 1/8/2023- last remdesivir dose 1/12 Consultants following: None Anticipated special isolation end date: 1/14/2023 Continue to wean O2 as able   Hypertension Restart home doses of lisinopril Monitor closely and give as needed labetalol as needed for systolic blood pressure more than 180 or diastolic more than 110 SBP controlled  COPD Not in acute exacerbation Continue Advair, albuterol Remote history of using oxygen?patient has not use oxygen at home for the last 8 years, previously with API with CPAP?  Elevated BNP In setting of cardiomegaly, increased calcification in coronary arteries noted on CTPA Follow-up 2D echo-EF 60-65% with grade 2 diastolic dysfunction and elevated LV filling pressures with no significant valvulopathy, no pericardial effusions no evidence of pulmonary hypertension.  There is a prominent fat pad.   Hyperlipidemia Continue home doses of statin   Depression Continue home doses of citalopram Qtc check 1/9 well under 500 in low 400s. Ok to continue at current dose   Patient seen and examined in full PPE on day of discharge.  Breathing continues to improve.  On 2 L nasal cannula.  She did walk with me in the room 2 passes from the bed to the door and back only dropped briefly to 89 but quickly recovered.  SBP was more consistently in the high 80s?low 90s.  O2 evaluation was completed qualified for 2 L nasal cannula.  Case management was consulted to help get this set up
Fatigue - feeling drained of all energy, very tired; Very lethargic; Chills; Chills - randomly getting sensations of being cold, even though on average I tend to always feel like I'm on the warmer side.; This is a spontaneous report from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 24Dec2021 (Lot number: FJ1611) at the age of 30 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Appendectomy" (unspecified if ongoing), notes: Appendectomy and "Normal birth" (unspecified if ongoing), notes: natural birth of healthy daughter. Concomitant medications included: GENERIC ALLEGRA; ASHWAGANDHA, FISH OIL and THE MANE CHOICE HEALTHY HAIR VITAMIN MANETABOLISM PLUS.  The following information was reported: FATIGUE (non-serious) with onset 25Dec2021, outcome "recovered", described as "Fatigue - feeling drained of all energy, very tired"; LETHARGY (non-serious) with onset 25Dec2021, outcome "recovered", described as "Very lethargic"; CHILLS (non-serious) with onset 25Dec2021, outcome "recovered", described as "Chills"; FEELING COLD (non-serious) with onset 25Dec2021, outcome "recovered", described as "Chills - randomly getting sensations of being cold, even though on average I tend to always feel like I'm on the warmer side". Therapeutic measures were not taken as a result of fatigue, lethargy, chills and feeling cold.  Additional information: Body weight was reported as 280ish and height 72". It was reported that the patient had no other medical anything. Known allergies was reported as 'none known'. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 22Jan2022 (Lot number: FJ6369) at the age of 30 years as dose 2, single for COVID-19 immunisation.
For the next three days, I got pretty sick. Low grade fever - around 100. If I took a Tylenol it would go away for a little bit but then come back. Pain in my arm. Nausea and major, major, major migraines. I had migraines consistently - couldn't move off my couch. Those symptoms mostly went away after the third day.  I saw my OB/GYN this week and they said that my fetus stopped growing about three weeks ago.  Pregnancy history - my third pregnancy; none have gone to full-term. I have had a miscarriage before that was very similar to this one.  Estimated date of delivery - December 2, 2021. I have recovered from the immediate side effects. I get the fetus removed next week.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/11/2023 DM 2 W CATARACT  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/11/2023 LIVER MASS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/11/2023 CONSTIPATION
No additional adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 7/29/2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUL-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally (strength, vaccination scheme and anatomical site of injection were not reported; lot number 1660981, expiration date: 13-APR-2021) as prophylaxis (product storage error). No additional adverse effect reported.  On an unknown date, the vaccine underwent a temperature excursion above 47 degrees Fahrenheit (F) / 9 degrees Celsius (C) (8.9C) for 33 minutes, as recorded by a data logger. There was no previous temperature excursion.
I took J N J vaccination on April 3rd 2021. I experienced weakness, body ache and muscle stiffness for a week. It's been more that 3 months since the vaccination, now the weakness has reduced but body ache and muscle stiffness still persists.
Headache starting 12 hours post vaccine and lasting ~12 hours Red and swollen injection site. Warm to touch
Rash on right side of neck; This is a spontaneous report received from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration on the left arm on 13Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients concomitant medications included bupropion (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). On 13Mar2021, at 16:30 hours after the vaccination, the patient experienced a rash on the right side of the neck. The clinical outcome of the event rash on the right side of the neck was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Patient complained of feeling feverish and mild headache after receiving the Janssen vaccine. He was seen by a medical provider on 12/22/21, and his vitals were within normal limits except mild tachycardia (100-113 bpm). He received Ibuprofen for symptomatic treatment.
I wish to report a reaction to the flu shot administered around 2:00 p.m. on October 29--something much worse than just feeling like I have caught a cold.  I was at Bell Choir practice (7:00-8:00 p.m. on Monday) and my throat became excruciatingly sore--like a burning furnace.  A cough drop was of no help at all; however by the next morning my throat felt back to normal.  I tried to talk to my daughter and granddaughter on the way home and couldn't get more than two words out and then gagging.  This continued all the way home--some 15-20 miles.  I didn't try talking and the problem disappeared by the next morning.  My mouth became exceedingly dry and my lips swelled.  The inside of my lower lip still feels "spongy" and the gums continue to hurt when I brush my teeth--especially the lower teeth.  This has not disappeared.  (I had a thorough dental exam and teeth cleaning on October 4 and there were no problems then).
Received 2nd dose of Moderna in left arm on 1/26/21 and on 1/29/21 redness, swelling, and warm to touch noted to all of the left arm including around the elbow.  Unsure if the injection site was muscle or subcutaneous.  Benadryl one time only dose ordered by NP and cold compress also ordered on 1/29 and area circled with marker.
headache, chills, fatigue, body aches, dizziness, nausea. Took tylenol.
9/22 + 9/23 Light headed, 7 AM - 9/24 Sat. Light headed - server - can't walk straight, felt like left side of head - empty, vomited 1 PM, Sun. 9/25 - Felt a little better, Mon 9/26 - Didn't got to  work - still light headed, not safe to drive, 9/27 Return to work, fell better.
The freezer temperature was up to 14-20 deg F then back down to 5 deg F.
Six hours after vaccination patient experienced pain and redness at vaccination site. She self treated with TYLENOL 500mg every 6 hours with no reduction in symptoms. She was advised to go to doctor to treat cellulitis by RPh on duty (came to pharmacy 72 hours after receiving vaccine).
Baby was fussy in the evening after the vaccines and woke up febrile @ 3:00 a.m,, temp 101.
Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 0.5 ml RECOMBIVAX HB (lot # K004989, expiration date 14-NOV-2015), intramuscular which was exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
On  day 9: slight itching at injection site  On day 10:  severe pain, especially lower back                           Continuous head shaking                           Feeling of chest compression, pressure                          Difficulty taking a deep breath                          Rapid pulse (90s and 100+ at rest)                          Decreased oxygen level  (below 90%, 94% at highest)                         Severe fatigue                         Explosive diarrhea                          Increased edema, especially hands, abdomen, and feet  Days 11-12:   Same symptoms but less severe  Day 13:  Most symptoms gone except back pain and fatigue                     Injection site warm for first time  Day 14:  All symptoms gone except fatigue
This spontaneous report was received from a other health professional (nurse) refers to an unspecified number of patients of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date all patients were switched to PEDVAXHIB in 4-dose series (dose, frequency, route of administration, lot # and expiry date not reported) rather than 3-dose series as recommended. No concomitant medications were reported. On an unknown date, patients were switched to PEDVAXHIB from ACTHIB which was given in a 4-dose series. No adverse effects were reported. Outcome of the events were not reported. No product quality complaint was reported. Causality was reported as not related to PEDVAXHIB. Additional information has been requested.
pt stated that was feeling dizzy but feels better now;02 sat 98%, P120, BP 140/82, RR 16;
pt was given an expired moderna bivalent lot# ...lot expired on 06/01/23 and was given 06/16/23
Patient started getting a fever and headache 1 day after receiving vaccination. Patient treating fever and headache with over-the-counter acetaminophen which has been helping with both symptoms.
pt recv 2 doses of vax 30NOV95 & 12FEB96 & prior to vax measles vax on 6JUL96;27MAR96 pt exp failure to seroconvert (ELISA 0.86);