chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So on 03FEB2023 I started feeling really really tired and I had had a known COVID-19 exposure I initially tested negative in the evening but the next morning I had a positive test but my husband tested negative later he tested positive on a molecular test.  At that point I set up a telehealth appointment  to try and get Pacxlovid appointments and we had no contra indications so I wanted Pacxlovid and wanted our children to not get the virus. We did our telehealth appoint and were prescribed Pacxlovid and we were able to get that Prescription late 04FEB2023.  I was very tired and it was hard to get up to do anything.  I took my first dose late 04FEB2023 in the afternoon , the next morning I had less fatigue and a mild sore throat on 05FEB2023 I felt more up to doing things and by 06FEB2023 we both felt pretty much fine and started back to work.  I did to have to miss any work due to Pacxlovid it is a wonder drug.
1 of 3 pts vaxed from the same vial who devel a fever of 103-104 & was very irritable w/persistent crying w/in 24hrs following vax;pt recvd vax 13MAR95;required MD visit;treated w/APAP;recovered w/no sequelae
chills, body aches, angry red raised bump at injection site about the size of a ping-pong ball
This spontaneous report as received from a pharmacist refers to a 49 year old female patient. No current condition was reported. No historical medication was reported. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23, lot number reported K0004542, expiration date- 19-AUG-2015, subcutaneous in the right arm. Patient received PNEUMOVAX 23, subcutaneously along unspecified influenza shot in her right upper arm. Concomitantly patient received Tetanus Toxoid in her left arm on 01-OCT-2014. On 02-OCT-2014, 2 days after onset of therapy the patient experienced pain in her right arm. Patient stated that she can hardly lift her right arm. The swelling is spreading under her arm toward her arm pit. Treatment given for adverse event was reported as no. The outcome of pain in her right arm and swelling is spreading under her arm toward her arm pit was reported as not resolved. No additional information was provided at time of call. No product quality complaint was (PQC) involved. Additional information has been requested.
Patient received two additional Pfizer vaccinations.  Patient did not report that she had been given previous Pfizer vaccinations on 1/24/21 and 2/14/21 while being admitted at a skilled nursing facility.  Patient reported only sore arm and body aches after receiving most recent Pfizer doses on 4/21/21 and 5/12/21,
This spontaneous report was received from a healthcare worker regarding his sister of 17 year of age. The patient has DDAVP (reported as DDAPT-bedwetting medication) allergy. No medical history was reported. On 21-JUN-2013, the patient was vaccinated with first dose of GARDASIL (lot#, expiry, dose, frequency not reported). No concomitant medications were reported. On 21-JUN-2013, the patient experienced grand mal seizures within 45 seconds after receiving the first dose of GARDASIL. The patient's mother held her head still, and then the patient got her blood pressure checked and breathing checked. Laboratory diagnostics studies performed was none. Patient sought medical attention (doctor's visit). The outcome of the event grand mal seizures was not recovered. Patient's brother stated that the patient had not experienced any subsequent seizures. Upon internal review the event of grand mal seizures was considered to be medically significant. Additional information has been requested.
BLOOD LINES BELOW NAIL TO END OF MIDDLE AND RING FINGER; FINGER SWELLING TO BOTH HANDS/RIGHT HAND SWOLLEN; LEFT ARM PAIN; FEVER; PAIN BELOW SHOULDER BLADE; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced pain below shoulder blade. On 22-MAY-2021, the subject experienced blood lines below nail to end of middle and ring finger. On 22-MAY-2021, the subject experienced finger swelling to both hands/right hand swollen. On 22-MAY-2021, the subject experienced left arm pain. On 22-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAY-2021, was recovering from finger swelling to both hands/right hand swollen, had not recovered from pain below shoulder blade, and blood lines below nail to end of middle and ring finger, and the outcome of left arm pain was not reported. This report was non-serious.
Soreness in upper left side of arm where vaccine was injected. Similar feeling to getting soreness in arm after a flu shot.
"Covid Arm"- a week after my initial shot I was getting ready for bed when my arm/injection site started itching slightly. When I woke up the next morning I had a sizeable welt on my arm that was very itchy and extremely hot to the touch, like a sun burn. It has subsequently receded into a ringworm like border around the outside of the welt surface. It is still itchy and that border portion is hot still. The majority of the welt has disappared.
rash on left side of the face; chills in her hands; Case reference number MOD-2021-008781 is a spontaneous case report sent by a Non-Health Professional on 18-JAN-2021, which refers to a Female aged 78 Years .  On 15Jan2021  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. 2 days later, the patient developed chills in her hands, the patient also developed rash on left side of the face.    The Non-Health Professional did not declare any relatedness between chills in her hands and Moderna COVID-19 Vaccine In their opinion,   PMH includes Covid infection in May2020. No further information provided. Caller consents to follow up.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 78 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Patient given 1 dose of moderna prior to turning the approved date of 18 years of age. Second dose due one week prior to 18th birthday.  Will be given following birthday.
REDNESS, SWELLING AREA ABOUT SIZE 2"X4", ITCHING, FEVER. ON 4/25/14 LARGER RED AREA WITH SORENESS UNDER ARM ALSO. HARD AND HOT TO TOUCH. CONTINUED SORENESS.
Fatigue, chills, dizziness, irritability, sore muscles, headache, fever, loss of appetite, restlessness from the soreness. Deep sore pain at injection site and sore muscles throughout body.
Got the flu shot 20 years ago and was sicker than a dog; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from the patient.  This case involves a patient (age and gender unknown) who got the flu shot 20 years ago and was sicker than a dog (illness), while the patient received vaccine Influenza vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu shot 20 years ago and was sicker than a dog (illness) (Unknown latency) following the administration of Influenza Vaccine.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
This spontaneous report as received from a pharmacy student and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified pediatric patients received adult doses of VAQTA 25/0.5, lot#N016805, expiry date: 04-SEP-2018 (dosing details, anatomical location and route were unknown) and multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), (Captured in MARRS 1708USA003180). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error. No adverse effects were reported. No product quality compliant (PQC) was present. Outcome of events was unknown. Follow-up information was received from the supervisor (other) on 14-SEP-2017 concerning a 14 year old patient. On 17-JUL-2017, the patient was vaccinated with the adult dose of VAQTA as opposed to the pediatric dose because of product confusion. This is one of the several reports received from the same reporter. Patient demographics, product details, event, reporter and narrative were updated. Sender's Comments: US-009507513-1708USA003180: US-009507513-1708USA003849: US-009507513-1708USA003180.
Symptoms  within 15 minutes of vaccination.  Staggering, flushed and dizzy.  Low pulse.  Passed out while sitting in the chair while waiting to go to ED.  Regained conscious within 1 minute, disorientated, complaining of chest pain.  Taken to ED  - thought to be a vasovagal episode.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were given. No treatment information were provided.   This case was linked to MOD-2021-410313 (Patient Link).
Vaccination adverse reaction/ severe reaction; Could not get out of bed; Held on to walk a few feet to bathroom; No appetite; No sleeping; A bit dizzy; Weak; Vomiting; Nausea; Tired; Fever of 101 for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite) and INSOMNIA (No sleeping) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction/ severe reaction), VACCINATION COMPLICATION (Could not get out of bed), GAIT DISTURBANCE (Held on to walk a few feet to bathroom), DECREASED APPETITE (No appetite), INSOMNIA (No sleeping), DIZZINESS (A bit dizzy), ASTHENIA (Weak), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Tired) and PYREXIA (Fever of 101 for 3 days) outcome was unknown. Not Provided          No concomitant medication information was provided.  No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received, contains information about the events occurred.
11 hours after the vaccination I got sudden and uncontrollable shivers as if all of my bones were frozen and I was cold from the inside out and my body felt swollen all over but it wasn't. I kept adding more clothing and blankets and finally fell asleep for a couple of hours. Then more blankets. I was still cold in the morning but not uncontrollably. Then a headache hit and all I did all day (the day after the vaccination) was sleep and sip water. I felt slightly dizzy and nauseous that night but nothing significant and those symptoms went away by Wednesday morning. Wednesday and Thursday were periodic sluggishness and napping. Friday morning, 4 days since the vaccination I awoke feeling fine.
Information has been received from a physician concerning her daughter who in December 2010 was vaccinated with a dose of PROQUAD (Merck). At the same time of vaccination she received amoxicillin. It was reported that "last week", the patient was admitted to a hospital by a pediatric dermatologist because she had a rapidly progressive EM-like eruption with early mucosal involvement. They were worried it was STEVENS-JOHNSONS spectrum and she got admitted with the thought they might be doing Intravenous Immune Globulin (IVIG). Luckily, it arrested itself after only a few oral macules appeared, but it was very scary. The patient's mother had a little fear it was a Drug Rash with Eosinophilia and Systemic Symptom (DRESS) like thing, because her hepatic function tests (LFTs) were elevated and her platelets were low (and she was febrile to 102.5), but her skin was never tender. The patient's mother stated that laboratories were repeated last Friday (31-DEC-2010) and luckily they all normalized, so hopefully they were just reactive. It was reported that "it was so horrible - she looked terrible". She had 80-90% BSA involvement when it peaked so if it had progressed "it would have been a disaster". The trick was that at first, she had a fixed-drug looking plaque at her vaccine site, but since it was the PROQUAD (Merck), the patient's mother was thinking it was a local varicella reaction. Then, a few days later she had a disseminated mild eruption (of course kept giving her the amoxicillin not thinking that it was related) that the patient's mother was wondering was measles-related. The next day she woke up and it was certainly not measles - she looked horrible, with facial swelling, and cervical lymphadenopathy. The patient's mother was just glad her daughter was fine. This is one of two reports received from the same source. No further information is available.
At 1000, pt feeling shaky, "different", feeling like going to fall. At 1050, lips itching, pruretic macular red areas on neck, no SOB. At 1115, scratchy throat. At 1125, scratchiness gone. At 1145, symptoms have ceased. At 1105, Sdrimedrol 125mg IV, Benadryl 25mg IV. Then Prednisone 6 tabs this afternoon, then 5,4,3,2,1.
Chills, joint pain, fatigue, rash pain at injection site.  As of 1/12/21, rash has not subsided.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK150390 for same patient. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018145428 and US2018GSK150388, reported by the same reporter.
received only first dose/Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received only first dose/Longer than Recommended Interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-May-2023 The pharmacist would like to know if the patient would have to restart the series. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 11 years before reporting date). On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: About 2 weeks before reporting date, the patient developed a shingles rash on the left side of his body. The patient was seen by dermatologist and diagnosed with shingles. The shingles was resolving but had not cleared up till the reporting time. The contact details of the physician were provided. The reporter gave consent to follow up.
rash appeared 12 days p/vax given; started as sl rash then turned to bumps mainly on face; they resolved in approx 7 days & other side effects
8/10/22 pt brought to ED from nursing home via EMS for hypoxia; O2 saturations in the 70s; intubated; hypothermic and hypotensive; given vasopressors; recent hospitalization on 7/13/22 for UTI and COVID infection and COVID pneumonia; treated with Rocephin; code stroke called; pt's condition deteriorated and she passed away in the hospital
injection site was swollen; arm was sore; red dot appeared at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (arm was sore), VACCINATION SITE ERYTHEMA (red dot appeared at the injection site) and VACCINATION SITE SWELLING (injection site was swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced AXILLARY PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (red dot appeared at the injection site).   On 11-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen).   At the time of the report, AXILLARY PAIN (arm was sore), VACCINATION SITE ERYTHEMA (red dot appeared at the injection site) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Localized redness and swelling of injection site.  Approxiate size 5cm x 3cm.  1 cm -2 cm swelling.  Diarrhea post injection x 3-4 times, same day.  Slight low grade fever.  Pain and continued tenderness.
HAIR LOSS AFTER COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT). At the time of the report, ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) had not resolved.     Concomitant medications were not reported.  It was unknown if the patient was enrolled in the COVID-19 vaccine trail.  The reporter causality for the event ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) was no reasonable possibility.  Treatment information was not reported.   This case was linked to MOD-2022-591492 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-JAN-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On an unknown date in 2015, the patient was treated by a physician for her painful symptoms and was diagnosed with herpes zoster or shingles. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.