chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # was reported as "L032761" exp. "24-FEB-2017", (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, was very, very cold but had normal temperature, very thirsty,   Headache, nausea, night sweats.  Injection site soreness, more than my collogues.  The lymph nodes in my injection site armpit and breast area were very, very swollen and painful, could not reach for or lift light objects without considerable pain for two days.  Was able to reach and lift by third day and lay  on my side again but still sore and swollen.
redness and swelling from their deltoid to elbow; redness and swelling from their deltoid to elbow; This spontaneous report was received from a physician via company representative regarding a 62-year-old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The physician described that on an unspecified date in October 2019, (also reported with in the past month) an unspecified patient vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) via intramuscular, lot # S012246 with expired date 10-FEB-2021, (strength, dose, route, were not reported) for prophylaxis. On an unspecified date in October 2019, (also reported on an unknown amount of time) the patient had redness (erythema) and swelling from their deltoid to elbow (peripheral swelling) and patient treated with unspecified antibiotics. The patient wanted to the doctor's office and there was no over dose, cancer and product quality complaint. The outcome of erythema and peripheral swelling was reported as recovered. The causality assessment was not provided.
Patient felt tired night of the vaccine.  Next morning getting out of bed she was shaky and had difficulty standing.  TEMPERATURE WAS 100.  She was evaluated in the emergency room.  Blood work was unremarkable.  She was evaluated  in the office by me on 10/19/21.  She reported feeling just a little bit better.  She appeared ill. She is tachycardic, blood work showed leukopenia and thrombocytopenia as well as elevated LFTs (mild).  Creatinine was slightly elevated above her normal baseline.  (Metformin had been stopped the ED because she received a contrast study for evaluation of possible pulmonary embolism-(had mild tachycardia and complained of some shortness of breath).  COVID testing was negative.  Repeat blood work 2  days later: Improved white count to normal, platelets improved but not normal yet, Transaminases  still abnormal in the 90s.  She is starting to feel better but still very tired and a little bit dizzy.
Fever; Chills; Malaise; Headache; This is a spontaneous report from a contactable health care professional (Pharmacist) reported for himself. A 29-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number:ER5318) via intramuscularly, administered on left arm on 25Jan2021 (at 13:30) (age at the time of vaccination was 29-year-old) as Dose 2 single for covid-19 immunization. The patient had medical history of Illness: Covid 19 from 05Apr2020 to 10Apr2020.On 11Nov2020, the patient was tested positive for SARS-Cov 2 (Covid-19) antibody Test. Historical vaccination included the patient received first dose of bnt162b2 (Formulation: Solution for injection, Batch/Lot number: EL1284, via intramuscularly administered on left arm (age at the time of vaccination was 29 years) on 04Jan2021 for Covid-19 immunization. On 26Jan2021 (at 01:00), the patient experienced Malaise, Fever/Chills and Headache. There was no treatment received for the events. The outcome of the events Malaise, Fever/Chills was resolved on 26Jan2021 while the outcome of the event headache was resolved on 30Jan2021.  Causal relationship: Is there a reasonable possibility that events Malaise, Fever/Chills and Headache was related to suspect products: Yes  The patient provide information to you regarding the reported adverse event with use of the Pfizer product and consider the Pfizer product had a causal effect with the adverse events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Moderna COVID-19 Vaccine EUA.  I had body chills and nausea from midnight to 3am then 101 fever which lasted until 5pm on wednesday May 5.  On Thursday May 6 I woke up feeling normal again
Fever (2 days, evening time only), body aches (evening time_2 days), headache (day 1, a couple of hours), sensitivity in area shot administered (sore for 3 days but going away 4th day)
NURSING HOME WAS NOT INFORMED THE RESIDENT HAD A PREVIOUS VACCINE BEFORE ENTERING FACILITY.  THEREFORE THE RESIDENT RECIEVED #2 DOSES OF MODERNA VACCINE AND PREVIOUS DOSE OF PFIZER.  PHARMACY FOUND OUT WHILE ENTERING IT INTO THE VACCINE SYSTEM.  INFORMED HOME BUT PATIENT WAS DOING FINE.
Patient reported low grade itching almost immediately after the second dose on 3/17/21 and continued though date of incident. Headache started 3/18/21 and continued through date of incident.   While sitting at work on 3/19/21, patient reported a sudden onset of sharp pain in her left sternum. CHS Healthcare Paramedic conducted an assessment and reports no dizziness or nausea, clear breath sounds O2 WNL, non-smoker, chest pain with a deep breath and while at rest. Provided 324 mg aspirin and 0.4 mg nitro with no resolution of symptoms. Patient transported to Unity Hospital for further evaluation.
Pt. had seizure and increased seizure activity since vaccines. 1st tonic/clonic.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 08-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:
This spontaneous report was received from a female physician who was reporting on herself. No information was provided regarding the physician's concomitant medications, pertinent medical history, drug reactions or allergies. On 16-NOV-2018, during the administration of VARIVAX to a child patient, the needle was not attached to the syringe properly and as a result some VARIVAX inadvertently squirted out of the syringe and into the physician's face and eyes at the end of vaccine administration. No adverse effect was reported for the physician. On an unknown date in November 2018, the physician had the varicella titer test and she was immune to varicella. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1812USA001633:
-Extreme fatigue, malaise, muscle and joint aches, injection site pain (lasted 48 hours   -chills, nausea, vomiting every 30min  (lasted 6 hours) -4 inch raised welt at injection site appeared several days after injection and lasted about 48 hours   Was unable to work for two days after receiving vaccine
Patient said she had a history of fainting with other injections and blood draws.  She was sitting in a chair when she began to feel faint.  She asked her sister to move her to the floor to lay down.  She was out for about 3 minutes and then came to.  She sat on the floor for a minute and then transitioned to the chair.  We offered cold cloths which she refused.  She did accept an orange juice.  She was fine after waiting 15 minutes and left the store.
vial was punctured on 7May2021 and given 13May2021; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021. The most recent information was received on 19-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not mentioned.  Treatment medications were not mentioned   This case was linked to US-MODERNATX, INC.-MOD-2021-132112 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19 Jul 2021. contains reporter details, patient demographic details, suspect drug details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132112:Same reporter
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAR-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M040623 with an expiration date 31-DEC-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis.  Other suspect therapies included sterile diluent (dose, route of administration, frequency, lot# and expiration date were not reported) used to reconstitute ZOSTAVAX. No adverse reactions were reported. Administered doses of ZOSTAVAX experienced temperature excursions from 15 to 46 degrees Fahrenheit for 720 hours. There was no previous temperature excursions. A digital data logger was not involved. According to the reporter sterile diluent did not have any temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA007528.
chills; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Left breast cancer).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown. Not provided.          No concomitant medications were reported.  No treatment medications were provided by the reporter.
This spontaneous report was received from a physician via a company representative and refers to an over 65-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, route of administration was reported as intramuscular or subcutaneous injection, in arm, as an active immunization for the prevention of pneumococcal disease (dose, lot# and expiration date were not provided). On an unknown date, after receiving an injection of the PNEUMOVAX 23, the patient completely blew up in a rash. The patient saw his physician and was given an unspecified antibiotic to treat his arm. The outcome of rash was reported as recovered/resolved. The causal relationship between the events and PNEUMOVAX 23 was not provided.
After receiving booster, patient was sent to monitoring area. Approximately 5 min later patient described feeling sweaty, fast pulse, heavy breathing. Thought he was going to pass out. Patient admitted to have been drinking for past 6-7 days. Response team was called to assist. Two to three minutes later team arrived and patient had calmed. After approximately 10 more minutes after team arrived, patient decided to leave on own. Response team was comfortable with decision.
Patient presented to the ED and was subsequently hospitalized for pneumonia of right lung, Sepsis with acute hypoxic respiratory failure without septic shock within 6 weeks of receiving COVID vaccination.
30 minutes after vaccine: numbness/tingling in and around nose ; I took benadryl in the event that it was an allergy (per my dr's recommendation). It lasted about 24 hours. LEG PAIN:  About 5 hours after my vaccine, both legs were very sore/painful.  Both legs have been sore every day since the vaccine. Pain/discomfort is worse in both calves than in upper leg. Pain/discomfort is least in the morning when I wake up. It gets worse throughout the day and with movement.  After 15 minute walk, my calves are tingling/crampy. I get some relief by laying down and putting my legs up the wall.
When I got the first one my arm was itchy didn't think anything of it. When I got my second one it was itchy, and sore. The next day I looked at my arm and felt warm, and still itchy. I checked later in the day and felt a welt. When I looked at it, it was good size, and in the welt it was bumpy. It's also very hard.
Vaccine leaked during administration, patient declined to revaccinate. The amount of vaccine that leaked is unknown.
Time of vaccine: Flushing, feeling faint/dizzy, fast heart beat., feeling hot. Later that day, about 6 hours after vaccine: difficulty swallowing/dyspepsia, unable to swallow food, water without pain, narrowing of throat.
Per mother patient developed rash on left thigh where vaccines were administered the previous day. Mother denies any additional symptoms, no redness at site, only small white papules covering left thigh.
Stroke, aneurysm, currently hospitalized  PS your form will not accept accurate information. I put in vaccination date in 2023 but for some reason the form kicks it back and says that vaccine was "not available in Aug. of 2022" but I did not put Aug. 22 in for date!
Pneumovax .5ml IM in right hip given on 1/22/02 at approx. 11:00. Had a raised area at the site. Pt began to complain of pain in the evening of 1/22/02. She saw MD at 13:30 on 1/23/02 and by the evening of 1/23/02, the area had increased. She was started on Keflex 500mg and is to see MD on 1/24/02.
Reaction was shortness of breath, headache, overall weakness, non-stop coughing with constant mucous, sore chest for a couple of days due to cough, injection site on L arm just a little sore Treated reaction with home remedies - Essential Oil Breathe cough drops, diffuser and drops in CPAP machine for several nights after the reaction. Breathe ointment in stick form on his chest Physician was contacted on 1/17/2021 and doctor advised him to go to the clinic.  He did not go to the clinic due to improvement and the fact that he had an upcoming doctor appointment on 1/27/21
Dad reported hardness at injection site and reaction size of baseball per phone triage. Seen on 04/03/06 and dime size induration noted by MD around injection area and macular circular area that is mildly hyperpigmented but not red or warm to touch- approx. 4 cm diameter. mild tenderness.
pt presented to rubella sx consisting of enlarged posterior cervical, posterior occipital, posterior auricular & inguinal lymph nodes, 2 cm liver & rash on 27JUN92; parents noted fever 101-102 & enlarged inguinal lymph nodes; ear infect;
Pain and swelling injection site (L) upper arm within hours. 2-3 days later swelling of (L) forearm and rash. 2 weeks after injection swelling pain and swelling of (L) 1st MCP joint and PIP (L) index finger.
35 year old female who reports having fever, chills, body aches on the night of vaccine administration to right arm. The following day client reported swelling on right arm. Client applied ointment to site (arnica) to present.  04/03/2012 client reported with continuous swelling of right arm.  Physician visit on 04/03/2012 prescribed antibiotics where clients states relief. 04/06/2012 client present to clinic to report incident. Presently right arm appears with mild redness, no drainage, tender/warm to touch. Patient no longer experiencing  fever, chills, body aches and presently still on antibiotics prescribed.
Pfizer Tris-Suc (PFR 5-11) given instead of Pfizer 12+
Missed the 2nd  dose of Moderna vaccine; Redness; rash in the left arm / rash over outer side of left breast; big lump was almost 6 inches in size on arm; left breast was swollen; left breast was sensitive to touch; Swollen arm / arm was swollen /  swelling of the left arm/still have lump; sore arm; Feeling hot and warm / warm to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Feeling hot and warm / warm to touch), PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen) and BREAST DISCOMFORT (left breast was sensitive to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Right breast surgery). Concomitant products included clonapril.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING HOT (Feeling hot and warm / warm to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump) and MYALGIA (sore arm). On 31-Mar-2021, the patient experienced LIMB MASS (big lump was almost 6 inches in size on arm), BREAST SWELLING (left breast was swollen), BREAST DISCOMFORT (left breast was sensitive to touch) and RASH (rash in the left arm / rash over outer side of left breast). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine) and ERYTHEMA (Redness). At the time of the report, FEELING HOT (Feeling hot and warm / warm to touch), LIMB MASS (big lump was almost 6 inches in size on arm), BREAST DISCOMFORT (left breast was sensitive to touch), INJECTION SITE SWELLING (Swollen arm / arm was swollen /  swelling of the left arm/still have lump), MYALGIA (sore arm) and RASH (rash in the left arm / rash over outer side of left breast) had resolved and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Moderna vaccine), BREAST SWELLING (left breast was swollen) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication listed in Source Document was Clonapril 10 mg daily.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow up
Positive vomiting, nausea, back pain, evanescent dysesthesias, positive blurry vision, shortness of breath and facial weakness - Tx. Plasmapheresis - 9/30, 10/1.10/20/09-records received for dates of service 9/27/28/09C/O numbness in face, arms, back and belly, vomiting, headache, blurry vision and shortness of breath along with decreased taste, diaphoresis. 9/28/09 worsening numbness, continued nausea and vomiting, left flank pain, severe fatigue. Consultation, continues with facial weakness and respiratory distress, and desaturation to 78%,intubated with abnormal arterial blood gas pH of 7.11, and respiratory failure, hyponatremia and hyperkalemia, multiple electrolyte abnormalities, new onset of bruising. 10/29/2009 Consult records and Lab and Dx studies from Inpatient stay 9/27/2009-10/16/2009. Patient with c/o's facial numbness, tingling in extremities, Neuro exam noted dec DTR's, dec sensation pinprick, temperature. EMG anormal with Dx of GBS. Tx: intubated for resp distress, IVF, IV ABX, C-section done.  12/09/09 DC summary for DOS 09/27/09  10/16/09. Final DX:  GBS.  Pt c/o generalized weakness, back pain, L flank pain, chest pain, SOB, changes in taste and sensation, diaphoresis, headaches, insomnia, facial weakness. On examination: Pt lethargic, worsening of weakness, lost bladder function. On 09/29/09, Pt tachypneic, SOB, anxiety, low oxygen saturation. Emergent intubation initiated. Pt transferred to ICU. Pt developed metabolic acidosis with hyponatremia and hyperkalemia.  On the same date, Pt underwent an emergent C section due to decelerating fetal heart beat and delivered a viable baby. Tx: plasmapheresis. Pt's respiratory status and weakness improved.  Pt discharged to a rehab center.          ICD-9 codes: 648.91, 518.81, 357.0, 358.0, 507, 446.6, 276.7, 276.1, 276.2, 788.30, 648.41, 670.22, 300.4, 296.90, 306.9, 659.71, 647.91, v270, v025.1, 356.9
Shingles; Information has been received regarding a case in litigation concerning a female patient (pt) of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and/or zoster-related conditions (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date (reported as subsequently after zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. It was reported that as a direct and proximate result of the pt's zoster vaccine live (ZOSTAVAX) vaccination, she had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the pt had not recovered from shingles.  The event shingles was considered as related to zoster vaccine live (ZOSTAVAX).