chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased levels of liver enzymes; This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC ENZYME INCREASED (Increased levels of liver enzymes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Increased levels of liver enzymes). At the time of the report, HEPATIC ENZYME INCREASED (Increased levels of liver enzymes) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.
Patient presented with erythema and injection site warmness starting the day following injection. By 3 days post injection rash was improving.
Pt. describes soreness in (L) deltoid for 2 wks after Iz. This discomfort radiated to her elbow. This has resolved. She also has pain in shoulder (L) with movement of arm above head or across body. This seems to be resolving slowly.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 73rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-217 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
12cm x 7cm localized histaminic response, no sign of infection, no other adverse response noted, no hives.
Left shoulder loss of movement and pain. Sent for MRI and Xray 11/9. Found no pinched nerve or break. Dr. treating for frozen shoulder. Started physical therapy 11/12/2021 - 12/21/2021. Revisit with Dr still having alot of pain and loss of movement in left arm. Dr. injected saline in the shoulder capsule and sent to therapy to try and loosen the shoulder up. Currently still in physical therapy.
imbalance/balance was off; Sore arm/arm soreness; Joint pain; headache; weakness; severe allergic reactions; light headedness/lightheaded; This is a spontaneous report from a contactable consumer (patient). Follow-up received from consumer via from a Pfizer-sponsored program  on 03Feb2021 was processed together along with initial information.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced imbalance/ balance was off, headache, arm soreness (at bedtime), joint pain (at bedtime), and light headedness/ dizziness (for 9 hours). The patient reactions that she had were not typical. She also said these side effects eventually went away, but she wants to know if there have been any reports of these side effects after receiving the vaccine. It was reported that the patient was scheduled for the second dose and she was checking before getting the second dose. It was reported that she had done V-check. It was reported that on the paperwork that there was a remote chance of severe allergic reactions. Signs can include dizziness or weakness. The next day she was fine. Outcome of events was resolved on an unspecified date.    Follow-up attempts are completed. No further information is expected.
Dizziness, fainting about 8 hours after receiving dose.  The following week, possibly related or combined with other factors: diarrhea, dizziness, fainting
Pt didn't disclose previously vaccinated on 1/15/21 and 2/10/21 with Moderna COVID vaccine.
Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever , malaise and severe headache. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt also describes a sore knot developed across her rt shoulder blade approximately quarter size which lasted about a week.  Pt in bed 1 week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation.  Called MD because she thought she had the flu and was not seen by MD but prescribed erythomycin on Oct 22. Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 2 inches by one inch in size no pain. Pt questions whether the vaccine was kept adequately frozen well since they had heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. Clinic Staff were contacted for lot number and clarified that vaccine was stored transported from another pharmacy off site in a cooler with ice packs. Clinic staff also mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
pt recvd vax & later that day exp arthus reaction characterized by fatigue, weakness, nausea, diffuse arthralgias, chills, & h/a which persisted into 13AUG92; seen by MD 13AUG92 & had t102.7; PE revealed erythema, edema, & tenderness
I've had moderate join pain in my hands, arms, calves, knees, elbows.
Patient was given Pediarix 0.5ml, Plus IPV 0.5ml, Hepatitis B 0.5ml, Prevnar 0.5 ml.
The patient previously had covid. She took the shot and now has cramps, pain in her legs for 2 months.
Left upper arm just below injection site red, 1/2 dollar in size warm, firm to trunk, limitations but flexible. Parents said child c/o arm last evening. no fever. Has been giving child Advil. Apply some cold compresses. Pt presents, child looks well and is able to attend day care. I asked parent to continue Advil and to apply warmth when they can. Also asked them to bring the child back 03/10/2003.
Child complain of itching to RtUA at site where varcella vaccine given during the afternoon, mom did not look at area till late evening, area swollen and red.
Patient states she woke up feeling very nauseated and dizzy. The nausea has continued into late morning.  Her arm at the injection site feels tense and sore.
Patient was monitored for 15 minutes post vaccination as proper protocol. Patient was also called the next day (13AUG2021) and Patient was doing well.
Pt felt dizzy and needed to lay down.  Pt laid down on floor.  Feet placed up on a chair.  Series of vitals taken until patient vitals stable in standing position.  Pt drank water and OJ as he recovered.  Patient stabilized and went home with spouse.  Instructions given to seek emergency medical care if  symptoms returned.
Pt recvd 2nd dose of vax & exp pain @ the inject site & 10 mins later exp lightheadedness, palpitations, diaphoresis, dyspnea;
The patient received a Moderna vaccine at age 16 when the FDA has only authorized Moderna for patients 18 and older.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003520: US-009507513-1801USA003527: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003612.
Moderna COVID-19 Vaccine EUA.   In the evening on the day of my injection (approx 12 hours later) I noticed a 2? x 2? red spot below the injection site (not at the injection site). It was hot and red but went away about 1-2 days later. Today (7 days post injection) the spot returned. It?s in the same spot but  larger than before, hard, red, itchy and warm to touch.
Engerix -B was administered to patient after being exposed to 73 F to possibly over 216 hrs on 5/19/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 23-year-old female patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 19-MAY-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix -B was administered to patient after being exposed to 73 F to possibly over 216 hrs on 5/19/2023). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAY-2023 No reactions were reported.  The reporter consented to follow up via email. The reporter reported that the Engerix -B was administered to patient after being exposed to 73 degree F to possibly over 216 hours, which led to incorrect storage of drug.
Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, lightheadedness, swelling of my extremities, injection site soreness felt like my heart was beating irregularly, cotton mouth, decreased appetite, mental fog. These all started about 12 hours after vaccination and lasted for 2 whole days.  Additionally, on Jan 31st, I experienced numerous occasions of "pins and needles" in my feet. This went away and came back over several hours of time throughout the day on Jan 31st.  Exhaustion and mental fog have continued through 2/3, but all other symptoms have resolved.
1/25/21 - 1ST COVID SHOT 2/19/21 - MONTHLY LAB, GFR DECREASED FROM11 TO 10.      2/23/21 - 2ND COVID SHOT 3/15/21 - MONTHLY LAB, GFR DECREASED TO 9        4.14.21 - MONTHLY LAB, GFR INCREASED TO 10 5/19/21 - MONTHLY LAB - GFR DECREASED TO 8      6/21/21 - MONTHLY LAB - GFR RETURNED TO 10 I am reporting this because people with chronic kidney disease may not be doing monthly labs like me.  Recommend perform lab to check GFR for these people. Also, on 8/18/2021, i had several growths on my scalp that came up gradually sometime after the 2nd shot.  They were diagnosed on 8//18/21 as seboreheic keratosis.  Never had these in my life. I also struggled through about 4 months of extreme fatigue after the 2nd shot.
7 days after receiving J&J COVID19 vaccine, patient developed left ear pain, left sided facial numbness/droop, vertigo. Pt was seen in clinic and physician diagnosed pt with Left Bells Palsy. Prescribed 12 day prednisone course. Pt on Day 3 of steroid course today and slowly feeling better.
Site: Bruising at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Medium, Systemic: Weakness-Mild
Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.   This person received his dose on 11/08/2021 it was previously reported as 11/05/2021 case #800738. That date of service was incorrect just want to be clear it was only 1 dose on 11/08/2021 not both 11/5 and 11/8 please disregard the previous submission . Thank you
He is not feeling well; Feverish; Tired; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EW0177) on 24Jul2021 and second dose (Lot number FC3181) on 14Aug2021, both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included Attention deficit hyperactivity disorder (ADHD). Concomitant medication included  lisdexamfetamine mesilate (VYNASE) 20 mg and escitalopram 10mg and vitamins. On 15Aug2021, patient experienced not feeling well, feverish, tired, headache, muscle pain. Outcome of event was feverish is not recovered, of other events was unknown.
Persistent left shoulder and arm pain. Evaluated by Dr on 12/12/19. Currently being treated with Voltaren gel, Celebrex, and recommended exercises. Pain and limited range of motion persist.
Elevated blood pressure and obvious blood thickening. 1. 4/6/21: triggered migraine 45 minutes after second shot. could not get out of bed for 5 days. 2. 4/13/21: blood draw for annual physical. 2. 4/27/21: results of blood test showed extremely high inflammation (C reactive protein). 3. 5/5/21: tried to donate blood. flow stopped after roughly a minute. technicians pulled out a 3-inch long blood clot with the needle upon giving up on the donation. 4. 8/10/21 & 8/17/21: blood draw and test results - verified inflammation reduction. 5. 11/15/21 & 12/27/21:  Doctor visit about elevated blood pressure since 2nd shot (160/120).  Ever since second shot, i cannot exercise due to immediate exhaustion. i get winded easily.
Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Patient was anxious prior to vaccination/hyperventilating. Allowed 5-10 minutes for her to calm herself.  Injection given left arm. Patient allowed to sit in chair with RN and mother for several minutes-drank water. She stated she felt dizzy and wanted to go out to the waiting area. Mother assisted her to chair in waiting area. Patient unable to stand/syncopal episode. Patient alert after incident, and transferred to chair. VS: BP: 98/56, O2 sat: 99% and HR: 60. Gave patient a sugary drink. Approximately 5 minutes later repeat B/P: 124/64.
AFter 15 minutes of waiting, patient reported feeling a "heavy head".  BP 140/72, HR 58-62, O2 sat 94-96% RA. Non diaphoretic. Pt alert and oriented, calm. Remained seated. Denied dizziness. Drank 2 cups of water. Pt took Tylenol on her own, because " that's what I take for headaches."  Pt. denied having headache, reiterating that she felt "heavy headed". Declined further care. Observed for 15 minutes more. Pt reported feeling better, and left.
Genralized jerky movements noticed around 6 hrs p/vax; no fever; pt was awake during & p/the jerky movements;
Swollen lymph node, tenderness in muscles, sore/achy muscles, limited range of motion
was in the shower and fell and bashed her face; was in the shower and fell and bashed her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURE UNKNOWN). The following information was reported: FALL (non-serious), FACE INJURY (non-serious) and all described as "was in the shower and fell and bashed her face".  Additional Context: The report is cross referenced to report ID: QLX7E9PJ Caller is calling about the COVID-19 vaccine that Pfizer gives kids under 18. She is calling about her now 16-year-old son that now has a heart condition. She states people are suing for this. Caller reports her son got the COVID-19 vaccine and now has a heart condition. Caller states she is so angry.  She reports this person was a 14-year-old girl who was in the shower and fell twice and bashed her face a week after the booster COVID-19 vaccine.  Caller states let me talk to the attorney about whether she can complete a safety report. She states she is unsure of what she can and cannot say. She states she will call back are file a report once she speaks to her attorney.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 5DEC96 & 13AUG97 pt exp a nl case of chickenpox w/about 200 lesions;7OCT97 pt presented to MD who stated the lesions never really cleared by that time & the scabs became infected;
I was extremely lethargic, severe chills and headache.  Had a bad cough that worsen to the point I almost went to the ER on 4/5.  I was struggling to breathe.  Same symptoms I had in Jan 2020 when I was sick.  A friend brought a nebulizer over and I used that for some relief.  Today my primary called in a refill on the same inhaler I had to use in Jan 2020
Seven days after the COVID booster injection I developed a head cold followed by flu like symptoms including fever, and chills.  After second day I conducted an at home COVID test which was positive, my wife who was vaccinated the same day also came down with similar symptoms and tested COVID positive the same day using a different test manufacturer.  I am at day four and am still experiencIng  flu like symptoms, fever has subsided.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 01-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
I developed the rash on the inside of my elbow about an inch and half in circular; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medications included lisinopril for blood pressure high. Patient stated she was keeping that under control with lisinopril. Patient stated she took bnt162b2 because she didn't want to die. Patient stated she got the vaccine shot on and 08Jan2021 and just this evening she developed the rash on the inside of my elbow about an inch and half in circular. Patient was fine, she meant it's just a skin rash nothing itchy. No treatment received in response to event. Outcome of the event was unknown.
At the injection site, there was a red rash & bump under skin. Vomited day after. Vaccine given slightly under in area. Cephalexin TID X 7d for treatment. Cool compresses
Patient presented to the hospital after falling, confusion, weakness and trouble getting around.  She was admitted for severe hypercalcemia with suspected hyperparathyroidism.  Patient was tested as part of a discharge plan to an ECF and found to be positive for COVID-19 on 1/26/22.  Previously vaccinated with Pfizer 6/18/21 & 7/10/21.  Discharged from the hospital 2/3/22
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 06-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to a 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
got sick at the same time; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick at the same time) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (got sick at the same time). In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, ILLNESS (got sick at the same time) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant medications were reported. Treatment none was reported.   This case was linked to MOD-2022-437834 (Patient Link).
Became feverish with severe joint pain. Took ibuprofen and began to feel better after six hours.