chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 3 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 10-MAY-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot # N024566 with expiration date 07-SEP-2019, (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of Oka/Merck VARIVAX was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001197: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447.
This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 3 of 5 (see case IDs A0885547A, A0885964A, A0885966A, A0885967A for the other reports).
patients may have been administered improperly stored vaccines; This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patients may have been vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot# S012468, expiration date; lot# S017245, expiration date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot# S015462, expiration date 20-MAY-2021 for prophylaxis (exact doses, routes of administration and anatomical locations were not reported for all vaccines). The vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 2 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. It was unknown if the diluent used to reconstitution of the vaccines was properly stored.  Follow-up information was received on 30-MAR-2020, a phone call request was made for administration dates and patient identifiers for those unspecified patients who were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) or varicella virus vaccine live (oka/merck) (VARIVAX) which had undergone temperature excursion.  Follow-up information had been received from a healthcare professional on 06-APR-2020. This report refers to a currently 4 years old female patient (patient identifiers were missing in the previous report). The patient's concomitant therapy included diluent.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA001910: US-009507513-2004USA002003: US-009507513-2004USA002008:
Moderna COVID-19 Vaccine  Fever, body aches, chills. Treated with acetaminophen, ibuprofen, and aspirin. Symptoms resolved in 48 hours. Left arm soreness, injection site swelling, redness, tenderness to palpation, skin around injection site itchiness, and warmth to touch. These symptoms present on 05/21/2021, and progressed throughout 5/22/21. Also treated with acetaminophen, ibuprofen, and aspirin. Used over the counter cortisone cream to address skin itchiness which provided short-term relief. Swelling , general left arm soreness, and warmth to touch nearly resolved on 05/26/2021. Slight red discoloration about the injection site remains as well as skin itchiness, and tenderness to hard touch/pressure.
Pt. c/o achiness, chills, fever of 101.2 and malaise - day 2 had mild rash on forearms. By day 3 all symptoms gone, only treatment was Advil for fever and achiness.
IM given in left arm 3rd dose. (Booster). Moderna Covid-19 vaccine Lot 05C21A given was removed from freezer on 10/6/21 @ 11:45 am.  Given on 11/5/21,out of time range.  Patient contacted that evening. Moderna manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let her know that Moderna let us know the vaccine was viable, no additional booster vaccine is required.
SHINGRIX caused patient allergic reaction, rash on all over her body, arms, trunk, face. She took OTC diphenhydramine, then the symptoms are getting better.
Extreme headache, body aches, nausea, pain at injection site and fatigue were experienced starting 12 hours after vaccine until 72 after vaccine. OTC ibuprofen used to somewhat manage headache and pain but didn?t fully resolve until after 72 hours had pasted.
In January 2022 my  husband noticed problems with my speech, went to doctor and after scans they found I had 3 CVA events. Currently taking medication Crestor, speech therapy, physical therapy, and continuing to work through headaches.
Child was immediately upset after shot and remained upset the rest of the day. He was fussy and irritable. He ran a low grade fever for 3 full days afterwards. A small lump was under the skin at the site of the injection in his Left Thigh. It became a hard little bump that stayed put for 3 months and was present at his 15 month check up. Child regressed in speech from 10 crystal clear words down to only 5 in 3 months time. Further regression down to only 3 words by 18 months time.
This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of Administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced increased fever (outcome: not reported). Linked Case ID(s): US-BEH-2017077450 (same patient). 06-Mar-2017 (System Update): Linked Case ID(s): 2017077450 (Patient Link).
Patient woke up morning after immunization with redness and hives on the arm and itching.
ErythemaMultiform & Palpitations Narrative:  Employee reported itchiness and burning at vaccine site. Redness was noted. She was also complained of heart palpitations and eye redness. Benadryl 50mg IM administered. She did not want to go to the ER. Husband was called to pick her up.
A nurse reported that the patient inadvertently received an injection of Acel-Imune instead of Td on 8/15/00. The next day patient developed an injection site reaction characterized by swelling and tenderness. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 462-355. Additional information received 8/21/00 indicated that the patient was "doing fine."
Patient called pharmacy on 4/8/20 to inform the manager that she thinks the flu shot administered on 3/6/20 was placed too high on the shoulder, impacting her shoulder joint. She has been in excruciating pain starting a few days after administration to the point where it is difficult to raise arm above her head to get dressed. Her primary care physician agreed with her assessment and prescribed a round of prednisone but patient did not get much relief.
Patient was admitted on 1/31 with complaints of worsening shortness of breath with minimal exertion. Initial COVID-19 test was negative. She was tested again on 2/8 pre-operatively and was found to be positive.
This spontaneous report as received from a physician and medical assistant refers to a 23 year old female patient. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date a long time ago the patient was vaccinated with series of GARDASIL (strength, dose number, lot number and expiry date unknown). No concomitant therapies were reported. Patient vaccinated with series of GARDASIL with different provider's office and patient had unprotected sex. On an unspecified date the patient experienced some pain and vaginal dryness. Patient was seen in office for medical attention to the events and an unspecified laboratory work was performed which showed that she was positive for unspecified human papilloma virus (HPV) Type. Action taken was reported as not applicable. The outcome of vaginal dryness, positive for unspecified HPV type and pain was unknown. The reporter did not provide the causality of vaginal dryness, positive for unspecified HPV type and pain to GARDASIL. No other information was available. Additional information has been requested.
Patient was vaccinated with an undiluted dose of Covid-19 Pfizer immunization.  I called patient and let her know of our mistake and told her that the dosage given was not harmful, but she may have an extremely sore arm.  She stated that she did have sore arm with swelling.  She took Tylenol and it relieved her symptoms.  She states that she is doing great.
This spontaneous report was received from a nurse prescriber (also reported as nurse practitioner) concerning a multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of M-M-R II (dose and route were not reported) lot # M000768 with expiration date 05-JAN-2018 and lot# K024825 with expiration date 02-DEC-2016, which was stored at 8.6 Fahrenheit Degrees for 1 minute, 6.5 for 1 minute and 47 Fahrenheit Degrees for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several reports from the reporter. Additional information has been requested.
Swelling/redness/warmth 4 inch circumference. Starting approx 2 inches BELOW injection site and extending downward toward elbow. Look like increased immune response and not infection.
Pt presented to hospital with a generalized seizure; hx of Alzheimer's, aphasia and hypothyroidism; O2 at 70-75% on room air; pt placed on comfort care and treated with Roxanol prn
3rd dose has not yet been administered; First dose / on 31-7-2019 and got another 6-11-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 31st July 2019).   On 6th November 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th November 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for the 3rd dose. The patient got another dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient had not received third dose which led to incomplete course of vaccination. The reporter consented to follow up. No additional information was shared.
30 weeks pregnant at time of receiving vaccine. Estimated due date May 20, 2021  Had dull headache immediately following vaccine. At 4pm I had chills and then started having contractions every 5 minutes. I called my OBGYN who recommended that I drink fluids and lay on my side to decrease the presumed Braxton Hicks contractions. This did not decrease the contractions. I came to the hospital where I was admitted to labor and delivery with contractions 2-4 minutes apart and a 99.6 degree temperature. I was given an oral medication to stop the contractions, a 2 part series of injections to speed up lung development of my unborn child, and IV fluids were administered.
Confusion (encephalopathy) and fatigue.  Onset about 10 hrs after shot.  Did not know how to dial a cellphone, did not realize I did not have glasses on, sent pt prescription to wrong pharmacy.  Was also extremely fatigued. Slept most of 1/14/21.  Confusion resolved 1/15/21, but still tired although better by 60% at 10 am on 1/15/21.
I had Atrial Fibrillation on the morning of Apr 12th. I have never had any Afib before this event. My heart was in AFIB for about 3 hours when it returned to normal by itself. I had to go to the emergency room where they took my EKG and was diagnosed as AFIB by my cardiologist (contacts above)
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 16-Jul-2022).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot was MOD. Patient was administered with full dose.  No treatment medication was reported by reporter.
Wednesday vaccinations at 3:45. By 4:30 fever of 102, doesn't rise and dips some so no treatment. Thursday 6 am 102 fever, ibuprofen. Thursday 12:15 pm 102 fever, ibuprofen. Fever doesn't come down and is up to 104.3 by 4:30. ER visit Thursday night, fever spikes again while there. Flu test neg, blood work normal, IV fluids given and prescription for antibiotic because of concern of infection at injection site. Site of Prevnar injection is red and extremely sore to the touch. Patient violently shakes when Dr presses injection site and shakes even if his leg is moved.  Friday am still 101 fever, ibuprofen  Fever breaks at 8 am, pool of sweat under him in bed  11:00 nurse says 98.5 fever 11:30 fever up to 103.7 11:45 Tylenol given at dr office 3:00 101 fever 2.5 ml ibuprofen  4:59 fever may be breaking. He's sweating profusely
Moderate to severe vaginal bleeding starting approx 24 h post inoculation. Duration 72 hours.
pt exp coughing, wheezing (asthma like sx), migraine, abscessed tooth within 24 hr
sore arm; Chills at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   Reporter did not allow further contact
rt thigh immed swelled p/IPV;massaged w/cotton ball;swelling dec sl mom instructed to apply cool compresses to leg;
heavy bleeding; female problems; became anemic; had hair loss; This spontaneous report as received from an office manager via a company representative refers to a 17-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (employee was unable to verify) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.     On an unknown date, reported as 1 month after receiving suspected vaccine, the patient started having female problems, heavy bleeding, became anemic and had hair loss. It was unknown if the patient sought medical attention or if she received any treatment.  The outcome of the events was unknown. Causality assessment was not provided.
Tested positive with home antibody test on 02Jun2022; Tested positive with home antibody test on 02Jun2022; Patient had fever; Chills; Stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE, solution for injection), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 02Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 02Jun2022, outcome "unknown", described as "Patient had fever"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "unknown", described as "Stuffy nose"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Tested positive with home antibody test on 02Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative, notes: Nasal Swab; (02Jun2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, pyrexia, chills, nasal congestion. Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination: No. Covid tested post vaccination: Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the latest shingles shot I began to feel nauseated that night and about 6 the next morning I passed out twice in the house.
Several months after receiving the second shot I started experiencing muscular weakness, then joint stiffness, then both plus pain and swelling. It got so bad I couldn't get out of bed in the morning and get dressed. In Dec2021 I had FESS sinus surgery and part of the post surgery treatment included a six day course of steroids. By day two all my muscle and joint symptoms were gone, but they came back within a month. Another dose of steroids for my sinuses yielded immediate relief for my joints and muscles again. Prior to these problems I walked at least a mile a day in our neighborhood or on our treadmill plus I utilized my Sneakers Program at a local gym a few times a week. After the symptoms came.  came back again and after discussing the problems with my physician I decided to start a very slow introduction of Ibuprophen, first one pill a day and then two. Within a couple of days the symptoms were around 75% gone and I'm living with it because I don't want to go back on steroids. There is no history of joint or muscle problems in my family history and prior to this I could sit on the floor with legs crossed and stand up without using my hands. I can't prove this was caused by the vaccine but the timing is quite suspect as there were no other probabilities.
PT GOT RASH ON HER UPPER CHEST AND BACK. SHE USED BENADRYL CREAM AND TOOK BENADRYL CAPSULES.
While I was on vacation  started having shortness of breath.  I was unable to walk up stairs or uphill.  I thought it may just be issues with elevation.  I had nausea.  On our way home, 4 days later, I was very tired and assumed it was changing time zones.  As it turns out another man I was with had COVID-19.  After getting home, I felt a bit better, but very tired.  On July 2nd, that night I woke up and had body aches all over and light headed.  I got up and then halfway through the next day I still felt the same.  I tested positive on Sunday.  As of today, my symptoms I still have fatigue and short of breath.  A lot of head congestion and nasal congestion and heartburn.  For two days, 5th and 6th, I had body aches still and a weird pain in my arms and hands.  They hurt really bad from my elbows down and a bit in my shoulders as well.  I had a fever for 2 days and it was about 101.
Extreme dizziness by 1:30. I presumed I needed air and food. Vertigo at 3:52pm. Fever by nighttime. As of next day, I am still dizzy, lightheaded, and feel weary.
do not know if related to vax, swollen inguinal lymph nodes on same side of body (lt) that shot was given (lt leg)