chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of sore arm in an 80-year-old female subject who was vaccinated with FluLaval for prophylaxis. The subject had no adverse events following receipt of prior immunizations. On 24 October 2006 the subject received unspecified dose of FluLaval in the right arm. Within approximately 3 months after vaccination with FluLaval, on an unspecified date on or after 24 October 2006 and before 16 February 2007, the subject experienced a sore right arm and was unable to lift the right arm. The subject was seen at a physician's office. The pharmacist considered the events were disabling. the outcome of the events was not reported.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included irritable bowel syndrome. On 28th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), premature ventricular contractions (serious criteria hospitalization), potassium decreased (serious criteria hospitalization) and electrolyte depletion. On 28th March 2019, the patient experienced diarrhea (serious criteria hospitalization). The patient was treated with potassium nos (Potassium Supplement). On 29th March 2019, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion were unknown. It was unknown if the reporter considered the diarrhea, fall, head injury, premature ventricular contractions, potassium decreased and electrolyte depletion to be related to SHINGRIX. Additional details were provided as follows: The patient experienced diarrhea the evening she received her first dose of SHINGRIX. The patient had severe diarrhea and continued into the night but ended by 6am the next morning. The patient fell in the bathroom, and hit her head probably due to loss of electrolytes from the diarrhea. She went to the emergency room and was kept overnight in the hospital for low potassium and because she had premature ventricular contractions (PVC's) on her heart rhythm. She was treated with potassium supplements. The patient had a follow up appointment with her primary physician on Friday. It was reported that she had a wheat challenge with a slice of bread on the day before date of reporting. She tried to determine if the diarrhea was from the vaccine or the bread. The reporter consented to follow up.
COVID-19/positive at-home test for COVID-19; COVID-19/positive at-home test for COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 4 (booster), single (batch/lot number: GH693) at the age of 42 years intramuscular, in left arm for covid-19 immunization; BNT162b2 (COMIRNATY), on 26Jan2021 as dose 1, single (batch/lot number: EL3247), in left arm, on 16Feb2021 as dose 2, single (batch/lot number: EL3247), in left arm and on 09Sep2021 as dose 3 (booster), single (batch/lot number: EW0217), in left arm, all intramuscular for covid-19 immunization. The patient's relevant medical history included: "polycystic ovarian syndrome" (unspecified if ongoing). Concomitant medication included: FLU VACCINE VII taken for immunization, on 21Nov2022 as dose 1, single; METFORMIN; SPIRONOLACTONE; JUNEL; LEXAPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2023 at 06:00, outcome "recovering" and all described as "COVID-19/positive at-home test for COVID-19". The patient underwent the following laboratory tests and procedures: microflex: (11Jan2023) positive, notes: nasal swab/at-home test for COVID. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient informed that the adverse event (COVID-19) started on 10Jan2023 at 06:00 AM and was positive at-home test for COVID-19 on 11Jan2023.
3 PM day of vaccination - arm hot, red, swelling, itching. Overnight - pain in swollen area. Weekend - swelling moving from injection site down arm to elbow. Circumference of arm increased x 2. Next 4 days - swelling, redness, reached left wrist - visit to Dr. Occasional antihistamine tablet.
Blistering; Very painful; This non-serious case was reported by a consumer and described the occurrence of blister in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included progesterone.   On 15-SEP-2023, the patient received Shingrix. On 17-SEP-2023, 2 days after receiving Shingrix, the patient experienced blister (Verbatim: Blistering) and pain (Verbatim: Very painful).  The outcome of the blister was resolving and the outcome of the pain was not reported.   It was unknown if the reporter considered the blister and pain to be related to Shingrix.     It was unknown if the company considered the blister and pain to be related to Shingrix.   Additional Information: GSK receipt date 23 Sep 2023 The patient reported that it was very painful and she would not be getting second vaccine The patient also had blistering. The symptoms were treated. Permission to contact was given.
Report 2001029903-1 describes motor tics in a 9 year old male who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee received no concomitant vaccines. In March 2001, the vaccinee received his third injection of Engerix B. One day post-vaccination, he experienced motor tics which "come and go." As of 12/13/01. the motor tics have not resolved.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness and tiredness. On an unknown date, the outcome of the dizziness and tiredness were unknown. It was unknown if the reporter considered the dizziness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received a shingles shot and experiencing dizziness and tiredness and was asking if he should be concerned.
Dizziness, feeling imbalanced on R side like he was going to fall. Pt's father never returned calls to follow-up on pts status. No other information available.
Pt received vaccines in march and April. Pt is now hospitalized on 08/07 with Covid as a diagnosis
Approx 5-10 min after vaccination with H1N1 FLUMIST client c/o severe posterior headache with tingling across posterior of headache and neck pain continued after rest and juice and proceeded to radiate down R arm. BP 142/80 and HRR 72. EMS called 15 min after onset and PT taken to hospital.
Began to feel tired, headache and achy at noon on Thursday- over 24 hours from vaccination.  Achiness, chills, muscle pain, fatigue, headache persisted Thursday afternoon and evening.  On Friday morning, began violently throwing up and continue to throw up everything attempted to eat or drink for 24 hours.  Threw up approximately 15 times.  Could not hold food down until Saturday.  All-day Saturday suffered chills, headache, fatigue, muscle aches and began to hold food and drink down. At 12 noon on Saturday began to have excruciating joint pain that progressed in right hip to the point where I was unable to walk Saturday evening.  Took one 200 mg motrin and was able to sleep Saturday night. Woke up feeling much better on Sunday morning. Still experiencing mild fatigue and moderate joint pain in right hip.
Pt. had large red area in left Deltoid, warm to touch. Tx'd with Benadryl, Tylenol and cool compresses.
My tongue felt funny. Then my throat clogged.  The paramedic took my blood pressure which became exceedingly high. The top number was over 200 and the bottom one over 160.  Then it was hard to swallow. I went to the hospital and was given intravenous steroids and benadryl.  After a while my throat unclogged and I could swallow again.  My blood pressure came down enough to go home. I followed up with my doctor. My blood pressure did not return to normal, and still has not. ( I am on a blood pressure pill now and my doctor is monitoring my progress.
Over last few months neuropathy and back pain have escalated to the point of being bedridden. I have not done anything out of the ordinary to explain symptoms. Neuropathy pain exists all day instead of occasionally at night. Can?t walk or stand for more than a few minutes at a time and back pain is non-stop, whereas before I could perform daily tasks.
Pt received KINRIX IM and Varicella Subq in R arm and MMR in L arm. Was sitting in childrens chair waiting while sibling got shots. Pat fall to floor and was unresponsive for approx 10 seconds. Was very stiff. Awake and responding normally after short time.
Weird side effect; pressure on her head; More intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Weird side effect), HEAD DISCOMFORT (pressure on her head) and HEADACHE (More intense headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis.   On 18-Mar-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. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (More intense headaches). On 04-May-2021, the patient experienced HEAD DISCOMFORT (pressure on her head). On an unknown date, the patient experienced VACCINATION COMPLICATION (Weird side effect). At the time of the report, VACCINATION COMPLICATION (Weird side effect), HEAD DISCOMFORT (pressure on her head) and HEADACHE (More intense headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was noted that after the second dose, the patient experienced more intense headaches than with the first one. These lasted six days. Patient noted she never had a headache before. On 01May2021, the headache came back. She noticed that the pain started when she read or used the computer, no matter for how long, but it would go away if she stopped. On 02May2021, the pain was described as "pretty intense" and this time, she didn't read or used the computer. On 04May2021, she woke up with a headache again. The patient noted it was the same kind of pain that she felt after both doses, in the top of the back of her head, and that if she laid down, it was worse. She described it as pressure on her head.   This case was linked toMOD-2021-102984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Events and out come of the events updated; Sender's Comments:  INC.-MOD-2021-102984:
Immediately after administration of Pediarix and Hib to left leg severe swelling and redness were noted to leg. Ice pack applied and Tylenol given PO 12:15pm swelling and redness minimal. Infant asleep PC will return if changes occur.
My daughter had a server out break of rash on the arms, legs and face.  As of 07/20/2007 she is still marked.  This happened 3days after the shots.  The appointment was for her yearly check up. She was NOT sick.  I also took took my 17year daughter and she had the shots as well no reaction.  But i will not contiune the series.
Three weeks after vaccine, I had sudden onset of severe fatigue, general myalgia, headache, cognitive slowing ("brain fog"), tachycardia, splenomegaly, hepatomegaly
This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number unknown), as dose number unknown, single, for COVID-19 immunisation, at a public health department. Relevant medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 10Mar2021, the patient experienced nosebleed. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 16:15 (Lot number: ER2613) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin", notes: known allergies Amoxicillin. The following information was reported: MYALGIA (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered" (20Mar2021), described as "tiredness".  Additional Information: The patient did not take other vaccine in four weeks and other medications in two weeks prior COIVD-19 Vaccination. The first shot caused muscle soreness on day 1 and 2 and tiredness day 1, 2, and 3. The second shot caused me to become loopy and lightheaded on day 1, 2, and 3 and whole-body muscle soreness on day 2 and a serious migraine and nausea on day 3 as well as tiredness and lightheadedness on day 4. The second one also caused my armpits to swell up really bad on day 2 and I am on day 5 after it and my left armpit is still swollen and sore. I started having a light cough on day 4 and still persists on day 5. Patient had no Covid-19 prior and post vaccination. Facility type vaccine was a facility.  No follow-up attempts are possible. No further information is expected.
Two months after COVID-19 vaccine I lost my voice with a sore throat and felt dizzy, lightheaded, congested, nauseous, with diarrhea and extreme fatigue; Had just started taking a new medication called BREZTRI and one of the possible side effects was having cold symptoms, so I thought I was just having a severe side effect; After being bedridden for 6 days I went to an urgent care, where I was tested for the Flu, COVID-19 and given a Chest X-ray, all results were negative; However I don't think the technician performed the COVID-19 test correctly, she barely stuck the swab in the testing fluid; I was told that I had Sinus infection and Bronchitis; I was prescribed the dual drug of amoxicillin with AUGMENTIN; Even though this was a month ago, I still have a dry cough.
Breakthrough case admission after 4 vaccines  Pfizer 1/22/21 lot# El9261;  Pfizer 2/12/21 lot# EL9267;  Pfizer 8/30/21 lot# FC3182;  Pfizer 3/31/22 lot# FK9895
Extreme chills; Tiredness; Slight headache; Slight rash; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and pacemaker. The patient had no known allergies to food, medications, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and metoprolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 06:00, the patient experienced extreme chills, tiredness, slight headache and slight rash. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 08Apr2021, the patient underwent lab test which included nasal swab test and tested negative. The clinical outcome of the events extreme chills, tiredness, slight headache and slight rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Narrative: 46 yo patient recieved Moderna COVID-19 vaccine first dose 3/18/21 and second dose 4/15/21. At PCP follow up 1/19/22, patient reported he had developed shingles after the vaccine, potentially two cases, around June 2021 and August 2021 for which he was treated with valacyclovir at an outside facility. Patient offered shingles vaccine and plans to get shingles vaccine at next visit.
Pt developed lower extremity rash which at 1st looked urticarial to 1st provider but clearly evolved into Henoch Schonlein purpura over lower extremities.
Patient states later in the afternoon after her vaccine was given symptoms of her Bells Palsy started to act up (headache, eye drooping, ear pain). On July 5th she woke up with a 3 inch round rash where the vaccine was givens and rashy welts about 6 inches in diameter from where the vaccine was given. She took Benadryl and went to her Dr. (a visit previously scheduled). The Doctor gave her a Vitamin B 12 shot and patient continued to take Benadryl. By July 9 th the rash and welts were cleared up. She states she is still having some ear pain and one eye is slightly droopy.
Spoke with patient and no adverse event reported by patient. She does not recall getting the vaccine on 11/22/22 and cannot find her COVID card stating it was received on that date.  Moderna Bivalent vaccine received on 11/22/22 and 12/09/22.
Caller received the first dose of the Covid vaccine on 07APR2021 and tested positive for the Covid virus yesterday; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age (age: 54, unit unknown) received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the COVID vaccine on 07Apr2021 and tested positive for the COVID virus yesterday (19Apr2021). She is scheduled to receive the second dose on 28Apr2021. She asked if she is able to receive the second dose at that time. The patient underwent lab tests and procedures which included Covid 19: positive on 19Apr2021. The outcome of the event was unknown.   The following information on the lot/batch number has been requested.
Expired Vaccine Administered to  patient; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient) had resolved.        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.   Nurse is calling to report that they have 80 doses of the Moderna COVID-19 Vaccine. Lot No:  053C21A  & MFG Date: 04/09/2021  sitting in the refrigerator since 07JUN2021.  2 doses were administered, 32 days after storage in the refrigerator began Administered on 09JUL2021.  Caller has limited information regarding the patients:  She states that It was their First Doses. A 77-year-old and A 22-year-old  non-pregnant individual were vaccinated with expired vaccine, 2 days past refrigeration expiration date.
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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M045204 with an expiration date 11-NOV-2018 for prophylaxis (dose and route of administration were not reported) reconstituted in properly stored sterile diluent (STERILE DILUENT) (lot# reported as N004801 with an expiration date 09-JUL-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature  excursion from 9 to 25 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1707USA008767:
I had all the typical previously reported symptoms up to the point when getting first injection as mentioned in print and on the news.   Headaches,  body aches and some dizziness.   They occurred shortly after the injection (within the first 3 days)  But,  i noticed (just like mentioned in the news now) that about 2 weeks after getting the 1st injection my chest had a odd "pressure" feeling.   Like something wasn't right in there.   At the time my work was from home that week so it wasn't a problem to just "take it easy" instead of doing anything strenuous.   And in a week or so afterwards it went away totally and I felt confident that the 2nd shot would be ok to take.     The 2nd shot had less side effects other than some minor dizziness that subsided within the first week totally.   The 2nd week did not have the first shots pressure feeling on my chest like my body had adjusted to getting the shot in some way.     Since  I have gotten both shots though it seems there is the intermittent "dizziness" that doesn't affect my thinking or motor functions in any way.   There just seems to be times where I feel "funny"  nothing that is adverse or causes driving or walking issues (motor functions).    It's just noticeable at times.