chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19  outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital  At no time during the hospital stay has she been more than minimal responsive.   She need O2 for Comfort   but on CXR and CT cardiopulmonary imagining  was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis.  On 1/12/2021 family made patient a DNR  and IVF were stopped and switched to comforted care.  Patient expired 1/13/21
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: non-significant follow-up information received on 08-Jun-2022. Reporter details was updated.
Received inj Tues afternoon.  Wed morning symptoms appeared.  This morning, and this afternoon worse (Thurs). At injection site: pain, swelling, knot, redness, heat, somewhat itchy.  Redness- size of a quarter; knot- size of 1/2 dollar; swelling area size of a baseball.  Treatment- Advil/Tylenol.
MOTHER NOTICED ON 06/04/2009 2 SMALL WHITE SPOTS ON ROOF OF MOUTH.  NO FEVER, DID HAVE DAY OF IMMUNIZATIONS. ANOTHER SPOT A DEVOLOPED THIS AM.
Pt devel myalgia, arthralgia & a red, raised rash 11 to 12 days following a vax w/Rubella vax;
Severe body aches, fever as high as 102.4; jaw pain, blister on roof of mouth, headache, fatigue
Child was seen in our office 2 days after shots given - continued to run high fever and (L) thigh area red and painful - would not bear weight. 1/27/09-records received for DOS 12/11-12/14/08-DC DX:Cellulitis versus reaction to DTaP in left thigh. Presented with C/O pain, redness and swelling left thigh and temperature 104. Unable to contact hasn't been seen since.
Information has been received from a licensed Practical Nurse concerning an 84 year old female with sulfonamide allergy who on 15-FEB-2008 at 12:15 was vaccinated SQ in the right arm with a second dose of zoster vaccine live (Oka/Merck) (lot # 658861/1822U). There was no illness at the time of vaccination. On 17-FEB-2008, the patient experienced itching at the injection site and a red blotchy rash on the back of her right arm, at the injection site. There were no lab studies performed. At the time of the report the patient's rash continued and is still slightly itchy, patient had no pain, and the rash did not spread anywhere else. Additional information has been requested.
Severe pain in left arm, a doctor appointments, a prescript. and now I am in physical therapy.
Insomnia - unable to sleep the entire night following the vaccination, 06/01/2018 11:00 pm - 06/02/2018 07:00 am. Insomnia not related to pain or other discernable cause. Resolved after one night of insomnia.
pt recv vax & devel redness, induration, warmth & pain @ the inj site;
Local erythema with superficial swelling 5x6 cm over vacc site apparently on the next day. Adv Motrin, OTC Benadryl, cold compress.
9 days post vacc., rectal temp. was 103.5. 36-48 hrs later, pt. had no other indication of illness.
05/02/21 "...pmhx of PFO, MS, MI, HTN, CVA, CKD, anemia, BPH CAD s/p stent that presents with AMS. Wife accompanies the patient who provides a majority of the history. She reports that he has been increasingly confused, lethargic and eating less over the past week. She saw him slump over his chair. She had been in touch with his nephrologist who advised them to go to the EC to get evaluated."; pt. discharged to rehab on 06/08/21.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a 55-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-OCT-2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis in the clinic. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 22-OCT-2017, she was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she required and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that she would in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the event was not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be disabling by the reporter.
My shoulder joint started to ache about 8 hours after injection. Stiff, shooting pains, mobility issues. It started to get better, almost normal, but on day 8 I woke up to the symptoms getting worse. It's day 9 now, and I'm in a LOT of pain (stiff, shooting pains, mobility issues again).  Is this normal?
Pain in stomach. Can not eat. Can not sit up. BP 162/86. Pulse 56. Doing ok next day. No symptoms next day. Did not see doctor.
Woke up with intense shoulder pain in both shoulders. Had hard time raising arms. This pain continues to this date.
Within 10 minutes, I experienced tachycardia, hypertension, Sweating and shaking.
Mild rash, low fever, & nausea throughout afternoon and evening; inability to move arm at bedtime.
mom states pt was tired but otherwise nl-acting;pt recv APAP p/vax;denies any itching, rashes, sneezing, trouble breathing yesterday or today;noticed swollen lt eyelid, sniffling this morning on awaking;
At 7pm on 10/23/06 pt c/o inside of L ear and eardrum became itchy.  As evening advanced, itching progressed to L eye.  At 6am pt c/o bilateral eyes and ears reddened and itching, neck and back of scalp burning, hot, reddened and itching.  Pt came to work at 8am and symptoms progressed where itching became intense and lips, chest, inside of mouth and throat became involved.  Pt called Public Health Nursing and was advised to seek medical assistance immediately.  Pt. seen at Dr.Is In T /?, P 85, B/P 140/76 and given steroid injection and Benadryl. Pt. returned to work and called clinic.  Advised to read discharge instructions and if sx worsened to go to call 911 and get to ED.
(R) ant. thigh reddened 1.5 x 3 inches in diameter hard to touch. Itching is present. Edema of upper thigh. This is reported by mother onset Tuesday 10/16/12.
This report was received from a nurse. The nurse reported that three patients were administered expired ROTATEQ vaccine. This spontaneous report refers to third patient (out of three patients who were administered expired ROTATEQ) of unspecified demographics. On 28-APR-2014, the patient received expired ROTATEQ, dose unspecified, (lot number H016249, expiry date 27-MAR-2014). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of received the expired ROTATEQ on 28-APR-2014 was unknown. No further information was provided. This case is linked with MARRS 1405USA001811 and MARRS 1405USA002805 as same reporter cases. Additional information has been requested.
Have some swelling in my lymph node and one of my armpits and it is like going down the side of my body now; This is a spontaneous report from a contactable consumer (Patient). A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date (reported as the other day) as a single dose for COVID-19 immunization, lot number: EK9231. Medical history and concomitant medications were not provided. Patient stated that had some swelling in lymph node and one of armpits and it was like going down the side of patient's body at the time of the report. Patient wanted to know if this was a normal side effect or if was needed to see a doctor. Outcome of the event was unknown.
Rash, erythema, inflammation, and warmth to injection site on right thigh. Symptoms began on 5/12/2021.
Redness, swelling approx 2 inch diameter. Fever approx 101F lasting 3 days, continuing on through time of this report.
Patient is a 66-year-old male with PMH significant for IBS, open b/l inguinal hernia repair, and prostate cancer s/p robotic prostatectomy who presented to ER for abdominal pain with associated constipation, bloating, nausea, chills and vomiting on 8/2/2022. In the ED, the patient was afebrile and hemodynamically stable. CT A/P demonstrated small bowel obstruction with transition in the TI and an additional 1 or 2 foci of caliber transition of small bowel. NGT was placed and pain medications given. Patient was admitted to general surgery service for medical management of SBO with isolation precautions due to having tested positive for COVID-19 on 7/29/2022. NGT output monitored. On 8/3/2022, NGT was removed. Diet advanced to which patient tolerated well. Discharge instructions reviewed. Was given instructions to follow up as indicated. Reference chart for further information. To be sent home with instructions to drink lots of water and continue daily Miralax.
feeling "very tired"; redness at the injection site; he had shivers last night; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUL-2023, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: feeling "very tired"), injection site erythema (Verbatim: redness at the injection site) and shivering (Verbatim: he had shivers last night). The outcome of the tiredness was not resolved and the outcome of the injection site erythema and shivering were resolved.   It was unknown if the reporter considered the tiredness, injection site erythema and shivering to be related to Shingrix.     It was unknown if the company considered the tiredness, injection site erythema and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUL-2023 The reporter was the patient.  Reporter stated he had shivers last night  Patient reported feeling very tired .  Patient also reported redness at the injection site. The reporter did not provide date of his first Shingrix dose. The reporter did not report adverse event with the first dose.  Not all information was available. Lot and expiry date was unknown. The reporter provided consent to follow up with HCP.
temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  Since 28-JUL-2020 (conflicting information also reported as 24-AUG-2020), measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion, the vaccine was stored at a temperature of -14 degrees Celsius (C) to -10 C (max -9.5C), during a time frame total of 38 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (T009929 lot number which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) (vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014788: US-009507513-2008USA014811: US-009507513-2008USA014853: US-009507513-2008USA014854: US-009507513-2008USA014858:
Full body/muscle aches, bone pain, nausea, vomiting, fever, chills, bloating, weakness
Pt developed high fever (106.4) and lethargy. Pt was seen and monitored in the ER and was sent home after Motrin and Tylenol was given.
Developed tennis ball size hemorrhagic ovarian cyst. Excruciating pain and vomiting starting 5-19-21. Admitted to Hospital via ER. Spent the night in the hospital on pain medication and had surgery 5-20-21 at 1300. Removed cyst and right ovary.
Pain affected my shoulder; Arm swelled up; I had pain; Doubt if the shot was done intramuscularly; Electric shock; Burning in second and third finger; A spontaneous report was received from a 67-years-old, female patient, who was also a nurse,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, and doubt if the shot was done intramuscularly.   The patient's medical history was not provided. Relevant concomitant medications reported included medication for blood pressure and diarrhea.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) in the left arm for prophylaxis of COVID-19 infection and experienced an electric shock and burning in her second and third finger, and she doubted that the shot was administered in her deltoid.  On 27 Dec 2020, about 6 hours later, the patient stated that her arm "was swelled up" and had pain.   Later, on an unknown date, the patient stated that the pain got a whole lot worse and it also affected her shoulder. She mentioned that it was not the normal kind of pain. Treatment included paracetamol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, were considered unknown. The outcome of the event, doubt if the shot was done intramuscularly, was resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a 67-years-old, female subject with medical history of hypertension, who experienced a non-serious unexpected events of product administration error, electric shock, burning sensation; a non-serious expected event of arthralgia, peripheral swelling, and pain in extremity. There were no reported AEs associated with product administration error. The event of electric shock, burning sensation, peripheral swelling, and pain in extremity occurred apparently 6 hours after mRNA-1273 administration. The time of onset was not provided for the event of arthralgia. The subject's concomitant medications included for hypertension and for diarrhea (details not provided). The event was treated with Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
First thing I noticed was frequent  trips to the bathroom. (EVERY TWO HOUR) All LARGE amounts of urine. The Second one is that Eye SITE was made a drastic change to the point I can barely see!
Patient went to her regularly scheduled dermatologist doctor appointment on 11/5/19 where she was told she had a blistery rash (Shingles) on her arm.
Elevated blood pressure and heart rate. 163/116 HR 125. I got up at 9:00 am with elevated BP and HR. I had missed a dose of Metoprolol the previous evening. I felt shaky/jittery and checked my BP and HR. Called the doctor on call at my PCP's office and he stated it is probably rebound hypertension and elevated HR due to missing the dose of Metoprolol last night. His direction was to check in two hours, and if still elevated, take 1/2 tablet Metoprolol. Current readings at 2:00 pm are 129/97 HR 99. Unsure if related to Covid vaccine. MD recommended reporting to CDC
Headache; fever; chills; aches and pains; painful underarm; malaise/feeling really sick; painful underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 12:30 (Lot number: FF8841) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma mild" (unspecified if ongoing), notes: other medical history: Asthma mild; "Known allergies:Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: CITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "aches and pains"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Oct2021 12:00, outcome "not recovered" and all described as "painful underarm"; MALAISE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "malaise/feeling really sick". Therapeutic measures were not taken as a result of headache, pyrexia, chills, pain, pain in extremity, malaise, axillary pain.  Additional information: adverse event Headache, fever , chills , aches and pains, painful underarm , malaise, feeling really sick and under the weather. If other vaccine in four weeks: No. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient admitted as observation on 8/15 due to weakness. Patient was tested for COVID-19 and was positive on 8/15.
Patient was mistakenly administered a third dose of Shingrix. He came to pharmacy to receive the RSV vaccination (Arexvy) and Shingrix was administered instead. The two products were next to each other in the fridge and Shingrix was grabbed and reconstituted and administered to patient instead of Arexvy on 11/11/23. It was discovered 11/12/23 due to inventory issues that patient received wrong vaccination. Patient was called and notified that he was mistakenly given Shingrix. Patient stated that he received 2 doses in 2020, and complained of only feeling "achy" as a side effect from the third dose of Shingrix.
Patient presented 4 days post vaccination with red splotch marks down her arm from the injection site to the elbow. She also reported that they were painful, but did not appear to be a rash.
Hallucinations; A spontaneous report was received from a consumer concerning 72-year-old male. The patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations, seeing ghost.  The patient's medical history was not provided.  Concomitant product use was not provided.  Prior to the onset of symptoms, on an known date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided), for prophylaxis of Covid-19 infection.  On 01 Feb 2021 the patient left a voicemail message to Safety stating that he began having, "what I guess you would call hallucinations" after receiving his first dose of Covid -19 vaccination.  He further stated, " I've seen ghosts". "I've never seen ghosts in my life before".  The patient then went on to ponder whether the event was vaccine related or possibly related to the fact that he experienced a problem in his eye some years ago that caused him to "see weird things".  No treatment or other relevant information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event hallucinations was unknown at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
PATIENT RECEIVED Tdap on 10-17-07. PATIENT REPORTED MUSCLE PAIN DOWN INTO THE ELBOW ON 10/22/07. DIAGNOSED WITH RIGHT AXILLARY LYMPHADENOPATHY.  PATIENT INSTRUCTED TO OBSERVE.
Initial unsolicited report received from a consumer on 30 July 2015. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced sore throat and could not swallow. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.