chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; felt unwell; Chills; Fever; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US031704_NS (Novartis).  A 76-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; MALAISE (non-serious), outcome "unknown", described as "felt unwell"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; VOMITING (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; Chest pains; Blood pressure is up; she has  been in the bed for the last 6 days; This is a spontaneous report received from a contactable consumer or other non health professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number EP7533), via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. The patient's medical history included severe allergies and allergic to latex, all from an unknown date and unknown if ongoing. The patient  stated she had very severe allergies and she was highly allergic to latex. Concomitant medications were not reported. The patient stated she got the Pfizer shot on 2nd (confirmed as 02Apr2021) and, her first one and she has  been in the bed for the last 6 days and with a real bad headache and she was having chest pains and her blood pressure was up. The patient needed to know if she need to take the second shot or not? She was due on 23rd (confirmed as 23Apr2021) to have the second shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
body aches all over , R + L arm pain,  fatigue , nausea , weakness   call dtR (Privacy) who is (Privacy).  Pt. is HOH. if information is needed
The pt developed a fever of 100 degrees and a severe injection site reaction characterized by swelling and redness extending past the elbow. The pt was treated symptomatically the symptoms resolved. The pt medical history includes residual lung scarring.
Headache, Myalgia, Fever, Fatigue, Swelling and pain to injection site Narrative:
Patient developed House-Brackmann Grade VI (total paralysis) Bell's Palsy. No other explanation for this occurrence other than his recent vaccination. Currently under treatment with prednisone.
No adverse events incorrect vaccine given - Mother - contacted & informed - S&S listed of reaction - Directions in care of inj site. Advised to take to ER if needed or RTC if so. 3-15-23 - Mother states child is doing well.
received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna Covid-19 Vaccine 2 weeks ago (lot # 032B21A) & states that they just learned the expiration date is 24Sep2021) had resolved.            No concomitant medications were reported. No treatment was reported.
On 10/27/2022, my symptoms began with heavy nasal congestion and a headache. I tested myself for COVID-19. The first was negative, the second was positive. My pulse oximeter reading was also low. When I began to develop a chest cough and fever, I called my physician who prescribed an antiviral medication and a cough suppressant. I began taking those on Friday, 10/28/2022 and took them both for five days. All of my symptoms have resolved with the exception of some nasal congestion.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 06-OCT-2011, the patient was vaccinated VARIVAX dose 1, lot # 669601/0138AA, expiry date 26-JAN-2013 (dose, route, vaccination site unknown). On 08-NOV-2011, the patient received improperly stored VARIVAX dose 2, from the same lot # 669601/0138AA, expiry date 28-JAN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
back pain has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain has gotten worse) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for Back pain.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced BACK PAIN (back pain has gotten worse). At the time of the report, BACK PAIN (back pain has gotten worse) outcome was unknown.            Concomitant medications were not provided by reporter.
KINRIX vaccine was given to pt. at 3 mos of age and indicated for 4-6 yrs.
Rash to left pectoral area that does not extend further down than breast. Rash is not itchy or painful. Redness has subsided slightly within 24 hours of the vaccine but remains there after 48 hours.
This is a spontaneous report from a contactable pharmacist (patient's mother). A 18-year-old male patient received TRUMENBA, via an unspecified route of administration, in Jun2018, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced pain at injection site in 2018 with outcome of unknown, fatigue in 2018 with outcome of unknown, headache in 2018 with outcome of unknown, muscle pain in 2018 with outcome of unknown. The pharmacist reported that it was unclear to her from the product information that a second dose was even necessary. Product information stated "the effectiveness of the two-dose schedule of TRUMENBA against diverse N. meningitidis serogroup B strains has not been confirmed". That was confusing, based on what she was reading, two doses may not give effectiveness. No follow-up attempts possible. No further information expected.
Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 3/26/2023 Discharge Date: 03/29/2023   HOSPITAL COURSE: 1. COVID.  Patient is a 80 y.o. male presenting with cough and fatigue, testing positive on admission for COVID. At an outside ED, patient was hypoxic at 87% on room air, requiring 2 L NC to maintain sats greater than 90%. Also found to have a mild AKI, with Cr at 1.57 (baseline 0.86-1.24). He was then transferred to hospital for further management.  Patient was given fluids, steroids, and 3 day course Remdesivir for treatment of COVID; patient's hypoxia resolved and he remained on room air. His AKI resolved with fluid resuscitation. Patient also treated for acute exacerbation of COPD, treated with scheduled duo-nebs, in addition to symbicort (added to his home meds upon discharge).    2. Right second toe pain.  Patient complained of right second toe pain, possible cellulitis, was started on Keflex (3/27-3/29, 9 doses). X ray R foot obtained which showed no acute fracture, no evidence of osteomyelitis. Did show moderate great toe arthritis. Overall, patient's feet with discoloration of multiple toes.  upon outpatient follow up, would consider vasculitis, arterial insufficiency.  (We considered endocarditis, but blood cultures negative).   3. Clinical diverticulitis.  Day of discharge, patient with LLQ abdominal pain, suspect early diverticulitis, so patient sent home with 7 day course Augmentin (this will also continue to treat his cellulitis). No CT scan done as early diverticulitis might not show up and we would still have treated the patient. Patient scheduled with close follow up with his PCP, with instructions to seek care earlier if he develops fever, chills, nausea, or vomiting.    4. Cognitive dysfunction.  The patient did appear to have poor memory, not always remembering us from the day before and asking the same question multiple times.  We consult at SLP for cognitive evaluation.  On 3/28/23 he obtained the following scores:  MoCA 8.3= 24/30 with a Memory Index Score (MIS) of 4/15, BCRS = 7/35,  O-Log =30/30.  This is consistent with mild cognitive dysfunction.  Since acute illness and Covid in particular can cause as issues with memory, we would recommend referral for neuropsychiatric testing.   5. COPD.  Symbicort added for chronic management.       In addition to adding Symbicort for COPD, patient sent home with 7 day course prednisone to complete 10 day steroid course for COVID.
1. Tingling of lips and tongue 2. Productive cough with post nasal drip and green mucous 3. High pitched ringing in ears
Information has been received from a 26 year old female patient, for GARDASIL, a Pregnancy Registry product, concerning herself with allergy to DARVOCET who on 18-SEP-2009 was vaccinated with the first dose of GARDASIL (lot number 0670Y). The patient was pregnant at the time of vaccination. The last menstrual period was not reported. Unspecified medication was sought. On an unspecified date a pregnancy test was performed. The outcome of the patient was not reported. Follow-up information received from a physician concerning the pregnant female patient with history of bladder problems, chickenpox, yeast, kidney problems, mitral valve prolapse, severe headaches and stomach problems and allergy to DARVOCET-N 100 and one normal previous full term delivery at 39 weeks gestation. The last menstrual period (LMP) reported as 28-AUG-2009, estimated conception date 12-SEP-2009, estimated delivery date (EDD) 03-JUN-2010. On 01-OCT-2009, a urine pregnancy test was positive. On 16-OCT-2009, the patient presented for an Obstetrics-Gynecology evaluation with a complaint of dysfunctional uterine bleeding. Since her LMP the patient claimed she had been without significant complaints, and denies the use of alcohol, tobacco and street drug. The patient was currently taking no medication. She was told to start taking prenatal vitamins. On 16-OCT-2009 the physician's plan for the patient was to have a quantitative BHCG test done and progesterone (dose, duration not reported). Additional information has been requested.
hyperactivity & agitation 2-4 hrs; pt delayed reporting condition to clinic unitl 1JUL93;
Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 14 months old patient who experienced patient received expired vaccine, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. On 19-Jul-2018, the patient received a 0.5 ml once dose of suspect PENTACEL lot C5219AA, expiry date-17-Jul-2018 in the left thigh, DTAP/IPV portion- C5390AA Expiry date- 17-Jul-2018. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills started at 10:00 pm same day as the second vaccine which was taken at around 11:00 am.  Woke up around 2:00 AM the next day with a fever, headache, chills, nausea, and fatigue.  All symptoms faded by about 5:00 pm the day after the shot.
I don't have the time to complete this. That's too much. Here is the summary Hours following the 2nd dose of Moderna Vaccine, I had double vision. I rushed to Hospital (I have over 200 pages in documentation) and they diagnosed it as 3rd nerve palsy - a form of Stroke as a result of the vaccine. The double vision cleared after 6 weeks, and following several visits to my neurologist and the Hospital and about $80,000 worth of Medical bills from 3 days at the hospital and other medical bills and lost nearly a month of work.
1/25 at approximately 2000, patient requested to transfer onto his bedside commode to have a bowel movement.  Caregivers assisted patient onto the commode, within 5-10 mins, patient was alert but not responding.  Sternum rub performed, patient reacted but still not responding, BP 210/180.  Patient still not responding, EMS was called.  EMS reported blood sugar reading at 21, patient had dinner 1 hour earlier.  Patient taken to Hospital.
Site: Pain at Injection Site-Medium, Additional Details: Patient states he had normal soreness for a few days after the vaccine was given. The pain, tightness, and stiffness have been consistent for almost two months now. He states when he inadvertantly sleeps on that side, the pain and tightness can temporarily worsen. He believes the vaccine may have been given too high in the arm. He has seen "several" of his normal doctor's and they all said it should go away with time.
Approximately 1 hour post injections pt returned to medical desk c/o SOB, itching. One adult epi pen administered to L thigh-transported to hospital via EMS.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-JAN-2009, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 24-OCT-2016, the patient was treated by a healthcare provider for shingles. On 24-MAR-2017, the patient passed away. The cause of death was not provided. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The cause of death was not provided.  Upon internal review passed away was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.
SKIN FALLING OFF; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced skin falling off. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of skin falling off was not reported. This report was non-serious.
This patient has been diagnosed with PDD-NOS, Mood disorder (depression/anxiety), ADHD, is s/p neuroblastoma in 2001 and has issues with obesity, sleep and aggression. His medications include BUPROPION, CLONIDINE, FLUOXETINE, CONCERTA, SYMBYAX AND TOPOMAX as well as ALBUTEROL prn and CLARITIN prn. He is followed closely by a child psychiatrist at our organization who has taken care of him for a few years now and took care of him when he was admitted to inpatient child psych ward in 2006. He actually has been relatively stable on his medications for some time and was able to function at school and at home, but the day after receiving Tdap, MENACTRA, VARIVAX #2 and Hep A #1 on 3/23/09, Mom and the school noted an abrupt change in his behavior. They noted that he had a much more difficult time focusing on anything for any length of time, had trouble with his speech and had a much decreased appetite. My understanding is that he has not had any prior immunization reactions to other immunizations and his immunizations are all up to date. The mother had to take him out of school due to his psychiatric decompensation and his child psychiatrist recommends inpatient admission to the child psych ward of a local hospital once again.  11/17/09:  Discharge Summary, Hospital records and ICD 9 codes received for dates of service 7/30/09 to 8/7/09.  Dx:  Mood disorder not otherwise specified; pervasive developmental disorder. Assessment:  Admitted to the child and adolescent psychiatric hospital for aggression and explosive, out of control episodes.  Admitted for psychological and medical stabilization and an increased level of treatment intensity.  Pt. was an active participant in the therapeutic ward milieu.  By the end of his stay he was cooperating with staff and peers.    ICD 9 Codes:  299.90, 296.90, 312.34.
Lt.upper thigh reddened ( 2 ins in diameter) and swollen around injection site. Mom stated reaction occurred approx. 24 hrs after shot given. Mom reported she applied warm cloths to area and gave Tylenol q4h.
vomiting and upset stomach on and off since yesterday. i instructed her to stay hydrated with alternating pedialyte or gatorade with water and if she begins to feel weak to contact her doctor to see how she needs to carry forward. there is a stomach bug going around in our area so she understood it could be related to that
pt noticed a 3 inch red area around her injection site that was warm to the touch before showering the day after her injection.  She had abdominal cramping that night and did not self treat as she was unsure if related to food or not.  This am (18th) she feels slightly better with still some cramping and her shoulder is no better visually.  Did take some Tylenol 1 gram at 8 am and feels little effect after 2 hours.  set up appointment with Dr at 11:45 am today.
pt ran fever 100 to 101 for 2 days p/vax but was well day a/died;mom states no signs of illness;taken to hosp suspected SIDS;autopsy being performed;
she is feeling dizzy; having a headache; feels so tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "she is feeling dizzy"; HEADACHE (non-serious), outcome "unknown", described as "having a headache"; FATIGUE (non-serious), outcome "unknown", described as "feels so tired.".  Additional information: Patient was feeling dizzy, having a headache but does not have a fever and feels so tired. She asked what medicine she could take and mentioned if she could take Tylenol as an option. Her 2nd dose scheduled on 29May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included menopause and headache (10 years before the date of reporting). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows; The age at vaccination was not reported. The patient experienced just a little sore arm. For tolerance of 1st dose of SHINGRIX, refer case US2018077610. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK080935. This case has been linked to US2018GSK186361, reported by the same reporter for the patients husband.
Pt recvd vax 20MAY91 & on 17SEP91 devel Haemophilus influenza, type b bacteremia & was hospitalized; pt was also found to be HIV pos; 21SEP91 pt recvd 2nd dose of HIB;
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 26-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019038, expiration date 17-JAN-2104, does, route and frequency were unknown). The reporter stated one vial of ZOSTAVAX in the carton of ten had a different lot number than the rest. The lot number on the carton and the other nine vials was K000456, Exp 15-DEC-2014. Lot H019038, Exp 17-JAN-2014 was administered to the patient. After the patient left the pharmacy, it was noticed the vaccine was expired. No adverse effects were reported. The patient did not seek for medical attention. PQC was filed. Additional information has been requested.