chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This registered nurse reports that an 11 month old male infant started Novartis H1N1, 0.25cc  pre-filled syringe, intramuscularly, once on 10/30/2009, accidentally. The child's relevant medical history, relevant concomitant medications and relevant past drug history are unknown. On 10/302009 the clinic received 3 boxes of Novartis H1N1 pre-filled syringes. Each box was labeled as "give to pregnant women, 6-24 month olds and children with chronic health problems".  Approximately 10 minutes after giving the shot, the nurse was informed that the boxes were mislabeled and that this formulation is really meant only for persons more than 4 years of age. On 09/30/2009 the child has not experienced any injury related to this event.
Patient received the 6 mos to 4yr Pfizer vaccine dose instead of the 5-11 yr dose accidentally. Patient had mild arm soreness and the chills after receiving the vaccine.
Chills for 8 hrs; Extreme fatigue; extreme mouth dryness; loose bowels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "RA" (unspecified if ongoing); "OA" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 21Apr2022 at 16:00, outcome "recovered", described as "Chills for 8 hrs"; FATIGUE (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "Extreme fatigue"; DRY MOUTH (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "extreme mouth dryness"; DIARRHOEA (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "loose bowels". Therapeutic measures were not taken as a result of chills, fatigue, dry mouth, diarrhoea.  Additional information: Patient did not have COVID prior vaccination. Patient has not been COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
No additional adverse event; MMR II that was reconstituted with DILUENT MRK that had expired; This spontaneous report as received from a physician refers to a 41-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-JUL-2020, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection for prophylaxis (strength, exact dose, frequency, route of administration, lot # and expiration date were not reported) that was reconstituted with sterile diluent, that had expired, lot # N029636, expiration date 29-MAR-2020 (formulation, strength, dose, frequency, route of administration, indication). No adverse event was reported
Spotty; Redness; Like a patch; Rash; Tender; Didn't really feel too bad; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), FEELING ABNORMAL (Didn't really feel too bad), RASH MACULAR (Spotty), ERYTHEMA (Redness) and RASH (Like a patch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Didn't really feel too bad). On 16-Feb-2021, the patient experienced TENDERNESS (Tender), RASH MACULAR (Spotty), ERYTHEMA (Redness), RASH (Like a patch) and RASH (Rash). At the time of the report, TENDERNESS (Tender), FEELING ABNORMAL (Didn't really feel too bad), RASH MACULAR (Spotty), ERYTHEMA (Redness), RASH (Like a patch) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.; Reporter's Comments: Based on the current available information which includes a strong  temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Rash consistent with the known safety profile of mRNA-1273. Injection site rash is consistent with the known safety profile of mRNA-1273.
Received first dose on afternoon of 1/22/2021.  No apparent side effects initially.  Then in early morning hours of 1/25/2021 he woke up throwing up, then dry heaving.  Found some Tums (only thing we had) and gave that to him.  He went back to bed and went back to sleep - nothing further for 3 days. Then on 1/28/2021 he again began feeling nauseous and ran to the bathroom and vomited. Again, it lasted a short time and was over.  Since then there have been 2 other episodes of random nausea, but this time without vomiting.  This is from a man who does not throw up EVER.  Then, sometime after the first shot, which was received 2 days after we returned from a trip to see family, he began having explosive diarrhea. Up until this time he had been suffering (for months or years) with chronic constipation - which we had been working with the doctor with to alleviate.  I do not know the exact date this started, as it   is not the kind of info Dad was keen to share, but I do know that it was NOT happening before the vaccine, as we were traveling and I would have had to make emergency stops for him (this has been so bad he has at times had to change clothes because he could not get to the restroom from his living room).  As I became aware of it I began gradually taking him OFF  stool softeners and osmotics we had him on, to the point that he now takes NOTHING and  yet he still has explosive diarrhea DAILY and multiple times.
pain in his left arm began after he received the 1st shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8732) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "pain in his left arm began after he received the 1st shot".  No follow-up attempts are possible. No further information is expected.
The injection site started to itch and then a small welt appeared; the size of a flea bite. Within several hours of my first noticing the bump, another small bump appeared and my upper arm was "reddish" in color. I took a "Claritin" at 5 pm on Thursday, January 28, 2021 but the swelling continued. By noon on Friday, January 29, 2021, the two small flea bit size bumps have merged into a large bump the size of a quarter. The redness around the bump is gone but the bump is red and itchy.
91 y.o. Male with diabetes, pacemaker, hypertension, history of DVT on anticoagulation, who had his second dose of Covid vaccine on 2/17.  After that, he experienced left arm swelling then developed a diffuse rash on his trunk and groin, and went to urgent care on 2/25 at that time noting blisters forming in multiple areas.  At that time he was started on a 10-day prednisone taper from 40 mg down and referred to dermatology. However, he then came to the ED on 3/13 complaining of worsening of this blistering rash he described as itchy, not painful, and not associated with fevers or chills.  Per his daughter he was mildly confused and complaining of fatigue. In the ED, he was afebrile with normal vital signs.  WBC 13.4 with neutrophil predominance, mild anemia, acute kidney injury with creatinine of 1.7, CRP 16, lactate 2.1, Covid PCR negative.  No imaging was done.  Blood cultures were obtained but no antibiotics were started.  He was started on high-dose Solu-Medrol and topical steroids and antihistamines as well.  ID consult requested for further recommendations.
Information has been received from a 25 year old female consumer who on 05 Dec 2006 was vaccainted with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The consumer stated that her period is normally 7 days long, and it started on 04 Dec 2006. On 08 Dec 2006, her period ended. two days earlier than normal. The consumer did not seek medical attention and stated the adverse experience did not improve. Additional information has been requested.
their neighbor down the street had died of Covid; This is a spontaneous report received from non-contactable Consumer.  An elderly patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: The reporter had mentioned that most people in her parent's living community were vaccinated, but that their neighbor down the street had died of Covid. The reporter did not know if that individual was vaccinated but this was an important detail. The patient date of death was unknown. The reported cause of death was COVID-19. It was unknown if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: their neighbor down the street had died of Covid
Two weeks post vax, the pt developed sore joints with stiffness which lasted two weeks. The pt had fever intermittently and was seen by a physician, who diagnosed viral illness with sore throat on 07/01/2000. The event resolved without complications.
Currently 23 weeks pregnant Headache 4 hrs post-vaccine. Sore arm, body aches, insomnia, headache 14 hrs post-vaccine.
Facial flushing (still present), Rash on torso and back (3 weeks), Headaches/Migraines (still present), Joint pain, muscle weakness and urinary incontinence x 4 days
Patient is fully vaccinated. Pt. presents to ED with cough, congestion times one week. Reports that he tested positive COVID on 12/22. Patient reports that he's having mild shortness of breath, no chest pain, has cough- productive, congestion, body aches, changes in smell and taste but denies losing his taste. Reports he has had some bouts of diarrhea. No nausea or vomiting. Denies fever. Positive for chills, headaches. BP 114/67 | Pulse 62 | Temp 97.9 °F (36.6 °C) (Oral) | Resp. 18 | HT 165.1 cm (5' 5") | WT 88.5 kg (195 lb.) | SpO2 97% | BMI 32.45 kg/m²  CXR: Subtle interstitial opacities bilaterally may reflect Covid 19 pneumonia. Sent information over for monoclonal infusion they will contact patient. Pt discharged from ED.
Seven days after receiving my first Moderna COVID vaccine I noticed ~2in wide (from edge to edge) red blotch centered around the injection site. It is hard, warm, and slightly itchy. There is no pain.
Swollen, hot and painful 3 inch red circle around injection site. Lasting headaches.
started on Saturday 4/3 with stiff joints, achy muscles and fatique but by Sunday 4/4 was feeling much better
Client experienced pain in left arm with onset 3-4 hours after receiving vaccination. She stated the pain started at the vaccination site and progressed down the arm to the wrist. She describes the pain as "intense". She denies any redness, bruising or swelling. Follow up phone call on 11/28/2001 client states pain is almost gone. She has some pain at injection site when lifting something. Denies any numbness or tingling of extremity.
Pt given 2nd dose of Menactra 6 mths after 1st dose was given. No adverse reactions noted to date.
patient got vacccination at 4:55 patient had syncopal episode while sitting immediately after vaccination. patient was lowered to floor then place in stretcher in trendelenberg BP 110/55, HR 59 oxygen was 98%on arrival to observation area, patient complained of nausea, and was pale, she was clammy to touch. Patient was hydrated with 8 ounces of water, and was observed for 1 hour with bp monitoring. at 5:20 bp was 95/57 HR 56 and oxygen was 98% , she reported feeling a little tired with no other symptoms,. no complaints, she was offered more water but does not feel like she can drink any  more . her HOB was increased to 45 deg with no complaints she was able to maintain the HOB to 45 degrees with no complaints. at 5:25 her BY was 101/52 HR 59,  @ 5:45 bp was 101/66,  she was placed in a sitting position on the side of the bed and at 6pm ER bp was 109/75. in a standing position at 6:05 her BP was 114/63 HR 83 and oxygen was 99%.  Patient was released with her significant other via wheelchair.
Severe acute headache which woke patient up from sleep, around 2:30am on 10/20/2021, patient took aspirin 81mg and drank 15 ounces of tap water and attempted to return to sleep.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2014, the patient was treated by the patient's healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, 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 outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Patient received a 3rd dose of Shingrix, after getting  2 doses in 2019 on 07/12/2019 and 09/16/2019. Patient states he had no issues at all, thought it was important to report the discrepancy.
This was second dose of Moderna vaccine.  First dose was on 1/19/21 and second dose on 2/12/21.   02/12/21 - Slight sore arm throughout day.  p.m. sore arm more intense in evening hours.  No redness noticed in arm.   02/13/21 - Sore arm,  headache, achy body muscles, chills throughout day and evening.   No redness noticed in arm.  02/14/21 - Sore arm, and notice redness about 3 inches below injection site.  The area of redness approx. 2" x 3" in a.m.  Area is hot to the touch.  By p.m. hours the area of redness has grown to approx. 3" x 4" and moving toward front of body and remains noticeably warmer than surrounding skin.  No other symptoms.  02/15/21 -  a.m. hours, at this reporting, area of redness on arm remains and is sensitive to touch.  Remains hotter to touch than surrounding area.
Headache; A spontaneous report was received from a consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) headache and wanted to know if he can take Tylenol or motrin for symptom relief  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
PATIENT DEVELOPED HIVES ON TRUNK (WAIST LINE AND NECK LINE) APPROXIMATELY 2 DAYS AFTER RECEIVING THE VACCINATION. PATIENT REPORTS THAT THEY ARE RED AND "VERY ITCHY." PATIENT REPORTS TAKING BENADRYL, BY MOUTH WHICH TEMPORARILY RELIEVES ITCHING AND CAUSES THE HIVES TO CLEAR UP. THEY REAPPEAR WHEN BENADRYL WEARS OFF.
Immed p/inject pt c/o dizziness & fainted; lowered tofloor w/assist; BP 98/60 P48-5 min BP 102/50 P48-15 min BP 102/50 P60-30min PB 112/84 P64;
Within 12 hours of receiving the second dose, I woke up with severe chills and muscle/joint pain concentrated in my neck and shoulders, underarms, hips and ankles.
has continued to experience a gnawing joint pain in her arm; Fever; Chills; Body aches; Vomiting; Diarrhea; Headache; Fatigue; Soreness in left arm where she received the vaccine; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0162), via an unspecified route of administration on 23Apr2021 (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient stated that she has normal to have lingering sensation from shoulder to elbow and the worst is down the arms. The patient medical history was not reported. Concomitant medication(s) included naproxen sodium (ALEVE) taken for headache, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533) 1st dose on 05Apr2021 (at the age of 48-year-old), administration site (left arm) for COVID-19 immunisation and experienced Headache and soreness in the left arm where she received the vaccine. After the 12 hours second dose the patient experienced on an unspecified date the patient experienced continued to experience a gnawing joint pain in her arm, on 23Apr2021 fever, chills, body aches, vomiting, diarrhea, joint pain, fatigue, Headache, soreness in left arm where she received the vaccine. The caller was calling about the Pfizer covid-19 shot. The caller got her second dose on 23Apr2021, and she had every side effect except shortness of breath. The caller has a lingering reaction, she has the joint pain in her arms and hands its gnawing pain from her shoulders to her finger tie sit tingling the same feeling as the body aches but it never went away in her arms and her fingers. The outcome of gnawing joint pain in her arm was unknown and rest of events recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021561630 similar report from same reporter
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 12-JUN-2015, the patient was vaccinated with a first dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 13-JUL-2015, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were not reported) as the second dose in vaccination series. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The relatedness between interchange of vaccine products and suspected therapies was not reported. Additional information has been requested.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 04-APR-2018, the patient was vaccinated with PROQUAD, by subcutaneous (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient also received vaccination with VARIVAX (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
stomach pain; woke up throwing up, with nausea; exhausted; sweating profusely; coughing; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (woke up throwing up, with nausea), FATIGUE (exhausted), HYPERHIDROSIS (sweating profusely), COUGH (coughing) and ABDOMINAL PAIN UPPER (stomach pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (woke up throwing up, with nausea), FATIGUE (exhausted), HYPERHIDROSIS (sweating profusely) and COUGH (coughing). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 01-Apr-2021, VOMITING (woke up throwing up, with nausea), HYPERHIDROSIS (sweating profusely) and COUGH (coughing) outcome was unknown. At the time of the report, FATIGUE (exhausted) had not resolved and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided          Patient is on concomitant medication but did not specify   Reporter did not allow further contact
hair loss/loosing hair in front and top of forehead; sick after second dose and booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after second dose and booster shot) and ALOPECIA (hair loss/loosing hair in front and top of forehead) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced ILLNESS (sick after second dose and booster shot). On an unknown date, the patient experienced ALOPECIA (hair loss/loosing hair in front and top of forehead). At the time of the report, ILLNESS (sick after second dose and booster shot) had resolved and ALOPECIA (hair loss/loosing hair in front and top of forehead) had not resolved.      No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of sick after second dose and booster shot with Humira(adalimumab) was no reasonable possibility. The reporter causality for the events of hair loss/loosing hair in front and top of forehead with Humira(adalimumab) was a reasonable possibility.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.