chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain @ site of inject-cried x 2 days now same location (both upper arms), aching; intermittent usually comes @ noc only; doesn't respond to pain relievers; not related to movement; exam nl; bitten by sick stray cat same day;
extreme fatigue, unable to stand alone, extreme pain in joints, weakness, nausea, glassy eyes
My symptoms were terrible headache, wrist and ankle joint pain, muscle and body aches, and fatigue for 2 days
Brief, intermittent sharp pain on R side of mouth; This is a spontaneous report from a non-contactable consumer. This 54-year-old female consumer (patient) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 06Jan2021 as a single dose for COVID-19 immunization at a hospital. Relevant medical history included Hypertension, allergic rhinitis. Relevant concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), HCTZ, magnesium oxide (MAG OXIDE), multivitamins. The patient was not diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date in Jan2021 about a week after vaccine injection, the patient experienced brief, intermittent sharp pain on R side of mouth, lasted 2 days. The outcome of the event was recovered. The patient did not receive any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19.      No follow-up attempts are possible. No further information is expected.
Idiopathic thrombocytopenic purpura IVIG x 3 + platelet transfusions.  ICU for a week platelets normalized after about 3 months
LARGE BUMP, RED AND SWOLLEN, WARM TO TOUCH, LESION, 8.5CM IN SIZE X2DAY AFTER VACCINATION. RECCOMENDED ICE/ MOTRIN LET PT'S MOTHER KNOW TO GO TO ER IF WORSENS OUTSIDE MARKED LINE. PT WAS TAKEN TO THE ER X3DAY HAD GONE OUTSIDE OF THE MARKED AREA 1 IN LARGER PER MOTHER.
hands were swelling like barbeque; cannot move his fingers; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers). At the time of the report, PERIPHERAL SWELLING (hands were swelling like barbeque) and MOBILITY DECREASED (cannot move his fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking Kratom organic drug supplement concomitantly. The patient went to the doctor and had laboratory tests. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse referring to a 7 year old patient of unknown gender. Medical history and concurrent condition were not reported. On 17-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot number, expiration date and dose were not reported), intramuscular. Concomitant medication was not reported. It was unknown if the patient sought medical attention. No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
High Fever, chills, and awoke at 3:00 AM with sweating and fever/chills. Body aches and did not go to work. First time ever after a flu shot.
Upset stomach, difficulty breathing through nose, puffy, itchy eyes, hives, swollen eyes and ears - Benadryl and Zyrtec.
heaviness behind eyes  Narrative: At 1250, Patient reported dizziness and heaviness behind the eyes,  approximately 15 minutes after receiving her 2nd dose of Pfizer vaccination. VS  were taken: BP 125/73, HR 77 and 980/0 02. Juice was given while Patient was  continued to be monitored. VS retaken at 1310. BP 113/74 and HR 71. Patient  was ambulatory after their 30 minute monitoring and reported feeling better,  saying symptoms cleared "a little," and thanked nursing staff.
Severe flu-like symptoms. Woke up at 4am with a splitting headache, my ears ringing loudly, and my whole body aching like crazy. Severe dizziness any time I stood up. Slightly short of breath. High fever and chills.  I?ve been taking ibuprofen every few hours and drinking lots of water, and I have felt better as time has gone on. Right now I?m still slightly achy but I don?t have a fever anymore and the dizziness and chills are gone.  My appetite is starting to come back too.
nausea; Severe lightheadedness and diziness; This is a spontaneous report received from a contactable other health professional (patient, self-reported). A 42-year-old female patient (age at vaccination: 42 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 24Mar2021 09:15 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes, osteoarthritis, fibromialgya, and arthritis. The patient was not allergies to medications, food, or other products. Concomitant medications included tetanus vaccine toxoid (TETANUS-VACCIN, in right arm) within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 24Mar2021 at 12:15 AM, she had severe lightheadedness and diziness. Due to dizziness, she couldn't stay stand. The patient also had nausea on an unspecified date. She couldn't guide; therefore, she couldn't go to the hospital. The patient did not receive treatment for the adverse event. Outcome of the events not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event dizziness and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was given 4 immunizations at approximately 3:07 pm.  Five minutes later the mother brought the child back into my office and the child had hives around the Dtap injection site and down his arm to his back.  The area was warm to the touch. He was crying because he thought he was coming back in for more shots.  After he was calmed down his vital signs were normal. Dr. of pediatrics was called by the nurse practitioner and he stated it was a non-specific reaction to the vaccine and to give him oral Benadryl 2 tsps none and then 1 tsp daily until resolved. He also stated that the child should receive vaccines in the future as indicated.  The child was alert and no apparent distress when they left my office.
Hives on both hands immediately following injection.  Given Benadryl 12.5mg PO by EMS.
Information has been received from a 16 year old female, who on 24-APR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included sleeping pills [therapy unspecified]. The patient reported that she experienced a headache and vomiting, which she felt were like "symptoms of pregnancy." At the time of this report, the patient stated that her symptoms had not improved, but that otherwise she was "fine." The patient confirmed that she had not sought medical attention. Additional information has been requested.
Information has been received from a  RN concerning a 5 year old female with no medical Hx and no allergies who on 10/22/1999 was vaccinated SQ in the LA with a first dose of varicella virus vaccine live. There was no concomitant medication. On 06/11/2004, the pt was seen with a mild case of chicken pox. It was reported that there were several cases at her day care. The pt was treated with diphenhydramine hydrochloride (Benadryl_ and colloidal oatmeal bath (Aveeno). No product quality complaint was involved. F
Vaccinated with Johnson and Johnson April 2021. Has Sore throat, body ache, chills fever and runny.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 9:30. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination dose on 2/7/2022. No adverse side effects or event as result of dose reported.
Information has been received from a registered nurse concerning 2 female patients who were vaccinated with Gardasil vaccine. Subsequently, both patients fainted. Medical attention was sought, "they were in the office office". Both patients recovered "within a few minutes". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscular. Frequency was not provided. On an unknown date the patient was vaccinated with GARDASIL dose 2, intramuscular. On an unknown date the patient was sick and she asked if it was ok to wait for a few days to get her third dose. The outcome of sick was unknown. The action taken regarding GARDASIL was unknown. The reporter causality was unknown. Additional information is not expected.
Site of injection was blistered , raised , red and tender to touch. No fever.  Plus irritability. Area around site was red x an elongated area appears "burned". Site raised.
The vaccine was administered 6 days too early by the vaccinator. The first dose was given on 1.6.22 and the second dose was given on 1.21.22. No adverse symPtoms were observed. Patient was observed for 45 minutes. Vital signs at 1656 BP 109/72, 94bPm, 100 % 18resPirations. Parents were instructed to seek emergency medical services for any signs or symPtoms and to call their Pediatrician immediately for monitoring.
Chills, fever, aches, tiredness, headache, nausea, and sweats.  Also injection site pain. Had to take a sick day from work. Started about 10 hours after the injection and lasted for about 26 hours.  Took Ibuprofen and Advil for Migraine. Still have the headache and arm pain (48 hours after injection) but am able to work today.
Within 2 minutes of second vaccine (Fluarix) patient asked if she could sit on the floor stating "This sometimes happens to me with needles, I feel dizzy and need to sit"    Immediately provided a space to sit on floor and assisted her to sit.  She then laid down flat and was monitored for 5 minutes.  No s/s of distress noted.  After 5 minutes she was allowed to sit for 5 minutes at which time she stated "I feel much better",  allowed to stand to determine if dizziness would return and monitored for an additional 15 mins while seated in a chair.  Encourage to drink fluids and call provider if any further symptoms of concern.  Was able to walk from clinic with no return of symptoms.   Called patient on 10/26/22 to assess needs. States she was "a little tired last evening" but feels "fine" today.  Denies any return of dizziness.   Encourage to drink fluids and call provider if any further symptoms of concern.
Numbness, tingling of low lip, tongue, right side of face for 5 minutes. Hours later developed temp, 101.2, headache. Took a Claritin.
found out my wife was positive. She had both Pfizer shots; found out my wife was positive. She had both Pfizer shots; This is a spontaneous report from a contactable consumer (husband).   A female patient of an unspecified age received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date as dose 1, single; bnt162b2 (BNT162B2, lot unknown) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband informed that he found out his wife was positive and she had both Pfizer shots on an unspecified date. The outcome event was unknown.  The lot number was not provided and will be requested during follow up.
Arm became swollen and hot to touch, overnight her face became swollen and eyes almost swollen shut.
Information has been received from a physician concerning a 13 year old female patient who on 20-OCT-1998 was vaccinated with the first dose of MMR II. The patient received the second dose of MMR II on 25-JAN-2001. On 15-JAN-2010, the patient experienced mumps. The date diagnosed was reported as 17-JAN-2010. The patient's symptoms included left parotitis and left side neck swollen. The outcome of the patient was unknown. No further information is available.
pt recvd 3rd dose of vax & failed to seroconvert; 15SEP94 & on 3OCT94 devel urticaria which persisted for 1wk; pt reported a prev history of urticaria assoc w/stress, felt that recent episode was also stress related;
soreness at site, severe headache, stiff neck, back pain from shoulders to waist, pain between shoulder blades, leg and knee pain, general body aches, nausea, sweats and chills, abdominal pain, left side
chills, nausea, feeling faint all briefly between 7 and 7:30 pm. 101.3 fever by 9:00 pm. Alternating too hot/ too cold with diarrhea all night. Felt like I had the flu all day the next day with headache, sore muscles especially neck,, fatigue, no appetite, low grade fever. By 9:00 pm temperature was normal. Slept well. Back to normal on 3/13.
Information has been received from a physician concerning a 15 year old male who on 14-MAR-1995 and 19-FEB-1998 was vaccinated with a first and second dose of MMR II respectively. On 30-NOV-2009 the patient experienced mumps. The body temperature was 102 F. Parotitis was on the left. The blood work was done on 03-DEC-2009 and the result was not reported. The pumps was diagnosed on 03-DEC-2009. At the time of the report, the outcome was not reported. Additional information has been requested.
73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building  10:47 CPR initiated 10:49 medical team/EMS  found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling;  11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department
Phone call with client after she cancelled her dose 2 appointment. She states that within 3 hours of dose 1 Pfizer, she had generalized hives which progressed to throat & mouth swelling & itching. She took Diphenhydramine & Zyrtec. She also has been in regular contact with her PCP who has her taking Zyrtec daily. The hives continue & she states they've "started resembling chigger bites". They seem to improve but she scratches them to the point of bleeding/breaking the skin. Her PCP told her not to get the 2nd dose & called this a "near anaphylactic reaction". She will wait several months before considering getting the Janssen vaccine, but for now she's content with the level of coverage one dose provides. I asked her to continue to stay in touch with her PCP & advised that she may need some steroids should this skin reaction continue. She verbalized understanding. Her dose 2 appointment is cancelled.
Erythematous area 3in x 2in at site of presumed DPT booster.
9/17 Extreme fatigue, chills pain on first day. 9/18:  redness and sweilling in patches covering approx 5 cm long area. 9/19 Redness & swelling grew to 8 cm x 7cm. 9/20 Redness spread to 11 cm long, but no swelling. The red area is not at the direct site of the injection, it's towards the inside of the arm. I have a picture of the area taken 9/19.
Narrative:  Pt was administered 2nd dose of Shingrix vaccine and complained of dizziness, SOB, throat tightness, lightheadedness, rash, and palpitations. Pt was administered EpiPen, solumedrol, Benadryl, famotidine, and fluids and symptoms resolved.
Patient fainted approximately 5-10 minutes after receiving the vaccine while in the waiting area. Pharmacist and staff rushed to patient to provide care and she had quickly regained consciousness. EMS arrived soon after and cleared the patient. No treatment was given and the patient was feeling normal before leaving.
fatigue; nausea; vomited; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomited) and CHILLS (chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomited) and CHILLS (chills). On 04-Mar-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (fatigue), NAUSEA (nausea) and VOMITING (vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Upper respiratory disorder; Nasal mucus increased; COVID-19; Device issue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second 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) UNK dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue). At the time of the report, RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue) outcome was unknown.            No concomitant medicine was reported. No medical history was reported. On unknown dates, the patient experienced UPPER RESPIRATORY ISSUES and FELT MORE SNIFFLE LIKE PATIENT HAD COLD.  In May 2021, the patient experienced COVID-19. Causality as per reporter for HUMIRA was Reasonable possibility. 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 No treatment medicine was reported.   Reporter did not allow further contact
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 11:15 as dose 1, single (Lot number: EN6201), in right arm, on 19Mar2021 at 11:45 as dose 2, single (Lot number: EN6208), in right arm and on 27Aug2021 at 14:30 as dose 3 (booster), single (Lot number: EW0187), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 30Mar2022 at 14:45 as dose 4 (booster), single (Lot number: 016J21-2A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "N/A" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022 at 11:00, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.Clinical course: Known allergies was reported as no.Other medication in 2weeks was reported as Unknown. Anti viral details: Product COVID 19 Treatment, Treatment stop date 17May2022, Indication Treatment of COVID-19.
Patient arrived to clinic w/ mom for well child check. Behind on vaccination schedule. Received PEDIARIX which is invalid dose for pt's age. No adverse signs/sxs from vaccine. Spoke with mom 4/17/17 and informed vaccine dose is insufficient for age, will need repeated.
pt recvd vax;w/in 24 hrs devel very swollen,painful,red arm;md felt rxn was cellulitis & pt tx w/ cephalexin & ciprofloxacin;sxs subsided in 4 days;
Per mom pt developed swelling and redness on right deltoid area where (Hep-B) was given. Mom described redness looked like a welt the size of a silver dollar. Mom reports by Saturday morning sxs became worse welt increasing to what mom described the size of the bottom of a coffee mug. Doing better after BENADRYL administering.
Within a few days to one week of receiving the 2nd dose of the COVID-19 vaccine, I noticed a sudden and sharp pain down my left arm, upon movement.  The pain was intense, and I could feel it from my shoulder down through my arm.  It lasted about 20-30 seconds.  This same pain has continued to recur on a regular basis, without improvement.  It occurs when I stretch my arm in certain directions, and as a result I have limited my arm movements to avoid triggering the pain.  It also occurs at night while I am sleeping, sometimes keeping me awake or disturbing my sleep.  And at times it occurs as I am getting out of bed in the morning.    I have not been treated for this condition yet, as I have been waiting to see whether it would reduce or resolve on its own.  It has now been just over two months, however, with no improvement.
Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727; expiration date: 31Jul2021) via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS), heart problem, and "allergies (the sinusitis)." Concomitant medications included atenolol from an unknown date for tachycardia, heart problem. Today (18Apr2021) the patient experienced a mild headache. She had the first dose and was fine there while she sat for 15 or 20 minutes. She was normal that day. Today (18Apr2021) she had a mild headache but she also had allergies and yesterday (17Apr2021) she drank a little bit of wine to keep her nerves because it was getting crazy, "this new variant and everything." The patient asked if it was okay to take paracetamol (TYLENOL), aspirin, or ibuprofen (ADVIL). The outcome of mild headache was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.