chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right leg numbness, suddenly became unable to walk.  Admitted to local Hospital from ER, underwent testing and treatment for 8 days, followed by admission to inpatient rehab facility for 12 days,  Received in home OT & PT and now scheduled for further OT & PT as an outpatient.
24 hours after vaccine, arm had slight itching and faint redness (0.75" x 1.0" oval) where vaccine was administered. Itching and redness have gone away 7 days after vaccine given.
24 hr after MMR was given small welt noted at injection site. After 48 hrs child had hives noted all over trunk and extremities. Pt treated with Benadryl and Oraped with resolution of symptoms.
A-FIB, TACHYCARDIA, SUPRAVENTRICULAR TACHYCARDIA,
I took my vaccine on febr 15. The next day I began feeling extreme pain in my arm and its continue since now...  this is my 5th weeks  I can moved my arm good. I was taking ibuprofen I went to the doctor I went to the neurology and I'm in the process to know what I have...  doctors doesn't understand my pain.... I can Drive car, write, cook, I can sleep on night the pain is constantly, I will like to know how to procedure     the laboratory is Novartis.  Can you help me please.  I'm desperate with this...
Information has been received from a physician assistant concerning an 18 year old female with penicillin allergy who on 06-OCT-2008 was vaccinated with her first dose of GARDASIL into the left deltoid (lot#: 658488/0930U). On 07-OCT-2008 the patient experienced shoulder pain on the same side as the arm where she received GARDASIL. The patient was seen in the office. Her pain was treated with Ibuprofen. The patient's shoulder pain persisted. Additional information has been requested.
This spontaneous report was received from a certified medical assistant via a company representative, referring to a 13 year old female patient. The patient's medical history or concurrent conditions were not reported. On 19-JAN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, anatomical site of vaccination, lot number and expiration date were not provided). On 21-JUL-2015 and on 24-MAY-2016 the patient received the second and third doses of GARDASIL 9 respectively (inappropriate schedule of vaccine administered). Information regarding concomitant medication was not reported. On 19-JAN-2015, the patient developed an acne-like a rash around the injection site and also had changes in her skin pigmentation around the injection site. Treatment was not given for the adverse events. The patient did not seek for medical attention. There was no intervention to prevent serious criteria, significant disability or incapacity, hospitalization or prolonged. Additionally, there was not life threatening and there was not product quality complaint involved. It was also reported that therapy with GARDASIL 9 continued. At the time of reporting, the outcome of application site acne, injection site discoloration and vaccination site rash was unknown. The causality assessment between the events and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Chills, reslestlessness, insomnia, nausea/vomiting, headache, body aches, weakness, fatigue, and fever
patient reported itching and redness at vaccination site. Also reported a blister on the face and having a sore throat. pt stated this started shortly after the vaccine administration and noticed it a lot on Friday 2/5 when pt reported it. Pt was attempted to be reached on 2/8 for follow up but no response.
pt recvd vax & ER MD said pt had been down 30 mins a/arrival @ 418PM; dx SIDS; pt arrived @ hosp intubated & CPR in progress;
Information has been received from a physician concerning a teenage female who on an unspecified date was vaccinated IM with a first dose of Gardasil.  About a week after the vaccination the patient developed "cluster of plantar warts on her one foot".  Unspecified medical attention was sought.  At the time of the report, the patient's status was unknown.  The patient planned to continue the series.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Additional information is not expected.
Information has been received from a registered nurse concerning an 18 year old female who in June 2009, was vaccinated with the second 0.5mL dose of GARDASIL (LOT# and route not reported). The patient received the first 0.5mL dose of GARDASIL on an unspecified date. In June 2009, after the patient received the second dose of GARDASIL, the patient tensed up and passed up for a couple of seconds, then recovered immediately. No lab diagnostics study was performed. The patient was seen by a nurse. No further information was available at this time of the report. Additional information has been requested.
Positive for Covid on 1/11. Sore throat, congestions, SOB, fatigue, loss of taste and smell.
Child was accidently given PCV-7 instead of MENACTRA.  0 adverse reaction
he felt mildly dizzy this morning and had some associated nausea.  He has been monitoring his temperature, given his wife's diagnosis of COVID, and has noted some low-grade fevers at 99-100 degrees. would require further set up for Remdesivir to complete his 3 days of anticipated therapy.  dose #3-9/8/2021 Pfizer-Lot# FC3184
2nd dose of vaccine.  When being administered, a blue topped syringe was used an some or all of the vaccine squirted out.  A 2nd dose was administered with a red topped syringe.  Side affect was a fever of 101.1 and joint pain with a minor headache
psoriatic arthritis flare up; Right middle finger triggered; covid-19 vaccine reaction was nausea; Feeling flu symptoms with Humira; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. 21K-163-4061923-00). A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 18Mar2021 as dose 2, single and on 18Feb2021 as dose 1, single, both via an intramuscular route of administration for COVID- 19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number: not reported) via Subcutaneous from on an unknown date to 2021 at an unknown dose (citrate free) and frequency for Psoriatic arthritis. Other Relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that on an unknown date in 2021, the patient experienced right middle finger triggered, psoriatic arthritis flare up and COVID-19 vaccine reaction was nausea and feeling flu symptoms with Humira. The outcome of the event psoriatic arthritis flare up not recovered outcome of other events was unknown.   The reporter's causality for bnt162b2 with respect to the events of right middle finger triggered and psoriatic arthritis flare up was Not Reported; covid-19 vaccine reaction was nausea and feeling flu symptoms with Humira was Not Related. The reporter's causality for co-suspect Humira with respect to the events of right middle finger triggered was not provided; psoriatic arthritis flare up was a reasonable possibility; COVID-19 vaccine reaction was nausea and feeling flu symptoms with Humira was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the reported events nausea and influenza may be related to suspect product BNT162B2, and events trigger finger and psoriatic arthropathy may not be related suspect product BNT162B2 but related to HUMIRA.
Patient was feeling great prior to the vaccine (given ~9 am), but right about 2:00-2:30 felt joint pain (hands, knees, ankles, etc) and rapidly developed chills, shakes.  Husband had to pick her up from work.  She was unable to get out of the car on her own.  She developed skin pain/sensitivity that felt like needles poking her skin.  Was running a temp of 104.7 F and had extreme thirst.  The diet coke she drank had a metallic taste (which has persisted since).  Also had a "headache from hell".  Took some Advil.  Wasn't able to eat, was nauseated, fatigued.  Tried to throw up but wasn't able to do so.  Was able to eat some french fries and an English muffin.  Saturday the fever was 103.  Sunday stayed in bed until mid-day.  Ate something on Sunday night which made her feel really sick to her stomach and nauseated.  Still had a fever Sunday night.  Woke up yesterday (Mon) w/ a metallic taste in her mouth but w/o a fever.  Stomach is still bothering her and food isn't tasting normal.  Had an intense HA last night w/ a dry mouth and dark urine.  Urine has been looking quite dark, but it's getting better.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not reported.  Treatment information not provided by reporter.
Child received DTAP, VARAIVAX vaccine 8-11-09 (L) deltoid. At scheduled visit 8-13-09 to primary care. Injection site was warm, red and tender. Treated with Keflex 250/5, 1 tsp P.O. q6 hours x 7 days.
rash on both forearms and face, itchy and warm to touch; applied topical hydrocortizone  cream with no effect.
Sunday evening, approximately 6-7 hours after receiving the vaccination shot (#1 of Covid), I began to really be effected by flu like symptoms.  I had terrible chills, my arm got hot and hurt to the fingertips.  My left arm was the vaccine site.  I was unable to sleep at all due to HOT FLASHES causing me to breath heavy ranging from 15 seconds to 1 minute long in regular intervals of 5-10 minutes a part until a Monday morning. Around 8 am Monday morning (22 hours from vaccination) I began to have explosive diarrhea and my arm began to pulse. I could only smell and taste metal STRONGLY and a ringing in my ears as well as a low grade metallic headache.  I also cried at every moment for NO REASON.  These symptoms lasted throughout Monday until I took a Vicodin and went to sleep at about 8p Monday evening. Tuesday morning I awoke with fairly severe diarrhea but the metal taste and smell are gone, the arm is hurting from back of shoulder to wrist but now achy not super painful.  I have no headache or hot flashes (aside from the menopausal norm) and all seems to be well EXCEPT the ringing in my ears is still very present.
HPV - 1st dose c/o rectal pain severe and went to E.R. - no findings reported. HPV - 2nd dose c/o severe throat pain and pain with swallowing - went to physician and was told it was reaction to HPV and not to get 3rd dose.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.49  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient received pneumococcal vaccine in right upper arm 4/12/2010. Later same day her arm began to hurt. On 4/13/2010 her arm was red, hot, itchy temp of 99.3 patient evaluated by PA in clinic on 4/15/2010. Prescription for MEDROL- DOSEPAK ordered.
Woke up with THE WORST HANGOVER and I don't drink. Severe headache and spinning feeling which was making me dry heave. This continued the whole next day and night.
symptoms of myocarditis; COPD flare ups after each dose; COPD flare ups after each dose; The initial safety information received on 28Sep2021 and 20Oct2021 was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 01Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (the patient). This consumer provided information for two reports. This is the first of two reports. This currently 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 17Feb2021 (Lot Number: EL9269; Expiration Date: 31May2021) as Dose 1, single for COVID-19 immunisation, and via an intramuscular route of administration on 10Mar2021 (Lot Number: EN6203; Expiration Date: 30Jun2021) as Dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and ongoing COPD emphysema since 2007, ongoing coronary artery disease since 2014 with open heart surgery cardiac tamponade stent (1st), coronary artery disease from 2018 with Stent in RCA (2nd), weakened immune system, and ongoing hypertension since 2021. Family Medical History Relevant included: heart disease, diabetes, hypertension, and coronary artery disease. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced COPD flare ups after each dose. The flare up lasted 6 months and was treated with oral prednisone for COPD flare ups from an unspecified date in 2021. It took 6 months to get control of COPD after the 1st and 2nd doses. On an unspecified date in 2021, the patient experienced symptoms of myocarditis. As of 01Nov2021, the patient stated, "I believe I have symptoms of myocarditis. I am currently seeking a doctor to give me tests to confirm myocarditis. This is very serious." The clinical outcome of the events "COPD flare up after each dose" was resolved in 2021 while the outcome of the "symptoms of myocarditis" was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-202101284220 same  patient/reporter, different AE/vaccine dose
Patient received 3rd dose of Covid19 Pfizer-BioNTech vaccine due to facility not properly keeping patient records. Patient status unknown at this time.
Diarrhea 2 days Headache 1 day Tiredness  2 days
Left vocal cord paralysis; hoarseness/raspy voice; dysphagia/has trouble swallowing; Choking sensation; Sore throat/throat pain; This case was reported by a lawyer and described the occurrence of vocal cord paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced vocal cord paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the vocal cord paralysis was unknown.   It was unknown if the reporter considered the vocal cord paralysis to be related to Shingrix.  The initial information received on 10 December 2020; via medical records as per records the male patient had history of hypertension. As per pharmacy records on 26 July 2019, he prescribed with SHINGRIX 0.5 ml , intramuscular and on 27 September 2019, SHINGRIX 0.5 ml , intramuscular. As per records on 06 September 2019, evaluation in regards to hoarseness. Onset was about 4 weeks ago. Afterward, he started to notice that his voice was raspy. He stated that throat feels closed off and something caught in his throat causing him to clear throat often. He reports dysphagia that was worse when he swallowed. He has a "choking" sensation". Throat is "sore". Pain scale 6/10. On 17 December 2019, he had was quite weak and he had trouble swallowing. His neurologist believed his VC paralysis was due to the Shingles vaccine. He also mentioned his doctor thought his gut paralyzed. This may be consistent with paralysis of the vagus nerve. On an unknown date, he was hospitalized for tonsillectomy.
3/12/21 around 10:00am episode of severe vertigo with the room spinning and nauseous. Happened again 11:00 pm -1:00 am Vertigo and nausea unable to sleep lying down. Had to sit up in a chair to sleep.
Within 2 hours after receiving Hep B vaccine patient reported to hospital emergency room complaining of being faint, dizzy, left side numbness, problem breathing, chest tight and heavy. Rash on chest, left upper arm swelling and nausea. Patient given Prednisone, Fomatodine. Home within 3 hours.
Tested covid-19 positive after first dose; Breathing messed/Have to catch my breath while talking/Too short of breathing; Sleep a lot; Fatigue; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested covid-19 positive after first dose), DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Difficulty breathing (Patient pre-existing condition includes breathing complication.). Concurrent medical conditions included HIV positive, Asthma and Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (Tested covid-19 positive after first dose), DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Tested covid-19 positive after first dose) had resolved and DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Coronavirus test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided. The patient had recovered from COVID-19 at the time of reporting.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events dyspnea, somnolence and fatigue, a causal relationship cannot be excluded. Patient's history of asthma and HIV are confounding factors that may play a possible contributory role. Further information has been requested. Based on the mechanism of action of mRNA 1273, it is unlikely to cause Covid 19.
Had a slight response but was over in a day. Felt worse after senior Flu Shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot). At the time of the report, IMMUNISATION REACTION (Had a slight response but was over in a day. Felt worse after senior Flu Shot) outcome was unknown.            No relevant concomitant medications were reported.  Bivalent booster shot was Moderna and was 0.5ml compared to 0.25ml for the previous booster shot. No treatment information was provided.
pt recv vax & approx 1mo later pt fainted;approx 1mo p/the fainting episode pt dx w/cardiomyopathy & ventricular tachycardia;the most recent info recv 3APR98 reports the outcome as unk;
1st lot # given in right arm, 2nd in left arm. About 3 days after first shot my eyes swelled to the point where my upper and lower eyelids were almost touching. I didn?t think much of it but now it?s happened after the second dose as well. First time I took 50mg of Benadryl but it didn?t help and took almost 2 days to subside.
No adverse effects reported.; two unspecified patients were administered expired doses of MMR II; This spontaneous report was received from a nurse and refers to two patients of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On 06-MAY-2019, the patients were vaccinated subcutaneously with expired doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N013868, expiration date 04-MAY-2019 (exact doses were not reported) for prophylaxis. No adverse effects were reported.