chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just tired; nausea; gas along with weakness; Gas along with weakness; chills; joint pain in knees; Arm Soreness; Midnight Fever developed; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 15:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19. Concomitant medications included Lisinopril/HCTZ (MANUFACTURER UNKNOWN) 20-25 mg from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Mar2021, the patient experienced arm soreness that started and worsened at 20:00, joint pain in knees at 20:45, chills at 22:00 and at midnight fever developed. On 18Mar2021, the patient experienced nausea and gas along with weakness at 02:00, 103 (unspecified units) fever at 04:00, which was still bad at 06:00; fever falling strength recovery at 08:00, just tired and arm sore at 10:00, was same at noon and 14:00 and at 16:00, just the arm for another 24 hours. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain in knees, chills, fever, nausea, gas, weakness, fever, pain in arm and tiredness was recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
Ringing in ears; Feeling of stuffiness; Sensitivity to noise; This case was reported by a consumer and described the occurrence of ringing in ears in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2022, the patient received Shingrix. On 17th August 2022, immediately after receiving Shingrix, the patient experienced ringing in ears, ear feels clogged and hyperacusis. On an unknown date, the outcome of the ringing in ears, ear feels clogged and hyperacusis were not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears, ear feels clogged and hyperacusis to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment:  The patient was the self reporter. The Reporter stated that soon after receiving vaccine the patient began to experience ringing in ears, along with a feeling of stuffiness and a sensitivity to noise. Since that date the symptoms had not lessened.
missed the 21-30 day dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The pharmacist stated that a patient who was between 55 to 65 years of age, was doing the accelerated dosing schedule and missed the 21-30 day dose.   The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Patient received vaccine from pharmacy. waited 15 mins and left the store. Was reported passed out in parking lot by spouse and store personnel called emergency medical service
Moderate pain/cramping at injection site starting a few hours after vaccine, resolved on its own after ~48 hours.  Red ring rash, slight burning/itching about 1.5in radius around injection site. Began 12 days after vaccine, mostly resolved after 24 hours.
Temp 99, headache, body aches x 24hrs, Less severe than the one on 6/9/04. Treated W/ Tylenol
Within a couple a hours after receiving vaccination left eye became blurred and had double vision. Has not been relieved at this time.
Redness and swelling at vaccine injection site onset 1 day after administration. improved with benadryl. Also now instructed to apply hydrocortisone.
Weakness; Tiredness; redness and swelling of the injection site for 2 days; redness and swelling of the injection site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Tiredness), VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days). On an unknown date, the patient experienced ASTHENIA (Weakness) and FATIGUE (Tiredness). At the time of the report, ASTHENIA (Weakness), FATIGUE (Tiredness), VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Reports lightheaded this morning lasts about one hour. Denies Sob, hives, weakness, nausea or fever.
On 3/27, I noticed my left arm had red splotches and was warm to the touch. Slight itchiness occasionally occurs.
My left supraclavicular lymph node is swollen to the size of a date.  It is not painful and is movable.
Had a seizure within the 15 minutes after the shot was given. Recovered almost immediately after the vaccine was given. No effects after the fact.
First dose of Moderna Vaccine was received at approximately 11:30 a.m. on 3/18/2021.  When I woke up on 3/19/2021 about 5 a.m., my lips were swollen and I had blisters inside my mouth.  I took Benadryl.  As of  3/24/2021, I still have blisters, but they are better.  Lips are not swollen as bad.   I have never had cold sores or fever blisters.
Initial report was received on 12 February 2013 from a health care professional. An elderly female patient had received TENIVAC, lot number U4068AA (route, site and date of administration not reported) and an unspecified amount of time later, experienced muscle weakness and inability to bend arm or lift arm across shoulder. At the time of the report the events had been ongoing for a month. The patient's outcome was not reported. Documents held by sender: none.
Racing heart, pain in arm, and dizziness 10 minutes after shot that lasted only a few minutes. Nausea, dry mouth with metallic taste, chills, head pressure and a rush sensation through the body for 2 hours after injection. Nausea comes in waves still 3 1/2 hours after injection.
Previous Gardasil 9 vaccine dates: 9/19/2019 and 10/25/2019  Fatigue Joint Pain Joint inflammation Neck stiffness/pain/decreased range of motion Falling asleep while talking Falling asleep while driving Overall Excessive Daytime Sleepiness   Started mental health therapy 12/13/2019 -GAD  Started at Sleep Specialist 5/12/2020 Sleep Study 7/28/2020 and 7/29/2020 -Excessive Daytime Sleepiness -Hypersomnolence Started Armodafinil 150 mg  Referred for MRI 11/20/2020-denied by insurance. Required to complete PT before it could be approved.  Completed PT then referred to MRI again along with an allergist.  5/21/21 completed Diagnostic Imaging- found abnormalities in pelvic area 6/4/21 MRI and CT completed 6/11/21 Ultrasound for abnormalities in pelvic area canceled due to financial cost of service  7/23/21 Started with allergist -Noted fatigue, allergies, occasional shortness of breath, swelling on ankles, joints positive for pain and swelling 8/20/21 Started immunotherapy   10/29/21 Started Ritalin 10 mg 3x/day  6/13/22 saw rheumatologist for pain -DX Fibromyalgia  7/25/22 PCP noted positive for fatigue, myalgias -Changed Effexor to Cymbalta for pain/depression  Fall 2022 added 20mg ER Ritalin   Other medication changes may have happened during this time as well.
Severe pain the hole body.  ER tx with sodium chloride, Tylenol ibuprofen.  Cipro 500mg tab (th) by MD ER.
I was feeling fine for a couple of hours after the shot. I started getting a headache at around 11:00am. By noon, I was feeling fatigued and started feeling confusion and lightheadedness. I had to leave work by 3:00pm. by 5:00pm, I was very concerned about the way I was feeling. The headache was severe and I was lethargic. I slept for most of the next 24 hours. 48 hours after the injection, I am still fairly lightheaded and have a headache, but I am improving.
Patient presented to the pharmacy on 7/5/17 at approximately 3:30pm. Patient explained to the pharmacist that later in the evening of 7/3/17, the area around her injection site on her right arm had become inflamed, red, slightly painful and warm to the touch. The patient explained that since that time, her symptoms have become increasing worse and that she has been feeling overly tired since the evening of 7/3/17. The patient explained to the pharmacist that she had been taking both ibuprofen and Benadryl around -the-clock to mange her symptoms.
had the worst flu ever going on my second week of coughing; had the worst flu ever going on my second week of coughing; Initial information received on 30-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who had the worst flu ever going on his/ her second week of coughing after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, form: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had the worst flu ever going on my second week of coughing (cough) (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (had the worst flu ever going on my second week of coughing).  At time of reporting, the outcome was Unknown for both the events (cough, influenza).
Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016459272) on 05-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified time frame following vaccination, the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm
4OCT96 pt devel swelling in foot & rt leg;reporter was not certain if the swelling occurred in same leg in which vax given;4OCT96 pt also devel 15-20mm large, blistery (vesicular) wheals all over;allerg rxn to mosquito bite;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was refrigerator R. This is one of several reports received from the same source. Additional information has been requested.
Grapefruit size knot at injection site. with a bullseye. Can see where the needle went in. Very itchy
Patient face is swelling up in one specific zone in the same side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection). At the time of the report, SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection) outcome was unknown.            No concomitant medications are provided. No treatment medications are provided.
Patient states that about 12 hours after getting the shot, she felt like her lamotrigine 50mg ER wasn't working. She felt that she was having her very angry, aggressive manic episodes which her lamotrigine was meant to prevent. She states it "felt like the shot was dissolving the medication so it wasn't in [her] system." Patient states the shot boosted her manic issues. This lasted for 3 to 4 days per the patient, and she states that after that she felt "back to normal."
After the initial vaccine they had to have me stay there for 5-10 minutes to see if I had a reaction. Around 7 PM when I got home, I started having a sensation that my throat was closing. I took over the counter sore throat lozenges. Around 8:30 or 9:00 PM I went to the ER, and they couldn't find anything, so they prescribed me Benadryl which I took and still felt the same sensation the next morning. And all the way up until late afternoon is when I started feeling better meaning I didn't have that sensation.
Grandmother/guardian reports headache every day for 4 days after 1st HPV dose on 04/01/2008.  Menactra also given that day. Then frequent headaches - 2-3 times/week. After 2nd dose of HPV on 05/29/2008 child complained of "not feeling right".  Grandmother reports she had "low energy" and a change in personality. On 09/02/2008 Child had an episode of unresponsiveness and was transported to hospital by EMS.  Hospitalized 09/08-09/09 for episodes of unresponsiveness.  Seizures ruled out. 9/18/09 Medical records (Middle School) DOS 3/14/08 to 11/14/08. Presents with painful finger. Lower abdominal pain. Constipation. Dysuria. Reports frontal H/A 8/20/08. Found unresponsive 8/29/08 and 9/2/08. Would not open eyes. Responded after ~10 minutes. Assessment:  Unresponsive. ? syncope ? hyperventilation.  On 9/11/08 found slumped in chair, pupils dilated. Assessment:  syncope. 9/30/08 parent declines HPV#3. Frequent headaches. Repeated episodes of syncope. Whole body shakes. Anxiety. "Attacks of lethargy'. Burning sensation from mid abdomen "up to heart." Gastritis. Found lying on floor in class, parent refused to have patient transported by EMS and took her home.   11/10/09 Medical records and discharge summarries received as follows:   Discharge summary received for DOS 10/02/09-10/07/09. Final DX: Depression NOS, PTSD, Severe Psychological Stressors, GAF 45 Patient w/increased suicidal ideation. Threatened to kill herself with knife. Auditory hallucinations. Prior admit for black out spells post vaccine. EEG normal. anorexia. low energy and poor concentration.  D/C to home. Condition guarded. Follow up w/psych    .    DIscharge summary received for DOS 9/19/09-9/25/09. Final DX: PTSD, Depression NOS, Oppositional Defiant Disorder, Extreme psychosocial Stressors, GAF 35. Admit for in creased aggression and agitated outbursts. Discharge to home. Stable. Guarded prognosis.   Discharge summary received for DOS 9/04/09-9/05/09. Final, .  DX: Non epileptic seizures, Normal EEG, Depression, Anxiety, PTSD. Presented with seizure like activity and syncope. Felt to be vagal.  Seizure preceded by convulsion. Unresponsive x40 min.  No ictal events. on organic etiology.  Conversion rxn s/t depression/anxiety.  D/C to home.   11/10/09 Discharge summary received for DOS 8/12/09-8/17/09. FInal DX: Depression NOS, PTSD, Generalized anxiety disorder, Acute sterss reaction. Histrionic personality disorder traits, Extreme psychosocial stressors, GAF 47 Axcerbation of depression. All labs WNL. UA increased bacteria resolved by d/c. D/C to home.   dsb
Moderna vaccine given 12 hours after opening; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given 12 hours after opening) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) 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 (Moderna vaccine given 12 hours after opening). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given 12 hours after opening) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Chills, muscle and joint pain  headache general malaise  for about 24 hours
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 33 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
COPD Excerbation; (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th), for Covid-19 immunization. The following information was reported: OFF LABEL USE (hospitalization) with onset 05Oct2022, outcome "unknown", described as "3rd Booster shot"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 10Oct2022, outcome "unknown", described as "COPD Excerbation". The patient was hospitalized for chronic obstructive pulmonary disease, off label use (hospitalization duration: 3 day(s)).  Clinical course: The patient got Pfizer's 3rd Booster shot on 05Oct2022, had a reaction, within 5 days developed COPD Exacerbation and was hospitalized for 3 days. This would take a while to get over and feel better again. The patient was just fine before the patient got the shot. Patient got the vaccine to not have patient's underlying condition. The patient had to wait 4 weeks to get a flu shot now. The patient would not get any more boosters; enough was enough.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.