chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long standing health conditions.     On 30-Mar-2022 at 10:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) to be not related.    Concomitant products were not provided.  It was reported that the patient neither diagnosed nor tested positive for COVID-19. It was reported that the event did not cause the patient to seek medical care.There were not any other potential causes for the event to occur and patient did not experienced a similar event in the past. It was reported that the vial was first stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursion. No patients had reported having any adverse events for now.  Treatment medications were not reported.
4/14/22: pt received vaccine and attended an outside appointment.  4/15/22: Pt has a chronic lisp but speech was more unclear than her usual. + word finding difficulties worse than her normal. + generalized weakness. No focal deficits. Neurological symptoms monitored for progression/resolution.  4/16/22: symptoms improved.  4/17/22: symptoms worsened in the evening. Family did not pursue ED evaluation upon their in-person visit with pt.  4/18/22: symptoms resolved. Resident attended out of facility activity when provider was onsite so was unable to be evaluated by CRNP. 4/19/22: Resident evaluated by CRNP and resident reported feeling 'foggy' but otherwise symptoms remained resolved. Speech therapy ordered.
Chills and 100 fever 7pm Fever persisted through 3-12-2021 Chills for 2 days  Diarrhea and vomiting started 10pm continued for 3 days.  Terrible headache for two days
Headache, 1st doses allergies both hand, 2nd doses allergies both hand and face and neck, 3rd doses allergies all body include my head and my private parts. over the counter medication, then I go to the primary doctor because my skin was already bloody from the itching. Office doctor given Dexamethasone 10mg injection, diphenhydramine 50 ml injection. Medrol 4 mg tablets packet, Hydroxyzine HCl 10 mg, Famotidine 20 mg and referral allergies.
Information has been received from a health professional concerning a 59 year old male who on 10/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent (lot # 641116/1160L). On 11/1/02 the patient experienced redness, erythema, soreness, and arthralgia at injection site (right arm) and mild tenderness in his left arm. The patient was seen by his physician on 11/1/02. The patient was instructed to take diphenhydramine HCl 25 mg every 6 hours prn and 50mg at night for 3 days. It was reported if the events persisted the patient would be prescribed levofloxacin 500mg daily for 7 days. Additional information has been requested.
patient receiving an extra dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Medical Information (GMI) (Reference number- 00817290).  This case involves a 48-year-old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], which was double dose of the vaccine (extra dose administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AB and expiry date: not reported) (Frequency twice) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Sep-2021, the patient received another dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ694AA and expiry date: not reported) (Frequency twice) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "he nurse was looking for any potential AE information in regards to a patient receiving an extra dose of Fluzone Quadrivalent."  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed fever and chills, 103F, body aches, which lasted about 24 hours; left with fatigue for another 24 hours. Injection site was swollen, red, hot with raised area about 4 x 4". Applied cold compress, took ibuprofen. Swelling and pain receded within 3 days, but injection site is still itchy. This was the second dose. The first dose was similar, but less severe.
Vaccine injury report December 10, 2012. Patient received the TDap vaccine at 10am on Friday, December 7, 2012. He immediately felt pain (left arm) at the injection site like a "charley horse" and felt the vaccine run through his arm. He seemed to be ok the rest of the day with just soreness in his arm. The following day he felt tired, his throat was slightly sore. On Sunday, December 9, 2012 he reported symptoms of headache, chills, lack of energy, mucus in his throat. As of early evening he had a fever of 100F and the headache pain increased. Overnight he did not sleep well. He had chills and fever all night with nausea. At 6am Monday, December 10, 2012, he presented symptoms of 103F fever, nausea, headache, chills, body aches and total lack of energy, uncontrollable body shaking and dizzy enough that I had to walk him to the bathroom. As of 6:50pm this evening he still has the same symptoms.
Caught Covid-19; They both had the Pfizer Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine). At the time of the report, COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine) outcome was unknown.            No medical history was reported. No treatment medications were reported. Company comment: This is a spontaneous case concerns a female patient of  unspecified age with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) in the context of the administration of a dose of mRNA-1273 vaccine (unknown dose number and schedule of vaccination). No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was unknown. It was noted that patient received 2 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerns a female patient of  unspecified age with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) in the context of the administration of a dose of mRNA-1273 vaccine (unknown dose number and schedule of vaccination). No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was unknown. It was noted that patient received 2 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Information has been received from a physician concerning a patient who on 09-APR-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). The patient developed a low grade rash of 10-12 small lesions over the patient's arms, neck, face, and trunk that were firm to touch. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt. states that after receiving the 2nd dose of Moderna 08/30/2021, started experiencing symptoms of Left arm pain, rash, headache, low grade fever, and fatigue. No Primary visit noted. Still continuing with current (self-care treating with Benadryl).
Low grade temp and aches resolved after 36 hours.; Aches resolved after 36 hours; Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla; Even some left breast swelling and tenderness that started one day after shot.; Even some left breast swelling; Dose number 3; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 15:00 (Lot number: unknown) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies Penicillin- rash. Concomitant medications included: VYVANSE; DUPIXENT and LEXAPRO. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified, Anatomical site: Left arm), administration date: 30Dec2020, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), administration date: 19Jan2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 15:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Large amount of under arm and axilla lymph node swelling/ Tender, swollen and lymphadenopathy in left axilla"; BREAST TENDERNESS (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling and tenderness that started one day after shot"; BREAST SWELLING (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Even some left breast swelling"; PYREXIA (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Low grade temp and aches resolved after 36 hours"; PAIN (non-serious) with onset 18Dec2021 at 08:00, outcome "recovered" (19Dec2021), described as "Aches resolved after 36 hours". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, breast tenderness and breast swelling.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Low grade temp and aches resolved after 36 hours. Large amount of under arm and axilla lymph node swelling. Tender, swollen and lymphadenopathy in left axilla and even some left breast swelling and tenderness that started one day after shot. Presently have this.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed shooting pains on left side of face, headache, and had red bumps on face starting on 12/3/12. Developed full blown shingles 12/4/12.
Extreme bad reaction in the lower arm; Difficulty to lift the arm; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction and mobility decreased. On an unknown date, the outcome of the adverse reaction and mobility decreased were unknown.   It was unknown if the reporter considered the adverse reaction and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced an extreme bad reaction on her lower arm and difficulty to lift the arm (not sure if it was on the injection site). It was reported that the patient did not report this to her doctor, but who reported this adverse event recommended to do so.  No further information regarding Shingrix vaccine was reported or any details from the patient experience.
Patient Age: 51 years old; pin point size rash all over his back; This spontaneous report was received from a pharmacist and refers to a 51-year-old male patient. The patient had no pertinent medical history, no drug reactions or allergies and did not take any concomitant medications. On 01-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, (lot # R030812, expiration date 24-OCT-2020, therapy type rHA) (dose was not reported), due to the unknown vaccination history, diluted in sterile diluent (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date, he experienced a pin point size rash all over his back. The patient did not receive any treatment for the event and had no laboratory studies performed.. On an unknown date in approximately January 2020 (reported as "over this past weekend"), the patient sought medical attention and presented to the pharmacy. The outcome of rash was reported as not recovered. The relatedness between the suspect therapies and adverse events was not reported.
POOR SLEEP; SENSATION OF SMELLING ROAST BEEF; CHILLS; HEADACHE FOCUSED AROUND EYES ,FORHEAD AND SINUS; MUSCLE ACHE; INTERMITTENT FEVERS; SINUS CONGESTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0U3A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced sinus congestion. On 05-APR-2021, the subject experienced poor sleep. On 05-APR-2021, the subject experienced sensation of smelling roast beef. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache focused around eyes, forehead and sinus. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced intermittent fevers. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache focused around eyes ,forehead and sinus, muscle ache, chills, intermittent fevers, poor sleep, sensation of smelling roast beef and sinus congestion was not reported. This report was non-serious.
Patient received a flu shot and her second GARDASIL 9. She was nervous in the immediate time period right before the shots were administered. She then said it hurt a lot. Approximately 1-2 minutes later she said, "I feel sick". She was as white as a sheet, then fainted leaning forward. I caught her and lay her down across her sister, who was seated on the exam table next to her. Her eyes rolled back, she started smacking her lips, and then had small jerking movements of all four extremities. This lasted approximately 10 seconds. She woke, complained of not being able to hear, and started crying. She calmed down after several minutes. She was lay down for 15 minutes and was given juice. She had fatigue and was subdued for the next 36 hours. She slept 11 hours that night, which is atypical, and then stayed in bed the next day until the evening.
I have had serious upper back pain since the first shot and then even more serious pain after the second shot.  It feels as if a bubble is trapped on the back left and right shoulder blades.  I have just started chiropractic treatments for this pain.  It has woken me from deep sleep and just the pain it feels as if it's going through my chest area.  I finally decided to do something about it since nothing seems to give me relief from the constant pain.  Even wearing a bra hurts like you wouldn't believe.  My doctor is the one that said I should report this.
mom brought pt in to be checked because of swelling & nodule in rt thigh; also bruise size of quarter on leg; no fever or crying w/leg;
Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil, injection.  The patient had considerable swelling and redness at the injection site.  When the patient had the second dose of Gardasil, injection the redness and swelling traveled up to her neck.  The physician elected to not let her get the third dose.  As of 11-JAN-2008 the patient was recovered.  Medical attention was sought.  The product quality complaint unit was not involved.  Additional information has been requested.
PT. STARTED WITH TIRED AND WEAKNESS, PROGRESSED TO SHIVERS AND CHILLS THEN A FEVER 100-101.  THESE SUBSIDED BY THE AM NEXT DAY BUT ARM WAS VERY SORE AND PROCEEDED TO BECOME RED, SWOLLEN AND TIGHT FROM SHOULDER TO ELBOW.  SYMPTOMS OF LOCALIZED REACTION STARTED TO RESOLVE TODAY 10/27/11 IN THE AFTERNOON.
Developed Typed 1 diabetes with no known family history from either parent. Health prior to presenting was excellent with no adverse habits.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was sitting in the recovery chair 5 minutes post vaccination and fell out of the chair (fainted) - immediately patient regained conciousness. Patient was instructed to elevate legs - still was feeling faint so patient was instructed to lie down. Patient was given a glass of water and some fruit snacks and monitored for additional 30 minutes. Patient's blood pressure was taken 103/51 mmHg. Patient was feeling okay after 30 minute wait period and left the pharmacy.
Got the vaccine, a week later got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got the vaccine, a week later got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that worst 2 experiences of his or her life. The patient got vaccine and a week later got shingles. The follow-up could not be possible as no contact details were available.
On going headache, nausea, fatigue and chills for 9 days after 2nd vaccination. Symptoms are ongoing at this point.
Patient with known history of ITP status post splenectomy in 2018, with stable platelet counts off treatment, developed petecchial rash in lower extremities 2 days after receiving COVID vaccine during a mass vaccination campaign.  Platelet counts check 2 days after the vaccination was 1,000.  Patient was admitted to the hospital for ITP, received 2 doses of IVIG and was initiated on prednisone with improvement in platelet count to 72,000 by 03/14/2021.  Give
Administration error: patient received the pediatric Pfizer vaccine (5-11yo) on 12/3/21 and on 12/23/21. No adverse events.
pt recv vax before noon, shortly p/lunch felt sick, tired, nausea, weak, upset tummy, lay down until about 430PM;hands started burning, itching then spread to whole body;devel whelps & hives;itched on hands, awoke off & on all noc;
Besides expected soreness in the left arm shot site, severe soreness in left hip and buttocks developed about 12 hours after receiving the influenza vaccine in left arm - no treatment so far and is still sore after 24 hours - plan to take Tylenol in hopes this helps
Arm is very red and hot to touch and swelled. Swelling is continuing more each day. Currently  6in by 3in. Tender to the touch but not really painful.
Pt developed varicella despite vaccine. Vax given at Dr. office - No clinical data.
Intermittent tingling & Numbness of Right arm approx 10 minutes after injection to Left arm. Dizziness and generalized weakness ~ 10 minutes after injection.
This serious spontaneous case initially received from other non-health professional (consumer) on 27-Apr-2018, concerning a 55-year-old, adult, male patient. The patient's current condition included sensitivity to dyes, chemicals and was on very strict plant based diet due to it. The patient had no other medical issues and concomitant medications. On an unspecified date in 2012 (reported in 2017 as 5 years ago), the patient was administered with INN (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed thoughts of hopelessness which turned into suicidal thoughts. It took 5 months for the patient to recover from the events- thoughts of hopelessness and suicidal thoughts.