chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low energy; feeling really really tired, fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE and SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue). At the time of the report, ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatments for the events is Unknown.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Fever of 101-24 hrs after immunization given, resolved with Tylenol. Spot s/p injection grown today into red eryth area, larger and warm to touch. 7x8cm indurated eryth sl tender to palp. No rash , no d/c. Benadryl 1 tsp tid follow.
Patient contacted the pharmacy on Saturday 10/21/23 to let us know that her arm was very swollen and hot from the injections. She said the swollen area took up a large part of her upper left arm. I advised her to keep an eye on it over the weekend and apply cool compresses, and if it was still very swollen on Monday to let us know and we could advise her from there. She followed up on Monday 10/23/23 to let us know that she was feeling much better and the swelling went down.
16 hrs post dose, I had chills, followed by temp of 99.9 at 21 hours. Normal temp for me is 97.8. Some muscle aches & joint aches similar to flu. No treatment at this time (now).
Severe headache; throbbing arm/Severe Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing arm/Severe Arm pain) and HEADACHE (Severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (throbbing arm/Severe Arm pain). On 05-Apr-2021, the patient experienced HEADACHE (Severe headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 10-Apr-2021, PAIN IN EXTREMITY (throbbing arm/Severe Arm pain) had resolved. At the time of the report, HEADACHE (Severe headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
ADR covid vaccine monitoring documentation. Patient seen in the ED 4/25/21 diagnosed with shingles. PT documented to have painful rash at the back of the neck noted to be shingles. The patient indicated they received first dose of Pfizer COVID-19 vaccine Lot EW0158 on 4/21/21 (3 days prior to arrival).
Whole body rash from head/neck to bilateral feet. Large red rash w/red splotches. Warm to touch. Afebrile. 98.5 today. Appeared 9 days after vaccines. Took 7 day steroid dose pack starting on 01/21/15-no improvement.
One respondent (3%) reported JIIM flare after the 2nd dose of the Pfizer BioNTech COVID-19 vaccine; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for COVID-19 immunisation, notes: DOSE 1,SINGLE, UNKNOWN MANUFACTURER. The following information was reported: IDIOPATHIC INFLAMMATORY MYOPATHY (medically significant), outcome "unknown", described as "One respondent (3%) reported JIIM flare after the 2nd dose of the Pfizer BioNTech COVID-19 vaccine".  The reporter considered "one respondent (3%) reported jiim flare after the 2nd dose of the pfizer biontech covid-19 vaccine" related to bnt162b2.; Sender's Comments: 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.
Paresthesia to L side of face, L arm, and L leg.  Led to flushing, palpitations and dyspnea.
Injection site was sore for 3 days. 2 days after that resolved I noticed pain and discomfort in the left arm (same arm the vaccine was administered); the lymph node in the armpit started to swell and was very painful for 3 days. The pain started to subside however there was still mild swelling. Day 11 I noticed the swelling is more pronounced and the armpit is painful again.
pt recv vax; w/in 3-5 min, c/o "not feeling very well"; devel body twitching, loss of muscle tone, not responsive to verbal stimuli for 4-5 mins;c/o neck feeling stiff; to hosp via amb;
Mom called stating pt was having a reaction to a shot with a big red bump.  No fever, no difficulty breathing.  Mom advised to apply cold compress and use Tylenol/Motrin and all office if symptoms worsened.  Next day, mom came to office with child stating bump was worse.  Red, raised and warm to touch on R thigh, 1 x 1/2 size area.  Dr. looked at area and advised mom that it is local reaction and to watch for worsening s/s.  continue cold compresses and Tylenol/Motrin for pain and swelling.  Please call office or ER if s/s worsen.
High fever only increased 103-104 x 2 days; treated with Ibuprofen.
Sedation, Myalgia, Fever, Injection site discomfort, fatigue, and tiredness Narrative:
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an adult male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 13-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 17-Apr-2012 and incorporated into the narrative: Suspect drug information, patient demographics and no late occurring adverse event.
Patient describes itchiness, rash and swollen bumps at the injection site. Also reports sneezing and congestion (severe) but no fever. Also says the injection site is warm.
Patient states her arm was sore at injection site and she had a headache and chills for a day.  When asked if she would have been able to go to work that day she said no she really didn't feel well.
Headache; A spontaneous report was received from a healthcare professional concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced headaches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of headaches was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of headache, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # K026533 with expiration date of 07-AUG-2015, lot# L002867 with expiration date of 11-NOV-2017, dose, strength and route unknown), which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received ZOSTAVAX subcutaneously in left arm on Wednesday 4/9/14. She returned on Sunday 4/13/14 to report she had local rash at injection site and swollen lymph nodes under left arm.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F"; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F") in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F"). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 19 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No Treatment medications were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Tested positive for COVID with home test kit on 28May2022; Tested positive for COVID with home test kit on 28May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 54 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus (Type 2)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "diastasis recti" (unspecified if ongoing), notes: diastasis recti; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins; "Known allergies: penicillins" (unspecified if ongoing), notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins. The patient's concomitant medications were not reported. Past drug history included: Sulfamethoxazole, reaction(s): "Known allergies: sulfamethoxazole,", notes: Known allergies: yes - sulfa, sulfamethoxazole, penicillins. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28May2022, outcome "unknown", COVID-19 (medically significant) with onset 28May2022, outcome "recovering" and all described as "Tested positive for COVID with home test kit on 28May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Sep2021) Negative, notes: Nasal Swab; (18May2022) Negative, notes: Nasal Swab; (28May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Investigation result: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, FF8841 fill lot EL3231, FF8835 and the formulated drug product lot EL3224, FA9156. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Flu like symptoms, headache, chills, joint pain, nausea, fatigue, sore arm. Aspirin helped symptoms. Started 8:00 pm 1/27 over by 10:00pm 1/28
Sore arm the night of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 16:15 (Lot number: EW0153) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "Sore arm the night of the vaccine". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Sore arm the night of the vaccine, lasting approximately 48 hours on both shots. Minimal side effects from 1st shot. Facility type vaccine: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
Exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Exposure via breast milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Exposure via breast milk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
Information has been received from a certified medical assistant concerning a 44 year old disabled white male with chronic obstructive pulmonary disease and joint disease, who on Jan 12 2005 at 8:00, was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N). There was no illness at the time of vaccination. Concomitant therapy included an intramuscular dose of tetanus toxoid (batch U1341AA) into the right deltoid, a tuberculin purified protein derivative test (batch C1710AA) given into the left forearm and an intramuscular dose of influenza virus vaccine (unspecified) (U1499AA) into the left deltoid. That night, the patient awoke with a sore site, Unspecified medical attention was sought. An exam of the patient noted that he developed a 5x7 cm area of induration, warmth, and tenderness at the site. The patient was treated with prednisone 50 mg 40/30/20/10 one day each, diphenhydramine hydrochloride (Benadryl) 25mg four times daily, for 48 hours and cool packs for comfort, No diagnostic laboratory test were performed. On Feb 16 2005, the patient wsa seen for follow up an he had no complaints. the patient recovered at that time or sooner. It was also reported that there were no adverse events following prior vaccinations. No product quality complaint was involved. Additional information is not expected. It was also reported that another patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N) and experienced adverse events (WAES0501USA04214).
Rash appeared on the right arm 24 hours after the vaccine was administered; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021, 24 hours after the vaccine was administered, the patient experienced rash on the right arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash appeared on the right arm 24 hours after the vaccine was administered was resolved on an unknown date in May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Seated in observation room after receiving 1st dose of Pfizer COVID 19 vaccine, pt reported feeling lightheaded and sweaty. RN elevated her feet onto a second chair facing the patient while 2nd RN obtained vital signs. Pt was hypotensive with BP 72/44. Otherwise vital signs were within normal limits. Pt remained with her feet elevated for several minutes and reported feeling better. Pt tolerated lowering her feet to the floor. BP was 97/67 She ate some of her lunch and then tolerated standing and walking. Left ambulatory, asymptomatic.
1st dose pain @ injection site 9 hours later. 2 days later, chills, muscle pain, headache( mild) diarrhea.
After putting the 2nd dose, I felt a strong current on both hands, they have swollen up and I can hardly do normal things with it. I can not open anything screw because the pain in the hands is intense. I wake up with my hands mega numb and feeling like an ant for several periods during the night I can barely get a good night's rest.
Covid Arm, It is day 12 and I still have a 4" diameter rash and it is warm to the touch
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Received Pfizer booster 12/17, admitted 12/20 after being found down for unknown amount of time, severe metabolic disarray, NSTEMI, AKI, also COVID +. Req. ICU admission
expired Hiberix vaccine today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   On 13-SEP-2023, the patient received Hiberix (intramuscular, right arm). On 13-SEP-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: expired Hiberix vaccine today).The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter called to report that she gave a patient an expired Hiberix vaccine , which led to expired vaccine used. The reporter consented to follow up.
sz w/in 60sec of administration of vax EPI given x 2 hr @ hosp; 2 grand mal sz since 25APR95 currently taking Tegretol & cont to have focal sz, no prev sz hx prior to vax;
Morning-back of R side throat discomfort, R eye tearing, 24 hrs later-   numbness of R side tongue, R side of lips and cheek lose of muscular control, R eyelid remains open.  Evaluated in ER 48 hrs after start of symptoms. DX-Bells Palsy treated with Prednisone & anti-viral. Symptoms continue.