chrisvoncsefalvay/vaers-outcomes huggingface dataset:
four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours; 0.3ml booster dose was administerd to the patient instead of 0.25ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 24-Jan-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml). On 24-Jan-2022 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (four patients received vaccine on 01/24/22 less than 48 hours after the expiration date of 01/22/22 but greater than 24 hours) and PRODUCT ADMINISTRATION ERROR (0.3ml booster dose was administerd to the patient instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  On 07 Feb 2022, case MOD-2022-460266 became valid as it was confirmed that the patient demographics was identified.  Therefore, this case was  logically processed as valid.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received: Report type and classification updated , Patient demographics added, Suspect product -dose, anatomical location added, previously reported event verbatim updated as per followup document, newevent product administration error added.
Pt was having heart palpitations, chest tightness, throat tightness. Pt was sent to ER for further evaluation.
Inner right arm, arm pit, right breast outer most right side swole up and started looking lumpy. This lasted for three days. Appearance of extremely swollen lymph nodes. The arm was too swollen to have the arm placed by my side. Tender to the touch.
The influenza vaccine was given using the egg allergic protocol. This is in accordance with the Red Book Protocol and current published recommendations. She received the full vaccine followed by a 30 minute observation period. ?After 30 minutes she was noted to have hives on her lower abdomen with a few small wheals on the upper left thigh. She received Zyrtec 2.5 mg (she had taken Zyrtec prior to the visit as well). She became mildly tachycardic and urticaria spread across her torso and involved her upper thighs. She was given epinephrine 0.15 cc. Symptoms improved over time and she was monitored for a total of 90 minutes. received flu vaccine two previous administrations on 12/2/11 and 3/15/12.
Narrative: COVID infection following COVID vaccine series 01/18, Pfizer, dose #1 02/08, Pfizer, dose #2 09/01, Pfizer, dose #3 12/24 COVID swab, result: detected 12/22 pt cc: cough, fever, sore throat, rhinorrhea, exposure: unknown  12/24 pt admit to ED cc: cough and body aches dx: Covid-19 infection LOS: 1 dose  12/24 SARS-COV-2 Variant Sequencing: pending 12/29 clinically resolved
The patient received DTaP vaccine IM in left thigh on 6/10/09. Patient was seen in the office on 06/12/09 with a 3 cm x 3 cm irregular area of redness around the injection site. There was a 0.5 cm central firm area. Area of redness was warm to touch.
Patient states that he experienced vomiting and diarrhea the next morning after his covid vaccine.  Symptoms began approximately 6:00 am on 11/3/21.  Patient does mention that some of the other men at work have been out with vomiting and diarrhea (unrelated to the covid vaccine).
24 hours after injection soreness at site and red erythema Left deltoid 6 inches in diameter
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue.   Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still  sore to the touch.  I?ve been taking ibuprofen for the last two days to help with the discomfort.
I have shingles. Pain in right side above hip started first two days later rash and blisters form shooting pains began from hip to Spine tighten of chest
she received her shingrix vaccine 9/14/2020. At the time of administration, she complained of a burning sensation. Then later that day and for several days afterwards, she could not move her arm. Pain was unrelieved by OTC tylenol. She could move her arm after several days, but general pain still was there even as of today. She developed a large bruise at the injection site. I believe the vaccine was administered too high up on the deltoid. The injection should be in the deltoid, 2-3 fingers below the acromion process. The bruise was 2 fingers at the acromonion. So it was not below the finger space required. She showed pharmacy the bruise on 9/22/20, which was 8 days post injection.
Burning sensation in arm; Arm is sore at injection site; Arm is swollen at injection site; Arm is dark; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Arm is dark), BURNING SENSATION (Burning sensation in arm), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E214) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced SKIN DISCOLOURATION (Arm is dark), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site). On 09-Aug-2021, the patient experienced BURNING SENSATION (Burning sensation in arm). At the time of the report, SKIN DISCOLOURATION (Arm is dark), VACCINATION SITE PAIN (Arm is sore at injection site) and VACCINATION SITE SWELLING (Arm is swollen at injection site) outcome was unknown and BURNING SENSATION (Burning sensation in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug reported. No treatment drug reported.
Breakthrough case of COVID-19 started on 05/04/2022 and is still happening today. I lost my voice and then had a cough, runny nose, diarrhea, fever of 101 that comes and goes.
Patient had no previous illness and developed a high fever over 101.  He awoke shaking in a mild seizure then proceeded to vomit all over the bed.  He had malaise for two days after and one repeat emesis that same night.  Treatment with Tylenol and hydration.  Patient had no prior vaccine reactions.  This was first flu shot plus 3 other vaccinations (dTAP, MMR).
Information has been received from a medical technologist concerning a female patient who on 4/1/05 was vaccinated with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/005R). It was noted that the patient had injection site reaction. On 6/6/05, the patient was seen in the doctors office with a red and hot arm. It was noted that she was taking Ibuprofen Motrin and or acetaminophen Tylenol. Unspecified medical attention was sought. The patients outcome was unknown. It was noted that the patient received this vaccine in the past. The caller was concerned about further use of this lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Patient was given two vaccines back to back and after vaccines were administered he came over with a  "glazed" look and went limp. He came to after a minute and was observed for 20 minutes and check out by the provider who saw him earlier. After observation period patient was back to normal.
1:32pm - Pt became disoriented for brief moment, diaphoretic. no difficulty breathing , no pain . Transfered to cot , Vitals E/N.  Pt given 2 juice boxes , power bar to eat . Initial symptoms resolved in 5 minutes. Patient remained on cot for 30 min . No facial droop , no arm drift , Neg speech . 1:40 B/ P 120/80, P58 ,RR14 spO2 98%. 2:10 Patient assymptomatic . Sat up with no symptoms . Significant other present to drive patient home . Encouraged to call 911 if symptoms return.
seen by breast surgeon on4/6/21 sonogram revealed axillarylymph glands swollen, extremely painful to lift left arm, sonogram of 11/4/21 swelling of axillary glands remain, no relief of pain in arm, lack of full mobility  follow up sonogram in 6 mos   reluctant to get booster
Pt recv vax on 12/2/98; on 12/3/98 pt exp seizure x 4min
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: about over a week later, injection site was very swollen and itchy, and had a welt the size of a baseball. temperature of injection site reads about 101.7 f. counseled pt to see doctor if injection site does not get better within 48 to 72 hours
rash/predominantly in my stomach area; have scars.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that his second dose is scheduled for 10Feb2021. As per report it was reported that he talked to his medical care provider and gave him some information on some. it was not severe, he guesses it was like a moderate side effect that he had after he received vaccine, it was kind of a rash, instead of a whole body- his was predominantly in his stomach area and he have scars. The outcome of events was unknown.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 15May2022 at 12:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient reported that the patient received no other medication in 2 weeks of vaccine. The patient received Anti viral details as follows, product=COVID 19 Treatment, Brand=paxlovid, Treatment start date=15Jul2022, Treatment stop date=19Jul2022, Indication=Treatment of COVID-19. Known allergies: Codeine. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
" bad reaction to the first injection of Moderna"; "left arm was swollen"; "Hot"; "I felt like the wind was taken out of me"; "Bedridden"; "Chills"; "Diarrhea"; "the most distressing part, my eyes is not what they were prior receiving the injection"; "I use glasses to read and another to watch tv.; "I had script, and never had to use"; "I didn't know vision could go."; "more energetic"; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me") and BEDRIDDEN ("Bedridden") in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A,031MZ0A,031MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS (Had SARS in 2003). Concomitant products included BROMAZEPAM (LECTOPAM) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic"). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg,daily for 1 week. At the time of the report, HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication was Tylenol 500mg Included.
Side effects after 12 hours:  Chills, Fever, Cold Sweats, Muscle Aches, Fatigue, Flu Like Symptoms Ongoing: Shortness of breath.  Noticed after first shot and also second shot.
Weakness, numbness/tingling in legs/feet hands and arms. Called rescue on 12/30/21 to transport to closest hospital transferred to Facility for treatment. Found pneumonia also at the time at started treatment for that. Tried to do a lumbar puncture but was unable because it hurt to much to try and lay still on my side for a period of time. Started a 3 day treatment of IVIG. Remained here for a total of 12 days. Transported to skilled nursing center where very little if any therapy was done. Got to a point where I could not move or lift arms or legs. Very weak and severe pain to move extremities. Spent 12 days here before I was transferred to Facility for additional treatment. Found now large amount of pulmonary embuli in right lung and embuli in left lung and a large amount of blood clots in upper and lower legs. Treated for 8 days for this and given a 5 day regiment of IVIG. on Feb 2 transferred to InPatient Hospital for rehab. Released on March 3, 2022 home for 6 weeks of home health care. Started in the middle of March 2022 for put patient rehab.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Injection site felt painful right after the injection and the pain  escalated and continued for 2 days and then started falling off.  Cannot sleep on the shoulder as the pain is felt when laying on the side / shoulder.  About 3 hours after the shot started feeling overly tired and achey all over.   During the night developed a head ache and spells of feeling very cold.  The  next morning felt like  I had an alcohol hangover on top of the flu.  Tried to get on with my day.  About noon just couldn't do any more.  Retired to the recliner where I spent the day and evening. Fever went up to 100.3.  Several bouts of chills, upset stomach and constant headache.   60 hours after the shot feel about 70% recovered.  Still cannot go thru a full exercise routine.  Hope to be better tomorrow.                                           QUESTION - is this vaccine 1 size fits all?  I am wondering if it is sized for the largest possible person say at 300 pounds.  I'm 135 pounds.  I'm thinking a smaller but still yet effective dose might not provide as sever a reaction.      Based on this experience I'm not sue if I'll go through with the second shot.
between my 1st & 2nd shingles vaccines / I had active shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. There was 18 months elapsed between 1st and 2nd shingles vaccines because the patient had active shingles.  Pharmacist was recommending a 3rd dose but company's literature does not. The reporter consented to follow up.
Moderna COVID-19 EUA  redness and itching at vaccination site March 25;  March 27 rash developed on left arm on inner side of the arm near the antecubital fossa; Mach 29 similar rash located on upper interior arm.   Vaccination site is still red and growing larger however it does not itch, however both of the new rashes itchy
Multi dose vile was opened on 6/22 at 2pm. Vaccine given on 6/23/23 at 10:52am. Vial opened for longer than 12 hours. In refrigerator. No out of range temps.
12 1/4 x 10 cm erythematous, indurated area lt anterior thigh site of vax;
Patient got rash after getting vaccine, 12 days after rash blister appeared, a few days after that blister were gone but area still itchy and painful. Patient received prescription for VALTREX 1gr TID x 7d.
pt recvd & exp fever, face burning, face flushing & arthralgia; pt was not seen by MD pt took DPH; reporter indicated the pt recvd dose 2 of Engerix-B w/o adverse effect;
Had a persistent metallic taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 28Jul2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On 28Jul2021 the patient experienced had a persistent metallic taste in her mouth. She is asking if this side effect is common and /or reported by other patients. Outcome of events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Joint inflammation; Pain bone; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation), BONE PAIN (Pain bone) and NECK PAIN (Neck pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Joint inflammation), BONE PAIN (Pain bone) and NECK PAIN (Neck pain). At the time of the report, ARTHRITIS (Joint inflammation) had resolved and BONE PAIN (Pain bone) and NECK PAIN (Neck pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events of bone pain and neck pain with Humira and Moderna vaccine.  The reporter assessed the event of arthritis as probably related to Moderna vaccine and not reasonably possible to Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient (unknown age) with medical history of rheumatoid arthritis, who experienced the adverse event of special interest of arthritis an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis, as well as the report that treatment medication of adalimumab was not working, is a confounding factor. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient (unknown age) with medical history of rheumatoid arthritis, who experienced the adverse event of special interest of arthritis an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis, as well as the report that treatment medication of adalimumab was not working, is a confounding factor. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The following reaction signs/symptoms were observed: abdominal pain, nausea and other dizziness with vomiting   Emergency response notified:  EMS (911)   EpiPen administered by RN as per standing order?:  No   Required VAERS reporting completed?: No   Report given to EMS (911)  EMT evaluated her  Found her to be stable enough to wait at parking lot until symptoms resolved. She stayed in lot with daughter on phone until 115 when she reports her symptoms resolved and was able to drive home   RN took vitals