chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a Medical Assistant concerning a 74 year old male patient. The patient's concurrent conditions included drug reaction/allergy to penicillin. The patient's concomitant therapies included unspecified blood pressure and cholesterol medications. It was reported that on an unknown date in 2016, the patient received PREVNAR 13. The patient had no pertinent medical history. On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 with lot number R009163 and expiration date on 06-JAN-2020, 0.5 ml once, administered intramuscularly in the left arm for prophylaxis (dose number was not provided). In July 2018 (reported as "within 12 hours of getting the PNEUMOVAX 23"), the patient's left arm was swelling around the vaccination site and spread to left hand. It was reported that the patient took BENADRYL and he recovered from the events in July 2018 (reported as "within three days after symptoms appeared"). No lab diagnostics or studies were performed. On 18-SEP-2018, the patient visited a physician. At the time of reporting, the causal relationship between PNEUMOVAX 23 and the events of vaccination site swelling and peripheral swelling was unknown.
8/23/11 - Felt fatigue, mild tachycardia at 1800. Chills, generalized body aches & severe joint pain by 2100. 8/24/11 - Fatigue & generalized body aches continued. 8/25/11 - Same as 8/24/11 but seems to be improving.
Pt devel induration & redness around inject site w/2 surrounding hives w/in 2 min of vax; Never had eggs in diet; Given DPH po immediately w/no further event;
face  turned red, hard time swolling, 15 min after shot. took a benedryl and went to bed.  next day really tired, wheezing, and coughing alot since.
Nerve pain following the injection; initial radicular nerve pain that traveled to 2-3 fingers, which has now resolved. Still has some localized nerve pain over the distal deltoid which seems be improving with time
On 3rd day after receiving immunizations, child had febrile seizure at 4:00 PM. Mom witnessed. Child had been sleeping alot on this day. Temp 101.8 in office 9/18/03 at 5:13 PM.
Redness and swollen at the site of injection. On 8/27/15, condition was diagnosed as cellulitis by the physician and was given cephalexin(500mg QID x 10days and sulfamethoxazole-TMP 160/800 BID x 10 days. Upon phone call on 8/29/15 to patient, she indicated "arm is getting much better and redness is going away". Instructed patient to complete antibiotic therapy.
Client had an anxiety attack diagnosed and evaluated by MD on site. Client verbalized her BP was increased the 1st time she received the COVID19 vaccine in this site was evaluated and was diagnosed with anxiety attack by her primary care physician. She felt very anxious. Vitals were taken 5 times.
Large lump at the vaccination site, sore, red, swelling, extreme pain, unable to lift arms or reach
directly after injection, patient felt like he was going to pass out, tunnel vision, assisted to floor by staff, feet placed up on chair. arrived to obs, admits to needle phobia/anxiety. clammy, diaphoretic and pale. bp 110/72 hr 55 rr 18 sats 99% on ra. placed in tredelenberg, states relief, color returned and sweating ceased. water and apple juice provided. 5 mins later bp 117/78 hr 59 rr 18 sats 100%. patient sitting up on side of bed 5 mins later bp 127/89 hr 65, then standing bp 118/65 hr 55. states he feels back to baseline and escorted to vehicle with no issues.
This is a spontaneous report from a contactable consumer (patient). A 44-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 44, via an unspecified route of administration, on Apr 15, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history: none. The patient has no allergies to food, medications or other products. Concomitant medications not reported.  Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 22:00, patient experienced allergy symptoms: runny nose, sneezing, red burning eyes and nasal irritation. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the event allergy symptoms runny nose, sneezing, red burning eyes and nasal irritation: not recovered (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Myalgia, Fever & NauseaVomiting Narrative:  bodyache; fever; nausea;pain/swollen arm
Patient received first H1N1 shot on 11/13/2009 and received second on 12/16/2009.
This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 15Jan2021 02:30 at single dose for COVID-19 immunization. Medical history included complex regional pain syndrome (reported as CRPS) and seizure disorder. No known allergy. Concomitant medication included lamotrigine (LAMICTAL) and birth control, multi-vit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache and fatigue approx. 24 hours following vaccine, headache worsened overnight and felt "un-well", achy on 16Jan2021 15:00 with outcome of not recovered. Therapeutic measures were taken as a result of events included Tylenol/advil. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Rapid heart beat and hyper feeling, fever chills and every single part of body hurt, severe head pain that has still not responded to Advil or tylenol
Red, circular rash at injection site - slightly warm to touch, irritated/puffy skin, slightly itchy and about 3-4 inch diameter
Two patients have not received the second dose of the vaccine after 42 days of the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two patients have not received the second dose of the vaccine after 42 days of the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in place. It was bad everywhere, but worse on my left side -- shoulder, elbow, wrist, hands, and knee. Also my right hand. I took ibuprofen and went back to bed. I wasn't able to do anything. I was extremely tired. I took ibuprofen throughout the day to manage the pain and slept much of the day. I also was coughing quite a lot. Today I feel mostly back to normal. Very little pain or stiffness in my left shoulder, elbow and wrist. Less coughing too.
Injection site became red; Injection site became swollen; Injection site started to itch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On 13th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and within two hours of getting the vaccine the injection site became red, swollen, and started to itch. The area involved was two inches in diameter. The reporter consented to follow up.  Unable to obtain additional details because the reporter wanted to end the call.
Kinrix was administered to a 1 year old patient; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 1 year old patient).  The outcome of the inappropriate age at vaccine administration 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: 25-AUG-2023 The reporter was a consumer who works for vaccines for children. The reporter reported that she thought she was in a chart that the Kinrix vaccine was administered to the 1 year child patient. Reporter was going to follow up with the clinic and look at the chart to ensure that she was correct. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Donor developed redness, swelling, tenderness, and a nodule at the injection site about 24 hours after immunization. Symptoms still present.
clinic experienced a temperature excursion with Kinrix vaccines; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T543J, expiry date 25-JAN-2025) for prophylaxis.   On 05-MAY-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: clinic experienced a temperature excursion with Kinrix vaccines). The outcome of the incorrect storage of drug 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: 11-May-2023 Pharmacist reports clinic experienced a temperature excursion with Kinrix vaccines on 4th May 2023 that lasted 45 minutes and reached a low temperature of -0.8 degree C.  On 5th May 2023 a dose of Kinrix was administered to 4 year old female patient.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received Kinrix vaccine, which experienced temperature excursion, which led to incorrect storage of drug. The follow-up would not possible as no contact details were available.
Patient became lethargic within 5 minutes.  Within 10 minutes she developed tightness in the chest, difficulty breathing, and numbness in both hands.  We administered an Epi-pen and symptoms began to improve in 10-15 seconds.  She then was evaluated by emergency medical personnel and taken to a local hospital for follow up.
patient was given a moderna vaccine that was 48 hours after vial was punctured. I called patient to get him rescheduled due to manufacture stated to re-vaccinate due to lack of efficaious. patient did feel feverish and chills last evening and will await 2 weeks before getting vaccine again.
Mother reported swelling, pain ,redness, heat and occasional itching, that started at time of injection and continued after arriving home. Symptoms got worse the next day, with swelling and pain increased.
rash generalized, elevated t102, cough, conjunctivitis; onset 22OCT92-25OCT92;
COVID vaccine breakthrough case  admitted for MVA, COVID was an incidental finding 32 weeks pregnant as of 6/2/22  dose 1 1/6/21 Moderna 026L20A dose 2 2/3/21 Moderna 007M20A
Moderate swelling, redness and pain at the site of injection. Pt reported nausea as well. Pt was given IM solumedrol 125 mg x 1, was advised to apply ice to area and take Benadryl every 4-6 hrs. She was subsequently started on a Medrol dose pack and zantac as well.
Nausea; Chills; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluoxetine hydrochloride (Prozac).   On 24th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced nausea and chills. On an unknown date, the outcome of the nausea and chills were not recovered/not resolved.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On Saturday, the patient started on Prozac. The batch number and expiry date of Shingrix was not reported.  Two days ago, from the date of reporting, the patient received Shingrix and felt nauseous and chilly. The reporter was not sure if Prozac played a part in events. Reviewed side effects and median duration of Shingrix per product information (PI) and reporter mentioned hopefully she would feel better at the day of reporting. Reporter willingly stated she would provide further information; however, reporter inadvertently disconnected.
Patient developed a rash on the opposite side of her from where the Zostavax vaccine was given.  Pt also recieved a HD flu shot on the same arm and rash was 3 inches below that shot.  Pt was concerned and went to an ER doctor who prescribed Keflex 500 1 qid for 7 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD w Stent", start date: 17Jan2023 (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BRILINTA, start date: 17Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Feb2023) Positive, notes: Rapid test + again on 04Feb2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Reddish urine; Body aches; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of CHROMATURIA (Reddish urine), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced CHROMATURIA (Reddish urine), MYALGIA (Body aches) and FATIGUE (Fatigue). On 31-Mar-2021, CHROMATURIA (Reddish urine) had resolved. At the time of the report, MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Urine analysis: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Celiac and probe to rashes, but got odd, very little blister rash. Blisters were far apart on my stomach, a few more on my right side. Did not bother me except when flu-like symptoms flared up in the afternoon for 4 days. The rash then itched and stung a bit. I used a cannabis ointment on it for comfort. I still have a few small dried scabs from the rash.
Started with abdominal cramping and dizziness followed by more intense abdominal cramping, tenderness and pain in abdomen.  Vomiting around 10:30 PM alleviated some discomfort. Symptoms resolved within 24 hours.
Pt recvd vax & devel pos test for Hepatitis following vax w/Hepatitis B vax; No further details were provided;
Stomachache, diarrhea. I went to my gastroenterologist he gave me diaphenoxlate-atropi and Dicylomine HCL. He sent me for blood work
Routine blood test shows extreme low blood platelets. Admitted to hospital and was treated with some steroid and a lot of lab work.
Information has been received from a RN concerning a 23 year old "healthy" female who was vaccinated with a dose of varicella virus vaccine live (643597/0895M). There were no other  concomitant  vaccinations given. There were no illness at the time of vaccination. Twenty two and a half days later the pt developed a flat, red rash. Unspecified medical attention was sought and it was unknown if any treatment was given. No product quality complaint was involved. Additional information has been requested.  Follow up information On 03/08/2004 at approximately 0800 the patient developed a severe headache that progressed to fatigue, night sweats, and chills. On 3/9/2004 at 1800 the patient developed the first signs of a rash that was itchy, flat or slight rasied. On 3/10/2004 the patient developed approximately 11 lesions on the abdomen, back, left leg and arms. Her temperature was 99.1. Unspecified medical attention was sought. She was much better after one week. On 3/23/2004 she was back to work. It was reported that the patient recovered and no specific treatment was required. No diagnostic lab test were performed. No product quality complaint was involved. It was noted that there was a possible secondary spread to a co worker. No other information is expected.
Atrial fibrillation 4 months after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medication information was reported.  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 a patient of unspecified gender, aged 76 years with no reported medical history, experienced unexpected serious (medically significant) AESI of ATRIAL FIBRILLATION four months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was unknown at the time of report. Elderly age could be risk factor to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2022-623722 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a patient of unspecified gender, aged 76 years with no reported medical history, experienced unexpected serious (medically significant) AESI of ATRIAL FIBRILLATION four months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was unknown at the time of report. Elderly age could be risk factor to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. US-MODERNATX, INC.-MOD-2022-623722:This case refers 72 yr old who had Atrial fibrillation 4 months after Moderna(same reporter)
sore & swollen arm, aching muscles, fatigue, fever (101.6) and chills
Child developed a rash on hands & face on 1/1/00. Per call to ER, she was advised to give Benadryl & rash disappeared but was visable again on 1/3, this time more noticable. Mom called child's MD, told to give Benadryl; no more problems.
Pt recv vax on 10/16/98; on 10/22/98 pt exp red, raised bumps behind left knee;tx=cortizone cream
3/24/21 3:00pm: I got the vaccine 9:00pm:  99.1 fever which increased to 99.4.  10:00pm: went to bed  3/25/21 2:00 am:  talking and moaning in my sleep talking gibberish in my sleep. Woke up 101.8 fever took tylenol 7:00 am-6:00pm: swollen red circle on left arm, body aches, headache, fever 101.6-101.8. Took Tylenol. Every 6 hours. 6:00 pm: noticed a tiny pea size lump above my left collar bone.  9:00pm- bump grew to the size of a gum ball and very tender. Left arm injection site grew more red, tender, and swollen. 3/26/21 7:00am 99.1 fever and lump grew slightly larger over left collar bone. Left arm still very red, swollen and tender. Approx 2.5 inch diameter circle around injection site.
Patient started having trouble breathing within 15 minutes of dose. 911 was called and arrived within 5 minutes. She was awake and responsive the entire time.
PNEUMOVAX 23 reaction: Pain where shot was given; redness and swelling where shot was given; irritation at shot site; felt tired and weak next morning; muscle pain. Arm much better after 3-4 days.
Neck pain and spasming - sharp shooting and progressing to ear and temporal pain.  Initially occurring a couple times a day and now more frequent.  Also, originally started on just the left side of the neck and is now occurring on both sides.
Severe swelling left deltoid, severe constant pain, unable to move her arm  Treatment with Gabapentin and Ketorolac