chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.            The patient had no adverse event.  No concomitant medications were mentioned. No treatment details were reported.
Pt had vasovagal reaction. Fell off chair and sustained laceration to forehead. Paramedics called and pt transferred to ED in stable condition.
90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
got COVID delta; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got COVID delta) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID delta). At the time of the report, COVID-19 (got COVID delta) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, after two doses of vaccine the patient got Covid delta. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred on an unknown date after the second dose of mRNA-1273. As reported, after two doses of vaccine the patient got Covid delta. No exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient reported bleeding at injection site at time of vaccine.  As evening went on, she began to feel arm pain, felt sick and achy, feverish, and said body felt on fire.  Took acetaminophen and iced shoulder.  Bump developed on arm where shot was administered.  Had arm pain and was hard to lift her arm the following day.  She had to leave work and go home to rest.
Pt with severe swelling at site of shot. Lymph glands under arm swollen.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced pain in arm after vaccination. The patient received a second dose of Shingrix in December 2019. The reporter consented to follow up.
pt recv vax; 4 hr later, c/o inc irritability; devel skin rash bumps;med ctr saw pt, appeared to be fine;rash went away a/ med ctr saw pt;no fever;
Terrible right trigeminal ache beginning night 2/2/21, continued until about 4:15 pm.  2/3/21 On right side all day with acute episodes around 10 am, 1 pm and 6-8 pm with double/blurred vision and ?drunk walking? throughout evening after 4 pm  Both days had bouts of piercing eye pain, headache, eye lid jumping/spasms  2/4 headache alternating with r trigeminal flares, worsening throughout the day and with mask use. Double vision starting in the afternoon.  Since shot and increasing over a week: Increasing trouble swallowing since within 5 minutes of the vaccine, white or clear immobile phlegm, sore throats, tinnitus, headaches, piercing eye ball pains, eye lid jumping/spasms, trembling, spastic muscular movements, personal earthquakes (huge uncontrollable  tremor movements) in limbs then jaw lasting about 10-20 minutes, neuropathies, parasthesias, fainting level pain if I touch the areas that are having parasthesias drunk walking, racing heart, bouts of severe irritability, new blister on roof of mouth where neuropathic pain and hyperactivity have been intense 2/5/21 is the first day I can feel this area at all and noticed the big blister, hot/cold without sweats, thirst, raw dry mouth/lips, fatigue, weakness, abdominal pain, L kidney pain, , periods of nausea, unexplained diarrhea, blurry/double vision, seeing stars/spots, increase in muscle cramps, especially hands and feet, temporary feelings of ?lock jaw?, REOCURRENCE OF TRIGEMINAL NERVE PAIN. When I got in the tub on Wednesday my body had huge convulsive movements for a few minutes. All of this was followed by the shingles, permanent tremors, continued difficulty swallowing, temperature regulation problems, more rashes
Slightly lightheaded immediately after, which cleared  up after 20  minutes, and I was able to walk home. Then, about 3-4 hours later, came down with chills, headache, body  aches, fatigue...felt like I had the flu and had to go to bed. Arm hurt.  Very fatigued  and  weak the next  day,.  It was only  until  Wednesday (four days later)  that  I felt back to "baseline".   More than a week later, my  left  arm is still sore -- it actually feels  more sore  now than a few days ago.
expired dose of Daptacel was inadvertently administered to a 2 years old patient ,no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 months old male patient who received 0.5 ml of expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE  [DAPTACEL] , lot C5307AA and expiry date 23-OCT-2019 via intramuscular route in the left thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error due to expired vaccine used.  AE symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
15min post vax pt devel faint small spots (reddish pink) on lt leg;no resp distress or swelling;no rash @ site of inj;2PM went to nurses room some rash on wrist-nothing on chest, abd;no itching;given DPH;815PM rash still present;
No Fever Sweats Body Ache Fatigue Nausea Blur vision headache Loss of apetite
Information has been received from a 67 year old female with no pertinent medical history and no known drug allergies, who on 30-MAR-2009 was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route and lot number not provided). Concomitant medication included "medication for hot flashes and thyroid medications". Three days after vaccination, on 02-APR-2009, the patient experienced headache. When she woke up on 03-APR-2009, the headache was gone. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
I started getting symptoms of congestion, headache, and a cough. On 4/25/2022-04/28/2022, I experienced a fever. The congestion until 5/6/2022. I received a positive COVID-19 test with an at home test on 4/27/2022. I contacted my doctor on 4/27/2022 and was prescribed PAXLOVID. The cough did improve but I did get another cough to develop again in May.  I did receive a negative COVID-19 test on 5/4/2022. I had a fever and cough. Then, I also did a PCR COVID-19 test on 5/16/2022 that was positive.
redness around injection site, expanding; swelling around injection site, expanding; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received Shingrix. In 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022158153   Additional Information: GSK receipt date: 01-NOV-2022 Reporters comment: The reporter herself reported that she received the  shingrix vaccine and the redness and swelling around the injection site was expanding. The patient asked if this was a concern No other information known . Additional Supportive information:The case US2022AMR158124 is identified as duplicate of case US2022158153  All future correspondence would be added in case US2022AMR158124  which stands as case of record for this patient and the case US2022158153 would be deleted.; Sender's Comments:  US-GSK-US2022158153:same reporter
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.68.  Concomitant products were not provided.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, total doses given for the day was 116 and at 10:00 AM, temperature was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2, 4 vials were sent to clinic with vaccine BUD date was 29-Oct-2021 and 04-Nov-2021 respectively.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 PM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46and 5 PM : 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
41 yo female with PMHx morbid obesity (s/p gastric bypass) and HTN, p/w LH, after COVID vaccine.     No h/o LH, palp, arrthythmia.   Has h/o HTN, on losartan and metoprolol.  Took meds today, no recent dose changes, though has had doses decreased in past year after gastric bypass. Has not had BP checked recently due to doctor visits being mostly virtual now. Has had h/o dumping syndrome, but none recently.   Felt better after sitting down, HR initially high 40s, BP 108/80, shortly after HR up to 55 with resolution of sxs.  After 20 min, orthostatics checked, which were negative.  Pt ambulated without symptoms.  Pt released after 30 min observation period.
After receiving the first covid vaccine on 12/18 in the morning, I had my period about 12 hours later. Throughout my life,  my periods are very regular and typically last 6 days. But after the vaccine, my period never stopped. I am still currently bleeding. I've seen a doctor for it and they said its a hemorrhagic corpus luteum cyst. For now the doctor isn?t too concerned,  but it?s unusual for my body to be going through this.
pt recv vax 10APR98 & 1MAY98 had chickenpox rash on buttocks & rt side of abd (12 spots);15MAY98 had 2nd episode of chickenpox rash on chest back, abd, buttocks, upper arms & upper legs; (40-50 lesions);
Shingles vaccine 5/15/08; Erythematous vesicles started 6/2-6/3/08; 6/3/08 - Increasing lesions - Admission to hospital "varicella like rash" 6/20/08-records received for DOS 6/3-6/6/08-DC DX:Disseminated herpes zoster. Treated with acyclovir. C/O progressive deveoping generalized rash. Chills
he had 103 fever; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number Unknown), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 18Dec2022, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 18Dec2022, outcome "not recovered", described as "he had 103 fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated, "Well my husband got the Pfizer Shot on Friday and he is 69 years old and he got, it is the Booster the last booster was available and the prior one was a Moderna (Moderna COVID-19 Vaccine) but he had done it somewhere else (withheld) and they did not have Moderna so, they gave him Pfizer (Pfizer COVID-19 Vaccine). Anyway by Saturday he was feeling pretty crappy which is normal and but last night he had 103 fever and he had diarrhea since Saturday and he still have the fever and he still has diarrhea." When probed for if reporter have any question regarding the concern: Reporter stated, "Is the diarrhea normal, I mean is this a normal reaction?" Reporter was provided with the number of Pfizer Medical Information as #1-#, Option#3 and informed about the timings. In response to further probing: Reporter stated, "No, not right now, I get to the end some of stuff, it is not the right time. Reporter was unwilling to complete the report. Thus further probing was not done.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient was asymptomatic. No additional AE reported.; accidentally administered PNEUMOVAX 23 instead of PREVNAR 20; product confusion; This spontaneous report was received from a clinical assistant referring to a 70-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 10-JUN-2022, the patient was accidentally administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (once, lot # U026796, expiration date: 28-JAN-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, dose, route of administration, anatomical location, indication, lot# and expiration date were not reported) (wrong product administered and product confusion). Agent was filing an event due to product confusion. The patient was asymptomatic. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Chest pains began last a few seconds and happening intermittentantly and have been ongoing for 2 mths - since 1st covid shot
PATIENT WAS BROUGHT INTO CLINIC BY FOSTER MOTHER. FOSTER MOTHER STATES THAT PATIENT HAD A FEVER BETWEEN 103-104 AND DIARRHEA AND VOMITING SINCE THE BABY RECEVIED SHOTS. (ALSO CHILD HAS HAD DIARRHEA OFF AND ON SINCE 6/10) PATIENT WAS THEN ADMITED TO MEDICAL CENTER. PATIENT WAS DISCHARGED FROM ON 7/9/10.
Low grade fever 1/8/21-1/9/21 max temperature 100.5 F, increased arm pain on left side 1/8/21
patient developed a lesion on her lip and asked us to report it as a reaction to the shingrix immunization, she is not planning to seek treatment at this time
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 50-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). The patient's past medical history included shingles. Concurrent medical conditions included diabetes mellitus. On 13th March 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, several hours after receiving SHINGRIX, the patient experienced chills, fever, erythematous rash and itchy rash. On an unknown date, the outcome of the chills, fever, erythematous rash and itchy rash were recovered/resolved. The reporter considered the chills, fever, erythematous rash and itchy rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: On awakening the morning after receiving the SHINGRIX, the patient noticed chills, fever and the body temperature was recorded as 102 degree F and a red, itchy rash from chest to navel. No pain or blisters were associated with the rash. All of these symptoms had resolved by the afternoon and the patient then reported to work.
only a little soreness in the arm that went away after taking medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "hypertense" (unspecified if ongoing); "Swelling in the face" (unspecified if ongoing), notes: before the vaccination. The patient's concomitant medications were not reported. Past drug history included: Epipen for antiallergic. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "only a little soreness in the arm that went away after taking medication". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021302501 same reporter/product/event, different patient
Rash appeared on arm more than 2 weeks after shot.  Looked like a bullseye and was very itchy.
allergic reaction on my shoulder; feeling terrible; exhaustion; This spontaneous report was received from a male consumer referring to himself. The patient's concurrent condition, pertinent medical history were not reported. The patient was allergic to Horse serum. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, frequency, dose number, lot/batch #, expiration date was not reported) in the left shoulder for prophylaxis. On the same day the patient was injected with other suspect therapy which was, hepatitis b virus vaccine rhbsag (yeast) (1018 iss adj) (HEPLISAV) (dose, strength, frequency, dose number, lot/batch #, expiration date was not reported) on left shoulder.     Subsequently, the patient experienced exhaustion (fatigue), an allergic reaction on shoulder (hypersensitivity) and the patient felt terrible (feeling abnormal). No product quality complaint was involved. The outcome of hypersensitivity, fatigue and feeling abnormal was reported as not recovered/not resolved. The reporter's causality assessment was not reported.
Suspect MMR rash. Pt developed pink macular rash on 5/14; initially few spots on legs, then on trunk and arms. Afebrile. Acting well. No other sx.
Within minutes I had lower chest pain and wired sensation in my lungs. My throat was swelling. I was very hot and red. I the gurney my right arm was tingling. Opposite arm from vaccine.
Headache, fever, body aches next day MRI brain to rule out other etiology Butalbital-acetaminophen
Induration greater than 3 cm painful  Body aches Sore throat moderate Fever Headache  Pink tinged sputum
My body started to feel 'ticklish' and uncomfortable about 24 hours after the shot was administered. It feels like restless leg syndrome, but over my entire body (arms, legs, hands, feet, shoulders, back, neck.)