chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day following the 2nd dose, runny nose again but also joint achiness; The day following the 2nd dose, runny nose again but also joint achiness; injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter; After the 2nd dose: arm (deltoid) was sore; This is a spontaneous report from a non-contactable other hcp (Patient, self-reported). A 50-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 18:15 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included hypertension, blood cholesterol increased, latex sensitivity and GI upset from eggs and soy. Concomitant medications included atorvastatin; fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient had received bnt162b2 (Batch/Lot number=EH9899), via an unspecified route of administration, administered in Arm Left on 18Dec2020 18:15, 1 ST DOSE, SINGLE. After first dose patient had extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use. Throbbing and painful to move/lift. I also had a runny nose the day after first dose. Symptoms resolved by 3rd day after injection. After the 2nd dose patient had arm (deltoid) was sore, but not as bad. Woke me first night, after taking Tylenol. The day following the 2nd dose, runny nose again but also joint achiness. Symptoms resolved by 2nd day after injection. However, on 3rd day after injection, injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter. Lasted for 2 full days - treatment with ibuprofen (day) and Benadryl at night. On 11Jan2021, the patient experienced the day following the 2nd dose, runny nose again but also joint achiness, injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter and after the 2nd dose: arm (deltoid) was sore. Therapeutic measures were taken as a result of the adverse events as Ibuprofen and Benadryl for inflammation/itchiness. The clinical outcome of the events were recovered on an unspecified date.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) similar report from same reporter.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Pt in for 15 mo PE. Prepared vaccines. Gave PENTACEL and PREVNAR 13. Crying and holding breath. Waited until not holding breath-gave MMR-held breath and fainted-consistent with vasovagal Rxn.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 042H22A and 053D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 04-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 24-Mar-2021, Moderna COVID-19 Vaccine (Dose 3) on 19-Nov-2021 and Moderna COVID-19 Vaccine (Dose 4) on 04-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hypertension.   On 03-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-730794 (Patient Link).
5 days post vax pt suffered heartburn-self treated w/antacids;10 days p/vax suffered severe hives-tx w/DPH;3JUL96 having occasional episodes of chest pressure & chest congestion w/deep breathing;MD visit 23JUL96 tx w/Clariton w/relief;
Patient was extremely nervous prior to receiving vaccine. She was visibly shaking her knees and shallow breathing. After receiving the immunization she stood up to leave and then collapsed onto the shelf. She regained consciousness immediately
pt recvd vax & devel a rash & arthralgia, characterized by migratory swelling, pain, & erythema;
Swollen right lymph node since vaccine to today, fatigue easily, right eye will go blurry at times.
This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient also experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
hypotonic episode, pale, limp w/o cyanosis 1wk p/vax;
p/vax pt exp a 4x4cm erythematous lesion w/a dusky/center on the lt thigh that was neither warm nor indurated;11/14/97 pt also devel a body rash w/small red spots;
within 24 hours of the 2nd dose I started to have extreme sensitivity in both nipple areas.  I had found some information about the possibility of the vaccine causing sensitivity to the lymph nodes.  It has now been over a month a when I called back to the clinic they said they had not heard of this being a side affect of the vaccine and recommended I contact CDC through this means.  In addition to the sensitivity both areas are still swollen and sensitive to touch..
inadvertently administered with 1.0 ml of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history reported).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine). On 10-Apr-2021, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided. No adverse reactions have been reported so far.; Sender's Comments: This report refers to a case of patient inadvertently administrated with1.0 ml of the vaccine for mRNA 1273, Lot # 016B21A with no associated AEs. Causality for the medication error is not applicable.
No adverse effects reported; Nurse reports the administration of one dose of an improperly stored vaccine,; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and historical drugs were not reported.  On 10-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) per oral route with lot # R030924 and expiration date 10-JUL-2020 for prophylaxis.   The administered dose of vaccine experienced the temperature excursion of 0.24 degrees Celsius (multiple) for 5 hours and 30 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Patients Mother warned us that sometimes patient faints when giving blood. I told her that I would like to vaccinate he lying down. When the time came to immunize she refused lying down and said that she would be okay.  She ended up fainting and even though she was sitting down and I was ready to try to catch her, it all happened so fast that I couldn't.  She fainted falling away from me and hit her head on the floor/leg of a steel folding chair.  Patient came to full consciousness nearly right away but continued to lie on the floor for a while until she regained her composure - took about 15 minutes.  She got a bump on her head.
Nausea, light headed, Numbness in arms, hands. ALS assessment  completed . Pt is SR on monitor. Vital signs stable. Said she is feeling better, and refusing transport to the hospital . Pt signed refusal.  VS 82/61, 64, 18, O2 sat 100%, set 32 110/72, 89, 18, O2 sat 100%
Limited motion of arm.; very severe pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient complained of tongue tingling and chest tightness approximately 15 minutes after administration of vaccine.  Pt has severe COPD, Anxiety, and possibly heart failure.  She was observed for one hour and treated with 50 mg of Benadyl which she frequently takes for these symptoms with her medications.  She used her personal inhaler and began feeling better.  Vitals were stable throughout the hour, pulse ox was 99% on her usual continuous nasal cannula O2.  Rapid response team evaluated the patient and the responding RN and MD felt the patient was improved.   Complaints of tongue tingling and chest tightness were improved.  The patient denied a history of allergic symptom relapse after taking Benadryl.  The patient requested discharge from the clinic accompanied by her caregiver.  She was discharged in her wheelchair with home O2 at 4:10 p.m.
Ten minutes after the shot the patient became shaky, light headed, dizzy, was nauseated, and was sweating.  after 45 minutes patient felt better and went home.
Information has been received from a consumer concerning her 24 month old male son with a mold allergy and a history of asthma who on 06/19/2001 was vaccinated with varicella vaccine. There were no concomitant medications or current illnesses. On 06/19/2001 it was reported that the pt had erratic mood swings. A week later, on approx. 06/26/2001, the pt broke out with chicken pox around the injection site and he developed eczema. Unspecified medical attention was sought. Additional info has been requested.
Caller reported AE of expired VARIVAX that was inadvertently administered to a patient. No known temperature excursions. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; No additional AE/; This spontaneous report has been received from a nurse and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 18-AUG-2023, the patient was vaccinated an expired vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (valid lot number U025202 [expiration date 13-AUG-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis (expired product administered) concomitantly with sterile diluent. No known temperature excursions. No symptoms reported.  No additional adverse event (AE).
Approx 10 min p/vax pt nearly fainted as entered residence; returned to site of flu clinic by then approx 15 mins post vax chilled & tremors; porgressed to swelling in throat, inc BP, dec pulse in 5 more minutes;
10/17 4:30 PM MMR vaccine given. 6:00 PM patient felt feverish. 10/18 1:30 AM broke out in hives - took 75mg BENADRYL. 7:00 AM took more BENADRYL - hives continues. 1:40 PM went to PCP and saw NP - continue BENADRYL. 10/21 - hives diminished but still itching.
an expired vaccine (34 days in the refrigerator) was given to 57 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) 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) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (an expired vaccine (34 days in the refrigerator) was given to 57 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided. The reported states that the Moderna covid-19 vaccine was left in the refrigerator for more than 30 days. The 30th day mark was on 19JUN2021 and the vaccine was administered from 20JUN2021 till today 23JUN2021 to a total of 57 patients.
Between 13:30 to 18:00 on the same day, began crying/screaming and couldn't be comforted. On 1/22/02, began a fever of 103F and not coming down with Tylenol. On 1/24/02, between 16:30 until 20:30, began high-pitched scream again. Seen by MD on 1/25/02. No signs or symptoms at that time. MD has recommended no more pertussis.
About 30-40 min after getting shot my breathing felt weird. It felt like I was breathing in hot scratchy air through my nose and throat.  I felt like my breathing was abnormal and it felt like I was possibly going to start wheezing. I became worried I was having an airway reaction and would need to go to the hospital but I did not end up needing to. The breathing issue did seem to resolve after 15-20 min even though my throat remained scratchy feeling that day. I have had panic attacks before and extreme anxiety and have never experienced any sort of airway reaction before. I am concerned I had a mild allergic reaction and am worried about getting the next shot. I did have Zyrtec in my system so I don?t know if that ha d any affect or not.
My partner noticed a rash on my face that went from my ear to my cheek on the left side. I went to dermatologist and it was a waste of my time. They were more concerned if it was lotions. They said to come back if it happens again and they would give lotion to put on it. I have never experienced these kinds of rashes before. Now I am getting them behind my knees and around my ankles. It happens every couple of months. It seems that it flares up in places where I have a lot of movement.
1 of 3 pts immunized who devel pneumonia or chest congestion & fever; pt recvd vax 24SEP92 & devel pneumonia between 24SEP & 10NOV; recovered 10NOV92;
Red 2-3mm papular rash concentrated over extremities.  Pruritic.  Approx 30 lesions total.
swelling of left arm from shoulder cap to elbow, tightening of skin and fevered body. Does not subside with compress ( warm or cold) or OTC drugs. Prednisone is currently being administered.
Within hours of administration she began to experience radiating pain down her arm. It was sever enough that it kept her from sleeping and she took ibuprofen to help with the pain. The next day she developed a large red bump located 3/4 down the deltoid and encircled the arm. It was warm to touch the first day. Denied itching or tenderness to area. Denied fever. Pain began resolving after 48 hours. Continuing to watch for resolution of the redness and follow up from primary care physician.
Chills, fever, Huge knot at the injection site that got larger the next day and is getting smaller. The knot is hard and hot to touch. Uncomfortable, itchy and hurts to lay on it.
Mom reports pt developed (R) LE edema, erythema from shoulder to forearm 1 day after INFLUENZA vaccine. Taken to ED was given IV abx. Improved after 3 d.
Developed pain and erythema at injection site increasing to 15cmx15cm region of erythema in right upper arm.
I developed swollen lymph nodes in my right neck and cheek and intense pain in my right jaw for 48 hours, i was unable to chew solid food during this time.
Within 10 hrs of vaccine, patient developed redness, swelling and tenderness limited to outer area if right bicep. Wife called me to report this the next afternoon. Symptoms hadn't worsened or spread since night before, so I recommended application of ice pack to site 10 min on, 10 min off as needed for comfort and ibuprofen as needed.
What if longer than 6 months for 2nd dose?; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient asked what if longer than 6 months for 2nd dose, also asked would be the series repeated. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No contact details were available.
I experienced acute arm pain after injection that subsided within 48-72 hours.  Last night, on day 8, after five+ days of no pain whatsoever, and through the night to today (day 9) I am again experiencing acute arm pain similar to  the worst pain I felt in the days after the injection, both at the injection site and radiating down my arm and into my shoulder.  I took Tylenol which has provided some relief, but my range of arm motion is still limited by sharp pain.
Pt received a light dose of the Pfizer covid 19 vaccine. 0.8mls of NS was used to dilute vaccine not 1.8 mls.  A dose of 0.3 was removed from that vial then another 1 ml of dilute was added. That diluted vaccine dose was then given to this pt. Pt contacted and reports no adverse reactions or events.