chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient adminstered Pentacel without mixing the Hib component powder with no  AE; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00537013) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 63 days old female patient who administered 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the Hib component (Lot U6842BA and UJ336AA expiry date 05-Jul-2021) once via Intramuscular in right thigh for prophylactic vaccination on 23-Mar-2021,(Product preparation issue).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  Health care professional reported that patient was given Pentacel without the Hib component.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Slight burning sensation in right upper leg below the groin area, present in the front of my leg.  This has been reported by other team members here at my work that have got the 2nd Moderna shot.
patient was given expired Ipol vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via Global Medical Information (GMI) (Reference number- 00567199) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old female patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021) (expired product administered) on 13-Apr-2021.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX for prophylactic vaccination on 13-Apr-2021.  No other vaccine received by patient.  Caller wanted to know what to do if 8 patients got expired IPOL vaccine.   It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.; Sender's Comments:  00567142 (original case):
Patient called the pharmacy on 10/5/22 stating that he started to notice a rash developing on his arm near the injection site around 10/3/22. He stated that today the rash has grown in size but has not caused more discomfort. He has had Fluzone-HD in the past with no issues.
Patient had a rash ~2inches by 2inches underneath the injection site. It was raised, red, hot, and painful. Patient said it hadn't gotten any worse, but it just hurt and was hot. I told her to monitor it make sure if didn't get any worse, and use appropriate otc measures.
received second dose after six months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of shingrix in February 2022.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The Pharmacist reported a patient who received the second dose of Shingrix after six months. Second dose was given few weeks after 6 months deadline. Pharmacist did not provide lot number and expiration date of any of the two doses already administered to the patient since these doses were given at different facilities. The reporter did not consent to follow-up. Additional Supportive information: The patient received second dose was given few weeks after 6 months deadline, which lead to lengthening of vaccination schedule. This case is linked to the case US2022134472, reported by the same reporter.; Sender's Comments:  US-GSK-US2022134472:Same reporter
Moderna COVID-19 Vaccine  Covid Arm?redness, swelling, itch, tenderness, hardness at injection site; mild nausea
Pain at the injection site; Redness, rash and itching at the injection site; Rash at injection site; Itching at injection site; 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.   Previously administered products included Chicken pox vaccine (received in 2012).   On 19th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site rash and injection site itching. On 19th October 2019, the patient experienced injection site pain. On 22nd October 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 51 years or 52 years. The patient never had chicken. The caller reported pain at the injection site within a few hours following vaccination that lasted approximately 3 days. On 20th October 2019, within 24 hours of vaccination, the patient had redness, rash and itching at the injection site that was still unresolved at the reporting date. The reporter did not consent to follow-up. The caller provided very limited information and only wanted to share side effect information for safety report.  The caller declined to provide pharmacy information.
Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.
03/23/2021 - large red patch at injection site;; 03/27/2021 - extreme under eye inflammation (have photos)
Stiff neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and HEADACHE (Headache) 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 29-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) and HEADACHE (Headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
had received his 2nd COVID 19 vaccine and got very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had received his 2nd COVID 19 vaccine and got very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; fever; flu like symptoms; Body pain; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 25th June 2019 04:00, the patient received the 1st dose of Shingrix .5 ml. On 25th June 2019, several hours after receiving Shingrix, the patient experienced chills, fever, influenza like illness and general body pain. On an unknown date, the outcome of the chills, fever and influenza like illness were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the chills, fever, influenza like illness and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in the left arm yesterday afternoon between 4:00 to 4:30 pm from the date of reporting. The same night she began to experience chills, fever and flu like symptoms. The patient stated that the only part of her body that did not hurt was her right arm. The reporter consented to follow-up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021 at 1:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 12:19 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 17-Feb-2021, Excursion time was 9 AM, temp was 22 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vial was moved to clinic. Vaccine BUD date was 13-Mar-2021.  On 03-Nov-2021, Excursion time was 10 AM, temp was 35 , total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 06 vial was moved to clinic. Vaccine BUD date was 05-Nov-2021.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  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 by using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided
Event started with severe shaking chills. Chills lasted several hours. Thirsty so ambulated to kitchen where experienced dizziness. Later got up again with thirst & indigestion. Ambulated to kitchen where again dizziness more severe so sat down on floor. Also experiencing headache, sore injection site & sore arm with movement. At 6am patient felt warm to touch, Oral temp 100.3. Recheck oral temp 7:30am 99.6. Still has headache although subsiding without med. Took Tums for indigestion episode with relief.
Narrative: Pt did not received COVID immunization from this facility, so limited information known about Moderna vaccine. 3/2/2021 - Pt called facility to report he had the 2nd COVID vaccine on Sunday 2/27/2021). The following day, Monday, he woke up feeling fatigued, no appetite, later in the day the diarrhea started and a rash developed all body. Pt began to vomit around midnight. Pt c/o these sx all started after the vaccine. Benadryl ineffective for allergic reaction. Pt reported he will go to hospital for care. Pt admitted 3/2/2021 - 3/5/2021 per patient call to facility. Skin rash: resolved with steroids and antihistamines...will dc on prednisone 20 mg mg daily x 3 more days.
severe pancytopenia; bone marrow consistent with aplastic anemia; bone marrow consistent with aplastic anemia; This is a spontaneous report from a contactable physician. A 13-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in Aug2021, 4 weeks after the first vaccine dose, at 13 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot number was not reported), administered in early Aug2021, at 13 years of age, as single dose for COVID-19 immunization, after which she had heavy menses and developed fatigue. The patient didn't receive any other vaccine in the previous 4 weeks. Within 2 weeks after the second vaccine dose, the patient noted to have severe pancytopenia, bone marrow consistent with aplastic anemia. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for 7 days and she received blood transfusion. The patient had not recovered yet from the reported events at the time of the report. In Aug2021 the patient underwent SARS-CoV-2 test via Nasal swab, which resulted negative.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101427272 same patient/drug, different vaccine dose/event
Nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it; His breast is still very tender; There is some discomfort in the left breast.; Pain; Extraordinary pain in nipple area, breast,; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; In my left arm, my left breast/nipple was swollen and was hurting; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date:), via an unspecified route of administration, administered in arm left on 07May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 08May2021, the patient experienced nipple pain/nipple which is on a flat chested body was so sore he couldn't touch it, his breast was still very tender, there was some discomfort in the left breast, pain, extraordinary pain in nipple area, breast, in her left arm, her left breast/nipple was swollen and was hurting. Patient stated he received his first dose of the Pfizer COVID-19 vaccine on 07May2021. the next day got in left arm c/o having nipple pain on left side could hardly touch it. He did call his HCP and had a mammogram done which did not show cancer. The pain has gotten better but still with some pain in the left nipple. In regard to the first one he did it in the left arm. The next day, his nipple which is on a flat chested body was so sore he couldn't touch it and it hasn't gotten much better. He went to his primary care doctor. He went in to see her right away, he was so worried. He was a 69-year-old man, and he can get breast cancer. She said normally with cancer you usually don't get pain. So, she sent him to have a mammogram. The left breast was so sore, and she didn't think it was cancer, should not be cancer and wasn't cancer. Knock on wood. And it's less tender as gone a long, but it's still tender. She seemed to be under the impression that usually women have this reaction in the breast, but men can have reactions in their breast. His breast was still very tender. This happened the day after Pfizer shot and that's the one, he wanted. In fact, that's the one he wanted, and he wants to know if it's a side effect. It's still tender, not as tender. He can touch his breast, but there was some discomfort in the left breast. His first shot was in the left arm and the next day he started having pain. The patient underwent lab tests and procedures which included mammogram: which did not show cancer on an unspecified date. The outcome of the event his breast was still very tender not recovered and recovering for all other events.  Information about the lot/batch number has been requested.
tiny red tender area on her arm after first vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Nurse (patient) reported for herself. This 83-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 24Feb2021 10:30 (Lot number: EL9269 or S, it is an E or S, unknown which one was correct) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included micro-bacteria AVIUM (she has had about 20 years, no additional details provided). Concomitant medication(s) included calcium (CALCIUM); calcium pantothenate, cyanocobalamin, folic acid, liver extract, nicotinamide, pyridoxine hydrochloride, riboflavin, saccharomyces cerevisiae, thiamine mononitrate (B COMPLEX), and multivitamin.  The patient experienced tiny red tender area on her arm after first vaccine on 24Feb2021 and went away after 24 hours. The outcome of event was recovered on 24Feb2021. Reporter seriousness for the event was Disabling. Causality assessment was reported as related.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event erythema cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Syncopal episode.  Pale and diaphoretic.  BP normal.  Recovered completely.
Erythema, induration and swelling on left thigh noted one day after vaccination. Pt started on po Keflex when seen in clinic 2 day after vaccination.
Covid Like Symptoms. SOB x 4 days with a cough.  fever, SOB, body aches, and has a prolonged cough x 4 days.
Sternal discomfort / pressure beginning 0730 on 040203.  Discomfort subsided briefly but resumed about 1100.  Went to ERD and was evaluated by MD. A cardiology consult is pending. Re: Patient recovered in # 9:  At the time of this report, the patient remains in the ER.
12:30 PM: Student accompanied by his teacher presents with scattered, bilateral rash on wrists. More promiinent on the left side. Alert and oriented to time, place and person. BP 122/76, Pulse 116, Lungs clear. Parents notified and child's mother notified pediatrician.
Pt called 4/12/08 approximately 11:30 AM. On Thursday AM, 11/10/08 she noticed a rash at site of injection. By 4/10/08 PM, the rash extended from site of injection to elbow. Rash is red, warm, itchy and painful. Rash stayed same through 4/12/08. On 4/13/08 AM, pt reported rash improving and not painful. 09/24/2008 Information has been received from a physician concerning a 67 year old female with no illness at the time of vaccination, allergies to penicillin and sulfonamides who on 09-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) SC in the left arm (Lot #659759/1873U) at 1:30 PM. On 09-APR-2008 at 8:00 PM, the patient noticed a rash at the site of injection. By 10-Apr-2008 PM, the rash extended from the site of the injection to the elbow. The rash was red, warm, itchy, and painful. The rash remained the same through 12-Apr-2008. On 13-Apr-2008, the patient reported that the rash was improving and not painful. Follow up information was received from the physician with no additional information. No further information is available.
N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) R42 - Dizziness R42 - Lightheadedness I95.9 - Hypotension Z45.02 - AICD discharge
Wide spread rash developed on thighs 7 days after vaccine. Rash not very itchy or painful
1. hardening, redness, swelling and pain at the application site that increased for the next 2 days and then began to decrease and then start to itch. 2. fever 3. chills 4. leg pain 5. hip pain 6. thigh pain 7. lethargy 8. fatigue
Immediate pain on injection. Deltoid soreness advanced to severe pain and limited movement due to pain at left upper arm. Profuse muscle pains for 3 days post vaccine. On going intermittent muscle weakness with mod-severe pain to left upper arm - injection site as well.
Pt recvd 2nd hep B vax & felt dizzy, n/v, & passed out;Later exp weakness,cramping,abdominal pain & inc bowel sounds.Tx w/ meds.Later, pt exp lightheadedness,dizziness & felt faint.
I had swollen left neck lymph node that continue for a while. On Feb 2nd, my lymph node got really bad. Both of my feet was swollen. My feet have been turning purple because of lack of oxygen. I went to my doctor about that and they said that I have an auto immune disorder now. I am being sent to a specialist for it.