chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose received: 3; My cousin let me know that she had itchiness on both forearms (gone the second day); Pain on the left arm and left armpit; Pain on the left arm and left armpit; Also had left body ache; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Jan2022 at 13:00 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as unknown. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 13:00, outcome "unknown", described as "Dose received: 3"; PRURITUS (non-serious) with onset 07Jan2022, outcome "recovered" (08Jan2022), described as "My cousin let me know that she had itchiness on both forearms (gone the second day)"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), all with onset 07Jan2022, outcome "recovering", and all described as "Pain on the left arm and left armpit"; PAIN (non-serious) with onset 07Jan2022, outcome "recovering", described as "Also had left body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, pain in extremity, axillary pain and pain.  Additional Information: It was unknown, whether the patient had any known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported pain level about 5 on a scale of 1-10. Less pain on the 3rd day (09Jan2022). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. No further information reported. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received by a health professional indicating that a 2 year old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200805, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
This case was reported by a consumer and described the occurrence of nausea in a female patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received the 2nd dose of Shingrix. In October 2018, less than a day after receiving Shingrix, the patient experienced nausea, exhaustion, fever, influenza and heart racing. On an unknown date, the outcome of the nausea, exhaustion, fever, influenza and heart racing were recovering/resolving. It was unknown if the reporter considered the nausea, exhaustion, fever, influenza and heart racing to be related to Shingrix. Additional details were reported as follows: The patient had Shingrix shots on Wednesday. The patient's physician was hesitant to give her the 2nd dose, but since she did not ever want to get Shingles, she had the 2nd shot. Within hours, it kicked in again, and the patient got the same hideous symptoms nausea, exhaustion, high fever, exhausted, flu, in addition to which her heart was racing in the middle of the night last night (she read that could be another side effect). At the time of reporting, the patient was marginally better and her fever was down (on third day). The patient was asking why there were some people did not have side effects other than a very sore arm, which she really did not get. The patient's husband had virtually no bad effects with the 2nd shot. The patient was asking if her immune system was stronger than some other people and reacts more violently to the proteins released by the shot. Was it preferable and stated If anybudy get a stronger reaction does that mean you might had greater immunity to Shingles. She had suggested to ask the research department and let her know. The patient had searched the web and did not find an answer. She had never had negative reactions to any other vaccines, including flu shots, the pneumonia shots. This case has been linked to the US2018GSK186407, reported by the same reporter.
Patient received Moderna at different location in Feb 2021. Patient was only able to get Pfizer due to military limitations.
Hives; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Pfizer).  This case involves patient with unknown age and gender who experienced hives, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not provided.  Final diagnosis was hives.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for hives.  List of documents held by sender- none. Information on batch number was requested.
extreme nausea; vomiting; headache; general body aches; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 02Mar2021 at 10:00 (age at vaccination 26-year-old, non-pregnant) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity allergy of sulpha drugs, food allergy shellfish allergy. Concomitant medication(s) included etonogestrel (NEXPLANON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 post vaccination. The patient previously took iodine and experienced drug hypersensitivity, pepto bismol [bismuth subsalicylate; calcium carbonate] and experienced drug hypersensitivity. Workplace facility type was clinic. Within 1.5 hours of receiving the vaccine on 02Mar2021 at 11:30 the patient experienced extreme nausea, vomiting, headache and general body aches. This lasted through the following 24 hours.  No treatment was received. The outcome of the events were recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
W/in 24 hrs p/immun, pt exp inject site rxn which included swelling & tenderness (4" x 4"); persistent crying for 1.5 hrs; tx cold compresses & APAP;
sick; hurt badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: hurt badly). The outcome of the sickness and pain were resolved (duration 2 days).   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that his/her friend states that he or she received Shingles vaccine and experienced sick as a dog and it hurt badly for 2 days. Follow up was not possible, as no contact details were available.
I noticed the next day at dinner time that I had a tightness in my left side breast area or heart!Still feeling the pain come and go on Sat I did then go to the ER on Sunday  I thought I may have pneumonia! They did an EKG which was all normal! And X-ray was normal I have continued to have the pain which will come and stay for a while and then goes away! on Monday which is today as I am writing this!
COVID-19 positive; COVID-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; negative. Reporter would like to know the time he can get a booster. He received his first and second dose of COVID-19 Vaccine. Tested positive for COVID-19 three weeks ago. Needs a booster shot. Has already tested negative for COVID-19 seven days ago. Reporter wants to know the timing for the booster, if he can get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Have developed "severe" constipation subsequent to receipt of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL8982) via an unspecified route of administration on 21Jan2021 at 14:15 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 immunization. The patient did not have any medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included amlodipine-benazepril and tamsulosin from unknown dates, for unknown indications. The patient did not have any allergies to medications, food, or other products. On 26Jan2021 at 08:00 the patient developed "severe" constipation subsequent to the receipt of the vaccine. The event was reported as non-serious. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The outcome of constipation was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
LEFT ARM INJECTION SITE PAIN ,PERSISTANT  Narrative:  Recommended That the Employee Been  seen by EOH.   Other Relevant History:
p/vax pt exp gen swelling, aching, fever of 102 & a wheeze;dx w/bronchitis, lasting x 1wk;seen in ER & seen by MD x6;pt found to have pneumonia;nurse practitioner feels pt had allergic rxn to vax;pt persistently incapacitated
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   This case was linked to MOD-2021-116356 (Patient Link).
Eight minutes after receiving the J&J vaccine the patient began sweating profusely, was very hot, had a tingling feeling all over his body and was lightheaded. He was breathing fine and talking the entire time. Used ice packs to cool patient down. Called 911, paramedics took him to the hospital ER where he was discharged to home doing well.
Sick for 1.5 week after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 1.5 week after receiving vaccine) in a 76-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ILLNESS (Sick for 1.5 week after receiving vaccine). At the time of the report, ILLNESS (Sick for 1.5 week after receiving vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   This case was linked to MOD-2021-075267, MOD-2021-075275, MOD-2021-075286 (E2B Linked Report).; Sender's Comments:  MOD-2021-075267:Crosslink - same reporter MOD-2021-075275:Crosslink - same reporter MOD-2021-075286:Crosslink - same reporter
Moderna COVID 19 vaccine appointment which is only three weeks between vaccination; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Moderna COVID 19 vaccine appointment which is only three weeks between vaccination) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Moderna COVID 19 vaccine appointment which is only three weeks between vaccination). At the time of the report, OFF LABEL USE (Moderna COVID 19 vaccine appointment which is only three weeks between vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Caller requests to be removed from email list.
Storage and handling excursion- Patient was given a dose of Pfizer vaccine past BUD time of 6 hours described in EUA - with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 6:03PM 8/11/2021 . No adverse events reported, extra dose not required at this time
Information has been received from a physician concerning a 35 month old male who in June 2004 was vaccinated with a dose of Varivax (lot # not reported). Subsequently the patient developed mild breakthrough chickenpox characterized by less than 50 lesions. The patient's outcome was not reported. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that she did not know who the patient was and that she did not report this event. Additional information is not expected.
IPOl being administered to a patient after the temperature excursion; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves seven patients of unknown demographics who was vaccinated with a dose of IPV (VERO) [IPOL] (Batch number: N1K931M and expiry date: 18-Nov-2019) (dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  It was a case of actual medication error due to incorrect product storage.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
Systemic: pt has not had a normal menstrual cycle since her 1st dose-Medium, Additional Details: menstrual cycle has been very abnormal, spotting break thru and extension of timing. this got worse with second shot
Patient had the panic attack, she did not faint , just said she had trouble breathing at first. She started shaking and said that she had anxiety. We gave her 25mg of Benadryl at first just in case.  We did call EMS but  refused any treatment
He stated couple days after administration of vaccine he had pain and fever and had been taking Tylenol. Stated site was sore and redness and swelling around arm and rash. Cold compressor applied to affected arm.
Febrile siezure 20 hours after immunization; seen in ER; follow-up in PCP office.
The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from other health care professional and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot number x019553, expiration date: 19-JAN-2025), administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided). The nurse was reporting that a patient received improperly stored vaccine (Improper storage of product in use). No additional adverse events were reported.
Achiness; Headache; Joint Pain; Malaise; Expired doses were administered; Vials were placed in freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and EXPIRED PRODUCT ADMINISTERED (Expired doses were administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 037K20A and 037L201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 09-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Vials were placed in freezer). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered). On 30-Oct-2021, the patient experienced MALAISE (Malaise), HEADACHE (Headache) and ARTHRALGIA (Joint Pain). On an unknown date, the patient experienced PAIN (Achiness). On 09-Sep-2021, PRODUCT STORAGE ERROR (Vials were placed in freezer) had resolved. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered) had resolved. At the time of the report, MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and ARTHRALGIA (Joint Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-370320, MOD-2021-370236, MOD-2021-370140, MOD-2021-370140, MOD-2021-370222, MOD-2021-382875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 contains Significant information. Route of administration of suspect product updated. Consent for safety provided. On 01-Nov-2021: Follow-up received on 01-NOV-2021,contains Significant information. Patient demographic details added. Vaccination history information added. On 08-Nov-2021: Follow-up information received on 8 Nov 2021 - new event added On 09-Nov-2021: Follow-up received on 09-NOV-2021,contains events were added On 09-Nov-2021: follow up received on 09-NOV-2021, 2 nd dose details were added
approx 8 hours after vaccination i experienced muscle aches in y legs and felt shivery.  Very tired.
pt recv vax 13SEP96 &  the vaccine may have been injected into the intradermal tissue;pt devel local redness & soreness;sx resolved in less than 24hr;
Daptacel was given to a consumer that expired 2 days prior, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5254AB, expiry date: 18-Sep-2019 via intramuscular route in the left deltoid on  20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccine included hep A (hepatitis A vaccine) and Flu shot (influenza vaccine)  It is an actual medication error case due to expired vaccine used. It was reported that by mistake gave an expired Daptacel.   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.  List of documents held by sender: none.