chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered; mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered; sore arm where the administration site was; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 6 patients. This is first of 6 reports.  A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3248, NDC number: 59267-1000-01, Expiry Date: Apr2021), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, expiry date: Mar2021) at 0.3 ml by injection in left arm for COVID-19 immunization. On 03Feb2021 around 2 PM (Yesterday as reported) they mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered it to six patients. The patient experienced nothing other than a sore arm where the administration site was on 03Feb2021. The outcome of the events was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Sore arm, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.  No follow-up attempts are possible. No further information is expected.
FEVER; HEADACHE; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and headache. This report was non-serious.
EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 09-FEB-2023 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 63 years old. No concomitant medications were reported. On 09-FEB-2023, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Shingles 2 years after 1st dose; Forgot to get her second dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient only had one dose of Shingrix and reported that she forgot to get her second dose of Shingrix. (lack of effect-missed dose). The patient received first dose of Shingrix and two years after vaccination with first dose she was diagnosed with shingles and stated that the vaccination and having the shingles were worst experiences she ever had. The patient reported that she advocated for others to get vaccinated with Shingrix. Limited information available from reporter. The reporter declined to give consent or any demographic information. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Started with extreme pain at the injection site. That same night I developed fever and chills. Next day I realized my entire upper arm was swollen and red and not just the inject site. I could even lift my arm. Saw a doctor the next day and he advised that it was cellulitis and prescribed my keflex 500 qid and ibuprofen 600 tid. Its been 4 days since I received the vaccine, I still have some swelling and redness. There is some swelling around my forearm now as well but its still minor. I had to call in sick for a day as well due to this.
Heart stent 4/26/2021   Blood Clot left leg diagnose 5/13/2021 Xarelto 20 mg
The first time i had soreness and extreme fatigue. Rash on feet ankles and herls but it didnt start until 8 days after dose one and i didnt associate w vaccine. Second shot  within 7-8 hours  the rash burst out like shingles all over feet and apread to full body plus some tongue  and lip numbness. Rash is ongoing. Also tired, sorr and alternating hot:cold
Pt has a history of COPD and had a COVID exposure at home.  She has had increasing shortness of breath and a fever.
PT VACCINATED WITH DTP DEVELOPED HIGH PITCHED SCREAMING FOR 45 MINS.
left leg got swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (left leg got swollen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (left leg got swollen). At the time of the report, PERIPHERAL SWELLING (left leg got swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  No treatment was reported.  Patient went to an urgent care and was discharged without any ultrasound done.   This case was linked to US-MODERNATX, INC.-MOD-2021-081295 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081295:2nd  dose case
Information has been received from a physician concerning a 10 year old female who on 6/12/01 was vaccinated with Hep-B vaccine recombinant (yeast) (lot 638720/0257L). On 6/12/01, about 4 hours later, the pt experienced a fever of 103.5F, headache, difficulty breathing and swallowing, dizziness and a stomach ache. She was taken by EMS to the ER, treated with oxygen and an unknown steroid. Subsequently, she was released. Upon internal review, the pt's experience was considered an "Other Medical Event". Additional information has been requested. F/U additional info is not expected. This report no longer meets criteria for expedited submission to the FDA because it has been determined that the pt's experience is an expected event.
This medically confirmed spontaneous report (initial receipt 19-DEC-2014) concerns a 66-year-old male patient. On 19-DEC-2014, the patient received intramuscular AFLURIA injection (batch number: 09249211A, expiry date: 30-JUN-2014) in the left a arm at 0.5 ml. The patient appeared fine after receiving the vaccine. The pharmacy did not realize that the vaccine was expired until the patient left. The outcome was not reported.
Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular first dose (lot number: EH9899) on the left arm on 26Dec2020 07:15 and the second dose (lot number: EL1283) on the left arm on 25Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included allergies, high cholesterol; known allergies: dust, pollen, trees, grasses. Concomitant medication included ubidecarenone (COQ10 [UBIDECARENONE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), fexofenadine, atorvastatin calcium (ATORVASTIN), montelukast and multivitamins. The patient experienced facial numbness around right eye and migrating 11 hours after injection. Similar sensation 2 weeks after first vaccination in Jan2020. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
was given Adacel and Menactra on 17-Sep-2018 and again today; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office staff) by phone.  This case involves a 13 years old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiry date not reported) in the left deltoid and 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6220AA and expiry date: 31-May-2020) in the right deltoid via intramuscular route on 31 July 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) on an 31 July 2019.  It was a case of actual medication error due to extra dose administered. The patient received dose of Adacel and Menactra on 17 Sep 2019 in the past and again received on 31 July 2019.  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.   Information on batch number was requested.  Documents held by the sender: none.
I was having intense chest pain, weakness/faintness feeling a few days after second dose of Moderna vaccine. I went into the ER after 4th day of pain.   ER did a CT scan and found a couple blood clots in my right lung (pulmonary embolisms) along with tissue  on lung. An ultrasound of my heart and legs were done to find the source of these blood clots and neither tests found blood clots or indicators that this is where they originated.   I am currently in blood thinners in order to reduce the clots.
Lower back pain.  Woke up to lower back pain. Can walk , but slowly.. Not sure if this is from vaccine.  Worked Tuesday, standing up for hours. (5).
She had 1 shingle blister appear; blister; scab; shingles blister itched, but was not painful; the scab has come off, but the spot is still there and red; shingles blister itched, but was not painful; the scab has come off, but the spot is still there and red; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past 6-8 years ago).   In FEB-2023, the patient received the 1st dose of Shingrix (left arm). On 04-MAY-2023, between 2 and 4 months after receiving Shingrix, the patient experienced shingles (Verbatim: She had 1 shingle blister appear) and blister (Verbatim: blister). In MAY-2023, the patient experienced pruritus (Verbatim: shingles blister itched, but was not painful; the scab has come off, but the spot is still there and red), red spotty rash (Verbatim: shingles blister itched, but was not painful; the scab has come off, but the spot is still there and red) and scab (Verbatim: scab). The outcome of the shingles and pruritus were resolving and the outcome of the red spotty rash and scab were not resolved and the outcome of the blister was not reported.   It was unknown if the reporter considered the shingles, pruritus, red spotty rash, blister and scab to be related to Shingrix.     It was unknown if the company considered the shingles, pruritus, red spotty rash, blister and scab to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter stated that she received her 1st shingrix dose and had 1 shingles blister. She was 90% sure it appeared on 04May2023 after administration of Shingrix in early February. The patient has had shingles in the past 6-8 years ago, and believed it was shingles based on her previous episode (preexisting Shingrix). The shingles was not diagnosed by a physician. The patient reported that the 1 shingles blister itched, but was not painful it was healing, the scab had come off, but the spot was still there and red on 26thMay2023.  The patient also reported that a day prior to receiving her 1st Shingrix dose, on 03rd May2023 she was scheduled for colonoscopy/prep and was sedated (No further information provided about this event). The patient did not have lot and expiry information for her 1st Shingrix dose. The reporter did not consent to follow up with HCP.
This spontaneous report as received from a registered nurse refers to a 4 patients of unknown age and gender. On 28-OCT-2014 the patient were vaccinated with improperly stored PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported). No adverse effect was reported. No PQC was involved. Additional information has been requested.
Chills, Fever, extreme tiredness 12 hours after injection.  The next day I was better but not 100%.  The 2nd day I was 100%. No treatment.
Initial case was received from a consumer on 23 October 2012. This reporter also reported another adverse event which was captured in case number 2012-09995. A female patient had received an injection of INFLUENZA (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a rash and her arm was so sore she couldn't lift it for two days. The patient saw a physician and was treated with steroids. The patient never had issues before. Outcome was not reported. Documents held by sender: None.
Hangover; Weakness; Ache; Nauseated; This spontaneous case was reported by a physician and describes the occurrence of HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated). At the time of the report, HANGOVER (Hangover), ASTHENIA (Weakness), PAIN (Ache) and NAUSEA (Nauseated) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported by the reporter. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
pt devel h/a,rash,splenomegaly,dec hgb,dec platelet,dec WBC,arthralgia
Vaccine's expiration date was 6/2/21. No ASE were noted since administration.
An anaphylactic reaction including peripheral and facial edema and urticaria.  Onset 24 hours post vaccine->2 od post vaccine.
Pt recvd vax & exp fever 101, h/a & nausea; sx lasted for 6 days;
9-16-10 at 0730 Pt. presented to clinic nurse w/ red, hot, edematous area to back of (R) arm. Physician prescribed CIPRO for cellulitis. Pt. reported worsening symptoms evening of 9-17-10. Sent to ER. Received IV antibiotics and Rx for Clindamycin.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA279966, 2018SA279967, 2018SA281637, 2018SA279973, 2018SA279965, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281634, 2018SA281632, 2018SA281687 and 2018SA281692, same reporter. This case involves a 16 years old female patient who received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On unknown date, the patient received injection of suspect MENACTRA lot U5984AB, expiry date 14-Aug-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. 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 and Module VI of the 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.
Rash (generalized) near trunk, below abdomen and legs and pruritis; Rx with Medrol dose pak x 6 days
Fever/ 103 F; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) and PYREXIA (Fever/ 103 F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure, VITAMIN B [VITAMIN B NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever/ 103 F). In 2021, the patient experienced FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA (Fever/ 103 F) had resolved. At the time of the report, FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 f (High) fever.         This case concerns a 64 year old female with no relevant medical history reported , who experienced Non-serious , expected event of fatigue which occurred on the same day  after  vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine )   and fever which occurred the day after vaccination with the 2nd dose.. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given and also the outcome of the event  fatigue is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-392001 (Patient Link).; Sender's Comments: This case concerns a 64 year old female with no relevant medical history reported , who experienced Non-serious , expected event of fatigue which occurred on the same day  after  vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine )   and fever which occurred the day after vaccination with the 2nd dose.. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given and also the outcome of the event  fatigue is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Approx 15 minutes after vaccination patient complained of a sensation that her throat is closing and difficulty breathing. She was given benadryl and utilized her home albuterol inhaler. She asked to be taken to the ED. In the ED patient received albuterol nebulizer (@1327), epinephrine 0.3 mg (@1345), famotidine 20 mg (@1327) and methylprednisolone 125 mg (@1327). She was discharged with a prednisone prescription.  Symptoms seemed to improve with albuterol and steroids. Epinephrine did not seem to improve symptoms. Patient was discharged with a diagnosis of asthma exacerbation.   Patient reported to ED again on 2/9 with feelings of lightheadedness and palpitations. All diagnostic evaluations were negative. Increased heart rate contributed to prednisone use for previous mentioned asthma exacerbation.
Cold sore on my lips; This is a spontaneous report received from contactable Nurse (Patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 as 1ST DOSE, SINGLE  DOSE for covid-19 immunization. The patient's past medical history and concomitant medication was not reported. It was reported that 5 days after the administration of vaccine, the patient experienced cold sore on her lips on 17Mar2021.  The patient was treated with Abreva cream on the area. It was stated that she just don't know if that was the reaction to it and don't know why she developed a cold sore which she never ever had and just want to know if it was safe to get the second shot. The patient did not receive any other products. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Pt states he developed shakes/shivers, fever, lack of hunger, joint pain all over, dry heaves, redness at injection site, and trouble hearing after getting the vaccines. I recommend he call his doctor now.