chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 24-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
had a reaction to vaccine; She stated there was pain, redness and lymph; She stated there was pain, redness and lymph node swelling; She stated there was pain, redness and lymph node swelling; This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Bexsero and not applicable after receiving Flu vaccine, the patient experienced adverse reaction, pain, erythema and enlargement of lymph nodes. On an unknown date, the outcome of the adverse reaction was recovered/resolved and the outcome of the pain, erythema and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Bexsero. It was unknown if the reporter considered the pain, erythema and enlargement of lymph nodes to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccintion was not reported. The nurse stated that, the patient received dose of Bexsero and experienced adverse reaction to vaccine. The nurse stated that, it was most likely from immune response, that the patient had other reactions to various vaccines including flu like, pain, redness and lymph node swelling. Immediately after shared the information, the nurse had to leave to tend to the patients. The reporter did not consent to follow up.
Information has been received from a physician concerning a female who on 10-JUN-2008 was vaccinated with a dose of 0.65ml dose of ZOSTAVAX (injection site unspecified). It was reported that on 12-JUN-2008 the patient developed irritation on the injection site and a little bit of swelling on it. The physician reported that the patient sought medical attention at the office. The outcome was not reported. Additional information has been requested.
Telephone call 5/5/01: rt arm red swollen 1"x3" slightly itchy and slightly warm to touch. Benadryl every 6 hours. Motrin every 6 hors and redness to be evaluated. 5-6-04: visit. rt arm redness, warm to touch, and hardness -98 degrees- 10x8 cm rash. --Augmentinx10days. F/U prn. Diagnosis: Vaccine reaction and cellulitis.
pt recv vax; father states was covered with pox; some in mouth and throat; fever, itching, nausea, cough; by the 18th, they were all scabbed over;
Patient did not report any adverse events, however patient received primary series of moderna at a different pharmacy and should not have received second shot of novavax until 4 months later.
12/17/2020 deep sharp pain in my arm and not just at the injection site it was the entire upper arm where I couldn't pick up my daughter. I took tylenol 12/18/2020 and within an hour later I had no pain in my arm and I was fine
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Patient wants to know if he can take Tylenol or ibuprofen 4 days after the shot.
Hip joint back pain started 48 hours after vaccination. Bending forward down hurts the muscle all surrounding hip. It feels like a stiff back and it has continued since 3/6/2021. It has been 6 weeks and it is not going away.
Patient was administered with vaccine which underwent temperature excursion; Patient was administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 018B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported Moderna vials had a temperature excursion involving 14 Moderna Covid-19 vials, mentioned that they have 4 thermometers data logger recorded a temperature excursion on 02 May 2022 of deviation plus 5.11F temperature which occurred for 7minutes duration.This was just found out when they had an inspection with the state department and they were advised to call Moderna to determine the viability of these vaccines.  It was reported that the vials were stored in freezer while temperature excursion, Now the vials were quarantined in the freezer and the vaccine state was reported as  still frozen i.e frozen at that time the temperature excursion happened.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Follow up received: Patient demography and suspect drug dose details.
Patient was administered a covid vaccine on 3/19/23 that was dated to expired on 03/14/2023. Pfizer and CDC was contacted and per Pfizer the vaccine stability data supports the storage between 2 to 8 C for up to 75 days.  No adverse event was reported from the patient.
pt states he got a couple of hives after taking the vax.  He was given Benadryl which helped with the hives.  Later that night after going to bed he woke up w/ his muscles and nerves twitching and tingling.  He says you can sometimes see the muscles spasms and then other times he feels it tingling under the skin. Pt is still having these symptoms. He had a sore arm for about 48 hours. For about 3 to 4 days he had a faster heart rate and higher blood pressure than normal.   He developed a headache that lasted about 2 days.  Currently he is having some brain fog  and his shoulder and biceps still have a heavy feeling like they are detached from his body along with the muscle twitching and tingling.  He does not feel like these symptoms are improving and will see his PCP on 3/29/2021.
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case is linked to case 2018SA196613 (same reporter). This case involves a 20 years old male patient who was given a third dose of MENACTRA instead of BEXSERO. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient was two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 16-Jul-2018, the patient received a 0.5ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA, expiry date 08-Mar-2019 via intramuscular route in the right deltoid. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was unknown whether patient experienced 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 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.
Per pt states as soon as she was given the TDAP vaccine on 1/26/18 she felt dizzy and had diarrhea, fever, laryngitis right after.
No diluent used, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered).
Patient received FLUZONE HIGHDOSE 9/18 and came back today intending to get SHINGRIX, but we misunderstood and billed FLUAD and administered that instead. She hasn't had any reactions but it still was an error that a second shot was given this season.
asked pt. their age and she said 65 so i gave her the form for the 65+ dose after giving pt. her vaccine she told me she was only 60. i gave her there higher dose for  elderly and wanted to report my mistake.
Fever up to 101; severe body aches; severe chills; nausea; fatigue; headache; BNT162B2 1st dose: 23Dec2020/BNT162B2 2nd dose: 09Jan2021 14:45; This is a spontaneous report from a non-contactable nurse reported that a 25-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231; expiry date: not known) on 09Jan2021 14:45 and first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK5730; expiry date: not known) on 23Dec2020, both intramuscular in the right arm at single dose for COVID-19 immunization, administered in hospital. The patient's medical history was not reported. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) (medication received in two weeks). The patient had no COVID prior to vaccination. The patient experienced fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache on 10Jan2021. No treatment was received for these reported events. The patient underwent lab tests and procedures which included nasal swab (COVID test) on 14Nov2020: negative. The outcome of the events fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache was recovering.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FF2587) and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Mar2023, outcome "unknown"; COVID-19 (medically significant) with onset Mar2023, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Mar2023) Negative, notes: after 5 days negative Covid test on a Monday; (09Mar2023) Positive, notes: by Thursday I had a positive Covid test; (unspecified date) Negative, notes: at home tests have been negative; (10Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: product=COVID-19 Treatment, Paxlovid, treatment start and stop date= 02Mar2023 and 05Mar2023,Treatment of COVID-19. After 5 days negative COVID test on a Monday by Thursday she had a positive COVID test and symptoms of stuffy nose. low grade fever today Saturday. Husband had been displaying COVID symptoms but his at home tests had been negative. He took a PCR test yesterday Friday 10Mar2023 so they will see this week if it comes out positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107495 same patient, different drug/event;
booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; booster was stored at 46 degrees and not at 48.; Patient received dose 3 (booster); Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; Patient experienced fever, chills, N/V; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 19Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fever", start date: 21Oct2021, stop date: 23Oct2021; "chills", start date: 21Oct2021, stop date: 23Oct2021. Family history included: "DM type 1" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Father: DM type 1; "Liver cancer hepatitis infection" (unspecified if ongoing), notes: Family medical history relevant to AE(s): , Brother: Liver cancer hepatitis infection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Date: 27Feb2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 27Feb2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Date: 20Mar2021, Anatomical site of Injection: Right Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202, Provided by patient), administration date: 20Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "booster was stored at 46 degrees and not at 48."; IMMUNISATION (non-serious), outcome "unknown", described as "Patient received dose 3 (booster)"; PYREXIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Patient experienced fever, chills, N/V".  Follow-up (07Jan2022): The initial case was missing the following minimum criteria: due to -Unidentifiable patient. Upon receipt of follow-up information, this case now contains all required information to be considered valid.  No follow-up attempts are possible. No further information is expected.
mom states pt had t102, cried for 2hr;arm back chest & neck swelled up on lt side;took child to ER given APAP x-ray done;r/o broken arm;sent home w/DPH & advil;16JUL97 saw PMD 17JUL97 told to cont DPH & advil;
Two weeks after my second Moderna COVID shot, I started to have pelvic pain.  I have never had pain like this before and it was not related to any pre-existing condition.   The pain has not stopped since.  (Began in August 2021).  After visiting multiple doctors, they could not find anything wrong internally.  I finally started seeing a pelvic floor physical therapist who told me that my pelvic floor muscles are extremely tight.  She is still having trouble getting them to release.
Administration of expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix adult) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-Jul-2022 Reporter's Comments: The reporter called in to enquire about expired Havrix. The reporter stated they inadvertently administered an expired Havrix (expiration date: 18th June 2022) dose to a patient on 1st July 2022. The reporter was unable to provide full vaccine and patient details. Additional Supportive Information: The patient was administered with expired Havrix vaccine, which led to expired vaccine used. This case has been linked to US2022102705, reported by the same reporter. Vaccine administration facility is same as primary reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022102705:Same reporter. Patient 2
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 27th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms. The patient was treated with prednisone. On an unknown date, the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, neck pain and sore back were not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in right arm. The patient reported flu like symptoms described as achy and fatigue. The patient also reported that her arms were both sore, her neck was still sore, and it radiated to her back. The events of flu like symptoms resolved, but the soreness was still being experienced. The patient's doctor had placed on a medication, which was Prednisone 2.5 mg and she was not sure about how many to take but knew they were 2.5 mgs. On 17th November 2018, the patient received 2nd dose of SHINGRIX. The reporter consented to follow up.
fever, nausea, vomiting, diarrhea, chills, body aches, loss of appetite, lethargy, headache, soreness at injection site=starting midnight the day of injection fever, chills, body aches, and soreness at injection site continued  for at least 12 hours vomiting 24 hrs after injection nausea, diarrhea, loss of appetite, lethargy, headache still current, over 72 hours after injection
Information has been received from a physician concerning a 69 yr old female with no allergies or pertinent medical history who on 17Feb05 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649912/0529P). On approx 17Feb05, the pt developed a 14 cm erythematous, macular papular diameter. Unspecified medical attention was sought and the pt was treated with oral diphenhydramine hydrochloride (Benadryl) and topical hydrocortisone. At the time of the report, the pt had not recovered. The physician requested a lot number check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Pt received COVID-19 vaccination, when he began to stand, vaccination nurse noticed that he became very pale. Nurse sat him on chair with back against the wall.  Pt asked nurse for water and juice.  Pt became very anxious and extremely diaphoretic (dripping), given ice pack and towels - Clinical Lead RN  called.    1631 - Clinical Lead RN called to room and observed pt to be very pale and extremely diaphoretic.  Attempted to take radial pulse from left arm, pulse too thready, irregular and weak to read.  Apical pulse was irregular and weak in 30's. B/P 60/32 Left arm. RN grabbed emergency kit to get Epinephrine.     1632 - Epinephrine given in Right Thigh. Pt appears confused and states he is scared and "doesn't know what is happening". 911 called  and Paramedics dispatched.    1636 - While Vaccination nurse continues to dry and talk to the patient, Lead RN continues to auscultate apical pulse, which slowly begins to get stronger, up to 70 bpm. (pt states that he is worried and asks if we are being honest with him, will he be alright). Pt states that the only med that he takes is Adderall and that he has no history of this happening before with other injections.   1640 - Color is slowly returning to patient.  Apical pulse is now up to 90 bpm and is strong and regular. B/P in left arm is 112/62.  Paramedics have just arrived and will be taking pt to  Emergency. Pt able to stand and is much more alert but seems a little in shock over what has just happened.  Pt able to stand and walk to gurney for transport.
Local reaction to left shoulder/deltoid with erythema, warmth and tenderness. No systemic symptoms.
Hospitalized (9.14.21);  COVID-19 positive (9.12.21);  fully vaccinated  Discharge Provider: DO Primary Care Provider: None Physician, MD Admission Date: 9/14/2021 Discharge Date: 9/20/2021 Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 09/14/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: PT is a 73 y.o. male family medicine physician whom is relatively healthy with past medical history significant for HTN, HPL, and DM 2 that was admitted for COVID 19 PNA and associated acute hypoxic respiratory failure. He was fully vaccinated with 2 doses of Pfizer 19 COVID vaccination. He was started on supplemental O2, His therapies included  Decadron, Remdisivir, Lovenox, IS, Acapella, Mucinex, Proning   He was gradually weaned off supplemental oxygen and began feeling better   9/20/2021 Pt S+E. Alert, NAD, VSS on RA. Stable at discharge Rx for prednisone and Eliquis sent to his pharmacy Patient in agreement with instructions to pick up prescribed medications and take as directed.
Right upper thigh red and swollen 5-6cm child had 99.2 fever was put on Duricef 250/5 7.5cc BIDx 7days, Prelon 15/5 5cc BID x 3days