chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day Use By Date; No adverse event; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder.    On 02-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 5 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729345:Patient 1
Patient given 2nd dose of HPV 8:45, at 8:50 became pale.  While holding her Mother's hand, she then had eye twitching and head shaking with movement to the left.  Unresponsive for approximately 30 seconds.  Then started to waken, unaware of what had happened.  Primary care physician evaluated heart, lungs, blood pressure, heart rate.  All normal.  After resting for 15 additional minutes patient was able to ambulate to lobby and discharged home.  Contacted parent at 4:30 pm. and was told she was able to attend school and had no additional problems.
Eight days after the initial vaccine injection, a painful nodule appeared.  I consumed a large amount of (simple and complex sugar) calories (around 4,000) the night before 3/13/21.  On the day of 3/13/21 I woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervical triangle.  Saw my doctor on 3/18/21 and she mentioned that the inflamed lymph node is probably due to the vaccine.  The lump is still with me, the size is the same, however the area in and around the lump  is not as tender and painful today 3/24/21.  This coming Friday 3/26/21 is my  appointment for the second dose of the Pfizer BioNTECH vaccine shot.
This spontaneous report was received from a pharmacist via a  company representative concerning a 80 year old female patient. Concurrent conditions, medical history and allergies were not reported. On unspecified dates the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency, anatomical location and lot were not reported) subcutaneous, five times. Other suspect and concomitant therapies were not reported. No adverse event was reported. No further information was provided. Additional information is not expected because the reporter stated he does not want to be contacted.
FELT LIKE PUSHING ON A NERVE; FELT LIKE A BULLET WENT THROUGH ARM FROM BEING SO COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, series 1 administered on 01-DEC-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-DEC-2021, the patient experienced felt like pushing on a nerve. On 01-DEC-2021, the patient experienced felt like a bullet went through arm from being so cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like a bullet went through arm from being so cold and felt like pushing on a nerve was not reported. This report was non-serious.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered  nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with 21 of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a  18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 24-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number:  1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
flushing feeling and appearance over most of my body 1.5 days after injection; extreme fatigue for 2 days; unbalanced; headache like halo shape on top of head; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 18Jun2021 at 17:30 (at 46 years old) as single dose for COVID-19 immunization. Medical history included fibromyalgia, degenerative disc disease, osteopenia, vulvodynia, and latex and bee stings allergy; all from unspecified date. Concomitant medications included tramadol, gabapentin, polycarbophil calcium (FIBER), duloxetine, and macrogol 3350 (MIRALAX); all from unspecified date for unspecified indication. The patient previously received papillomavirus (human types 6, 11, 16, 18) (HPV VACCINE) (vaccine received within 4 weeks prior) on unspecified date in 2021 for immunization. The patient also previously took erythromycin, meloxicam (MOBIC) sulfa medications, mushrooms, and penicillin. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 20Jun2021, the patient experienced flushing feeling and appearance over most of my body 1.5 days after injection, extreme fatigue for 2 days, unbalanced, headache like halo shape on top of head; out of sorts. Outcome of the events was recovering.  Information on the lot/batch, further information has been requested.
Mild to severe muscle pain at injection site for the last 5 months.  Certain arm movements result in severe pain and weakness.  No pain from touching the arm?pain starts with arm movements.
drooping on face; aches; Numbness; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for an unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drooping on face, aches and numbness. The patient was hospitalized. The outcome of events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on available information a contributory role of   BNT162B2 to the reported  drooping on face, aches and numbness cannot be totally excluded.  Case will be reassessed if additional information is  received.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
had a few aches; had a few pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation; Bnt162b2 (Dose: 2), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "had a few aches; had a few pains".  Additional information: The reporter was unwilling to complete the report when asked about the lot number. The NDC number and expiry date was not provided. There were no other products or investigation assessment provided. The patient was at home because of the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients' were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429 expiration date 09-AUG-2017 (strength, dose and route of administration were not provided). The patient's concomitant medications were not provided. The physician stated, he needs to check his records to see if any were administered, but he "believed some were administered". The physician reported the following temperature excursion for the administered vaccine: 30.2 degrees F for 4 hours, 31.1 degrees F for 10 hours, 34.5 degrees F for 10 hours and 34.6 degrees F for 10 hours (cumulative time out of range was 34 hours). No previous temperature excursion was reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of two reports received from the same reporter.
high fever & red rash 5-6 days p/vax; high fever persisted even p/the rash for 1-2 days;
2 min after TRUMENBA pt with LOC resulting in post head injury and concussion. Head CT WNL, LOC for 60-90 seconds.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a unspecified number of patient's who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 8 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, general body pain, fever and lethargy. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, general body pain, fever and lethargy were recovered/resolved. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, general body pain, fever and lethargy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that in general, younger patients under 60 or in their 60s and with healthy immune system experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours they feel like they get the flu, flu- like symptoms including body aches, fever and lethargy then about 24 hours after their injection the symptoms all resolved. The reporter consented to follow up.
2:00 am light headed and losing consciousness, laid down for 3 minutes got up again and same symptoms happened, laid down again for 3 minutes, sweating, never fully lost consciousness. Unable to sit up or stand for more than 30 seconds without feeling like fainting again. After an hour symptoms passed. 9:30 am migraine like headache, still occurring as of 11:15 when filling out forms.
pain in her lower right arm; pain in her neck; started having pain in her head; started having pain in her ears; her ears were bright red; had extreme pain in her stomach; Nausea; Vomiting; Diarrhea; tiredness; had weak spells; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, neck pain, fatigue and weakness. On 4th February 2020, the patient experienced headache, ear pain and erythema ear. On 6th February 2020, the patient experienced stomach pain, nausea, vomiting and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, neck pain, ear pain, erythema ear, stomach pain, nausea, vomiting and fatigue were resolved with sequelae and the outcome of the headache, diarrhea and weakness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema ear, vomiting, diarrhea and weakness to be related to Shingrix. The reporter considered the neck pain, headache, ear pain, stomach pain, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experianced pain in her lower right arm and neck. She stated that, she had no pain around injection site.  She said that the next day, she started having pain in her head and ears, her ears were bright red, the pain in her neck also continued.  She said the following Thursday, on 06th February 2020, 3 days after receiving Shingrix, she had extreme pain in her stomach, with nausea and diarrhea, Benadryl helped ease these symptoms.  The patient said, she also had weak spells and tiredness for a week after receiving the vaccine. She said that, all other symptoms also resolved in 7 days.
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with lot # M017983 and expiration date on 30-MAY-2018 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA006600: US-009507513-1705USA010489.
Vaccine product experienced brief temperature excursion. Vaccine administered without knowing about excursion and before verifying product stability with Seqirus. Verified with Seqirus afterwards that vaccine was stable at the time of administration according to their data.
Patient made us aware that she fainted after the first dose. Patient fainted within 10 minutes of getting dose 2. She came to a few seconds after while cold pack was held to forehead. Epi Pen was thought to have been given but ended up being trainer pen. Told ED regarding this. Called emergency services and EMTs arrived within 5 minutes and took her to Medical Center.
This spontaneous report as received from a doctor of pharmacy refers to a male patient of unknown age. The patient was vaccinated intramuscularly (IM) with a 0.65 ml dose of ZOSTAVAX (lot # and expiration not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that her husband was given ZOSTAVAX administered IM instead of subcutaneously (SC). After an unspecified amount of time (date unspecified) he needed hip replacement surgery and later developed shingles. No treatment information was reported. The patient sought unspecified medical attention. The outcome of hip replacement surgery and shingles was unknown. The relatedness for hip replacement surgery and shingles was not provided for ZOSTAVAX. Upon internal review hip replacement surgery was considered to be medically significant. Additional information has been requested.
Severe itching on injection site; Redness at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0939904) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Anxiety, Drug allergy, Drug allergy, Drug allergy, Penicillin allergy and Drug allergy.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided
At 0919, 14 minutes after patient received first dose of Covid Vaccine, patient verbalized feelings of shortness of breath. Rn and LVN present. Patient immediately given 1 Liter of oxygen via nasal cannula, vital signs assessed 134/87 81 O2 98 % on RA 99% of 1 liter, Dr.  notified and site manager notified. Patient verbalized additional symptoms; tiredness, dizziness in minutes following initial symptom.  0924: BP 123/83 P 80 O2 99% on 1 liter. Patient verbalized improvement of shortness of breath but dizziness and tiredness were unchanged.  0929: Patient complaint of nausea. Dry heaves started at 0931  0933: Verbal order received to administer Zofran 4 mg sublingual now on-time per Dr. BP 137/85 P 80 O2 99% 1 liter.  0934: Patient self removed nasal cannula due to self reported improved breathing. O2 98% on RA.  Dizziness and tiredness improving.  0937: Patient verbalized decreased nausea, denies shortness of breath but remains tired.  0941: BP 137/88 P 68 O2 98% RA. Patient verbalized decreased nausea and tiredness but new onset of headache.  0946: Patient verbalized no nausea, decreased headache, unchanged tiredness.  0952: BP 123/82 P 69 O2 98%   0958: Patient verbalized generalized relief of all symptoms and verbalized being capable to stand, walk, and drive self home 10 minutes from clinic. Patient provided with work note with all information. Patient understands that she will receive a call within the next hour to check on her and was advised to go to ER if symptoms worsen, if shortness of breath continues or  develop a fever of over 100.4. Patient's questions and concerns addressed. Patient verbalized understanding.
Felt like face was swelling Narrative: Employee was brought to clinic for evaluation, but left without being evaluated.
Cough, tms red, throat minimal mucous, rhonchi, loose cough.
Vaccine was expired (4 days), manufacture was notified, Moderna is evaluating the effectiveness of the expired vaccine and we are waiting for a response.
Possible symptom 1: Within approximately a day or two of the shot, I developed a severe and persistent lower abdominal/groin pain.  The pain was very pin point in location and lasted for approximately 10 days before easing up.  Very small isolated pain severe enough to go to the DR, but I could not afford to on account of my wife having severe unknown abdominal pain and being in the ER and DR  multiple times herself (she got the same vaccine an hour before me?).  Possible symptom 2:  4-5 days after the shot I developed an isolated and severe pain in a preexisting nodule/mass (lymph node?) located on my mid right thigh, it has never had any sensation before.  The pain was persistently severe for approximately 7 days before easing up.
Pt recvd vax & 30 mins p/vax pt exp upper body tingling which lasted for a 30 min duration;
Injection site became swollen, red and indurated.  It was also "hot to the touch" and itchy.  5 days later redness has dissipated but site is still indurated and itchy.  Treatment Benadryl and calamine  lotion applied to the site.