chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix 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: 12-JAN-2023 Reporter's comment: The reporter asked for information regarding the administration of an expired dose of Twinrix to a patient.  The reporter asked how to proceed with the patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
teeth sensitive; teeth hurt; gums hurt; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 16:00, all of patient's teeth were sensitive and hurt and patient's gums hurt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event teeth were sensitive, teeth hurt and gums hurt was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left thigh is swollen from diaper line to 2" above knee after a raised area the size of a lemon. Redness in entire area. Tender to touch warm to touch. PT resists touch to area. Does not want clothes to touch area. Is active and alert. Running and playing and respiratory distress.
(R) shoulder pain occurred 2-3hrs after vaccination and worsened that night. No reaction noted at the injection site eythema/edema/skin rash.
Patient inadvertently received vaccine after expiration  date. Modeerna Company analyzed lot 007B21A and indicated vaccine maintained activity necessary to protect against covid19 at time of administration. Also patient did not call in with any adverse events.  This is administrative error without adverse event .
Dull ache, tingling, numb feeling in upper arm, shoulder, lower neck above injection site. Still persists as of today 10/5/16.
Presented w/ weakness. Covid + pneumonia tx w/ Decadron, zinc, Vit C
Pt developed a "severe cellulitis" about 2 weeks after receiving vaccine. It was reported that the nurse alluded to the fact that this was "not an isolated case." Unspecified medical attention was sought. Addtl info has been requested.
25Jan91 Engerix B admin.31Jan91 progressive fullness in throat.12Feb91 difficulty swallowing.Seen by Dr-Thyroiditis.TX /w Medrol for 6 days-improved in 24 hrs.22Feb91 vax admin.23Feb91 awakened by throat sx(same).Took Advil.Subsided in 3 da
Yesterday patient noticed that the injection site was turning blotchy and red. Then later noticed swelling, itching, a nodule, and tenderness where a shirt sleeve causes discomfort.
I got the moderna covid vaccine. I received the normal side effects plus it seems to have effected my thyroid. Light headed, memory loss, balance issues, vertigo, weight gain, exhaustion. 6 weeks later, I'm still sick
Client states that she went to bed at 10pm and felt fine. Awoke at 11pm very cold and shivering. States that she did not take her temperature. States she took a muscle relaxer and fell back asleep. This morning she felt fatigue, nauseated.
9 Year old pediatric male accompanied by his Father on receiving Pfizer Covid pediatric dose vaccine, immediately turned pale, voiced "I am not feeling well". RN Vaccinator informed the Medical evaluator. Patient placed in modified tredelenberg position, pulse oximetry reading continues and pulse check. Vital signs remained stable. Onsite EMS called. HR ranged 73 -74, SPO2 98-100%. There was no changes in mental status and activity level. No  hyper/hypoventilation, respiratory distress, tachycardia, chest pain, laryngeal spasm/edema, skin rash, or swelling. Place on a stretcher, Continued monitoring. No deterioration. Color return after 10 mins. Stable the monitoring period. Tolerated water and snacks.
The reporter was inquiring about administration of TWINRIX and the dates of vaccination of previous dose of Hep A and Hep B was not provided. The patient did not receive the vaccine till the time of reporting. Therefore, the case was deleted from core.
day 1 post immunization: rash/ blotchy redness on left thigh with localized swelling,  seemed to limp on left side was still active per normal does not seem affected by touch, warm to touch. redness continued for 5 days.  no fever.
got sick 2 days later with the flu; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown age, who experienced got sick 2 days later with the flu (influenza), while he/she received influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  On an unknown date in 1964, the patient received influenza vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got sick 2 days later with the flu (influenza).  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, event outcome was unknown for flu.  There will be no information available on the batch number for this case.
Working as provider RN, doing phone triage, work with desktop and phone system, clinic RN workstation area.  Received influenza vaccination 10/16/23 after huddle that afternoon. That evening I started to note a change in neuropathy and pain symptoms affecting my neck and upper body; right side. The following day the neuropathy and pain symptoms progressed and by the end of the day I was experiencing stiffness and pain with turning my neck to look over my shoulder. I am noting extreme electric like pain affecting around my right ear, my right facial cheek, my right temple area, the base of my skull on the right side, my neck, going into my chest and right shoulder, and I am not able to move when that happens until the pain passes. I am having weakness and stiffness of my neck. Neuropathy pain affecting the fingers of my right hand has worsened. Wednesday 10/18/23, my symptoms were more significant, I was trying heat therapy which didn't offer relief.  I am noting mild neuropathy symptoms affecting my index finger and thumb of my left hand; intermittently.  Head, Neck. Face  Right  Is seeing her allergist in November. Similar reaction to COVID vaccines in 2020 and 2021. Allergies and neuropathy started. Flu shot seemed to make it worse
I have fibromyalgia and it has made my pain worse; On injection site I feel like I have a knot and it is very painful; On injection site I feel like I have a knot and it is very painful; have numbness on my arms, hands and fingers; This is a spontaneous report from a contactable consumer.   This 42-year-old (non-pregnant) female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration into the left arm on 30Aug2021 at 14:45/02:45 PM (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing (I have fibromyalgia; Other medical history: Fibromyalgia). Concomitant medications included zingiber officinale root (GINGER ROOT [ZINGIBER OFFICINALE ROOT]); fenugreek [trigonella foenum-graecum] (FENUGREEK [TRIGONELLA FOENUM-GRAECUM]); cinnamomum verum (CINNAMON) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for unspecified indications, start and stop dates were not reported and milk t. No other vaccine in four weeks. No treatments, no Covid prior vaccination nor Covid tested post vaccination. On 30Aug2021, the patient experienced she has fibromyalgia and it has made her pain worse, on injection site she feels like she has a knot and it was very painful and have numbness on her arms, hands and fingers if she was on one side for too long. Outcome was resolved on an unspecified date for all the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Right arm reddened, inflamed, warm, and swollen 8.5cmx8.5cm area for 6 days (9 days after symptoms).
The patient describe having severe pain in her left shoulder in the injection sight. Severe pain in her knees, hip and elbow 3 days after receiving the vax. Patient was seen by her PCP and orthopedic dr.
The vaccine had expired on 29-SEP-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29-SEP-2023) for prophylaxis.   On 16-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 16-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: The vaccine had expired on 29-SEP-2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date- 19-OCT-2023 The patient was administered 2nd dose of Shingrix which was expired on 29-September-2023, which led to expired vaccine used. Nothing else was reported.  The reporter consented to follow up.
Staff erroneously administered pediatric 0.25 ml dose to patient who is 65 years old. Staff called the health dept for advice and was advised to administer a regular adult dose 0.5 ml flu shot. Pt was called back in and additional dose was administered same day.
expeirenced severe head ache, body aches, chills, Fever of 100, extreme fatigue lasting 7 days.
palpitations; Fever of 101 (Degree)F; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (unknown lot number and expiration) for COVID-19 immunization on unspecified date.  The patient called to report the side effects she experienced after administration of the second dose of the COVID-19 vaccine. She mentioned that 20 minutes after the administration of the second dose of the COVID-19 vaccine, she experienced palpitations and now she has a fever of 101 (Degree) F (unspecified dates).  The patient was recommended by the nurse to manage fever with Tylenol. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Feeling druggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling druggy) in a 42-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling druggy). At the time of the report, FEELING ABNORMAL (Feeling druggy) had resolved. Not Provided          Patient was feeling druggy since receiving the vaccine.  Concomitant medications were not reported.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-110112 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110112:
Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M013636 and expiration date on 15-FEB-2018 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. On 20-JAN-2017, the vaccines had an unspecified temperature excursion (reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 26 minutes. Also it was reported that the vaccines had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved.      This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA012268: US-009507513-1702USA002235:
8/19 fatigue at 3PM by 6PM fever 103-4, headache, body aches, chills, rash started 8/21, face, head, itchy, sl raised, no swelling of lymph nodes. Took Advil and Tylenol per MD's Instructions, ID specialist felt it was Td-serum sickness, very sick til 8/28.
The patient had chronic fatigue; This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown gender around 40 years of age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On an unknown date, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (product quantity, lot #, expiration date and route were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic fatigue.    At the time of the report, the outcome of  chronic fatigue and the relationship between chronic fatigue and of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown)  were not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008263:
Began at 7PM with a severe headache.  took a nyquil and woke up in the middle of the night with very strong shaking, chills.  Memory of the nighttime is very spotty, don't believe I was fully aware.  I recall 'coming to' at points in the night where I would drink water and lay back down.  Around 1:45AM the severe shaking/convulsing stopped .  I was able to walk and got up and went to the restroom where I got my thermometer and was at 100 temperature.  Went back to bed and regularly took my temperature - it proceeded to have temperature circles between 99-102 until around 5:30 am where it settled off at 100 degrees for the rest of the day.  Severe joint pain which made it difficult to hold my legs straight or bend them.  Around 5PM on 2/1/2021 almost everything was gone except for a lingering headache.  Went to bed on the 1st and woke up 2/2nd completely back to normal except for a headache which I believe would be diet related.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (rHA) (Lot# L034730, expiry date 09-SEP-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer and described the occurrence of erythematous rash in a adult patient who received SHINGRIX. On 26th May 2018, the patient received SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash and itchy rash. On an unknown date, the outcome of the erythematous rash and itchy rash were unknown. It was unknown if the reporter considered the erythematous rash and itchy rash to be related to SHINGRIX. Additional details were provide as follows: The age at vaccination was not reported. On 26th May 2018 (Saturday), the patient received SHINGRIX. On 27th May 2018 Sunday, the patient experienced a pre-shingle kind of rash on the left ankle. On 28th May 2018 (Monday), the patient had a new one on rash on the left ankle, they were both bright red and itchy. The patient enquired that if this was normal adverse event after receiving the SHINGRIX vaccine. The patient will call physician on 29th May 2018, when the holiday would be over.
Patient initially had mild flu-like symptoms after receiving her second dose.  Wednesday evening she suddenly couldn't stand, pivot or transfer into her wheelchair or be able to get up from her handicap accessible bathroom toilet.  Emergency services were called and she was taken to the hospital for testing.  After 7 days in hospital she was transferred to a nursing rehabilitation facility to hopefully get her to regain muscular strength to return home.  After 12 days little improvement is being seen...
Shingles presented on the morning of June 1. Skin lesion eruptions occurred on my right underarm and in a circular ring around my right chest. I have never had shingles before in my entire life. It's now June 20 and the lesions are starting to recede, however I am experiencing extreme "jabbing" and "searing" discomfort under the skin around my right rib cage and right underarm consistent with the locations of the shingles lesions.
PNEUMOVAX 23 given on 2-17-16 - cellulitis, subjective fever and discomfort.
mom states 304 hrs p/vax noticed pt was lethargic & had lack of appetite & was a little fussy; sx lasted thru next 2 days;
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a five-months-old male patient who was vaccinated with 0.5 ml second dose of ACT-HIB (lot: UI974AAA, expiry date: 04-Apr-2020, via intramuscular route in right thigh), which was reconstituted in sterile water, on 01-Mar-2019. Concomitant vaccinations included a dose of PEDIARIX for Immunisation; a dose of PREVNAR 13 for Immunisation and a dose of ROTAVIRUS VACCINE orally for Immunisation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a nurse used sterile water instead of the diluent that came with ACTHIB vaccine on Friday 01 Mar 2019. No symptoms were experienced. 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.
pt reports had a positive COVID test on 10/1/22 and was given Paxlovid; x3 days has had a productive cough, worsening weakness and fatigue; SOB; 10/4/22 family called EMS; placed on 100% NRB; CXR showed right sided pneumonia; another COVID test was positive; started on ABX, Remdesivir, Decadron; dc'd Remdesivir due to bradycardia; pt's condition worsened; placed on comfort measures; pt passed away in the hospital
Swelling induration at injection site <24 hr after injection. Swelling and erythema approx 15-20 cm in diameter. Mild 101 deg fever
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 041A21A and expiry: Unknown) dose was not reported, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient underwent an antibody laboratory test for spike protein antibody test which returned negative (confirmed immunological vaccine failure) about a month after receiving the Janssen covid-19 vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000179849 The suspected product quality complaint has been confirmed to be Void: No based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210533168 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS