chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reconstituted the lyophilized component with another sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA656A, expiry date 31st January 2023) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Menveo. On 28th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: Registered nurse (RN) stated that a CMA reconstituted the lyophilized component of Menveo with another sterile diluent than the one supplied. The reporter consented for follow up via postal.  Additional Supportive Information: the patient received the Menveo which was reconstituted the lyophilized component with another sterile diluent than the one supplied, which led Wrong solution used in drug reconstitution.
Cramping; Mood swing; Heavy pink discharge like spotting; Had a lighter than normal period; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm on an unknown date in 2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 03Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 06Sep2021, the patient had a period that was lighter than normal period. On 18Sep2021, the patient experienced cramping, mood swing, and heavy pink discharge like spotting while the patient had her period on the 06Sep2021, this never happened. It was also reported that the patient had no chance of being pregnant. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent a nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cramping, mood swing, heavy pink discharge like spotting, and had a lighter than normal period was not recovered at the time of this report.
persistent crying for more than 6hrs; high fever 102-103 x 3 days; afeb x 2 days then febrile again;
It was discovered on 8/30/17 that we had PREVNAR in stock that had expired 5/31/17.  We also discovered 1 other patient (separate report completed e-report ID 123496). We contacted Pfizer, who deferred to the agency's recommendation to have the patient re-vaccinated. We contacted the patient to complete this. We also logged the error via STARS (Strategic Tracking and Reporting System).
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient reported that when she was 12 years old she had shingles. On an unspecified date about a year ago approximately in 2013 the patient was vaccinated with ZOSTAVAX (dose strength, daily dose and route was not reported). Patient also reported that she was using 18 other unspecified medications made by the company even at the time when she received ZOSTAVAX and also reported that she was going to tell her doctor that she would rather die than use any other product by the company. Last week approximately in March 2014 the patient developed shingles in the form of a red rash and feel terrible. The outcome of event shingles in the form of a red rash and feel terrible was unknown. The relatedness between the drug and the event was unknown. Additional information has been requested.
Diagnosis of basal cell carcinoma L upper arm x2; patient believes they are at sites of prior vaccine administaration.  All flu vaccines from 2010, 2011, and 2012 flu seasons were administered in L deltoid area.  One of her 2 basal cell carcinomas was at a site that could have been site vaccine was administered; second is lower on her arm and likely does not correlate.  Patient requests that this be reported as an adverse event due to flu shot.
Client c/o shortness of breath and generalized dizziness that lasted for a few hours.
Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased neck and body soreness after series of injections. Pt. continues to c/o discomfort. Lot number 559011a, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1500 units. 150 I. U/ml Grifols lot number exp unknown. ND13533-0618-10.
Pt felt soreness in muscle following injection and is now continuing 1 wk post injection. No redness, swelling or warmth at injection site or in arm. Pt also notes numbness in arm. Pt says after her vaccination, she returned directly to work which includes a lot of heavy lifting. Referred pt to her primary care physician.
Post vaccination day 12. Patient awoke with raised pruritic rash on back and extremities. No headache, fever, chills, dyspnea or cough. Morbilliform rash. Symptoms resolved over 3-4 days after oral antihistamines and steroids.
3 1/2 X 5 inch raised, erythematous area to right deltoid warm to touch.  Vaccine given 12-22-08, reaction began on 12-23-08 around 1:00 pm.  Reaction evaluated 12/24/08 @ clinic.  Instructed ct if redness, swelling increases she need to go to ER.  Due to Holiday ct to RTC 12-29-08 for reevaluation.  12-29-08 ct rtc for re-evaluation; erythema at swelling minimal.  Ct went to ER 12-24-08. Given SOLUMEDROL, BENADRYL, pain medication.  Release of information sent to ER for visit records.
Patient developed 2 days pain, erythema, and tenderness of left arm, spreading into forearm.
Chills, fever, stomach upset, weakness, exhaustion,  general pain, diarrea that lasted 3 days then began improving.
Hematuria and UTI symptoms with urgency, fever to 102F, leukocyte positive on OTC urine dip.
Fever and chills on evening of vaccination. Visit to MD on 10/16. Left arm has 10cm area very painful, red and hot, with redness extending down arm. Not described as cellulitis. Patient reports itching over entire body, without hives. T37.4, HR 91, comfortable, not distress. BP 130/83. Prednisone 60mg daily x 5 days. Reports feeling better by October 18.
I was hallucinating; Fever; Chills; Headache; Abdominal pain; Nausea; I was weak; Couldn't get to sleep; life miserable; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old patient of an unspecified gender received bnt162b2 (Batch/Lot Number: EW0175), Solution for injection, via an unspecified route of administration (dose 2), administered in arm right on 27Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing depression. Concomitant medication included fluoxetine hydrochloride (PROZAC) Oral, at 40 mg, daily for depression. In Apr2021, patient suffered from fever, chills, headache, abdominal pain and nausea. Patient stated 'worst part of it was I could not get to sleep because I thought that if I sleep through it I will get through the symptoms of vaccine. I expected some problems but not as many as I had. When I tried to go to sleep I could not sleep. I was awake for 24 hours no matter how hard I tried to go to sleep. I had taken Aleve for the pain (treatment). Nothing worked. After 24 hours I eventually was able to fall asleep. When I woke up I was weak and I was hallucinating in Apr2021 but the fever is gone and now I just feel weak and frankly I am a little angry. I had a severe reaction to this vaccine second dose and I had it within 12 hours of the injection and it really made my life miserable for 24 hours at least. I was just in misery I was not just uncomfortable I was in misery and I am really upset with it and if I had known that I was going to be this sick I never would have given myself opportunity of having 2nd shot and my concern after having 2nd shot is what's gonna happen to me down the road. I am now afraid that you cannot put this kind of medicine under my arm without having serious problems happening down the road'. The outcome of the event fever is recovered in Apr2021 and outcome of other events was unknown.
I got exposed to someone who had Covid-19 on 9/10/21. I started feeling bad on 9/13/21. The symptoms I have had have been a bad headache, no energy and not feeling very well. I have been having congestion and coughing. The 2nd day my lungs hurt but they don't anymore. I have had a real mild fever. My ears have been stopped up as well. I had a virtual appointment and will be receiving the antibody treatment in about 20 minutes.
This spontaneous report was received from a registered nurse (RN) refers to 11 months male patient. Primary reporter called and stated that the patient had received the first dose of VARIVAX (Merck) (lot # unspecified) (dose, frequency, route unspecified) as chicken pox vaccine was administered on 15-MAY-2010, prior to the patient's first birthday, and the second dose of VARIVAX (Merck) (lot # unspecified) (dose, frequency, route unspecified) as chicken pox vaccine was administered on 08-AUG-2008. The patient had titers drawn on an unspecified date, and the titers came back as negative. The patient experienced allergic reaction to the sulfonamide antibiotic (unspecified manufacturer) on unspecified date. The patient suffered Stevens Johnson Syndrome as result of the allergic reaction to the sulfonamide based antibiotic on an unspecified date. Outcome of Stevens Johnson Syndrome was not reported. No treatment was given for the events. Action taken was reported as not discontinued. Upon internal review, the event Stevens Johnson Syndrome was considered to be medically significant. Additional information has been requested.
Cellulitis and abscess of upper left arm. Severe pain, burning, aching of arm - unable to move due to pain. Arm redness and severe swelling, spread through arm. Fever, fatigue, body aches, headaches, malaise. Treatment: Clindamycin 300 mg 4x's a day for 10 days.
pt recv vax in lt deltoid (minor edema/redness);lower/posterior part of upper arm has hive-like area 3" x2" but not over site of inj;
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm.  Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
intermittent fatigue, joint pain, headache, hot flashes. Constant chest heaviness and mild shortness of breath day 3 post injection.
pt developed itchy rash on wrist w/i 20 minute, over 24 hours increase dto both wrist , both feet- still has resolving rash on feet 3 weeks. small red papules, not hives .
Developed redness, pain and swelling at injection site approximately 2 days after injection. Swelling and pain started migrating into armpit and then into breast. She was experiencing breast vein distention, pain, generalized swelling to L armpit and breast, and a lump in her axilla. The redness, pain and swelling at injection site resolved after two weeks. She noticed the pain to the L breast lasted about 1 month, but she is still currently experiencing breast/axilla swelling and does not feel like this has resolved. She also noticed chest pain and tightness in the chest about 3 weeks after injection. She is not currently experiencing chest pain today.
Patient had a CVA on 8/25/21, the day after she had the vaccine. Patient had left frontal acute infarct. Patient was given tPA and did well. Patient diagnosed with cryptogenic stroke as she has had strokes in the past.
Mom states after receiving the first GARDASIL vacc. the patient started experiencing light and noise sensitivity. When patient chews he "covers his ears". If someone speaks too loudly, patient will ran off and gets angry, or sometimes cries. Pt not experiencing anymore light sensitivity. Mom not sure when symptoms started after receiving the vaccine.
This is a spontaneous report from a contactable pharmacist who reported for a patient. An 88-year old female patient of an unspecified ethnicity received PREVNAR13. (NDC number: 0005197105), intramuscular, on 06DEC2014 at 09:30 AM. She had a history of ear infections. There were no concomitant medications. No other vaccine was given on same date along or within four weeks with PREVNAR13. No adverse event was reported following prior vaccination in patient or siblings. The patient experienced severe pain in neck on 06DEC2014 12:30, She said that later on an unspecified date in DEC2014 she experienced severe pain in her left ear. Then, she had dark yellow liquid coming out when she put a Q-tip in her ear. She had a physician visit on 00DEC2014 and when her doctor looked in her left ear, she saw blood. The doctor advised her not to tough that ear for a while. No relevant test was reported. She was improved from the reported events at the time of the report. The reporter considered the event severe pain in neck as related to PREVNAR13, causality for events severe pain, dark yellow liquid coming out and blood in left ear was unknown. The physician did not confirm the occurrence of the events reported by the patient. Follow-up (29DEC2014): Additional information reported from a contactable physician includes physician not confirmed adverse event.  Follow-up attempts completed. No further information expected.
About 25 minutes after getting vaccine, patient's upper lip was starting to feel tingly.  Pharmacist gave patient diphenhydramine 50mg.  Patient stated she had an epipen on her.  Patient stated she was ok to drive home with the instructions that if any other allergic reactions came on, to use the epipen and call 911.  On the way home, patient started experiencing anaphylaxis.  She went to a nearby fire department where they called the EMTs.  Patient was doing ok the next day when pharmacist spoke to her, but was aware to use Benadryl/epipen if any other reactions came up.
18 hrs after Dtap, IPV, comvax, prevnar pt noted to have high pitched scream and vomiting with low grade vefer to 100ax.  Vomiting and fusiness lasted for approximately 12 hrs.  Seen in office, afebrile, easily consable, well hydrated.  Recommended progressing from pedialyte back to breast milk, tylenol for fever, call prn.
1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023; bi-polar and mood disorder; suffers headaches/non-stop headaches; constant ears are ringing; it hurts/ pain on walking; my monthly Menstruation stopped; suffers from mental health; depression; 5'9" is fading away by weight loss; suffer hair loss; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FA7485) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No.: FA7484), administration date: 05Aug2021, when the patient was 48-year-old, for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "5'9" is fading away by weight loss"; BIPOLAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "bi-polar and mood disorder"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "constant ears are ringing"; DEPRESSION (non-serious) with onset 2021, outcome "unknown"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "it hurts/ pain on walking"; AMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "my monthly Menstruation stopped"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "suffer hair loss"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suffers from mental health"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "suffers headaches/non-stop headaches"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023". The patient underwent the following laboratory tests and procedures: Weight: Loss, notes: 5'9" is fading away by weight loss; 130. Clinical course: She got sick for a whole month after she was forced to take the Pfizer vaccination on Aug2021. She was disabled.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305019 same reporter/product, diff event/patient;
Expired Boostrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 1st February 2023, the patient received Boostrix. On 1st February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: A pharmacist called in to know how they should proceed after accidentally administering an expired dose of Boostrix.  Medical information was given and the details about the vaccine and patient were collected. The reporter seemed to want very specific information, even though it was explicitly stated that it was not available.  It was extremely difficult to understand the reporter in various instances which hampered the quality of the call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
This case was reported by a medical assistant and described the occurrence of itching on bottom of feet in a 49 year old male patient who received hepatitis B vaccine recombinant (Engerix-B).  On 03/09/2004, the patient received the first dose of Engerix-B.  Approximately 3 days after administration of Engerix-B, on 03/12/2004, the patient experienced itching on bottom of feet.  On an unspecified date, the event resolved.  The medical assistant considered the event to probably be related to vaccination with Engerix-B.
fever; body and muscle pain; headache; body and muscle pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Apr2021 at 7 pm after her 2nd dose, the patient experienced fever, body and muscle pain and headache. She said she still had these symptoms on the day of the report, on 03Apr2021. The patient had not recovered from the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a patient received the DTaP-IPV diluent separately and did not receive Hib/ no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA261800 and 2019SA261801.   This case involves a 12 months old female patient who received DTaP-IPV diluent separately and did not receive Hib (inappropriate reconstitution technique) of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel] Lot  UJ060AAA, ActHIB- Lot  UJ060AA (Expiry date 04-Oct-2020) on 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Jerk; Wobble; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of jerkiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced jerkiness (Verbatim: Jerk) and walking difficulty (Verbatim: Wobble). The outcome of the jerkiness and walking difficulty were not reported.   It was unknown if the reporter considered the jerkiness and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the jerkiness and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and experienced jerk and wobble so the vaccine did not work. Follow-up would not possible as no contact details were available.
LockJaw accompanied by recurring severe Spasms and seizures causing me to bite through my tongue and cheeks repeatedly...all the while with complete locked down tightness in jaw.
Moderna COVID-19 Vaccine EUA  Mild symptoms following injection:  soreness at site, mild redness, malaise X 2 days January 1:  growing redness and heat at site of injection
Redness, soreness, rash at injection site. Visible day after injection. Day 2 - rash has expanded (coverage area 3.5 in), redness and sensitive to touch.
the patient's titers being low; This spontaneous report was received from a pharmacist and refers to a 27-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date (reported also as "within 5 years"), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported) and in approximately 2019 (reported as "about 3 years ago"), the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported), both for prophylaxis.  On an unknown date, the patient's varicella titers were low. The prescriber indicated that he would like to administer the third dose due to this event, however at the reporting time, the third dose had not been administered. The outcome of the event was unknown.  The causality assessment between the event and the suspect vaccine was not provided.