chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 3 vaccines Pfizer 4/29/21 Lot# Ew0176;  Moderna 11/15/21 lot# 067F;  Moderna 4/26/22 Lot# 001M21A
This spontaneous report was received from a pharmacist and refers to a 41-year-old an immunocompromised patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. According to the reporter, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, anatomical location, route of administration, lot# and expiration date were not reported) on an unknown dates (also reported as "at 41 years and 47 years"). No adverse symptoms reported.
Dizziness, lightheaded, tingling in arm, vision going white, sore throat - within minutes of injection - propped feet up, - pt improved. Called 911, just in case.
Developed vesicular rash on legs. Rash has spread along legs & on arms and on face. Patient afebrile & does not appear ill.
Red, raised, painful and itchy at injection site. I noticed this within a few hours of receiving the injection.  Around noon the next day, I started having horrible body aches, raised temperature (99'), fatigue and dizziness. I am on day 3 and the only change is that body aches are now slight and temperature is gone. Though I am still sweating for no reason, arm is still raised, red, itchy and painful and I'm still somewhat dizzy.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of ROTATEQ, oral, lot # L008996 and expiration date 11-NOV-2015. No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
h/o adverse reaction to J&J vaccine. Mast Cell specialist recommended mRNA vaccination in graded fashion in facility capable of treating anaphylaxis. Administered 0.1 mL increments of Pfizer monovalent vaccine with 30 minute interval X 2 doses. 20 minutes after second (of planned 3 doses), developed hypertension, flushing, itching, eye swelling & severe abdominal cramping. Procedure aborted. Treated with total of (2) doses epinephrine 0.3mg IM, Pepcid 40 mg PO, Diphenhydramine 50 mg IV. Transferred to emergency department for continued care. Admitted to ICU with epinephrine drip for recurrent symptoms.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
2 days after vaccine, started the extreme tiredness and that's continued thru current day, day 2 nausea ,vomit, lasted a few days , since Vax head foggy thru current day, Nov 1st exposure from co worker who tested positive for covid, I started feeling a cold coming on Nov 4th and went to get a covid test which came back negative on Nov 4th, Nov 6th started to lose voice in the early afternoon and having coughing episodes since the 5th Nov,  by end of day Nov 6th lost voice completely and lost Taste and smell completely which is still ongoing to current day , everyday since Nov 6th have had foggy head , extremely tired ,headaches have occurred daily since vaccine,  and since Nov 6th not able to feel warm liquid when swallowing
Swelling at injection site; Rash at injection site; warmness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site) had resolved and INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
stinging all over is the same, especially with the back of her neck; rash; Felt like needles sticking; itchy skin; Initial information received on 05-Apr-2021 regarding an unsolicited valid  non-serious case from a non health care professional via Media Information (inquiry number 00547585).  This case involves female patient of unknown age who experienced stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   In 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that caller stated she had the 2020 FLUZONE HIGH DOSE and had a terrible reaction that the company warns about. Caller stated she called several weeks ago and reported adverse reactions. Caller wanted to know what was in part 2 of the flu shot. Caller request the exact name.The caller wants to know the ingredients of the Fluzone HD Quad and said that she had called about having an extreme reaction to the second part of the Fluzone HD Quad injection. She stated during the call that the stinging all over was the same, especially with the back of her neck. She wanted to know what in the Fluzone HD Quad was she allergic to.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the patient did not recover  from the event pain , while the outcomes were unknown for rest of the events.  There will be no information on the batch number for this case.
pt recv vax & by the evening temp reached 104.0;pt had body aches & severe swelling of arm;It became immobile;sx lasted 5-7 days;pt was given APAP to bring temp down;cool compresses to the site;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 96th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
This spontaneous report was received from a nurse and refers to a 66 year old patient of unknown gender. On 02-JUN-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported, lot # K010523 with expiration date: 25-FEB-2016). No adverse effects reported. Additional information has been requested.
high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  An adult patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) for 1 day as dose 2, 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 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller would like to know if after the 2nd dose the patient had a high fever would that be a reason to not get the booster dose.  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.
On 1/28/21, I experienced severe lower abdominal pain with extreme nausea; no vomiting or diarrhea but severely weak after. Again on 2/6/21, severe lower abdominal pain with subsequent weakness. The symptoms last about 4-6 hours each time.
pt recv vax 14APR97 & serum liver enzymes including bilirubin, were nl on 30APR97;5MAY97 a routine urine sample was collected & elevated bilirubin was noted;bilirubin level will cont to be monitored;plan is to give the vax dose 2;
5 minutes after the administration of the Pfizer vaccine, the patient became extremely anxious and started scratching everywhere stating that she was itchy everywhere and could not breathe. She stated that her throat felt itchy and was closing. At this time, VS were unable to be obtained because the patient was flailing her arms. Her skin was red where she was scratching , but hives were not observed. A Code was called for assistance. An Epipen was administered and the patient began to vomit. Benadryl 50 mg was administered IM. She was still extremely anxious and crying and scratching her entire body. Examined by physician who noted no throat swelling and no hives, but she continued to state she could not breathe. Paramedics arrived. VSS...transported to hospital where she was seen and treated in the ER with Solumedrol and discharged with Benadryl.
I was afraid to receive any of the none PDA approved vaccine shots because of side effects. After my 1st dose i felt pain later that day and i had diarrhea. My left arm was sore and my left lung hurt worse. I know the arm is supposed to hurt but not my lung.  After two days my arm didn't hurt as much but it's day three and my lung still hurts so bad. With every move i make my lung slows me down. I haven't been able to do my daily task or sleep at night. I just want the pain to go away. My  family and friends are scaring me by saying that i might have a blood clot developing in my lung. Today i have taken Tylenol to ease the pain and i made my own ice pack. If there's no change by morning i'm going to the ER. This pain makes me not want to get my second dose.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated that he had the Pfizer COVID 19 vaccine and right after his last report with V-safe, he tested positive for COVID. His doctor has put him on Paxlovid. The patient asked do you have a similar reporting program for paxlovid, like V-safe.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I started to have pain under my left arm and my lymph nodes under my arm started to swell the next day and the pain and achiness was increasingly bad for about 4-5 days. The pain and achiness lingered for about 3 weeks, the pain finally subsided and went away.
Patient call to say that the evening of the shot , she experience extreme jerking of the body  during  the night . In the morning this condition stopped
Clot blood; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced clot blood on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, tingling in upper extremities, severe arm pain Narrative:  Other Relevant History:
I went to Pharmacy the morning of 12/1/14 for a routine flu vaccine.  The vaccine was administered high into my left shoulder.  I did not think much of it at the time, but by early afternoon I began to experience pain and I was barely able to move my arm.  I receive the flu vaccine every year and I attributed this to normal muscle pain associated with the vaccine. By Wednesday December 3rd, my pain had increased leading to lack of sleep at night and I was unable to perform simple tasks that required moving my arm.  I called my physician informing her of the issue and she told me it could take 7 to 10 days to heal if a nerve was hit.  On December 11th, I made an appointment with my physician since the pain was getting worse and my range of motion was more limited.  She was alarmed to see bruising on the upper part of my shoulder from the needle and informed me that this was not the proper place to administer the vaccine.  It was injected above the muscle in the area of the bursa. She was also concerned that this pharmacist was improperly trained on administering injectables and urged me to contact the pharmacy immediately.  I underwent xrays and an MRI to determine if any structural damage occurred to my shoulder.  I am currently undergoing physical therapy to alleviate pain and increase the range of motion in my shoulder.  Pharmacy did not return my call seeking assistance in reporting this issue.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD lot # M00152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager). This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289666, 2018SA289688, 2018SA289640, 2018SA289651, 2018SA289702, 2018SA289731 and 2018SA290377, same reporter. This case involves a 6 years old male patient who received IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPV (VERO) lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. 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.
This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on arm left on 06Mar2021 01:00 PM (age at vaccination: 53 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included psoriatic arthritis (I have psoriatic arthritis) and known allergies to Shrimps and opoids. If other vaccine in four weeks and other medications in two weeks was reported as no. The patient Concomitant medications was reported as none. COVID prior vaccination was reported as no. COVID tested post vaccination was reported as yes. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on 27Mar2021 01:00 PM (at the age of 53 years) as DOSE 1, SINGLE for COVID-19 immunisation and reported that I have psoriatic arthritis and after the first shot I had pain and swelling. It was reported that he had psoriatic arthritis and after the first shot he had pain and swelling that he thought was just a bad patch, after the second he was in so much pain that got worse by the day and his feet swelled to the point where he could not put on shoes and had difficulty walking, his whole body was riddled with skin blemishes that he never had before but like the pain and swelling were extreme versions of his preexisting condition. He was in so much pain he cannot lie. He was scared. This was all because of the vaccine making his condition rage in his body. Several doctors said they have seen this sort of amplification of existing symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit.The lab test included SARS-CoV-2 test(nasal swab): Negative on 01Apr2021. Therapeutic measures were taken as a result of events and treatment included Acupuncture, chiropractic, pain meds, Humira.The outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.
p/vax pt devel urticaril appearing lesions 3 on lt elbow, 2 on lt knee which persisted in same location x >2 days + bronchospasm;pt does have hx of bronchospasm & had URI sx which were improved @ time of vax;
Initial report was received from a consumer through another manufacturer on 31 October 2012 under service request number 1-5680231899. A 78-year-old female patient had received an injection of Influenza Vaccine manufactured by Sanofi Pasteur (lot number, route, site and date of administration not reported) and two days later developed shingles. Treatment included Prednisone and an antiviral medication. No additional information was available. Outcome was not reported. Documents held by sender: None.
Cellulitis tx with 1 gram ROCEPHIN IM. BACTRIM 4 tsp PO BID x 10 days. KEFLEX 13 mL PO BID x 7 days. 2 trips to emergency room. Ultrasound done.
facial flushing; face felt warm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (facial flushing) and FEELING HOT (face felt warm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FLUSHING (facial flushing) and FEELING HOT (face felt warm). On 11-Feb-2021, FLUSHING (facial flushing) and FEELING HOT (face felt warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extremaly swelling glands on the neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Extremaly swelling glands on the neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (Extremaly swelling glands on the neck). At the time of the report, SWELLING (Extremaly swelling glands on the neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reported. Treatment details was not reported by the reporter.   Reporter did not allow further contact