chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complaint of difficulty swallowing and tightness in throat.  Said she had to concentrate to be able to swallow.
Starting maybe around May 2021, I started feeling really tired and exhausted. I started having what I felt was an ear infection in the right ear and heard a strange noise in my ear "like a rumbling of a motor" that you hear on an airplane. I had an exam and they said that the eustachian tube was collapsed. I was put on an antibiotic and a decongestant. I was on the antibiotic for 10 days-2 weeks. It came back 2 other times: once a few months later and once after receiving the third dose. After the rumbling went away, what remained was some Tinnitus in both ears. After the booster dose, the tinnitus persisted and to this day its bothersome, especially when I am trying to sleep. Also, my hips hurt whenever I lay down on either side of my body. As long as I readjust myself to take pressure off the hip, the pain goes away. This started around the same time as the rumbling in my ears. It comes and goes randomly. Nothing seems to instigate it.
DELUSIONS/THE IMPOSSIBILITY OF DISTINGUISHING BETWEEN REALITY AND DELUSIONAL DREAMS; PAIN; FEVERISH; This spontaneous report received from a patient via social media (Janssen ) via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced delusions/the impossibility of distinguishing between reality and delusional dreams, pain, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feverish, pain and delusions/the impossibility of distinguishing between reality and delusional dreams was not reported. This report was non-serious.
Patient sitting in chair of observation area.  Suddenly felt dizzy.  Observation staff RN brought patient to triage.  Patient states she felt dizzy.   Lightheaded, nauseated, started vomiting, vomited two times. Slightly diaphoretic. She is warm and dry BP elevated.  Patient started to scratch back, lower and mid back.  noted with scattered raised red rash.  Patient drowsy and altered mental state gave Benadryl.   Patient to triage cot, cold pack applied V.S and N.S. measured.  Charge nurse present.  Benadryl 50mg IM given per protocol.  EMS activated.  report given to paramedic crew.  No further vomiting.  V.S.S. SR on monitor O2 sat 99%.  Remains orientated to name, place and date.  Cannot open her phone or recall family emergency number.  Patient sent to hospital with EMS.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathic pain and Menopause. Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Menopause, GABAPENTIN for Neuropathic pain, VITAMIN D3 for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 15-Feb-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 29-Jul-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 06-Aug-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 19-Nov-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 25-Nov-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 23-Dec-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 29-Dec-2020, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 06-Jan-2021, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 27-Jan-2021, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive. On 09-Feb-2021, SARS-CoV-2 test: inconclusive (Inconclusive) Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient has not received any treatment.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 12:00 as dose 1, single (Lot number: El1284), in left arm and on 27Jan2021 at 12:00 as dose 2, single (Lot number: El1282) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 009c21a), in right arm for covid-19 immunisation. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) positive, notes: On 19May2022 he got sick again, tested positive by antigen again; (25May2022) positive, notes: He finished on 25May2022. He is still testing positive for COVID antigen; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID treatment). Subsequently, the product quality complaint group via CITI reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL1284, fill lot EL1282, the bulk formulated drug product lot EL1280. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
strong metallic taste in his mouth; strong metallic taste in his mouth; 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.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown, Lot Number: Not provided), administration date: Sep2021, for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Not provided), administration date: Feb2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not provided), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), PRODUCT TASTE ABNORMAL (non-serious) all with onset 28Apr2022, outcome "unknown" and all described as "strong metallic taste in his mouth".  Additional Information: The patient had strong metallic taste of all food whether it was ice cream or dill pickles, they all taste the same and this event was ongoing. Their family doctor could not see anything wrong in their mouth or tongue that could cause this. They called to check if this was a side effect of the Pfizer product Covid Booster Shot and if so how long it is expected to last if this was temporary or permanent. Caller was unwilling to complete this report, this is the 3rd department they have been given the number to call or transferred to and they just wanted their inquiry addressed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Abnormal uterine cramps; nausea; confusion; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2022 15:45 (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing), notes: other medical history: Celiac, CPTSD; "CPTSD" (unspecified if ongoing), notes: other medical history: Celiac, CPTSD. There were no concomitant medications. Past drug history included: Gluten, reaction(s): "Allergy", notes: known allergies: Gluten. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer , prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details, prev dose administration date=20Apr2021 , prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 20Apr2021, when the patient was 19 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer , prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details, prev dose dose number=1), for Covid-19 Immunization. The following information was reported: UTERINE SPASM (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "Abnormal uterine cramps"; NAUSEA (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "nausea"; CONFUSIONAL STATE (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "confusion"; DIZZINESS (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of uterine spasm, nausea, confusional state, dizziness.  Additional information: Patient reported facility type where the vaccine administered was Pharmacy or Drug Store. No other vaccine received in four weeks of prior to the vaccination. No other medications taken in two weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt was administered a PENTACEL (DTAP, Polio, HIB) and a HIB vaccine at the same time. Pt showed no reaction.
Patient fainted right after received the shot and regained her conscious 2 seconds later.  She was needle phobic according to mom, but she did not mention that to the vaccinator.  Patient drank a glass of orange juice and went home 30 minutes later.  She was doing find
My arm hurt a lot right after the shot. A few hours after like about 5 my entire  right side went numb and I couldn?t feel it.  I also get intense headaches everyday after I got the shot. I was also very tired for the next 3 days.
Patient reports becoming nauseated upon waking up.  She went to the bathroom and the reports waking up on the floor sometime later.  Nausea continuted after the episode.  Upon presentation she was fatigued and nauseated.
Administered following vaccines; Tdap, Hep B, Hep A and meningitis and patient passed out in chair. Was not able to give MMR- used ammonia inhalant and patient came around- was pale and sweating. Pt. ambulated to table. Pt. vomited several times-called med life ambulance. They arrived about 10:25-lelft with patient at 10:46am.
react to MMR vax given 17MAY94; 26MAY94 t103.2, lethargy 27MAY94 devel heavey rash on trunk of body some on extremities/face; rash faded 2-3 days;
This case was reported by a physician via sales rep and described the occurrence of fatigue in a 54-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Vitamin B12, FERREX, DEPLIN, ESTRACE, zoledronic acid, calcium and magnesium. In June 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown. The reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was taking some medications at the time she was given the vaccine, FERREX 150 Forte Plus 50-100 mg capsule, DEPLIN 15 15-90.314 mg capsule, Vitamin B12 100 mcg tablet, ESTRACE 0.1 mg/gm cream, Zoledronic acid 5mg/100ml solution (given months before the vaccine), calcium 600mg tablet, magnesium 300mg tablet. The patient was seen by physician about 6 weeks after receiving SHINGRIX, for continued fatigue and general body aches. Both reporter and patient think that her symptoms were due to the vaccine.
Patient said one week after his first dose he experienced vomiting and diarrhea that lasted two days. He has reason to believe it may have been food poisoning, however, and recovered at home.
Patient reported getting an itchy rash around her neck the evening of 11/3/20. She used lidocaine ointment which helped but said the rash came back. On 11/6/20 @ 5:15 pm after speaking with patient, she said the rash is no longer itching and seems to be clearing up. She had no difficulty breathing or weakness.
DIARRHEA, RASH (ARMS, CHEST, ABDOMEN, AND BACK), RASH TO LEFT THIGH AROUND INJECTION SITE, LOSS OF APPETITE
10x6cm area of erythema & induration. Dx. cellulitis. Rx KEFLEX 500bid x 7d.
Patient reported localized pain at the time of the injection, she massaged it to reduce the pain (I didn't realize). Feelings of faintness; at night time electric jolts on nerves in toe, legs; recovered the following day.
Redness, swelling. Tx. Cold compress, Nsaids, Benadryl, Keflex 500 qid x 10d.
per ED note: 58-year-old male presents emergency room with complaints of cough and shortness of breath that has had over the past 3 days.  Cough is productive of yellow phlegm.  Patient states he has had previous episodes of pneumonia.  Patient is normally on home O2 of 3 L and was found to be a 9% on his home O2 of 3 L.  Patient states he developed a fever today.  Patient admits to central chest pain with coughing.  Patient states he has occasional wheezing.  No abdominal pain nausea vomiting or diarrhea.  Patient does complain of bilateral lumbar back pain and right side pain.  This is also been present over the past 3 days.  Patient admits to having urinary urgency to the point that he cannot make it to the bathroom in time before he urinates on himself.
2 weeks after receiving Varivax, has broken out in mild case of Varicella.
This spontaneous report as received from a medical assistant refers to one unidentified patient of unknown age and gender. It was reported that on an unknown date the patient was vaccinated with an improperly stored PEDVAXHIB (lot number and expiration date not reported) (dose and route not reported), that were stored as low as 30F on multiple occasions. Concomitant therapy was not reported. No adverse effect reported. This report is linked to MARRS 1305USA001150. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and h1n1 influenza. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were unknown. It was unknown if the reporter considered the vaccination failure and h1n1 influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The healthcare professional reported that they had the patient who received the FLUARIX QUADRIVALENT 2018-2019 season that was just confirmed with the flu. On an unknown date, the patient underwent lab test resulted strain Novel 2009 H1N1 positive. This case was considered as a suspected vaccination failure case as the time to onset for influenza were unknown. The reporter was unsure if this was a vaccination failure or not. Lab Comments: On an unknown date, the patient underwent lab test resulted strain Novel 2009 H1N1 positive.
Allergic to thiomersal; Rash; This spontaneous case was received on 08-Jan-2021 from physician via Med Communications (reference number: SEQW21-00113) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported. The patient's past vaccinations included Flucelvax Quadrivalent on 25-Oct-2018 and Afluria Quadrivalent on 04-Oct-2019 for flu prevention, after which the patient developed rash both times.  On 24-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed rash and discovered that she was allergic to thiomersal.   The outcome of the events was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100471 and 202100472 (the same patient).  Company Comment: A female patient of an unknown age developed allergy to chemicals (reported as allergic to thiomersal) and rash after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology is unclear, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A female patient of an unknown age developed allergy to chemicals (reported as allergic to thiomersal) and rash after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology is unclear, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
knot on lt deltoid came up-rash appeared-lt wrist & hand swelled w/ 2+-3+ edema;no SOB, no nausea, no vomiting;has occasional h/a;
Patient is 17 years old but received a Moderna COVID19 vaccine at a school based clinic.
Pt was given school shots including IPV, DTAP, and MMR on 3/15/06. Pt had localized redness and edema at injection site of DTAP. Grandmother took pt to ER due to this. Swelling was marked at ER and grandmother was instructed to watch for more swelling.
Headache, Myalgia, Arthralgia, Fever, L arm injsite pain bump lasting 48 hours,, as well as above symptoms. Narrative:
Two days after second shot frequent urination as if I had a UTI, did not have a UTI symptoms were often on for the last two months. Had frequent Jaren before but not as bad after second shot.; Two days after second shot frequent urination as if I had a UTI, did not have a UTI symptoms were often on for the last two months. Had frequent Jaren before but not as bad after second shot.; This is a spontaneous report from a contactable consumer or other non-health care professional reported for herself. A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 16Jun2021 at 15:00 (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. Medical history included ongoing anxiety, ongoing depression, food allergy, ongoing obsessive-compulsive disorder, Wisdom teeth removal on 02Jul2016. Concomitant medication included sertraline hydrochloride (ZOLOFT) within 2 weeks. The patient previously took amoxicillin and experienced hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0185, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 26May2021 at 15:00 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. On 20Jun2021 at 12:00, the patient experienced two days after second shot frequent urination as if he had a urinary tract infection, did not have urinary tract infection symptoms were often on for the last two months had frequent Jaren before but not as bad after second shot. Treatment was received in response to adverse events with Cather for urine test. No other vaccine was received prior to vaccination within 4 weeks. The patient stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.