chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 02Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and seasonal allergies, and the patient was allergic to dyes, and a kind of antibiotic. Concomitant medications included bisoprolol celecoxib (CELEBREX), amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate (ADDERALL), esomeprazole magnesium (NEXIUM), and multivitamin (MANUFRATURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 at 03:00, the patient woke up with heavy wheezing and a lot of coughs. He had tried and breathed shallow to not cough. Coughing lasted about an and couldn't controlled it. He took an over-the-counter allergy pill that seemed to help after about 40 minutes. He had to call in sick to work because excessive movement would get coughing again. It was reported that, at 11:00 he was breathing better. His left side of back was hurting from all the coughing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. As the result of adverse events an unknown over-the-counter allergy pill was taken as therapeutic measure. The clinical outcome of the events wheezing, coughing and back pain were recovering.  No follow-up attempts are needed. No further information is expected.
In upper R-Arm-Red down to pink very wide with swelling line from top of outside arm down and into inside of arm past elbow, burning feeling. (Still light pink-6-16-2016. Very little burning). In ER IV with Morphine and antibodies/home with clindamycin 300mg NORCO EQ/325 mg.
Information has been received from a health professional concerning a female patient "around 9 years old" who on approximately 13-FEB-2008 was vaccinated with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 659071/1475U). There was no concomitant medication. On approximately 13-FEB-2008, the patient developed a large red welt around the injection site and severe pain (location not specified). It was reported that at the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Since the Vaccine PT developed symptoms of headaches, arm pain, fatigue, nose drip, palpitations, anxiety, depression and cramping in stomach that resulted in an emergency visit to the hospital followed by Emergency appendectomy surgery.
Intussusception. Patient presented to clinic due to poor feeding and apparent discomfort. Subsequently patient had bloody bowel movement in clinic and was immediately referred to local Emergency Department (Hospitalized x 24-48 hours, treated by enema).
1 of 9 pts immunized from same lot# 366949; not same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ inj site; nodule persisted 6-8wks;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 5:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 5:22 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received vaccine past its 30 days expiry date on 28-Jan-2022 at 17:22:35. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment details were reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-AUG-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster and post herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Complaint of pain when vaccine given and states arm hurt from vaccine sight (left deltoid) to elbow.  Hurts when raises arm.  No swelling - redness or atrophy of muscle.  Called on 06/10 to report.  Talked again with patient on 06/13/2005 and she says it is getting better.  Advised to let us know if worsens or need to see PMD.
After less than five minutes after vaccine an excessive heart rate was noticeable. I have trouble checking it myself so after 15 minutes when I noticed it had not gotten better I asked the people available to check my vitals: Heart rate after sitting for 15 minutes was ~118 and blood pressure was 168/58. I otherwise felt fine so I left.
HURT; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hurt was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611888.
migraine like headaches; nausea; brain fog; phonophobia; losing my balance when walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 at 08:00 as dose 2, single (Lot number: EN6205) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: CELEBREX; ALLOPURINOL; TAMSULOSIN; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6205, administration time: 08:00 AM, location: Left arm), administration date: 15Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (disability) with onset 18May2022, outcome "not recovered", described as "brain fog"; BALANCE DISORDER (disability) with onset 18May2022, outcome "not recovered", described as "losing my balance when walking"; MIGRAINE (disability) with onset 18May2022, outcome "not recovered", described as "migraine like headaches"; NAUSEA (disability) with onset 18May2022, outcome "not recovered"; PHONOPHOBIA (disability) with onset 18May2022, outcome "not recovered". The events "migraine like headaches", "nausea", "brain fog", "phonophobia" and "losing my balance when walking" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) no clear cause; SARS-CoV-2 test: (05Jan2023) Negative. Therapeutic measures were taken as a result of migraine, nausea, feeling abnormal, phonophobia, balance disorder. Clinical course: No other vaccine in four weeks. In May2022 daily, patient had migraine like headaches began, nausea began next, then brain fog, then phonophobia, until in October, he was losing his balance when walking. He could not attend his son's wedding reception. He offered to quit his job, but his boss gave flexibility to go home when symptoms were unbearable. He was diagnosed with migraines although all 3 neurologists said it historically doesn't begin at age 66. MRI's and a trip to reveal no clear cause. He believes this was one of the numerous neurological Pfizer vaccine injuries. He was on migraine preventative med and symptom remediation. He was hoping for intermittent fasting, exercise, and Vitamin D would help. Without help, he was headed for disability and resigning his job.
-Sore muscle around injection site lasting for about 24hours -approximately 24 hours after injection I had muscle, joint and skin aching all over my body that lasted about 7 hours
BEGINNING ON DAY 5 HAD INTENSE PRURITIS OVER ENTIRE BODY, HEADACHE 5/9, GENERALIZED MALAISE AND CHILLS WITH FINE PAPULAR RASH OVER BODY, PRIMARILY NECK, ARMS, BACK WITH FACIAL FLUSHING; RESOLVED IN 4 DAYS
A registered nurse reported that a 6 month old male received Prevnar vaccine and subsequently developed fever, irritability, inconsolable crying and was not eating. No additional info was available as of the date of this report.
Dermal Hypersensitivity on the trunk; Intense burning; Intense itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of HYPERSENSITIVITY (Dermal Hypersensitivity on the trunk), BURNING SENSATION (Intense burning) and PRURITUS (Intense itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), BUSPIRONE, LEVOTHYROXINE, OMEPRAZOLE, FLUOXETINE, TAMSULOSIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Dermal Hypersensitivity on the trunk), BURNING SENSATION (Intense burning) and PRURITUS (Intense itching). At the time of the report, HYPERSENSITIVITY (Dermal Hypersensitivity on the trunk), BURNING SENSATION (Intense burning) and PRURITUS (Intense itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Urticaria. Given Deponedrol 80 mg, oral Prednisone and hydroenyzme.
Patient was given the second dose of the Pfizer Covid 19 vaccine after two weeks; This is a spontaneous report from a contactable pharmacist. A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified date for covid-19 immunization.It was reported that patient was given the second dose of the Pfizer Covid 19 vaccine after two weeks instead of three weeks. It has already been reported via agency, but caller does not have the report number. Patient was concerned about potential harm. The outcome of event was unknown.  Follow up needed, further information has been requested.
horrible joint pain in my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "horrible joint pain in my hands".  Additional information: Reported as, patient now have horrible joint pain in hands and was told it was from the vaccine. patient received two vaccines and a booster. patient hands were in constant pain like patient had never had before. patient was a surgical technologist and patient hands were patient job and now patient can barely use them. patient was 43, patient was barely able to use hands to work anymore. patient was going to lose job because of vaccine that patient was convinced and pressured and forced to take or lose my job.  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.
Rash around injection site with swelling; Rash around injection site; Fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisdexamfetamine mesilate (VYVANSE) and escitalopram oxalate (LEXAPRO); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced rash around injection site with fever and swelling. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash around injection site with fever and swelling was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EN5318), in left arm and on 11Feb2021 as dose 2, single (Lot number: EK9231) at the age of 66 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 050F21A), in left arm and on 24May2022 at 17:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOLTERODINE; VENLAFAXINE HCL; FAMOTIDINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The patient was not pregnant at time of vaccination. Other vaccine in 2 weeks was reported as yes. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (31May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: covid 19 treatment.  Clinical course: It was reported that, the patient got 4th booster on 24May2022, began with symptoms of COVID-19 on 25May2022. Stated that, contacted her healthcare provider on 26May2022 and started Paxlovid that evening. Stated that, the patient took full 5 day course. Felt better but still lethargic and tested negative on 31May2022. On 02Jun or 03Jun2022 began to feel exhausted and had headaches. On 05Jun, felt more exhausted and had headaches. On 07Jun2022, nasal congestion, exhaustion, headache, coughing, sneezing. Worse on 08Jun2022. Dyspneic with speech. No fever. Diarrhea throughout past 2 weeks. Called PCP who ordered Paxlovid again.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Pt accidentally given Pediarix rather than Pentacel.  No adverse outcomes reported by parent.
period lasting 2 months from 5/21/21 until present 7/9/21
Patient experienced symptoms (fever, nausea, chills, etc.) one day post vaccine and recovered. More than a week later on 04/09, she experienced rash and itching at injection site as well as extreme nausea and vomiting.
After receiving the flu shot I felt pain in my arm at the injection site.  This is normal. I've had a flu shot every year for at least the past ten years. However, the pain persisted and after a few weeks spread to my shoulder.  I called my doctor two or three times within the first month and was told to take Naproxen and use ice or steam on the area.  My arm became stiffer.  I made an appointment with this internist plus another appointment with a doctor outside of Northwestern.  I was told by my doctor to continue taking Aleve and icing the area and if it didn't improve, go to physical therapy.  I also did blood work at the other doctor's office, which proved nothing.  I went three times to a chiropractor who did massage, electronic stimulation, accupuncture, ultra sound on my arm with no real improvement.  I started with an integrated internist who sent me to an orthopedic doctor and a neurologist (appointment next week).  The orthopedic doctor ordered an MRI which showed a "frozen Shoulder".  He told me to take Naproxen twice per day and go to physical therapy, which I've been doing 2-3 times per week this month so far.  There is some improvement, but I still have pain and limited mobility in the shoulder.
Patient arrived at pharmacy for 2nd Moderna vaccine with father and mother. Mom had to remain in the car so father and son switched back and forth between being at the pharmacy and in the car. Patient confirmed incorrect name when asked by RPhT for injection; the name and number in dose series was relayed to the patient, Pfizer 2nd dose. 2nd MODERNA dose was due but miscommunication caused the patient to receive Pfizer instead of Moderna.  The mistake was explained to patient who thought his first dose was Pfizer which is why he did not realize the technician had the wrong patient. Patient made aware he does not to complete either series.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around 01-NOV-2016, the patient was inoculated with ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: The prevention of shingles. Shortly after receiving ZOSTAVAX vaccine, the patient suffered tinnitus and hearing loss. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review hearing loss was considered medically significant. Hearing loss and tinnitus were reported to be disabling. Additional information has been requested.
My shoulder began hurting with a shooting pain running down it on September 7th. I could not life my arm up and the pain shot down to my fingers. I was having difficulty lifting my arm above 90 degrees. My shoulder was injected with cortisone and the orthpaedic doctor diagnosed me with tendonitis of the shoulder. I was unable to life my arm above 9o degrees until it was injected on September 21, 2021
Following the injection, I made my way to the observation room to wait for 10 minutes. After about two, my left arm began to get extremely hot and I called the nurse in the room over. I began to ask her if it was a normal side effect and began to lose my vision and hearing while talking. I passed out and was wheeling to the side of the room where the doctor was. Upon waking up (after 2/3 minutes) I threw up. The doctor took vitals and such and said everything looked okay. After about 15 minutes I was able to stand and head home.