chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BIVALENT PFIZER COVID VACCINE GIVEN AS DOSE 1 OF PRIMARY SERIES RATHER THAN MONOVALENT
Arm was extremely sore for several days and sore to touch for a week. It seemed to subside and then soreness returned and I incurred tenderness in lymph nodes under arm. There is now a rash measuring approximately 4 inches x 2 inches at the injection site.
No reaction  vial was past the 12 hour expiration- vial was opened/punctured on Friday Nov 18th, 2022
03/01/22 presents to ED for "generalized weakness, bradycardia". PMHx of "insulin-dependent diabetes, CKD, CAD"
At the time of the injection, there was a slight burning sensation, which resolved within a day. Day 2, bruising began. Today, the 8th day, I woke up with a large red rash in the area of the injection. The rash is approximately 3-5 inches in diameter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jun2021 as dose 1, single (Lot number: EW0168), in left arm and on 17Jul2021 as dose 2, single (Lot number: EV0202) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known_allergies pineapple" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM, start date: 01Jan2018. Past drug history included: Codeine, reaction(s): "known allergies : Codeine"; Asparaginase, reaction(s): "known allergies :asparaginase"; Xanax, reaction(s): "known allergies :Xanax".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Pxizer Treatment start date was 13Dec2022 and stop date was 14Dec2022.; Sender's Comments: The contributory role of the suspect vaccine to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Myalgia & Arthralgia Narrative: body aches, chills, night sweats for 48 hours  Other Relevant History:
Client reported a breakthrough case of COVID-19 diagnosed by a medical provider after receiving 2 doses of Moderna on 03/07/21 and 04/07/21 from this ARNP.
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an adult male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2009, the patient was inoculated, by a physician, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On or about 28-SEP-2011, the patient was treated, by other physician, for the onset of a severe vesicular rash, which was diagnosed as acute zoster. It was prescribed FAMVIR for management of his painful symptoms and chronic pain (post herpetic neuralgia). The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure). As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury, pain and post herpetic neuralgia was unknown. The reporter considered all the events to be related to ZOSTAVAX.
Started with fever, then projectile vomiting after every feeding. Continued to get worse, keeping very little milk down, then diarrhea started. Seemed to get slightly better on Sunday, then worse again Sunday night and Monday (today). Still projectile vomiting as of right now.
Patient developed right arm lump where she received the Flucelvax and COVID-19 vaccine. It has been painful and itching since day of administration (approximately 1 month at this point).
Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Modern a COVID-19 Vaccine EUA  Nausea, headache, body aches, fatigue
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for  two days.  Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE COMPLEX PARTIAL EPILEPSY, RECURRENT
She is having trouble seeing out of the left eye; face was fluffy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0154, expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was having trouble seeing out of the left eye and her face was fluffy. The patient got Pfizer vaccine, the first dose and was having an adverse reaction. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:13 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) 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 allergies were reported as unknown. It was also unknown if the patient was diagnosed with or tested positive for COVID-19. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was minus 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. Total 280 patients received Moderna COVID 19 stored at minus 82 degrees Fahrenheit.  No treatment information was reported.   This case was linked to MOD-2021-402935 (Patient Link).
High Fever (102.8). Lethargy. Headache and Chills.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number LB7NS, expiry date unknown) for prophylaxis. Previously administered products included influenza shot (received every year with no problem). In September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In September 2018, less than a month after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced extensive swelling of vaccinated limb and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site pain were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling and pain from injection site almost down to her elbow. The patient was aware of the reactions but wondered why. The patient had a lot of sensitivities to different things and the patient would like to know how the Flu shot was made, straight up, all the details, how it was grown, in what type of matter and exactly what is added to it, every step and every product added to it or that it touches.
patient received a 2nd Fluzone HD dose for the year, 1st on Septmeber 18th 2023 . no reaction at this time will follow up with patient during the week
Extreme fatigue and muscle/body aches for 48 hours post vaccine.  The aches have subsided somewhat but I still feel very tired.  Excessive sleeping.
neuropathy in my left foot; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced neuropathy (Verbatim: neuropathy in my left foot) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported.   It was unknown if the reporter considered the neuropathy to be related to Shingles vaccine.     It was unknown if the company considered the neuropathy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received one dose of Shingles vaccine and experienced neuropathy in his/her left foot.  Follow up was not possible, as no contact details were available.
Swelling at the site of the injection that started nine days after injection.. Area is also warm and red. Muscle pain in arm.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
It began with a problem gripping and twisting with my right hand about 2 weeks to 1 month after the vaccine I had in June.  As it progressed I developed a balance and gait issue and movement started to slow and gradually became full of tremors when attempting to move (especially my right arm).  By January I was fully diagnosed as Parkinsonian.
Severe pain and swelling in the shoulder, neck, and back, fever, nausea, vomiting lasting two days, limited range of motion in right arm due to pain at vaccination site lasting since 10/17/2011.
Patient received the vaccine 6/7 during the day, that evening into the next night he developed subjective fevers and chills. Overnight, he had several episodes of NBNB emesis and had some chest pain. By 6/9, his fevers, chills, and chest pain resolved. However on 6/10, he began having chest pain again; this pain was in the middle of his chest, without radiation. It was worse with laying flat and walking around. He went to his pediatrician, who obtained an EKG and checked some labs. Patient had an elevated troponin of 2.04, CKMB of 12, ESR of 31, and BNP of 39. His EKG was normal but he was directed t come to the emergency room for further workup. Repeat troponin that evening showed up trending troponin of 4.77 and patient was admitted for further workup and monitoring. His chest pain resolved and his troponin levels downtrended through the next day (4.77 -> 2.3 -> 0.4). Patient was monitored on telemetry and had no events of arrhythmia. Echocardiogram obtain did not show any evidence of decreased cardiac function. Patient was scheduled to under cardiac MRI (at this time, results of MRI are pending)
Swollen lump found under the right armpit 5 days post vaccination; sore and painful to touch; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration in arm right on 01Feb2021 13:00 (at the age of 32-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient has not had covid prior vaccination. The patient was not tested covid post vaccination. The patient's concomitant medications were not reported. The patient previously took ibuprofen for an unspecified indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swollen lump found under the right armpit 5 days post vaccination which is sore and painful to touch on 06Feb2021 18:30. At first discovery, the size of the lump was about the size of a quarter. The lump has decreased in size 2 days later, however still sore. The patient did not receive any treatment for the events. The outcome of event was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning a female patient (age not reported) who on 16-OCT-2007 was vaccinated in the right arm with both a dose of PNEUMOVAX 23 (lot # not reported), and a dose of influenza vaccine (manufacturer not specified). After an unknown duration of time, the patient developed redness at the injection site that spread down her arm. On 19-OCT-2007, the patient returned to the office and was diagnosed with cellulitis. Treatment included an injection of ROCEPHIN, and a prescription of LEVAQUIN. On 22-OCT-2007, the patient returned to the office, and was advised to "ice the area." At the time of this report, the outcome of the event was unknown, and additional appointments had been scheduled. Additional information has been requested.
Dizzy, lightheaded, pain, excessive fatigue, memory loss. After first shot it lasted for about 2 1/2 weeks. After second shot, it has lasted a week so far.
Extreme dizziness; nausea; It felt like the worst motion sickness all day; Disorientation/Hard time with orientation; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 04Feb2021 09:00 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 05Feb2021 09:00, the patient experienced extreme dizziness, nausea, it felt like the worst motion sickness all day, and disorientation/hard time with orientation. No treatment was given as a result of the events. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.
Cellulitis at injection site. Keflex 500 mg by mouth 4 times a day for 10 days. Elevate, warm pack.
fever, fatigue, headache, chills, body aches, shortness of breath, nausea
No adverse event; Nurse reported that an expired VAQTA was given to a patient today.  No additional AEs were reported, No further information provided.  No PQC.; This spontaneous report was received from a registered nurse, and refers to a 13-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions, concomitant therapies and medical history were not reported.  On 08-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscularly, in the right tight, 0.5 milliliters once, lot #W006214, for prophylaxis.  The administered dose of hepatitis a vaccine, inactivated (VAQTA) expired on 04-MAR-2023. The vaccine was obtained with private funds.   The physician was informed. No adverse events were reported.
fatigue; muscle sore (arm); muscle sore (arm); This is a spontaneous report from a contactable other hcp (patient). A 41-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Jan2021. It was reported that the patient had only Fatigue and Muscle sore (arm) were the side effects. The patient consider the Pfizer product had a casual effect to the adverse event. Outcome of the events was unknown.  Information on lot/Batch number has been requested.
This spontaneous report was received from a physician via company representatives and from a support services director, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There were no concomitant medications provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "PFS 6x1 10mg/1ml w/o SftySyr" (dose, dose number, route and anatomical location were not reported) lot # J010164 and expiration date 18-APR-2017. On an unspecified date, the RECOMBIVAX HB had 2 temperature excursions of 9120 and 6660 hours. The lowest recorded temperature was 20 degrees Fahrenheit (-6.666666667 degrees Celsius). No adverse effects reported. No product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "Refrigerator (R)". This is one of several reports received from the same reporter. Addition information has been requested.
Chills for 3 hrs Fever 102 and higher for 36hrs large lump and redness of arm from elbow to shoulder day 5 rash on injection arm has spread to underarm and breast  has spread to other armpit. looks like shingles, itchy and painful
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Somewhat overweight, otherwise, none" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 15Jan2015, stop date: 17Dec2022; OMEPRAZOLE, start date: 08Apr2016.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Five days after finishing paxlovid course my Covid symptoms returned. Same symptoms as before, sinus congestion, mild cough, headache. Patient took medication from 17Dec2022 to 21Dec2022. No Known allergies.  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.