chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in the macula; Optic Neuritis; central loss of vision to left eye; ischemic optic neuropathy; myalgia; headache; fever; pain at injection site; This case was reported by a consumer and described the occurrence of optic neuritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced optic neuritis (serious criteria GSK medically significant), central vision loss (serious criteria GSK medically significant), ischemic optic neuropathy (serious criteria GSK medically significant), macular swelling (serious criteria GSK medically significant), myalgia, headache, fever and injection site pain. On an unknown date, the outcome of the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain were unknown.   It was unknown if the reporter considered the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain to be related to Shingrix.  The patient received the Shingrix vaccine on 12/17/2018. For three (3) days following the vaccine, The patient was ill (myalgia, headache, fever, pain at injection site) and experienced loss of vision in his left eye on 12/24/2018. The patient suffered from swelling in the macula and was ultimately diagnosed with ischemic optic neuropathy/optic neuritis. The patient's treatment regimen has included steroids, which provided some improvement. He has yet to regain his eyesight and the prognosis is permanent vision loss.
headache, nonproductive cough, chills, shortness of breath, body aches, ear pain, sinus congestion, post nasal drainage, chest congestion, ear fullness, starting on 10/2/21, recent travel
pt recv vax 22AUG95 & lt arm was red, warm & swollen noticed by grandma the next morning; no fever; arm was red down to elbow; pt was brought to ER on 24AUG95; T101; took Motrin & was better the following days; dx allergic pertussis; foll;
shingles or herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) in 2016, as prescribed and/or administered by physician at a Health Center for the long-term prevention of herpes zoster or shingles. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician at the Health Center, for shingles or herpes zoster (onset date not provided). As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # J015378, expiration date: 09-APR-2016) (dose, route and strength were not provided). Concomitant medication was not provided. No adverse effects were reported. It was also reported that temperature was -0.1 degrees C, time frame was 15 minutes and it was not previous temperature excursion. This is one of several cases from the same reporter. Additional information has been requested.
Seizure less than 24 hours after GARDASIL shot. Happened in the shower. Fell to the floor.
Patient started developing rash on 8-19-19, concerning Mom for Chicken Pox Virus. Patient seen in office 8-20-19
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen"; Phenothiazine, reaction(s): "Known allergies: phenothiazine"; Torecan, reaction(s): "Known allergies: torecan"; Phenergan, reaction(s): "Known allergies: phenergan"; Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19  and The suspected drug cannot be ruled out.
Patient was working her shift and came to the clinic for her COVID-19 vaccine on Sunday, May 23, 2021.  She stopped by the pharmacy today stating she was feeling really dizzy and nauseated.  Note; we had the patient take a chair outside the pharmacy due to the dizziness, she called someone to pick her up from work as she did not feel safe to drive.  It was recommended that she see a physician.  Also note; today the white of her left eye was bright red, she stated she poked herself in the eye by accident.
About 2 1/2 hours after injection I started getting hives and a general feeling of illness.   Hives were whole body including head and bottom of feet.   I had them worse in the beginning but were much better as the days went by.  They lasted about a week.
Itching, swelling at injection site, pain, heart palpitations, lymph node swelling
impaired responses to the pneumococcal vaccine (PPV23); This literature marketed report has been received from the authors in a published literature article, entitled as stated below and referred to a female male patient who initially presented in the author's clinic at 13 years of age secondary to recurrent infections. She was diagnosed with autism spectrum disorders (ASD) at 36 months of age due to a notable delay in development, followed by an onset of seizures at 40 months of age: her seizures were initially manifested as partial complex seizures, but became secondarily generalized. Her seizures were refractory to many anti-epileptic drugs (AEDs). She responded favorably to a modified Atkin's diet and became seizure-free between 6 and 11 years of age. However, clusters of clinical seizures recurred after starting puberty. A high dose of valproate (375 mg at breakfast, 1125 mg at lunch, and 2250 mg at night) was prescribed by her neurologist at the time of initial presentation. She then started to suffer from recurrent respiratory infection around 12 years of age. Since valproate induced hypogammaglobulinemia had been reported, she was worked up for secondary immunodeficiency caused by AEDs.   On an unspecified date, the patient treated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the initial workup revealed impaired responses to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). Supplemental subcutaneous immunoglobulin (SQ Ig) controlled her recurrent respiratory infections and decreased seizure frequency. The outcome of vaccination failure was not reported. The causality between the vaccination failure and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was assessed as related.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report
Information has been received from a pharmacist concerning an 82 year old male with no medical history or concurrent condition who was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 665309/1173Y) 2 weeks ago (on approximately 19-MAR-2010) and experienced chills and shaking which "gradually built up" until he notified the doctor on 01-APR-2010. There was no concomitant medication. The patient was admitted to the hospital on 02-APR-2010. No rash was reported. It was unknown if he had a fever or pain. The patient did not report a history of shingles prior to being vaccinated. At the time of report the patient had not recovered. Additional information has been requested.
right after vax started having throbbing pain in legs and genitals, now has no feeling in legs or arms, cant eat, cant sleep, constipated for 8 weeks, worsening eye site
Redness/swelling at DTaP site-upper left deltoid muscle. Evaluated at clinic on 8/15/03. Dx: local reaction only. No Tx except Motrin and cold compresses.
broke out in fine and big hives; lost her voice; This is a spontaneous report from a contactable consumer.   A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, solution in prefilled syringe), via an unspecified route of administration on an unspecified date on the upper left arm (Batch/Lot number was not reported) as unknown, single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient wanted to know the ingredients to the COVID vaccine. She wants to explain why she wants to know and states a few years ago she had the pneumonia vaccine at her providers office. After getting it, she broke out in fine and big hives all over her body, the product was the PREVNAR 13 vaccine. That night into the next day she lost her voice totally. She was taken to the ER the next and was kept for a half a day to monitor; the doctor gave her medication to restore her voice and it did. Now in the pandemic time with Pfizer making the vaccine and she got to thinking about this. She spoke to her doctor and was told by the doctor that the physician would look into it. It was also recommended by the doctor that she go ahead and schedule her appointment.  It was explained that the hives but they went away but she is not sure how long before they resolved. The fine hives were on arms and upper and lower extremities and the big ones were on her butt.  The loss of her voice resolved the day after once she left the ER and after getting medication; does not know the name of the medication administered for treatment. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Preschool Called stating that the child was having displaying "eye twitching".  He was NOT displaying any LOC or respiratory signs or symptoms at this time.  They were encouraged to seek medical advice by his medical provider. No one medical personnel from our District Health Department Nursing or our medical director ever saw this child while he was displaying this "event" Nor has any Medical provider ever reported anything to us regarding this event. Follow-up with school has been done. Child has not shown any further s/s.  School has stated parents have not mentioned anything about this any further. This nurse left a message for mother to call back with no returned phone call. RN
Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema.  We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.
pt disoriented, nauseous & felt ill;pt exp no feeling on rt side of body;body totally affected w/paralysis;lt leg numb;walks w/sl limp-rt leg very painful diff & painful to walk;legs stiff;no energy;dx diabetic neuropathy;
This spontaneous report as received from a pharmacist refers to a 77 year old female patient. The patient had no drug reactions/allergies. On 08-AUG-2012 the patient was vaccinated with ZOSTAVAX (dose and lot# were unknown) by the intramuscular route. The patient had an indented area with small scab at the injection site. The outcome of events was unknown. No treatment was given for adverse event. The patient had sought medical attention via contact pharmacist. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004034: US-009507513-1711USA004033: US-009507513-1711USA004035.
Developed left arm pain after vaccination which has persisted, there is associated restriction in the shoulder range of motion.
Information has been received from a physician concerning a 19 year old female with a history of rhinitis allergic who on 05-APR-2008 was vaccinated IM with 0.5 ml of the first dose of GARDASIL. (lot#659655/1486U, site not reported). Concomitant therapy included CLARITIN and RHINOCORT NASAL SPRAY. On 06-APR-2008, one day after receiving the vaccination, the patient experienced rash with red dots on her chest, itching of arms and itching of chest for 1 to 1.5 weeks. No other vaccinations were given, no change in soaps or laundry products. The patient had sought unspecified medical attention in the doctor's office. Subsequently, the patient recovered. Additional information has been requested.
Unable to lift arm; Arm hurts/it is painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Unable to lift arm) and VACCINATION SITE PAIN (Arm hurts/it is painful) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced HYPOKINESIA (Unable to lift arm) and VACCINATION SITE PAIN (Arm hurts/it is painful). At the time of the report, HYPOKINESIA (Unable to lift arm) and VACCINATION SITE PAIN (Arm hurts/it is painful) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Presented pale, diaphoretic and anxious. BP WNL. Stated difficulty swallowing associated with a raspy voice. Benadryl administered. Ambulance called. Transported to hospital for further evaluation.
had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day; the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose) and PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose) and PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 10-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. There was no adverse event and product complain associated with this case.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2022: Live follow up received and Batch Number was added.
14 hours after my 2nd Moderna vaccine, on Feb 24, 2021, I had severe abdominal cramps and passed out briefly. That followed by severe diarrhea for several days. At day 5 I was dehydrated and admitted to the hospital, where I was quickly tested and diagnosed with C. Diff. I had 3 days of a course of Clindamycin a month prior.  After 3 days of Vancomycin in hospital I was discharged and much improved.
Fever, chills, diarrhea & nausea two hours after vaccination. Left shoulder numbness radiating to the entire left arm, fingers are always cold up to date.
9/4/21 Injection site painful all throughout arm. Had stomach pain, Nerve pain in some fingers. Left side pain and very Tired. 9/5/21 Woke up with severe muscular pain in my left shoulder going up the left side of my neck. This continued for 2 days and developed into a stiff neck on 9/7/21. The neck stiffness continued for over a week. 9/14/21 I experienced nerve pain in  a tooth in my upper left jaw. 9/20/21 My upper lip broke out in a fever blister.
Patient received a Pfizer vaccine on 11/05/2021 and 11/11/2021
it is itching; very uncomfortable; so much pain; skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere; fatigue; body aches; headaches; pain in the lymph nodes under the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 013M20A or 0BM20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm). The patient was treated with HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCORTISONE) (topical) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm) outcome was unknown.            second night after booster shot the patient developed a skin rash in the palm of their hands and the palm of their feet and everywhere.   This case was linked to MOD-2021-404412, MOD-2021-404413 (Patient Link).
Flushed face, feeling very anxious, nervous, moving around the house restlessly, feeling very hyper, feeling confused and disorientated.  Pain, redness & swelling at injection site. Daughter was just not feeling well at all.
Fever, seizure, stopped breathing, CPR. Swollen lymph nodes, swollen testicles. 2 Seizures 1st - 15 min, 2nd - 8 min.
Pt stated ?feels like my tongue has doubled in size ?  difficulty  swallowing  and chest tightness
Chills, nausea, dizziness, weak, fatigue, body aches, fever
100.4 fever; Malaise; muscle pain; knee pain. Took acetaminophen. Greatly improved by morning