chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant and treatment medications were reported
This spontaneous report received from a health care professional concerned a 52 year old male patient of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series 1) and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination (dose number in series 2) (RRT: Received half dose for their booster dose, LLT: vaccine underdose, and Off label use). No concomitant medications were reported.  As by the investigator, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and received a half dose for booster was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211201443, 20211220152, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211219926.
My energy level remains fairly low, and I lie down frequently during day; Didn't sleep all night; erythema; Extreme aching of all muscles and joints in body; Extreme aching of all muscles and joints in body; chills; felt back itchy at night, saw rash in mirror the next morning; felt back itchy at night, saw rash in mirror the next morning; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), PRURITUS (felt back itchy at night, saw rash in mirror the next morning), ERYTHEMA (erythema) and RASH (felt back itchy at night, saw rash in mirror the next morning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Urticaria, Hay fever, Drug allergy (swelling of fingers,lips) since 1960, Drug allergy (rash, stomach upset) since 2019, Drug allergy (Rash) since 2019, Arrhythmia since 2011 and Urinary retention (self catherize twice daily). Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Arrhythmia.   On 27-Jan-2021 at 12:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning). On an unknown date, the patient experienced ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. On 06-Feb-2021, PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning) had resolved. At the time of the report, ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills) outcome was unknown.            Concomitant product also included Centrum Silver for good health.   This case was linked to MOD-2021-029271 (Patient Link).
tongue hurt; whole mouth is tender and hurting I can eat and it mainly annoying; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (tongue hurt) and ORAL PAIN (whole mouth is tender and hurting I can eat and it mainly annoying) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (tongue hurt) and ORAL PAIN (whole mouth is tender and hurting I can eat and it mainly annoying). At the time of the report, GLOSSODYNIA (tongue hurt) and ORAL PAIN (whole mouth is tender and hurting I can eat and it mainly annoying) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case meets vaccine breakthrough criteria .  SXS HEADACHE, COUGH, FEVER, CONGESTION, POOR APPETITE.
Started having tinnitus and ears are plugging up and having some balance problems. Earlier in the week have had real sore arm, sore muscles all over and body and head aches. Have had more than usual fatigue and felt super weak. Blood sugar also seems higher than normal for extended periods
sore thorat, yellow cough, hard to breath, checst hurt from coughing, chills and fever,
Numbness, extreme pain in extremities worsening until diagnosis and infusion start up Feb 2023.  Now in wheelchair because of mobility issues Treatment gammagard infusions
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GK0924) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included 15Oct2023 to 19Oct2023. Clinical Course: Patient started taking Paxlovid two days after symptom onset (sore throat). It worked fine, he had very little symptoms after started to take it. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350557 Same reporter/patient, different drug/events;
9:35AM pt. returns with c/o malaise, pallor, diaphoretic, hypotensive with no Sxs of SOB or resp. distress. V/S: B/P 96/.  10:45 EKG performed; read by Dr. (=) normal. Glucose: 120, adult 70-100, children 60-109 (=) normal range.
Narrative:  Pt is a 91 yo M with PMH of BPH, AMD, hearing loss, PVD, carotid artery occlusion, HLD, and DM. No indication in chart of cause of death; pt appears to receive primary care outside of this facility.
Lethargic on 9/15/11 in the evening, decreased appetite, low grade temperature, and regression in what he could say or do. Mom states "acting more like a 2 yr old than a 3 yr old". 9/17/11 - language ability changed.
Starting that night 12/19/20 at approx 8pm I became nauseous with a 100.8f fever. I felt achy for the 2 days with the fever subsided. On Monday 12/21/20 I was at work (Firefighter) when I started to have palpitations. I was able to obtain a 12 lead EKG right away which showed a ventricular rhythm lasting for approx 5 min. After that I was having multiple PVC's / Ventricular beats. I was taken to Hospital where I was admitted. Over night the rhythm subsided, all my labs were good with other test's being done. I was discharged home. I have not had any other episodes since Monday. I was cleared by our Occ Health Doc who suggested I fill this out.
2 days after administration of vaccine patient developed double vision     ER visit - no acute disease on MRI and CT of brain.  Ophthalmology  referral is pending
Fever 99.7F Body & muscule aches Fatigue Slight soar throat Light headed
This spontaneous report was received from a pharmacist refers to 44 year old female pharmacist who is the patient also. There was not medical history, drug reactions or allergies. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX vial 19400, plaque forming unit (PFU) in the arm, strength, lot number and expiration date were not reported. Because her mother came down with a case of shingles. Concomitant therapy was not reported. The reporter informed that on 25-JUN-2014 the patient presented to the pharmacy with what appeared to be a silver dollar sized wheal at the injection site, also informed he advised to apply ice to the injection site and administered BENDADRYL and CLARITIN (unspecified forms strengths) to treat the symptom. The reporter informed that on 26-JUN-2014 (also reported as today) that wheal has moved from the injection site down to the patient's elbow. The pharmacist believed that the patient my have developed cellulitis. None laboratories studies were performed. The patient sought medical attention by a pharmacist visit. The outcome of the events was not recovered. Additional information has been requested.
acute hearing loss in her right ear and was diagnosed with profund sensorineural hearing loss; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-JAN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an acute hearing loss in her right ear and was diagnosed with profound sensorineural hearing loss. She also suffered a painful and red rash on the right side of her abdomen and chest. The rash was diagnosed as shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she 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 pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of acute hearing loss in her right ear diagnosed as profound sensorineural hearing loss was considered to be medically significant. Both events were considered to be disabling.
Information has been received from a physician concerning a male Patient who was vaccinated with a dose of Zostavax. Subsequently, he experienced injection site rash which was characterized by the physician as "not zoster like rash". Medical attention was sought. Subsequently, he recovered from injection site rash. The product quality complaint was not involved. Additional information has been requested.
Burning sensation in left eye for about 1 minute.  Felt like "wind blowing in my eye".
post-herpetic neuralgia; Information has been received regarding a case in litigation from a lawyer, referring to an approximately 78 years old patient (pt) of unknown gender at the time of the report. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications.  On or about 20-MAY-2013, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions at local pharmacy. Subsequently, pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: post-herpetic neuralgia. The pt claimed damages as a result of injury to themselves and economic losses. The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Severe body aches, unable to sleep, headaches, weak, no appetite and 101 fever at day 3 of onset. Then left arm swelling, itching, raised red area at injection site on day 11. Not painful. Symptoms have subsided by day 12.
Ongoing fever (100degs) > 2 days; pain, swelling and redness at injection site; headache; fatigue; general aches
Information has been received from a nurse practitioner concerning a 63 year old female with mitral valve prolapse and a thyroid nodule who on 26-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LEXAPRO, PROTONIX and ADDERALL TABLETS.  On 05-JUL-2007 the patient developed one red spot on her stomach.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Initially developed redness and swelling of left arm at vaccine site 2 days after vaccines administered. Shortly after, developed hives at the vaccine site as well as all over body. No other symptoms - no vomiting, facial swelling, coughing, trouble breathing
Slight soreness immediately after shot, took extra strength Tylenol. 11:00 am next day start becoming queezy and aches were developing all over including an ever increasing in pain head ache. Went home from work took more extra strength Tylenol. Slept for 4 hours. Headache and queeziness persisted, took more Tylenol. Symptoms lasted till the next day. Next morning minor head pressure remains
We mistakenly thought we received the Pfizer Bivalent vaccine but received the regular Pfizer vaccine and administered that to the patient. We called the manufacturer and their recommendation is to wait the 2 months and then give the patient the bivalent vaccine. We called the physician's office and after explaining it to them they were fine with the patient waiting the two months for the bivalent. The patient is fine and showing no symptoms or side effects.
Today it is about 4 inches and has bumps; swollen; itches; red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PRURITUS (itches), ERYTHEMA (red) and RASH (Today it is about 4 inches and has bumps) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (swollen), PRURITUS (itches) and ERYTHEMA (red). On 24-Mar-2021, the patient experienced RASH (Today it is about 4 inches and has bumps). At the time of the report, SWELLING (swollen), PRURITUS (itches), ERYTHEMA (red) and RASH (Today it is about 4 inches and has bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient reported having difficulty breathing  and wheezing  chills with temperature up to 101 .  spoke to her the next morning her temperature had subsided and breathing difficulty significantly reduced but pt will be going to get a COVID test to verify symptoms are not COVID  related.
Child received her influenza vaccine in this office. Her temperature was checked and normal prior to vaccine administration. Child reacted with a very brief cry and then was playful self. Mother took child home. Child was eating breakfast in her high chair and let out a "loud pitched squealing cry". The child's arms and legs were stiff and child was shaking. After the shaking stopped mother removed child from the high chair and brought her back into this office. Child does not have a fever. Mother advised there is a family history of seizure activity. I spoke with the provider in the office and created a plan for patient. I scheduled an evaluation for this week and reviewed with mother if child has any additional symptoms prior to visit she will need evaluated in the emergency department. Mother in agreement with this plan.
Approximately beginning 10 hours after injection, I began running a temperature last measured at 99.9. Followed by chills. Bed time and 2 ibuprofen alleviated symptoms. Fatigued and sluggish for next 24 hours.
She got her vaccine, made sure to sit there and talk for a few minutes about 10 minutes.  She felt a little bit strange and did not think much about it.  She started driving and went to the grocery store with a friend, and the next thing she knew they got into the grocery store and felt bad, a little wobbly.  They were on their way back to the house and it was like she had gauze in front of her eyes, not able to see.  She was sitting there stating that her eyes were doing something funny and they needed to get back to the house.  Her friend told her that her eyes were swelling.  Her friend went to get the Epi-Pen as she knew she was having an allergic reaction.  She waited and got an ice pack and put it on her eyes, which helped.  She got to sleep that night and when she woke up around 3:00 AM she was having a lot of problems.  Her eyes were so swollen that her right eye was swollen shut.  She also realized that her nasal cavity was swollen almost shut, and her throat felt like somebody had taken a wire brush and gone and down in her throat.  She had no itching like she has when she has had other reactions.  It was just the burning sensation in her throat and her eyes.  The right eye was totally closed and it was humongous.  She let it take it's course, was real careful and can barely talk as she has lost her voice.  There was 2 days that she did not say anything to anybody, did not drive, could see partially out of her left eye and run her hand down the wall to see where she was going.   She did not have to use the Epi-pen.  Today her eye is much better, open some and bright red when she looked on it, the left one was like pink eye and she did have conjunctivitis in it.  She did not call her doctor as it was the weekend, and they would not have been open and they would tell her to go to the hospital and she knew what to do from prior experience and she could use the Epi-pen and roommate could call 911.    She is better today, her eye on the right side is not fully opened, but it is not like a softball anymore, but she is able to see out of it.  Her throat is still feeling scratchy and sounds scratchy and is having to drink water and getting more irritated.    Has had all her previous COVID vaccines and had never had a reaction.
Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant; Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 ml. On 27-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that a vaccine given to a patient that was reconstituted wrong (Inappropriate Reconstitution Technique).  This was 1 of 2 cases, reported by the same reporter. The reporter consented to follow up. The reporter reported that the Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023103552:Same reporter