chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he had been having potential adverse events after receiving the Moderna COVID-19 vaccine; asked how he was doing. Caller stated "Not good."; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good.") in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good."). At the time of the report, IMMUNISATION REACTION (he had been having potential adverse events after receiving the Moderna COVID-19 vaccine) and MALAISE (asked how he was doing. Caller stated "Not good.") outcome was unknown.        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.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
I had muscle aches to the point where it felt like the chest and back were caving in at the same time. I had fast heart palpitations. I got dizzy and felt weak at points. I went to the Doctor and it was also determined that I was wheezing when he checked my lungs. He prescribed me a 30 day usage of the Albuterol Sulfate pump to help with the wheezing 3x a day.I saw the doctor January 23rd.3 days after receiving the Moderna Covid-19 Vaccine EUA.
Patient developed virtigo and hearing loss in his right ear on 2/12/2021.  He was evaluated by urgent care, and ED visit, PCP, and an ENT.  The ENT performed a hearing test on 3/24/2021 which showed clinically deaf in his right ear.  An MRI was completed on 4/14/2021 and showed no signs of abnormality.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Approximate 4 hours after receiving his vaccine the patient developed extremely painful right shoulder pain.  He initially was able to move his arm above his head that progress to the point where he could not lift it against gravity.  Any movement worsened the pain was passive or active.  The patient was brought to the emergency department and was evaluated by orthopedics.  The patient had a right shoulder aspiration that was grossly abnormal, consistent with septic arthritis.  He was then brought to the operating room for washout where they found pus in the sub deltoid bursa.
Case number PHEH2015US023718 is an initial spontaneous report from a pharmacist received on 12 Nov 2015. This report refers to a 27-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 151201) intramuscularly. On 27 Oct 2015, one day after vaccination the patient experienced arm pain. The event resolved on the same date and returned about 2 weeks later. The final outcome of the event was unknown. The seriousness and causality of the event were not reported.
Pt administered vaccines, within 1 minute after last dose pt's breathing pattern increased, and patient appeared lethargic. Extreme diaphoresis happened within seconds. RN asked patient how he was feeling, he replied "dizzy and sweaty, and blurry vision". RN broke 1 ammonia inhalant and waved under patients nose. Immediately patient was able to sit upright and opened his eyes. Due to signs of shock, RN positioned patient with legs up in adjoining chair and then RN administered 0.3ml epinephrine in L arm and called 911. 1:50pm VS BP was not able to be recorded in L arm, pulse ox was 98% room air, HR 50. 1:55pm RN could still not get reading BP reading (dt stethoscope and pt position in chair) VS 98% pulse ox, room air HR 47.  Pt then stated, "I feel like I have to go to the bathroom", " I really have to go number 2". RN assisted patient to stand and walked patient to toilet. RN sat patient on toilet and stayed right outside door. After using toilet patient reported, "I am feeling a little better". At this time ER personnel arrived from fire dept first, then EMT's. Pt's BP at 2:01pm was 126/60; approximately 8 minutes after being administered epinephrine.
pt recvd vax; V 2x at school & 1x at home w/ abdo pain;seen by MD,felt influenza;seen in Med ctr w/ influenza (but difficulty walking);pt adm w/ classical  Guillain Barre synd;CSF protein=78;
8-14-07 Injection site became red, very itchy hot. 8-15-07 Increased redness, swelling at site, itchy, Nurse contacted. 8-16-07 Redness/swelling increased, began travelling down arm towards elbow. Doctor visit - concern about infection - antibiotic/antihistamine prescribed. Lab work taken (blood). Cellulitis, possible allergic reaction. 8-17-07 Lab results received. Extremely low platelet count; referral to hematologist, who followed my progress and continued until counts back in normal range.  11/28/2007 MR received for OVs beginning 8/13/07 to 8/16/07.  Seen 8/16/07 for Reaction to Shingles vaccine.  L arm with large red indurated area. Txd with abx and antihistamines.
hard lump at the injection site; redness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE MASS (hard lump at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. The patient reported no pain injection. Treatment medications were not reported.
Started with chills and progressed with body aches, sharp pain in lower back, fever.   At 7:30 pm temperature was 101.2.  At 11 pm temperature rose to 101.6 and heartbeat was very elevated and felt to be pounding and rapid.  Around 4 am fever had diminished and minor soreness.  At 7 am no further issues.
Fever, body aches, jaw pain, inj site pain-pt taking TYL alt ibuprofen-watch if unimproved recheck with MD.
mucus in stool; This spontaneous case was reported by a consumer and describes the occurrence of MUCOUS STOOLS (mucus in stool) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUCOUS STOOLS (mucus in stool). At the time of the report, MUCOUS STOOLS (mucus in stool) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she  did not self treat and notified healthcare provider.
Big red hive on left cheek which was hot and to touch, then migrated to the ear 2 days later. Cheek was then blotchy with a red mark across the upper lip. Physical symptoms ceased on 11-19-07. Later ran a fever for 6 days on and off.
inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The patient had not received 2nd dose of Shingrix yet. The reporter forgot to ask about follow up, pharmacy address in health care professional (HCP) details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degrees Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of GARDASIL (also reported as product unspecified) Lot # K010215 and expiration date: 05-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # M043424 and expiration date of 06-JUN-2018, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown) which were stored in the range of 9.8  Celsius degrees for 1 hour. Previous temperature excursion was reported: 10.5 Celsius degrees for 2 hours and 14.7 Celsius degrees for 3 hours. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA006745.
This spontaneous report as received from a physician via an unspecified gender, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mL Vls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 384 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies no adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Felt dizzy, nauseous and palpations, which resolved within 5 mins of laying down. Also complained that both legs felt a little heavy. Patient reports that she has a fear of needles, had same experience vaccines in the past.
Patient states shortly after getting the vaccine and alone in her apt her head began to hurt and her back aching. States her chest began feeling "funny" and she tried calling her daughter. With no answer she called the ambulance and was transported to ER. She was told upon arrival she was having a heart attack and transferred to cath lab. Blockages were found and 3 stents placed to right coronary artery.
patient was afraid of needles to begin with, she warned me that she has passed out before, I gave her the injection, she did with the shot but after 5 mintues , she started feeling dizzinees, and fainting, so I asked to call 911 , she wouldn't let me, I gave her bottle of water , she told me to check bp so I checked bp and it was 80/50, then she said she felt good, few  minutes later, i told her your bp is really low so gave her some crackers from the store, she ate, ,but then she felt like throwing up so I called 911, and attended her, emergency came they checked her bp , it was 80/50, they told her they needed to  take her to hospital, but she refused, and said she will be ok, she left with her boyfirend, and was ok
This spontaneous report as received from a pharmacist refers to 8 patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reported stated that she held a ZOSTAVAX clinic and 9 out of 11 patients were administered ZOSTAVAX lot number K000456, expiration date 15-DEC-2014, dose single dose, route SQ for vaccination. Eight patients developed redness, swelling and induration at injection site, redness on an unknown date. At the time of report none of the patients had required medical treatment. The outcome of redness, swelling and induration at injection site is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1405USA003862 via same reporter link. Additional information has been requested.
I noticed a rash of small red dots on his neck and sides of face. I undressed him and rash was all over his torso, underarms, back, neck, tops of inner thighs.
Patient received 1st covid vaccination injection and sat in observation clinic for 15 minutes. Complained of light headed dizziness at 0940, eyes red, left arm red blotchy rash, complained of some throat constriction. Given fexofenadine 60mg, PO @ 0950 with apple juice. Denied shortness of breath. Was advised to go to ER by RN and Nurse Manager, but patient adamantly refused. At 10 am, she stated she felt better, denied further throat constriction, no shortness of breath, faint rash on left arm. Patient asked to leave clinic. Was advised to call 911 or go to ER I any further shortness of breath or constriction developed.  Patient verbalized understanding and stated she would. Left Covid clinic at 10 am with husband driving. Patient was escorted to car outside of facility.
Was completely fine about 13-15 I got dizzy and blacked out. I was not able to talk. I don?t think I completely passed out but everything went black. Spent a couple hours on a gurney being monitored. My blood pressure (normally low/normal) went up to 170/101. And my heart rate was in the 140s. My oxygen saturation at one point was 82% but I was not having any trouble breathing and was breathing normally. I had a terrible headache and was shaking uncontrollably for about 20 min. Eventually I felt well enough to go to work. About five hours after my shot, I passed out again. I was taken to emergency room. My blood pressure was high and my heart rate was still elevated. They ruled out anything being wrong and eventually sent me home. I had a migraine and fatigue for two days. I felt tired for two weeks. And everything that usually  hurts, hurt extra bad.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Febrile seizure; generalized tonic clonic 5 minute seizure. Maximum fever 101. Child hospitalized as observation/hold for 23 hours. No other problems or consequence.
Profound expressive aphasia lasting several hours, then resolving over course of ED stay, with otherwise non-focal neurologic examination
Trigeminol Neurlagia; Sever Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) and FATIGUE (Sever Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048AZ1A and 040B21A) for COVID-19 immunisation.     Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, CITALOPRAM, ROSUVASTATIN, PIOGLITAZONE and DULAGLUTIDE (TRULICITY).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) and FATIGUE (Sever Fatigue). The patient was treated with CARBAMAZEPINE (TEGRETOL) for Trigeminal neuralgia, at a dose of times daily for five days and OXCARBAZEPINE for Trigeminal neuralgia, at a dose of 150mg three times daily. On 19-Mar-2021, FATIGUE (Sever Fatigue) had resolved. At the time of the report, TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) had resolved.            concomitant medications include Treatment medications were not provided.
Patient had a rash develop after the soreness in his arm went away (he approximated 3 days) after vaccine on his left arm.  It is red, round about 2 and 1/2 to 3 inches in size, occasionally itchy.  It is still present 9 days after it showed up.  Has no other symptoms.  Patient is going to take some benadryl to see if it will help with the local reaction and itching.  If it does not resolve he is going to schedule a visit with his PCP.  On his way to a health care coach visit.  I urged him to mention it to them and am also going to contact his PCP for him.
Ears ringing, both ears, noticed after 2nd dose when had fever for 36 h following dose.
I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated, "I have a fever of 100.3 F, is that normal in Jan2021." The outcome of the event fever was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I got a rash on my torso (stomach and back) and upper arms (both arms).  It's slightly itchy and has seemed to spread since it started.  It started on day 8, 9, or 10 after receiving the vaccine, and has gotten a bit worse.  I've now had the rash for about 10 days.  A dermatologist told me to use a steroid cream on it, which hasn't helped.  I'm seeing another dermatologist today.  I'm unsure if I should receive the second vaccine, and trying to find out, but have not been able to get an answer.  If someone could call me to let me know, I would appreciate it. My number is (number).
Burning of left arm and itching at time of vaccine administration. Severe HA developed on 10/16/16. Widespread rash on bilateral upper arms with warmth and itching. No MD or ED visit required. Employee planned on taking BENADRYL.
tiredness; felt lousy; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced tiredness and feeling bad. On an unknown date, the outcome of the tiredness and feeling bad were unknown.   It was unknown if the reporter considered the tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was unknown. The reporter did not agree to follow up. This case has been linked with the case US2019AMR071497, reported by the same reporter.
pt called our office (her PCP office) to report she got Shingrix vaccine at her pharmacy yesterday and is now vomiting, body aches, arm pain at injection site. Denies fever, chest pain, sob, wheezing.
On 12/02/21 fluzone vaccine was administered.  Patient had already received this vaccine on 10/13/21, was not documented in system. Mom consented to vaccine in October, dad was unaware and consented to vaccine when offered on 12/2/21. Was not aware she already received it this season.
Whole body itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Whole body itching) in a 95-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Whole body itching). At the time of the report, PRURITUS (Whole body itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact