chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had vaccine, first feeling the cold, and stayed on the couch.  Then a burning sensation was felt in her legs and throughout her body.  She felt hot/burning sensation.  She took off her clothes as she had that sensation to feel more comfortable as she felt the clothes felt like pins and needles.  Then she had problems falling to sleep.  Her arm was hurting as well, and then had a mild headache.  She woke up early around 5:00 AM, and her arm was hurting to the ponit that she could lift it.  She had pain in the muscles of her legs, thighs, calf and then her stomach started aching, and her whole body was aching.  The arm was still unable to move, headache, and stayed in the bed all day, was very very tired as well.  The next day she felt so tired, stayed in bed, body aches, headache, and then she started noticing her vision was going.  Very very blurry vision on 4/21/21, and sensation to the light.  She was this way all day Wednesday and still problems on the light.  On 4/23/21, she was still tired, her arm was not hurting as much.  When she woke up her extremities were shaky.  Today her arms are shaking, her vision was tweeking and she could feel it, and also the headaches.    She called her doctor on the 24th, and told him her symptoms.  Her vision is bad to the point that she cannot use her phone as she cannot see, focus well and has blurry vision.  Yesterday at 4:00 Am she went to the hospital and they kept her over night.  They ran blood work, then they took an MRI of her brain, head MRI, and did not see anything of concern and told her to FU with a Neurologist.  to have further tests done but as she is pregnant (5-6) weeks they would probably have to wait.   Some of her side effects are still there, but has nausea and feels that her vision continues to be bad, and daily she wakes up and is worsening.  She has slight dizziness, and headaches, and feeling shaky.   She has not seen her doctor as far as her pregnancy yet, but has an APT on 6/10/21.  She has an APT to see her PCP on Friday, 4/30/21 at 9:00 AM.
Soreness after administration followed by extreme pain, soreness, and tingling one week after vaccination.
Information has been received from a health professional concerning a 21 year old male with no pertinent medical history and no known drug allergies/reactions, who on 04-JAN-2008 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659116/1363U). Concomitant vaccination included hepatitis B vaccine, recombinant (RECOMBIVAX). About one month, on "02-FEB-2008 or 03-FEB-2008" after vaccination with varicella virus vaccine live (Oka/Merck), the patient developed four 1 mm skin lesions under his eye. The reporter indicated that the lesions looked like abraded skin or dried vesicles. It was noted that on an unspecified date, the patient had a negative varicella titer. A dermatology consult was planned. At the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Per patient, 2-3 days after receiving first dose, area around injection site swelled up and red spotty rash appeared. Patient started feeling hot and had shortness of breath; injection site had become hard and hot to the touch; it was unrelieved by ice and SOB unrelieved by sitting/resting; patient went to ER where she was treated. Patient denies pain, only reports inflammation and SOB
Pt is 15 years old and was given bivalent booster for 5-11 yrs old.
Sore arm, increased and loud heartbeat, shortness of breath, lightheaded, and tinnitus.
Patient was diagnosed positive for Covid-19 after receiving Janssen Covid-19 vaccine 4 June 2021.
Chills, fever, severe headache, nausea, severe body aches, injection sight soreness, at injection site 12" by 4" bright red inflamed area, sweats. Bedridden for 2 days.  NO food or water intake for 24 hours.
I received the vaccine at 9:30 am and about 7:00 p.m., I had some shoulder/arm aching and felt very tired.  Ibuprofen relieved the aches and I felt fine the next morning.  One week after the shot, the arm I received the shot in began itching and within a few hours was swollen, very red and warm to the touch.  The itching lasted 24-36 hours but was not constant.  The redness lasted about 48 hours.
Patient felt flushed feeling which is sometimes a trigger for seizure.  Patient observed for 15 mins, no seizure activity or other sx noted.
difficulty breathing; pretty severe reaction; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills) outcome was unknown.            No concomitant medication was provided. Within 5 hours of receiving the 2nd dose patient started to experience a reaction.
Patient was given the vaccination as a result of an automated process to identify necessary immunizations. After comparing results of a manual process of required immunizations the issue was identified.  The patient did not display any symptoms or adverse reactions to the immunization.
Patient received Moderna monovalent vaccine as a booster on 9/1/22. No symptoms.
tinnitus started 2 wks after first moderna vaccine.  Got second dose and symptoms dramatically worsened.  She reached out to me today.  I referred her to ENT.
After receiving the vaccine, I felt fatigued so I slept for about an hour. When I woke up I was not able to move my arms or legs. I was not even able to move them slightly to make a call for help. It took 30 mins for my arms to be able to move. I took 16 hours for my legs to begin moving again. Even when my legs were able to move again, I was not able to walk without leaning or holding on to support. My stamina was also decreased. On the morning I called my doctor, I experienced another episode of paralysis but this time it only affected my legs. I saw Dr. who increased my prednisone. This helped in that it prevented my muscles from locking up all the time. I was also doing physical therapy which I am still doing at the time. After receiving the 2nd dose, I expected to have those flu like symptoms again but instead I just had a headache. I would say I have recovered 95% from these events.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long). The patient was treated with HYDROGEN PEROXIDE ongoing since an unknown date at an unspecified dose and frequency and HAMAMELIS VIRGINIANA LEAF (WITCH HAZEL LEAVES) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (it's driving her crazy) and VACCINATION SITE PRURITUS (the injection site got very itchy/it's 4 inches wide and 5 long) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications details included thyroid medication. Treatment included aloe gel.
patient received the DTaP-IPV portion of PENTACEL and not the ACTHIB portion/no AE; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from non-healthcare professional via call center via Medical Information (Reference number- 00778882).  This case involves a patient of (unknown demographics) who received the dtap-ipv portion and not the HAEMOPHILUS TYPE B (HIB) VACCINE [ACTHIB] portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (on the same day).  It was reported "caller would like to know if sterile water or 0.9 percent sodium chloride can be used to reconstitute the ACTHIB vial that was left from the original administration and how to get the patient back on schedule; patient has not yet received the ACTHIB portion of PENTACEL, caller would also like to know what volume of 0.4 percent sodium chloride is required to reconstitute the ACTHIB vial of PENTACEL."  At the time of report, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Pt recvd 3 doses of Engerix-B vax on 31AUG89, 16OCT89, 26FEB90 & 10AUG91 titer=2;
Pt received Varicella booster 7/26/10 (R) arm. 7/27/10 had redness and swelling at the site. No fevers, plus itchy moderate erythema over right upper arm. Some edema and tiny vesicopapular lesions. No actual vesicles or pustules present at time.
Spike in temperature/ low grade fever; feels sick; sinus congestion; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration in the left deltoid on 22Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient said she got her first shot of the COVID vaccine on 22Dec2020 the day prior to the report. At the time of the report, she had a spike in temperature. This morning at 6 AM it was 99.7 and then just now at 4 PM it was 102.9. She received the shot at her place of employment at the hospital. She just felt sick, like she had a normal fever. She knew there would be side effects. The patient was wondering side effects just like a low grade fever and some sinus congestion. The outcome of the event "Spike in temperature/ low grade fever" was not recovered, while the other events were unknown.
1min post vaccination, pt was feeling dizzy on walk over to observation.  Pt was assissted to the ground and had a syncopal episode. Pt was flushed and sweating.  Pt assissted to wheelchair once alert and taken to medical tent.  Syncopal episode only lasted seconds.  Pt given juice and crackers remains clammy and flushed but states that she is feeling much better.  Pt states that her BP normally runs low.  After 15mins of observation, Vital signs and pt states that she feels better and is comfortable going home.  Pt stable w/ strong/steady gait upon leaving. Vitals: 95/53, 68, 14 -- > 97/57, 74
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
PHARMACIST RECONSTITUTED PFIZER GRAY CAP VACCINE WITH 1.8 ML 0.9% NACL  . ADMINISTERED 0.3 ML IM TO PATIENT.  SUB THERAPUETIC DOSE.
both of my legs were very much painful; I could hardly walk; I could hardly do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything). At the time of the report, PAIN IN EXTREMITY (both of my legs were very much painful), GAIT DISTURBANCE (I could hardly walk) and MOBILITY DECREASED (I could hardly do anything) outcome was unknown.            No concomitant medication is reported No treatement of medication is reported
Information has been received from a consumer concerning her brother who on an unknown date was vaccinated with a dose of MMR II (Lot # not reported) when he was a young child. The patient experienced febrile seizures after receiving MMR II. It was reported that the patient also has ADHD and eczema. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Upon internal review febrile convulsion was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
patient said 2 min after receiving the moderna vaccine he started feeling nauseous, shaky, sweaty and paralyzed for about 2 seconds. then he was fine. EMT checked him out after and he seemed fine
Felt terrible; Night sweats; No appetite; migraine headache; foggy brain; Couldnt lift arm; Arm pain; Chills; Injection sight redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache) and MENTAL FATIGUE (foggy brain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement (Hip replacement 6 weeks ago).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Patient receive yellow fever vaccine on 02/17/05. On 02/20/05 noted tenderness in arm from arm pit to elbow. No outward symptoms.
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable.  My throat then started to get dry and began breaking out with a rash on my neck and chest.  This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine).  Within 2 hours after receiving the vaccine, all symptoms had subsided.  Treatment - at the vaccine clinic, EMTs observed me and took my vital signs.  My blood pressure was slightly elevated, but did not require medical treatment.  They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse.  No further treatment was sought out as symptoms all started to improve.
This spontaneous case reported by a consumer, describes the occurrence of back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening) and chills in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 21, 2021,  patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unspecified dose. On Apr 21, 2021, patient had muscle tightness (muscles started tightening), chills and vomiting (puked 3 or 4 times). On Apr 22, 2021, patient experienced back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt) and aching headache. At the time of the report, back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening), chills, vomiting (puked 3 or 4 times) and aching headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Exhausted.  Came home from work at 6am and went to bed.  Did not get up for two days except to go to the bathroom.  Had same affect from the booster show on 12/21/2021.
Pt states sneezing, rapid heartbeat, fever of 101, swollen lymph nodes, and welps on lower arms (not vaccination site); treated at hospital 8/31/15 and prescribed Keflex and Bactrim for cellulitis.
Information has been received from a registered nurse concerning a 57 year old female social worker with a thimerosal allergy and no medical history who on the morning of 10/18/04 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647178/1200N), IM. There was no illness at the time of vaccination. On 10/19/04, within 24 hours of the vaccination, the patient developed a red, raised, itchy rash on the upper arm about 4 inches around the injection site. The rash formed a band around the injection site. The patient was given fexofenadine hydrochloride to treat the rash. No diagnostic tests were performed. Subsequently, the patient recovered. It was also reported that in 1999 the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine with no problems. No product quality complaint was involved. there were no relevant diagnostic tests or laboratory data. Follow up information was received from the reporting nurse. It was reported that the patient was initially prescribed diphenhydramine HCl over the phone, but had no results. The patient was seen and evaluated by a physician. The patient's reaction was considered to be an allergic reaction. The patient was not sent to the emergency room or hospitalized, but was sent to an allergy clinic for further evaluation. The patient was treated with fexofenadine HCl and subsequently recovered. The nurse did consider the patient's experience to be serious. Allergic reaction was considered to be an other important medical event (OMIC). No further information is expected.
4 hour post vaccine pt developed fever 103.4F, bilateral swelling of lip, SOB and vomiting.
expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was placed in the refrigerator on 29-Oct-2021.Vial did not undergo any temperature excursion.  No adverse event was reported.