chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
Post vaccine the usual symptoms- fever and body aches, I developed alopecia 3 months post injection. I don't know if it related to the vaccine. The endocrinologist suggested it might have been connected to the vaccine. The endocrinologist asked me if I had COVID-19 before, I said no. Not to my knowledge, I have not had COVID-19 and I have been tested several times and I have never tested positive. The endocrinologist said if I had COVID-19 it might have been related to that. I went to see dermatology. They gave me steroid cream to put in my scalp and that was it. I have not recovered from the adverse event, although it has improved some, I am still having problems with hair loss.
Discomfort started the same evening as injection.  By morning left arm was sore. red mark as large as a the band aid and the large marble knot.  The knot and the rash continued to increase. The largest size was an egg size knot and the red rash the size of a large band aid.  3/5/2021 was peak size, also had fatigue and some cold chills. No detectable fever. injections site itches on and off. As of 3/8/2021 morning  the knot is gone, rash looks like burse, site still tender to the touch, slightly itchy.  Evening site is slightly itchy, no rash, no discomfort.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Endometrial cancer (18mg Lenvima daily, taking with Keytruda). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 26-Oct-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer. 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms). The patient was treated with LISINOPRIL on 02-Nov-2021 for Hypertension, at a dose of 10 mg once a day. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 02-Nov-2021, Blood pressure measurement: 177/94 (High) 177/94.On 06-Nov-2021, Blood pressure measurement: elevated (High) Diastolic has been in the 80s as opposed to the 90s lately (around 06-Nov-2021).The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Patient reported having diarrhea symptoms since starting Lenvima. The patient had originally got the vaccine she had the same reaction that lasted about 3 days prior to Lenvima. Patient had diarrhea symptoms had been less severe lately (around 09-Nov-2021). This case was linked to MOD-2021-388710 (Patient Link).
2 hours post vaccination nurse noticed angioedema in  1 eye and puffiness in the other eye. Nursing staff gave 25mg of Benadryl and used a cold compress. Swelling went down  quickly  and patient is doing well.
swollen arm; It itched, it was like a bee sting; it hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt 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 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 23-Sep-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Antibody test: low (Low) Low.         No concomitant medication was provided. The first dose was fine. After second dose the patient had a swollen arm, it hurt at the injection site, and it itched, it was like a bee sting. No treatment information was provided.
Pt came back today 9/28/17 and showed redness around area, a little swelling.
Patient had nausea and vomiting. 18:42: 99/57, 77, 17, 100%, 98.0ºF. 18:52: 98/57, 80, 17, 100%. Patient stable and released from the vaccination site.
Flu-like symptoms Patient was seen today for cough, shortness of breath, headache and covid-19 screening.
Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of unknown demography who received vaccine TENIVAC and reported TENIVAC latex contraindications. The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult lot number not reported via unknown route in unknown administration site. It was a case of contraindication to vaccination. It was unknown whether adverse event occurred after the injection. 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 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. List of documents held by sender: none.
10 mins p/vax mom noticed pt had large pink blotches over entire body, especially where immun were given; blotches subsided in about 10 mins; t104.0;
Encephalitis, Seizures hospitalized at medical center, including ICU stay. 3/23/07 Received medical records from hospital which reveal patient experienced vomiting, fatigue, weakness, facial & chest petechial rash.  Patient lived in dormitory at school, home on weekends.  Seen by PCP who sent to outlying ER for w/u.  While in ER patient had seizure & was admitted to ICU.  Had another seizure in ICU & was transferred to higher level of care on 12/7/06-1/5/07.  On admit exam showed not responsive to commands but opening eyes to voice & pain.  DTRs absent.  +Babinski on R & - on L.  Consults by neuro, ID & neurosurg.  Tx w/antibiotics, antivirals, multi antiseizure meds & IVIG.  Experienced rash & all meds d/c.  Then seizures recurred & antiseizure med restarted x 1.  Developed mild bone marrow suppression thought to be due to antiviral med.  Patient began to respond on 12/20 & gradually improved to almose full function by d/c on 1/5 to outpatient rehab. FINAL DX: Encephalitis.
FEVER OF 101.8F FOR TWO DAYS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fever of 101.8f for two days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.8f for two days. This report was non-serious. This case, from the same reporter is linked to 20210905680.
Patient with 3 doses of vaccine tested COVID PCR + 9/18/22 and was admitted to ICU.
mom states vax was swollen leg & red @ 2wk-now has area of hardness knot & dimpling when child stands;
Feel sick; Severe nausea; Fever; Recieved half a dose; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, immediately after receiving Boostrix, the patient experienced sickness, nausea, fever and underdose. On an unknown date, the outcome of the sickness, nausea, fever and underdose were unknown.   It was unknown if the reporter considered the sickness, nausea and fever to be related to Boostrix.  Additional information was provided as follows: The patient was about 10 years old. The patient received Boostrix but she received half a dose at the time because it made her feel sick with severe nausea and fever. The patient received hald dose, which led to underdose. The reporter consented to follow up.
Body aches, fever of 100.9 the morning after the vaccination.  Took one Naprosyn and about an hour later (~1:00pm ) symptoms completely resolved.
Vial at room temperature 2 hours 18 minutes prior to first puncture; No adverse event; COVID-19 vaccine given after 33 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator), PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022 at 3:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022 at 3:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator), PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture).    Concomitant product use was not provided by the reporter.  The patient's age was reported as 2 years, 8 months.  The vial initially stored in refrigerator on 23-Sep-2022 at 12:31.  The vial stored at room temperature on 26-Oct-2022 at 13:32.  The vial at room temperature 2 hours 18 minutes prior to first puncture and on 26-Oct-2022 at 15:50 the vial first punctured.  The patient received vaccine from vial with blue cap/magenta border for 6 months-5 years.  Treatment information was not provided.
pt exp hives @ inject site, in the upper lt arm; MD dx a localized react to the MMR prescribed Tavist & Medrol; hives lasted 24 hrs;
Bathroom often, not the runs but needed to be with in 10 minutes of bathroom. I'm getting better.
The pt experienced wheals in the left deltoid, feels warm to the touch. The area measured 3 1/2 x 4 1/2 inches in size.
Pt. was vaccinated on 3/17/21 at 0924. At 0940, pt. had bounded carotid pulse and decrease level of consciousness. Pt. progressed to having no pulse and chest compressions were given for about 1 minute. Pt. was given 6L of O2 and 9-1-1 was called. Pt. regained consciousness at 0945. BP 140/90, HR 62. Ambulance arrived at 0953 and pt. was assessed by EMT. Pt.?s daughter provided pt.?s medical history. Pt. has history of passing out, atrial fibrillation and seizures. Pt. left via ambulance at 1003.
1. Immediately after injection I experienced chest pressure and pain into throat. This has gotten better but never gone away. I have an appointment 10/14 for cardiac evaluation. 2. The day after my injection my left foot and halfway up my left shin was numb as well as 2 fingers on my left hand. Over the next week or so the foot was not as numb but still did not have normal sensation. The feeling came back in fingers but was replaced by whole hand buzzing sensation. Gradually I began noticing on my daily walks that my left left did not move like my right one and that I had to make conscious effort  when going up and down curb. This has gotten progressive worse since shot. I also began having "twitching" of muscles in my left leg soon after shot. In the beginning is was not often but now it is almost constant and now is in my right leg as well. Now both arms have the sensation (like past carpal tunnel that I had during pregnancy) constantly. I have had some intermittent ringing in my ears. During all of this I have not been able to think clearly and having memory issues.
Day After first shot, I awoke in total body pain. This lasted for about a month. I would be in utter tears some days & was on opiates daily just to get by. 2 days before my second dose the pain stopped, (minus the constant migraine I?ve had forever, but I can?t complain). I worry as I just received the second dose yesterday, and was told to report this.
I started noticing that I was breaking out in bumps, not really a rash (where there are a bunch of bumps together) but just random bumps everywhere on my body that itch.  Have been using Benadryl cream, did call the pharmacy and they suggested I also take Benadryl tablets to help with the itching.
Pain onset in upper and lower arm 2 days after injection. This was followed by weakness in shoulder muscles.
Pt. received 1st dose Pfizer Pediactric dose 0.2 mL on 11/23/21. Pt presented with father today for second dose. Pt was screened in registration and determined to be eligilbe for 2nd dose. Screener was not aware the this facility did not offer Pediactric doese to 5 to 11 y.o. Pt received adult dose of Pfizer 0.3 mL in error today, 12/18/2021 as second dose. Vaccinating nurse reported the error to this reporting supervisor.
tired; achy; doesn't feel like herself; upper lip tingling; prickling in her throat and tonsil area; hard time swallowing; shooting chest pain, around heart; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (upper lip tingling), PHARYNGEAL PARAESTHESIA (prickling in her throat and tonsil area), DYSPHAGIA (hard time swallowing), CHEST PAIN (shooting chest pain, around heart) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA ORAL (upper lip tingling), PHARYNGEAL PARAESTHESIA (prickling in her throat and tonsil area), DYSPHAGIA (hard time swallowing) and CHEST PAIN (shooting chest pain, around heart). On 18-Mar-2021, the patient experienced FATIGUE (tired), PAIN (achy) and FEELING ABNORMAL (doesn't feel like herself). On 17-Mar-2021, PARAESTHESIA ORAL (upper lip tingling), PHARYNGEAL PARAESTHESIA (prickling in her throat and tonsil area), DYSPHAGIA (hard time swallowing) and CHEST PAIN (shooting chest pain, around heart) had resolved. At the time of the report, FATIGUE (tired), PAIN (achy) and FEELING ABNORMAL (doesn't feel like herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Exhaustion; Upper arm soreness; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 36-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 23Mar2021 11:45 (Lot number: EN6203) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies to sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (DOSE 1; Lot Number: EN6203; 11:45 AM; left arm), administration date: 01Mar2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Upper arm soreness". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional Information: The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a workplace clinic facility. Exhaustion was also reported to be administered within 2 hours of the vaccine. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a 6 year old Caucasian female who on 6/1/95 was vaccinated with 1 dose of varicella virus vaccine live (site unknown). There was no illness at the time of vaccination. It was reported that the child had been exposed to "virus" during the 1st week of May. On 5/7/01, the pt "started breaking out" (previously reported as on 5/8/01). The pt developed a suspicious rash. The pt was seen in a physician's office on 5/8/01 (previously reported as 5/9/01), to verify, and was dx'd with varicella. Upon follow-up, it was reported that the pt has since recovered with no long term complications.
Pt has a learning disability in school & DEC93 became sick w/sore throat; dx bacterial infect appearing as mass on lingual tonsils; had surgery; MAR94 has arthritis in legs & arms; 06JUN83 tetanus toxoid given; 16JUN hives developed;
Shot given on January 25. Legs sore most of week. Saturday evening, January  30 started having extreme soreness and weakness in hips. Extreme pain while standing and difficulty walking. Persisted  and went to see regular doctor on 2/2/2021. No fever or other symptoms. Gave Toradol shot in hip. No relief. Soreness and difficulty walking  continues
I woke up with a red, burning/itchy in the same arm as the injection site that then spread on my back and down my sides. This itchy/burn lasted many days and was only calmed by the use of fluocinonide 0.05 % ointment.
Patient subsequently developed pain to the right arm with associated numbness and muscle weakness. She developed weakness of grasp and decreased sensation from the deltoid muscle into the digits of the right hand.
itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included OMALIZUMAB (XOLAIR) for an unknown indication.    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 PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a LPN concerning a 15 month old male pt with no medical history, no illness at time of vaccine and no adverse events following prior vaccination. On 05/06/03 the pt was vaccinated with a dose of MMRII (Lot # 644507/1038M). Secondary suspect medication included vaccination on the same day, 05/06/03 with a dose of Prevnar. Subsequently the pt developed a red rash and itching. Unspecified medical attention was sought. The pt was treated with comfort measures including anti itch medication and Tylenol. It was reported that the pt was scheduled to be seen in the office on 05/09/03.  Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse noted that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported. Follow up information received from the LPN reported that "Upon further investigation, this was a reaction to the Prevnar vaccine." It was also reported that the pt had recovered. Further follow up information was obtained from the nurse. She reported that the pt had received MMRII and Prevnar on the same day. She reported that the child had been seen in the office and the rash that the child had on his leg (also reported as red rash) was "definitely a reaction to Prevnar and not MMRII".  The records of testing prior to release of this lot have been check by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching and one of those children had also developed a fever (WAES # 0305USA01564 & 0305USA01563).  No further information is available.
6 1/2 hours after vaccine administration, site was swollen, red & tender. 24 hours later seen by MD. Area of swelling 4-5 inches in diameter. Advised BENADRYL and ADVIL.
Lost my voice, congestion in my chest an throat, cough producing deep green mucus , possible benign spot developed on my lower right jaw . Needing surgery to remove along with 8 teeth