chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning her 15 year old sister with no known drug reactions/allergies and no known pertinent medical history who on 30-AUG-2008 received the first dose of GARDASIL (Lot # 655849/0263U) into the right arm. On 08-AUG-2009 was vaccinated with the second dose of GARDASIL (Lot # 662300/0100Y). Concomitant vaccine included Tetanus toxoid and MENACTRA (Lot # U2662A). The medical assistant reported that after second vaccine the patient experienced injection site swelling and redness. On 11-AUG-2009, in the afternoon, the patient fainted on the sports field (according to the medical assistant the event was not environmentally connected); the syncope was followed by a 30 second convulsion which was witnessed by the coach; when the patient came out of it, she had a pounding headache which lasted a week; patient refused any treatment at the time. The patient saw a neurologist on 13-AUG-2009. On 17-AUG-2009, an MRI of head, MRI of neck and EEG were performed (results not expected until 25-AUG-2009). At the time of reporting the patient was recovering. The patient sought medical attention. Upon internal review seizure was considered to be other important medical event. Additional information has been requested.  8/27/09 Neuro consult received dated 8/13/09 with assessment: Cervicalgia-worsening, Convulsions-new, Headache, worsening. Pt presented after episode of generalized tonic-clonic seizure.  Pt also reports daily H/As x 1 year-recently worse, neck and back pain and stiffness.  PE (+) for trigger points and mildly decreased ROM of the neck.  Sent for testing. PT for neck.
sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 30Jan2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Medical history included several allergies with food and hay fever from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that the second dose will be on 20Feb2021at 4:30PM, she was asking if it's okay to take it earlier than 4:30 because she doesn't want to sit for too long due to an allergy (though she did not elaborate about the allergy). She said that she has several allergies with food and hay fever. She said she got a sore arm and took Tylenol after the first dose. The outcome of the event was reported as unknown.   Information about lot/Batch number has been requested.
Patient had the 2-dose Moderna for 6mo-5yr and should have received the Pfizer bivalent 5-11yr and received the Pfizer bivalent 6mo-4yr dose. Parent was notified, provider elected not to revaccinate.
I had pain at the injection site which started about 2 hours after the shot.  (I had had this after the first shot as well, but it happened faster this time and was a little more severe).  About 12 hours after the injection, I started to feel feverish, and went to bed - fever seemed to spike during hours 12-16 post-injection.  (I did not take my temperature because I was in bed and really not feeling well.)  I had chills, sweating, muscle aches, restless sleep, and a headache.  I remained feverish most of the next day and had a migraine level headache the entire day; temperature reads were in the 100-101 degree range for the entire next day, until about 10pm (a full 24 hours after the onset of symptoms, 36 hours from injection.), when it went down to 99 degrees, and then finally seemed to subside.
6OCT97 faintly sore-no swelling;7OCT97 very sore, hurt to do anything;8OCT97 very sore-no redness;some swelling-c/o deep pain;pt exp fever & hives all over body & face, red & swollen rt arm;remained painful & diff to use;
On Mar 9 @1:30am  I went to sleep and woke-up at 1:30am on 10 Mar.  I was out for 24 hours.   Sluggish the next day.  Okay  the third day.
COVID-19 vaccines given after BUD date of 4/29/22.  Expiration date 5/31/22.   Letter being sent to patient to be re-vaccinated.
2SEP93 parents stated pt was dx'd as having died of SIDS; this was 17 days following vax (w/no known adverse reaction);
patient received only the DTAP-IPV and not the ActHIB portionof Pentacel, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who received only the DTAP-IPV and not the ACT-HIB portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot and expiry date was not reported, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse 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 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.  Information on the batch number is requested.  List of documents held by sender: none.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL. On an unknown date the patient suffered pain, redness and stiffness at the injection site after the administration of GARDASIL. It was not reported if the patient sought medical attention. Outcome was not reported. The reporter did not assess drug relationship. Additional information has been requested.
This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19.  No other adverse reactions to the vaccine were reported. The patient tested positive for COVID19 on 12/30/2020
Fever; flu-like symptoms; chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 hrs after receiving Shingrix, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the influenza-like symptoms and chills were unknown.   The reporter considered the fever, influenza-like symptoms and chills to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right arm. The patient experienced flu-like symptoms, fever of 103F and chills, ten hours after receiving her 1st dose of Shingrix. Her fever was slightly better the day after receiving Shingrix. The patient did not get medical treatment for this, except for reaching out to reporter to report her symptoms. The reporter believed that the symptoms were 100 % likely to be caused by the Shingrix. The reporter provided the consent for follow-up      Lab Comments: On an unknown date, patients body temperature was 103 F
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Same day post second Prevnar on 07/15, parents reported temperature of 100 the day before the vax,  but the pt was feeling fine and had no fever at the time of the exam. That afternoon the pt had temperature of 100-105. Then she experienced a generalized tonic-clonic seizure lasting 3-4 minutes. Taken to ER where fever of 104. Pt apparently looked well at that time and no blood, urine or LP were done. Pt had received a shot of some kind 'for the virus.' She had a low grade fever of 100, 7/6 and 7/7. She had also had diarrhea for 2 days. On 07/07 she looked completely well and was afebrile. The seizure was most likely due to fever and viral infection but since this is a new vaccine, the physician thought it should be reported.
I had a severe tinnitus issue. It went away which followed super hearing afterwards. The doctor (ENT specialist) ran a whole bunch of tests (Hearing tests).
Pt calling to report a vaccine reaction to the 1st dose of covid vaccine. Pt describes about an hr after the shot she experienced dizziness, flushed face, tightness in throat, feeling of obstruction in her throat.
Not sure it was related, but I got shingles about 2 months after my second vaccine.
About 1 hour after patient had vaccines she started itching and body was covered in hives and started coughing and difficulty getting breath.  Went to ER:  they gave her Epinephrine, Steroid and Benadryl which cleared up symptoms in a few minutes.
Soreness, itchiness, and red rash all around the injection sight that didn?t show up until a week and 1 day after  the shot was given
Narrative:  80yo male pt residing in nursing home since 4/2021 died on 9/14/2021. No information given regarding pt's death. Likely death is not related to covid vaccine given on 1/14/2021 from outside agency given pt's advanced age & long time span between vaccine given date & date of death.
bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.
Somewhere between 3-4, maybe after 1st booster, I started feeling very tired. That's gotten worse and seems to have plateaued and I have half the energy I used to. 2nd thing that is new is night sweats. I'll wake up in the morning and I will just be wet with it. I've never had this problem ever. Another symptom I've experienced is brain fog. Went to my PCP for the vertigo as well and he noted BPPV Benign paroxysmal positional vertigo and was prescribed Meclizine. We weren't sure if that was due to the vaccine or if this just came back since I had it 15 years ago. Intense fatigue and exhaustion as well.
16 y/o given Moderna 0.5 ml in left deltoid.  Seen in Hospital by Dr. on 4/24/2021.  No adverse reaction noted.  Client is to return for second dose of Moderna vaccine on May 22, 2021.
Pt. had tinnitus just prior to vaccine but worsened after vaccination.  1st 48 hours had typical aches/pains/sweats/chills/headache/fatigue.  Around 48 hour post injection she experienced increased ringing in ears, tingles In the face and elevated BP of 170/110.  Episodes of palpitations, fluttering in her chest.  Pt. has subsequently been started on Valium 2 mg q 6 hours for vestibular neuritis.  Amldopine 5 mg  daily (ncreased to 10 mg on 1/29), Clonidine 0.1 mg prn BP Prednisone  60 mg daily for 5 days, HCTZ 25 mg daily added on 1/30. On 2/2/21, started on Toprol XL 25 mg daily and on 2/3/21 started on Solu-Medrol 1 gm IV daily x 3 days
erythema, edema, induration & tenderness; edema involved entire thigh; sx occurred w/in 24 hrs of inject; cold compresses applied 2nd observation;
lots of confusion; fatigue - that he is used to; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (lots of confusion) and FATIGUE (fatigue - that he is used to) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included NAPROXEN for Product used for unknown indicaton, GABAPENTIN, DULOXETINE, CLONAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (lots of confusion) and FATIGUE (fatigue - that he is used to). At the time of the report, CONFUSIONAL STATE (lots of confusion) and FATIGUE (fatigue - that he is used to) 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.   Treatment medication were not reported
Swelling of joints and muscle pain in lower body, hips/knees/ankles within hours of vaccination. Bedridden for the next week. Movement and walking is extremely painful and must be assisted with either a wheelchair or cane.
fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever after second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced PYREXIA (fever after second dose). In June 2021, PYREXIA (fever after second dose) had resolved.            No concomitant drug was reported.  It was reported that the patient received her first vaccination with no side effects, in early May.  No treatment medications were reported.
but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of appetite and fever; headache; had chills and shivering and couldn't get warm; had chills and shivering and couldn't get warm; My temp started to climb overnight Friday; It felt like my face was going to explode; This is a spontaneous report from a contactable other hcp. A 42-years-old female patient reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 07:00 as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 11:00  as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient got second dose Friday morning, 29Jan2021, at 07:00. By 4 pm on Friday she had chills and shivering, and couldn't get warm. By 6pm on Friday, a headache started. The headache got progressively worse overnight Friday, the worst headache she had ever experienced. It felt like her face was going to explode. Her temperature started to climb overnight Friday. Got up to 101.5 by early Saturday morning. By noon on Saturday, headache started easing up, but was dizzy/weak. By 4:00 pm Saturday she was feeling a lot better, just weak from lack of appetite and fever. The patient underwent lab tests and procedures which included body temperature: started to climb on 29Jan2021, body temperature: 101.5 on 30Jan2021. On an unspecified date, the outcome of the events was resolved.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Narrative: She reports no issues with the first vaccination and alerted staff to c/o arm pain (same side as the injection) that began within 5 minutes after receiving the vaccination. Patient notes experiencing left-sided shooting electric-like pain radiating from the injection site over her left deltoid up her neck. She denies prior injury or other issue with the left side of her neck or left shoulder. The pain was initially described as a 10/10 and prevented her from being able to left her arm about her head. It began to spontaneously improved to 3/10 within a few minutes w/o intervention No decrease in strength was experienced. During the evaluation, her pain continued to improve w/o active intervention and function improved. She was provided with an ice pack, which further a/w discomfort. During the ~20 minutes of evaluation/observation after she alerted staff to the reaction- the pain had almost completed resolved. No other common adverse effects noted other than injection site tenderness. No s/sx concerning for immediate allergic reaction or angioedema. O: BP 132-93 HR 67 RR 12 SpO2 97% on RA Gen: anxious in appearance, not in distress, answering questions appropriately HEENT: atraumatic/normocephalic Ext: moves all 4 spontaneously, no edema. Full; passive ROM, slightly limited active ROM of left shoulder past 150 degrees overhead. No obvious deformities. Tenderness reproducible only over injection site (not over neck) MSK: tight b/l shoulder, trapezius, back muscles Skin: no obvious lesions or rashes, injection site over left deltoid in appropriate anatomical area (eg not concerning for cervical injection). Salon pass patch in place over low back Neuro: no focal deficits. B/l grip strength 5/5 Psych: initial pressured speech improved /resolved during evaluation A/P: 48 yo woman with adverse reaction s/p 2nd Moderna COVID-19 vaccination described as almost immediate neuropathic pain radiating from injection site to neck. Issues improved spontaneously, and almost to resolution, with minimal intervention of ice and time. *Reassurance given *Common adverse effects + concerning adverse effects and whn to seek care re-reviewed (previously reviewed with vaccinating RN).  *If still having pain when return home - advised icing, massage, and potential anti-inflammatory depending on her medical history *Provided with additional handout with shoulder range of motion exercises
Shortly after receiving the second dose of Moderna, I got shingles first (I have been vaccinated for Shingles) and now after that cleared, I was diagnosed with Bells Palsy in the ER.
Associate was given a flu vaccine. She stated the vaccine was given too high up on her right arm and she has continued to have pain in right upper arm
Patient reports exacerbation of cough, increased mucus and respiratory symptoms with fever 4-5 days after influenza vaccine. Still has symptoms. Has not seen MD. Taking OTC cough syrup and Tylenol.
Within 12 hours, site of HIB or Pneumococcal vaccine became swollen, firm with dime size redness.
2/14/2021: Runny nose and half of left side of lips filled with painful cold sores.
My shoulder, it begin to hurt, it is sore and I can't lay on that side; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. (at the age of 75 years) Medical history included diabetes, Kidney problem, Asthma Bronchitis, High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included glipizide (GLIPIZIDE) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure measurement, start and stop date were not reported; Lasix (Unclear and not clarified hence not captured in tab) for diabetes one shot a week. Patient may take some over the counter Tylenol for the pain but nothing else (Further not clarified hence not captured in tab). On an unspecified date of Jun2021 Consumer stated my shoulder, it begins to hurt, it is sore, and I can't lay on that side. Consumer stated, Well, I have been feeling for a while but now that I have started doing a lot of stuff it is been hurts bad for the last couple of weeks and I cannot lay on it because I took the shot it was in the March now, I can't lay on it at all. I cannot lay on that side on the arm it hurts bad. Oh god I want to say I do not know what date it is. Maybe it is the 1st of July it started hurting some but June, July last July around middle July it starts hurting bad and now it is hurting even if I take a nap. I don't know what day it was. It was the middle of June. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness, Headache, NauseaVomiting, malaise Narrative:
Low-grade fever (100.5) 24 hours following the shot which lasted about 12 hours and took Ibprophran to keep the fever down. Arm soreness at the injection site and underarm swollen and sore under the arm of the injection site for the following three days and took Ibprophran to relieve pain and discomfort. Muscle weakness in hands. A rash across the chest appeared five days after the shot and is slowly going away.
Face got very hot, then mild numbness throughout cheeks, in eyes, tongue, and throat.