chrisvoncsefalvay/vaers-outcomes huggingface dataset:
struggled to stay awake; achy; hot; couldn't get back to sleep; very tired; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received the second dose of   BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3249) in the hospital, via an unspecified route of administration on 20Jan2021 at a 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. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine and it was also unknown if the patient received any other medications within 2 weeks of the vaccination. The patient received the first dose of BNT162B2 (lot number: EJ1685) in the hospital on 30Dec2020 for COVID-19 immunization. It was reported that on 21Jan2021, the patient struggled to stay awake. She took Tylenol and woke achy and hot at midnight and couldn't get back to sleep.  She woke again at 2:30 AM and took Motrin and got back to sleep about 3:30 AM still hot and achy.  By 5:30 AM, she said she was less hot and achy, but very tired. Treatment was recevied for events struggled to stay awake, achy, hot and couldn't get back to sleep. It was unknown if treatment was received for the event very tired. The outcome of the events was unknown. The events were reported as non-serious.  Since the vaccination, it is unknown if the patient had been tested for COVID-19.
The day before, I had a 45 minute exposure to a woman who had COVID-19, unknown at the time and we were not wearing masks. I felt that we were social distancing but I guess not. I got sick suddenly on Friday, and it really hit me hard. I had to lay down and couldn't move. I was completely exhausted. I had a fever. My chest hurt. I had sinus issues. I've never felt this sick and it happened so quick. So I called my doctor and he said to take a COVID-19 test in 3 days. I remember feeling achy, very achy. I just got very sick very fast, miserable. I found out on Sunday that the woman I was with had COVID-19. Her 3 tests came back positive and she was sick also. I think I got my COVID-19 test on Monday at the pharmacy and I got my results Tuesday or Wednesday and I tested negative. I was sick from about that Friday, 24 hours, then got better. I had that exhaustion and fevers too. I was so exhausted, I couldn't walk to the car and couldn't even get to the pharmacy. I was loopy and couldn't think straight. I couldn't do the basic or important things like grocery lists, etc. It was debilitating and I was miserable. I started to feel better in the beginning to mid April. Sometimes I was so tired I couldn't write and couldn't make out my letters. That's why my doctor thought I had COVID-19 because I had the exhaustion and the fevers. I had a GI doctor in the area and she assumed I had COVID-19 as well. I have noted that March 21, I felt loopy. Less exhaustion on March 28 but thinking issues, taking naps. I started taking walks on April 3rd, so I may have started to feel better. I'd say around April 7th, I was incredibly tired. April 8, noted I was miserable. April 10, I noted that I had a lot of energy to do basic things. So I'd say mid-April was when I started feeling better. I could focus on what I needed to do and take walks. It was hard for me to take walks when I was miserable. I couldn't even walk steps. I was exhausted and it was horrible, head felt miserable and I couldn't think straight and I couldn't walk. It was very hard and frightening too. I feel fine now, recently had a 4th dose on April 19, 2022. Felt miserable for 2 days and now I feel fine, like it never happened. I also took a second COVID-19 test on March 15, 2022 and I got the results on March 16 and it was negative. Due to the symptoms, doctors assumed that it was COVID-19 and possibility of false negatives.
I came down with a bad headache about 2 1/2 hrs after the shot, but then at approximately 11am my right eye developed a red welt on the eyelid and then my eye proceeded to puff up until it was swollen and my eyeball was bright red.
Recipient had a 20-30 seizure 8 minutes following vaccination. Medic arrived during seizure, repositioned for safety, recipient came back to consciousness with no memory of symptoms. Recipient still felt "shakey". Blood pressure: 120/58, HR: 55, SPO2: 100%. She was sent immediately to Hospital. Report called into ER before she arrived.
First time seizure. Postictal for 45 minutes. Iv. Ecg/12 lead. Bgl, Head CT, MRI, EEG. All negative. Awaiting sleep study and M.S. appointment in May. Unknown cause at this time. My neurologist wanted me to report it.
Increasing soreness at site of injection accompanied by mild itch and mild body ache same say as vaccination. Increasing body aches and fever of 100.5 F within the first 24 hours accompanied by fatigue. Possible mild cough with sneezing, but not certain if this is normal seasonal allergies.
The doctor told me to take ibuprofen, they did lab test for D-dimer. They did discover I have High Blood pressure. I went to emergency on 12/7/2021 because I was experiencing chest pain and I have never had this kind of chest pain. I had COVID at the beginning of October, I did recover well. I did have COVID last year same time in 2020.
Cellulitis left upper arm. Rx: Co-trimoxazole suspension 2 tsp BID x 10 days.
Client was vaccinated on 5/13/21 and she was 11 at the time with the Pfizer vaccine. She received 2nd dose on 6/3/21. Her mother did sign up with an incorrect date of birth which is why she went through unnoticed. I called mother and she states that she though client was 12 years at the time. Mother states that client experienced no adverse reactions from both doses of Pfizer.
Woke up with a severe headache, nausea, diarrhea. Also experienced horrible leg cramps. Vertigo and head spinning when down from bed. Recovering.
Raised, swollen, red, hot area about 2 inches by 1 inch at site of injection.  **NO** "blisters".
Chills and fever started from 15 hours after administration; Chills and fever started from 15 hours after administration; This is a spontaneous report received from a contactable other- health professional (in response to HCP letter sent in cross referenced case). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration on 10Feb2021 (at the age of 47-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced chills and fever started from 15 hours after administration. The patient took 1 extra strength TYLENOL as therapeutic measure for both. Fever went away and did not repeat any other symptom. It was reported that the patient did not receive re-vaccination. Outcome for chills was unknown and for fever was recovered in 2021. Do you consider the Pfizer product had a causal effect to the adverse event: Yes.  No follow-up attempts are needed. No further information is expected.
2nd dose injected on 02/19/2021 death on 2/24/2021
Patient started developing throat swelling, shortness of breath, and paresthesia of the left upper extremity and neck approximately 10-15 minutes after receiving the first dose of the Pfizer Covid Vaccine. Visual examination detected slight facial and periorbital swelling but no posterior oropharyngeal edema. Patient was slightly hypertensive (150/93) and tachycardic (105 bpm) upon arrival in the ED.  Patient had no rash or urticaria. Diphenhydramine 50 mg, famotidine 20 mg, and lactated ringers administered IV. Patient was observed for several hours in the ED, and discharged in stable condition.
Pregnant patient when received first dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose). The delivery occurred  on 21-Jan-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
5 minutes, post vax, pt stated "I am feeling very lightheaded. Pt was pale, diaphoretic over head and upper torso. BP was 80/40 and pulse rate was 100. He appeared to be having a near syncopal episode. Denied chest pain, SOB, difficulty breathing. could realize symptoms and did not lose consciousness. Pt was instructed to lower his head between his knees while in a sitting position. BP at 14:18 80/40, pulse now weak at 60; still perspiring. Alert and oriented x 3. Still pale. 911 called. At 14:23, reported to RN that he was feeling better. No chest pain, rash, hives or SOB. His BP-100/72 and pulse 78 and regular. EMS team arrived and assessed the pt. BS per finger stick 186; BP-124/78; color improved. EMT performed portable EKG and recommended that the pt be transported to MCU ER via ambulance. O2 by mask applied and pt was assisted X 3 and ambulated to stretcher. Exited venue alert and oriented without further complaint.
received PENTACEL, DAPTACEL and ACT-HIB so the DTAP and Hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 years old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], daptacel and act-hib so the dtap and hib, portion is doubled with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Hib Vaccine Conj (Tet Tox) (Act Hib) and Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination.  On 22-Aug-2023, the patient received a dose of Suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot: UJ737AAA, Expiry date: 18-Sep-2023) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) (extra dose administered) (latency- same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, 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.
I noticed an inflamed with an area about 2" surrounding the injection site.  It was firm, very warm and reddened.  By Saturday morning around 7 AM this area had doubled in size, the area now reaches from my elbow to my armpit and has also started to feel itchy.
dizziness and loss of coordination in left leg; diagnosed TIA at hospital per symptoms; MRI and echocardiogram were normal
Patient was given Moderna Vaccine for 3rd dose. Patient does not fall under the approved Moderna age group.
Grandmother called stating that she thinks that child had reaction to shot given on 02/24. Child ran temperature and was given Tylenol all weekend. On Monday 02/28 child, still had temperature and began to vomit, had rash on back and face. Child then went stiff and was not breathing.  Ambulance was called. At the ER, doctor was advised of the shots he she received. Grandmother stated that they told her they did not believe it was a reaction from the IZ. They admitted the child with a dx of bronchitis. She was released the following day. After speaking with the nurse, it was noted that the doctor had stated no correlation between and illness and vaccines received. Confirmed hospitalization for pneumonia, ear infection, and bronchitis.
Sx began - 12-12-16 - pain/soreness (L) arm quarter size red raised bump- warm to touch. Pt taking ibuprofen and applying cool compress to site prn.
Headache, nauseous, fever, arm redness, dizziness, eatless.
Burning and extreme pain in legs and feet, eventually spread up my body. Lost the ability to walk and use hands. Extreme burning in limbs hands feet and face diagnosed with CIDP
Dermatology          9 year 10 month old female presents with c/o Rash HIB and Pneumovax was given yesterday. On left thigh where this was given there is a large area of Lacey rash. The area is also very painful to move or touch. Mother noticed this am.       Hip/Thigh          c/o Pain on upper left thigh where HIB and Pneumovax was given yesterday.       Constitutional          Denies : Fever.
Swelling and pain in ankle (the one I recently had surgery on). Increased pain and muscle spasms in back
burning on back neck shoulders with rash, red break out on arm  and face, tight feeling around the neck area, itching on skin and in ear, has continued off and on for two weeks now
COVID-19 symptoms started on the evening of 06/28/22; tested positive on 06/29/22. Symptoms were fever over 101, cough, headache, body aches, chills, and fatigue. My PCP started me on Paxlovid and then I'm also taking Mucinex, Tylenol, and Ibuprofen for the fever and the pain. Symptoms are still lingering today and since Paxlovid they have significantly decreased.
01/08/22 presents to EC ED for "left sided numbness and weakness". PMHx of "HLD, tobacco abuse, alcohol abuse"
I sustained sudden shortness of breathing and admitted to the hospital  I was diagnosed with extensive pulmonary embolus and was in the hospital for 4 days I was given eliquis  and  I am still on it I never had any history of coagulopathy nor do I have family history of clotting disorder I never smoked and I was active at the time of the incidence seeing patients in my office daily , I am thin and had extnsive work to exlude malignancy and all negative
didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Patient was concomitantly taking blood pressure medications.   Patient received IV fluids as corrective treatment.  Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine
Diarrhea; Severe stomach pain; Couldn't eat nor drink anything; Down in bed for 4 days; Couldn't eat nor drink anything; No strength; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days) and FEEDING DISORDER (Couldn't eat nor drink anything) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-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 DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days), FEEDING DISORDER (Couldn't eat nor drink anything) and ASTHENIA (No strength). Not Provided
pt recvd vax & had crying spells approx few hrs after vax; taken to er 19jul94 crying spells; PMD instructed cont w/ ped dt instead of dtp;
Rash--both arms, chest, both legs, red face. Neck and face felt like it was on fire; itchy. Taking Benadryl.
Induration Rt deltoid area - 1 1/2 diameter red - Pt. is able to use Rt arm freely. Warm compress, Zyrtec (pt is already on.) Pt. had no fever. "Local reaction only."
21JUN91 large, red, inflamed & swollen area around inject site; Llt below inject site is an area w/white raised bumps; 24JUN91 father stated involved area is better--most of redness & swelling gone;
Pt. states that after receiving the 3rd Booster of Moderna 11/01/2021, started experiencing symptoms 11/02/2021 of chills, fatigue, incontinence, double vision, and nausea. No noted Primary visit/communications. Fatigue remains, other side effects have subsided.
At 10:25 AM patient stated, "I'm dizzy. " Patient began sweating. BP 120/80, P 56, R 20, equal and unlabored. T 97.7, Oxygen Saturation on room air 100%. Patient alert and oriented to person, place, and time. At 10:40, patient denied dizziness. Patient stopped sweating. Patient stated, " I feel better". BP 139/89, P 56, R 20, equal and unlabored, Oxygen Saturation on room air 100%. No signs and symptoms of distress. Notified provider and patient cleared for discharge. Instructed to follow up with primary care physician. Instructed to report to ER or call EMS if any symptoms of distress occur. Patient and wife verbalized understanding. Discharged from site at 10:52 AM.
I had a sore throat; headache; fever; fatigue; and  nasal congestion. I went to an urgent care client and ran test and tested positive for COVID-19. My symptoms lasted for 6 days.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated with a dose of MMR II, lot # L024266, expiry date 01-JUL-2017 (dose, route of administration and anatomical location were not specified). The administered dose of MMR II underwent temperature excursion under 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several case received from the same reporter. Additional information has been requested.
None. Patient received 0.25mL of FLULAVAL QUADRIVALENT vaccine which is only licensed for those 3 years old and older.
She came back about 90 minutes later and her entire arm , face, and upper back were beet red like she got a sunburn. Her legs were a little wobbly. She is allergic to Benadryl.  I checked on her the next day and she said she was feeling much better.
first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series; Product availability issue; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (first dose of the Moderna Covid 19 vaccine on December 17, 2022/Patient has not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series) and PRODUCT AVAILABILITY ISSUE (Product availability issue).    No concomitant medications was reported. Patient reports no side effects after the first dose. No treatment medications was reported.  Patient had not yet received his second dose of the Moderna Covid-19 vaccine series. More than 36 days between first and second doses of the Moderna Covid-19 vaccine series The patient cannot find a vaccination provider to give him his second dose of the Moderna Covid-19 vaccine series. Patient was also told by a Pharmacy that he could receive the Pfizer vaccine for his second Covid-19 vaccine dose.