chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart seemed to be racing; Rash; muscle aches; tiredness; low grade fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included historical allergic reaction to Penicillin and also got itchy over 40 years ago. The patient's concomitant medications were not reported. After first dose of vaccination, patient experienced mild symptoms, including, muscle aches, tiredness, a low grade fever which was around 99 point something. He took ibuprofen and went to bed. It lasted for 12 hours. But on an unspecified date, his heart seemed to be racing for first few hours and had a rash on his body. Patient asked if that was a severe reaction and does it prevent him or contraindicate him from getting the second vaccine dose. It was also reported that that he already informed his primary care physician and physician wasn't sure and advised him to call Pfizer to speak with a medical professional. The outcome of the events his heart seemed to be racing for first few hours and had a rash on his body was unknown and of all other events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 9 days after my 1st dose, I developed a red raised bump on my L upper arm at the injection site. This itchy bump grew larger throughout the day and is currently about 2 inches in diameter.
UrticariaPruritus  axillary adenopathy. Initially on the right side but also is occurring on the left side. Several days later  Narrative:  employee with several different medical issues including IBS with constipation and diabetes. Patient reported developing adenopathy about 6 days after having the first vaccine under her right arm and now has also developed some adenopathy under her left arm. Recommended that she follow-up with her primary care physician for further evaluation.
lung problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems".  Additional information: The caller would like to know where she can get the Pfizer COVID-19 vaccine because she stated that in her area, all of the pharmacies have moderna and they don't have the Pfizer vaccine. The caller also said that she is immunocompromised and has lung problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy). On 24-Feb-2021, DIZZINESS (dizzy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
The pt was waiting in center for 30 minutes wait and 20 minutes into wait she experienced flushing of both arms and face, c/o of severe, intense headache centered in the middle of forehead, Also nasal stuffiness. Dr notified and we continue to watch pt x a total of 1.5 hours. Flushing disappeared w/in 5 minutes and pt felt better at 1.5 hour late. Pt took a Benadryl.
Experienced typical side effects the day of the shot. Took Tylenol and Ginger Ale and slept. The next day the usual sore arm, started developing a sore throat around 2pm. The next morning, sore throat was still lingering but started developing a cough with it. Cough lingered all day. Currently the next morning , sore throat still present and cough also, but feels like I have mucus/phlegm in my chest/throat when i cough. Like a typical cold/flu symptom of sore throat/cough
Headache, full body rash, hives, itchy after 1 hr post shot. Limited difficulty in swallowing. Relieved by BENADRYL.
PT HAS HX OF SHINGLES;  PT CC: INJECTION SITE SWELLING/REDNESS--BASEBALL SIZE; PATIENT REPORT NUMB LIPS--SAME SYMPTOM WHEN SHE GOT SHINGLES, PT CONCERNED WILL SHINGLES FROM THE VACCINE
hives; rashes at injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and VACCINATION SITE RASH (rashes at 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) 2 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE RASH (rashes at injection site). On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) and VACCINATION SITE RASH (rashes at injection site) outcome was unknown. Not Provided          Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD21-081932 (E2B Linked Report). This case was linked to MOD-2021-090626 (Patient Link).; Sender's Comments:  MOD21-081932:
Mother states that about 20 mins after injection when patient was getting in the car she noticed a red rash going down patients right arm. Within the hour the patient was covered in a red rash on back, arms and abdomen. After examing the patient it was clear that he had a allergic reaction to the vaccine.
Fatigue almost immediately, lasting 36 hours Intermittent headaches, treated with ibuprofen lasting 36 hours Whole body aches starting 12 hours after injection, lasting 24 hours Injection site bruising and soreness
SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included reaction to high does flu shot, and concurrent conditions included allergic to shell fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious
Patient was given a Pfizer bivalent orange top 5-11 years old instead of getting a 12^ bivalent grey top. Called guardian to return today to receive the other half. Patient unable to return today and will call to schedule to come in and get revaccinated.
Information has been received from a lab technician in a physician's office concerning a 4 year old female who in May 2000 was vaccinated with a doe of varicella virus vaccine live. The reporter indicated that in approximately March 2003 to April 2003 the pt developed a mild case of breakthrough varicella. It was noted that the pt recovered. Follow up information indicated that the pt had a "light case"; no problem or fever were noted. The reporter also indicated that the pt's sibling had a similar experience after vaccination with a dose of varicella virus vaccine live (WAES # 0307USA01574).  No further information is available.
Parent phoned Health Dept to report child has a diffuse light pink rash all over body and asked  if her child's rash could be caused by vaccines he received on 5/16/19.  She currently does not have a  pediatrician until the first of the month.  Parent reports that rash is not raised or itchy.  Child is not accompanied by a fever or any type of illness.  Instructed parent if she did not feel comfortable about the situation and went to the ER to let doctor know that vaccines were given.
This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 30-DEC-2015, the patient was vaccinated with an expired dose of M-M-R II subcutaneous injection (lot # J016234 and expiration date on 19-DEC-2015) (strength, dose, frequency) were not reported. There was no concomitant medication reported. The nurse reported that there was not known adverse effects. Additional information has been requested.
H received Pfizer booster 1/28/22 (first two Pfizer 7/14/21 and 8/4/2)/ Admitted to medical center of facility 2/14/22 with massive stroke. No clear risks for stroke he died 2/20/22. He had acute left mca occlusion and L ICA thrombus on CTA
Narrative: Pt is 72 yo with PMH of RLS, arthritis, depressive disorder, insomnia, PTSD, opioid abuse, alcohol dependence, cannabis dependence, GERD, back pain, ADHD. Patient had first dose of Janssen COCIV-19 vaccine 3/10/21. Per provider note 11/23/21 pt had small rash after first dose of COVID-19 vaccine. No documentation in chart that a rash after first vaccine was reported by patient. No other documented ADRs. Rash treated with antihistamine (non-facility hydroxyzine) and OTC hydropcortisone.
(2nd vaccine injection) Significant bleeding from L arm during injection, that evening developed severe abdominal pain, diarrhea, chest pain and heart racing. Went to the ER. Symptoms continued  to worsen with difficulty swallowing, after diarrhea became constipated (no motility), tinnitus, spinal chills,and joint pain, L inguinal pain.  Several months later and still having difficulty - neuro problems developing
This spontaneous report as received from a physician refers to a 4 year old male patient. On 08-MAR-2013 the patient was vaccinated with a dose of PROQUAD, subcutaneously and the second dose of VARIVAX (merck) inadvertently. No adverse effects reported. Additional information has been requested.
After about 2 minutes of receiving the vaccine, patient started to feel itchy, developed hives, and had an "itchy throat"... about a minute later she went into anaphylaxis
5 hours post injection - extreme fatigue; 7 hours post injection - diarrhea; 12 hours post injection - extreme body aches, chills, headache, and swollen/painful lymph node on underarm of injection site; 12 - 48 hours post injection - fatigue, body aches, and headache continued; 55 hours post injection - consistent itching sensation on lower extremities (all over legs, would not stop, had to apply cortisone cream all over both legs).  I had no side effects with first injection.  It's been  5 days since I received the second injection.  During that time, the diarrhea and  headaches have been off and on.  Headache does not go away with Tylenol.  I do also suffer from migraine headaches and have had to take 4 abortive migraine pills to keep the headaches manageable since receiving the injection.  All of the side effects I experienced, are (from what I have read), common with the second vaccine with the exception of the itchy legs.  I did not have any rash or hives develop on my legs, but they were itching so badly it was keeping me from being able to go to bed and fall asleep.  I do not have allergies.
Hives to face. Given 1 mg/kg BENADRYL orally. Hives resolved within 5 minutes.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient got sick the next day but her symptoms were resolved by the end of the 3rd day (unspecified). For tolerance to next dose, refer case US2018GSK182018.
The following evening awoke with auditory hallucinations that repeated multiple times throughout the night; 12 hours after the second dose awoke with extreme abdominal pains.; Threw up 3 times; dry heaving for 12 hours nonstop; Woke up in a sweat; They were like nightmares that continued to hear after woke up.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 14:15 (Batch/Lot number: unknown) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 21Nov2021, when the patient was 8-years-old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: HALLUCINATION, AUDITORY (medically significant) with onset 16Dec2021 01:00, outcome "unknown", described as "The following evening awoke with auditory hallucinations that repeated multiple times throughout the night"; ABDOMINAL PAIN (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "12 hours after the second dose awoke with extreme abdominal pains."; VOMITING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "Threw up 3 times"; RETCHING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "dry heaving for 12 hours nonstop"; HYPERHIDROSIS (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "Woke up in a sweat"; NIGHTMARE (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "They were like nightmares that continued to hear after woke up". The patient reported nothing like this ever happened before. The events "the following evening awoke with auditory hallucinations that repeated multiple times throughout the night", "12 hours after the second dose awoke with extreme abdominal pains.", "threw up 3 times", "dry heaving for 12 hours nonstop", "woke up in a sweat" and "they were like nightmares that continued to hear after woke up." were evaluated at the physician office visit. The patient was not hospitalized for the events. Therapeutic measures were not taken as a result of hallucination, auditory, abdominal pain, vomiting, retching, hyperhidrosis, nightmare. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
58 yo female 2nd dose Pfizer. Pre-medicated with antihistamine 30 minutes prior to inoculation. Approximately 15 minutes post-inoculation she complained of tingling on the roof of her mouth and a mild itching sensation on lips. Observed for 30 minutes without intervention. Discharged to home.
5 days p/vax, pt devel inj site rxn w/tennis ball-sized area of redness & "pimple-like bumps". Next day bumps resolved but area became warm. Pt to MD who described rxn as"4 by 4 irregular red patch w/bright red margin".
22-year-old female presents to the ER with possible reaction to a Covid vaccine.  Patient states that she received her Covid vaccine.  Approximate 10 minutes later she states she started having tingling down her right arm where she got the vaccine.  The staff report that patient went to get up and felt lightheaded and dizzy and nauseated and almost passed out.  They state that they immediately brought her here to the ER.   Currently here in the ER patient denies any problems swallowing or problems breathing.  States she does not feel short of breath.  Patient states she just feels really tired.  She reports she has not ate today and has only had a couple sips of liquids.  States she is been in her usual state health up until the incident today.  Denies any cough congestion.  Denies any chest pain shortness of breath.  Denies any vomiting or diarrhea.  Denies any headaches or visual changes or focal weaknesses of the extremities.   Denies any itching currently or rash.
1/19/23 TC from client. Client reports on 1/11/23 sx began with unsteadiness and arm soreness. Client states on 1/12/23 arm soreness worsened along with site redness, swelling and itchiness. Client states he took benedryl which alleviated sx. Client states on 1/16/23 he felt uncomfortable with chills and nausea and vomiting with vomiting continuing through 1/17/23. Client went to the ER on 1/16/23 and was tested for both flu and Covid and was negative. Client states he also had a CBC blood test done by his Oncologist which showed elevation in immature granulocytes. Clinet was prescribed Ondansetron for the nausea by his Oncologist. Cllient reports his got better on 1/18/23.
Breakthrough COVID-19 case with symptom onset 8/27/2021: Fever >100.4, Chills, Muscle or body aches, Runny nose/Congestion, Cough (new onset or worsening of chronic cough), Shortness of breath or difficulty breathing, Chest pain, Fatigue or tiredness, Nausea or vomiting, Diarrhea (>/=3 loose/looser stools in 24 hr period). Hospitalized 9/3/2021. Still in hospital 9/7/2021 at time of interview. In ICU.
a 37y.o. at 37w3d gestation  admitted to hospital for planned C-section due to  transverse spine down presentation. Patient asymptomatic tested prior to surgical procedure and delivery per protocol. No known history of previous positive test. Patient managed on isolation while in the hospital. Infant required NICU care on delivery O2 stats  in the 70's-80's. Deep suctioning performed and oxygen administration performed. BW Weight: 3330 g. Infant being managed in NICU for needed care and on isolation per protocol pending COVID testing x2 at 24 and 28 hr - both which have resulted negative at the time of this reporting
No reaction to the 1st dose. Throat began swelling after 2nd dose; took Benadryl every 4-6 hours. Chest and legs began to break-out in rash.
her blood pressure has been going up and down; arm was hurting; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer wanted to report since she got her first Pfizer covid vaccine on 17Feb, her blood pressure has been going up and down. When she wakes up in the morning, it is high. She is taking an extra blood pressure pill and is checking her blood pressure three times a day. When she first got the shot, her arm was hurting. The patient underwent lab tests and procedures which included blood pressure measurement: going up and down on an unspecified date, blood pressure measurement: in the morning, it is high on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Pt with likely anaphylactic reaction to vaccine given today.  Mom reports pt received vaccines and developed vomiting, drooling, lethargy and swollen lips within minutes of discharge.  On arrival pt appeared pale, was drooling, was sticking his hand into his mouth, and had wheezing on exam.  0.3 mg of epinephrine given and 911 was called.
This spontaneous report was received from a pharmacist regarding to a female patient of unknown age. The patient's medical history, concurrent condition, concomitant medications and drug allergies were not reported. On an unknown date, as a child the patient was vaccinated with M-M-R II (albumin status, dose, frequency, strength, lot/batch # and expiry date were unknown) as vaccine. On an unspecified date the patient was diagnosed with thalassemia and since unspecified dates, received blood transfusions every 3 weeks. The reporter refused to answer if any medical attention was sought, if any intervention was made to prevent serious criteria, if there was hospitalization or prolonged hospitalization and if the event was life threatening. The outcome of event thalassaemia was reported as not recovered. The causality of the event thalassaemia was not reported. Upon internal review the event thalassaemia was considered to be serious (medically significant).
Pt started feeling nauseated several hours after administration. The morning after ran fever of 102. Small amount of localized swelling noted at that time. Treated fever with OTC meds. Pt without fever or symptom within 2 days.
Normal arm soreness started around 4:00 PM. Aching in joints started around 6:00 PM.  Fever, aching, chills, and shaking started around 9:00 PM and continued for a few hours until going to sleep. Felt better about 24 hours after vaccine but fever came on again around 12:00 pm. Fever off and on for the next 24 hours despite alternating between Tylenol and ibuprofen every 3 hours. Fever 104.0 degrees F.
Pain surrounding a large, red lesion surrounding the injection site. The redness increased on day 3. The area is warm and hard  to the touch. It is also occasionally itchy.
1st dose of SHINGRIX on June 8, 2023 and second dose on June 21, 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 bouts in the past). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUN-2023, the patient received the 2nd dose of Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose of SHINGRIX on June 8, 2023 and second dose on June 21, 2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter is the wife of the patient. The patient received both doses of Shingrix vaccine at the nursing home. The reporter did consent to follow up. The patient received 2nd dose of Shingrix early than recommended time frame, which led to shortening of vaccination schedule.
Mom first noticed rash yesterday (04/12/16) afternoon, then noticed patient rubbing (R) side of face this morning (04/13/16). Rash isolated on groin and trunk area yesterday (04/12/16) that had spread to (R) hand today (04/13/16). TYLENOL was given at 0800 on 04/13/16 at home by mom and BENADRYL 2.5 mL at 1230 in office.
Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The next morning, the patient experienced extreme nausea. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No laboratory diagnostic studies were performed.No product quality complaint was involved. Additional information is not expected.
A local reaction below the site of adm. Given in upper right deltoid. S/S erythema and swelling twice the size of left arm.