chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My daughter has passed out TWICE since receiving these injections and experiences increased headaches while the finishing up the series. She has no previous history of passing out and has always been the picture of health. We are very concerned over the long term effects of Gardisil and want the consequences of her receiving these shots documented with both the FDA and her PCP office. Thank you.  9/15/09 PCP medical records received DOS 7/10/07 to 8/24/09. Assessment: Acute strep pharyngitis. Mother says child fainted after first HPV vaccine but did fine with 2nd and 3rd doses. Presents with sore throat, decreased appetite, decreased activity, cough. Tonsils +3 with exudate, mild erythma oropharynx, tender enlargement of anterior cervical nodes. Acute pharyngitis. Headache. Difficulty swallowing, problems falling asleep, nasal congestion/discharge, abdominal pain. Left forearm deformed, tender, numbness, tingling. Left breast tender.
Pt developed full body rash including fine sandpaper rash as well as multiple hives within ~ 24 hours of flu vaccine. Hives controlled now with Benadryl (PO & topical), but hives reappear as Benadryl wears off. He was also taking a magnesium supplement when he received the vaccine, so he discontinued that when he saw the hives.
Mother notified someone at front desk that her daughter might be having a reaction to the shots. Mother stated that her daughter was breaking out with a rash. On observation, child is having red areas on lower abdomen and also all over back. Mother denied any wheezing while she was in clinic waiting area. Notified PCM about situation and she went to speak with mother. PCM said she was going to prescribe BENADRYL for patient. Patient just had reaction about 20 min. ago so not sure of what the outcome will be. Child was here for well child checkup and mother stated that the rash was not there before vaccines were given.
Approximately 2 weeks ago the patient began feeling unwell. He missed his second vaccine appointment due to feeling unwell. He describes a two week history of cough, SOB, and fatigue. He reports he has not eaten anything in 5 days due to loss of appetite. He presented to the ED on 4/28/21 with an SpO2 of 85%, which improved to the mid-90s on 2L nasal cannula. The patient tested positive for COVID-19 on a rapid swab on 4/28/21. He received dexamethasone in the ED and was admitted to the hospital for further management.
Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series.; This is a spontaneous report from a non-contactable other hcp.   A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 48-year-old), as dose 1, single for COVID-19 immunization (No reaction on previous exposure to vaccine). It was reported that on 13Aug2021, "Patient has tested positive for COVID-19 following the completion of the COVID-19 vaccine series" and it resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 test): positive, on 13Aug2021. The type of the COVID test was unknown. It was unknown if the patient received treatment for the events. The outcome of the events was reported as not resolved.   No follow up attempts were possible. No further information was expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
vertigo; slight headache; minor chills; sore arm; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 16:00 (Lot number: EN6202) at the age of 68 years as dose 2, single for covid-19 immunisation. Family history included: "vertigo" (unspecified if ongoing), notes: mother had vertigo in her 70s due to Menieres syndrome of the inner ear; "Menieres syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 04Mar2021, outcome "recovering", described as "vertigo"; PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "sore arm"; FATIGUE (non-serious) with onset 26Feb2021, outcome "recovered" (09Mar2021), described as "tiredness"; CHILLS (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "minor chills"; HEADACHE (non-serious) with onset 28Feb2021, outcome "recovered" (01Mar2021), described as "slight headache".  Additional information: Patient mother had vertigo in her 70s due to Meniere's syndrome of the inner ear. The patient was asking for her vertigo because she mentioned that 6 days after the second dose it was still there. Then she started to have episodes of vertigo on day six and that worried her. It did happen many times during the day whenever she would turn her head or get up or sit down. She has had the vertigo every day since from 04Mar2021 to today although it seems to be getting less. Mentioned she was very healthy and did not take any medications. The patient did not have any prior vaccinations (within 4 weeks). There was no relevant test. There were no additional vaccines administered on same date of the Pfizer suspect.  No follow-up attempts are possible. No further information is expected.
25-year-old Caucasian male with no significant past medical history, he was seen in the hospital on the 24th of March for right facial weakness, prescribed a week of steroid and antiviral, his symptoms started with an ear infection on the right side a month and a half ago, he did not have a rash in or around the ear but it was beet red, [he had the zoster vaccine as a child], 1 week later, he had drooping of the right side of the face, went to urgent care where he was given 3 days of amoxicillin, it did not help and he developed nausea, it was stopped, then he went to the hospital and was treated, there was no improvement, hence went to ENT where he was given a 12 day dose of tapering p.o. prednisone 60 mg and decreasing by 10 mg every 2 days to nothing and 14 days of repeat antiviral therapy, he finished them 3 days ago, right-sided facial weakness has not improved, there is no pain, when all this started, he had vertigo with spinning sensation all the time for about a week and a half with decreased balance, both have resolved, he had a brain MRI in the hospital that was unremarkable, his hearing is normal, denies any problems with speech, he thinks the right eye closes when he sleeps, he does not patch it or use artificial tears, no headache, no numbness or weakness reported, no facial pain, no prior history of similar problems, left side of the face is fine, 2 weeks prior to symptom onset, he had the first dose of the Pfizer Covid vaccine.  No history of COVID-19.
her vein on left arm is alleviated and is dark blue in color; hard to touch; sore; site of injection has big red mark; chills; Bodyache; Joint ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection has big red mark), CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore). On 11-Feb-2021, the patient experienced VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color). On 06-Feb-2021, CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had resolved. On 10-Feb-2021, VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore) had resolved. At the time of the report, VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.4. On 06-Feb-2021, Pyrexia: 100.4.         Treatment information was included Tylenol  No concomitant product was provided
Patient called morning of 10/24/17 to say that her left arm has swollened down to elbow. She was told to go to clinic/ER. Follow up on 10/25: Patient reported swelling has gone down but area still red/warm.
Breakthrough COVID-19 case with symptom onset 8/27/2021: Fever, Shortness of breath/difficulty breathing, Fatigue or tiredness, Chills, Cough. Hospitalized 8/27/2021-9/3/2021. She spent 7 days on full oxygen and receiving treatments, and is back home.
Information has been received from a licensed vocational nurse concerning a 64 year old female with diabetes, hypercholesterolaemia, hypertension, emphysema, morbid obesity and drug hypersensitivity to ACTOS, codeine, DARVOCET, dexamethasone (MSD) (WAES # 0807USA00172), GLUCOPHAGE, ketoconazole, LIPITOR and ezetimibe (MSD) (WAES # 0807USA00173), who on 24-JUN-2008 was vaccinated subcutaneously in the deltoid with 0.65 ml of ZOSTAVAX (Oka/Merck) (lot # 659409/0409X).  Concomitant therapy included DYAZIDE, estradiol, HUMULIN, sitagliptin phosphate (MSD), LYRICA, NASACORT AQ, enalapril maleate (MSD) and LUNESTA.  A nurse stated that a patient's tongue, face and throat began to swell after receiving a dose of ZOSTAVAX (Oka/Merck) (Lot # 659409/0409X) on 24-JUN-2008.  The patient was treated with epinephrine and BENADRYL and the symptoms resolved.  No other symptoms or treatment reported.  The patient recovered on 24-JUN-2008.  Medical attention was sought: office visit.  There was no product quality complaint.  Upon internal review, tongue, face and throat swelling requiring epinephrine were considered other important medical events.  Additional information has been requested.
Slight headache; Arm swollen; Arm hurt for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:45 (Lot number: ER8734) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: AMLODIPINE taken for hypertension. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Mar2021, outcome "recovered" (31Mar2021), described as "Arm swollen"; PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "recovered" (01Apr2021), described as "Arm hurt for a couple of days"; HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (03Apr2021), described as "Slight headache".  Additional information: No additional vaccines administered. No prior vaccinations within 4 weeks. Patient (Pt) reported that she began taking amlodipine about 2 years ago and that she took a different medication prior to amlodipine. Pt was diagnosed with high blood pressure when she was 37, about 11 years ago. Patient was calling to report a side effect, reported that when she got the first dose of the Covid-19 vaccine, her arm was swollen and hurt for a couple of days and reported that everyone was saying that the sore arm was happening to them and she didn't think that she needed to report the event to Pfizer. Pt arm started hurting real bad when she went to drive off from the vaccination facility on 30Mar2021. Pt experienced a nagging headache, the pain was right between her nose and states that she saw that a headache was listed as a side effect. Later Pt got the second dose of the Covid-19 vaccine in her left arm because her right arm had hurt so badly after the first dose. No Emergency Room or Physician Office visit. No details provided on the other patients that reported a sore arm after receiving the Covid-19 vaccine. Pt reported that she took the vaccine first because her parents are 70. Pt reported that her parents did not want to get the Covid-19 vaccine, so said that she would get it first so her parents would see that it was fine. Pt reported that if she tells her parents about her side effects, they will not get the Covid-19 vaccine. Pt reported that she is not going to tell her parents about her side effects because she wants her parents to get the Covid-19 vaccine. Pt reported that she does not like needles and was not going to be getting any more shots than she needs to.  No follow-up attempts are possible. No further information is expected.
Pt received flu shot, TD and HVP on 09/25/18. Pt called on 09/26/18 reports she had feverish, swelling in her throat, and dizziness. She took IBU and her symptoms resolved. Reports he had a cold last week.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from the rash), RASH (Rash on her neck, rash on her torso, little rash in her leg, little spots), MYALGIA (Severe muscle aches and body aches), CHILLS (Chills) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for Reflux gastritis, LEVOTHYROXINE and ATORVASTATIN for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (Severe muscle aches and body aches), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.4°F) and FATIGUE (Very tired/ A little tired). On 08-Mar-2021, the patient experienced PRURITUS (Itching from the rash) and RASH (Rash on her neck, rash on her torso, little rash in her leg, little spots). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (Itching from the rash), RASH (Rash on her neck, rash on her torso, little rash in her leg, little spots) and FATIGUE (Very tired/ A little tired) outcome was unknown and MYALGIA (Severe muscle aches and body aches), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 100.4°F) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nov 2nd I started coughing and  I took cough medicine and it stopped. Friday Nov 5th I had a low grade fever of 99.7 and my job made me take a PCR test. It came back positive. I have not experienced any other symptoms. I have been taking Sudafed, steroid pack- Z pac. I work in a doctor office and a doctor there prescribed them to me. Can not return back to work until the 13th.
3 in x 3.5 inch rash at site with a second, connected 3 in x 3.5 inch rash below it, both red and warm.
Around 4 pm I realized that the headache that started sometime earlier was growing significantly. I decided to check my blood pressure as I've experienced a headache due to BP spike before. At that time my BP was approx 140/90. I kept checking my blood pressure and it continued to rise. At its highest point it was 167/105 with an excruciating headache and a severe burning skin sensation all over my body but in particular on my head. We had Hydrochlorothiazide 12.5 mg left over at the house so when my BP reached approx 160/100 by 6 pm I took one pill. The BP continued to rise and as i had no pain killers at home other than aspirin i sent my husband to get me tylenol for the headache. I took two pills around 8 pm. This is also when the BP was at its highest. It finally stabilized around 11 pm and the headache went away.
Information has been received from a physician concerning a female patient with allergy to other unspecified vaccine and a history of becoming disoriented and loopy when other vaccines administered who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently the patient experienced becoming disoriented, lethargic and loopy. She would not receive any further treatment following the first dose. After vaccination the adverse event improved. There was no treatment given for the adverse events. The vaccination of GARDASIL was discontinued and not reintroduced. The patient did not seek medical attention. At the time of the report, the patient recovered from the events. Follow up information has been received from the physician concerning the 18 years old student patient with no illness at the time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 24-APR-2012 at 15:02, was vaccinated with first dose of GARDASIL (lot # 672652/0022AE) IM in the left arm. It was reported that on 25-APR-2012, the patient felt hot, felt emotionally unstable, unstoppable crying, patient felt "off today" and had trouble focusing. Parents stated that she was speaking slowly and was not herself. On an unspecified date, flu test showed negative result and blood pressure was normal. On 26-APR-2012, the patient recovered. The patient required and ER visit. No further information is available.
Patient complained of nausea/vomiting at 3PM on 10/2/13, diarrhea on 10/3/13 and woke up with hives on Friday 10/4/13. Patient isn't having any trouble breathing. Advised her to take BENADRYL for rash and to call or if worsened.
This case was reported by a physician via sales rep and described the occurrence of welts in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced welts and swelling. On an unknown date, the outcome of the welts and swelling were unknown. It was unknown if the reporter considered the welts and swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported to the representative that patient's (HCP's son) arm blew up and there was a welt on his arm. No additional information was provided. The reporter would like a follow up from the safety department.
Dehyrated and tiredness for the first 2 days; dizziness over the course of several days. Symptoms have improved daily.
Shortness of breath and coughing began day after vaccine, since then it has continued and worsened and now I have a heaviness in my chest as well as occasional heart fluttering
STARTED AS SMALL RED AREA ON 10/19, ON 10/20 AREA BECAME MORE SWOLLEN, AREA 11CM X 13CM AREA INDURATION TO LEFT DELTOID. TREATED WITH BENADRYL AND HYDROCORTISONE 1%.
11 y seen in the office 9/3/03, history of varicella vaccination 2 weeks ago. 2 day history of rash diagnosed today as chicken pox. Mild rash with 1 days history of fever.
I started to feel sick 06-27-2021. My fever went up to 103.F on 06-28-2021. I started with chills, nausea body aches but by early afternoon on 06-29-2021, that's when I got pain on the center of my chest. Felt like someone was squeezing my heart, had pain on my left shoulder, upper chest and neck. In the middle of the night on 06-30-2021 at 2:30am my wife took me to the hospital and I was eventually diagnosed with pericarditis. I felt like I was having a heart attack or thought I had pulmonary embolism and these were ruled out at the hospital. A CT scan was also performed to rule out any damage. I was in ICU for couple of days. I am definitely not 100%, I still feel very tired and I am not cleared for strenuous physical activities. This has affected my daily living activities.
pt recv vax;PC to mom; mom states pt cried "screamed" p/ vax;T 101 & lost appetite;saw er MD who gave dph; pt lost 1 lb;sx lasted 2 days;had a rash; saw PMD 14aug95, pt has eczema;
pt admitted to Medical Center on 12/30/21 and dx with COVID and AHRF; dc'd to home on 1/12/22; 1/17/22 became increasingly SOB, EMS called; O2 saturation in 70s; brought to ED and placed on BiPAP; no evidence of PE; placed on steroids and ABX; transferred to ICU; sepsis; worsening respiratory status requiring intubation and mechanical ventilation; continued to decompensate; given vasopressors; went into cardiac arrest; CPR performed; didn't achieve ROSC; pt expired in the hospital
No known adverse effects; reported that an administered dose of PNEUMOV AX underwent a temperature excursion on 11/27/2019; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.      On 02-DEC-2019, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S026366 has been verified to be a valid lot number, expiration date was reported and validated as 17-SEP-2020) (product storage error). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 51 degrees Fahrenheit for a time frame of five hours on 27-NOV-2019, without any previous temperature excursion; which was detected by a digital data logger.
Patient was given Hepatitis B dose 3 too early at 4 mos. old. Patient was only 4 mos. old and should not have received the vaccine until patient is 6 mos. old. Patient was not harmed in the event. Patient received extra vaccine and will be re-vaccinated when correct time is due 2/2/18, appointment scheduled.
First day after the shot my arm was a bit sore and I had a slight headache that went away in a few days.  Nine days later in the evening my arm swelled beneath the site of the shot and became feverish, swollen and hard. I had no bodily fever. I took some benedryl after about an hour, but that did not help. The next morning the arm looked and felt the same with a persistent dull ache and in addition to the redness on top of the arm  underneath was also red and I have a small lump on my bicep.  I also woke with a headache and took ibuprofen. That helped to relieve the hard swelling in the arm.  I saw a physician at my provider's office who instructed me to monitor it and if it worsens to return. I am due to have a booster on 2/9/21, but a bit reluctant at this moment.
Bell's palsy. Treatment: Prednisone for 7 days. Slow recovery from nerve damage and partial facial paralysis. Mild symptoms 2.5 months after onset.