chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Eye aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 17:00 (Lot number: 3303680) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Penicillin, notes: known allergies: penicillin. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose Number: 2), administration date: 31Mar2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (MANUFACTURER UNKNOWN, Dose Number: 1), administration date: Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "Headache"; EYE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Eye aches". The events "headache" and "eye aches" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19. The patient received eye drops as treatment for the event. Adverse event required a visit to Emergency Room/Physician Office.  No follow-up attempts are possible. No further information is expected.
Redness covering almost all of the upper right arm. Warm to the touch and itchy.
Pt recvd 3 doses of Engerix-B & following 3rd dose exp severe flu-like sx for 24 hrs p/inject; no known tx;
Information has been received from the pharmacist and from the 79 year old female patient, with no drug reaction/allergies and no pertinent medical history, who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 671075/1197AA, Expiration date 25-OCT-2012, diluent lot number is H001976, diluent expiration date February 2014) (dose and route not reported). The patient also called to add information that she took an unspecified blood pressure pill. The pharmacist reported that on 11-JUN-2012, after receiving the ZOSTAVAX (Merck) the patient developed redness and swelling at the injection site along and itchiness all over the body. The patient sought medical attention by called the pharmacist. TYLENOL as the treatment was given. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was not reported. Follow-up information was received from a physician who stated that the 79 year old retired female patient with Ca colon at time of vaccination, who on 11-JUN-2012, was vaccinated IM in the left deltoid with the first dose of ZOSTAVAX at 10:00 am. On 12-JUN-2012, the patient experienced rash on left arm, leg and chest. The patient also experienced pruritus that continued to present. The patient was treated with BENADRYL and CLARITIN and it helped. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
I have developed cluster headaches since shortly after recieving the J&J vaccine. I get a very intense headache daily. It comes on super fast and last about 20-30 minutes. Its always on the  left side right above my temple. I will massage the area and will often take 2 200mg of advil liqigels. I will also use peppermint essential oil on the area.
Hard to swallow as she feels like it's kind a  lumpy; Fever; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy), PYREXIA (Fever) and FATIGUE (Tiredness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) and FATIGUE (Tiredness) had resolved. At the time of the report, DYSPHAGIA (Hard to swallow as she feels like it's kind a  lumpy) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were not applicable. No treatment information provided by the reporter.
Reports temp of 101 at 9:30pm. States around 10am began feeling heart flutters and used pulse oximetery at home. Reports heart rate up to 160.
Left thigh swollen, red, painful starting approx 12 on 3/5/03.
Woke up Thursday with mouth and face droopy, unable to retain liquids. She went to her MD, who told her take aspirin and go to ER if problem persisted. She went to the hospital on Friday and they had her overnight for observation. She had an MRI and EKG and CT scan as well as BW. She was prescribed prednisone and valacyclovir and told to see a neurologist.
approxiametly 2 weeks after dose 3 of Gardisil patient complaining od left hip pain. Seen 9/11/09 cough, leg pain headache, rib pain.                                             Seen 9/15/09 epigastric pain, fatigue, back pain.                                             Seen 09/23/09 flank pain, nausea, cough,congestion
Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills.  About 3 am I had a fever of 99.9 degrees F ( normally 97.2 for me).  The next day I had a headache and felt fatigue.  I had diarhea 3 more times.  My spine ached a little when I went to bed about 11pm. No side effects by 1/10/21
Pt experiencing redness, swelling, itching, heat and pain at injection site.  Itching started Wednesday evening  (1/15) followed by rest of symptoms on Thursday (1/16)
Noted left upper arm red itchy rash, about 12-13 days from injection.  About 6" high by 4.5" across.  Not raised.  Lasted for about 4 days.  Was advised via online patient portal to get the second injection in the opposite arm.
Two weeks and two days after receiving the Varicella vaccine patient broke out the approximately 20 pox.  They began on her thigh.  Pt ran a fever of 102F.  Tylenol was given to treat the fever.  Child was taken out of school until the pox had scabed over.  This is this childs second dose of varicella the first given on 10/26/04
Initial information received on 28-Sep-2018 regarding an unsolicited valid serious case received from a consumer. This case involves male patient (age unknown) who experienced bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey, while he received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, back in the 90s, the patient received injection of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious bad reaction to td, he was fighting for his life, it was an anaphylactic reaction, sort of (anaphylactic reaction) and was turning grey with Unknown latency following the administration of DIPHTHERIA AND TETANUS TOXOIDS. This event was assessed as life-threatening. Lab data was not provided. Final diagnosis was (Life-threatening) bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for bad reaction to TD, he was fighting for his life, it was an anaphylactic reaction, sort of and turning grey. List of the documents held by sender- none. Sender's Comments: This is a poorly documented case in which male patient was reported to have bad unspecified reaction to TD vaccine in 1990's, patient was fighting for his life, it was a sort of (anaphylactic reaction) and was turning grey after vaccination with DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer. The time to onset is unknown. No information regarding medical history and tolerance to previous vaccinations was reported. Laboratory tests for alternative diagnoses were not reported. Based upon reported information, the role of one vaccine cannot be assessed.
Narrative:  COVID infection following completion of COVID vaccine series 12/21/20 COVID vaccine dose #1 01/08/21 COVID vaccine dose #2 08/02/21 Pt presents to screening reporting cough, headache, runny nose x3 days (07/31); COVID POSITIVE 08/03/21 Pt reports mild chills, mild cough, low grade fever (99.5), headache that gets worse with coughing, loss of taste/smell, muscle pain, runny nose, and mild SOB 08/04/21 Pt reports constipation and intermittent hot flashes and chills 08/05/21 Pt reports symptoms resolving and fatigue is improving 08/13/21 Pt calls into clinic reporting pleuritic chest pain, severe cough, and wheezing; advised to go to ED; CXR and CTA from ED visit WNL; pt is discharged home with rx for prednisone, albuterol, and azithromycin 08/21/21 Pt reported to be doing better but with persistent cough; rx given for benzonatate and fluticasone/salmeterol
PER PATIENT:   APPROXIMATELY 1 HOUR POST-VACCINATION, A.C. STARTED TO EXPERIENCE NAUSEA, NUMBNESS AND TINGLY SENSATIONS, RASH ON ARMS, LEGS, SWELLING IN ELBOWS, KNEES, CHEST PAIN, CHILLS, SLIGHT SHORTNESS OF BREATH.  THESE SIDE EFFECTS PROGRESSED AND WERE WORSE 4 HOURS POST-VACCINATION.   THE DAY AFTER VACCINATION, AFTER REGISTERING WITH V-SAFE, A REPRESENTATIVE CALLED A.C.  AND TOLD HER TO TAKE 75 MG DIPHENHYDRAMINE.  THE REPRESENTATIVE STATED THAT A.C.  WAS HAVING A MODERATE REACTION TO THE VACCINE (A.C. DID NOT EXPERIENCE ANAPHYLAXIS).  MOST OF THESE ADVERSE REACTIONS IMPROVED AFTER TAKING THE DIPHENHYDRAMINE.   TODAY, 2 DAYS POST-VACCINATION, A.C.  IS NO LONGER HAVING ANY SIDE EFFECTS AND IS RECOVERED.
Tremors, sweating, severe headache, vision flashes, pain in arm, fatigue, confusion, reduced consciousness, fainting, loss of balance, unable to ambulate or communicate, adrenal crisis, started in morning, treated at home with oral steroids for Addison's disease, doubled dosages for the next few days, pain and headache lasted beyond these symptoms.
Within 24 hours of administration, the patient complained of local edema and erythema. Forty-eight hours after administration, the patient has a 18cm x 13cm area of induration and inflammation with some urticarial lesions on her chest. The patient was treated with Benadryl and Prednisone.
Information has been received from a registered nurse concerning a pt who on 09/08/99 was vaccinated with several vaccines. In June 99 the pt broke out with a few lesions and experienced a runny nose and low grade fever. Unspecified medical attention was sought. It was reported that the pt's symptoms lasted for a few days. the patient is recovered. Follow up information reported that the pt developed a breakthrough disease with 10-22 pox noted. On an unspecified date the pt recovered.
Origianl COVID vaccine was by one manufacturer, 2nd dose was administered with different manufacturer by mistake.  Patient currently is aware and not experiencing side effects.  Told patient that agency does not recommend vaccination in this manner, but it is OK and does not recommend revaccinating
he most pain occurred in my left shoulder where I received both covid shots/All of my replaced joints started to be painful on the morning of 05May; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 (at the age of 79 years) as 2nd single dose for COVID-19 immunisation. Patient medical history included O.A (osteoarthritis), joint replacement. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM), meloxicam (MELOXICAM), omeprazole (OMEPRAZOLE) potassium (POTASSIUM) all taken in two weeks for an unspecified indication. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration, administered in left arm on 25Jan2021 as 1st single dose for COVID-19 immunisation. Patient reported that he had O.A. in both of his knees and both of his shoulders replaced. All his replaced joints started to be painful on the morning of 05May2021 at 09:00. The most pain occurred in left shoulder where he received both covid shots. A month later patient was still having pain with no relief. Doctor gave him a steroid shot in his left shoulder with no relief. The doctor and he had no idea what to do next. Patient received the treatment as pain pills, steroid shot, heat for the event. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report was received from a nurse concerning to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, route were unknown) lot # M041507, expiration date: 09-APR-2018 for prophylaxis, which had a temperature exposure of 15°F to 49°F (-9°C to 8°C) for 8 hours. The temperature exposure was not detected due a data logger. There were no previous temperature excursion. This is one several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010168:
Localized tenderness; chills; Underage patient who received the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (Localized tenderness), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient who received the vaccine) and CHILLS (chills) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient who received the vaccine). On an unknown date, the patient experienced TENDERNESS (Localized tenderness) and CHILLS (chills). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient who received the vaccine) had resolved. At the time of the report, TENDERNESS (Localized tenderness) and CHILLS (chills) 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.   Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K014191 with expiration date 10-MAY-2017 and lot # K010574 with expiration date 08-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Last week patient had a needlestick injury. Patient is a nurse practitioner.  Per corporate Employee Health protocol her labs were drawn.  Her Hep B titer came back negative.  She was given a Hep B booster on the evening of 3/13/14  (Lot #K94NR Exp 6/8/14 Left deltoid)  The next morning, 3/14/14, patient woke up with vertigo.  Her symptoms got worse all day and continued through Sunday night 3/16/14.  When patient woke up Monday morning she was feeling much better, but still has lingering symptoms.   No underlying medical conditions, her only medication is a hormone cream.
After receiving the vaccine I had redness at the injection site. Then in May 2022 I believe I had caught covid from my husband who wasn't wearing a mask at a sporting event. When I caught covid I had a headache for the first 3 days, and I took some Tylenol for it. I had mild cold symptoms. I was sneezing, coughing, and had congestion. I was prescribed Paxlovid for 5 days.
No additional AE reported; the vaccine was administered at the six month checkup instead of the twelve month check up.; Information has been received from a healthcare business professional(HBP), referring to a 6 months old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 11-JUN-2021 (at the six month checkup instead of the twelve month checkup), the patient was administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, strength, frequency, therapy type, route, lot# and expiration date were unknown) for prophylaxis (Inappropriate age at vaccine administration). No other adverse event was reported.
PATIENT CAME IN ON 04/05/21 STATED THEY HAD AN ADVERSE REACTION THAT STARTED 2 DAYS AFTER VACCINATION THAT MADE THEM HAVE SWELLING OF THROAT AND TROUBLE BREATHING.  PATIENT STATED IT LASTED 2 DAYS.
On Friday, symptoms began with weak knees, then parathesis of right foot which progressed to his hands. By Tuesday, the patient could barely walk. He came to emergency department with progressive weakness. He was admitted to the hospital and treated for Guillain Barre Syndrome.
severe angioedema resulting in intubation to protect his airway and ICU admission.  pt recieved the 2nd dose at 0755 am, woke up from a nap at 2200 the same night with tongue swelling.
Febrile seizure occurred approximately 9 days after immunization with MMR. Was well following immunizations, no runny nose, cough or other URI symptoms until 03/25/19 when began feeling tired after dinner. Put to bed early but when mom went up to check on him he was moving oddly, then when she rolled him over to his side his eyes rolled back in his head and he tensed. EMS was called. Episode lasted around 5 minutes. No resuscitation needed. Temp on EMS arrival was 102.8. Post ictal state observed in ER x2 hours before discharge home. Followed up in our office next day. Flu negative. Afebrile since prior evening. Full examination completed and no other source for fever identified on exam. Suspect febrile seizure related to febrile immune response from MMR vaccination.
STARTED WITH A DULL ACHE. A HOUR LATER, SHOOTING PAIN DOWN ARM FROM ELBOW. I PUT AN ICE PACK ON IT FOR THE REST OF THE NIGHT. SINCE THEN A CONSTANT ACHE. CAN NOT LIFT ARM ABOVE SHOULDER HEIGHT. NOW HAVE PAIN SHOOTING UP MY NECK ON LEFT SIDE.
fatigue; injection site soreness in the arm soreness; injection site soreness in the arm soreness; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EN6204) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6204), administration date: 18Mar2021, for COVID-19 immunisation, reaction(s): "Fatigue"; BNT162b2 (DOSE 1, SINGLE, Lot: EN6204), administration date: 18Mar2021, for COVID-19 Immunization, reaction(s): "injection site soreness in the arm soreness", "injection site soreness in the arm soreness". The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "injection site soreness in the arm soreness".  Additional information: It was reported that, the patient got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness for a while. Caller also added that his primary care physician says that the only important vaccines are the 2 primary better, which was the reason why he also believes they could ware off. He finally added that he had no regrets with the first shots, but that he's regretting to get this new one, that he's not happy, and now he's nervous of how long the side effects could last, so he doesn't think he made the right decision. He also stated that He had previously taken his original Pfizer Covid vaccinations when they first came out. He got the first two vaccines 2 weeks apart. Then, in 6-8 months he got his first booster. Then, 6-8 months later her got a second booster. He had relatively the same side effects for those. His side effects were common and expected. They all cleared up by the following evening by the most part. All the other shots, they asked him to sit for 10 minutes before he left, and each time everything was okay. Typically, with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. He had a soreness in his arm that wasn't soreness anymore it was hurting. Sender's Comments: Linked Report(s): US-PFIZER INC-202300163844 same patient/event, different vaccine dose.
My  adverse reactions to the Fluzone HD was hearing loss and jaw pain.  I cannot prove that but my wife, who is also reporting to you, had the same vaccine at the same time and had the same two problems at the same times as I have had them.  Such has never happened before therefore we am convienced Fluzone HD was the cause. I have been deaf in my left ear for several years however my hearing was good in my right ear untl November 2, 2019, three days after receiving the Fluzone HD vaccine.   I lost most of my hearing in my "good" ear that day.  I was virtually deaf intil I got my hearing aids Feb 13th, two and half months later.  A week after my hearing loss, I started having pain in both my jaw joints and it continues more some days and less other days.  My wife's jaw joint pain which started the same week is only in her right jaw.  We don't think this could be coincidence.
"Severe flare of arthritis" with pain in shoulders, neck, spine, ribs and hips. Low grade fever. Lab tests showed very elevated C reactive protein and new anemia. Responded to prednisone. Total duration of illness over 2 months.