chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of injection site burning in a 70-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, arthritis, hypertension and hypothyroidism. Concurrent medications included SYNTHROID, Indapamide, Omeprazole and Potassium chloride. On 7 November 2008 at 11:00, the subject received unspecified dose of Influenza vaccine (unknown, right arm). On 7 November 2008, immediately after vaccination with Influenza vaccine, the subject experienced injection site burning, swelling injection site, injection site redness, injection site warmth. On 11 November 2008, the subject experienced injection site itching. On 13 November 2008, the subject experienced double vision. On 21 November 2008, the subject experienced optic nerve disorder and eye disorder. On an unknown date the subject experienced hardness injection site. The subject reported the GSK influenza vaccine lot number as "GSK 375B4". The subject reported that on 07 November 2008, she received GSK flu vaccine injected into her right arm. She immediately noticed burning at the injection site. She stated that I started swelling and immediately got red and hot. She says it stayed that way and she still has a hardened area on her arm two months later. She took ALLEGRA for two days. She says that on the 6th day after the flu vaccine injection that she developed double vision. She called her internist and he referred her to her ophthalmologist. She had an MRI on 21 November 2008 and was told that the 6th optic nerve of the left eye was affected by an event that affected the muscle of her left eye. She is now wearing a patch because of the double vision but they have not recommended any treatment but recommended a "wait and see" approach for about 3 months. In addition, they have discussed that she might need surgery to correct the muscle or prisms in her glasses. She says she is still having double vision although it has improved. The subject called where she received the vaccine and "they read from the package insert regarding flu vaccines causing optic neuritis and advised her to call GSK to report an adverse event". In addition, she stated that she gets a flu vaccination every year and she estimated that she has had 25 previous flu vaccinations without incident. This case was assessed as medically serious by GSK. The subject was treated with Fexofenadine and eye patch. At the time of reporting the events were unresolved.
possible syncopal episode while in the care on the way home, lasting approx. 30 seconds, patient subsequently awoke, but groggy per mom. NO seizure activity noted.  Observed in office, alert and responsive, then fell asleep (nap time, per mom).
3/25- headache, muscle aches, fatigue, very uncomfortable and Tylenol did not relieve pain 3/26- moderate stomach ache, eating food makes stomach hurt more.  Fatigue, headache, and muscle aches less painful than 3/25
This spontaneous report as received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Not being able to sleep; This is a spontaneous report from a non-contactable consumer. A patient (reporter) of an unspecified age and gender received first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was unable to sleep after taking the vaccine. The start date of the event was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythematous rash with mild pain and itching developed to upper arm, vaccinated arm, starting one week after vaccination.
covid arm, appearing about 9 days after 1st dose - red blotch about 2X3 inches in size - soreness after blotch formed
Per child the day she got the two vaccines she went home and around 1:00 PM, she started getting a headache. All of a sudden the pain started getting worse she states it felt more like a Migraine, she ran downstairs to let guardian know. Guardian told us she was scared because the patient was crying non stop that she couldn't tolerate the headache and it was getting worse. Guardian gave child an ibuprofen pill and told her if the pain wouldn't go away they were going straight to the ER. She then states hours later the headache went away and has not experience anything since then.
WITHIN 10 MINUTES POST-VACCINATION, PATIENT COMPLAINED OF AN ITCHY RASH ON NECK AND SCALP.  I GAVE THE PATIENT 2 TABLETS OF ORAL DIPHENHYDRAMINE 25MG TABLETS AND TOPICAL HYDROCORTISONE 1% CREAM TO APPLY TO AFFECTED AREAS ON NECK.  THE ITCHY RASH THEN MOVED TO HER LEFT UPPER ARM.  ALL ITCHY RASH AREAS WERE RELIEVED AFTER 30 MINUTES AND THE PATIENT WAS TRANSPORTED HOME BY HER FATHER.  THE PATIENT CALLED THE WAREHOUSE TO NOTIFY US THAT SHE WAS SAFELY AT HOME AND RESTING WITH NO FURTHER COMPLAINTS OF A RASH, I SPOKE WITH THE PATIENT THIS MORNING AND SHE IS EXPERIENCING COVID-LIKE SYMPTOMS: FEVER OF 101 DEGREES, COUGH, HEADACHE AND TIREDNESS.  SHE HAD A VIRTUAL OFFICE VISIT WITH HER PHYSICIAN THIS MORNING.
The patient inadvertently got the adult spike vax instead of the children's dose, despite the child only being 10 years old. This was caught immediately after the vaccine was given. And the patient and mother were notified. Possible adverse effects were reviewed with them, and they were told to contact us or their provider if there was anything concerning that they noticed in the coming days. They voiced understanding. I have yet to hear from the family as of yet, but I intent to follow up with them later this week.
Irregular menstruation including disruptions in length of time between periods and extremely long periods of bleeding 17+ days resulting in anemia.
Swollen Throat; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration in left arm, on 12Jan2021 04:15 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient's medical history included Pennicilin allergies. Concomitant medication was none. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medication received within 2 weeks of vaccination. The patient experienced swollen throat on an unknown date. No treatment was received for the event. The outcome of the event was recovered.  Information on the lot/batch number has been requested.
hives on both arms & shoulder blades;worse on lt arm, taking DPh;pt spoke to PMD on phone;
Patient's pulse slowed to 40s Blood pressure dropped to 40/60 Patient fainted in sitting position
Information has been received from a 50 year old female registered nurse who was vaccinated subcutaneously into the right arm with a 0.5 ml dose of PNEUMOVAX.  Subsequently, she developed warmth and redness at the injection site and the redness traveled down her right arm.  She was treated with oral antibiotics for one week.  Subsequently, the patient recovered.  Additional information has been requested.
Information has been received from a physician concerning a 15 month old male who was vaccinated with a dose of MMR II (dose, route, and lot# not reported). On 10-JAN-2010 the patient experienced mumps. On 12-JAN-2010 the patient was diagnosed with mumps. The parotitis was on the right side. The patient was afebrile and experienced swelling and pain under right ear. On 12-JAN-2010, a first blood work was performed and showed that: IgM, 0.17. Additional information has been requested.
Per child's mother, child developed fever, itching and body rashes to face and arms the next day following his receiving Flumist dose during clinic.
0912.2019 -patient reporting side effects :arm sore(cannot lift),nausea,vomiting (2 times). fatigue,heaache,shivering,fatigue . 0914.2019-patient is ablet to move her arm but still nauseated and has fatigue. 09.16.2019-patient is feeling better and all side effects are resolved.
Patient had a raised, sore, red lump in middle of arm after 1 day after flu shot. Shot was given too low. MD thought possible allergy or cellulitis.
Has progressively gotten worse throughout the day; Numbness on left lip and under left eye; Tingling on left lip and under left eye; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness on left lip and under left eye), PARAESTHESIA (Tingling on left lip and under left eye) and ADVERSE REACTION (Has progressively gotten worse throughout the day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure. Concomitant products included RIVAROXABAN (XARELTO) for Heart failure.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on left lip and under left eye) and PARAESTHESIA (Tingling on left lip and under left eye). On an unknown date, the patient experienced ADVERSE REACTION (Has progressively gotten worse throughout the day). At the time of the report, HYPOAESTHESIA (Numbness on left lip and under left eye) and PARAESTHESIA (Tingling on left lip and under left eye) had not resolved and ADVERSE REACTION (Has progressively gotten worse throughout the day) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (Inconclusive) Results not reported.     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 product include blood pressure medications (unspecified).  No treatment information was reported.
blood pressure was up and it was 150/83; Left arm pain; Pain across right breast immediately after shot which passed right away; pain across chest; whole left side of the body where patient got the shot hurts/ pain on left side; left side of the face, whole left side of the body where patient got the shot hurts; pain on left side, left shoulder; pain on left side, ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 08Mar2021 17:00 (Batch/Lot Number: LAB-1451-1.1) at 63 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included High blood pressure. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, she was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine and olmesartan, both taken for unspecified indications, start and stop dates were not reported. The patient previously took acetaminophen and experienced allergies. On 08Mar2021 17:15, the patient experienced left arm pain and pain across right breast immediately after shot which passed right away (as reported). The patient woke up with pain across chest. She called an ambulance and they checked her out. Her left side of the face, whole left side of the body where patient got the shot hurts. Her left ear, left shoulder. Felt like someone has taken a bat and hit me on my left side. The patient called the ambulance, and they came because patient thought she was having a heart attack, but she was not. The patient had pain across chest, pain on left side, ear and chest and shoulder and all on her left side have that pain. Events started on 08Mar2021 17:15, right away on Monday when she had the vaccine, right away it happened and then it stopped (as reported). When the ambulance came, they said patient's blood pressure was up and it was 150/83 mmHg on an unspecified date and her blood pressure was never that high. Patient stated that she was still experiencing the events and it worsened. At the emergency they told me to take 4 Baby Aspirin and it was 81 mg. Also, she has been rubbing alcohol on chest, on ears everywhere it is hurting, shoulder because she was hoping that would calm the pain. Events resulted in Emergency room/department or urgent care. No seriousness criteria provided. Outcome of event "blood pressure was up and it was 150/83" was unknown; while all other events were not outcome of not recovered.   No follow-up attempts are needed. No further information is expected.
Severe skin rash mainly in arms and legs. Moderate rash in torso. Treatment OTC Benadryl Dye Free 2 capsules 25mg each. Still with skin rash
Extremely pain arm about an hour after receiving injection; shoulder joint begin to ache and then the rest of his joints ached painfully the rest of the night.  Severe nausea during the night; vomited once.
Information has been received from a pharmacist reporting on an 84 year old female patient. The patient had no drug reactions/allergies, pertinent medical history or concomitant medication. On 12-JAN-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscular, right arm, lot # M038359, expiration date 13-MAY-2018 for prophylaxis (strength not reported). On an unspecified date in 2017, the patient developed pain in the right arm. The pharmacist reported that the patient still experienced pain at times when lying in bed at night. No lab diagnostics/studies were performed; the patient did not seek medical attention and it was unknown by the reporter if treatment given for the adverse event. The outcome of the event pain in extremity was reported as not resolved. The causal relationship between the event and therapy with PNEUMOVAX 23 was not reported.
48 hrs after vaccine, slight petechial rash developed on face. No fever, no cough. D/W asx.
Pretreated with Benadryl and Pepcid. Chest tightness, parasthesias 15 minutes after administration,  worsening and shortness of breath took more Benadryl at 1hr , worsening  1hr 15 min post, epinephrine given. Improved for about an hour, resound reaction epi dose 2 given, prednisone given. To Ed for observation. Prescribed 5 days of steroids
Body ache; sore left arm; felt drained of energy.; a constant feverish feeling; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 04May2021 at 14:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 05May2021, the patient underwent lab test for nasal swab COVID-19 PCR test and the result was negative. On 04May2021 at 23:45 the patient experienced body ache that started the night of the dose and continued through the next morning, sore left arm, and a constant feverish feeling and felt drained of energy. The clinical outcome for the events general body pain, pain in arm, feverish and loss of energy were recovered with sequel in May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Treatment Received should be No; known allergies: No captured in narrative; Stop Date/Time captured as May2021.
Little bit of a sore arm the day of and the day after. But the third day i had a very swollen lymph node in my right arm pit.
8days after vaccine, site around injection site became hot, raised, red, itchy. Day 2after onset and it has increased in size and upper portion of arm is swollen. Nearly spread circumference of arm.  Moderna COVID-19 vaccine EUA
Swelling, redness, warmth on opposite side of injection arm. Spread down arm over the course of 2 days. Not itching, but tight skin (swelling) and radiating warmth, with significant pain upon movement.
swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; Initial information was received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 35 year old male patient who had a swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch (feeling hot, swelling, tenderness and pain) while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 10-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA, expiry date: 12-Apr-2022) via unknown route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch (feeling hot, swelling, tenderness and pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. He had no fever.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.
Information has been received from a health professional concerning a 6 year old female patient who on 04 JUN 1997 was vaccinated with varicella virus vaccine live (lot #622972/0418E). There were no concomitant vaccines that day. On approximately 29 JUN 2001 the patient experienced more than 50 lesions. The patient had not yet been seen by a doctor. It was noted that the patient's three cousins (WAES #'s 01071354; 01071706; 01071707) had similar experiences after receiving varicella virus vaccine live. No further information was provided. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a registered nurse concerning a 27 year old female patient with no pertinent medical history and no know drug allergies/reactions who on 19-JAN-2009 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 660616/0570X). There was no concomitant medication. On 20-JAN-2009 the patient experienced joint pain on her left arm where the vaccine was administered. The next day the pain spread to all joints along with fatigue. No lab diagnostics were performed. One week after the vaccination the patient recovered. The patient sought medical attention via seeing a physician. Additional information has been requested.
From initial info received at manufacturer on 1/23/03, it was reported that 4 y.o. male child was vax'd with 5th dose of Daptacel in the right deltoid, Ipol in the upper right arm, and MMR in the left arm on 1/20/03. On 1/21/03, the PT experienced swelling, redness and warm to the touch of the right arm from his shoulder to 2" below his elbow. The PT was seen in the ER / MD's office. The PT was not taking any medications or had any illnesses at time of vax. It was reported that the PT has no medical conditions or allergies. It is not reported whether the PT recovered from the event.
pain at injection site, fever, chills, all over body aches, throat closing, extremely tired
Initial report received from a healthcare professional on 29 August 2013. A 48-year-old female patient, had received an intramuscular dose of ADACEL vaccine (batch number: U4618AA, expiry date: 23 October 2015) in the left deltoid on 23 August 2013. The patient had medical history of hypothyroidism and had no acute illness at time of vaccination. The patient received Synthroid for hypothyroidism. The patient also has sulfa drug allergies. On 27 August 2013 i.e. 4 days post vaccination, the patient developed redness, itching and a welt like area at the injection site. Laboratory investigations were not reported and the patient advised over the phone by the practice to take OTC ALLEGRA 80 mg (Fexofenadine) or BENADRYL as corrective treatments. The patient outcome was unknown. Documents held by sender: none. The follow up was received from Health care professional on 07 October 2013. Patient's address detail added. Responsible physician's name updated.
pt recv vax 5JUN96 &  10JUN96 to 11JUN96 pt exp a fever of greater than 102;pt responded to APAP;14JUN96 pt devel swelling of the eyelids & face;17JUN96 devel raised, morbilliform rash;dx koplik's spots & ROM;
Elevated blood pressure, headache and dizziness.  from about 4 pm until 11 pm.  No treatment was not seen by provider
Patient called the pharmacy 1-21-2022 in the afternoon and wanted to speak with the pharmacist who administered her vaccine yesterday. She was concerned about some possible side effects she may have been experiencing. She then explained that she had a vaccine yesterday and was having some intense side effects. I asked what was happening and she explained that she was have experiencing significant pain and discomfort from head to toe and was also having tingling down her body and legs. I expressed concern that this was not in the normal expectation and that should be addressed immediately. She also sounded like she was in pain and was struggling. I asked her if I needed to call 911 for her and she stated that she would call the doctor herself. I made it clear that this may be serious and that she definitely needed to be evaluated by a physician before I hung up so she could call them.
Client stated that night after receiving the vaccine she became dizzy, had chills, had vision issues where her eyes could not focus, and her vision was blurry. Client stated that she felt like she was doomed, and maybe having a stroke. Said her symptoms lasted about 2-3 days.
HPV vaccine and MENACTRA vaccine administered to patient. Patient felt faint and nausea approximately one minute s/p vaccine administration. Two RN's witnessed eyes rolling back in and head and patient was postictal.
My right arm felt very heavy within an hr of vaccine. My arm in the deltoid area felt swollen like a body builder arm. Area of injection red circular warm to touch and tender. Forearm down to hand is puffy and tight feeling
Exactly a week after getting the vaccine, I developed a sudden severe diplopia.  Because of my age, the next day I was examined by a neurologist. His diagnosis was: Horizontal diplopia due to a Mononeuropathy of the left VI Craneal nerve.