chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she could not lift her arms or fingers and her muscles had enlarged on her arms; she could not lift her arms or fingers and her muscles had enlarged on her arms; Initial information received on 21-May-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient). This case involves a female patient of unknown age who could not lift her arms or fingers and her muscles had enlarged on her arms (diplegia), while she received vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE.  Medical history included pain (she was on prednisone and laying in terrible pain for 3 months).  Past medical treatment included PREDNISONE (she was on prednisone).  Past vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious she could not lift her arms or fingers and her muscles had enlarged on her arms (diplegia)(muscle swelling), (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS (not otherwise specified) PERTUSSIS VACCINE.  It was also reported that she was totally paralyzed from it. She was very concerned because of her reaction to DTP to get the Covid (corona virus disease) vaccine. She had the ingredient list for the Covid vaccine, but she doesn't had the ingredient list for the DPT shot.  Seriousness criteria was assessed as medically significant as per important medical event list.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a female patient who experienced diplegia and muscle swelling after vaccination with DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. The time to onset is unknown. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccines cannot be individually assessed.
Symptoms included: severe pain in the right eye with swelling, redness, and significant tearing. Corneal Ulcer and Eye Infection in the right eye diagnosed by Dr. on 26 Feb 2016. Treated initially with antibiotic eye drops followed by antiviral pills and steroid drops.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 07-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
w/in 1 day site of inj devel erythema, pain, induration-15cm circumference;
Information has been received from a registered nurse concerning a 74 year old female with no pre-existing allergies, birth defects, medical conditions, who on 12-OCT-2007 at 9:30 AM was vaccinated IM in the left arm with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 658965/1355U) instead of zoster vaccine live (Oka/Merck) (MSD). Concomitant therapy included: pneumococcal 14v polysaccharide vaccine (lot number:651357/0391F) (MSD) SC in the right arm; Fluzone (lot number U244288) IM in the left deltoid. It was not considered to be a product confusion by the office. The nurse that gave the varicella virus vaccine live (Oka/Merck) was new and made a nursing error. No symptoms or problems note. No further information available. Unspecified medical attention was sought. There were no relevant diagnostic tests and laboratory data. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Patient had 1st adverse symptoms when she collapsed to the floor and was unable to move her lower extremities. These symptoms resolved within 7 days and she gradually regained the strength in her legs. In Dec '15 she developed pain in legs and shoulders. In the next months she developed fatigue, intermittent muscle spasm, tingling in the legs, leg weakness, cognitive dysfunction, dry mouth , night sweats, headaches, and episodes of dizziness. While hospitalized in May '16 she tested positive for POTS- postural orthostatic tachycardia syndrome.
nausea, diarrhea, dizzy;tx-fluids -ER if needed;
Stomach cramps; frequent loose stools; GI issues; This is a spontaneous report from a contactable physician, the patient. A 37-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 16Dec2020 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 16Dec2020 at 21:30 the patient experienced gastrointestinal issues, stomach cramps and frequent loose stools reported as beginning several hours after the vaccination and lasting until the next day. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the gastrointestinal issues, stomach cramps and frequent loose stools was resolved on 17Dec2020.  Information on the Lot/Batch number has been requested
HEADACHE; fever; muscle aches; nausea; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, once total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, fever, muscle aches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, muscle aches and nausea was not reported. This report was non-serious.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No relevant medical history). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite) and CHILLS (Chills). On 01-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore). At the time of the report, COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy), PAIN IN EXTREMITY (Arm has been a little sore) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. When agent asked for the lot number she provided both numbers as listed 011J20A and 012M20A. She thought the first one may have been marked out. Treatment drug used is ibuprofen.
ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 9/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A report has been received from a Physician concerning a 34 year old, female subject. No concomitant medication or relevant history was provided. The patient received Nasal FLUMIST on an unknown date. FLUMIST administration to pregnant female on 27-Sep-2012 she had a cold for one and a half week after getting FLUIMST. The action taken with FLUMIST was unknown. The outcome of the event of administration to pregnant female was unknown. The outcome of the event of she had a cold for one and a half week after getting FLUMIST was recovered. The report was considered to be non-serious by the reporter. Corrected report on 04-Oct-2012: reporter as Administered By was added. Summary of follow-up information received by AstraZeneca 18-Oct-2012: New event of cold added. Case is now unsuppressed. Corrected report 20-Nov-2012: The event of administration to pregnant female has become a KUR term, therefore the case has been updated accordingly.
Patient was given the pediatric dose of Engerix-B instead for the adult dose (20mcg/mL).  -Per GSK and provider, the patient will need to be vaccinated with the correct dose.
Sharp pains in feet, cramping in feet and lower legs, involuntary spasms of feet and legs all night.  Still have some pains in feet this morning, but not as severe as during the night. Injection site quite sore, but that was expected.
Low grade fever; headache; fatigue; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills). At the time of the report, PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
she has lost 60% of her hearing in one ear/and 30% of her hearing in the other; headache; taste like metal; brain fog; This is a spontaneous report from a contactable consumer. This consumer reported for a 75-year-old female patient ( the reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration on an unspecified date at single dose, and second dose, via an unspecified route of administration on an unspecified date at single dose, all for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced lost 60% of her hearing in one ear, headache, taste like metal, brain fog, all on an unspecified date. The reporter stated her mom (the patient) received both doses of the Pfizer Covid-19 vaccine and has experienced headaches for awhile with other "really weird symptoms." The reporter stated the patient can't eat because everything tastes like metal and she had lost 60% of her hearing in one ear and 30% of her hearing in the other. The reporter stated patient experiences brain fog at times. The reporter stated that she was not sure if these symptoms were stemming from the vaccine or something else. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Right and Left upper arm with round,red, slightly raised, warm and painful areas. Temp 98.4.  Client reports that last noc both arms hurt more, today 8/29/08 @ 3:20pm the pain is still present but less.
Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. All symptoms subsided within 48 hrs except for the swelling at the injection site.
warm arm; chills; redness at injection site; very itchy injection site; swollen arm at injection site; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm arm), CHILLS (chills), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (very itchy injection site) and VACCINATION SITE SWELLING (swollen arm at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, 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 experienced FEELING HOT (warm arm), CHILLS (chills), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (very itchy injection site), VACCINATION SITE SWELLING (swollen arm at injection site), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, FEELING HOT (warm arm), CHILLS (chills), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (very itchy injection site), VACCINATION SITE SWELLING (swollen arm at injection site), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received on 20-Jul-2021 contains no new information.
Erythematous patch (about 5 cm) surrounding injection site, warm, mildly tender.
Patient stated that her vision blacked out - had loss of vision and was overheated - pt described as "hot and sweaty".  Patient was alert and responsive and had no difficulty breathing.  Patient did not have any swelling of mouth, face, lips, or throat and did not experience any nausea or dizziness.  Attempted to take patient's blood pressure and when the cuff expanded, patient stated she was losing vision again.  Patient began to lose vision ~5 minutes after initially receiving vaccine and regained vision shortly after.  Paramedics were called to the pharmacy.
Fever Left arm soreness, hot/chills, bitter taste in mouth, weakness, malaise, insomnia, Narraitve:
Patient inadvertently received a dose of Vaxelis and Hiberix; medication error due to administering VAXELIS and a HIB vaccine in the same day resulting in extra dose of HIB; This non-serious spontaneous safety report, with (Inquiry Number: 01625364), was received by partner on 23MAY2023 and forwarded to agency on 24MAY2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient inadvertently received a dose of Vaxelis and Hiberix and medication error due to administering VAXELIS and a HIB vaccine in the same day resulting in extra dose of HIB".  Further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of blotchy in a 63-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine and Bupropion XL. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd May 2018, 5 days after receiving SHINGRIX, the patient experienced blotchy, itchy rash, erythematous rash and raised rash. On an unknown date, the outcome of the blotchy, itchy rash, erythematous rash and raised rash were not recovered/not resolved. The reporter considered the blotchy, itchy rash, erythematous rash and raised rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient had originally contacted via social media. The patient received SHINGRIX in left arm. At night (before reporting), the patient experienced a sudden rash that started out on her sides and then spread to a good portion of the trunk of her body. The patient mentioned within last 3 hours she had developed an almost full body itchy rash and she was angry. The rash then spread rapidly to around her waist, the tops of her ears, her arms and thighs. The patient stated when she woke up in the morning of the reporting date, the rash had gone away mostly and there were only a few splotches left. The patient laid down for a nap in the afternoon and when she woke up, the rash was back. The patient stated that she had not done anything different, no new detergents, etc. The patient described the rash as red, itchy and raised. Also, the patient stated that some of the spots were big, the largest one being 2 by 3 inches and some of the spots were small. The patient called her doctor and left a message and was waiting to hear back from her. This patient originally contacted GlaxoSmithKline via social media and was advised to call to report the adverse event. The patient provided the confirmation number that she received in the social media response and details of her doctor. The patient did not have the information on the SHINGRIX vaccination she received.
Patient received shot 8-26-19 mid day. That night experienced headache and chills alternating with hot flashes. The chills and flashes went away but the headache got progressively worse until he went to the ER the next morning at 6:30am (8-27-19).  He went home and slept most of the day after receiving ondansetron and ibuprofen. When he woke up in the afternoon the headache came back and got worse again until he went to the ER at 11pm.  There he received toradol, fentanyl, anti-nausea med and a cat scan which came back normal.  He went home at abour 3am on 8-28-19. He also complained that today (8-30-19) he has a very tender upper mouth which is preventing him from eating and that the roof of his mouth seems to be covered in some sort of film.
(1969) At age 16, patient had re-vaccination with smallpox and experienced encephalitis.  Patient was advised to never received smallpox again (headache and fatigue for 4-6 weeks).
While sitting in the waiting area after receiving my shot I started having very minor muscle twitches in my upper arms and thighs, which I thought were odd but didn't think was enough of an issue to report at the pharmacy. By the time I got home they were more pronounced and widespread, concerning me enough that I felt I needed to inform my doctor.  After a few hours they did dissipate. I also was infected with covid 5 weeks after receiving the shot.
Hep B dose given, pt described "arm on fire, very dizzy" and became clammy and nauseous
Prior to immun pt bumped head on playhouse; Pt recvd DTP/OPV/MMR on 18MAR91 w/in 5 min was reported that pt was having grand mal sz; Seen by MD; EEG normal; MD felt rxn was from immun;
The 3rd dose was a booster and she received another booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster). At the time of the report, EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient was concerned because she experienced arm pain with the previous 3 doses but not with this one. The patient felt because she was not having any side effects, she might had been given an expired vaccine. She believed because she received a vaccine so close to the expiration date the vaccine had lost a little potency.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-525546, MOD-2022-525602, MOD-2022-525609 (Patient Link).
On 07/2021 I started experiencing weight gain, fatigue, and depression. I went to the doctor last summer and they did a thyroid panel with a TSH and it was like 8. They re-did blood work in February and my TSH was 23.93. They started me on medication then. They diagnosed me with Hypothyroidism. On 11/2021 I developed kidney stones. I went to the doctor and they did an x-ray and I had surgery on 03/01/2022. I also developed sleep apnea. I did a sleep study the week of 12/07/2021. I was diagnosed on 02/2022 with sleep apnea and I received my sleeping machine yesterday. On 12/12/2021 I was diagnosed with Covid. I had headaches, fatigue, fever, cough, chills, sore throat, and a lot of body aches. I had the infusion and antibody treatment. I went back on the 20th because I was still having symptoms after the infusion. They gave me steroids and medication, but I do not remember what it was.
Patient reports she has been experiencing headaches since her first dose of the Pfizer COVID19 vaccine, it started with daily headaches x1 week after the first vaccine and then on and off headaches which dissipated about 1 week prior to the 2nd round of vaccine and have now begun again. Has been taking tylenol for these.
(L) arm slightly red warm to touch large ant edema, painful MD assess antibiotic given.
Reports around 1230 she started to not feel right; pt. Reports she feels like her throat is closing Treatment during the ER visit : diphenhydrAMINE (BENADRYL) 50 mg/mL injection   25 mg, Intravenous, NOW, Mon 10/14/19 at 1500, For 1 dose   Given 10/14/2019 3:15 PM EDT 25 mg      famotidine (PEPCID) 20 mg in iso-osmotic 50 mL premix IVPB   50 mL (20 mg), Intravenous, NOW, Mon 10/14/19 at 1500, For 1 dose   New Bag/New Syringe 10/14/2019 3:15 PM EDT 50 mL 100 mL/hr       methylPREDNISolone sod succ (SOLU-MEDROL) 125 mg/2 mL injection   125 mg, 2 mL, Intravenous, NOW, Mon 10/14/19 at 1600, For 1 dose   Given 10/14/2019 3:15 PM EDT 125 mg         NS bolus infusion 1,000 mL   1,000 mL, Intravenous, Administer over 120 Minutes, NOW, Mon 10/14/19 at 1500, For 1 dose   New Bag/New Syringe 10/14/2019 3:15 PM EDT 1,000 mL 500 mL/hr          Father given school notes. One rx for Prednisone sent to pharmacy. All above events was reported from the ER reports
Post vax, the patient experienced tenderness and redness at the site of injection. Supportive care was given.