chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early morning on 2/16 woke up disoriented and found myself lying on the floor in a hallway between bedroom and bathroom.  Not sure how I got there.  Attempted to vomit but only gaged.  Friend called at 700am and I wasn't making much sense.  Later in the day I seemed alright, became cold in the evening and fever had returned.  At 4 am morning of 2/17 I woke up soaking wet.  Went back to sleep and seemed to be fine when I got up at 8am.  It is now 2 weeks since I had this shot and I have experienced no further problems.  My daughter-in-law Is a doctor and she said I should report these side effects.
patient presented to EC at Hospital with shortness of breath, cough, hypoxia, chest pain and myalgia on 8/22/2021
Red, swollen, itchy arm started a couple of days after the shot.  Better after taking Benadryl.
Arm was really sore, it had heat in it. Tiredness, headache, and then I got numbness on my left toes except my pinky toes. All my toes were numb, it was scary. Then on the sole of near my big toe was numb. I could feel pressure but no feeling. It was a couple of days with tiredness and headache but the numbness in the sole (palm part) of my foot and my toes wouldn't stop and I kept stomping my foot to try to get feeling in it. It's a bit better now but still not the feeling back. Sometimes I would feel even more of the numbness feeling and sometimes less of the numbness. But numbness never went away. I did have stress going on. On the 18th, I then had welts on my whole body. They were everywhere, they were welts and not hives. Under my chest, back and under my arms etc., welts. I took prednisone and Benadryl and I had my Epi-pen but the fact that I wasn't itching and it wasn't hives I decided not to take it. I kept taking those things but then I got scared because the welts weren't going away and my tongue was swelling. They told me I wasn't giving myself enough prednisone but my friend took me to urgent care on the 18th. My throat was itching and tongue was swelling and the welts traveled. It started with my upper body but by that time it had gone to my legs. The only thing I still have today is the numbness in my toes/foot.
I experienced and are still experiencing a reduced libido as well as reduced sexual function of my penis. Noticeable difference in activity within 12 hours of the second shot.
On 10/20/00 at 05:00, had upset stomach, nausea and vomiting with severe headache and shakes. No temperature. Phoned physician and he prescribed something for nausea. On 10/20/00 at 17:00, doctor took her to hospital and was seen in ER. Gave her orange juice. Never had temperature. BP increased to 177/60. On 10/23/00, feels weak but retaining food.
Tiredness; Mild temperature elevation 1.5 degrees; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 02Mar2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, diabetes type 2, penicillin allergy, and sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Mar2021 at 07:00, the patient experienced tiredness and mild temperature elevation of 1.5 degrees. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. On 03Mar2021, the patient underwent body temperature test and the result was mild temperature elevation 1.5 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness and mild temperature elevation was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Soreness all over, headache, legs hurt, stomach ache, vomiting, diarrhea
throat tightness, VP 112/63, O2 sat 99%, HR 87
Headache; Sore arm; Minor body aches; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received 2nd dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 17Feb2021 at 14:45, at workplace clinic as dose 2, single (age at vaccination: 23 years) for covid-19 immunisation. Medical history included polycystic ovaries and milk allergy. Concomitant medications included metformin, spironolactone, buspirone and ethinylestradiol, levonorgestrel (CAMRESE). Historical vaccine included patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 27Jan2021 at 14:45 as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 17Feb2021 02:45 PM, the patient experienced headache, sore arm (pain in extremity) and minor body aches (pain). No treatment was taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patients mother returned to clinic the following week and stated that the child fainted 1 hour after they left clinic and was taken to the emergency room for evaluation.  The vaccines were administered at 11:43 AM.
maculopapular red rash w/itching to arms, legs, & trunk w/in 10 mins p/immun; pt given DPH; 24 hrs later some rash still present but improved w/no itching;
Information has been received from a pharmacist concerning a pregnant female who is "due any day now" that was vaccinated with MMR II and is testing low for her mumps titer. The pharmacist did not have any patient information and is not sure if the patient has received one or two doses of MMR II. The patient's present status is reported as low mumps titer. No product quality complaint. Additional information has been requested.
On day 8, post injection, after having all other vaccine Dude effects subside, my left arm, at the injection site, developed a lump. It is hot, itchy, red, and painful.
¨the pain won´t let me sleep at night , the pain woke me up¨; ¨it seems to be a little Swollen¨; four hours after the injection, started having pain in the arm of the injection ( right arm); not able to move his right arm ; not able to lift the arm; the pain is constant; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨), LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant), VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)). On 29-Apr-2021, the patient experienced INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨) and VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨), LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant), VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)) 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.   No concomitant medications were provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-098298, US-MODERNATX, INC.-MOD-2021-098351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098298: US-MODERNATX, INC.-MOD-2021-098351:Reporter case
After 10 days, from vaccine shot, chills and fever in middle of night. Took two extra strength Tylenol and fever went away
muscle spasms; shivering; migraine headache; Head ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Jan2022 20:15 (Lot number: FJ1614) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pain relief" (unspecified if ongoing). Concomitant medication(s) included: NAPROXEN SODIUM taken for pain; IBUPROFEN taken for pain. Vaccination history included: Bnt162b2 (Dose 1, Time: 13:00, Anatomical Location: Upper left arm, Patient route of administration: Intramuscular, Lot No: EP6955), administration date: 26May2021, when the patient was 19 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Time: 13:00, Anatomical Location: Upper left arm, Patient route of administration: Intramuscular, Lot No: EP6955), administration date: 17Jun2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 30Jan2022, outcome "recovered", described as "shivering"; MIGRAINE (non-serious) with onset 29Jan2022 14:30, outcome "not recovered", described as "migraine headache"; MUSCLE SPASMS (non-serious) with onset 30Jan2022 01:00, outcome "recovered", described as "muscle spasms"; HEADACHE (non-serious) with onset 28Jan2022, outcome "recovered", described as "Head ache"; CHILLS (non-serious) with onset 28Jan2022, outcome "recovered", described as "chills".  Additional information: The facility where the COVID-19 vaccine was administered is Pharmacy or drug store. Prior Vaccinations (Within 4 weeks): None. Typical AE post vaccination with third Comirnaty dose, Headache, chills/ shivering. Though she also experienced uncontrolled muscle spasms in the legs the night following the vaccination, which self resolved and have not returned.   No follow-up attempts are possible. No further information is expected.
Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "throat tightness and difficulty swallowing" and returned to observation area with husband.  Client also reported chest pressure while walking to observation area.  Client reports this also happened with first COVID vaccine 3 weeks ago.  Vital signs stable, able to have conversation and answer questions.  RN offered Benadryl, client declined.  Chest pressure resolved, throat tightness stayed the same.  Client left home with husband.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/13/2021. On 8/6/2021, pt presented to ED with increasing diffuse abdominal pain that started 3 days prior. Pt reports he was diagnosed with COVID-19 on 8/5/21 and had increasing shortness of breath with cough and headache which began 8/1/21. CT showed acute uncomplicated appendicitis and confirmed patchy ground-glass opacities within the bilateral lung bases consistent with COVID pneumonia. He was given 1 g of Tylenol, 1 g of IV Rocephin, 6 mg of Decadron, 500 mg of IV Flagyl, 2 doses of 4 mg of morphine, 4 mg of Zofran and 40 mg of IV Protonix in the ED. Pt also received remdesivir. He developled hypoxia on HFNC 50/50 sating 84-87%. pO2 49. Patient was able to maintain sats in the lower 90's CXR showed worsening pulmonary edema and he was given 20mg IV lasix. Patient transferred to MICU service for worsening respiratory status on 8/13. Patient was intubated and started on proning protocol. He continued to require pressors and sedation with propofol, versed, and dilaudid. Palliative was consulted and discussed with family comfort care. Patient expired on 8/24/21.
Client began to feel dizzy around 10:55am. At 11:05am a nurse observed client appeared pale and brought her an ice pack and crackers. Around 11:14am the client stated that she felt less dizzy and was ok to drive. Nurse educated client on what to do if she became dizzy again and released her to client's personal car.
Numbness from right arm at site of vaccination up into right side of face.  Lasted 3 hours, then resolved completely.
Dizzy; Had period again/period deep dark red; Period not normal, very heavy, heavy clotting; Foggy; 50 cents painful; Purple bruise on L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (50 cents painful), CONTUSION (Purple bruise on L arm of injection), MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting) and FEELING ABNORMAL (Foggy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS (Immunosuppressed). Concomitant products included VITAMIN D [VITAMIN D NOS], HYDROXYCHLOROQUINE, PREGABALIN (LYRICA), TRAZODONE, CLONAZEPAM and METHOTREXATE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (50 cents painful) and CONTUSION (Purple bruise on L arm of injection). On 19-Mar-2021, the patient experienced MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting) and FEELING ABNORMAL (Foggy). On an unknown date, the patient experienced DIZZINESS (Dizzy). On 21-Mar-2021, PAIN (50 cents painful) and CONTUSION (Purple bruise on L arm of injection) had resolved. At the time of the report, MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting), FEELING ABNORMAL (Foggy) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Headache; Fatigue; Pain in armpit; Sore throat; This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Topamax.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and AXILLARY PAIN (Pain in armpit) 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 medications includes Water pill for blood pressure. treatment information includes Cough drops, Lozenges, Took lots of water.
pt recv vax in MAR96 & exp severe arthralgia,fever & h/a,& was unable to care for children;
On Wednesday 5/26, days after vaccination I started having a itch on my chin, then a welt appeared and another one came up shortly after. By Friday it spread and got red and itched. The ones that camp on my had itched and on Friday 5/28 my hands started itching and it looked like a beginning of a chicken poc and that evening there was a sore spot by left nostril the spot looked like what was on my hand and it is spreading on my breast, shoulder. On 5/31 there was a spot on my belly button and on the right side of my leg by my groin the red mark was the size of my hand, and on my waist line, then more of the blistery bumps come up on check on face and around right side of my lip and chin and chin line on left side.  The doctor provided a steroid cream. I was diagnosed with Hydyshydistic Eczema
This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site discomfort and injection site deformation. On an unknown date, the outcome of the injection site discomfort and injection site deformation were not recovered/not resolved. It was unknown if the reporter considered the injection site discomfort and injection site deformation to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2018-2019 season in the left arm. The patient experienced a dent forming in the upper part of her left arm starting about 2 weeks ago. The dent had gotten worse, such that her arm looked deformed, or like something was dislocated. On 28th January 2019, the patient  saw her chiropractor, who verified that it was not a problem with her bones and that she had all of her range of motion. She then went to a specialist who never saw anything like it. The specialists best guess was that it was a delayed reaction to the flu vaccine which she received in September 2018. There was a round circle in the middle of the dent that looked like it could have come from the vaccine injection. The reporter consented to follow up.
Symptoms started about 3 hrs after receiving Moderna COVID vaccine. Lightheadedness, headache, extreme fatigue, body (back mainly, legs) feel heavy & leg heaviness started next day. heaviness resolved in 3 hours. Next day fever T=98.5 B/P=136/80, P=84 & fatigue is improved. Referred to Dr - PCP
Pt. c/o sore arm x 4 days post vaccine. Also had some dizziness. Went to urgent care, COVID test on 1/11/2021 was negative.
Hot flashes; tired; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (Hot flashes) and FATIGUE (tired). At the time of the report, HOT FLUSH (Hot flashes) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Bone pain at injection site 12 pm; tiredness/low fever 100.6; leg and upper body spasm; hives 11pm lasted for 2 weeks; went to ER they gave Benadryl.
cold; cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms".  Additional information: Caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 29Mar2021, she was scheduled to receive the second dose of the vaccine on 19Apr2021. The patient said that her mother had cold and she was catching cold too because she has a symptom. She would like to know if she could still receive the second dose of the vaccine while having a cold or cold-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm vaccinated Left deltoid, 1-31-21 dystonia of the left arm, numbness tingling arm and left thigh, arm symptoms radiates to left jaw cause unintentional clenching and neck pain. Episodes last 10-15 seconds. Episodes slowly increase to 18 episodes a day.
pain at injection sight, headache and body aches, chills, diarrhea and abdominal cramping.
skin rash yesterday in the forehead and scalp, also near the left eyelid that persist; chills; fever; This non-serious case was reported by a physician via sales rep and described the occurrence of skin rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18-SEP-2023) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, several days after receiving Shingrix, the patient experienced chills (Verbatim: chills) and fever (Verbatim: fever). On 19-JUL-2023, the patient experienced skin rash (Verbatim: skin rash yesterday in the forehead and scalp, also near the left eyelid that persist). The outcome of the skin rash was not resolved and the outcome of the chills and fever were resolved.   It was unknown if the reporter considered the skin rash, chills and fever to be related to Shingrix.     It was unknown if the company considered the skin rash, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter is a physician who informed Representative that the patient received first dose of Shingrix on 14th July 2023 and everything was fine.  Then patient called today 20th July 2023 to report he had fever and chills a couple of days after vaccination and went away.  The patient developed a skin rash yesterday in the forehead and scalp, also near the left eyelid that persist.  Medical office contacted. Information verified with nurse. The reporter consented to follow up.
Lethargy 10-15 minutes after vaccination. He said he could not stay awake. He said he felt himself going to sleep (chin going to chest); someone asked if he was ok. He then woke up and put his head back and hit it ("just a bink on the wall."). Brought to ED via w/c from vaccination monitoring room. Assessed by this RN and as he explains it, he had a loss of consciousness. Ambulated to ED with steady gait; denied dizziness. He states he took a Percocet at 10AM on date of vaccination. He said he has taken Percocet in the past for sciatica and has never had this lethargy and what he reports as a loss of consciousness in the past.
Felt suddenly hot, sweaty, dizzy. H20 given, resolved on own stayed 30 min