chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; itching real bad; Rash; Drowsiness; Fever; Nausea; Cold; soreness at injection site; itching at injection site; He woke with a sweaty neck; Weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm on 12Mar2021 10:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included injection site pain from 29Jan2021 and ongoing soreness from allergy shot. In the area of where he got the allergy shots his arm was sore    injection every 2 weeks RECOVERING/RESOLVING, injection site pruritus from 29Jan2021 to 29Jan2021 itching with allergy shot RECOVERED/RESOLVED. There were no concomitant medications. The patient previously took bnt162b2 for covid-19 immunisation and experienced asthenia. The patient experienced itching real bad on 16Mar2021 with outcome of recovering , rash on 16Mar2021 with outcome of not recovered, dizziness on 16Mar2021 06:00 with outcome of recovered with sequelae , drowsiness on 12Mar2021 with outcome of recovered , fever on 12Mar2021 with outcome of recovered , nausea on 12Mar2021 with outcome of recovered , cold on 12Mar2021 with outcome of recovered , soreness at injection site on 12Mar2021 with outcome of recovering , itching at injection site on 12Mar2021 with outcome of recovering , he woke with a sweaty neck on 12Mar2021 with outcome of unknown , weakness on 12Mar2021 with outcome of recovering. Therapeutic measures were taken as a result of itching real bad, rash. Time the Vaccination Was Given (24 hour clock): 10:00am No follow-up attempts are possible. No further information is expected.
Vaccine MMR given 10/10/2001. 10/17/2001 fever. 10/20/2001 rash, twitching, myozlmic jerks.
Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
Temperature of 103 "O" x2 nites with temperature of 100 "o" nightly since.  Severe headache x1 night.  Denies discomfort at injection site.
Ache, chills, fatigue, headache.  Fever of 101 at 7pm on 1/12/2021. Fever resolved by 11pm that nighr.
VARIVAX was administered after the TE.; No reported adverse reactions; This spontaneous report was received from a medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (strength, vaccination scheme, anatomical location,  and route of administration were not provided) following a temperature excursion (Improper storage of product in use).  No reported adverse reactions.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2310USA000671:
Fever of 101-102 for 24 hours; shakes for 8 hours; Throwing up twice; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in left arm on 19Sep2021 (at the age of 23-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. The patient had no known allergies. Concomitant medications were none. The patient did not received any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 29Aug2021 at 13:00 as single dose for COVID-19 immunization. The patient experienced fever of 101-102 for 24 hours, shakes for 8 hours, throwing up twice and headache on 19Sep2021 21:00. No treatment was received as a result of the events. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered in Sep2021.  No follow-up attempts are possible. No further information is expected.
Broke out in a rash all over body; told her to wait until the rash clears before taking the 2nd shot.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Broke out in a rash all over body) and OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.). On an unknown date, the patient experienced RASH (Broke out in a rash all over body). On 02-Apr-2021, OFF LABEL USE (told her to wait until the rash clears before taking the 2nd shot.) had resolved. At the time of the report, RASH (Broke out in a rash all over body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR- outcome of the event updated. Patient had received second dose. The listed events was resolved.
Tested NAAT positive for COVID 9/3/21 after being fully vaccinated.
States she woke up with a swollen lymph node on left side above collar bone that was painful to the touch and pain extended into neck/chest area.
3 month after receiving first covid vaccine, patient developed new chronic normocytic anemia, and was monitored over the next year and ultimately found to have lymphoplasmacytic lymphoma
I had the Shingrix vaccine on 8/5/19. On 8/10/19, I developed a chicken-pox like rash across the back of both shoulders. They were in a thin strip all the way across from one shoulder to the other. They were tiny little bumps that turned scabby over night. They were very itchy. I took antihistamines which helped.
Patient reports today (11/12/21) that she had hives in her throat and esophagus. She states that she also gets Nutcracker esophageal syndrome from the hives. Patient reports per phone conversation today that she had hives for 3-5 days post vaccine and continues to have Nutcracker esophageal syndrome. She notified her primary physician today (11/12/21)
Patient developed cellulitis-like reaction (redness, swelling, pain) at injection site a few days after vaccination. She sought medical care and received antibiotics for the infection.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine) was received from a healthcare professional regarding a 16 month old female pt who experienced an injection site reaction characterized by a lump, ithcing, and bleeding. The patinet received a dose on 05/01/03. Event Details: On 05/01/03- at an unspecified time post immunization, the pt developed an injection site reaction characterized by a lump, ithcing, and bleeding. The pt was examined at a physician's office. The events were unresolved at the time of reporting. No additional information was available at the time of this report.
Patient received his second dose of the Pfizer vaccine today. He is accompanied with his mother. He had no issues with his first dose.  Approximately 15 minutes after administration, patient developed mild itching to his bilateral forearms and on examination, he had a few scattered erythematous papules to his bilateral forearms. He had no other rash. No swelling.  He had no other symptoms. No shortness of breath, wheezing, cough or chest pain. No angioedema or throat/tongue swelling. He was talking in complete sentences and eating/drinking without any issues. Lungs were clear. See vitals below.  Patient took Claritin last night and Allegra this morning for a history of seasonal allergies. He was monitored for greater then 30 minutes. The pruritus had improved, the rash did not get any worse. Patient and mother felt comfortable going home and had no further questions or concerns. Patient will go to the ED with any severe/acute symptoms.    Vitals   07/07/21 1147 07/07/21 1148 BP: 110/80 108/80 Pulse: 80 79 Resp: 16   SpO2: 98% 98%
Lesser effects day 2 but lymph nodesall over started hurting; Sore behind ears and pain worse on left side; pain at injection arm and armpit; pain at injection arm and armpit; Bad insomnia since then, waking up unable to go back to sleep, normally don't have insomnia.; Extremely heavy feeling in my head then whole body; Extremely heavy feeling in my head then whole body; woozy felt; disoriented or drunk; Weakness, having trouble standing withoutleaning on something.; Slight chills; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198,) via an unspecified route of administration in the left arm on 28Feb2021 at 12:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergic rhinitis, conjunctivitis, attention deficit hyperactivity disorder (ADHD), depression, anxiety, pollen allergy (tree pollens), allergy to molds, strong seasonal allergies and had loop electrosurgical excision procedure (LEEP) procedure 10 days before the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), atomoxetine (MANUFACTURER UNKNOWN), and many more unspecified medications; all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. On 28Feb2021 at 15:45, the patient had an extremely heavy feeling in the head and then to the whole body and also felt woozy, disoriented or drunk, weakness due to which trouble standing without leaning on something and slight chills and all these effects occurred very fastly. On 01Mar2021, day 2, the patient had lesser effects however the patient experienced lymph nodes all over hurting, sore behind ears and pain worse on the left side, pain at injection arm and armpit. On the same day, the patient also experienced bad insomnia since vaccination due to which the patient woke up but was unable to go back to sleep and was reported that normally the patient did not have insomnia. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included the psychiatrist's suggestion to off bupropion medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy feeling in the head then to the whole body, felt woozy, disoriented or drunk, weakness trouble standing without leaning on something, slight chills, lymph nodes all over hurting, especially sore behind ears/ pain worse on the left side, pain at injection arm and armpit and bad insomnia were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose on 24th April 2018, refer case US2018151874). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, muscle pain, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing. On 20th August 2018, the patient experienced nausea. In August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fatigue, muscle pain, shortness of breath and muscle discomfort were not recovered/not resolved and the outcome of the nausea, influenza-like symptoms, chills, fever and pain were recovered/resolved and the outcome of the shallow breathing was unknown. The reporter considered the fatigue, muscle pain, nausea, shortness of breath, headache, influenza-like symptoms, chills, fever, pain, muscle discomfort and shallow breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot in left deltoid. The patient experienced extreme fatigue, headache for 3 days, chills, fever, aching, flu-like symptoms. The patient was so tired a day before reporting after running errands that she was "almost nauseous." The patient still felt very tired on the reporting date. The patient stated that if she did much of anything the muscles in her back and shoulder ache. The patient said she was having difficulty taking deep breaths. She said it was uncomfortable to take a deep breath from the diaphragm so she was taking shallow breaths. The patient said that if she took a deep breath she would experience muscular discomfort "like a pleurisy" especially under the left shoulder blade. The patient reported her experience with the second shot to the pharmacy and to the health department but not her primary care physician. The patient had denied permission to contact their physician because she said the physician was unaware of these events.
12/01/20: headache in evening after injection, resolved with 400 mg Advil; generally feeling ?icky? 12/02/20: headache upon waking, mild nausea, resolved with 400 mg Advil and light meal; headache returned in afternoon; headache persists into evening, nausea returns (too intense to eat), chills, generally feeling lousy and want to go to bed 12/01/20: arm hurts after injection, muscular soreness all day, hurts to sleep on left side 12/02/20: arm very sore at injection site, red, swollen
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX (batch number T5242, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX which led to incomplete course of vaccination.
2 1/2 hrs p/vax pt started w/fever (felt warm); gave advil 1 1/2tsp; 5 hrs later 145AM t104 gave Advil; cried 2 hrs then fell asleep 430AM; 5 mins later had sz lasting 1 min; transported by amb to ER;
230AM awakened by itching & burning red rash on face, neck, chest, & arms eyelids puffy; Later it was felt that pt was having rxn to Septra instead of vax;
Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated with ZOSTAVAX vaccine on or about 26-MAY-2010 as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2015, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir and LIDODERM for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
human leukocyte antigen (HLA) sensitization subsequent to vaccination; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/merck) (manufacturer unknown), with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) with diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid and with pneumococcal vaccine conj (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010291: US-009507513-2209USA010293:
Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for about 48 hours. After 48 hours the rash started on top on both ankles. That lasted probably 8 days and didn't get better with cream.  The muscle aches started in my neck and upper body and about 11days ago decided to settle in my knee (right). I though I maybe slipped or fell but didn't because of the pain. The pain is cross between a  cramping muscle and  shin pain.  I've been walking with a limp.  I got in yesterday with my PCP and sending me for an ultrasound to rule out a blood cot. He doesn't believe it is because it moves, I don't have any swelling or redness. I have just been really fatigue. I had BP done to make sure my Thyroid is ok and it is.  The past 3 nights it has stopped waking me up at night.   I've been doing epsilon salt baths, I can't put weight on it and still walk with a limp.  I go for ultrasound tomorrow.
Extreme fibromyalgia symptoms in my arms, back, chest and thighs.   I had had fibro years ago and have NOT had a flare up in 3-4 years.    The pain was worse than I ever had before.
PATIENT STATED THAT SHE GOT EXTREMELY COLD, EXPERIENCED A HEADACHE, FELT FEVERISH AND FELT ACHY THROUGHOUT HER BODY.  PATIENT TOOK TWO 650MG ACETAMINOPHEN.  PATIENT STATED THAT SHE STILL DIDN'T FEEL GREAT THIS MORNING, BUT AS THE MORNING WENT ON SHE FELT SHE WAS IMPROVING.
Covid symptoms started on 05/08/22; tested positive on 05/10/22. First symptoms were sore throat and I would say maybe fatigue. The sore throat sort of started fading and was replaced by stuffy nose, sneezing, a little coughing from scratch in throat, and fatigue. Then today, I had stuffy nose, loss of smell, sneezing, and the sore throat is gone. First 2 doses were Pfizer.
Awoke early morning with headache; felt dizzy.  Went downstairs for Tylenol; on return to bed felt nauseated, sweaty, dizzy.    Passed out on bed for approximately 15 seconds.   Husband shook me and called out then I awoke and gained consciousness. Rested in recovery the remainder of the day and was able to take the Tylenol and resume normal activity by midday.
A report has been received from a Health Professional concerning a 14 year old. Male subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST (INTRANASAL) started on 14-Jan-2014. On 14-Jan-2014, the patient received expired FLUMIST QUADRIVALENT. They administered expired vaccine to 3 patients. The outcome of the event of RECEIVED EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Went to ER after parent noticed child turning blue & not breathing. All our office received was an ER report and we have not been able to contact parent for outcome.
Patient received her ZOSTAVAX and FLUVIRIN immunizations around 12 pm 11/26/12. That evening at 4-5 pm, the arm that had ZOSTAVAX started to turn red and started to itch. She also had a fever of 99 degrees. Swelling and redness continued until 11/30/12 and then subsided.
Information has been received from a Licensed Practical Nurse concerning a 4 year old male patient who on 08-JUN-2005 was vaccinated with first dose of VARIVAX (Oka/Merck) (Lot # 650224/1107).  Subcutaneously on 01-FEB-2009 the patient experienced 2-3 papules vesicular lesions in face and neck.  The patient did not seek medical attention.  Additional information is not expected.
During/after vaccination patent screamed and cried very loudly triggering, breath-holding spell and subsequent fainting.
Blood pressure low; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure low) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002021A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension in 1998, Diabetes in 1998, Benign prostatic hyperplasia in 1990, Neuropathy in 2008 and Stroke in 2010. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) from 1990 to an unknown date, LISINOPRIL, PRAVASTATIN, GLIPIZIDE, CARVEDILOL, METFORMIN, CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE BESILATE (NORVASC) and GLUCOSAMINE & CHONDORITIN.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Feb-2021, the patient experienced HYPOTENSION (Blood pressure low). At the time of the report, HYPOTENSION (Blood pressure low) had resolved.            This case was linked to MOD-2021-019879 (Patient Link).   Reporter did not allow further contact