chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a consumer, who was also the patient, on 09 October 2012. A 76-year-old female patient had received a dose one intramuscular injection in the right deltoid of FLUZONE (lot number unknown) on 27 August 2012 and the same day the patient's left fingers got swollen and turned black and blue which then went all the way up her hand. The patient's little finger was still swollen at the time of the report. The patient's past medical history was unknown. The patient's outcome was not recovered. Follow-up information was received from a healthcare professional on 20 December 2012. Due to the new information received, this case has been upgraded to serious. The finger does not feel to be infected. Treatment included MEDROL 4 mg dose pack) and continued antibiotic therapy with a follow-up in ten days. It was unknown if the patient had any illness at the time of vaccination. Medical history type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled and essential hypertension, benign. Concomitant medications included alprazolam, ibuprofen, atenolol, LASIX, MAXZIDE, metformin, NIASPAN, PREVACID, simvastatin, SYNTHROID, nystatin-triamcinolone cream, KLOR-CON and meclizine. Outcome remained not recovered. Documents held by sender: None.
Had slight headache and slight nausea which went away after a few hours. As the evening wore on my arm at the injection site started to hurt. I removed the bandaid and felt the site and there was a small hard lump. This morning, my arm hurt and felt itchy and swollen. I looked at the injection site and there was a band of red across the top of my arm which was swollen and hard and itchy. My sister is a physician on her hospital's COVID vaccine task force and I sent her a photo of the arm. She said it looks like "a robust antibody reaction." She told me to put hydrocortisone creme on it. I did. It isn't as itchy or red but it's still slightly swollen. After 1st injection on 3/8/2021 I developed what they called COVID arm. I had a sharp pain for 2 weeks on and off at the sit of the injection and developed a slight rash on my shoulder and the back of my neck but not on my arm. My arm just hurt a lot and then it subsided and went away.  No problems at all with the 2nd shot or the 1st booster.
Chest pain w/elevated troponins and small ST elevations in infero/lateral leads concerning for myocarditis
hives/  on the right deltoid at the injection site; mild edema/ on the right deltoid at the injection site; mild erythema/  on the right deltoid at the injection site; itching/  on the right deltoid at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number F3NL3, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th July 2021, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hives, injection site edema, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives, injection site edema, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site hives, injection site edema, injection site erythema and injection site itching to be related to Boostrix and Boostrix Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Boostrix on 14th July 2021, in the right deltoid. HCP (healthcare professional ) stated that, the next day on 15th July 2021, the patient began to experiencing itching, mild erythema, mild edema, and hives on the right deltoid at the injection site. The patient had received Benadryl for side effects. The reporter consented to follow up.
Three months after I received a Covid-19 vaccine, I developed a urinary tract infection. I was admitted to the hospital with a fever and low blood pressure. Urine culture showed presence of E. coli. This was treated with IV fluids  and antibiotics, followed by oral antibiotics. I am still taking Cefuroxime daily to prevent recurrence of the UTI. I had another UTI on March 18, 2021 - this was between my first and second Covid-19 vaccines. The first UTI happened one day after a cystoscopy. There is no evidence that either UTI was related to the Covid-19 vaccination.
Bilateral lower extremity weakness, diagnosed with Guillain Barre Syndrome treated with IVIG
On Sept 1st pt came to clinic c\o pain to R outer arm at the site of injection, also c\o swelling at site. Doctor saw pt and prescribed Zyrtec 10MG 1 tab PO QD, and Advil PRN pain. Pt came in Sept 3 also c\o pain and swelling at injection site. Doctor saw pt and diagnosed as improved, event being reported as adverse today Sept 3.
Headaches, elevated blood pressure, inflamed lymphnodes, sore neck on left side, eye twitches.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Patient complained of loss of motor control of hands and lower extremeties-Medium
red swollen hot rt upper arm, 15 cmx 12.5 cm in size, started day 11 after injection, low grade fever (100 deg  F), numbness in rt arm 1st day of reaction , each day area of redness worsening
Routine 12 month physical today.  I ordered MMR and Var (along with Hep A and flu) to be administered.  Tech administered MMRV and Var (along with Hep A and flu).  As of this evening, the patient has not had an adverse reaction, to my knowledge.
Mild heart palpitations at first injection , felt dizzy and slightly disoriented but able to walk and do things. Got home experienced kidney pain in right side- woke up in the night with heart palpitations and continuing kidney pain - drank water went back to sleep- in AM felt typical flu like vaccine symptoms. Rested most of the day- in the evening I started having muscular arm spasms and also in my thighs/legs like my nerves were jumping. The next morning my arms continued to twitch and spasm along with my face, legs, neck and abdomen- made worse when stressed - laid down half the day trying to get spasms under control .
Vaccinated on 9 Dec 2005, symptoms started 12/20/05 with rash on both arms, back and stomach.  No itching except at injection site. Treated with Zytrec, Zantac and Keflex.
11 y/o patient (who was turning 12 y/o in 4 days on 12/18.) was given adult dose of pfizer for dose 1. No SEs reported following observation.
Body aches, fever up to 102.6°, chills, bad headache, tiredness, nausea, loss of appetite   Using ice and taking Tylenol every 4 hours
This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age and ethnicity received PREVNAR, on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms and felt sick on Mar2016 with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Irritability, hyperactivity, complaining of itchy skin, allergic eczema on arms, mood swings, erratic behavior, a neurological 'tic' of shaking head.
Injection 4/8/21 12:40pm. 4/9/21 3:00am: Severe headache , while first dose did not generate side effects, 4/9/21 6am: Chills, backaches. Aches and chills persisting thru early afternoon 4/9/21
febrile sz 4FEB98 adm to hosp x 2 days;
Information has been received from a registered nurse concerning a 10 year old male who on 19-Sep-1995 was vaccinated with a dose of varicella virus vaccine live (Lot #609289/0433B). On 10-Jan-2004 the patient presented with a low grade fever and about 30 vesicular lesions on his face and chest. The patient was prescribed amoxicillin (+) clavulanate potassium (Augmentin) as a prophylaxis against secondary infections. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
3 or 4 days after the first vaccine I developed a diarrhea illness. I went to my GI doctor after the second dose (which I received on 03/23/2021-lot number 0Y0A21A) on 04/15/2021. He ordered different tests for me and I ended up having a colonoscopy in 06/09/2021, which was normal. They also did blood work and they were some abnormalities. He said the vaccine created an autoimmune response that caused the diarrhea. I also ended up having tinnitus in my left ear after the second dose. I went to the ENT and audiologist on 04/20/2021 because the tinnitus will not go away. I had a hearing test and it showed no loss of hearing. They also did an MRI of my auditory canal on 05/20/2021, which came back normal. My ENT said they have seen more tinnitus since the pandemic. The audiologist also said they have seen more tinnitus since Covid. By 04/24/2021 all of my GI symptoms seem to have resolved. Sometimes the tinnitus gets really loud. It's like a high pitch ringing. I talked to another doctor and he did not know about it was caused by the vaccine but he said since it was unilateral it should go away.
Information has been received from a physician concerning a 33 month old white female in good health with no medical history and no known allergies who on 21AUG2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. On 21AUG2001 the patient was also vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation), a dose of haemophilus B conjugate vaccine + hepatitis B vaccine recombinant yeast, a dose of Streptococcus pneumonia vaccine (Prevnar) and a dose of diptheria toxoid + pertussis vaccine + tetanus toxoid (DTaP CONN). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The patient's mother reported that on 22APR2003 (previously reported as approximately 15JUL2003) the patient developed breakthrough chicken pox with less than 50 lesions after exposure to community chickenpox. The patient developed the first lesions following exposure to a cousin who had chicken pox.The patient did not have a fever at first, but developed a mild fever 2 days after the first lesions. There were a total of about 20 vesicles on the arms, legs and trunk. No diagnostic studies were performed On 22JUL2003 the pediatrician saw the patient's mother and reported that the child was at home with chickenpox. This could be described as a mild case. On 22JUL2003 there were only 4 lesions remaining. Unspecified medical attention was sought and no treatment was necessary. The physician "indicated" that there were other cases in her practice, but she could not now recall the patients. It was reported that the chicken pox lasted 3-5days and subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
2 vaccines one year ago and got shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, between 11 and 12 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: 2 vaccines one year ago and got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient had the 2 vaccines one year ago, and 5 days before, surprise the patient got shingles. Not bad, for at the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
8 days after receiving the shot, I developed a flaming red patch about three inches long  on my left arm where I had had the shot. It lasted about 24 hours and then began to fade.
Swollen face left side; Headache left side; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swollen face left side) and HEADACHE (Headache left side) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 04-Feb-2021, the patient experienced SWELLING FACE (Swollen face left side) and HEADACHE (Headache left side). On 04-Feb-2021, HEADACHE (Headache left side) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and SWELLING FACE (Swollen face left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 77-year-old female who experienced NS unexpected events of sore throat and face swelling and NS expected event of headache.  Sore throat onset the same day as the first dose of mRNA-1273, with headache and face swelling 8 days after mRNA-1273. Headache resolved. Other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up received included no new information. On 20-Apr-2021: Follow-up received included no new information.; Reporter's Comments: This case concerns a 77-year-old female who experienced NS unexpected events of sore throat and face swelling and NS expected event of headache.  Sore throat onset the same day as the first dose of mRNA-1273, with headache and face swelling 8 days after mRNA-1273. Headache resolved. Other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt experienced mild lightheadedness and nausea for 5-10 minutes. The pt was instructed to lie flat on back with cold compress applied to forehead. Symptoms occurred immediately post administering of MMR.
The pt experienced soreness in her left breast and swelling in her left underarm, 24 hours later. No swelling or redness at the site of the injection but did have soreness at injection site. Swelling in her left underarm was the size of her hand. She saw her PCP whom stated that the pt had immune response (systemic).
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. The action taken with Shingrix was unknown. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
started w/blurred vision 2 hrs post vax; followed by h/a on rt side of head followed by numbness of lips, fingers & hand on rt side of body; this was like migraine pt had 1 year earlier; nausea & vomiting;
Pain in the armpit at site of injection, plus underneath the arm, redness, swollen gland in neck on the left, stiffness in back of neck.
LEGS BRUISED; LEGS SWOLLEN; IN AGONY; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced legs bruised, legs swollen, and in agony. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs bruised, legs swollen, and in agony. This report was non-serious.
Fever, chills, tiredness, malaise, abdominal pain and myalgia.
After finish contract with the military in June of 2003 I have been diagnosed with hypertension. Also I have problems with memory process and a sleeping disorder.
Coughing, breathing problems, pain in left lung. Sought medical attention on May 9, 2016 2:30 and was treated for bronchitis. On May 17, 2016, Dr. diagnosed me with pneumonia in my left lung. I have permanent damage in that lung now-bronchiectasis.
Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.
Diarrhea, chills, headache, neck pain, sleepiness, weak and painful legs and bottom part of the body, confusion, loss of taste and some smell, chest pains. This lasted for almost 2 weeks.
Left side of ribcage to hip bright red, itching, then hives. Slight fever, half an hour after left started to get hives my right hip area started to itch and get hives also. Severe pain at injection site on my arm, could barely tolerate lifting it. Took 3 benadryl, symptoms started to decrease after 40 minutes
Initial misuse report received from a healthcare professional on 23 May 2013. Only the DTAP-IPV portion from PENTACEL was administered to the patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
an expired dose of PENTACEL was administered/ no AE; Initial information was received on 29-Jun-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661687) and transmitted to Sanofi on 29-Jun-2021.  This case involves a patient (unknown demographics) who was vaccinated 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ350AAA and expiry date 22-Jun-2021) via unknown route in unknown administration site on 24-Jun-2021 for prophylactic vaccination and reported that an expired dose of PENTACEL was administered with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.