chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. Follow up information was received from the nurse on 03-SEP-2014, reporting the lot number of the ROTATEQ that underwent a temperature excursion. Lot number K001194 expiration date 06-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Large local erythema and induration following anthrax immunization #3. Onset with local itching within 4 hrs. ER visit with nausea, lightheadedness. Treated with Benadryl, Phenergan, hydrocortisone 10x5cm erythema; 5x5cm induration and tenderness.
Approximately 3 weeks after vaccination, patient complained of sore arm and a small clean injection site lesion.  Symptoms continued.  Saw Dr who found small lesions on arm and truck - healing and shingle-like on 10/22/07. Follow-up information from the pharmacist indicated the patient developed shingles and injection site pain after receiving ZOSTAVAX (lot# 658083/0885U). The patient developed several lesions around his body. The lesions resolved, but he still had injection site pain, a lot check has been requested. Follow-up information from the pharmacist indicated that the patient's injection-site pain persisted. Follow-up information from the physician indicated that the patient called the phyician and reported he continues to have pain at the injection site and wanted to know when he could exepect relief. Additional information has been requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactoy. The lot met requirements and was released by the regulatory agency.
Sore arm, dizziness, nausea, headache, low blood pressure, fatigue, body aches and chills
1210 Patient arrived after vaccinations administered with hives on face and chest, no respiratory distress. Was examined by Dr. 1215 7ml BENADRYL given PO. 1232 HR 116 Pulse Ox 99%. 1238 ZYRTEC 2.5 mg tablet dissolved in water given PO. Observed in office 55 minutes. Pt. symptoms improved, rash and hives were improved, no respiratory distress noted.
broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
stomach cramps; diarrhea; chills; fatigue; vomiting; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN) for Blood pressure management, TESTOSTERONE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced NAUSEA (nauseous). On 13-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and VOMITING (vomiting). On 14-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 13-Jun-2021, VOMITING (vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
low fever; chills; Amplification of local reactions; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, chills and local reaction. On an unknown date, the outcome of the fever, chills and local reaction were recovered/resolved.   It was unknown if the reporter considered the fever, chills and local reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced amplification of local reactions, chills and low fever for almost 48 hours. The patient experienced no problems after 2nd dose of Shingrix. The physician was unable to provide patient or vaccine details, provided these reported events as general events reported by patients.
First dose as Pfizer Covid19 Vaccine, second dose as Moderna; Pediatric patient received the Moderna Covid19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine). At the time of the report, OFF LABEL USE (First dose as Pfizer Covid19 Vaccine, second dose as Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric patient received the Moderna Covid19 Vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
2MAY96 930Am, t100.3 then had gen sz, lasting 3min seen @ ER hosp;no specific tx has been well since area of erythema on arm site of inj (7x5cm);
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 25-NOV-2009, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy (by an unspecified health care professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 25-AUG-2014, the patient was treated by a physician at a family group medical office for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 25-AUG-2014, the patient sough(t) subsequent treatment from a physician (name was the same as the physician's name at the family group medical office; unclear if it was the same physician) at an ophthalmology office for the diagnosis of Herpes zoster ophthalmmicus (shingles with interference in the eyes). On or about the dates of 02-SEP-2014 and 08-SEP-2014 the patient sought additional treatment from the physician (same name) at the family group medical office for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 14-NOV-2014, the patient was further treated by the physician (same name) for ongoing and worsening symptoms of zoster infections. The patient was prescribed famciclovir  (FAMVIR), methylprednisolone (MEDROL), gabapentin and hydrocortisone for management of her painful and persistent symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.   Upon internal review, the event of Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
So sick; muscles aches; flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31-MAR-2023, the patient received Shingles vaccine. On 31-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: So sick), muscle pain (Verbatim: muscles aches) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the sickness, muscle pain and influenza-like symptoms were not reported.   It was unknown if the reporter considered the sickness, muscle pain and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the sickness, muscle pain and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shot on the day of reporting and was so sick with muscles aches and flu like symptoms. The follow-up could not be possible as no contact details were available.
Pain in arm right away after shot. Could not lift arm for two days after. Have loss of mobility now 3 weeks later.
At 48 hours had 3" diameter cellulitis. Patient has a history of IgG2 deficiency. Treated with KEFLEX BACTROBAN. Cellulitis at site of DPAT.
Person was 16 year old and he received the Moderna vaccine. No vaccine reactions were observed or reported.
Got shot at 4pm, waiting 15 min. At Pharmacy went home and developed a rash on my upper body, it was light at first, then faded and came back 15 min. Later & was red and blotchy and felt like my skin was burning/on fire/felt so warm and my heart was racing. The Rash traveled down my arms- more so on the arm where the injection was. It also traveled up my chest and was really red there and went up my neck and my ears & nose were extremely red and I felt like I might pass out. I then went to Urgent Care and called my Dr. URGENT CAEE gave me dexamethasone Sod Phosphate PF 10MG solution to swallow, which Dr. Said it would last up to 4 days in system. and I took Benadryl 50mg. The rash disappeared that night on 6/3/21. On 6/4- it hasn't returned.
I suffer from MS so my neurologist warned me that MS patients typically did experience a health event following the vaccine. I woke up at 2AM and I could not move. I finally made it to the bathroom but was unable to get off the toilet. My husband assisted me with getting back to bed. For the next 12 hours, I felt lethargic and sick. I woke up the next morning and was totally fine. This also happened following the 1st booster-(Moderna 017F21A-10-23-2021-dose 3).
Redness and swelling from shoulder to elbow within 24 hours of immunization; resolved around 72 hours later.
poss. sterile abscess - R ant. thigh 3 cm erythema 6-7 mm induration non tender tx: observe
Numbness in right cheek, jaw and lips  Headache mid right back of head Lasted most of day but decreased severity Mid level pain Numbness lasted into following day + Did not seek treatment  Extremely painful injection diminished within three hours. Sore for four days
swollen legs from the knee down to the feet; painful swollen hands; swell and pain at the knee joint; struggles to walk; muscle cramps; spasm; Not able to sleep; Unable to wear their shoes; swell and pain at the knee joint; sore ankles; Pain at the shoulder blade; pain at the top of the head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk) and MUSCLE SPASMS (muscle cramps) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A211(4 or A)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint) and ARTHRALGIA (sore ankles). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK UNK, qd; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK, qd; IBUPROFEN ongoing since an unknown date at a dose of UNK, qd and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of UNK, qd. At the time of the report, PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint), ARTHRALGIA (sore ankles), ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head) 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.   No concomitant medications were reported.   This case was linked to MOD-2021-182438, MOD-2021-181936 (Patient Link).
expired IPOL was administered to a patient with no reported adverse event; Initial information received on 22-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional.   This case involves an unknown age and unknown gender patient for whom it was reported, "expired ipol was administered to a patient"while receiving POLIOMYELITIS VACCINE (INACTIVATED) [IPV (VERO) [IPOL]].   The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) [Suspension for injection,lot R1D973M and expiry date: 17-Jul-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  On 22-Jul-2021, "expired IPOLwas administered to a patient" (expired product administered) (latency: on the same day) following the administration of IPV (VERO).  There were no laboratory data/results available.  It was unknown if the patient experienced any additional symptoms/events.  At time of reporting, the outcome was unknown for the 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 the 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.
Patient became diaphoretic stating "I don't feel good". Pt had syncopal episode. Patient placed on stretcher, +pulse and +resp., Pt immediately regained consciousness and talking. Pt taken to ER. Determined to have vasovagal response and discharged.
29 weeks pregnant at time of Moderna booster.  13 days after vaccine, started with hives, and skin becomes warm to touch and itchy.  Pruritus persists, but has become less severe and less frequent since initial start on 12/13/2021.
Redness, painful/fading itchiness approx 6-8 am R upper arm began this hrs after vaccine
Headache; Fever/ 101F; Chills; muscle pain especially in legs; Fatigue; sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Information on concomitant medications was not provided and the patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318) in the left arm on 23Feb2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 22:00 patient experienced headache, 101F fever, chills, muscle pain especially in legs, fatigue and sore arm at injection site. The patient did not receive treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, 101F fever, chills, muscle pain especially in legs, fatigue and sore arm at injection site was recovered.   No follow-up attempts are needed. No further information is expected.
Information has been received from a 75 year old female patient who on 19-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 19-JAN-2011 the injection site became sore and itchy. It did not become swollen and that she did not develop a rash. She denied any other AE. The patient did not receive any medical attention. On an unspecified date, the patient recovered. Additional information has been requested.
Hi,   My I am the mother of a patient and here I would like to report an incident that happened on 12/30/2022. I schedule for Covid Vaccination for My Son  at a local clinic:    Clinic started the Covid vaccination 1st shot and after that my son was sick for 4-5 days with high  fever, headache, stomach upset, weakness etc. On 12/30/23 nurse didn't tell us that she has given him incorrect sort of Covid Vaccination.   After 21 days, on 01/20/2023 when we went for his 2nd shot of Covid vaccination, nurse/clinic supervisor says, they don't have second shot of Covid vaccination and I should go to a local pharmacy and get second shot, I said okay, please give me a Covid vaccination card and I can go and get the second shot. At that time first they give me a yellow stick note specifying name, dob, and saying he got first shot of covid vaccination. I got surprise by that as no office does such things for patient records, I told them and requested them to provide me the valid copy otherwise no other pharmacy will accept that and after wait of a hours they gave me a copy of the document which says patient got "COV-2 - Bivalent Booster" and when I saw that I enquiry for it and Clinic Supervisor says these days Covid 1st sort and booster are giving together and that why it's written this way.   As they don't have the Covid vaccine available they auto schedule for second shot to different clinic office location:   on 1/27/2023.   When I went their on 01/27/2023, nurse checked the document and says this is wrong, boy shoudn't get the booster sort first, I said as per the Previous office clinic supervisor these days 1st sort and booster you guys giving together, she says nope that is never a case, she went and checked the lot of medicine 2 times as well as checked with her clinic supervisor/manager and they confirmed that this lot is booster shot not Covid 1st shot and then we come to know that my son got booster sort first instead of regular Covid vaccination shots on 01/27/2023 and nurse says they cannot start the vaccination now.  After this, I went to the vaccinators doctors office and told them what I come to know and then they said, the other clinic is saying incorrectly but kind of accepted that it's booster and it was a mistake. So by reading all this now you can see, the doctors office administrator is misguided, pass incorrect information, not taking patient parent/guardians concern before giving the shot to minor and not transparent with patient on the mistakes they did.   As my son keep complaining about headache after every 3/4 since 12/30/2022, so now knowing all this, I've scheduled a visit to review/discuss this case and see what all impact my son can face and how it will impact his overall health because of negligence incidents. I tried to reach out to Manager/upper staff of that facility with no luck and they didn't response.  Please let me know if you have any further question. I can be reach at my email address