chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called pharmacy one hour from FLUZONE dose (IM) said she could not move her arm much at all, felt like it hurt if moved any direction. Not swollen but red. Next 24 hrs still hurt and hard to move and bruised at injection site. Patient told to try Ibuprofen and Ice. Helps somewhat. Patient will call their MD if not better by 10/19/11.
Arms itched again after second shot; Rashes on both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arms itched again after second shot) and RASH (Rashes on both arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Arms itched again after second shot) and RASH (Rashes on both arms). At the time of the report, PRURITUS (Arms itched again after second shot) and RASH (Rashes on both arms) outcome was unknown.            no treatment information was reported no concomitant medication were reported     Reporter did not allow further contact
This spontaneous report as received from a pharmacist via field employee refers to an unspecified number of patients. Field employee stated pharmacist had no patient details and no specific lot information. On an unknown date, the unspecified number of patients were concoi6tantly vaccinated with ZOSTAVAX, 0.65 ml (milliliter), once and PNEUMOVAX23, o.5 ml for unknown indication, for an unspecified period of time. Field employee learned from pharmacist that some of the patients who received concomitantly administered ZOSTAVAX and PNEUMOVAX23 developed nausea and fever post vaccination. Patient sought medical attention (consulted pharmacist). There was no intervention to Prevent Serious Criteria. Action taken with respect to suspect therapy was not applicable. Te outcome of events was unknown. Causality was not provided. No product quality complaint (PQC) was involved. No further information provided.  Additional information has been requested.
Early menstrual cycle and very bad cramping. It was even worse after the 2nd shot. Cramping to the point where she was unable to sleep several nights. It improved with the cycle after but the periods are still not back to normal.
Skin rash on his whole body; Urticaria; Right mouth swelling/left mouth swelling; Swelling face; Lower lip is swollen; Touches his face, the skin feels thicker; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that about 13 days ago, on 22Apr2021, he had the Pfizer Covid-19 Vaccine. He thinks that about one week or 8 days later he had a skin rash on his whole body. Treatment of skin rash on his whole body was applied. The patient added that he took Benadryl 25 mg only once and and a few hours later the rash faded. One day later, it was completely gone and was no more (as reported). Today, this morning (as reported), the patient woke up and his right mouth right below the chin to the mouth area to the lower lip is swollen. The patient adds that his body had urticaria. He took Benadryl, another one, 25 mg and one or two hours later his body urticaria disappeared. Right mouth swelling: the patient adds that his face was swollen below the cheek to lower the lip line and it is not disappearing but seems a little bit smaller. It used to be a bump and now it feels like skin is still thick but he feels better on the right side. Left mouth swelling: the patient adds that he thought probably he would caller interrupts statement  and says he does not know why but it turned to the left side, the left lower lip and it became swollen again (as reported). The right side has come down a little more but still feels like the inside of his mouth on the right side, he does not feel anything now, except when he touches his face, the skin feels thicker (as reported). Now, it has become to the left side left lower lip area, and lower chin. He does not know what to do. The patient confirms that this was his first dose of the Pfizer Covid-19 Vaccine. The outcome of the event "Skin rash on his whole body" and "Urticaria" was resolved, the outcome of the other events was unknown.   No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-events temporal association and considering the nature of the reported events suggestive of a possible allergic reactions (the events urticaria and skin rash are also mentioned in the safety profile reported of the suspect product), the company deems there is a reasonable possibility that all the reported events are related to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
mom states began running fever 2hr p/shot;pt got a call @ work that fever was 102 & that pt had sz;pt rushed to ER;pt had prev VAERS report @ age 6mo;
PREVNAR received on Wed, began to redden on Sun, on Mon was itchy and hard, symptoms resolved spontaneously on Thursday following. No medical attention, but did use topical BENADRYL.
she had an infection; her arm was swollen; her arm was red; her arm was very painful; had a temperature of 99 degrees; couldn't move her arm for a couple of days; Information has been received from a 67 years old female patient referring to herself. The patient's pertinent medical history was not provided. The patient's drug reactions/allergies included antibiotics, erythromycin and amocacillion sulfa type. The patient's concomitant medications included antibiotic, gliponide for heart rhythms and raloxifene hydrochloride (EVISTA) for bone density. The patient also received a flu shot and a pneumonia shot on the same day with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  On approximately 16-SEP-2020 (reported as about a week ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose/frequency 1 (unit not provided), route of administration: injection; strength, lot # and expiration date were unknown) because she worked in healthcare and wanted to be careful with not getting sick, and wanted to keep her immune system strong.      On an unknown date in September 2020 (reported as last week), the patient had an extreme reaction to the vaccine. The patient had an infection and her arm was swollen and red, very painful, had a temperature of 99 degrees, and could not move her arm for a couple of days. The patient stated the pain and swelling was from the injection site all the way down to her wrist. The patient had to go to urgent care because of the side effects she was experiencing worsened, and while she was admitted they gave her an antibiotic to help with the reaction. The patient was wanting to know if there was certain ingredients in the vaccine that would be an indication that this was an allergic reaction or if it could have been cellulitis. All the events recovered in September 2020. The causality between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.
Vaccination site pain; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Slight fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Granuloma annulare. Concomitant products included CORTISONE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Slight fever). On 12-Feb-2021, PYREXIA (Slight fever) had resolved. On 14-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also include oral antihistamines. Treatment details include self administration of topical cortisone and oral antihistamines. Patient prefers phone or physical mail contact, as she does not have an email address. Patient consents to follow-up with safety.Patient agreeable to speaking to her physician.   This case was linked to MOD-2021-109686 (Patient Link).
This case was reported by a physician via sales rep and described the occurrence of blood in urine in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced blood in urine. On an unknown date, the outcome of the blood in urine was unknown.  It was unknown if the reporter considered the blood in urine to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The physician did not provide any further information and said he would agree to follow-up from GSK.
currently in the hospital with shingles; shingles after the 1st dose; Too sick to get the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Too sick to get the 2nd dose). On an unknown date, the patient experienced HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) (seriousness criterion hospitalization). On 23-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Too sick to get the 2nd dose) had resolved. At the time of the report, HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were reported.  Per the reporter: the patient's doctor said he was too sick to get the second planned dose scheduled 23FEB2021.  No treatment details were reported.  This case concerns a male patient of unknown age who missed second dose. The patient also experienced shingles and due to temporal association between the reported event and the administration of mRNA-1273, causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster in patients Event of missed dose is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: A follow up received on 25 MAY 2021 has no new information; Sender's Comments: This case concerns a male patient of unknown age who missed second dose. The patient also experienced shingles and due to temporal association between the reported event and the administration of mRNA-1273, causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster in patients Event of missed dose is assessed as not applicable.
Armpit swelling; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and asked could the Shingles vaccine cause armpit to swell. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old male patient who received SHINGRIX. In February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th February 2018, 5 hrs after receiving SHINGRIX, the patient experienced fever, injection site pain, tiredness and headache. The patient was treated with ADVIL. In February 2018, the outcome of the fever and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the tiredness was recovering/resolving. The reporter considered the fever, injection site pain, tiredness and headache to be almost certainly related to SHINGRIX. Addition details were provided as follows: The patient received SHINGRIX on the right arm. About 5 to 6 hours after vaccination, the patient experienced fever, administration site soreness, tiredness and headache. The patient took 1 ADVIL to help manage symptoms. Fever and headache were lasted for about 30 hours. The patient had denied permission to contact their physician.
a 48 y.o. female patient who received her first dose of Pfizer Covid vaccine at  Hospital immunization site. Pt has reported several allergies and delayed reactions to vaccines in the past and based on this information she had been assigned a 30 min observation post vaccine.   Thirty four minutes in to her observation patient c/o of itchiness hives and chest pain. BP 208/94, P 73, Oxygen Sats on RA 99%. Code Five response was activated. Pt given 25 mg of po Benadryl elixir and was transported to the ED for further observation and care.
Information has been received from a registered nurse concerning a 75 year old female with no known medical history who on 21-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot # 656859/0357U).  There was no concomitant medication.  On 21-MAY-2007 the patient developed local redness and swelling at the injection site.  On 01-JUN-2007 the patient developed shingles and the rash was mostly on her forehead and temple.  She went to a different clinic to see a physician who prescribed pain medication and antiviral medication.  At the time of the report the patient had not recovered.  No laboratory tests were performed.  There was no product quality complaint involved.  Additional information has been requested.
her arm hurt with the previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348067 Same patient, different vaccine dose number, different AE;
Patient received Pentacel vaccine component DTaP IPV and second dose IPV during routine 4 yr-old immunizations. Mom was made aware of incident and to monitor child for any adverse or unusual reactions. FNP was notified immediately. HIB component of Pentacel was not given.
chill; pretty nasty headache; sweating profusely; queasy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 23Oct2021 11:00 (Lot number: FF2590, Expiration Date: 31Dec2021) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot no. EP7534, Expiration date: 31Jul2021), administration date: 16Mar2021, for Covid-19 immunization, reaction(s): "extreme tiredness", "soreness in the injection spot"; Bnt162b2 (Dose 2, single, Lot no. ER8734, Expiration date: 31Jul2021), administration date: 06Apr2021, for Covid-19 immunization, reaction(s): "extreme tiredness", "soreness in the injection spot". The following information was reported: CHILLS (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "chill"; HEADACHE (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "pretty nasty headache"; HYPERHIDROSIS (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "sweating profusely"; NAUSEA (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "queasy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache, hyperhidrosis, nausea.  Additional information: Saturday patient received the booster shot which was the Pfizer vaccine, around like somewhere between 11 am and noon and later on that evening probably around 6 to 7 pm, patient just started experiencing like the those guess chill and got a pretty, pretty nasty headache and then started just sweating profusely and then just started was queasy from Saturday evening until this morning, so patient had never experience that. Treatment: included, "two Tylenol tablets." No follow-up attempts are possible. No further information is expected.
Adacel which reached 33.5 degree Celsius that was vaccines were administered to 11 patients; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.  This case is linked to cases 2019SA192651, 2019SA192618, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 21 years old patient who was vaccinated with  0.5 ml second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6273AA and Exp. Date 24-Apr-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  It was an actual medication error case due to product storage error temperature too high.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
On 1/12/2021 (two weeks following the injection) the injection site became hot to the touch, quite red, itchy, and slightly swollen. On the morning of 1/13/2021 I noticed that it was still swollen, hot to the touch, mildly itchy, less swollen, but now has a large red ring around the injection site with a pale center.
Moderate or above lower back pain on the right side with no triggering event or history of back pain
About a week after getting the first dose, blood blisters started to form on my hands, arms, legs. Bruising has been noted.
This is a 4 Years old Male, dad, complaining of skin rash for 1 day after receiving the vaccine.  Skin rashes is on the right leg.  Patient also received a vaccine on the left leg but has no rash there.  Dad did give Benadryl about 2 hours ago.  Negative fever. Patient has cellulitis that does not require IV antibiotics and therefore will be discharged home.  Patient has currently been stabilized in the emergency department. Based on history, exam and any tests done, I don't suspect an emergency cause of cellulitis such as, but not limited to, necrotizing fasciitis, bacteremia, sepsis, etc. Patient will be discharged with strict return precautions and follow up with primary MD within 48 hours for further evaluation.  Diagnosis/Assessment/Plan: 1. Vaccine reaction  2. Cellulitis
Headache; Vomit; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 09:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 10:00, the patient experienced headache, vomit, upset stomach and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 25Feb2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events headache, vomit, upset stomach and diarrhea were unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
12 hours post Moderna booster (and shot 2), experienced increased anxiety and/or feeling of an increased rate rate (not sure if anxiety or actual heart), causing an inability to sleep/nap despite exhaustion. Persisting almost 24 hours post-booster. Went away within 48 hours with shot 2. Taken Tylenol for fever/chills/severe headache.