chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MIGRAINE; SCRATCHY THROAT; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2020 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2020, the subject experienced migraine. On 2020, the subject experienced scratchy throat. On 2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, fatigue and scratchy throat was not reported. This report was non-serious.
COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There was 22 patients who received COVID vaccination during this time frame.  The vials were pulled out the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Eh9899) solution for injection in the left arm on 29Dec2020 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma, pituitary adenoma, IBS (irritable bowel syndrome) and COVID (prior to vaccination). Concomitant medications were unknown. Past drug history included known allergies: ciprofloxacin hydrochloride (CIPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. In Dec2020, the patient experienced nausea, body aches, headache and unable to sleep. No treatment was provided for the events nausea, body aches, headache and unable to sleep. The outcome of the events nausea, body aches, headache and unable to sleep was recovering. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on 30Dec2020 and result was pending.  No follow-up attempts are possible. No further information is expected.
Started developing hives on inner forearms, thighs and buttocks; worse in the evenings.
It was actually both shots that had a similar weird event. 1st shot, I got my period the very next day. I was close to my due date so I thought nothing of it. This shot, I got my period a week early and a few days before that, I had some severe and acute pain around my clitoris and some light brown/tan/yellow discharge. I'd never had anything like it in my life.
Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, via in left arm on Mar2021 (Batch/Lot Number: EN6205) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included deep vein thrombosis, allergies PCN (penicillin). Concomitant medication(s) that patient within 2 weeks of vaccination included apixaban (ELIQUIS). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, via in left arm on 13Feb2021 08:30 am as 1st dose, single dose for covid-19 immunisation. The patient did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19The patient experienced entire right side from head to toe affected. pains, numbness, tingling, limb sleep paralysis on 23Mar2021 at 07:00. The patient underwent lab tests and procedures which included (nasal swab) sars-cov-2 test: negative on 24Apr2021. Patient visited emergency room/department or urgent care for reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.   Follow-up attempts are possible. Further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K005427, exp date 15-APR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Both times that I received the vaccine I got a tooth infection the very next day. The first time far worse than the second. Both times I had to be prescribed antibiotics.
Hive like rash at the injection site 8 days after injection. Rash is tender and warm to the touch and shoulder is a little sore. No fever and no other symptoms.
pt recd 1 dose of Engerix-B & exp bruising @ inject site involving neck & arm;
2\6\2007 Darian was given the Pneumococcal Polysaccharide vaccine in upper right are at approx. 10:30 am.  At 2:30 pm when I picked him up from school he was complaining the arm was very sore and difficult to raise.  I thought it just tender from the shot so I put ice on it and did not look at it.  At 8:30 pm when he went to take a bath he said he could not get his shirt off, I tried to pull it over his head and he immediately screamed and dropped to the floor.  He was crying hysterically and begging me to cut his shirt off.  I got the shirt off and noticed immediately his arm was swollen, red and feverish.  I called the emergency number for the pediatrician and left a number for a return phone call.  The nurse had me measure the arm, it was 2.5" larger in diameter than the left and very painful at that point he had no fever.  She advised me to bring him in early in the morning.  The doctor looked at the arm and said that is the worst reaction we have seen, we will keep an eye on it.  They drew around the area with a sharpie marker and told me to tell them if it got any bigger, he had no fever that day either.  It extended from 2" above the shot area to 2" above the elbow.  I took him to school and received a call from his teacher at 2 pm.  Darian could not lift his arm, it was very painful and the redness and swelling had spread below the elbow.  I called the doctor and was told to bring him in the next day.  I took him in on 2\8 and they decided it had doubled in size now and we were going to treat it with prednisone and cephalexin, he had a slight fever of 99.2.  His arm was swollen from the shoulder blade to below the elbow.  The right arm was now swollen over 4" in diameter larger than the left.  He was not able to use the arm for almost 3 days.  I was not told of the possibility of temporary paralysis until the third doctor visit, if I had been told, he would never had taken the shot!  He also had a Hep A vaccine and Tetanus booster on 2\6 however, they were in the left arm and only the pnuemonia shot was in the right arm, it was the only area of adverse reaction.  Three days in a row we had to go to the clinic for which I was charged each and every time.
Mastitis in left breast.  PCP prescribed 10 days of Doxycycl HYC Tab. 100 mg. PCP doubted that the mastitis had anything to do with the vaccination.
PATIENT DEVELOPED HIVES FROM AFLURIA (EGG) VACCINE. THE HIVES BEGAN ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION AND SPREAD DOWN HER ARMS TO HANDS AND WRIST AT WHICH POINT I ADMINISTERED 8ML OF BENADRYL (2:45PM) AND MARKED THE RASH AROUND THE INJECTION SITE. WITHIN MINUTES THE HIVES ON HER HANDS AND ARM BEGAN TO DISSOLVE. AT APPROXIMATELY 3:20PM THE INJECTION SITE HIVE HAD COMPLETELY DISAPPEARED AND PATIENT WAS FREE OF HIVES. DURING THE WAITING PERIOD I ATTEMPTED TO CALL PTS PCP, OFFICE IS CLOSED FOR THE OBSERVANCE OF THE HOLIDAY. WILL INFORM THEM OF REACTION TOMORROW MORNING. ADVISED BOTH MOM AND DAD TO REDOSE WITH 8ML BENADRYL IF RASH REAPPEARS IN 4 TO 6 HOURS AND TO SEEK MEDICAL EVALUATION. THEY CONFIRMED THEY HAD BENADRYL AT HOME TO DOSE WITH IF NEEDED
This nurse looked at the wrong paper in the refrigerator to check the expiration date, as the paper needed to verify was under the envelope that was on top. The vaccine had expired on 9/19, and was administered on 9/20. Contacted Janssen to get further guidance. They sent information on current studies, but stated the validity of the dose would have to go off of our own professional judgment. Our medical director was contacted, and he stated the dose was a valid dose and did not need to be repeated. That if the client was concerned for effectiveness he could receive another dose or a dose of mRNA in 4 weeks to improve efficacy. Notified patient of situation. He was feeling fine after administration. He felt if our team felt it was still a valid dose, then he trusted the professional judgment. He did not feel a need to get another, or to get a dose of the mRNA. He did request to be notified at a later date if evidence came out that it was not effective, and he would get another for the efficacy.
Patient did not state had received 1st Dose of Pfizer on 12/26/2020
the night after she had these shots she started to get fussy, irritable but did not have a temp. then on the 24th, she became short of breath, fussy, irritable, inconsolable and so we took her temperature and it was 103.4 so we took her to the hospital. they were able to take her temp again and it was 101.9 and so they gave her tylenol and took again and it was 100.9. they sent us home and today, the 26th, it is at 102.6 again.
No adverse event; Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered).    No concomitant medications were reported.  It was reported that 2.5 mL size vial of Moderna COVID-19 vaccine, Bivalent had passed beyond use date i.e. 13-Oct-2022. Only one patient was administered the vaccine. It was not reported when the vial was initially stored in the refrigerator It was unknown if vial had undergone any temperature excursions.  No treatment medications were reported.
Four year old with onset of full body urticaual rash about 1 hour after receiving influenza vaccine.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients received doses of GARDASIL (lot#, dose, route not reported) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Redness, pain and swelling around site of injection. Saw Dr 10/29/2010 for evaluation and was given Doxycline 100mg po bid for 7 days. Dr states it was cellulitis and allergy to Tdap.
Patient reports having 6 "chicken pox" blisters appearing 2 weeks after receiving the SHINGRIX vaccine. She said they scabbed over the next day and healed.
Delayed Dizziness, Brain Fog, Fatigue, Light-Headedness, Nausea all beginning 6 days after first Pfizer covid Vaccine.
30MAY96 t103;1JUN96 hives started on whole body;2JUN96 pt taken to hosp ER states problem is vax assoc;3JUN96 pt seems much better;
1st injection - 25 minutes afterwards I experienced a slightly  heavy sensation - like a drop in pressure in the head, chest, and stomach. 5 minutes later, I experienced multiple tiny sharp pains in left calve and foot and same in right side of head, They were mildly painful, pins and needles and it was scary with regard to wondering if it was a stroke. Then 15 minutes later, I experienced random skin itching in different spots. The neurological attacks continued and came on randomly in short attacks in mostly the extremities, but sometimes the face. The facial skin seemed also to have swollen and aged very rapidly after 1st shot, Also, blurred vision. 2nd injection, 4 weeks later, no immediate response but 11 hours later neuro and vascular symptoms began to come on. in left foot and right arm. pins and needles and neuropathic itch in left foot.  8 hours following, full on fever and weakness and severe flu symptoms, Weak and disoriented and sweats and chills with fever in mornings of 102 or greater. Heavy chest and head congestion, dizziness, rigidity, inability to function - quite sick for days.
Patient had fever 101.4 in the evening the day she received her vaccine and severe diarrhea for 1 1/2 days afterward. She said arm not only sore at injection site but also down her arm towards her elbow.
About 20 minutes after shot began experiencing pain. Arm swelled. By Saturday afternoon, pain from lifting caused me to feel nauseated.
This spontaneous report as received from a pharmacist refers to a 66 year old male patient. Pertinent medical history, drug reactions or allergies were not reported. On 26-SEP-2014 the patient was vaccinated with expired ZOSTAVAX lot # J001693, expiration date 08-MAY-2014, 0.65 ml, subcutaneous in the right arm (dose number was not reported). No adverse effects reported at the time of this report. No concomitant therapies were reported. The outcome of the events was unknown. Additional information is not expected because reporter refused additional contact.
segment elevation myocardial infarction. Unrelenting chest pressure starting about 24h after dose 1 of the Pfizer/BioNTech vaccine. Initially unrecognized as cardiac, after 4 hours of pain he eventually called 911. He was found to have anterior STEMI, with a thrombotic proximal LAD lesion which was revascularized. He had distal embolization of thrombus to the small coronary vessels, with TIMI I-II flow and wall motion abnormality.
Pneumonia bacterial; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriasis. There was no reported medical history. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA BACTERIAL (medically significant), outcome "recovered", described as "Pneumonia bacterial". The action taken for adalimumab was unknown. It was reported that, the solicited report from the privacy by a consumer of an adult female patient with an event of non-serious bacterial pneumonia with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was also considered as suspect. It was unknown whether the patient was enrolled in a covid-19 vaccine trial. The primary reporter contact for lot number information was unsuccessful.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of bacterial pneumonia was not reported. The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for the event of bacterial pneumonia was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact 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
A spontaneous report was received from a consumer concerning a 76 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced fatigue, chills.   The patient's medical history and concomitant medication were not reported.  On 11Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscularly for prophylaxis of COVID-19 infection.  On 12Jan2021, the patient experienced fatigue and chills. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events fatigue, chills were unknown.  The consumer assessed the event fatigue and chills were not reported.
Went to the doctor for aches; Muscle ache and it says joint pain on the paper; Muscle ache and it says joint pain on the paper; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 01Jun2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she went to the doctor for aches. She had muscle ache and it says joint pain on the paper. It was only on her right leg. The patient stated that she had her second dose and then she took her mom to the pharmacist. She gave her paper with all the side effects. She was currently feeling like muscle ache and it says joint pain on the paper, and she knew there was something that could cause. The patient did not have laboratory test. She thought she did one last year. Right now, she was taking medication which included muscle relaxant Orphenadrine citrate and Diclofenac sodium, and she was not taking any medications before. Outcome of the events was unknown.  Reason for no lot number: of COVID Vaccine: Other: Is it EW0217 that is for the second dose, I am not sure if this 2 or 0. they kind of went over the number. I think so because They also have like 2 over 0 or 0 over 2. I am not too sure.  Information about lot/batch number is requested.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm). At the time of the report, ILLNESS (Really Sick) and INJECTION SITE ERYTHEMA (Red Ring around Arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.