chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a maedical assistand and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M024680 expiration date  18-MAY-2018 (dose and route of administration were not reported). The vaccines were reconstituted with proplerly stored sterile diluent (lot# and expiration date were nor reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 32 hours. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested.
the top of my head is feeling numb; I have a rash on my legs, no itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Fluocinonide). Concomitant products included ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS, FISH OIL and PROBIOTICS NOS for an unknown indication.    On 23-Aug-2021 at 6:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021 at 3:30 AM, the patient experienced HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching). At the time of the report, HYPOAESTHESIA (the top of my head is feeling numb) and RASH (I have a rash on my legs, no itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient visited Doctor's office to make sure everything was Ok.   On an unknown date, Body temperature was 97.3F and Blood pressure was 90/60mmHg No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant follow up-outcome reported; Updated Race information, Ethnicity, Vaccine facility information. Added body temperature and  Bloos pressure in narrative.
right shoulder and arm swelling, redness, warmth, itching and pain, with participant reporting feeling increased arm pain when lying down.
Pfizer on 2/20 and 3/12. Positive on 11/10
2nd Pfizer Covid vaccination was given one week early.  Foster Mom notified patient did not have any ill side effects. Notified patients PCP with no new orders.
1 of 4 pts who recv Tetramune from the same vial exp a fever;pt vax 11JUL; had a low grade fever 12JUL-13JUL; no sz; pt recovered;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ6342) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL0142), in right arm, on 09Feb2021 as dose 2, single (Lot number: FL3302), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 06Mar2022 as dose 4 (booster), single (Lot number: FK995), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type II DM" (unspecified if ongoing). No allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included: Paxlovid from 03Mar2023 to 08Mar2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine and BNT162b2, BNT162b2 omi ba.4-5 vaccine can not be excluded for the reported events of COVID-19 and vaccination failure due to temporal relationship.
Then at 30 hours post injection experienced very severe sciatic nerve pain that lasted 48 hours total; 11 hours after 2nd vaccine injection; experienced pins and needles all over body including head and face; That night experienced flu like symptoms; Severe muscle ache; Chills; Fever 103 F; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 22Apr2021 at 11:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sensitivities to a number of medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included thyroid (MANUFACTURER UNKNOWN) (reported as thyroid hormone), ketotifen (MANUFACTURER UNKNOWN) and typical supplements (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, 11 hours after the second vaccine injection, the patient experienced pins and needles all over body including head and face, that night experienced flu-like symptoms, severe muscle aches, chills - fever of 103 F; then after 30 hours post injection (23Apr2021 at 17:30), experienced very severe sciatic nerve pain that lasted forty-eight hours total. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events pins and needles, flu like symptoms, severe muscle aches, chills, fever of 103 F was recovering whereas that of sciatic nerve pain was recovered on 25Apr2021 at 17:30, after the duration of forty-eight hours.  No follow-up attempts are needed. No further information is expected.
Onset of weakness and tingling in Left arm 24 hous after receiving flu vaccine.  The vaccine was administered in the Left arm.  The weakness occurred in the forearm and hand.  Described as feeling like "pins" and "poor circulation".  No swelling, no redness. Good capillary refill, color pink. Given Ibuprofen 600 Mg. 1 po q 8 hrs prn.
Large  5? diameter  hard lump with extreme itching. Started around day 5 or 6. It is progressively shrinking and becoming less itchy, everyday. I didn?t treat it.
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles  Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently  48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried.  *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection  72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
Extreme anxiety attack, mental distress, calmed down by days end, back to normal by Sunday night.
This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on 13 May 2021 (at the age of 41-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing blood pressure high and diabetes, asthma and vertigo from an unknown date and unknown if ongoing. Concomitant medication included amlodipine taken for blood pressure high from an unspecified start date and ongoing; metformin taken for diabetes from an unspecified start date and ongoing; atenolol taken for an unspecified indication, start and stop date were not reported; olmesartan taken for blood pressure, start and stop date were not reported; cinnarizine taken for vertigo, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to Covid vaccine. Facility where the COVID-19 vaccine was administered was Hospital. Patient stated, first time she didn't take anything she just took TYLENOL but her arm swell up the same day on 13May2021 and she couldn't move my arm for 2 days, it was stiff she couldn't move my hand. she put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that she woke up swollen and she couldn't move on an unspecified date in May 2021. This was freaking me out. Under my arm and all the way down she don't think it should swell up like that and it is on whole body on an unspecified date in May 2021. Patient stated, she took TYLENOL for relief joint discomfort and inflammation on an unspecified date in 2021. The patient underwent lab tests and procedures which included TSH test: unknown results on 22Apr2021. There was investigation assessment reported. Therapeutic measures were taken as a result swollen arm, mobility decreased, limbs stiffness, joint discomfort and inflammation. The outcome of events was unknown.
Lightheadedness, dizziness, sweating, diffuse redness across chest - within 5 minutes of administration, almost immediately upon ambulation.
Parasthesia in left arm within 5 minutes of vaccination. Parasthesia radiated into fingers (tingling but not painful). Parasthesia in left arm resolved in about 1 hour with no treatment.  Parasthesia in tongue within 5 minutes of vaccination. Parasthesia in tongue (tingling but not painful) lasted through the evening (~5 hours). Resolved without treatment.  Heartbeat increased (bounding heartbeat) onset within 5 minutes of vaccination; resolved within 5 additional minutes with no treatment.
I experienced sever headaches and my doctor ordered X-rays that showed a severe sigmoid sinus infection. I also went back to the doctor on 05/07/2021 for a Colonoscopy which showed an increase number of precancerous cells (scheduled another appointment for next year) along with Gasterosteus. (prescribed medicine).
Got the vaccine 8:37 am December 30 and six days later got sore arm and redness and itchiness. The sore arm for one or two days. The redness three to five days and itchy. I couldn't do strenuous work - but just too Tylenol and that helped a bit. I went to my doctor (on the 8th) and he gave me Alertec medicine and Prednisone. That resolved the symptoms.
Pt recv vax on 11/16/98; on 11/17/98 pt exp red, tender vax site; 11/19/98 pt exp nausea & vomiting
Employee gave vaccine to patient from a vial from the fridge that had been punctured greater than 12 hours. Vaccine remained in the fridge so there was not a temperature excursion, only the vial being punctured longer than 12 hours.
12/22/2004 9hrs after vaccines given pt had 30 second episode of stiffening and whole body shaking, then staring and quiet for few minutes after event, then ok. Event occurred while drinking bottle
Sore arm; Mild body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   This case was linked to MOD-2021-162013 (Patient Link).
her blood pressure which was 208/189; really bad shakes a fever of 102 degrees; really bad shakes a fever of 102 degrees; This is a spontaneous report from a contactable other HCP(patient). A 46-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization.  Medical history included COVID-19 in Nov2020/Dec2020. The patient's concomitant medications were not reported. 12 hours later the patient had really bad shakes a fever of 102 degrees and she checked her blood pressure which was 208/189. She went to the Emergency Room to get checked out and she was told that it was probably due to the vaccine. Patient wanted to know if she should receive the second dose of the vaccine since she had this type of reaction after the first dose. She had COVID-19 in Nov2020/Dec2020. She was told in the Emergency Room that since she had a previous COVID-19 infection that she would experience worse side effects from the first dose of the COVID-19 dose than the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported blood pressure increased. 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.
fluzone pfs, that were expired was administered,with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case is linked to cases 2022SA417187(CLUSTER) and 2022SA418817(CLUSTER).  This case involves a 7 months old male patient who whom expired Influenza Quadrival  A-B Vaccine [Fluzone QIV] was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar); Hepatitis A Vaccine (Hepatitis A) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunisation.  On 07-Oct-2022, the patient received 0.5 ml of expired Influenza Quadrival  A-B Vaccine with no reported adverse event (expired product administered) (lot UT7378MA and expiry date- 30-Jun-2022) via intramuscular route in unknown administration site for immunization or TB test.  Action taken: Not applicable.  Outcome: Unknown   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.
Reaction to 2nd booster with covid arm syndrome, red dots and rash on arm and leading down to wrist and arm
The patient reports developing CP and SOB about 1 hour after receiving the vaccination which resolved within 3-4 minutes. The patient denies seeking medical treatment and these symptoms were reported to employee health on 12/28/2020.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with her first dose of GARDASIL and later that day went to work out at the gym and started experiencing numbness in her legs. The patient went to ER where she had different tests (including EKG and other unspecified tests) done and everything came back normal. The next day the patient came to the physician's office for a follow-up visit and was experiencing heart palpitations and was referred to a cardiologist. It was unknown if the patient had recovered. No further information is available.
feels warm to the touch; rash and itch in the mouth; rash and itch in the lips; rash and itch around the face; Pink rash in her face and neck/ lip/ mouth; puffiness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feels warm to the touch), MOUTH ULCERATION (rash and itch in the mouth), LIP PRURITUS (rash and itch in the lips), RASH PRURITIC (rash and itch around the face) and RASH (Pink rash in her face and neck/ lip/ mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (feels warm to the touch), MOUTH ULCERATION (rash and itch in the mouth), LIP PRURITUS (rash and itch in the lips), RASH PRURITIC (rash and itch around the face), RASH (Pink rash in her face and neck/ lip/ mouth) and SWELLING FACE (puffiness). At the time of the report, FEELING HOT (feels warm to the touch), MOUTH ULCERATION (rash and itch in the mouth), LIP PRURITUS (rash and itch in the lips), RASH PRURITIC (rash and itch around the face), RASH (Pink rash in her face and neck/ lip/ mouth) and SWELLING FACE (puffiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were  provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and addition of new event puffiness..
On May 8th, around 2:15 pm, I started getting severe double vision in my left eye. I could barely see out of my left eye because of this. I thought this could be a sign of a blood clot, so I drank a few glasses of wine and the symptoms went away after about 15 minutes. It has not reoccurred.
Pt recvd Hep B vax on 3JUN92 & approx 6 to 7 days p/vax pt exp lightheadedness & diarrhea;
Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.   Reporter did not allow further contact
rash on my mid thighs to top of my knees; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other healthcare care professional (Nurse, Patient reported for herself that).  A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158), via unspecified route of administration in right arm on 24Apr2021 (at the age of 56-years-old) as DOSE 2, SINGLE for COVID-19 immunization. patient was not pregnant at the time of vaccination. Medical history included High blood pressure. Patient concomitant medications included losartan and metoprolol for an unspecified indication and therapy dates were also not reported. The patient previously received BNT162b2 (COMIRNATY, Batch/Lot Number: EW0151) via an unspecified route of administration in right arm 06Apr2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced outbreak of HSV1 on 10Apr2021.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received Losartan and Metoprolol within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, Patient developed a rash on her mid thighs to top of her knees (4 days after vaccination) and received inappropriate schedule of vaccine administration. Patient did not receive any treatment. The outcome of the event rash was recovering.  No follow-up attempts are required. No further information is expected
Fever, chills, nausea, diarrhea, body aches, headache.
Systemic inflammation throughout the entire body diagnosed by a nuerologist, elevated heart rate, pain in chest, back, shoulders, brachial neck pain. Burning throughout the arms, shoulders, upper back. Sinus tachycardia. Vertigo, nausea, dizziness, feeling flushed of all energy, almost losing consciousness on several occasions. Unable to sleep, patient jolted out of their sleep gasping for breath. Patient was prescribed prednisone 4mg for inflammation, 500mg methocarbamol for muscle spasms, 50mg diclofenac for pain medication by neurologist. 1mg clonazepam for anxiety by PCP.
VACCINE ADMINISTERED TO A 15 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old female. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient experienced vaccine administered to a 15 year old. On 24-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to a 15 year old was not reported. This report was non-serious.