chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breaking out in lesions/Caller reported that not all of the lesions itch, and that some hurt; Sore arm; Lips constantly dry, more than usual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 10:15 (Lot number: EN6208) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Narcolepsy", start date: 2020 (ongoing), notes: Verbatim: Narcolepsy; "Depression" (ongoing), notes: Verbatim: Depression; "respiratory problems" (ongoing), notes: Verbatim: History of respiratory problems; "Unspecified thyroid condition" (ongoing), notes: Verbatim: Unspecified thyroid condition; "Surgical history" (unspecified if ongoing), notes: Verbatim: Surgical history. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); LEXAPRO taken for depression (ongoing); MODAFINIL taken for narcolepsy, start date: 2021 (ongoing); HYDROCODONE/APAP taken for pain (ongoing); ESTER-C [ASCORBIC ACID] (ongoing). Vaccination history included: Shingles vaccine; Flu vaccine; Pneumonia vaccines.  The following information was reported: SKIN LESION (non-serious) with onset 13Apr2021, outcome "recovering", described as "Breaking out in lesions/Caller reported that not all of the lesions itch, and that some hurt"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (11Apr2021), described as "Sore arm"; LIP DRY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Lips constantly dry, more than usual". The event "breaking out in lesions/caller reported that not all of the lesions itch, and that some hurt" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin lesion.  No follow-up attempts are possible. No further information is expected.
Left upper arm and shoulder: warm, erythematous. RX: Keflex 250mg/1 tsp 3/4 tsp PO TID x7 days.
Red, splotchy rash that itched intensely and spread all over body.  Reaction began about an hour after the flu shot was given.
Severe insomnia.  I normally fall asleep within 15 minutes of going to bed.  Monday after receiving the second shot I never closed my eyes.  I was awake the entire night.
Hazy/foggy vision, temporary. For about 7 days after both doses, my eyesight got very foggy, severely limiting my ability to get anything done. It took about 2 days to get to its worst, was bad for about three days, then about 2 days to clear up. Vision basically returned to "normal" after each event.
Pt alerted me that she was starting to feel very anxious, felt as though her blood pressure was elevated, headache, slight confusion and brain fog, and some tingling in her mouth following her 2nd shot of Moderna today. After assessing the patient I thought it best to administer 25 mg oral liquid benedryl and I had an epipen ready if symptoms worsen. About 10 minute later she reported that she started feeling better. We monitored her for an hour to make sure she was feeling back to normal.
Swelling in glands of neck looked like mumps severe; couldn't eat or swallow had t102; MD said allergic to eggs;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TELMISARTAN, start date: 10May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 25Nov2022, to 05Dec2022 for COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I am pregnant I am 32 weeks and 6 days and I have experienced, nausea, dizziness, headache and all over the body, redness and swelling in the area where the vaccine was given
I remember very little of day after except not being able to think about getting up. (I imust have gone to the bathroom.)  I must have had aches and a headache, but I don't remember. High fever. I recall 102.7 or 103.7. Surely not 103.7, but I have no way to verify any of it. (I generally run low.) Two thermometers in the drawer: a Kinsa and an old one. A few days later, I checked the Kinsa, and there is no record. I either used the old one, or nothing at all. I was called twice and said I was sick, but they didn't come check on me. I wos likely dehydrated, and tylenol might have helped.  The next day -- two days after 3rd dose (not the 50% booster), I had difficuty focusing my eyes -- felt like they were darting right and left. Had some difficult putting words together very well. Both of these were frightening. I think I called my doctor that day, but it might not have been until the next day.  I am fairly certain it has taken a couple of months for me to speak and write as fluently as I did before.
12/14/09 @ 9:44am - pt rec'd nasal H1N1, about 10:10 am began with c/o stomach ache B/P 124/68 P=88, R=20, denies SOB, lungs clear to auscultation; 10:13 am pt c/o SOB, bilateral wheeze ausc, call made to "911" and child's parent, Epi .35 cc given SQ l deltoid, B/P 130/90, P= 100, R = 20, pt alert, cooperative, coherent. 10:17 am - EMS arrived on scene.
profuse sweating with extreme light headedness Same symptom occured on 3/3, and 3/5 with feeling of tiredness afterwards. No symptoms since.
Forehead numb; Face became red; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included ATENOLOL, LEVOTHYROXINE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red). On 11-Mar-2021, HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Tightness and warmth at injection site. Red circular rash around injection site. Not painful. Not itchy. No treatment. Ongoing at time of this report.
Start of rash to buttock and lower back 07/15 rash spread 07/08 to legs and chest.  07/09 covered in rash multiple red bumps seen in MD office.  Prescribed atarax.
Spots in vision and double visions for about 40-45 minutes afterwards. About 1-1.5 hours afterwards tingling and numbness in both hands and mouth started and lasted for about 30 minutes.
Patient developed substernal chest pain that began about 3 days after her first Pfizer Covid shot.  It was worsened by laying flat and relieved somewhat by sitting upright or forward.  NSAIDS were slightly effective at improving the pain.  It took about a week to totally resolve.  The patient went to a walk-in clinic initially and they noticed right-axis deviation on an EKG and sent her to the Hospital for further workup. She was discharged from the ER several hours later with no clear diagnosis but a suggestion that it sounded clinically like a viral pericarditis.
rash on the arm; muscle aches, especially on legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the arm) and MYALGIA (muscle aches, especially on legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the arm) and MYALGIA (muscle aches, especially on legs). At the time of the report, VACCINATION SITE RASH (rash on the arm) and MYALGIA (muscle aches, especially on legs) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment information provided
extremely tired and worst fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired and worst fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (extremely tired and worst fatigue). On 12-Mar-2021, FATIGUE (extremely tired and worst fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Patient's wife states his symptoms of tremors, loss of coordination, startle myoclonus, and memory loss began after receiving the COVID-19 vaccination (symptom onset late 11/2021). COVID-19 booster was given in conjunction with a flu shot but it is currently unknown which type of influenza vaccine and  the lot number of said vaccine.  He himself is unable to provide reliable history and wife refuses to entertain possibility of symptom onset prior to vaccination, only repeatedly saying there are no symptoms prior to this event. Patient's symptoms have progressed until hospital admission was necessary. He met all criteria for Probable Creutzfeld-Jakob Disease. He denies ingestion of any wild game, receiving blood transfusions, and being out of the country in the past 10 years. Given the pathophysiology of the disease and the mechanism of the vaccine, it is difficult to draw a correlation between two events outside of coincidence. CJD  occurs sporadically in over 90% of cases. Wife is requesting a report be filed given the onset of symptoms after Moderna booster dose.
Employee presented with redness, edema, induration, warmth and itching around injection site right upper arm Denies fever
This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) and refers to a patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # L050907, expiration date 14-JUN-2017, dose and route not specified). The vaccine was stored at 10 F for 45 minutes. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Red rash on left arm at the location where the vaccine was delivered. Noticed it about a week after receiving my first vaccine.
Large blood clots- that are not normal for my period. Large clots, 1/2 dollar size 4-5 times a day. Which is not normal, my period should be winding down, and it is ramping up and at like Period Day 6, bleeding through a pad an hour or 2 hours and large clots. Clots started and higher bleeding after the vaccine.
the vaccine that was administer was covid 19 moderna booster (NDC 80777-275-05) and supposed to be toddler
Information has been received from a registered nurse concerning a 2nd grade male student in an elementary school who on 02/23/1998 was vaccinated with a dose of varicella virus vaccine live.  In mid December 2004 he developed chickenpox.  It was reported that 58 other elementary students developed chickenpox in mid December 2004 and according to the school nurse, 34 of the children had previously been vaccinated with a dose of varicella virus vaccine live.  Unspecified medical attention was sought.  There was no information regarding the present status of the 2nd grade male student.  No product quality complaint was involved.  Additional information has been requested.
pt was given vaccine from a vial that had been punctured over 12 hours, thus expired.
Mild fatigue, muscle soreness, body aches, occasional chills (no fever). All symptoms were minor and did not require treatment. Most lasted 24 hours, mild fatigue lasted 36 hours.  This was my second vaccination.  Only slight muscle soreness with the first vaccine.
Fever 102-104 started on 12/12/15, 12/13/15 mom noticed red, splotchy area on right arm, complaints of dizziness, and off balance, back, neck, and stomach pain, headache.
at 1230 on 1/5/2021 mentioned individual begin to feel she was having trouble concentrating, felt cold and hot and tingling on scalp and nausea and felt like she was about to faint.
flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old  male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown.  No follow-up attempts are possible; No further information expected.
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 23-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.   The patient's medical history included allergy to soy.  No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 23-year-old patient who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred same day (exact time not provided) after the first dose of mRNA-1273 (Lot number: 041L20A) administration. The treatment included EpiPen injection. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient was vaccinated with third dose of RabAvert vaccine on day 14 instead on day 21; Case reference number US-BN-2022-001380 is a spontaneous case report initially received on 23-Jun-2022 from a health care professional (reference number: USBAV22-0402) and concerns a *32-year-old female patient*.  The patient *had no medical history and was not taking any concomitant medications.*  On an unknown date, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown) at unknown dose or route of administration for unknown indication.  On an unknown date, unknown amount of time after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number unknown) at unknown dose or route of administration for unknown indication.  On *23-Jun-2022*, 14 days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: *YRBA841B, expiration date: 28-Feb-2024*) at unknown dose, *intramuscularly, in the left deltoid region*, for unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered').  *It was confirmed that the patient did not experience adverse event.*  Additional information received from Bavarian Nordic on 24-Jun-2022 included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from other health professional (nurse) on 28-Jul-2022: New information included date of administration, batch number, expiration date, anatomical location and site of administration for the third dose of RabAvert; patient's details.; Reporter's Comments: A 32-year-old female patient was vaccinated with the third dose of RabAvert for unknown indication, as reported, on the day 14 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history and was not taking any concomitant medications. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old female patient was vaccinated with the third dose of RabAvert for unknown indication, as reported, on the day 14 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported with the reported medication error. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no medical history and was not taking any concomitant medications. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Pt had vaccine 9/11/20, 9/12/20 pt had a red papular rash all over body. Mom sent a picture to Dr & gave Benadryl.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-JUN-2016 the patient received an improperly stored (Oka/Merck)VARIVAX (lot # L031066, expiry date: 13-JAN-2017 (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No informatino on their medical history, concurrent conditions or concomitant drugs was provided. On 24-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004267, expiration date: 12-JUL-2014; dose, site and route were not provided. Dose supported. No adverse event was reported. Additional information has been requested.
Arm swelled, turned red & hot, itched and then later was very painful.  This was not just local.  The swelling spread to encompass whole upper arm and into the elbow.  Swelling was over 8-9 inches vertically in the upper arm and spread around the full width of the arm to include the underside ~13-14 inches.  Also had some minor swelling of hand.  During this time I ran a low grade fever became light headed and weak.  Though I was still up and around.  It is now 24 hours later and the swelling has not gone down yet though I have taken Allegra and Advil.
left arm painful and limited range of motion for two days.  then a rash developed and a cellulitis that lasted three days.   after second shot on same arm,  had pain and limited range of motion and strength within 6 hours.   Aches in arm went up to shoulder and into scapular area and upper spine/cervical area.  Took Tylenol  times two doses and put heating pad on upper arm for relief.  No rash noted and pain in arm lasted about three days.  But a week later,  I noticed a paresthesia of thumb and first finger.  Also extreme weakness in grasp and forearm.  I am a CRNA and was unable to intubate for two days.  Getting strength back and paresthesia is improving.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of M-M-R II (Lot# and expired date unspecified) and other vaccines were administered to unspecified patients (dose, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/ temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant FU - Primary Reporter address updated