chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 21-year-old female who in 1986 and 1992 was vaccinated SC with a 0.5mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 24-MAY-2006 a titer was 1.04 for measles. Another dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) was administered on 30-MAY-2006. Unspecified medical attention was sought. No further information is available at this time. There was no product quality complaint involved. Additional information has been requested.
extreme foot swelling in both feet; horrible lung wheezing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0196), via an unspecified route of administration in left arm on 10Jun2021 at 15:00 (at the age of 37-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history of the patient included asthma. The patient had no known allergies. There were no concomitant medications. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: Ew0187), via an unspecified route of administration in right arm on 17May2021 at 12:00 (at the age of 37-years-old) as single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The patient reported that on 10Jun2021 at 16:00 an hour after receiving the second vaccine, patient had extreme foot swelling in both feet, and horrible lung wheezing after 40 hours. The events lead to the emergency room. Therapeutic measures were taken as a result of events that included Prednisone. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
2 weeks post vaccine, I began having extremely muscle weakness and fatigue. This has continued for months and has progressively gotten worse. The weakness, fatigue and tremors is debilitating.  Tingling in arms and legs on left side.  I am now 3 months post J&J vaccine with neurological issues and no answers. Like I mentioned above, debilitating weakness and fatigue.
Menstrual flow (spotting) started on 07Mar (day 5 of new combo pill pack), light flow started on 12Mar; as of report date 18Mar, still experiencing light menstrual flow; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as a Dose 1, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included dienogest, ethinylestradiol (LARISSA) taken for contraception, started on unknown date, which was ongoing. Patient had no significant medical history. The patient experienced menstrual flow started on 07mar (day 5 of new combo pill pack), light flow started on 12Mar2021 as of report date 18Mar2021, still experiencing light menstrual flow on 07Mar2021. It was reported that, patient was currently on Larissa (combo pill, birth control). Normal cycle was 28 days, lasting for 5 days, with moderate flow. She been on Larissa for 3 years, never had irregular period, always 28 days cycle. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fatigue: Soreness; muscle soreness; soreness at injection site; nasal drainage; respiratory issues that felt like a cold and became something in my lungs after a few days.
On 7/14/16 mom says she had not had a bowel movement for a week and constipation continued. On 8/4/16 she says she is not talking as much as she used to.
I took the Johnson and Johnson vaccine approximately 1 week after it was available in my area ,through facility. I was fine the day of the shot and next day. But the 3rd day, I woke up at 5:00am feeling terrible: extreme weakness, difficulty breathing, chest pain, elevated heart rate (110-120/min), decreased O2 sat (pulse oximeter in the 80s), and mild difficulty with thinking and concentration. My doctor told me to go to the ER. After about 6 hours in which I was screened for heart attack and other differentials, and I was on IV fluid, and I think they gave me Tylenol, I was stable enough to send home.  I recovered slowly over the next 3 days.  About 10 days later, I had a flight into health -- all my COVID-19 long haul symptoms cleared up -- and I have stayed healthy since.
Began fever @ approx 630PM; APAP given by mom- played & slept until 1015PM; felt hot; mom treated w/APAP; had difficulty breathing, began shaking, eyes rolled back; c/o stop breathing, t100.3, convuls, cranky, elevated WBC, cannot r/o infec
I started feeling achy and fatigued; I started feeling achy and fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 09:30 (Lot number: EN6208) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "degenerated discs L4-L5, L5-S-1" (unspecified if ongoing); "neuropathy (feet)" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ALFUZOSIN; ATORVASTATIN; BUPROPION; CLOMIPHENE CITRATE. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin"; Penicillin, reaction(s): "known allergies: Penicillin". The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "I started feeling achy and fatigued".  Additional information- Similar to first dose, I started feeling achy and fatigued, around 48 hours after receiving second dose On the 4th day, I had a small rash or irritation inside right armpit. That spread to my chest by day 5 and I suspected shingles. On day 6 I had a video appt with a doctor who confirmed shingles and prescribed Valtrax, which I took twice daily for 7 days.  The condition worsened and became more painful, and I developed migraine like symptoms for several days. Today is day 23 of feeling these ill effects, I have some improvement but am still not up to working or physical activity. The patient had no Covid prior vaccination. The patient did not had Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
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 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     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 medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Arm got itching; Arm had a big red lump; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), PARACETAMOL (TYLENOL), CHOLESTEROL and CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES) for an unknown indication.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump). At the time of the report, INJECTION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Arm got itching) and INJECTION SITE MASS (Arm had a big red lump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were reported as Blood pressure meds, Cholesterol meds, Pre diabetes meds, Tylenol and Aspirin.   No treatment information was provided.
swollen nodule in Left deltoid. Reports was itching so patient was rubbing affected area. Reported swelling.
Hives on face and neck; Hot ears; tingling/vibrating skin on face after any exercise daily (still occurring 7 days after shot); severe headaches; chills; fatigue; hot flashes; sleeplessness; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at  09:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient's had allergies to penicillin, pollen and tree nuts. The patient's concomitant medications included cetirizine hydrochloride(ZYRTEC, birth control medication (unspecified) and multivitamin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 12:00, the patient experienced hives on face and neck, hot ears (red ears), tingling/vibrating skin on face after any exercise daily, severe headaches, chills, hot flashes, fatigue and sleeplessness. Therapeutic measures taken were not reported. The clinical outcome of the events hives, red ear syndrome, tingling skin, headaches, chills, hot flashes, fatigue and sleeplessness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
MONOVALEN VACCINE WAS GIVEN INSTEAD OF BIVALENT BOOSTER THAT WAS NEEDED. NURSE DISCOVERED THIS ERROR THE NEXT DAY AFTER VACCINATION
Pt was inadvertently given 0.5 cc instead of 0.3 CC dose
Mother noticed redness right thigh next day...DTaP and MMR placed right thigh, diphenhydramine 12.5/5ml 2.5 ml TID PRN itching. KEFLEX 250mg/5ml 5ml QID x 7 days.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 96 year old patient. Weight: not provided: height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, route of administration: intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the measure remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-3026 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 4-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
My son got his vaccine on the 3rd, by wensday the 8th ( of September 2021, this is all in the same month) but by wensday the 8th he started to have. Runny nose and sneezing, and a slight cough. ( Mind you he gas seasonal allergies) so that is what we thought it was. By Friday the 10th our roommate Davey took sick, chills, cough, body aches, dirrieha, vomiting, and low grade fever with lose of taste. On the 11th that is when myself  took ill all with the same symptoms except no dirrieha, vomiting and I lost both smell and taste. And by this time my son got worse. On Sunday the 12th is when my husband took sick, with the same symptoms as me. We all got covid test that came back postive. Now NO ONE in my house goes anywhere unless that have a mask. The schools here make kids stay 6ft apart and a mask at all times, my roommates work is very careful as well. Me and my husband don't leave unless of a doctor's appointment and even then we try to keep them vitural I have sezuiers, my 7yr old who s autistic, and has sezuiers. And my 15yr old who has asthma they all got it a couple days later. Luckly they are doing better. I myself am allergic to the flu shot, so I have been staying home because I'm scared to death on getting the covid vaccine and now that no sooner than my son gets his vaccine everyone in my house is suddenly sick? This worries me even more. No one that my children at school have came down with it. And they were all check for being in close contact with my kids, and same with our roommates work. Everyone came back negtive that worked around him and kids that were around mine. Now I'm not agaisnt the vaccine. But this alone scared the crap out of me. And three weeks later my roommate is still testing postive, and I keep getting random low grade fevers still. My son is doing. Bit better, my husband better, and my other 4 children better. But my roommate is still sick with the postive test results, and coughing. And I with the low grade fever still.
red spotty rash on both lower legs & forehead immed following vax; no other adverse sx noted; no breathing difficulty, color of skin remained pink, no crying;
Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days.  Diagnosis was later rendered that patient had suffered central pontine myelinolysis.
Pt developed uticaria, and macular erythematous rash to R arm and across anterior/posterior thorax. Denies pruritis or other symptomology.
Information has been received from a registered nurse referring to 10 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route not reported and lot # L033690 with expiration date 14-JUN-2018). The vaccines were exposed to 0 degrees Celsius for 8 hours. All the vaccines were gone through a second temperature excursion of 13.4 degrees Celsius for 1 hour 50 minutes. It was unspecified if the improperly stored doses of LIQUID PEDVAXHIB were administered after the first excursion (0 degrees Celsius for 8 hours) or after the second excursion (13.4 degrees Celsius for 1 hour 50 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child received an inactivated dose of Polio vaccine that had been stored for 27 minutes above safe temperature storage range.  Polio vaccine was being stored in a punctured multi-dose vial.  The vaccinating nurse was unaware of storage problem that had occurred one day prior on  4/1/2019.
About four minutes after receiving the vaccination, patient complained of nausea and feeling lightheaded with some tingling in both of her arms.  Received vaccine at 2:20 pm, symptoms began 2:24 pm. Vital signs stable, HR 101, BP 101/72, oxygen 96% on room air. Symptoms resolved at about 2:40 pm. Monitored in room for 30 minutes. Patient discharged at  2:50 pm. She states symptoms have completely resolved.
Patient states approximately 1 month following vaccination she is still having muscle pain/soreness/weakness in her deltoid and has a small indention where the vaccine was administered.
large circular erythematous, indurated area, pos tenderness around shot site w/in 24 hr, no fever;1st dx as shot rxn, circle w/pen told parents to call if spread that evening extended induration, tenderness down leg;rx cellulitis IV ATB
1st dose on 17Jan2022, 2nd not received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 17th January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 17Jan2022, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 The reporter was the wife of the patient who states that she and her husband received their first dose of Shingrix on 17th January 2022. She states that she and her husband never received their second dose.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2023039146 reported by the same reporter.; Sender's Comments:  US-GSK-US2023039146:Same reporter - wife case
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back.  CT done.  received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck.  Also sore throat, red throat, headache, nausea, and diarrhea.  Doctor prescribe antibiotics and Norco.   Stomach pain returned 12/31.
A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, the pt developed warmth, pain and redness at the injection site. The reporter described this as cellulitis. The reporter Indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Fever; Headaches reappeared; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headaches reappeared) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PYREXIA (Fever) and HEADACHE (Headaches reappeared). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and HEADACHE (Headaches reappeared) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. Reporter stated that the headaches are not so bad as to take medication, except in some situations when he got some Tylenol.   This case was linked to MOD-2022-441545 (Patient Link).
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured.  I was very weak and at times was unable to get out of bed or stand.  I had significant joint and overall body pain, at times unable to stand up straight.  As this subsided about 36 hours I remained quite weak.  On the night of 16 March I was woken up at 1 am with a very severe headache.  I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours.    I additionally had stomach cramping but no vomiting or diarrhea, and  had no bowel movements until the episode cleared up.    During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine.  I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered.  I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.
Chills,  dizzy, headache, body aches, hurt to move / walk, lethargic, confusion.
The patient is a 66 year old female who presents with a complaint of adverse reaction to Shingrix. Recieved first dose of shingrix on Friday morning (3 days ago) and has experienced a headache, nausea, and a large area of erythema around the injection site and progressing to the inner part of the upper arm that is itching.
pt recv d vax 9MAY94 & wednesday mom noticed a 1/4" red area in the area of DTP, there was a clear area then 2" down from inject site there was a 2"x2" area of red, warm to touch; pt felt warm but mom did not take temp;
About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred.  Resolved after about 2 minutes after removing glasses and drinking water
20 minutes after vaccine administration the patient reported throat tightness, dyspnea, nausea and vomited. She felt generally weak. EMS reported stridor. No rash or itching. No abdominal pain or diarrhea. No reported hypotension.  She received 50mg of benadryl and 0.5mg of epinephrine.   By arrival to the emergency room the symptoms had largely resolved. She was hemodynamically stable. Still complained of feeling tired though. she was observed for several hours and then discharged after progressive improvement of symptoms.
The vaccination was painful at the site immediately. An hour or two later started feeling light headed and my skin became sensitive. Around 6pm, I became really fatigued and feeling nauseous. Around 9 started getting a fever, which peaked at 100.2 and began shivering uncontrollably. Today, I'm still very fatigued, achey and feverish.