chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's noted; improperly stored GARDASIL 9 administered to the patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 31-MAR-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637648, expiration date: 19-JUN-2022, dose/frequency: 1, route of administration and anatomical location were not reported). The vaccine was stored in -0.1 degrees Celsius for 4 hours and 11.5 degrees Celsius for 11 hours and 30 min. Digital data logger was involved. No additional adverse events (AE's) noted. Patient was asymptomatic. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
shingles in left arm/ Suspected vaccination failure; Shingles; PAIN; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated 6 weeks after Shingles vaccine had shingles in left arm another month of pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case has been linked to the case US2021AMR233752 reported by the same reporter for 2nd outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233752:2nd outbreak
Within 5 minutes of receiving vaccine, pt complained of tongue swelling.  Was immediately evaluated by EMS .  90% O2 sat on RA,  BP 180/100s, HR 120s wheezing throughout lung fields.  Received 3 doses of epi , 50 mg benedryl, duoneb.  O2.  Transported out of facility within 10-15  mins.
approx 2 days p/vax pt exp intermuscular pain there on for approx 8 more days;it was painful to lt arm d/t pain;
Rash itching, left arm with red bump, @ 2200 the night of injection had a rash on both hands. took OTC tylenol Narrative:
elevated temperature 101.1, throbbing headache, body aches, chills, malaise, fatigue, pain at injection site
Pt received vaccine, walked to the observation area, and sat down. Stated she started feeling warm,  dizzy, lightheaded, and nauseous. Vitals at 1515 were BP 108/71, HR 87. Gave her some water and assisted her into a wheelchair. Wheeled her into the private area/cot room and assisted her onto the cot with legs elevated.  BP recheck at 1523 was 101/64. Pt reports an improvement of symptoms. Sat her up and recheck BP at 1527  was 112/68, HR 77bpm.  Gave her a snack, reports feeling symptom free. Stood her up and rechecked BP was 115/77, HR 90.  Instructed her to sit for 15 more minutes in the observation area and to notify if feeling unwell. Suggested calling a family or friend to drive her home. Pt states she feels better and symptom free.
07/16/2021 4 months after my vaccine, I noticed a rash in the center of my back and it was partly on my left and right side as well. It was blistering, and I went to my doctor, and they diagnosed it as shingles. It started on my back and went down my back and to my left side, going around to my front as well. The doctor gave me a topical cream and oral medication to combat the symptoms. Unfortunately, it continued to develop worse causing tenderness on the left side and it took weeks for it to disappear, however the pain is still managing to stay around as well. Currently I have no rash however the pain is still there and is slowly going away.
Information has been received from a registered nurse concerning a female patient who in 1994 and on Oct 25 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (second dose lot # 649913/0577P). Subsequently, the patient developed a fever, arm swelling, redness, and pitting edema in the arm, The arm had a cellulitis type of appearance, medical attention was sought. The patient was treated with a methylprednisolone (Medrol) dose pack, Diphenhydramine (Benadryl) and ice was ordered, The patients outcome was unknown. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (second dose lot # 649913/0577P) and developed AE's (WAES0410USA03951, WAES0411USA0180). Additional information has been requested.
Upper arm swollen, red and warm at site of vaccination. This lasted for 3 days, from March 30-April 1, with some slight warmth and swelling persisting for a few more days. I called my primary care doctor's office to consult with them. They said they were seeing this delayed response with a number of patients (not sure whether they specified that the patients all had received Moderna vax) and to contact them again if it got worse, didn't go away, or if I had further concerns.   I felt reassured and let the symptoms take their course without additional treatment, feeling grateful to have had the vaccine at all!!
Headache, nausea, extreme tiredness (falling asleep randomly), weakness,  extreme brain fog, higher than normal heart rate when exercising.   Symptoms lasted almost 4 months. Headache and nausea began to subside in the 2-3 month range. Fatigue continued for about 4 months, same with the brain fog.
Low grade fever, chills, body aches began w/i 24 hrs. Body aches increased for 48 hrs. Injection site red and slightly swollen x 6 days.
BAD RASH ALL OVER BODY, LEGS, TORSO, ON BACK; ITCHY RASH; DIARRHEA; HEADACHE; REALLY TIRED/ WORN OUT; RINGING IN EARS; THROWING UP; GENERAL MUSCLE ACHES; SEVERE CHILLS; LIPS WERE SWOLLEN; COUGHING; CONGESTION; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 1855791 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 02-JAN-2022 at 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022 at 19:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced headache and took 2-500 milligrams (mg) of Extra Strength acetaminophen tablets.  At 23:00 the patient came to the bedroom coughing, throwing up (which was reported to be recovered the same night) and was complaining of severe chills, general muscle aches, was really tired/ worn out, had ringing in the ears, and her lips were swollen. The patient had no fever reported. The patient drank tea and wrapped up in blankets. On 03-JAN-2022 after 04:00 morning, the patient experienced bad rash all over her body, on her legs, up her torso, on her back, but not on her arms or face and that the bed was shaking with her scratching from the itching (coded as itchy rash) and diarrhea in the morning. The patient took 2 more acetaminophen 500mg tablets at 4am. It was reported that the patient still had the rash, muscle aches, cough a little bit to clear up the congestion, worn out tired, and chills at the morning, while the ringing in the ears was gone in the morning. On an unspecified date in JAN-2022, the patient experienced congestion. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were swollen, and ringing in ears on 03-JAN-2022, and throwing up on 02-JAN-2022, had not recovered from coughing, severe chills, general muscle aches, really tired/worn out, diarrhea, bad rash all over body, legs, torso, on back, and itchy rash, and the outcome of headache and congestion was not reported. This report was non-serious.
Immediately following injection pt felt dizzy and became diaphoretic. Pt monitored in emergency tent and found to have bradycardia and hypotension. With continued observation pt continued to be dizzy, diaphoretic, hypotensive and bradycardic. EMS called and found glucose to be within normal range.
Swelled, reddish arm, elbow-shoulder. BENADRYL-not sure if effective yet.
Muscle ache, fever, chills, nausea and syncope.  911 was called. Patient was stable and declined going to the hospital. Symptoms lasted 3-5 days.
8-10 days /p vax pt felt cold sxss, sneezing,"sick all over",10 days /p that aching in lt arm &rt hip.2 wks later aching in lt hip &rt arm, ache cont's, difficult to raise arm &walk, Seen by MD TX:Cortisone & meds, Still has cold
2/18/21, 9:00 p.m. Fatigue, fever, chills ending on 2/20/2021 10:00 a.m.      Arm tenderness  2/18/21 7:00 p.m. ending 2/22/21 10:00 a.m.   Rash 2/22/21 10:00 a.m. continuing through 3/3/21. Oval redness - 3 inches long x 2 inches wide, mild itch.
Patient received both flu and COVID (Pfizer) vaccines by the nurse while seated in the immunization at approximately 10:30am. Soon after receiving both vaccines, the patient immediately fainted while seated and started turning pale and lips were turning purple. I was not aware of this until I was flagged by the pharmacy cashier to go into the immunization room to triage the situation. After being informed that the patient fainted, I had the patient elevate her legs. I proceeded to call 9-1-1. During the call, the patient started feeling better. I insisted that EMS take a look at the patient and let them decide if they should head to the hospital for further evaluation. EMS arrived around 10:40am and evaluate the patient. 10 minutes after evaluation, EMS reported the vitals were within normal limits, but recommended that the patient go to the hospital. The parent of the patient refused transport to the hospital. EMS left, and then after that the family left without further incident. Per the parent, this is the first time the patient has ever fainted from a vaccination. This was likely a vasovagal response. Will note this incident within patient profile.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-036535 (Patient Link).
06/17/2021 - Sent to ED for evaluation of CP, SOB and palpitations 06/12/2021 - Developed chest pain, shortness of breath, palpitations, fever and diarrhea.  04/17/2021 - Developed rash to both lower extremities
3 cm oval erythemic/blanching lesion with central bruising (L) thigh. Started 8/14/12. Monitor for fever, discharge.
Dry, constant cough. That is not responding to the normal treatment of Singular, Albuterol inhaler, Zyrtec
Patient still has a red mark on vaccine site. It is not hot to touch per pt, or raised. The bruise is fading but very slowly.
BlurredVision, Headache & Fever Narrative:  Severe headache, blurred vision, Temp of  100, pain at injection site
Pt recv vax on 11/17/98; on 11/23/98 pt exp fever (103-104); pt hosp; 12/3/98 pt exp fever & glucose level was off
shaking chills and total body achiness S/x lasted 48 hours, leaving me somewhat weakened
ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in both ears) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included VENETOCLAX (VENCLEXTA) for Cancer.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (ringing in both ears). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and ESCITALOPRAM OXALATE (LEXAPRO) at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in both ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include hearing aid.   This case was linked to MOD-2021-109857 (Patient Link).
29y/o female c/o soreness @ inject site immediately p/receiving first inject of the series; 3 hrs later pt exp dizziness & nausea; t100, hard to breathe; felt as if chest was being held down; could not move neck & shoulders (pain);
In September pt developed nephritis and then in October 2022 patient developed metastatic melanoma to parotid gland.
pt's mom reported that pt is in the hospital as he started shedding skin after getting covid vaccine.unknown dates or length of hospital stay. it is unknown if patient is taking tadalafil in hospital. unknown if md aware. no further information available or dates are known or were reported.
8/26/2021 about 2 hours after shot I had soreness in my right arm and  a headache that lasted for about 2 days stopping around the 28th. 8/27/2021 about 7:30 am I woke up feeling tired and the soreness was now also in my neck and I had some pain at the lower part of my head also. This lasted about 2 days ending around the 29th. I did take Tylenol a few times on the 27th and 28th and only once on the morning of the 29th. 9/12/2021 around 8:00 am I woke up with my left shoulder being sore when I moved it around and as the day went on it continued to get worse. By Monday morning, the 13th, I could not move my left arm and the pain in my shoulder was constant even when I was not moving my arm. I had my daughter take me to the Emergent Care Center. They did not do any x-rays since the pain wasn't a result of some type of injury to the shoulder and said they believed it was Bursitis. They gave me a steroid shot and three prescription to take for it. The pain lessened around 10:00 pm on the 13th. When waking up today on the 14th the pain is only there when my arm is moving around and it is not as severe as before. If the soreness and pain are still affecting me in 2-3 days I will schedule an appointment with my doctor.
Injection site red.  Headache, followed by flu like symptoms lasting about 24 hours.
IRREGULAR MENSTRUAL CYCLES AFTER ONE DOSE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: menstrual cycle was very predictable before receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the patient experienced irregular menstrual cycles after one dose janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular menstrual cycles after one dose janssen covid-19 vaccine. This report was non-serious.
onset of  shoulder pain with persistence over 3 weeks, including deltoid, triceps, pectoralis minor and posterior deltoid. Dx SIRVA
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 69-year-old male patient received BNT162b2 (BNT162B2), on 09Jul2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 treatment with Anti viral Paxlovid (Lot: GC4800) from 13Jul2022 to 17Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3hr post vax T102, chills, all over sick feeling, extreme hardness @ inj site;pain to movement & touch;10hr post vax dry cough & lung sensitivity to cold air, sick feeling;
This spontaneous report was received from a 62 year old female consumer refers to herself. The patient's current condition included arthritis in hip. The patient had no drug allergies. On 14-NOV-2013 the patient was vaccinated with ZOSTAVAX, one dose injection in the upper right arm (dose, LOT # unknown). There was no concomitant medication. On 14-NOV-2013, after receiving ZOSTAVAX the patient developed a red, oval shaped rash that was slightly raised and hurts. The patient was treated with ALEVE. The patient didn't seek medical attention. There was no lab performed. The outcome of the events was reported as recovering at report time. Additional information has been requested.
overall body aches; headache; really tired; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever), MYALGIA (overall body aches), HEADACHE (headache) and FATIGUE (really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, SIMVASTATIN and COENZYME Q10 [UBIDECARENONE] for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). On 04-Mar-2021, the patient experienced MYALGIA (overall body aches), HEADACHE (headache) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, CHILLS (Chills), PYREXIA (fever), MYALGIA (overall body aches), HEADACHE (headache) and FATIGUE (really tired) had resolved.
Patient came in with her father to get 2nd Pfizer vaccine. Patient stated with the first shot, she felt a little dizzy but then it went away. Her father said she was nervous/anxious to get this vaccine. Patient got the vaccine first, then sat in the observation chair while her father got his vaccine. While her father got the vaccine, I checked on her and she said she felt a little dizzy. Patient agreed to put paper towel on back of neck and wrists. As soon as her father finished his vaccine, we moved her to the immunization room to monitor her (such as blood pressure - readings given to paramedics.) Her heart rate was a little high (I believe 107), then  went back to normal. However then her blood pressure started getting lower (around 80/40s) and began feeling worse. Laid patient down with feet elevated and called 911. By the time ambulance arrived, her blood pressure was starting  to improve. Her father agreed with ambulance to bring her in to get checked out.
Narrative: Patient reports that symptoms of pain following vaccine presently continue at time of this note ~4 weeks since vaccination. Documenting reaction as severe due to cause of longstanding health issue,
sore arm; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown demographics who experienced sore arm (pain in extremity), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date, (latency unknown) after initiation of suspect vaccine therapy, the patient experienced sore arm (pain in extremity) and that was only once in awhile.   Further, it was reported that the patient getting a flu shot for about the last 30 years, and never had flu symptoms.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was resolved (experienced for a couple of days).   There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 30-MAY2012, the patient was vaccinated with an improperly stored dose of VARIVAX lot # 671861/1907AA (dose 2). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Menorrhagia. My period usually lasts for 4-5 days. I started 05/10 and it is now 05/18 and I am still bleeding.
Associate began to c/o hand numbness to left arm with fingers tingling.  1135: 183/98 BP, HR 68, Oxygen 100% on room air. 1140: BP 179/111, HR 79, oxygen 100%  1145: BP 160/104. HR 72. Oxygen 100. Associate states numbness has resolved and to followup with her PCP about elevated BP and numbness.
Pt. recv'd. red, hard, swollen area at injection site. Left thigh.
Rash, Urticaria Pruritus & URTICARIA; RASH; SWELLING OF ARM