chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few minutes after receiving flu & pneumonia vaccine patient reported sharp severe pain in (R) hip running down into her leg. After several minutes pain began to subside & patient felt better. She refused to go to hospital. She had her son come pick her up to take her home.
7/7/05 15:00-pain to left arm; evening-swollen  fingers/sore left arm, difficulty lifting arm more than halfway. 7/8/05 09:00-decreased swelling and pain; 14:00-no swelling left arm, feels better some aching.
Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.
Received H1N1 and seasonal flu 11-4-09 - rash all over body - 11-11-09 acute pharyngitis neg quick strep test.
Patient went to PCP for evaluation of facial and cheek swelling secondary to a recent cat bite to the face. The patient was given antibiotics and TETANUS TOXOID on 09/04/2009. On 09/17/2009, the patient reports that he awakened with tingling in feet. The following day, he felt tenderness going up his legs and felt very weak and unsteady, which progressively worsened. Over the next couple of days, he was very weak with multiple falls in his household. On 09/21/2009, the patient presented to the ER secondary to weakness. He was transferred to a higher acuity hospital where he was diagnosed with Guillain-Barre Syndrome.  10/21 & 10/22/09:  Primary care records received for Date of service 9/4/09, ED records received for Date of Service 9/21/09 and Hospital records received for Dates of Service 9/21/09 to 10/8/09.  Dx:  Guillain-Barre disorder, new onset hypertension, possibly associated with autonomic dysfunction and imbalance associated with Guillain-Barre syndrome. Assessment:  Presented to PCP on 9/4/09 for treatment of a cat bite to the face. Treated with Tetanus shot and antibiotics.  Three days later started to feel poor energy.  Poor energy continued, 10 days later he awoke and noticed numbness on the bottom of his feet. The next day there was tingling of the feet that increased up to knee level.  Also noticed tingling in the tips of the fingers bilaterally.  He fell 3 times on 9/20/09 due to loss of balance or weakness.  He notes pain in the shoulders and calves. Seen in the ED on 9/21/09 with weakness, numbness and areflexia. Given IV fluids and experienced urinary retention requiring a foley cath.  EMG with no evidence of demyelinating polyneuropathy, LP with normal protein.  Admitted.  IVIG initiated. Experienced swallowing difficulties and kept NPO overnight.  EMG consistent with GBS. 12/29/09 Inpatient neurological consultant records received. Sevice dates 9/21/09 to 9/25/09. Assessment: Guillain-Barre Syndrome. Difficulty standing, knees buckled. Sore throat, trouble swallowing. Left facial weakness. Aching lower back. Tingling fingers and feet. Weakness lower extremities. IVIG administration. Left carpal tunnel syndrome, left ulnar neuropathy.
Patient experienced hyperventilation with syncope within 30 seconds of getting her immunization, complaining of the pain just seconds before leaning forward, head in her mothers lap and then almost violently throwing her self back, unconscious.  Her mother and I got her into supine position on the floor without her hitting her head and she regained consciousness within 20 to 30 seconds.  After a bit of disorientation and fear she settled and progressed from supine, to sitting in recovery position on the floor, to sitting in chair to eventually walking out of pharmacy with her mother 20 minutes later. We monitored her blood pressure and heart rate every 5 minutes throughout the event. She consumed a bottle of water and mom and grandmother speculated that she may have been dehydrated at the time. Mom says she has never reacted adversely to vaccines in the past, but she has had several episodes of fainting, usually at site of blood.
I got my second booster on Sunday, May 29, 2022 at 11:10 am. I had aches, exhaustion, chills and night sweats that night, and night sweats for the following 3 nights.  On the morning of Sunday, June 5, I woke to find a grape-sized lump on my back, left side, just below iliac crest. No pain, but tender. Context: my husband recently died of cancer. I went to Urgent Care and was diagnosed with "1 Benign lipomatous neoplasm of skin and subcutaneous tissue of trunk"(a fatty cyst). I have a history of cysts in my 20's and 30's, including a Pilonidal Cyst that was incised twice. I am seeing my I am seeing my dermatologist tomorrow for follow up. I would not have made the connection were it not for a friend who says she breaks out in pimples like a high  schooler after each shot. Socausative or coincidence? Don't know.
Arm hurt; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 24 -years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN8204) via an unspecified route of administration in the arm left on 17Mar2021 as a single dose (at the age of 24-years-old) for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and omega 3 (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 (the day after vaccine), the patient experienced headache, fatigue and on 25Mar2021 (8 days after vaccine), the patient experienced arm hurt so bad that patient could not move it. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events headache, fatigue and arm hurt were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient received Gardasil HPV vaccine. After receiving vaccine patient was standing and waiting to sign in for blood work when she passed out, falling straight back, hitting head on floor (cement with indoor/outdoor carpet). Pt. had brief loc per mom and tech. On arrival of RN patient was alert complaining of severe head and neck pain. 911 was called and patient was transferred to ER.  9/16/09 ER records received DOS 9/4/09. Assessment: Vasovagal Syncope. Fell and hit head after standing up. Lost consciousness for 30 seconds. Some confusion. Pain in back of head. Concerned she may be pregnant. Tenderness and swelling posterior scalp. Labile affect with irritability.
8/19/04: Developed fever 103.7 and febrile seizure. Evaluated in ER and treated for pneumonia. Around 2 days prior to event, pt had rash. Well since. No repeat seizure.
The injection site started hurting at 1/23/21 at 10:00 PM Around 1:00 Am on 1/24/21 I started feeling fatigue. All day 1/24/21 I felt some fatigue, but not as bad as first shut.  Around 6:00 Pm on 1/24/21 huge sweat came on me I became very hot, then few minutes later, it all disappeared, then I felt good, no more side effects.
Patient came in for Flu vaccine only. Patient returned the following day because of redness and swelling at injection site. Provider prescribed tylenol and ice prn . Patient returned again, 2 days after injection. Area was no longer red or swollen. Patients stated that no pain was noted.
Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub with a huge lump on my head bleeding.
Moderna vaccine dose 1 was administered at around 1:40 PM. Pt reports itchiness, N/V,and dizziness about 10 minutes after injection. Epinephrine 0.3 mg administered IM LVG 15 minutes post vaccine. S/S resolved for about 5-10 minutes. S/S returned including SOB, with throat/tongue/lip swelling and tingling. Started PT on 2 L O2 via NC. Administered another 0.3 mg of epinephrine IM LVG. S/S did not resolve so another 0.3 mg of epinephrine was administered IM LVG. Patient still reported SOB, generalized itchiness, and throat swelling. 125 mg of Solumedrol was then administered IM RVG. 50 mg of diphenhydramine was administered IVP in the left forearm. EMS was called and patient refused transport to hospital. S/S resolved.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:35 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 62.58 for dose administered on 03-Mar-2021 and 62.66 for dose administered on 31-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51,34,35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-April-2021. Product moved to clinic on 31-Mar-2021 .  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
PSORIASIS; FLARE UP; UNEXPECTED BENEFIT; SORE JOINTS AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to 12-MAY-2021 for moderate to severe adult crohn's disease, and ankylosing spondylitis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis, flare up, unexpected benefit, and sore joints after covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from psoriasis, and the outcome of flare up, unexpected benefit and sore joints after covid-19 vaccine was not reported. This report was non-serious.
8 inch erythematous indurated area started 2 days after vaccine.  Centrally increased induration and vesicles. Tx acyclovir, Prednisone, BENADRYL.
Extreme fever chills and night sweats Began after the second dose of the COVID 19:vaccine  and still continue
Pt. states that after receiving the 3rd dose of Phizer 11/03/2021, started experiencing symptoms 11/20/2021 of extreme fatigue, IUD fell out, and  Iron dropped 9.3, (Serrous Gluc 324mg prescribed). Hematologist visit recommended for Follow-Up. Pt. still experiencing symptoms.
Fever 103.9 the morning after vaccines given with superficial localized erythema matching bandaid location w/2 to 3mm vesicles at corner of bandaid. No significant induration.
Patient was given expired tenivac with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician.  This case involves an unknown age and unknown gender patient where patient was given expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7189AA and expiration date- 30-Sep-2023) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- 4 days).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
HEADACHE, ELEVATED BLOOD PRESSURE, ELEVATED HEART RATE, CHEST PAIN, PALPITATIONS
Patient began to experience headaches. Familiar with high blood pressure symptoms, she took her blood pressure, it was extremely high (220). She called the doctor, doctor prescribed her a second blood pressure pill. A couple of days after second pill, blood pressure remained high. Patient was admitted to the hospital where she stayed overnight to be administered blood pressure medication intravenously.
About 3 hours after vaccines (MMR, VZV, Hib, Prevnar, DTaP) had 45 min seizure and fever 102.
Pt received undiluted orange cap pfizer 0.2 mL into the right arm. Pt does not report feeling distress or ill, did not received re dose.
Rash; red knot and hot; red knot; red knot; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced rash, feeling hot, local swelling and erythema. On an unknown date, the outcome of the rash, feeling hot, local swelling and erythema were unknown.   It was unknown if the reporter considered the rash, feeling hot, local swelling and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Several patients from a nursing home who experienced after the second dose of Shingrix a rash, did not know exactly how many, if they were female or male, but provided with a vaccine data of one that was administered. The health care professional described symptoms as big red knot and hot. The reporter consented to follow up. No patients data was provided.
24 hrs after vaccine started having fatigue and feverish for one day - I took Tylenol and Motrin. Was feeling better the day after the symptoms started.
Pt complained of "so much drainage" in her throat and chest and had labored breathing. This started the day after immunizations were given and lasted 8 days. She took a decongestant for this. Four days, post vax, she noticed a tiny "knot" under the site of MMR injection and this has been getting bigger each day. It is hot to touch, tender, swollen and red.
Left forearm skin started out feeling almost totally numb, like my arm was asleep (not pins and needles though). It's been almost 2 weeks and it hasn't gotten better. Now my bicep and tricep feel like they are being squeezed off and on
Pain/trigger finger, arthritis pain in all fingers, the pain is bad every morning and gets better during the day. At night my fingers will get stuck in the trigger finger and it hurts awful bad and wakes me up.
severe muscle aches in various locations and left shoulder pain with dose 1 of Moderna COVID vaccination on 3/3, which worsened after the 2nd dose on 3/31 and have continued to worsen to the present (6/2/21)
lightheaded / dizzy; achy; queasy; This case was reported by a nurse via sales rep and described the occurrence of light headedness in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 3 hrs after receiving Bexsero, the patient experienced light headedness, pain and queasy. On an unknown date, the outcome of the light headedness, pain and queasy were unknown.   It was unknown if the reporter considered the light headedness, pain and queasy to be related to Bexsero.  Additional case details were provided as follows: The patient's mother narrated the adverse events to the nurse and she reported to GlaxoSmithKline. About 3 hours after receiving the Bexsero vaccine, the patient started feeling lightheaded, dizzy, achy and queasy. The patient however did not faint. The reporter consented to follow up and provided her details.
Redness/swelling /warmth of upper arm below injection site, beginning a few hours after dose administered.   Per patient report to pharmacy 8/9/19,  swelling is decreased since yesterday but arm is still red and warm to the touch.  Area is about 1/2 the circumference of the arm as of now.  Patient had not yet sought medical treatment but was advised to do so.   We requested that the patient report the outcome of visit to us
The adverse symptom from the shot was an increase of abdominal pain in the liver area and in the lower intestine. This pain has not subsided and occasionally gets worse.
About 3 days after the 2nd dose I began having itchy skin on my arms, legs, hips, and thighs. I thought that I had dry skin and need to drink more water and use lotion more often. The itching got worse over the next few days and began getting painful. At times I would get a burning sensation on my hands and feet with some swelling on my left hand. I went to the health clinic at work and was prescribed anti-inflammatory medication and allergy medication. The doctor was not sure what it could be because the skin appeared to be normal with no redness or rash but did notice an allergic reaction in my ear canals. I was recommended to go to my dermatologist if the itchiness returned or persisted. THe allergy medication helped but the itchy ness has returned and persisted. My whole body is itchy with no rash as long as I do not scratch. When I scratch my skin turns red and has small bumps. When I clean my ears the inside and outside area of the ear becomes very uncomfortable with itching.
Information has been received from a consumer concerning his daughter who in November 2008 and on 23-JUL-2009, was vaccinated with first and second doses, respectively of GARDASIL (dose, route and lot number not reported). On 23-JUL-2009, the patient felt hot and flushed all over. After 15 minutes she felt better. It was not specified if the patient sought medical attention. Additional information has been requested.
Migraine w/ Aura; mucosal thickening; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for 72-year-old female consumer patient that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265, Expiry Date: Unknown) via intramuscular on 01Feb2021 (at the 72 years of age) as dose 1, single for COVID-19 immunization. Medical history included hypercholesterolaemia from 03Dec2010 and ongoing. Concomitant medications included oral ezetimibe, simvastatin (10-4mg) taken for hypercholesterolaemia from 18Nov2010 and ongoing; oral eicosapentaenoic acid ethyl ester (VASCEPA) 1g taken for hypercholesterolaemia from 03Dec2020 and ongoing; oral nadolol (NADOLOL) 80mg taken for arrhythmia from 29Feb2012 and ongoing; oral sertraline hydrochloride (ZOLOFT P) 50mg taken for anxiety from 19Apr2021 and ongoing; oral escitalopram oxalate (LEXAPRO) 10mg taken for anxiety from 22Mar2021 to 19Apr2021 (Discontinued Lexapro due to he felt sick to his stomach). The vaccination facility type was community event center and not military facility. Patient had loud Pfizer vaccines back in Feb2021. 1st dose was 01Feb2021 and 2nd was 22Feb2021. Patient did have an MRI Brain u1 and u10 contrast 3 days prior to first shot due to Migraine w/aura and also experienced mucosal thickening In Feb2021. MRI was normal except for some white spots and mucosal thickening. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine after allowed expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow Up received on 01-JUL-2021 contains No New Information
severe swelling under arm and on chest.  Then on day 11 post vaccine, I broke out in hives.  I've had terrible hives for the past 4 weeks and they are not yet gone away.  I have been taking Zyrtec and will be going to an allergist this week