chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore and painful arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Very sore and painful arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE) and PROPRANOLOL for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Very sore and painful arm). At the time of the report, PAIN IN EXTREMITY (Very sore and painful arm) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported by the reporter   This case was linked to MOD-2021-361994 (Patient Link).
14 year old patient given a 5-11 dose of Pfizer COVID-19 vaccine.
Immediately felt dizzy, then fainted, regained consciousness, BP was 76/60; 90/70, 119/75. Paramedics arrived, recommended taking patient to ER to check BP. Patient discharged from ER after EKG okay.
Patient came in with weakness, headaches, and intermittent chest pain resulting positive for COVID-19.
thinks she has cellulitis in right arm; redness; swelling; fever in the arm; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 26Oct2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2606, Expiration Date: 31Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (intervention required, medically significant), outcome "unknown", described as "thinks she has cellulitis in right arm"; VACCINATION SITE ERYTHEMA (intervention required), outcome "unknown", described as "redness"; VACCINATION SITE SWELLING (intervention required), outcome "unknown"; VACCINATION SITE WARMTH (intervention required), outcome "unknown", described as "fever in the arm". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown Results, notes: will be getting an MRI done today for that. Therapeutic measures were taken as a result of cellulitis. Clinical course: (NDC number of Prevnar 20: 00005200010). The caller called about a lady's reaction to Prevnar 20, thought it was just a reaction then the patient went to the doctors office in the morning since the reaction got worse and thought she had cellulitis in her arm. This was reported in the morning. The doctor thought it may have been creating a boil or cysts and will be getting an MRI done for that. Doctor put her on antibiotic as treatment.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of vaccination site cellulitis with redness, swelling and warmth cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
This spontaneous report was received from a nurse and refers to a 69 year old male patient with chronic kidney disease. On 11-FEB-2016, the patient was vaccinated with ZOSTAVAX in the right arm (exact dose, route of administration, lot # and expiration date were not reported). Other suspect vaccine received on 11-FEB-2016, included DTaP (unspecified), tetanus toxoid, in left arm (exact dose, route of administration, lot # and expiration date were not reported). The patient was vaccinated at local pharmacy. There were no concomitant medications provided. On approximately 25-FEB-2016 (reported as "two weeks later"), the patient was seen in clinic by a physician assistant for bilateral upper extremities papules. The patient was diagnosed with scabies and he received unspecified treatment. The outcome of the event was unknown. The relatedness between the scabies and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
inappropriate schedule of vaccine administration; inappropriate schedule of vaccine administration; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS #2105USA001456), concerning a 63-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications was reported. Before vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient received hepatitis B vaccine (26-AUG-2000, 21-SEP-2000 and 26-FEB-2001), influenza H5N1 vaccine (14-DEC-2009) and zoster vaccine live (ZOSTAVAX) (20-APR-2015). The patient was vaccinated with 3 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) on 12-JUN-2015, 26-JUN-2017 and 29-JUL-2020, respectively (doses, routes of administration, lot numbers and expiration dates were not provided) at a clinic for prophylaxis (inappropriate schedule of product administration) .  This is one of three reports concerning the same patient.; Sender's Comments:  US-009507513-2105USA001456: US-009507513-2202USA000889:
Fully vaccinated with two doses of Moderna. Tested positive for COVID 19 on 01/14/2022. Admitted to hospital on 01/25/2022. Expired on 01/28/2022 while still hospitalized.
Day after vaccines, fever 103.7, mom says his eyes rolled backwards & his body shook EMS transported to Hospital ER. Septic work up neurosonogram - all negative.
N/V,  joint pain, itching.  Treated with benadryl and ondansetron, bentyl.  1 day later improving, but not completely improved.
Later in the day on 11/11/13 and over the course of 2 days (patient returned to clinic on 11/13/13), a rash developed on the left anterior thigh around the site of the Kinrix vaccine. Additional symptoms included redness, itchiness, warmth and swelling and some bruising at the injection site.  Rash grew to cover anterior portion of left thigh.  No fever or respiratory symptoms reported. Patient was treated with diphenhydramine 12.5 mg/mL oral suspension with directions to take 2.5mL by oral route every 4 hours as needed and cephalexin 250/5mL oral suspension with directions to take 7.5 mL by oral route every 12 hours for 7 days. Patient returned to clinic again on 11/15/13 and per the provider, symptoms had improved.
Patient couldn't move arm 3 days after vaccine and couldn't get out of bed. Patient got an MRI and was told it caused nerve damage. She also needed physical therapy and couldn't move her arm for almost a year.
I had a headache, a lot of coughing, chills, and very very tired. I called my physician and had a Telehealth visit and she called in PAXLOVID.
Swelling, dark spot, clot like appearance. Not painful but unsightly. Possibly hematoma.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-OCT-2012, the patient was inoculated with ZOSTAVAX, administered by a physician at a medical group, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-JUL-2015, she was treated by a physician at a medical group for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient has been prescribed valacyclovir, for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
After vaccination that night he was nauseated, chills, fever and days followed he had persistent fatigue and pain in both arms. He went into a Hemolytic Elliptocytosis crisis following injection.
Pt became pale & unresponsive; state of unresponsiveness lasted approx 5min; no apparent local rxn @ sites of immun;
Information has been received from a pharmacist concerning a female patient in her 60s who on an unknown date was vaccinated SQ with a dose of ZOSTER vaccine (lot number and injection site unknown). Seven days after vaccination, the patient returned to the pharmacy with redness at the injection site. The area was 4 to 5 inches in diameter. It was not a hematoma. The pharmacist stated that the patient is fine now. No further information is available.
PATIENT HAD A RASH AND SWELLING IN HIS LEFT ARM. THIS WAS THE ARM THAT THE VACCINE WAS ADMINISTERED IN.
Information has been received from a physician concerning a 2-month-old female who on approximately 04-JAN-2007 was vaccinated PO with the first dose of Rotateq (human-bovine). The physician reported that on approximately 04-JAN-2007, within eight hours of being vaccinated, the patient developed GERD. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. At the time of this report, the patient was noted to be recovering. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified date, the patients were vaccinated with VARIVAX which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 22 year old female patient. On 28-JUL-2014 at 11:47 am, the patient might have been immunized with a dose of (Oka/Merck) VARIVAX lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
This spontaneous case was received on 09-Oct-2017, from other health professional, concerning a 25-year-old female pregnant patient with 31 weeks of pregnancy. The patient had a history of preeclampsia and 6 pregnancies and 4 miscarriages. The patient had no spontaneous abortion or still births or no contraceptives were used. The patient's son has haemophilia. The patient's current conditions included hypertension, with previous pregnancy and haemophilia carrier. The concomitant medications included labetalol, amlodipine,  DICLEGIS, UNISOM, pyridoxine, prenatal vitamins. The LMP (last menstrual period) was reported as 04-Mar-2017. On 09-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 1618621, expiry date: Apr-2017). It was reported that expired FLUVIRIN was administered to the patient during 31 week of pregnancy. No adverse events occurred. The patient wanted to know whether to get revaccinated or not. The reporter assessed the report as non-serious. The EDD (estimated date of delivery) was reported as 10-Dec-2017. Significant case correction received with IRD 09-OCT-2017: Preeclampsia previously changed from current condition to historical condition and narrative was amended.
The patient developed a rash, swelling, and redness at the injection site. The patient was flushed, nauseated, had hand, arm and shoulder pain. The patient's tongue was numb and tingling.
One day after receiving the pneumonia vaccine he had redness appear on his left arm. There is minimal pruritus and no pain. The redness is at the site of the injection.
This infant started running a temp of 100.6 the evening of his immunizations. The next morning, 10/20/00, his leg was quite swollen (entire leg). The doctor checked him on 10/21/00, and advised us that the patient had an immunization reaction.
Hospitalized 10.10.21;  COVID-19 positive (10.10.21);  fully vaccinated    Admission Date: 10/10/2021 Discharge Date: Oct 12, 2021 PRESENTING PROBLEM: Hypoxemia Hypokalemia Acute hypoxemic respiratory failure due to COVID-19  COVID-19  HOSPITAL COURSE: Patient is a 68-year-old female who presented for evaluation of nausea, vomiting and weakness. The patient has a history of Addison's disease, hypothyroid, GERD and recent lumbar lami and spinal fusion. In the ER the patient was found to have a positive UA, no leukocytosis and hypokalemia. She was treated with rocephin. She was also hypoxic and a CXR showed possible edema vs infectious process. Her BNP was normal and she was found to be COVID positive. She was started on dexamethasone and given a dose of IV hydrocortisone and admitted to the hospitalist for further management. She was quickly weaned from oxygen and not treated with further dexamethasone or remdesivir. Her nausea and vomiting resolved however she continued to feel very weak. She was treated with additional stress dose steroids. PT/OT evaluated the patient and felt she was appropriate to return home to resume home health. On the day of discharge she was feeling better. She was encouraged to follow up with her PCP for continued monitoring after discharge and to quarantine for 10 days after symptom onset. She verbalized understanding of these instructions and discharged home in stable condition.   * Pneumonia due to COVID-19 virus Assessment & Plan Symptoms began 1 day before admission Patient is fully vaccinated CXR showing pulmonary edema vs infectious infiltrates BNP normal and COVID positive  Hypoxic in the ER on room air requiring 2L NC initially, weaned to room air today Will stop dexamethasone and remdesivir  Monitor daily CRP, CMP, CBC, D dimer Lovenox for VTE prophylaxis  Supportive care Wean oxygen as tolerated  Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Resolved Now on room air  Weakness Assessment & Plan Patient feeling weaker than baseline Will continue to monitor today and ask PT/OT to eval Will treat with stress dose steroids given Addison's disease
Severe Ear ache; This is a spontaneous report from a contactable non-health care professional, the patient. A 60-year-old non-pregnant female patient received BNT162B2 (BNT162B2) Lot/batch no: EP7534, via an unspecified route of administration in the left arm on 15Mar2021 at 11: 00 (at the age of 60-year-old) as first dose, single for COVID-19 immunization. Medical history included complex regional pain syndrome (CRPS). The patient did not have any allergies to medications, food or other products. Concomitant medications included dexamethasone and ropivacaine for unknown indications. 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 15Mar2021 at 19:15, the patient experienced severe earache. The patient was not recovered from the event. No follow-up attempts are needed. No further information is expected.
febrile sz 26hr p/vax w/hives on face, arms & legs;
Autoimmune diseases: Started having severe stomach problems and after lots of tests I got the diagnosis of Crohn's Disease. Mom realized it was right after the vaccination but never did anything about it and when I realized a few months ago that it was probably related, she agreed. She still had me get the third GARDASIL vaccine even though she suspected that's what triggered my autoimmune diseases.
Pain at injection site, severe chills, did not sleep much last night, migraine, and body aches on 2/8.
Pt received dose #2, was given outside the recommended timeframe of 28 days for Moderna vaccine
lump in left armpit and painful; 4-5cm lump in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on 13Apr2021 at 12:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) all taken for unknown indication on unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 as a single dose. 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 13Apr2021 the patient experienced 4-5cm lump in left armpit and painful about 12 hours after vaccine injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. The clinical outcome of the event axillary lump and axillary pain was ongoing at the time of this report.   No follow-up attempts are needed. No further information is expected.
10 minutes after injection patient passed out and had a seizure for 30 sec. Then 5 minutes later it happened again for about 10 sec. Patient felt weak and heavy after both seizures and had nausea and vomited about 5 minutes after 2nd seizure.
3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats per minute. I ended up checking myself into the emergency room 5 hours after the vaccine shot because my heart rate wouldn't slow down and my blood pressure increased. They found out my heart had gone into atrial fibrillation. I have had no known history of atrial fibrillation in the past and prior EKG's at physicals have been normal.   I am an otherwise healthy individual.The doctor conducted an emergency  Cardioversion to return the heart rhythm to normal.
The day after I got my second dose of the vaccine I had painful lumps under my arms. It was much worse on the left side. I went to the doctor after a month and they said it was Lymph Nodes. It was painful to put my arms down. It has been seven months and the Nodes are still a little swollen but they are not painful. The pain lasted for about a month. It was sensitive to touch.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines RECOMBIVAX HB (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
10/27/21 in ED with Covid symptoms: diarrhea, cough, syncope, dehydration.
Adult patient was given pediatric Dtap (Infanrix) instead of TDap (Boostrix).  No reaction to report.
25 minutes after injection, pt came to me complaining of swelling in hands. I noted lips were slightly swollen also. Pulse 88 reg, respires unlabored. Advised Benadryl 50 mg PO and ER if Sxs worse.
Patient was given covid vaccine 6month-4yr dose, patient is 5years old, and should have been given 5-11 dose.
Headache started approximately 1 hr after Tdap. Vomiting started approximately 12 hours post injection.
Since I received the shot at the end of January my arm has been sore at the injection site. It was very sore for the first 4-5 days after receiving the shot. The pain was continuously subsiding over the next weeks, but for the last 5 days there has been no change. It feels as if the pain has now stabilized. My arm is not debilitated, but the upper arm is sore and the pain is noticeable. Will I have to live with this pain for the rest of my life? I am supposed to get the 2nd shot tomorrow and I am very worried. Should I get the 2nd shot or no? If I decide to get the 2nd shot, I will have to do it in my other arm. Then, will I have 2 sore arms for the rest of my life? I have not done anything concerning treatment, since the soreness has to wear off on its own. There is no magic bullet. The question is, Will the soreness ever completely disappear? It has been a month now, and I have never had this kind of long-term soreness to any injection or vaccine before.
Arm soreness; Administered moderna vaccine that was in pre drawn syringe for over 6 hours; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown and PRODUCT STORAGE ERROR (Administered moderna vaccine that was in pre drawn syringe for over 6 hours) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow up received included No New Information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.