chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About two weeks after receiving second Pfizer shot I started having pain under my right arm. By day 3 my lymph nodes under my right arm where I received the shot at became very swollen and sore I could hardly put my arm down. By day 4 I went to the ER. They examined me and confirmed my lymph nodes were swollen. They prescribed me ibuprofen and sent me home. I did a follow up appointment with my primary doctor two days later and I broke out in hives. My doctor confirmed I had shingles and that's when I told her about the 2nd vaccine shot I had a few weeks ago. She then suggested I report this adverse reaction.
On May 08, 2022, I tested positive for COVID, this has been very mild. The symptoms have been mucus in my sinus cavities and lungs. I have been using Afrin at night, over the counter mucus relief, and prescription cough medication as needed. No fever, my oxygen has stayed within normal range.
pt recv vax 23FEB96 & that same day pt exp a 3x5 inch splotchy area w/a 1.5 inch bright red wheel @ inj site which was painful;MD reported that the exp started immed p/pt recv inj in leg;
Narrative:  Geriatric patient, wife reported agitation and delirium to treating physician the evening of vaccination, improved by the day after vaccination. Symptoms:  Agitation & Confusion Treatment:
left sided facial numbness; decreased movement of the facial muscles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 15Mar2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. The patient had no known drug allergies. Concomitant medications of included amlodipine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), OZEMPIC and lisinopril (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date. 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 vaccination, the patient had not been tested positive for COVID-19. It was reported that within an hour or two patient experienced left sided facial numbness and decreased movement of the facial muscles and asymmetrical smile. It was reported that symptoms had improved slightly but still persists. On 15Mar2021, the patient experienced facial numbness and decreased movement of the facial muscles. The patient contacted doctor of medicine (MD), but instructed if symptoms worsened to seek emergency care. The patient did not receive any treatment for the reported events. The clinical outcome of the event facial numbness and decreased movement of the facial muscles was not recovered at the time of report; information about lot/ batch number cannot be obtained. No further information is expected.
No adverse event, advised patient and if any reaction, to urgent care or emergency room. Call office back on Monday with update.
Tinnitus in both ears that started approximately 5-7 Days after the second shot and is ongoing
Developed pain and stiffness in neck. Went to ER. Dx swollen lymph nodes in neck. Lasted 3-4 days. Rx -  ibuprofen prn. Also had red rash and pain L arm -  lower posterior area. Rash is fading at present.
dizzy, presyncope, nausea, headache, head foggy, tired,  sent home from work, stayed horizontal for the day,
Information has been received from two health professionals the authors of a literature article concerning a 15 month old male who was vaccinated with MMR (lot number not reported). It was reported that the patient's mother received a dose of MMR  after his birth and was subsequently breast-fed for six months and at first developed normally. He received his MMR at age 15 months. By age 18 months, he developed chronic diarrhea, stopped talking, and became withdrawn. He has been diagnosed with autism, after extensive work up that was otherwise negative, including normal chromosomal studies. The authors also reported that subsequent children of the patient's mother were afflicted with learning disabilities, mental retardation, pervasive developmental disorder, Tourette syndrome, prematurity, hypoplastic left heart syndrome, and a single kidney. Family history was negative for autism and the mother had normal chromosomal studies. No further information is expected. (OMIC)
Patient states approximately one to two weeks after receiving her Covid bivalent Pfizer booster she developed several tiny white blisters on her tongue.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient tested positive for Covid-19 (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000178477.; Sender's Comments: V0: 20210506427-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
entire body start burning after the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (entire body start burning after the injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (entire body start burning after the injection). At the time of the report, BURNING SENSATION (entire body start burning after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
a nurse accidently grab the wrong dose of HepA and now I have a PFS with capped needle on it, how long is it good for?"; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter was licensed practitioner nurse and asked how long would Havrix A PFS good for when syringe was opened and capped with a needle. The reporter had a nurse who accidently grabbed the wrong dose of HepA and now the reporter had that PFS with capped needle on it and asked how long would it good for. The reporter did not consent to follow-up.  No further information was shared. The reporter's consent for follow up was not asked since the case was received on chat
Facial flushing, throat tightness for 10 minutes; administered BENADRYL 50 mg with good effect.
Bleeding at the injection site; Soreness; fatigue; low grade fever; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE HAEMORRHAGE (Bleeding at the injection site), PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 042 L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease, Alcohol use (Wine, 2 drinks a week (started 2020)), Attention deficit hyperactivity disorder, Adhesive tape allergy (Rash) and Allergy to vaccine (Whooping cough manifested to Anaphylactic reaction). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, ETHINYLESTRADIOL, LEVONORGESTREL (SRONYX) for Birth control, SULFASALAZINE for Crohn's disease, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 26-Jan-2021, the patient experienced PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever). On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Bleeding at the injection site). On 26-Jan-2021, PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (Bleeding at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Soreness), FATIGUE (fatigue) and PYREXIA (low grade fever) to be probably related. No further causality assessment was provided for INJECTION SITE HAEMORRHAGE (Bleeding at the injection site).
12 hours inconsolable distressed crying. 104 Temperature. Regression of baby babbling for 3 months after. Moving hands in a rolling manner. Development of severe eczema that she would scratch open to bleed. Since treated with antibiotic and steroid for eczema. Started a probiotic and dha supplement, has significantly improved.
Headache, Fever 101.4, Nausea, Vomiting, Fatigue, Dizziness, Lethargic, Body Ache, Unable to work or function as normal for 2 days. This is submitted 3rd day, still some lingering neck pain; but improving   Phone Consult to G. P.  prescribed Zofran for  Nausea
Pt received Flublok recommened for 18 years and older.  Pt is age 15 years old.   Mother states pt reacted fine to vacccine.  No adverse side effects.
On 3-15-2021, Pharmacist administered Janssen COIVD-19 vaccine to patient (16 yrs) who is under the approved age of 18. No symptoms or ADE for patient and gaurdian signed off
CHRONIC RESPIRATORY FAILURE 1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
After the first does started having heartburn and intensified greatly after the 2nd shot; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) on 01Apr2021 (at the age of 41-years-old) as a second dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not have any history of heartburn or acid reflux. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, around 2 weeks after first dose of vaccination, the patient started experiencing heartburn which was intensified greatly after the second dose of vaccination. The patient had varying degrees of intensity of heartburn every night and some during the day. The patient did not receive any treatment for the reported adverse event. 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 the events heart burn was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Patient nearly fainted and appeared as though in a catatonic state for about a minute. When asked if dizzy, patient responded yes. Also, mentioned throat being sore, but this went away after drinking fluids (water, orange juice). Patient's father was there for the entire episode. The episode resolved within 10-15 minutes of onset.
Information has been received from a registered pharmacist concerning a 76 year old female patient with no pertinent medical history or drug reactions/allergies who on 10-AUG-2010 was vaccinated SC with a "standard dose" of ZOSTAVAX (Merck) (Lot number 665525/0695Z, ex 28-APR-2011). Concomitant therapies included: PLAVIX, simvastatin (manufacturer unknown), oxybutynin (manufacturer unknown), ranitidine (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). In August 2010 after getting ZOSTAVAX (Merck), the patient developed an injection site reaction. The site was red, warm and round. The patient sought medical attention by seeing pharmacist. There was no lab diagnostic test performed. At the time of report the patient's status was recovering. Follow up information has been received from the registered pharmacist concerning the 76 year old female patient with aspirin allergy, hypothyroidism and hypercholesterolemia who on 10-AUG-2010 at 09:20 was vaccinated SC in the left arm with a dose of ZOSTAVAX (Merck) (lot number 665525/0695Z). On 11-AUG-2010 at 09:00 the patient developed small red, slightly firm, oblong patch, warm and slightly elevated. No pain or discomfort or fever. The symptoms went away 4 to 5 days later. Patient felt remarkable. The patient recovered on 14-AUG-2010. Additional information is not expected.
no adverse effect; intramuscular route rather than subcutaneous; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, drug reaction/allergies or concomitant medications were not reported.  On 07-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)  intramuscular route rather than subcutaneous route for prophylaxis(dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). No adverse effects were reported.
Arm was very painful right after adminstration. Pain went down the arm. Could not lift arm up.  Soreness and range of motion has improved, but 3 months after injection he still does not have full range of motion and arm is still mildly sore.
Pt. rec'd 2 mo imm. in office on 8/23/16. Seen 8/25/16 for round petechial purplish/red macular dots to bilat legs. Afebrile; no URI. No decreased appetite. PCP consulted with cardiologist D/T DX - ? concerns for bleeding D/O or future contraindications. (No concerns noted).
Fever of 102 for over 24 hour (night of 5/17 and all day and night of 5/18); rash on arm that was red, raised, itchy, burning and radiating heat for multiple days (5/19-5/23); brain fog and large gaps in memory (5/18-5/27)
Noticed lymph node under my arm; Arm below the injection site is red; Hot; swollen; Infected; Sore; Started itching belowthe injection site; A spontaneous report (United States) was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - itching below the injection site/vaccination site pruritus , noticed lymph node under arm/ vaccination site lymphadenopathy, red/vaccination site erythema , hot/vaccination site warmth, sore/vaccination site pain, swollen/vaccination site swelling, infected/vaccination site infection.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril , Estradiol, Medroxyprogesterone and Clonazepam (for unknown indication).  On 06 Feb 2021, prior to the onset of the events the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced itching below the injection site.On 7 Feb 2021, the patient developed lymph node under her arm that was sore and swollen.Arm below the injection site was red, hot and swollen. The patient went to urgent care and told it was infected.  Treatment details included-  Prescribed antibiotics Cephalexin 500mg, Atarax 10mg , Diflucan (Fluconazole)150mg (but did not take any of these yet).  Action taken with mRNA-1273 in response to the events was unknown   The outcome of events- started itching below the injection site, noticed lymph node under arm, red, hot, sore, swollen, infected  -was unknown.
Patient started to feel light headed and dizzy less than 5 minutes after the vaccine. Patient was given water and laid down for 10 minutes. After 10 minutes of laying down and drinking some water, the patient felt back to normal.
One week post vax, pt developed urticaria and headache. Unspecified medical attention was sought. No further info is available.
Patient presented to office after having vaccines with erythematous papular urticaric rash. Treatment was Benadryl.
Pt was given two doses of the approved 4 year vaccine schedule 10 months apart.- MFR contacted no adverse reactions occurred and no further action required
c/o generalized body malaise which progressed to weakness w/high grade temp, chest congestion, coughing & inability to do physical works; pt took Amoxicillin, felt somehow better, but went to see MD & given Augmentin & Dexamethasone shot;
This is a spontaneous report from a contactable consumer reported for herself/ himself. A patient of unspecified age and gender received PREVNAR 13 on an unspecified date at single dose for immunisation . The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date, the site where got the injection was red and had like a little bit of pus in the middle (a little dot in the middle of the red), but it went away. It looked like little pus sores on legs and arms but not on body. It had like a little sore in the middle of redness where the needle went in. Lately patient found had like some kind of hives or itchy, the itching was horrible (driving patient crazy, it was so itchy).Patient went to  urgent care and diphenhydramine hydrochloride (BENADRYL) was given may be for the itching. Patient still had itching; vaccination site pustule recovered, while outcome of the other events was unknown.
This initial spontaneous case, was received from other health professional on 03-Oct-2017, concerning a 29-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV ( dose: 0.5 ml, batch number: 195124 (as reported), expiry date: Apr-2018, route of administration, anatomical location: not reported). On the same day in the night, the patient developed red at injection site, swelling, hard, painful, hot to touch and continuously hurt. It was reported that, the patient still felt redness, warmth at injection site, diarrhoea and sore throat. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 16-Oct-2017: The event onset date was confirmed as 03-Oct-2017. On 09-Oct-2017, the patient recovered from the events. Narrative was amended accordingly. Nonsignificant follow up received on 25-Oct-2017 from a nurse: It was reported that the patient had no relevant medical history. Significant case correction received 03-Oct-2017: The listedness of the event 'Injection site swelling' in CORE flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'sore throat' in flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'diarrhoea' in CORE flu vaccine cell subunit was corrected from unlisted to listed.
localized erythema, induration, pruritus from 2 days p/vax to present;5x7 cm;
I had severe Hives all over body, itching, headache for 2 days. Went to urgent care and they gave me a steroid.
This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with VARIVAX (Merck) 2 doses. Lot number, dose, route and frequency were not provided. On an unknown date the patient's antibody titers were negative. The patient was now 8 months pregnant. No problems were reported. The pregnancy outcome was pending. The outcome of antibody titers were negative was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a 35-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent .5 ml. On 27th October 2015, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to FLULAVAL quadrivalent. Additional details provided were as follows: The healthcare professional reported that, there were 2 patients (for other patient see case US2015GSK159506) who received FLULAVAL quadrivalent and experienced the events. These reports could be a duplicate of a previous cases reported. However, according to the patient identifiers provided in both these case, no duplicate reports has been identified. An unspecified time after vaccination the patient in this concerned case experienced left arm pain and also the patient was unable to lift the left arm since 27th October 2015. The patient received physical therapy as a treatment.