chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 by 4 inches hives on her left arm/she has hives on her left arm that now measure 6X4 inches; one giant red area; she has severe itching to the area; its burning and she has a rash on top of the hives; swelling in the left arm; Reported rash on the top of the hives on the left arm; This is a spontaneous report from a contactable consumer.    A 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , intramuscular on 14Nov2019 at 0.5 ml single as vaccination Medical history included allergy to latex, sulpha and cellulose. The patient's concomitant medications were not reported. On 14Nov2019 the patient experienced 6 by 4 inches hives on her left arm. In Nov2019 the hives were taking up over half her arm, they were now going round the back of her arm. Patient stated it was one giant red area, she had severe itching to the area, burning and she had a rash on top of the hives on the left arm. Patient went to the doctor twice and she has been told that the arm is not infected. Patient reported that the hives were worsening: she had hives on her left arm that measure 6X4 inches and seems to be increasing. Patient was using diphenhydramine hydrochloride (BENADRYL) 25mg capsule and triamcinolone cream 0.1% for the hives: She has been told to take diphenhydramine hydrochloride a couple times a day, and she took 2 full doses on 21Nov2019 and a half dose on 22Nov2019 and she stated it was helping her. She also applied triamcinolone quite a bit to cover the area and she has been using the cream for 3 days, and reported that the hives are not disappearing. She clarified that this was the only treatment that she did not feel was working for the hives. On 21Nov2019 she also received a Cortisone shot for swelling in the left arm. The swelling has not gone completely down, but has gone down some.The final outcome of the event hives was not recovering, swelling was recovering and outcome of all the other events was unknown. Patient wanted to know what ingredients in the product may have caused the reaction. She stated that she had a lot of allergies and she did not see anything in the pneumococcal 13-val conj vaccine ingredients that she's allergic to. Information on the batch number has been requested
JUL89 pt vax w/hepta B; devel severe diarrhea for 2 weeks. Ineffective tx w/Imodium & other pres. drug. Lab revealed normal CBC & liver function tests.  Stool culture for ova & parasites and hepta profile tests neg. See worm...
Arthralgia, myalgia, fatigue, low grade temps, chills, sweats, mild nausea. Right arm sore and heavy
Patient presented and reported a lump under his left arm that appeared sometime after his Covid19 booster.
Pt recv vax on 3/2/99; on same day pt exp high-pitched cry; dx=colic
Injection site became red and raised and swollen- patient describes as 2x2 oval area. Patient also noted body aches, headache, chills, rash across chest and upper back, sore throat and swollen glands in throat. Symptoms started within 6 hours of injection and came and went over the course of the next 5 days. Patient took acetaminophen and ibuprofen and noted relief. As of today- 02/02/2021, the only remaining symptoms are the injection site redness and swollen gland in her neck. Patient instructed to follow-up with her primary care physician for further evaluation.
received only one dose of shingrix on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received one dose of Shingrix in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The pharmacist reported the patient had received only one dose of Shingrix. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
increased phlegm in throat-felt like lump back of throat lasted several hours-onset 2hr p/vax; all sx resolved 10/7/99;
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 at 21:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Huge hot reaction at injection site; Itchy reaction at the injection site; Burning reaction at the injection site; Injection site hurt; A little red patch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site), VACCINATION SITE PAIN (Injection site hurt), VACCINATION SITE ERYTHEMA (A little red patch around the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid nodule (large). Concomitant products included PROPRANOLOL, FISH OIL and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (A little red patch around the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Ice therapy) for Vaccination site warmth; Physical therapy (Ice therapy) for Vaccination site pruritus; Physical therapy (Ice therapy) for Vaccination site pain; Physical therapy (Ice therapy) for Vaccination site erythema and Physical therapy (Ice therapy) for Vaccination site pain. On 09-Jan-2021, VACCINATION SITE PAIN (Injection site hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site) had not resolved and VACCINATION SITE ERYTHEMA (A little red patch around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take  Tylenol and use ice.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Follow-up received on 20-JAN-2021 contains information regarding patient demographic details, medical history, concomitant medications and the events. On 13-Apr-2021: Follow up received on 13-Apr-2021 does contains any new information.
Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given
Vaccinee completed course of Engerix-B vaccinations (dates unspecified). Antibody test, done one month p/last dose or sooner, showed she was a non responder.
Day after vaccine administered patient complained of a small bump at sight of injection, redness and swelling.
Pt vaccinated with HIB developed temp of 103 taken by mom 12AM on night of vaccine. Broke out in hives after that on arms & legs.
symptoms started 8/14, last night had fever and chills, temp T100.2, mainly cough, nasal and chest congestion today.  No shortness of breath.  Home COVID test positive.
Fever, body aches, exhaustion, These symptoms went away after 24 hours. Moderna arm rash with swollen, red, itchy patch at injection site appeared the day after shot. Still there on 3/14 when I am filling this out.
A week after the shot, my arm starting hurting really bad (worse than the first four days after the injection).  The pain went away after a day and a half, but now I have this big itchy red rash down the side of my arm.  I googled this and it seems like I have "COVID Arm", but I am not a doctor.
Patient reports that 2 to 3 hours after administration of vaccine he began having trouble breathing. He laid down and after resting symptoms resolved without further treatment.
Fever (102.00) that doesnt subside much with medication (going between 500-800 mg ibuprofen, 500mg of acetaminophen); vomiting; nausea; diarrhea; sore throat; chills; muscle and joint aches; muscle and joint aches; rashes; rashes and lumps underneath both armpits; ear pain; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 24-years old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (at the age of 24-years old) as dose 2, single for covid-19 immunisation. Medical history included angioedema, bouts of anaphylaxis, rashes, Penicillin allergy and Septra allergy. Concomitant medication included ethinylestradiol, norelgestromin (XULANE). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 14:15(at the age of 24-years old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has unknown if covid tested post vaccination. On 14Apr2021 patient experienced Fever (102.00) that doesnt subside much with medication (going between 500-800 mg ibuprofen, 500mg of acetaminophen), nausea, vomiting, diarrhea, chills, muscle and joint aches, rashes and lumps underneath both armpits, ear pain, sore throat. I am suffering bruh. Patient underwent lab test and procedure included Body temperature 102.00 Fahrenheit. It was unknown if patient has taken treatment for events.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3X3 CM AREA OF INDURATION RIGHT UPPER ARM. NO TENDERNESS. POSITIVE ERYTHEMA, 10 CM AREA OF RIGHT UPPER ARM. NO TENDERNESS, NO STREAKING.                                                                                           APPLY ICE PRN, MOTRIN PRN, RETURN TO CLINIC IF INCREASED REDNESS, SWELLING, PAIN, FEVER, OR STREAKING.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 06-APR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K003601, expiry date: 19-MAR-2015, 0.65 ml, subcutaneous). No adverse effects were reported. Additional information has been requested.
No adverse event; A patient was given a fourth dose of Gardasil; This spontaneous report as received from a nurse refers to a patient of unknown age and gender.      The patient's pertinent medical history, drug reaction, allergies and concomitant medications were not reported.  On an unknown dates, the patient was vaccinated with the first, second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On 23-SEP-2019, the patient was given a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# S008151 with expiration date of 20-NOV-2021, intramuscular injection, for prophylaxis (dose was not provided) (product use issue). No adverse effects reported.
still having fever off and on day 12; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Nov-2021 and was forwarded to Moderna on 24-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (still having fever off and on day 12) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PYREXIA (still having fever off and on day 12). At the time of the report, PYREXIA (still having fever off and on day 12) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: negative (Negative) Had a fever work-up, blood cultures and everything have been negative after day 7 post-vaccine..     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 medication reported. No treatment information was provided.
Received phone call from mother, concerned because son had broken out in a rash all over body about five hours after injections received. Child alert and "normal for him." Consulted with Dr. advised to give BENADRYL if itching worse or for comfort. To go to ER if swelling around mouth or throat or rash increases. 9/2/09 @ 10:00 Am - per mother child taken to ER 9/1/09 PM told by MD child has hives RX'd BENADRYL and PRELONE.
Fever for 2.5 days. Severe rash after the fever. Extremely irritable. Lethargic.
The patient's parents report the onset of a papular rash with vesicles/pustules on 10/04/2001.
This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, within weeks of vaccination with FLUARIX, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was assessed with a product complaint as the "doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from the lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX QUADRIVALENT, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The pain radiates up in to her shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other case with FLUARIX QUADRIVALENT. See A1050680A and A1050681A for details on the other cases.
Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; Body aches; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received first dose (BNT162B2, Lot number Eh9899), via an unspecified route of administration on 28Dec2020 17:30 at 35 years old at Arm Left at single dose for COVID-19 immunization.  The medical history included Allergies to Penicillin. The concomitant medications were none. On 28Dec2020 21:30 the patient experienced Severe arm pain, decreased mobility, Headache, Fatigue, Sore throat, Body aches, Feverish. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The information on the batch number has been requested.
Patient noted approximately 3-4 days after receiving the td vaccine that arm was red and swollen at injection site..left deltoid.  Denies c/o itching, pain, shortness of breath, etc.  Information reported 03/31/04.  Site still red, swollen, denies c/o at this time.
Individual received vaccine 2/18/21. Woke up morning of 2/19/21 with pain to right eye. Redness and drainage noted to eye on morning of 2/20/21.
Arm very sore at vaccination site.  The evening immediately after vaccination throat became red & sore.  For 2 weeks following was fatigued and had flul like/cold symptoms.  Treated with rest & fluid juices. No vomiting or dia.
86 year old manager received the two doses of the Moderna vaccine and died; A spontaneous report was received from a consumer, concerning an 86-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unspecified date, it was reported that the patient passed away after receiving both doses. The cause of death was unknown. It was unknown if an autopsy was performed.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable.  The outcome of event "86 year old manager received the two doses of the Moderna vaccine and died" was fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No autopsy report provided. Further information has been requested.; Reported Cause(s) of Death: 86 year old manager received the two doses of the Moderna vaccine and died
on 12/6/22, rt noted to have confusion, and was complaining of being weak and having no energy, early morning of 12/7/22 rt was found on floor in bathroom, he was sent  to hospital, with subarachnoid hemorrhage where he hit his head, also found to have multiple brain bleeds (intraventricular hemorrhages, and extensive microvasculopathy,
Reported to us that patient received Flu shot on 10/17/2011 and went to ER.  Admitted to ICU with septic shock and multiple organ failure.
Information has been received from a certified registered nurse practitioner concerning a 16 year old female student with no pre-existing medical history who on 18-JUN-2009 at 11:30 a.m. , was vaccinated intramuscularly with the second dose of GARDASIL (lot# 659054/0315Y) into the left deltoid. There was no concomitant medication. On 25-JUN-2009 one week after the vaccination, the patient experienced a pain from the injection site area down the arm to her wrist. She denied any edema, erythema or fever. She had normal movement and strength to the extremity. There was no illness at the time of vaccination. She visited the doctor for medical attention. No relevant diagnostic tests performed. On 29-JUN-2009 the patient recovered. Additional information is not expected.
Left ear got red and warmer than normal limp nodes on left side of neck swelled up  Left ear started to feel pressure and hearing was muffled. 07/20/2021 had left eardrum myringotomy to relieve fluid no tube placed 09/02/2021 had left eardrum  myringotomy to relieve fluid and drain tube placed in ear
This spontaneous case reported by a consumer, describes the occurrence of severe chest pain radiating to the right arm, hypoesthesia (numb fingers) and arthralgia (severe joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 033B21A) for COVID-19 immunization. No medical history reported. On Jun 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 3, 2021, patient had severe chest pain radiating to the right arm), hypoesthesia (numb fingers) and arthralgia (severe joint pain). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; ibuprofen, at an unspecified dose and frequency; and Biofreeze (menthol), at an unspecified dose and frequency. At the time of the report, severe chest pain radiating to the right arm, hypoesthesia (numb fingers) and arthralgia (severe joint pain): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:  Employee reports that she felt like she was coming down with the flu roughly 10 hours after the vaccination (HA, chills, body aches, joint aches, nausea and fatigue. She checked temperature on 1/6/21 around 2:00p and it was 102.2. She did not think to check it previously. Employee setup for COVID/Flu/RSV panel for 1/7/21.
I am a breastfeeding mother of a 8 month old. Two days after receiving both does of the COVID-19 vaccine, my daughter broke out in a full body rash. The rash looked like welts. The rash lasted for 7 days and then she had a very high fever for 3 days. Both times we were told that there wasn't anything we could do and that they were unsure of the origination of the body rash and fever.