chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives like reaction a week after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives like reaction a week after the vaccination) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives like reaction a week after the vaccination). At the time of the report, URTICARIA (Hives like reaction a week after the vaccination) outcome was unknown.            No concomitants were reported.  Treatment information was not provided.  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Roving severe joint pain; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E/9267) via unspecified route of administration in the left arm on 28Feb2021 at 11:00 (at the age of 66-years-old) as a single dose for Covid-19 immunisation. Medical history included HBP (high blood pressure) and cholesterol. Concomitant medications were not reported. 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 02Mar2021, patient experienced roving severe joint pain. The patient did not receive any treatment for the adverse event. The events resulted in doctor or other healthcare professional office/clinic. The clinical outcome of the event roving severe joint pain was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
Pt received PNEUMOVAX 23 on 10/13/17. Came in today (10/15) to inquire about extreme sore arm and redness radiating around circumference of injection site. Pt took two ibuprofens just prior to coming to pharmacy today.
Got Ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS. At the time of the report, ILLNESS outcome was unknown.            No concomitant medications were reported.   Treatment information was not reported.
Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1),  dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate.  It is now the 3rd day and except for tiredness I'm feeling more normal
Taste of mental q couple hours after having injection, pain in both arms upper body and frontal and to head pain by prior to 10pm. Inflammation thru out my body, swollen lymph nodes, side pains, heaviness in lower extremities. Then within 24 hours increased into inflammation. Since my inflammation has increased since receiving injection. I had been seen in OBGYN due to change in menstruation cycle for the last 3 months.
Intradermal vaccine given in left and did not wheal. Recorded as med error and repeat dose of intradermal vaccine given in right arm successfully.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 DF (reported as "vaccine dose") lot# reported as N011475 with an expiration date 08-AUG-2019 for prophylaxis (route of administration and anatomical location were not reported). On an unknown date, the patient experienced injection site pain, injection site swelling and injection site erythema. The outcome of injection site pain, injection site swelling and injection site erythema is unknown. Lot number N011475 is an invalid lot number for ZOSTAVAX.
Twenty four hours after injection felt tired, without usual energy. Warm to touch. Forty-eight hours after injection had terrible headache and had red, swollen, 1/2 dollar size area @ injection site. No fever. Lasted 2 days.
Left deltoid with tenderness and slight pain. Left middle hand finger twitching. Seen by Dr.
Extreme pain at injection site, chills, headache, muscle aches, fever over 101.2 lasting approximately 42 hours.
Hypotonic hyporesponsive event approx 3 1/2 h after routine 2 month vaccinations. Event happened at home witnessed by mom. Lasted seconds and was self-resolving. To ED with normal exam no recurrent events. Babe has not had DTaP since without fever.
Child was given H1N1 injection on 11/09/2009 and then given a second one on 11/18/2009.
difficulty sleeping; Arm tender; Arm hurt/Arm painful; Great deal of discomfort; could not elevate arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Great deal of discomfort), MOBILITY DECREASED (could not elevate arm), TENDERNESS (Arm tender), INSOMNIA (difficulty sleeping) and PAIN IN EXTREMITY (Arm hurt/Arm painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis. Concomitant products included FISH OIL, ASPIRIN [ACETYLSALICYLIC ACID] and CALCIUM for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced LIMB DISCOMFORT (Great deal of discomfort), MOBILITY DECREASED (could not elevate arm) and PAIN IN EXTREMITY (Arm hurt/Arm painful). On 11-Mar-2021, the patient experienced TENDERNESS (Arm tender). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping). At the time of the report, LIMB DISCOMFORT (Great deal of discomfort), MOBILITY DECREASED (could not elevate arm), TENDERNESS (Arm tender), INSOMNIA (difficulty sleeping) and PAIN IN EXTREMITY (Arm hurt/Arm painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
I got in the shower & I removed the bandage & about 2 inches from injection site I noticed a big round red bump & it was sore  to the touch & then I washed my hair & I noticed my head had bumps in my scalp & also my lip started swelling & I knew something was wrong so I took 2 Benadryl & all bumps were gone.
This is a spontaneous report from a non-contactable consumer (patient).  A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 (at the age of 40-years-old) as dose 2, single for covid-19 immunisation. Medical history included food intolerance. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2 (Batch/Lot Number: Unknown) as dose 1 on 03Jun2021 (at the age of 40-years-old) for covid-19 immunisation and experienced bruise on her right foot. On 15May2021, the patient experienced "one dr said i do have something vascular going on", within like 2 days after i got my second shot i got the same bruise in the same spot, feeling of restlessness, a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. Days after the patient got the first shot, she got a bruise on her right foot. Went away. Within like 2 days after she got the second shot she got the same bruise in the same spot. Since then started getting them on her arms as well, back on foot, feeling of restlessness and a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. One dr said it was something vascular going on. Blood and urine test came out ok. Doctors did not rule out that it could a reaction. She got several opinions and nothing explained why. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Device time stamp was provided as 09Sep2021. Outcome of the events were not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101185903 same reporter/patient/product, different dose/event.
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 06-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Informatio has been received from a physician's assistant concerning a 22 year old female who on 25 Jan 2007 was vaccinated IM with a second 0.5 ml dose of Gardasil. On approximately 25 Jan 2007, the patient experienced a 1.3 inch area of swelling, redness, tenderness and itchiness at the injection site. The patient notified the physician's assistant 5 days after vaccination. It was unknown when the events started. The patient was treated with cool compresses and antihistamines with unknown results. No diagnostic laboratory studies were performed. Subsquently the patient recovered from swelling, redness, pain and tenderness at the injection site. It was also reported that on 07 Nov 2006, the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information is not expected.
No additiona AE; A patient was inadvertently administered expired dose of ROTATEQ; This spontaneous report received from a medical assistance and refers to a patient of unknown age and gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported.  On 28-DEC-2021, the patient was inadvertently vaccinated with expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally lot# 1691303 and expiration date 21-DEC-2021 (frequency was not reported,) as prophylaxis (Expired product administered).   No additional AE reported. No PQC reported.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and nausea. On an unknown date, the outcome of the fever, influenza-like symptoms and nausea were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In 2018, two or three weeks ago from the reporting date, the patient received the SHINGRIX vaccination and experienced fever, nausea, and flu-like symptoms. The symptoms resolved within about two days.
After receiving the injection mid-afternoon on 6/23/2019, I woke up on the morning of 6/24/2019, at about 8:00, with an aching back and feeling lethargic.  Later in the morning, I took ibuprofen, which made my back stop aching, however the feeling of lethargy remained all day. I felt fine when I woke up the second day, 6/25/2019.
One day after ADACEL injection, developed tenderness, warmth and induration at injection site. Overweight healthy. Treatment-BENADRYL, cold compress.  Follow up - Lot number for Hep B vaccine C2689AA
On 3/15/07 pt received second dose of Rotateq vaccine LOT # 1365F exp9/08.  On 3/25/07, mother reports bright red blood from rectum mixed with mucus. No fever or pain.  Child acting fine otherwise.  Unclear whether this is due to vaccine or if the baby has developed milk protein alleric colitis.  He had no stool abnormalities with the first dose.
The first shot, same Lot number, my heart went crazy irregular for about 3 weeks. The second shot, my heart starting hurting REALLY bad, Lightheaded, severe chest pain. Put on meds for pericarditis.
Patient had the signs and symptoms of Bells Palsy a couple of weeks after receiving her first Shingrix vaccine. She went to MD office where they diagnosed her with Bells Palsy.
He fainted. we put him down... Soon he came back up... Called 911 but he was feeling better so refused treatment.. He had not eaten or drank properly the whole day.
Approx. 5 minutes after vaccine admin patient started to experience dizziness, flushing, vomiting, elevated BP (150/110).  She was immediately treated with 50 mg Benadryl which provided little to no relief of symptoms. EMS was called due to patients severe level of feeling "not right" and continue elevated BP.
pt states the afternoon after getting the flu shot she developed tightness in her throat, she had trouble swallowing and talking.  She also had unusual hoarseness along with swelling of the throat.  She was having a swooshing sound inside her head.  The next day she still was not feeling well.  About then days later she wasn't feeling well and went to a walk in clinic.  She had pain in her lower left abdomen and ringing in her ears.  She has developed a respiratory infection but is feeling some better now.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as L049455, expiration date 03-DEC-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of PROQUAD experienced the temperature excursion of -11 degrees Fahrenheit for 44 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
22 y/o male was complaining of spreading vesicular lesions involving his hands, face, neck, abdominal, back, and genital areas. Lesions originated on hands about 14 days after initial smallpox vaccination. Pt stated no h/o eczema. Pt was referred to disease management for further analysis the next day and was diagnosed with vaccinia from vaccination. Pt denied and any flu-like symptoms or painful urination. He was prescribed Benadryl, Zyrtec, and was placed on 7 day quarters. Pt was instructed to f/u with infectious disease or PCM post 1 week.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 12:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "headache".  Additional information: Patient was reported to be aged 62 and was asking if she can take 2 Tylenol post vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with hives on body and difficulty breathing and swallowing. The hives lasted for several months. Around august 6th the breathing issue came back. Along with the breathing,  it started to become challenging to swallow. Tingling and almost a sensation of loss of feeling in left arm and leg. This occurs periodically throughout the day, at random times. It has been every day now since august 6th
8/29/2006 Localized reaction, inflammation R Triceps 8/31/06 fever, inflammation shoulder to elbow R arm 4" wide, red, pruritic 9/1/06 Rash, bilateral legs, anterior, posterior and inside legs #100's. 3-4 lesion L arm. Seen by PCP, rash described as rose petals with dew drops. Antihistamine prescribed.
IM injection given in right thigh due to bilateral mastectomy, and prior significant swelling of right arm with flu vaccine in 10/2019, with small mass remaining.
Patient experienced a warm rash outbreak from her neck all the way to the bottom of her torso. This included her arms.
Anaphylactic Shock. 10 minutes after injection - vomiting, shortness of breath, throat swelling, chest pain. Self-administered EpiPen and went to the ER, given multiple doses of epinephrine, solumedrol, Benadryl, Pepcid. was monitored overnight and sent prednisone and Pepcid.
Chills, fever, headache, body aches, dizziness, joint pain. I did not seek medical treatment.
Fever, hot flashes, exhaustion, injection site heat, injection site sore, tiredness, chills
The patient reported filling a tingling and itching sensation in her throat. The doctor on site administered 20cc's of Benadryl and monitored the patient for 30 minutes at which time the patient reported feeling better prior to being cleared to return home.
NO EVENTS UNTIL 1-19-2021.  INJECTION SITE BEGAN ITCHING.  WOKE UP 1-20-2021 WITH ARM ACHY, SWOLLEN, RED, FEVERISH, ITCHY
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting treatment with AFLURIA the patient experienced dizziness, headache, and vomiting. Event Treatment: The patient did not treat the events. Reporter's assessment: none stated.
Swollen, raised, red and very itchy rash about 2-3 inches below injection side; lasted but gradually faded in color over about 4 weeks but remained somewhat itchy
feel like crap; This case was reported by a consumer via media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles vaccine and felt like crap. The follow-up would not be possible as contact information was not available.
Information has been received from a nurse practitioner concerning a 15 year old male patient who "in the last couple of weeks", was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unknown date, "within 5 minutes of receiving the injection", the patient developed lightheadedness and almost passed out. The nurse practitioner stated that the patient had a drop in blood pressure and his heart rate lowered. The nurse practitioner stated there was no other adverse event to report. The patient sought medical attention in the medical office. The patient did not receive any treatment for the event. The patient recovered quickly. This is one of several reports received from the same source. Additional information has been requested.
PT. REC'D ZOSTER VAX. ON 1/29.09.  HIS WIFE CALLED CLINIC CHARGE NURSE 2/23/09 TO REPORT PT. HAD DEVELOPED A BLISTER WITH EXUDATE ON THE ARM HE'D GOTTEN THE SHOT IN.(RT.). SITE WAS NOW SCABBING OVER. SITE HAD ACHED PRIOR TO APPEARANCE TO BLISTER.  SHE FELT SHOT HAD CAUSED SHINGLES AND STATED MD AGREED.  NO CULTURE DONE.  PT. FELT WELL OTHERWISE.  AFEBRILE PER WIFE.
Arm swollen and red (2 inches high x 2 inches wide) breathing problems, 101 deg fever, eyes red-allergy, stomach pain and vomiting, Dr gave Prednisone - same Dr that prescribed Zostavax
Development of autoimmune effects including permanent scalp hair loss, thyroid irregularities, loss of menstrual period/development of menstruation irregularities, food allergies (none previously existing), ear pain, chronic fatigue.
pt recvd vax MAY89 & exp discomfort (arthritic-type pain) in lower back, hands, rt knee; also exp edema of the rt knee & fingers; pt treated w/ASA;
14 days p/vax pt exp a varicella like rash. on 1feb99 mom rpt to MD  pt had an outbreak of lesions.
BUBBLES ON BOTH LEGS; LEGS WERE SWOLLEN; BUBBLES POPPED UP AND LEAKED YELLOW LIQUID; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included sulfa allergy, allergy to lyrica, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use and had no fever, no cough, no asthma, no sob. The patient received Covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced bubbles popped up and leaked yellow liquid. On 13-APR-2021, the subject experienced bubbles on both legs. On 13-APR-2021, the subject experienced legs were swollen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bubbles on both legs, and legs were swollen, and the outcome of bubbles popped up and leaked yellow liquid was not reported. This report was non-serious.