chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Superficial redbumps; This is a spontaneous report from a contactable pharmacist.   A 19-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via intramuscular route of administration in the left arm on 29Apr2021 (at the age of 19-year-old), as dose 1, single for COVID-19 immunization. Patient relevant medical history included food allergy (known allergies: fish containing products). Patient took unknown concomitant medications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an intramuscular route of administration in the left arm on 08Apr2021 (at the age of 19-year-old), as dose 1, single for COVID-19 immunization. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021, the patient experienced superficial red bumps. The patient reported that superficial red bumps did not previously recall on left inner thigh; the patient was encouraged to stay further after drinking 16 fluid ounces of water. The patient did not receive any treatment for the events. The adverse 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 event superficial red bumps was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's PC box unticked, Patient's initials updated, Patient's email removed, Vaccination facility country added, "Prior to the vaccination, the patient was diagnosed with COVID-19" removed from narrative, Concomitant therapy captured as yes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3(booster) , single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2 (Batch/Lot number: unknown) and as dose 1 (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "EGPA" (unspecified if ongoing). Concomitant medication(s) included: NUCALA, start date: 04Sep2018. The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test positive: positive. Therapeutic measures were taken as a result of covid-19. Clinical course : Primary Immunization series completed from an UNKNOWN MANUFACTURER. Anti viral details, Product: COVID 19 treatment, Treatment start date: 26Apr2022, Treatment stop date: 01May2022, Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Slight redness at injection site, 10 min after injection. Fainted on examination. Hit head examined paramedics, released to parent.
LOCAL SORENESS AT SITE DAY 1  DAY 2 SORNESS ON SITE AND UPPER ARM GOING INTO SHOULDER DAY 3 @ 3AM FELT HEANEYNESS IN CHEST, SEVER BODY ACHES, PRODUCTIVE COUGH,  COUGHING UP ACID TASTE
I'm currently breastfeeding a 14 month old.  I think my right breast had a little hard spot the morning before I got the vaccine, but in the past when it happened I just breastfed and massaged the spot and nothing would come of it.  The day we got vaccinated I don't recall noticing any symptoms when breastfeeding. But, the morning after the vaccine, my right breast had a red patch and a little hard patch and let down was painful.  I went to the doctor that afternoon and was diagnosed with mastisis. I haven't had it before, that I am aware of. The doctor prescribed me 10 days worth of antibiotics. My symptoms subsided in a few days. Now it's been a week and I feel fine. I am still taking the antibiotics as reccommended. The doctor thought it was most likely not related to the vaccine.  I am reporting it since the CDC called me since I was signed up for VSafe.
side effects; in his upper right chest, next to his breast, is sore; it runs from his right breast to his right arm armpit; swelling of lymph nodes but he's unsure; soreness at the injection site; in his upper right chest, next to his breast, is discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit) and LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C16M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DISCOMFORT (in his upper right chest, next to his breast, is discomfort). On 09-Feb-2021, the patient experienced ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient stated that he had the vaccine but his only side effect was the sore arm and it has gone away. Provided up-to-date contact information. Does not want safety to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
No additional AEs were reported; patient received possibly improperly stored vaccine due to lack of temperature readings; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 06-JAN-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000560: US-009507513-2205USA000503: US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000553: US-009507513-2205USA000544: US-009507513-2205USA000545:
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date ,the patient was vaccinated with a dose of M-M-R II by intramuscular route instead subcutaneous route (indication, strength, dose, frequency, lot number and expiration date were not provided) for prophylaxis, which was administered with a sterile diluent.
This spontaneous report has been received from a medical assistant refers to a patient of unknown age. On 25-JUN-2013 the patient was a expired dose of 2 ml vaccinated with ROTATEQ (lot # 1539AA, expiry date 15-JUN-2013). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
- DTAP #5 was given (R) leg 4-12-10, pt was seen 4-13-10 without redness & without cellulitis in area of injection site.
FEVER, COUGH, SORE THROAT, RUNNY NOSE, HEADACHE FOR 3 DAYS.
One day after receiving PREVNAR noted lower abdomen and between thigh c/o itching. Rash spread trunk, arms and leg. BENADRYL given w/ improved rash and decreased itch.
Temp 97.7 pt was given Flu vaccine at 2:13 PM at approx 2:20 PM pt had developed hives to face and arms. No difficulty breathing 911 called and taken to ER.
On 6/29/99, the pt developed an injection site reaction characterized by an area of redness, swelling, and warmth the size of the palm of her hand.
Early the next morning after the vaccine I woke up with chills, body aches and felt feverish so I took 2 tylenols and went back to sleep.  Around 7am I woke up still with the same symptoms so I took another 2 tylenols.  I remained up but started feeling bad so I laid down and took a nap.  Around 4pm I took 2 more tylenols because I just didnt feel well.  I didnt feel well the remaineder of the day and laid down for bed around 7pm and woke up the next morning and all symptoms had subsided.  I was 16 weeks gestation at the time of the vaccine. EDD-8/25/2021.
I woke up and have been experiencing severe body aches, a dull headache, and it feels like I might have a low grade temperature but when I check my temperature it is normal.
When mother put child in bathtub this AM (6:28), she noted puffiness of hand and feet and redness of feet. There was a rash on legs and arms.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
RASH DEVELOPED ACROSS LEFT SIDE OF CHEST (VACCINE GIVEN IN LEFT ARM). BEGAN THE NIGHT OF ADMINISTRATION; WHEN PATIENT WOKE UP, THE RASH WAS MORE PRONOUNCED. RASH STILL PRESENT AS OF 9/5/2012, AND ARM IS STILL TENDER.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA282120. (Same Reporter). This case involves a 91 years old male patient who received a partial dose of vaccine FLUZONE QUADRIVALENT which was leaked out from hub of syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. Reported as no other vaccines given. On 04-Oct-2018, the patient received a 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301NA expiry date: 30-Jun-2019 via intramuscular route. It was reported that do not know the site of the vaccination was given. It was a case of actual medication error due to vaccine under dose. It was reported that vaccine leaked out from hub of syringe during administration to patient, reported partial dose was given to patient. It was also a case of syringe issue. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Received Hep B #1 on 11-5-01 at 1130 am and called 130 pm to state feels itchy and have redness around injection site and complained of some tightness in chest. Referred to emergency room. Took Benadryl self and went to private doctor. Received order to get Hep B #2 after taking Benadryl. Had Hep B #2 12-1701 at 935 am and by 945 complained of tongue thick and throat swelling. epinephrine 5 ml given SQ with symptoms alleviated Took Benadryl 25 ml at home prior to #2 Hep B.
48hr of tenderness + induration at vax site; max induration 6-7cm; devel dermatitis 3day p/vax, however, pt has hx of gardening w/ development of poison ivy dermatitis just like this; pt gardened day of vax
Information has been received from a nurse practitioner concerning a 9 year old female with no known drug allergies or medical history who on 30Sep1996 was vaccinated with a dose of varicella virus vaccine live. On 20Feb2004 the pt presented to a school nurse with a mild case of chicken pox. Unspecified medical attention was sought. It was noted that the school in this county had an outbreak of chickenpox. No product quality complaint was involved. It was also reported that 2 additional children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. No further information is available.
Left upper arm hot, erythematous swollen (22 cm right arm) 24.5 cm swelling 7x8cm erythema
Headache; Fever of 99; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever of 99) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever of 99). On 29-Jan-2021, HEADACHE (Headache) and PYREXIA (Fever of 99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 99. On 29-Jan-2021, Body temperature: 97.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
itching, redness, raised area around injection site, warm to touch, 99.5 fever, water filled blister.  A round injection site barrier bandage was used. Patient was instructed to go to see a physician
Very heavy and painful period that came 4 days early the morning after the vaccine. I have never had a period this early and am very regular with my cycles every 28 days.
on the the day right arm warm was itching, large knot on arm, red and raised up and hot, continued to spread down her arm for the next 7 days, became very weak, unable to eat and very sick for the next 6wks. very weak couldn't get out of bed.
It was reported that a male patient received a YF-VAX vaccination in 1969. Reportedly the patient developed Hepatitis C after receiving the vaccination in the military. No specific provided. Further information requested.
pt c/o nausea, vomiting, diarrhea, chills & shivers; temp not taken; feels achy; unable to keep fluids down; began around 10AM this AM 4NOV94;
I no longer have working legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Open angle glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "I no longer have working legs". The event "i no longer have working legs" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated that, he got his shot about a week ago and last night, he came in from a day of working outside and sat down on computer, couple of hours he worked there and when he went to got up, his knees were effectively all rubbery. Patient could not support himself. He had to use his arms in order to hold himself up. So, the patient thought it would get better in the morning, it did not. So, Patient went into the urgent care locally, they did a full X-ray of his knees on each side. They also did a CAT scan of his brain. They also took blood samples, and they could not detect anything immediately on the radar. The consumer stated he no longer had working legs. He did not receive vaccine from the previous 9 months or so.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
The area around the injection at 1/4" in diameter became sore and hot to touch on 11/14/06 and the same area itched on 11/15/06.
Ruptured appendix with minimal clinical prodrome. Resulted in phlegmon/abscess.
Hives, swelling of eyes, cough for 20 minutes, given Benadryl in office observed for 60 minutes gave Orapred 30 mg by mouth twice, gave Zantac 15mg/ml 3ml bid x 3 days, Zyrtec 5mg daily x 3 days.
first dose September 22, 2022, second on October 25, 2022; Chills; Muscle weakness; Muscle soreness; Lack of motivation; Head strain (back of the head); This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced chills, muscle weakness, muscle soreness, lack of motivation and headache. On 25th October 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the chills, muscle weakness, muscle soreness, lack of motivation, headache and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, muscle weakness, muscle soreness, lack of motivation and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The patient self-reported this case. The patient stated that he received his first dose of Shingrix on 22nd September 2022, and his second dose on 25th October 2022 (AE Inappropriate Schedule of Vaccine). The patient also stated that after receiving the second dose, he experienced chills, muscle weakness, muscle soreness, lack of motivation, and head strain (back of the head). The patient did not wish to provided date of birth. The patient did not give consent to follow-up with HCP(Health Care Professional). The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule.
Developed itching and hives 2-3 days later. 1 week later developed swelling around eyes and involving lips
erythema mult w/serum sickness like rxn beginning 5 days p/vax;
Right arm edema after 2 days. Tx: Benadryl and hot compresses.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL which had lot # K016966, expiry date: 10-MAY-2017 (route, dose not reported). The vaccine was exposed to temperature of 53 degree Fahrenheit for 50 minutes. No previous temperature excursion and no adverse effects were reported. The vaccine was brought back in range. No further information provided. Additional information has been requested.
Varicella vaccine given in UR thigh SQ on 02/06/2003. On 02/18/2003 site became red and swollen. Dx Cellulitis right leg , Tx Bactroban and Keflex 125/5
Redness, swelling pain at injection site one day after administering. Pt. used ice and otc anti-inflammatories to help. Pt stated after injection on 4/5/17 that she had previous reaction to pertussis as a child.
Patient states she experienced severe pain that radiated down her arm which led to her not being able to use the arm for an extended period of time (she wasn't able to grab, extend or hold anything  with her left arm); it went away after a week and she claims the same symptoms have returned 8 months later.
Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Redness, itchiness, swelling on left arm around injection and burning pain around left wrist; started 4/10 5 days after vaccination.
about 3 or 4 hrs p/shots pt cried inconsolably for 3 or 4 hrs; no fever;
red firm hot to touch area surrounding inject site rt thigh measuring 14 cm x 8 1/2 cm, no deg noted; ambulating-no limp;
Patient stated he felt 'little dizzy", appeared clammy. No other reaction noted, denied any SOB.
Raised fine rash on face, neck, and chest.  Swelling of face and eyes, some wheezing occurred.