chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach pain; Chest tightness; Body aches; Lethargic; severe pain at injection site; Fever, hot to touch; chills; Extreme Nausea; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  extreme nausea/ nausea, stomach pain/ abdominal pain upper , chest tightness/ chest discomfort, fever, hot to touch/ pyrexia, chills, body ache/ pain, lethargic/ lethargy.  The patient's medical history was reported as allergies to sulfa, azithromycin, wheat, eggs. Concomitant medications taken by the patient included bupropion, birth control.  On 23 Dec 2020, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 025J20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at right arm site for prophylaxis of COVID-19 infection.  On 24 Dec 2020, after the first dose patient experienced extreme nausea, stomach pain, chest tightness, fever, hot to touch, chills, body ache, lethargic. All these events lasted for three full days and was reported that the patient recovered from the events.  Treatment activities for event was done with paracetamol, ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, extreme nausea, stomach pain, chest tightness, fever, chills, body ache, hot to touch, lethargic was resolved on an unknown date.
Developed the shingles rash / still has lesions today; Developed the shingles rash / still has lesions today; still has lesions today; This case was reported by a other health professional and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, 32 days after receiving Shingrix, the patient experienced shingles, rash and skin lesion. On an unknown date, the outcome of the shingles, rash and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vacciantion was not reported. The reporter stated that, 1 month ago from the date of reporting, the partient developed the shingles rash, and still had lesions on the day of reporting. The reporter consented to follow up.
PC from pt 02/28/08 AM reporting that she "broke out in hives" on back at bra strap and arm and at elastic bad area where underwear come to; took BENADRYL. Referred to ER-Advised to go to ER/ Urgent care. 02/29/2008 PC to pt-did not go to ER/ urgent care, symptoms no worse, ED work up can't take BENADRYL at work-makes sleepy. Advised go to ER/Urgent care.
3 hrs after dosing chills, malaise, fever, next AM: Fever 102.3. Blurred vision-unable to drive. Sxs x 3-4 days. Resolved. Never presented to MD (Not reportable but significant)
This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a elderly female patient who received Influenza vaccine Quadrivalent. Previously administered products included BREO ELLIPTA with an associated reaction of nasopharyngitis (inhalation, was taking for about one year, for tolerance refer case US2018GSK008155) and INCRUSE ELLIPTA with an associated reaction of bronchitis (inhalation, was taking about 6 months, for tolerance refer case US2018GSK008155). Concurrent medical conditions included chronic bronchitis, chronic obstructive pulmonary disease and asthma. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and cough. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, influenza and cough to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was received from the consumer via the vaccine patient assistance program (PAP). The age at vaccination was not reported. The patient had flu for three weeks and was feeling better at the reporting time. The patient had influenza strain B that was going around. This case was considered to be a suspected vaccination failure as the exact time to onset for the event was unknown. This case was not associated with product complaint. The reporter agreed to have GlaxoSmithKline Biologicals safety team to follow up with them via postal mail.
Received MMR, DTA, IPV 08/30/2002. On 08/31/2002, left upper arm swollen and child had fever. Mother gave Motrin. On 09/01/2002, child awoke with left upper arm swollen with presence of blisters, arohhold diagnosed staph IM antibiotics and antibiotics to take by mouth. 09/03/2002 resolved.
Information has been received from a licensed practical nurse concerning a female with shellfish and iodine allergy who was vaccinated with a dose of PNEUMOVAX 23.  Subsequently the patient developed a local injection site reaction.  The reporting licensed practical nurse did not know then extent of the reaction.  The patient was seen by the physician.  Subsequently, the patient recovered.  Additional information is not expected.
est 6 hr p/shot got hive-like rxn all over started going away the next day;
Redness, swelling, tenderness 2 days after vaccine. 3 days after - blisters which broke open into an open wound/burn. Seen for follow up on 7/15/13.
Patient called the pharmacy a few days after her 2nd Moderna vaccination and stated about a day after her shot she started experiencing abdominal cramps. Patient was pregnant so was very concerned and went to the hospital.  Unsure how far along she was but she wanted us to know she had a miscarriage.  We are unaware if this is linked to the vaccination but patient is stating that's the only thing that has changed since her three previous pregnancies that had no issues whatsoever. Reporting this since she called the pharmacy so we were aware and since we are not aware if the hospital filed this report.
given in error - - has already had 4 vaccines and didn't need 5th dose no symptoms at this time
Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested.
mom called morning of 14MAY99 child refusing to walk c/o pain in legs;recommended advil & DPH & mom should not carry pt around;15MAy99 child much better walking on own;
Does not have a good grip in (R) hand trouble bending thumb on (R) hand.
headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient (not pregnant) received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) at the age of 74 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. No known allergies. No other vaccine in four weeks. On 12Feb2021, patient had headache for 2 days after getting the second dose of the vaccine. No treatment received for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered on 14Feb2021.  Information about the lot/batch number has been requested.
Adenocarcinoma in my lung very small one. Diagnosed on September 7, 2021 with a biopsy. I have been meeting with doctors and discussing treatment options. No symptoms.
Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot.  Constant pain.  Painful to touch.  Spurts of searing, burning pain on back side of toe.   2.  Exacerbated arthritic pain in both hands.  Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment.  Referral to Rheumatologist
I began experiencing chest tightness/pain (initially concentrated on left side) some hours after receiving the vaccine. Two days later, I visited the hospital and all heart/blood tests appeared OK. It is now a week out and chest discomfort continues?it has manifested itself in other parts of my chest as well and is more present at certain times than others (e.g. when taking a deep breath). Minor shortness of breath. My primary care provider advises it may be costochondritis. Note: I had COVID-19 in late March.
Headache 1 day Body aches  3 days Fever 99.7 - 100.8 1 day
This case was reported by a healthcare professional and described the occurrence of headache in a 50-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 August 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route and injection site). In an unsp August 2014m at an unspecified time after vaccination with BOOSTRIX, the subject experienced headache, nausea, fever (39.1 Deg. C), lethargy and decreased appetite. On 27 August 2014, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. No further information was available. The case was closed.
Pt received Varicella vaccine in summer of 2006. Contracted varicella (was seen in office and diagnosed by primary care provider) May, 2007.
Flu: Initial information received on 30-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from Regulatory Authority a via consumer non health care professional under reference number: US-SA-SAC20211103001270.  This case involves Adult and unknown gender patient who was experienced flu (influenza) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event flu (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.
After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose: bad headaches that wouldn't go away with NSAIDS, chest pain, hot diaphragm, fatigue. She reports still having these symptoms and it is day 4 after the vaccine.
Shot was given in left arm.  Arm became extremely painful to move.  In order to raise arm, had to pick it up with right arm.  Pain extended into neck.  Had chills and later fever.  By the next morning, all symptoms were gone except for some soreness in left shoulder which took several days to completely leave.
Mom called and stated child's right upper arm was red, swollen, painful and had blisters on it.  Patient was brought to clinic and assessed by Nurse Practitioner.  Small blisters noted below injection site.  Redness and swelling measured.  Mom told to give Benadryl and Ibuprofen and return to clinic the following day.  Go to ER immediately if symptoms worsen.  Mom called the clinic the next day and reported the child had much improved.  Child brought to clinic on 10/07/16 and assessed, redness and swelling had decreased and blisters were no longer raised or visible.
patient has been given pentacel and pedirex on the same day with no reported adverse event; Initial information received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient who had been given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) both for Prophylactic vaccination.  On 02-Jun-2023, the patient received a dose of 0.5 ml once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ3733000; expiry date: 09-Sep-2023) (dose/series: 6 month vaccination) via intramuscular route in the right thigh and on the same day, the patient also received an unknown dose of suspect PEDIARIX not produced by Sanofi Pasteur (formulation; strength; lot number; expiry date unknown) for prophylactic vaccination (Immunization).  On 02-Jun-2023 the patient had been given pentacel and pedirex on the same day with no reported adverse event (extra dose administered) (latency: same day).  It was reported, "They both address polio and Diptheria, Tetnus and Pertusis. What should they tell the mother as far as side effects and how should they schedule their future vaccination visits?"   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982   Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis.  Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process
Torn rotator cuff on her right side; SORE ARM WITH SECOND COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side) and VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side). In 2021, VACCINATION SITE PAIN (SORE ARM WITH SECOND COVID-19 VACCINE) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (Torn rotator cuff on her right side) outcome was unknown.            Concomitant medication was not reported.  Patient reported she had a torn rotator cuff on her right side. She had only sore arm with second COVID-19 vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna.
Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly; Like a hard ball like; Lump hurts when touched; Red spot at injection site; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 14M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient took Tylenol, just have a little fever, but was not hospitalized.) in September 2020. Concomitant products included METOPROLOL, RIVAROXABAN (XARELTO), SIMVASTATIN, OMEPRAZOLE, VITAMIN D NOS, ZINC and PARACETAMOL (TYLENOL) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Palpitations). On an unknown date, the patient experienced VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site). At the time of the report, PALPITATIONS (Palpitations), VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site) had resolved.            No treatment information was provided. Patient stated that she was scheduled for an operation, surgery for her Pacemaker the week after she took the second dose of vaccine as reported.   This case was linked to MOD-2021-051766.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The event outcome was updated from unknown to recovered/ resolved.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Stomach pains, vomiting multiple times, Diarrhea for 3 days, Fainting, dizziness, trouble breathing. Sleepiness, weakness.
Numbness and/or tingling in the lips; Numbness and/or tingling in the lips; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 44-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered on left arm on 25Apr2021 16:00 (at age of 44 years old) as dose 2, single for COVID-19 immunization. The patient's medical history included sulfa allergy eventually resulted in small dose epinephrine injection, asthma, and COVID-19. The patient's relevant past drug history included sulfa, all -mycins, latex, and aspartame. The patient previously received Pfizer COVID-19 (Batch/Lot number: unknown), via an unspecified route of administration, administered on left arm on 29Mar2021 17:30 as dose 1, single for COVID-19 immunization. On 29Apr2021 07:45, the patient experienced numbness and/or tingling in the lips. The hospitalization prolonged was reported as no. The facility where the most recent COVID-19 vaccine was administered in a Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered/not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
5 days after the injection my hand started feeling tingly.  It has done it off and on for the past 4 days.  Today my injection site is red, a little itchy, and I can feel a knot.  Feels like I have laid on my arm and it has gone to sleep at times.  My arm upper arm/arm pit feel like they may be swollen some.
I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. I went to medical facility for a COVID19 test on the morning of 12/31/2020. I ended up testing Positive for COVID19.