chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflamation of both legs, and hips, chronic pain in full body and limbs, vomits, aggressive and irritation, lost of taste, vinegar taste constantly, breathing difficulty. Visit to hospital 15 days ago due to chronic pain and legs inflammation. Provided injection for relieving pain.
L arm mid-way between shoulder and elbow slightly posterior patient had area of erythema 70mm x 65mm. Within the erythema patient had a 15mm x 20mm bruise. Patient decided to seek care at primary medical provider office.
Myalgia ARM PAIN, BODY ACHES AND FATIGUE  Narrative:  Other Relevant History:
a triangular rash very itchy on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (a triangular rash very itchy on her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (survivor of 22 years.).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced RASH PRURITIC (a triangular rash very itchy on her left arm). At the time of the report, RASH PRURITIC (a triangular rash very itchy on her left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other relevant concomitant medication were reported. No treatment information were reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR : AE details and event outcome details were updated as recovered/Resolved
Left deltoid area became hot, swollen, hard. White from top of shoulder to elbow afternoon of pneumococcal vaccine.
Severe Headache which could not be relieved with pain medication.  Lasted until waking the following day.
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (numbness in arms and hands from elbow down in both hands), pain (like carpel tunnel pain) and product dose omission issue (missed dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 021B21A) for COVID-19 immunization. No medical history provided. Concomitant products included atenolol, losartan, potassium and amlodipine for an unknown indication. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (numbness in arms and hands from elbow down in both hands), pain (like carpel tunnel pain) and product dose omission issue (missed dose). At the time of the report, hypoesthesia (numbness in arms and hands from elbow down in both hands) and pain (like carpel tunnel pain): resolving; and product dose omission issue (missed dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The patient noted he also had back surgery. Reporter did not allow further contact.
Vaccination initially caused only a sore arm day 2.   Very mild no fever, joint pain or muscle aches.  No HA. Day 7  late in the day I developed axillary pain.  By the next morning the site of injection was hard warm, red and raised.  Palpable tender mass which resolved over 4 days.  I am not sure if I should have second vaccination.  This was clearly a delayed reaction to the vaccination.  I have seen others complain of the same reaction.
At 10:12am, this nurse notified that attendee had complaints of dizziness and lightheadedness. On-site fireman notified. Fireman at side and vital signs at 10:14am: blood pressure 148/82, pulse 99, temperature 97.4F, respirations 22, O2 sats 100% on room air. At 10:14, attendee had complaints of "throat feeling weird" and "upper lip quivering" and "fingertips tingling". Attendee states she has a history of anxiety and has these same symptoms with anxiety attacks. Fireman encouraged patient to slow her breathing. Vital signs at 10:30am: blood pressure 135/80, pulse 81, respirations 20, O2 sats 99% on room air. Daughter present with patient. Attendee stating she was feeling better and more calm and that she did not feel the need to go to the hospital and that sensation of lightheaded and dizzy have passed. Attendee instructed to have her daughter drive home and to contact urgent care or her primary physician if she had any other concerns/issues upon leaving the vaccination site or upon returning home or later in the day. Attendee ambulated out of facility with daughter at about 10:42am. No acute distress noted.
On 6/1/2023,The vaccinator inadvertently took a vial of vaccine with a BUD (10 weeks refrigerated) of 5/29/2023. No ill effects known to date. The report is being submitted simply as a result of the vaccine being given 2 days after its BUD.
Itching starting at scalp progressed to lips, tongue, ears neck, chest , hands & legs. 2 Benadryl  taken. Slightly itchy next day
The patient received the vaccine on Friday 10/06/2023 and said on Saturday her left arm became sore and swollen. Then on Sunday, she said she couldn't move her arm and on Monday it was still very sore and she still hardly could move it. She said it hurts from her neck down to her fingers. She went to the doctors and they gave her Nsaids and muscle relaxers to treat the issue. She said the shot was given very low and even the doctor said they could tell it was give only like 1.5 inches above her elbow. She said her right arm was just red, but also given very low as well.
a 4 years old female patient was administered Quadracel vaccine which had temperature excursion due to exposed at 27F for more than 3 hours,No AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a four year old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which had a  temperature excursion due to exposed to 27f for more than 3 hours (lot number S025913 and expiry date: 20-Aug-2021) via an unknown route and administration site for prophylactic vaccination on 21-May-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
I had a immediate pain, numbness and tingling on the left side of my body. My menstrual cycle came earlier than normal and I also had a swollen ankle.
Soreness in arm - started the same day at night (lasted three days). It was very painful first two nights. A rash on my left arm - it looked like an allergy - it was very itchy and it resolved in a week. I did not treat either symptom. I had a regular monthly test (since I'm pregnant) for THS level and it was higher than normal.  Pregnancy history - 2nd pregnancy; Estimated date of birth: July 23, 2021
BRUISES ON RIGHT LEG AFTER MODERNA VACCINE; HAND SWELLING; HAND PAIN WORSENED/COMES AND GOES; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE), PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE), PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES). The patient was treated with TRAMADOL at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE) had resolved and PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of bruises on right leg after moderna vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event of hand swelling and hand pain worsened/comes and goes with humira(adalimumab) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial case received from a consumer on 06 July 2011. A 19-year-old female patient, with no reported medical history, received an injection of ADACEL (lot not reported) on 25 February 2008. Three years post-vaccination, on 20 June 2011, the patient presented to her physician with a 3-week history of coughing. She returned to her physician on 22 June 2011 with ongoing symptoms, and was prescribed Z-PAK. Laboratory testing at that time serologically confirmed pertussis. She was subsequently admitted to the hospital due to dehydration secondary to post-tussive vomiting. Outcome was not reported.
Headaches-migraine headaches bones pains-nervous conditions receiving treatment at hospital 8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia.  8/15/07-records received DX: Back pain. Adjustment reaction with anxious mood. Derangement of lateral meniscus. Pain in knee. Lumbar Radiculopathy. Pure Hyperglyceridemia. EMG:abnormal study. Evidence of chronic right L5 radiculopathy with evidence of re-inervation. Bilateral leg pain begin in 9/9/05 after a motor vehicle accident during military service. 1/11/2010 I have seizure headaches. Itching on my skin. Right arm pain and numbness, also E.D. and depression. 02/02/2010 Headaches, a lot of pain in BOHES, nose and right arm hurts.
Patient received booster dose about noon and reported to her sister feeling like she had been drinking about 5:30pm.  Her sister noted she was slurring her words and staggering.  About 630 pm patient passed out in an armchair and slid onto floor. Sister could not wake her and called 911. In the ER patient reported taking 2 edible CBD gummies. ER determined the reaction was likely a combination of the booster and the CBD gummies and prescribed rest and fluids.  Patient received Pfizer as the initial COVID series with no problem.
opened IPOL had been administered since the excursion with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom opened IPV (VERO) [IPOL] had been administered since the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date temperature excursion occurs for unopened ACTHIB, MENACTRA, DAPTACEL, ADACEL and opened IPOL due to power outage and refrigerator issue (Human Error: no) with reported Temperature 48.9°F for 153 hours, 12 minutes. All products deemed unsuitable for use. None of the products were used to administer a dose except for the opened IPOL. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. Reporter noted that the opened IPOL had been administered since the excursion with no reported adverse event (poor quality product administered) (dose, strength, formulation: unknown) (lot number:V1A021M, exp date: 17-Feb-2022) via unknown route in unknown administration site for Immunization.  Action taken: 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 Directive 2001/83/EC 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.
16 year old male who got first Pfizer Covid vaccine 4/30, then by the next morning experienced non-bilious emesis for a few hours, as well as fever, chills, body aches, and HA.  The body aches and HA continued through today when he began experiencing chest pain while lying down.  Chest pain improved on sitting up, standing, sitting forward. No shortness of breath.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with first dose of GARDASIL (Lot number and route was not reported)approximately in 2010 (reported as unspecified date 2 years ago)and the second dose of GARDASIL on approximately 18-SEP-2012(Lot number and route was not reported)(reported as about 2 weeks ago). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
Patient was given 0.25ml on 9/14/22, and came back on 9/16/22 for a full dose of 0.5ml
The patient experienced dyspnea and chest tightness several minutes after receiving the shot.  She did not notify anyone, and after her 15 minute wait, she went home.  Her respiratory symptoms worsened despite taking a dose of diphenhydramine.  At the urging of her family, she went to the ER four hours later, where she was evaluated.  No treatment was done, and she was told that she was having a mild reaction.  Her symptoms resolved after several hours.
2 x hives on left leg first noticed at night on Saturday. Unsure when first appeared. Hives now on left (2) and right leg (1), also on arm (1). Rash on upper shoulder and back has now resolved without treatment. Rash in pubic area, has now resolved without treatment. Had swelling under right eye and cheek, now resolved without treatment.
Extreme fatigue, chills, nausea and headache. Patient was concerned that symptoms were lasting several weeks into the 2nd and 3rd week after shot. Was concerned that might be worse due to recent Bell's palsy episode on 5/5/2018. She said she still had slight facial numbness when she got the shot. Her doctor had recommended shot since she's at risk for shingles. After 3 weeks patient felt better and is fine now.
Died on 2/12/2021; diagnosed as a COVID-19 related death; 1st vaccine dose on 12/22/2020, 2nd vaccine dose on 1/14/2021.  Hospitalized for acute respiratory failure with hypoxia and pneumonia due to COVID-19 infection.
High fever, red, hot and swollen from top of shoulder to the elbow, with a hard mass in the middle. Went to ER diagnosed with cellulitis.
Onset of anaphylaxis (tightening of the chest). Mild symptoms.  Self-treatment with Epipen, followed by liquid Benadryl.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates (either 17-SEP-2015 or 18-SEP-2015), the patients were vaccinated with improperly stored PEDVAXHIB (lot # L012835, expiration date 11-MAR-2018; Lot# L002867, expiration date 11-NOV-2017; Lot# L014427, expiration date 09-MAR-2018) (dose and route of administration were not reported). No adverse effects or product quality complaint were reported. This is one of the three cases reported by the same source. Aditional information has been requested.
This spontaneous report was received from a pharmacist concerning a 66  year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009283: US-009507513-1707USA009293: US-009507513-1707USA009294.
Cough  Muscle or body aches  Headache  New loss of taste or smell
POST VACCINE AND AFTER WAITING THE REQUIRED TIME , PER PATIENT WHEN SHE STOOD UP SHE FELT DIZZY AND HER LEGS FELT LIKE JELLO. PT STATED SHE FELT LIKE THIS AFTER HER FIRST DOSE. PT CAME TO MED OBS  VITALS AS FOLLOWED: 5:06 BP 106/69 HR 70 RR 18 SPO2 100 5:11 BP 116/80 HR 86 RR 18 SPO2 100 5:26 BP 110/75 HR 87 RR 18 SPO2 100 5:29 BP 119/83 HR 82 RR 18 SP02 100
I had the shot around 12noon - waited the 1/2 hour with no issues.  So was released and came home.  About 1:30/2pm, suddenly felt short of breath (couldn't catch or take deep breath), increase of heart rate & dizzy, and when I tried to stand my legs gave way.  Felt like I would pass out.  I was short of breath, dizzy, dehydrated, strange feeling in brain and extremely weak for about 2 1/2-3 hours.  Then it passed without medication/Epi-Pen.  After that, I had typical side effects (chills, exhaustion, muscle pain - particularly at old injury points, dull headache).
Constipation; Diarrhea; Body aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), CONSTIPATION (Constipation) and MYALGIA (Body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included ANASTROZOLE (ARIMIDEX) for Breast cancer.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches). On 25-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced CONSTIPATION (Constipation). On 26-Feb-2021, MYALGIA (Body aches) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and CONSTIPATION (Constipation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: negative Negative. On an unknown date, Stool analysis: negative Negative.     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.
Given 10 mcg of the Moderna Bivalent instead of the recommended 25 mcg
Missed period and did not ovulate for several months after 2nd vaccine dose.  Flair up of endometriosis that had not happened for years.  It's now the most severe it's ever been, including very heavy and painful periods and abdomen pain, swelling.
Contracted Shingles; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 12:00, the patient experienced contracted shingles. The event did result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Reaction of swelling, itching, and hives on face; Reaction of swelling, itching, and hives on face; Reaction of swelling, itching, and hives on face; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection and COVID-19 on an unknown date. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, the patient experienced a reaction of swelling, itching and hives on face after getting dermal fillers. The doctor thought it could be due to vaccination as she had fillers many times with no reaction. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with methoprednisone and antihistamine. The clinical outcome of the events swelling, itching and hives on face were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had rash and pain on my right arm and the whole upper body was in pain and mild headaches. I went to the doctor and they took chest x-ray and gave me a medication. It went away after 10 days. I also had diarrhea.
pt recvd vax; mom c/o knot large Lt thigh;warm compresses applied; called hlth dept; states leg dark in inject area; called hlth dept again approx 1 mo later; dark 1 1/2 inch horizontal area across Lt thigh;pea size knots palpated at site;