chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 86-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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.   No concomitant medications were reported. No treatment related information has been reported.
1/19/2023   I started getting a fever and chills. I tested positive for COVID with an at home COVID test. I had such a bad headache, it felt like my skin was peeling off. My fever got up to 102.  I had a Telehealth that day and was prescribed Paxlovid. On 1/20/23 I started the Paxlovid for 5 days.  Things got better and I tested negative on 1/27/23. On 2/2/23 , I tested positive and had COVID again for 9 days.
A few days after my first vaccine I started having chest pain. I had an ekg, and xrays done because I went to the dr twice in August for the pain. I have had chostochondritis before and that is what my dr said it was this time. I had not had a flare up in years. This one is still on going even 3 months later. I have been treated with steriods and NSAIDS and they help only while im taking them. My sternum feels like it is going to break. I did recieve my 2nd shot 3 weeks later and it did not make it any worse. That first shot just really had affected my quality of life as I have to take medicine everyday to not hurt. The Nsaids in turn make me have reflux.
mild rash on chest and both upper arms.  rash was itchy and consisted of raised red spots about 1 cm in diameter. rash persisted for one week and then disappeared
Sinus infection-type symptoms but with no preceding illness: very stuffed up nose, pressure and pain in maxillary and ethmoid sinuses, fatigue, generally feeling ill.  I do have a history of sinus infections but they are not chronic.
Extreme fatigue; Aches; Chills; Low grade fever; Dizziness; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, heart disease, arthritis and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included teriflunomide (AUBAGIO), hydrochlorothiazide,losartan potassium (LOSARTAN HCTZ), escitalopram (MANUFACTURER UNKNOWN) and baclofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 13:00, the patient experienced extreme fatigue, aches, chills, low grade fever, dizziness and injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, aches, chills, low grade fever, dizziness and injection site soreness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt broke out in a vesicular rash which was very painful over the right anterior thigh to the knee with a strip up the outer surface of the buttock. It was treated with Zuvirax and cleared.
swollen lymph nodes; elevated or rapid heart beat; muscle pain; fever; swelling at the injection site; This is a spontaneous report from a non-contactable consumer(patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration, on unknown date, at the age of 65-year-old, at dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no concomitant medications. On 30Sep2021, the patient experienced swollen lymph nodes, elevated or rapid heart beat, muscle pain, fever and swelling at the injection site. The outcome of the events was unknown. The patient also received BNT162b2 (COMIRNATY; Lot Number and expiry date were  not reported) via an unspecified route of administration on 07Oct2021, dose 2, single COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numbness on left leg; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 14Jan2021 10:30 at single dose in Left arm for COVID-19 immunization. Medical history included hypertension, covid prior to vaccination. Concomitant drug included unspecified products which the patient received in two weeks.  There were no other vaccines received in four weeks. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergies.  The patient did not have COVID tested post vaccination. Approximately 10 hours after the patient got the vaccine on 14Jan2021 21:00, she felt numbness on her left leg. It got worse this afternoon so she left work to go to urgent care. She had diminished sensation on the lateral aspect of her left leg from knee below and her whole left foot on 14Jan2021 21:00. The reported adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of events 'diminished sensation on the lateral aspect of left leg from knee below and whole left foot', 'felt numbness on left leg'. The patient underwent lab tests which included blood works with unknown result on an unspecified date. The outcome of the event was recovering.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a pharmacist concerning a 33-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 15-Dec-2010. On 17-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
pt recvd vax & inc tiredness & nausea; No further details were provided;
I started having heart palpitations and shortness of breath in June and it continued occasionally until November. In November, I started having palpitations to the point where I almost passed out. I was having episodes more often and almost daily at this point. I was experiencing shortness of breath, tightness in my chest, lightheaded, rapid heartbeat, irregular heartbeat, heart palpitations that made me feel like I was going to pass out. This was going on fromNov- Jan.
Initial onset - Chills, Fever 102 degrees, Muscle Aches Treated with Tylenol, symptoms diminished over the next 24 hours.
Patient called today November 19, 2017 stating she had soreness in her left arm and a small knot appeared on the same arm 2 days ago on Friday 11/18/2017. Pharmacist advised patient it was normal to have soreness after tetanus / Tdap immunization, but knotting would be unusual and any that is of concern should be referred to a doctor or her regular physician.
(please note: I am an infectious diseases specialist) Erythema multiforme on both feet and legs occurred about 5 days after vaccination.  We gave him one dose of ibuprofen after receiving the menectra, but he has had that many times before with no reaction. No symptoms other than itching.  No oral sores or herpetic lesions anywhere.
Initial report was received on 04 May 2011 from a consumer who is also the patient. A 50 year-old male patient who had no illness at the time of vaccination had received an intramuscular left arm injection of FLUZONE SV2007-2008, lot number U2507AA and approximately two months later developed shortness of breath and could  not lie flat. His left arm became useless and "floppy" and in January to February 2008 both arms became affected and he was unable to use them. The patient was diagnosed with Motor neuron disease (date not reported) and stated he is unable to hold his head up. According to the patient, his lower extremities have not been affected. Treatment since May 2008 included a "special type of ventilator, which uses nasal prongs or face mask". Other medications, pre-existing conditions and adverse events following prior vaccinations and other vaccines with in four weeks of suspect vaccine were reported as none. No further information was available at the time of the report. The patient's outcome was reported as not recovered and resulted in permanent disability. Documents held by sender: none.
Headache severe which continued for ~29 hours.  Acute hacking cough continued for about 2 hours.  Heart odd pulses and weird beating patterns. Lasted ~3 hours.  Sore left arm, hurts, odd bump where shot was given. Continued for ~32 hours.   Took 3 baby aspirin a day, vitamin d3, drank hot tea.
MULTI PASSING OUT; FEELING SOME SIDE EFFECTS MORE STRONGLY THAN AVERAGE; This spontaneous report received via social media from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is mutant.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, Patient reported that as he is a mutant, he was feeling some side effects more strongly than average (coded as adverse drug reaction) and experienced multi passing out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling some side effects more strongly than average and multi passing out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210422293- Covid-19 vaccine ad26.cov2.s- multi passing out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Mother and patient came in 9/3/15 approx around 3:15 pm with a large area swollen, red, and warm to touch. Mom said patient noticed it today 9/3/15, it was itchy. Dr. examined area and said it was a local reaction to vaccine. Outlined area. Advised to tx w/ BENADRYL, cold compress. If not better next day to come back in.
Rednesss (approx. 3 inches X 3 inches), induration (approx. 4 inches X 6 inches), warmth, and severe itching.
On day 9 after the injection, April 18, sudden swelling at the site, right arm; on day 9 after the injection, April 18, sudden swelling at the site, right arm; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; rash on entire body with excessive itching sensation and redness; Obvious allergic reaction.; This is a spontaneous report from a contactable healthcare professional, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, hypothyroidism, vitiligo, asthma, hypertension and known allergies to sulfa, latex, adhesives and walnuts. 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 COVID-19 vaccine. Concomitant medications included regular treatment (unspecified), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin; clavulanate potassium (MANUFACTURER UNKNOWN) and experienced drug allergy. On 18Apr2021 at 20:00, day 9 after the injection, the patient experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness and obvious allergic reaction. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with diphendydramine hydrochloride (BENADRYL) until the events got resolved. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced sudden swelling at the site, right arm and rash on entire body with excessive itching sensation and redness was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning an 8 year old male with no known allergies or pertinent medical history who on 24-AUG-2000 was vaccinated IM with a 0.5 ml first dose of Varivax (lot # 634514/0539K). There was no concomitant medication or illness at the time of vaccination. On 30-MAY-2006 the patient developed a breakthrough rash of 15 lesions which started to appear on his abdomen and thighs. The rash began with three, then progressed to 15 "rashes". No fever was reported. Unspecified medical attention was sought. There wee no labs or diagnostic tests performed. On 06-JUN-2006, after one week, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Received report from child's mom on 5/12/08 at 9:35 am by phone that child was taken to the emergency room on 5/8/08 - 2 days after shots were given due to redness, swelling of the left arm.  She stated that left arm felt hot and child's fever was 101F.  Child was given IV ABT and was checked by the doctor on 5/9/08 and 5/10/08 for follow-up.  She stated he has recovered well today.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 (Lot number: ER8735) at the age of 51 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Poultry" (unspecified if ongoing). The patient took concomitant medications which included birth control. Vaccination history included: Bnt162b2 (Dose 1, single, Lot No: FO7218, administered in Arm Left), administration date: 23Apr2021, when the patient was 51 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot No: EW0182, administered in Arm Left), administration date: 14May2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (medically significant) with onset 01Feb2022, outcome "not recovered", described as "broke out in hives"; INSOMNIA (medically significant) with onset 01Feb2022, outcome "not recovered", described as "sleeping 3-4 hours a day". The events "broke out in hives" and "sleeping 3-4 hours a day" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, insomnia which included Benadryl and prednisone. Course of events: A few weeks after her booster, the patient broke out in hives. The hives have not stopped and have gotten severe now every day. They are on her forehead, face, eye lids, ears, entire neck and all the way both arms/hands/palms, her back/bottom, her chest all the way to her lady parts, entire legs/ feet and bottom of her feet. She was rushed to the ER on Wednesday this week and had to get it to give Benadryl and prednisone. This is her 3rd round of prednisone during the 7 weeks. The medicine is not enough to get her through 24 hours, so she was sleeping 3-4 hours a day. She took 2 Benadryl pills at night but that gives her about 3 hours to sleep before that wears off and she woke up half covered again. 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 has not been tested for COVID-19.
Information has been received from a 70 year old female consumer with rheumatoid arthritis, allergy to heavy metals including gold and mercury, penicillin, aspirin (ringing in ears), formaldehyde, iodine (injection and topical), raloxifene HCL, indomethacin, lisinopril, ezetimibe and alendronate sodium allergy, and latex/band aid allergy and a history of bone cancer (1989), left lower leg amputation and platinum containing chemotherapy who in October 2001, was vaccinated with Pneumovax. Concomitant therapy included vitamins (unspecified) and herbs (unspecified) including POLICOSANOL. In October 2001, the day after vaccination with Pneumovax, the patient developed Stevens Johnson syndrome. Symptoms included "blisters, internal heat, and horrendous pain". The blisters were the size of quarters on the patients torso. The patient was bed-ridden. Her skin was sloughing off and she became allergic to water. The patient wore cloth gloves under rubber gloves to avoid contact with water. When water touched the patients wrists, blisters would form. When the patient wore sleeveless shirts, the skin under her armpits and around her shoulders would rub off. The patient became "delirious" and experienced hallucinations. The patient was not certain whether she had hallucinated due to medications which were ordered to resolve her symptoms. The medications included prednisone, ATARAX and DECADRON. The patient also mentioned that she took "nerve blocks" for sciatica. After 3-6 months, the patient's symptoms resolved. Upon internal review Stevens Johnson syndrome was considered to be an other important medical event. The patient also mentioned that she experienced drug reaction with lisinopril (manufacturer unknown) NWAES0702USA03984, ezetimibe NWAES0702USA03994, indomethacin NWAES0702USA04037 and alendronate sodium NWAES0702USA03985.
Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose; This spontaneous case was reported by a patient and describes the occurrence of GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient had never got COVID+ test or diagnosis in the past.  Previously administered products included for COVID-19 vaccination: Pfizer (1st primary series dose) on 13-Apr-2021 and Pfizer (2nd primary series dose) on 04-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Codeine (rash)), Asthma (Started 30 years ago and still has rare occurrences. No recent change in status such as improvement or worsening reported), Blood pressure high (Started from more than 10 years ago. No recent change in status such as improvement or worsening reported), Atrial fibrillation (Started more than 10 years ago. No recent change in status such as improvement or worsening reported) and Hashimoto's thyroiditis (Started more than 10 years ago. No recent change in status such as improvement or worsening reported).  On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose). At the time of the report, GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose) outcome was unknown.     Concomitant medications included unknown medication for high blood pressure and thyroid.  Dosage text was reported as first booster dose.  It was reported that the only other time patient had a gout flair was around a week or so before receiving the second Moderna booster dose.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-596614 (Patient Link).
Swollen joints; mattery eyes; achy all over -flu like symptoms; tons of phlegm-bloody sputnum; headache; cough; loss of energy-tired; hard breathing. Went to doctor at local clinic got super drugs for cold prednisone and antibiotic-my lungs sounded good -so no xray-after I got home I got to thinking about the vaccine and maybe it caused my problems as it was not a lung issue- so I did not start the antibiotics or prednisone yet.
Seizure; Weakness; Difficulty Breathing; tiredness; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LETHARGY (Lethargy). On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), ASTHENIA (Weakness), DYSPNOEA (Difficulty Breathing) and FATIGUE (tiredness). At the time of the report, SEIZURE (Seizure), LETHARGY (Lethargy), ASTHENIA (Weakness), DYSPNOEA (Difficulty Breathing) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Refusal to swallow. Increased fussiness, increased stooling. Lasted < 24 hrs given I.V. fluids supplement.