chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So much pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (So much pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (So much pain). At the time of the report, MYALGIA (So much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Few hours after TdAP in left deltoid, pt. developed swelling at site, fever, chills and lymph node enlargement, supraclavicular area.  Now is resolved.
He developed Guillain-Barre syndrome in late May, 2018, after receiving hepatitis A vaccination about five weeks before. I am not certain of the exact formulation of the hep A vaccine which was given, if this was "HAVRIX" or the other one.
Unusual fatigue; went to bed early. Woke up next morning, my entire R armpit was painfully sore. I took 2 Arthritis Strength Tylenol around 6:00 AM, some relief, but by 10:30 AM, it was painful again. Entire site of injection painful and in glands under armpit, it is 2:30 PM.
itching in scalp and face specifically in her forehead; rash in scalp and face specifically in her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.
diarrhea; felt as beating all over body; "felt as beating all over body,'horrible muscle pain; neck ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), DIARRHOEA (diarrhea), SENSATION OF FOREIGN BODY (felt as beating all over body), HEADACHE (headache) and MYALGIA ("felt as beating all over body,'horrible muscle pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), LAMOTRIGINE (LAMICTAL), TOPIRAMATE and IBUPROFEN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced NECK PAIN (neck ache). 17-Apr-2021, the patient experienced HEADACHE (headache). On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhea), SENSATION OF FOREIGN BODY (felt as beating all over body) and MYALGIA ("felt as beating all over body,'horrible muscle pain). On 20-Apr-2021, NECK PAIN (neck ache), DIARRHOEA (diarrhea), SENSATION OF FOREIGN BODY (felt as beating all over body), HEADACHE (headache) and MYALGIA ("felt as beating all over body,'horrible muscle pain) had resolved.            Patient has history of gastrointestinal hypersensitivity.
I had symptoms beginning with a lower rib pressure and pain. I thought I had a rib out of place because I've had that before. I was going to go see a chiropractor but it kept getting worse so I knew it was something worse. It was mild symptoms for 24 hours and then suddenly got worse with inhalation. I was taking very shallow breaths because it hurt. That came on suddenly that evening on 03/29/2022 at 06:00PM. The pain I was experiencing was on the left side. I had a follow up with the pulmonologist within a week after visiting the ER.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills, fatigue Narrative:  within 48 hours of vaccine employee reported vomiting and diarrhea, self resolved; then 7 days after vaccine developed fever to 103.8, headache, chills, fatigue, body aches. Testing for COVID was recommended, employee tested negative for COVID on 01/11/21.
slight body aches and chills afternoon of 4/14 significant arm discomfort evening of 4/14 Slight chills and extreme fatigue during day 4/15 4/16 extreme L arm pain (10 out of 10) and bright redness 2/3 down my arm with L arm swelling and enlarged lymph glands under Left axilla 4/17 continued bright redness down L arm, swelling and new symptom of extreme itching. Used some cortisone 1% cream with little relief 4/18 continued redness, color starting to subside, but still with extreme itching and discomfort is a 6 out of 10
This case meets criteria for vaccine breakthrough review. SxS include N/V, malaise, body weakness, nasal congestion, cough, diarrhea, known exposure to COVID+ son.
First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; nausea; This is a spontaneous report received from a contactable other-HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number :UNKNOWN) via an unspecified route of administration in left arm on 17Feb2021 at 05:00 PM (at the age of 41-years-old) as single dose for covid-19 immunization. Facility type vaccine was Hospital. Patient medication history included severe preeclampsia, Patient allergic with penicillin and concomitant medications as ibuprofen (IBUPROFEN), Zolpidem tartarate (AMBIEN) and paracetamol (TYLENOL) were reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. On 18Feb2021 at 03:30 am, the patient experienced fever of 103.2 F, Chills, sweating, fatigue, headache, muscle pain, arm pain, nausea, insomnia. Treatment was given for events. The outcome of the events was recovered. Information about lot/ batch number has been requested.
Where the shot was given: Pain, redness, swelling and fever 100.8. He also has body aches, painful to raise his arm.  Treatment so far: New appointment at facility and ice on arm.
14 year old received 1st dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna) in a 14-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Within days of both shots: - increased fatigue, dizziness, nausea, headaches lasting days; fatigue and dizziness continuing on and off - knee and joint pains, especially on shot arm
Both series on 1/14/2022 and 2/04/2022 had same affect. Right arm at injection site formed a golf ball size knot approx. 6 hours after injection. Extreme pain, swelling, throbbing and eventually ?fever? in arm (at night only) occurred. This pain is from neck to wrist . Loss of sleep due to extreme pain and ?fever? in arm as well as nausea/diarrhea. This occurred for 4 days/nights with first dose and now on day 3 so far with second dose. No other symptoms so far from either dose.
I have excruciating pain in the arm that the flu shot was given. I have almost no range of motion and am unable to do everyday activities. For example getting dressed & undressed, driving, carrying groceries, picking up my nieces and nephews and the list goes on. I have tried taking otc pain relievers, heat/cold compresses, tiger balm patches, massages nothing is helping me out for more than 30 minutes to a hour. At night I wake up in tears because the pain is so unbearable. I am wondering what went wrong with this years flu shot to cause so many people to have this issue with shoulder pain and how long will we have to live with it??
A report has been received from a Pharmacist concerning a 51 year old, Female subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) was started on an unknown date. It was reported that on 12-Sep-2014, 51 year old patient received FLUMIST. The outcome of the event of A 51 YEAR OLD RECEIVED FLUMIST was unknown. The patient was considered to be non-serious.
Rapid heart beat/my heart seemed to be beating faster when I woke up; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection,Batch/Lot Number: EL9Z6F) dose1, via an unspecified route of administration on 04Mar2021 (age at vaccination was 75 years) as single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown. Concomitant medication included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. On06Mar2021, the patient experienced rapid heartbeat/my heart seemed to be beating faster when woke up then it went back to normal. She wants to know if this is something she should be concerned about. Caller states she weights 220 lbs. The patient underwent lab tests and procedures which included heart rate: rapid on 06Mar2021 this morning heart seemed to be beating faster, weight: 54.43 kg on an unspecified date. the outcome of the events was recovered on 06Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient given the COVID vaccine for the wrong age group.  Patient should have received a dos of the COVID Bivalent 5y-11y and should have received a maroon top dose for 6mo-4y.
Side effects were significant fatigue, headache, and some muscle pain (though muscle pain was not significant).  Some soreness at the injection site occurred but this seemed normal.  With the first Shingrix shot, I had no significant side effects.  However, with the second shot I had significant tiredness and headache which interfered with my normal activities.  The side effects lasted 3 days, until midday on 2/1/2020.
patient received a dose of Daptacel that expired on 01Mar2023 with no adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case from a physician.  This case involves a patient of unknown age and gender who received a dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that expired on 01-Mar-2023 with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Mar-2023, the patient received suspect diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection at a dose of 0.5 ml once (lot C5829BA, expiry date: 01-Mar-2023) via unknown route in unknown administration site for immunization.  On 16-Mar-2023 the patient received a dose of daptacel that expired on 01-Mar-2023 with no adverse event (expired product administered, latency: same day).  It was reported that that most vaccines only have a month and year listed for the expiry date, and that having the date listed also with a day contributed to the error because the person wasn't paying close enough attention. He did not have time to provide additional details, saying that he must see the next patient. He stated that he would have to have his nursing supervisor call back with more details. He then abruptly disconnected the call.  Action taken: Not applicable.  Outcome: Unknown.   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.
G47.33 OBSTRUCTIVE SLEEP APNEA 3/7/2022 HYPERGLYCEMIA
My arm became itchy and hive like lumps.  The arm is warm to the touch and the redness is spreading. This happened 5 days post injection.
I had been doing very well after my cyro-ablation in 2018 to correct/prevent A-fib.  A little over two weeks after getting the second vaccination shot, my atrial fibrillation returned and I had to seek medical attention and restart taking anti-arrhythmia medications again.
diarrhea twice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea twice) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea twice). At the time of the report, DIARRHOEA (diarrhea twice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the Moderna vaccine 3 months ago and on the first dose patient got diarrhea twice and it went away. When patient  got the 2nd dose one month later, patient  had diarrhea every day and  getting very fatigue.       This case was linked to MOD-2021-163580 (Patient Link).
Information has been received from a pharmacist concerning a 71-year-old female consumer with no known allergies who on 10-SEP-2007 was vaccinated SQ in the left upper arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658083/0885U). Subsequently, the patient developed a firm, itchy nodule at the injection site of the left upper arm. The nodule was "flesh-colored" and "about the size of a pencil eraser." Medical attention was sought, the patient spoke to the pharmacist. There were no lab studies performed. At the time of the report the patient had not recovered. The patient was planning to consult her physician next week. There was no product quality complaint involved. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received which reported that the patient did not see the doctor when her spouse came for vaccination and she thought the firm, itchy nodule was where injection was given, but the physician thought it was to center of arm "to" much. No further information is expected.
Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 11:00 single dose for preventive. Medical history included depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for depression. The patient previously took flu vaccine for immunization. The patient received the Covid 19 vaccine on Wednesday. Patient stated there was a possibility of feeling achy just a general possibility of not feeling well like feeling tired, like it was she had that flu, vaccine too. But, her symptoms had persisted and she also had an isolated sore throat that started after she got her vaccine. She understood that the vaccine did not cause Covid but she was not sure like if having a sore throat was what other people have reported or this was something where she should go and get tested. Physician stated that question hadn't been answered by the previous department. When probed if the indication was a preventive measure for Covid, Physician stated "Preventive." Event (sore throat) started on 23Dec2020. The patient was given the vaccine at 11 am and her symptoms started probably at around 21:00 (9 pm). Patient further stated she received vaccine on 23Dec2020 around 11am and developed side effects of sore throat, fatigue/general malaise that evening. She couldn't find any data specifically reporting on sore throat. She was wondering if she should get tested for covid. Investigation assessment was no. The outcome of the events was unknown.
Slight non-itchy rash noted after vaccine administration. Rash well demarcated, nontender approx 4x4 cm, no desquamation. No other sxs, no respiratory sxs.
Itchy rash/hives on arms, legs and hands Abdominal cramping and bloating
8/20/08-8/21/08: Developed fever, headache, muscle ache, aching eye (Flu-like symptoms). 8/22/08 - Muscle achiness, cold symptoms, no fever. Took Tylenol purchased local pharmacy (unknown dose). 8/23/08 - Had Bilateral pelvic to ankle numbness. 9/3/08 - Numbness to (R) lateral pelvic to ankle, loss of some strength to (R) arm and (R) leg.
eyes began itching in the middle of the night; woke up with red swollen eyes; woke up with red swollen eyes; swollen face; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. 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 21Apr2021, at 00:00 the patient experienced eyes began itching in the middle of the night. On 21Apr2021, the patient woke up with red swollen eyes and a swollen face. 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 eyes began itching in the middle of the night, red swollen eyes and swollen face were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Report 2002000935-1 describes dermatitis around the injection site in an approx 30-year-old female pt who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions and concurrent medications were not specified. On 09/18/2001, the pt received her 1st injection of Engerix-B (lot ENG5186C6). Subsequently, she had a "dermatitis reaction" around the area of the vaccination. The pt was seen by a dermatologist, who reportedly made a diagnosis of dermatitis related to the hepatitis B vaccination. As of 01/11/2001, the outcome of the event was unknown.
08/27/22 presents to EC ED for "fall". PMHx of "advanced chronic systolic congestive heart failure, dementia, chronic kidney disease (stage unknown ),  mechanical mitral valve, on anticoagulation with Coumadin"
This spontaneous report as received from two medical assistants concerning a patient of unknown gender and age. On an unknown date the patient was vaccinated with an adult dose of RECOMBIVAX HB (route, injection site and lot # not provided). It was reported that the RECOMBIVAX HB was improperly stored. No adverse effects reported. Additional information has been requested.
After receiving  Hep B vaccine, employee immediately stated her right ear "went numb" and that she feels "pressure and tingling". Employee waited 15 mins and was checked again and stated she had the same feeling. Employee called her PCP who then stated that employees symptoms are unlikely due to vaccine. PCP also states that employee has history of severe migraine and earache could be a migraine coming on. After 45 min break, employee states she is now feeling nauseated and getting a headache. Employees PCP contacted the employee again and told the employee she can come in to be seen in urgent care. employee was sent home for the day.
Redness to both thighs at site of injections about quarter size. Fever - 102 degrees.
Upon awakening morning after receiving 2nd dose of Moderna COVID-19 Vaccine EUA: pain & tenderness at injection site, fever of 101.5 F. , extreme fatigue, headache, muscle pain and stiffness all over body, chills, woozy, can't think. Next day: slight fever, all symptoms 50% better. Today: fever gone, all symptoms 90 % better.
Shingles and Bells Palsy- Diagnosed in office 3/23/2021 Pt prescribed Gabapentin
My husband and I were in France. I had a sore throat and was a little tired, one of the people in our group tested positive for COVID-19 so we tested using our home COVID-19 test that came back positive. I had brought my Flonase, Magic Mouthwash so I used those as I did not have access to a physician where I was at the time. By the time I returned in June 25, 2022 I had fully recovered.
On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:unknown) Intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced itchy on the neck/pruritus, rash on the neck./rash. on an unknown date the patient experienced fatigue.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of itchy on the neck/pruritus was resolved. The outcome of rash on the neck./rash, fatigue was unknown.