chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A) for COVID-19 vaccination.     The patient's past medical history included Injury (Foot ball injury).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided. Consumer reports that back pain is due to prior football injury.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient diagnosed with Autoimmune Hemolytic Anemia in September 2006 complicated by EBV infection. Received vaccine prior to Splenectomy on 1-29-07. On 3-17-07 started having progressive weakness consistent with Guillan Barre Syndrome. 7/25/07-records received for DOS 3/27-4/18/07- DC DX: Guillain-Barre syndrome. Respiratory failure secondary to Guillain-Barre syndrome. Urinary tract infection. Autoimmune hemolytic anemia. Diabetes mellitus. Seen in ER with C/O low blood pressure 82/40. C/O profound weakness and dizziness for past few day. No fever, no chills no nausea, no vomiting, no diarrhea, no chest pain, no shortness of breath.  Treated with IVIG. Transferred to rehabilitation facility. 1/4/10 The patient was subsequently diagnosed with Angiaimmunodible T cell lymphormin with continued deterioration.
About a week after my second Moderna vaccine my heart began pounding out of my chest multiple times a day It was quite painful. Nothing like this had ever happened before. I am very fit and healthy with no history of heart problems. I have since been diagnosed with two aneurysms and a heart valve that doesn't close properly.  The cardiologist is monitoring for a possible open heart surgery. I was a fitness model and I can no longer work out.
lost weight; He said his skin lesions that look like rheumatoid arthritis are improving, cognitive abilities are functioning and improving, increased by 50 points. 'I was doing things which normally I have never been able to do; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost weight) and THERAPEUTIC RESPONSE UNEXPECTED (He said his skin lesions that look like rheumatoid arthritis are improving, cognitive abilities are functioning and improving, increased by 50 points. 'I was doing things which normally I have never been able to do) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) and THERAPEUTIC RESPONSE UNEXPECTED (He said his skin lesions that look like rheumatoid arthritis are improving, cognitive abilities are functioning and improving, increased by 50 points. 'I was doing things which normally I have never been able to do). At the time of the report, WEIGHT DECREASED (lost weight) and THERAPEUTIC RESPONSE UNEXPECTED (He said his skin lesions that look like rheumatoid arthritis are improving, cognitive abilities are functioning and improving, increased by 50 points. 'I was doing things which normally I have never been able to do) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-060368, MOD-2021-060546 (Patient Link).
Arm swollen around injection site.  Whole arm hot, hard, red, swollen and painful.  Patient with fever, also pitting edema in the arm.
This spontaneous report as received from a health care worker refers to a 60 year old female patient with no drug allergies. The patient's current conditions included benign hypertension, insomnia and sinusitis. On 28-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot# J012658, expiry date: 10-JAN-2015), subcutaneously to prevent shingles. Concomitant medications were none. On 10-JUN-2014, the patient developed a shingles outbreak on the lower back and the right hip. The patient sought medical attention by contacting the physician. The patient was treated with hydrocodone (manufacturer unknown) and VALTREX on 10-JUN-2015. The outcome of shingles on her lower back and the right hip was reported as not recovered. The causality was not reported. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female with no known pertinent medical history or drug reactions/allergies who on 24-AUG-2010 was vaccinated with the first dose of GARDASIL (lot#666163/0664Z). Concomitant therapy included SEASONALE. The physician mentioned that the patient developed soreness, redness, and itching soon after. These symptoms would resolve but return after showers or exercise "up the arm" beyond the injection site. The symptoms returned after receiving the second dose of GARDASIL (lot# 666948/0886Z) on 25-OCT-2010. The patient sought unspecified medical attention. At the time of reporting, the patient was not recovered. Additional information has been requested.
Administered incorrect vaccine to patient. Administered a MMRV instead of  a MMR.
A few drops dripped out and flowed down my arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm) 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 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm). On 04-Apr-2021, PRODUCT ADMINISTRATION ERROR (A few drops dripped out and flowed down my arm) had resolved. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Right arm and hand swollen (puffy) below injection site. Symptoms occurred 2 days after receiving injection. Patient did not need any treatment/hospitalization. Swelling going down. Symptoms improved by 9/12/10.
The side effects started early morning the day after the vaccine with body aches chills and tiredness and also a light headache.  Very similar symptoms to COVID 19.
Patient developed shingles, pain started 10 days after vaccine. Rash started 11-12 days after vaccine.
Swelling, redness and large blisters (L) upper arm at site of PCV 13 injection.
I started to have symptoms on Friday afternoon. My symptoms included body aches, scratchy throat, swollen glands, and a headache. Friday evening, they symptoms continued. I took a home COVID-19 test, and it was negative. I developed a terrible cough. The symptoms continued to get worse. My throat especially. I couldn't swallow. I had terrible congestion a runny nose. I had to continuously blow it and was coughing. On Sunday morning, I took another COVID-19 test and tested positive. That afternoon we went to an immediate care clinic. We were given another COVID-19 test that was positive. The doctor prescribed antivirals. Today, I finished my last dose of Paxlovid and tested negative for COVID-19 yesterday. I've progressively been feeling a little bit better each day.
24 days after receiving vaccines, 25 yo female c/o headaches with eye pain. Pt referred to Ophthalmology c/o left eye pain with light sensitivity, temporal pressure radiating to back of head.
Inconsolability and fever.  Fever started 5/2/14 and lasted 3 days.  Inconsolability and fussiness started on 5/5 and have been present for 4 days.
This spontaneous report as received from a doctor of pharmacy concerning a 68 year old male patient with no allergies and a history of pain who on 18-JUL-2012, was vaccinated SQ in the back of left arm with 0.65 ml dose of ZOSTAVAX (lot# 0366AE, exp 23-MAR-2013). Concomitant medication included VOLTAREN GEL. The pharmacist stated that the patient called him on 20-JUL-2012 to state he experienced generalized flushing throughout his body. Post vaccination with ZOSTAVAX, approximately on 18-JUL-2012, the patient noticed some slight flushing after taking his hydrocodone, but when the patient took another dose of hydrocodone last night "approximately on 19-JUL-2012" the flushing was spread throughout his body. The patient did not have any treatment given. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Three doses of the MMR-II that were not supported in that temp stability case were inadvertently administered; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. Information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHa) (M-M-R II) lot # S025155, expiration date 13-AUG-2021, once (dosage regimen and route of administration were not provided) for prophylaxis.   The improperly store vaccine experienced a temperature above 47-degrees Fahrenheit (71.92 F) for 4 hours and 55 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA010584:
Rheumatoid arthritis; This is a literature report for the following literature source(s): "Progression from palindromic rheumatism to rheumatoid arthritis after COVID-19 vaccination", Rheumatology, 2022; Vol:1, pgs:100-101.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for palindromic rheumatism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: >250 IU/ml; >250 IU/ml; C-reactive protein: normal; 17.2 mg/dl, notes: elevated; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; Red blood cell sedimentation rate: normal; Rheumatoid factor: 28 IU/ml; Ultrasound scan: effusion and synovitis in the radiocarpal joints; X-ray: normal; normal. Therapeutic measures were taken as a result of rheumatoid arthritis.; Sender's Comments: Based on available information in the case the reported event Rheumatoid arthritis assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Fever & then sz; 18mo old hydrocepalic w/no prior hx of neurological problems;
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, unknown after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were unknown. It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at vaccination was not reported. The reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, the reporter had starting giving BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GlaxoSmithKline Medical Science Liaison said that, email from the GlaxoSmithKline Sales representative stated that, the reporter said a 12th grader whose age and gender is now unknown to the GlaxoSmithKline Medical Science Liaison had a sore arm at the injection site as well as fatigue and fever following vaccine administration which occurred on a Monday. The GlaxoSmithKline Medical Science Liaison said that she spoke with the reporter but did not discuss about this patient and had no further related details to provide.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in approximately February 2017 (reported as "since the beginning of February") the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M031650, expiration date: 16-MAR-2018 (doses were not reported). The ROTATEQ doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006301: US-009507513-1703USA006308: US-009507513-1703USA006310:
Pain at injection site on left hand for 2 days till 6 may. Left hand turned cold for 2 days.  Very less thirst for initial 3 days and so corresponding reduced urine output even after drinking water unwillingly many times a day. Constipation. This normalized after 3 days  On 6may, light headedness almost whole day and fatigue. In morning feels difficult to get up, continuing today also. Sleep disturbance and sleep pattern changed  Vision disturbances. Difficulty focusing.  See very less dreams normally (1 in 2-3 months). But now dream frequency increased and dreams are more lucid, more realistic looking.
may be blood clot; Something happened with my knee and it has just got worse; I was thinking maybe it is a pulled muscle or something but it is very bad now; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old female patient (5 feet 1 inches, about 120 pounds) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198, patient was not sure) via an unspecified route of administration at left arm on 22Feb2021 (83-year-old at time of vaccination), at single dose; the second dose of BNT162B2 (lot number: unknown) via an unspecified route of administration on 15Mar2021 (83-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she has got both the shots of Pfizer (Covid-19 vaccine) and at the end of the first one or it is like eighteen days, just before the second shot, something happened with her knee and it has just got worse (from 12Mar2021). She did not connect that with the Pfizer shot and I was thinking maybe it is a pulled muscle or something but it is very bad now. She would like to know what she can do. Also, she is thinking may be blood clot at this point and she would like to have it checked. She thinks that she should be able to contact somebody to actually get some physical test on this. She tried heat and cold alternate and Absorbine Jr. and Aspirin. It varied with the days, she thinks she has taken Aspirin about twice a day and it is a tablet and it was 325 mg and she took two of those, orally. Therapeutic measures were taken as a result of the event and included "heat and cold alternate and Absorbine Jr. and Aspirin". The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
menstrual cycle has worsened since vaccination; menstrual cramps have been sever ever since - the pain of the cramps keeps me up at night and requires ibuprofen. have never had problems with menstrual cycle/cramps/pain until received vaccination.
Patient felt a sensation that vaccine was running down arm. She has felt pain radiating from her fingers to her neck.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered PEDVAXHIB (dose, units, route of administration, lot number were not reported) that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Minimum side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient was a platelets donor at local hospital. The patient developed minimum side effects from the shot. The patient waited 60 days after second dose to make platelets donation. The patient received a call stating that could not be a donor for platelets any more because antibodies had changed. The patient had not been ill.
FACIAL ERYTHEMA AND DYSPNEA , SHE TOOK BENADRYL AND WAS OBSERVED FOR A LONGER PERIOD OF TIME. SYPTOMS RESOLVED WITHOUT FUTHER TREATMENT
Blisters at site of injection that spread if they are opened. 100.6 degree fever.
Immediately following injection I had a metallic taste in my mouth. My heart felt like it was racing and shortness of breath. The lady who have shot said my face turned really red. Blood pressure spiked - they took it. Normally it's 107/70's-80's and it was 148/98 and my pulse was around 100 or a little more. Called Drs - to check heart. Okay. BP started going down and I sat for a little bit and I went home but I didn't drive. Went to work next day but I felt really tired. BP was in high range but not quite as high as yesterday. I was so tired and I went home for the day to rest because I couldn't work. Blood pressure started going back in normal range about 48 hours later. Metallic taste lasted about 3 days.
Altered mental status, tested positive for covid. Also in ketoacidosis from uncontrolled diabetes and hypertension
01/06/2021 Patient complains of sore throat onset 2030 01/07/2021 Patient continues to have sore throat, temperature 100.1 at 1300 with headache and body aches. Pt also found out she had direct exposure to COVID on 01/04/2021
Pt reported receiving first dose as Pfizer and gave a different name and came to us for a second dose. We found a match in database for the same person under a different name later showing the first dose was of Moderna on 4.21 at another facility I put a ticket into the help desk to combine the two accounts. I cannot find the record showing the Moderna dose. I was advised to put a VEARS report in for the administration error.
SARS COV-19 Infection. Cough, Congestion, Runny Nose, Nausea, Fever, Loss of Taste and Smell, Headache, Shortness of Breath, Sore Throat, Chills
This spontaneous report was received from a physician refers to a 11 year old female patient. The patient's pertinent medical history, drug allergies or reactions and concomitant medications were reported as none. On 23-MAR-2015, the patient was vaccinated with GARDASIL (lot # not reported) dose 1. On 13-OCT-2015, the patient was vaccinated with GARDASIL (lot # K072764, expiry date 02-MAR-2017) dose 2. On 23-MAR-2015, after 5 mins the patient experienced dizziness, a drop in blood pressure, feeling that she was going to pass out and weakness. Physician reported that symptoms resolved after approximately 30 minutes. On 13-OCT-2015, within 5 minutes, the patient experienced dizziness, feeling that she was going to pass out, weakness and her blood pressure dropped to 89/56. The Physician stated that the only treatment he provided for the patient was that he had the patient to lie down. Lab diagnostics performed was reported as none. Physician reported that the patient was recovering, but not yet fully recovered after 30 minutes. Physician reported that the adverse experience was "worse after the second administration, than with the first administration". Additional information has been requested.
After the vaccine, I woke up at 2AM feeling bad. I took 2 Tylenol and within 2 minutes my mouth started to itch and swell up. My wife called the ambulance because my eyes, tongue, and face was swollen. The EMT gave me Benadryl and was worried about my breathing so transported to ER. At ER, I received more Benadryl. I received observations at ER. It was declared that I had anaphylactic shock. I was in the ER for approximated 7 hours until the swelling went down and until I was breathing normally. I now have to carry an EpiPen and allergic to Tylenol and was never allergic to Tylenol before.
Covid Arm.    Swelling. Rash,  hardness about 5? in diameter.  Some itching.   It?s been tree days since the vaccine and  arm is still swollen and sore.  Reaction after the first vaccine lasted about 5 days.
Patient received Adult dose of Pfizer and unknown side effects as patient got less than one hour prior to submission.
Three hours after the vaccination I developed rigors lasting about 45 minutes followed by fevers >101 lasting about 24 hours; also generalized myalgias
Woke up in the middle of the night feeling extremely nauseous.  Tried to go back to sleep, but after an hour had to jump out of bed to throw up.  I haven't thrown up in years and I've never thrown up in the middle of the night.  Felt better right away, but if I hadn't waken up before vomiting, it might have bad.
Client reports "internal" itching throughout body and joint pain since receiving Hepatitis TWINRIX on 5/22/08. Returned to clinic 8/13/08 with these complaints.