chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was tired for a couple of days after receiving the vaccine. I tested positive for COVID-19 on 07/18/2022. I was exposed to COVID-19 from my neighbor. I had a high fever; it was difficult to function, and I was very tired. If I had to bend over, I got very disorientated or if I got up to fast, I got disorientated. I called my doctor, and my doctor did not recommend that I take Paxlovid, and I was in too good of health. At the time I was sick, Paxlovid was in short supply too. Now I have long COVID-19 and that I have fatigue and brain fog.
just got over the flu too; Initial information was received on 04-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who had just got over the flu too after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient had just got over the flu too (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (just got over the flu too).  At time of reporting, the outcome was Unknown for the event just got over the flu too.
chills; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 41; unit: unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number and expiration date: not known), on 24Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got vaccinated on 24Dec2020 and after 1 week, which was exactly last Friday afternoon (01Jan2021), she started to experienced chills, headache and body ache. The patient wanted to know if this is normal and how long before it goes away. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a health professional refers to a four unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 28-NOV-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M028551 and expiry date 07-MAY-2018) for prophylaxis. No adverse reactions were reported. The vaccine was exposed to temperature excursion of 34.3 F for 5 hours. The vaccine was previously exposed to temperature excursion of 25.2 F for 3.5 hours. No product quality complaint was filed. Additional information has been requested.
05/20/06 injection site sore next am, in pm relates became achy and sore with temp 100 deg with warmth, swelling and knot at injection site took Tylenol. 5/21/06 felt worse with temp 101 chills, flu-like symptoms and warmth arm and sore. Had 4x4 swelling at left deltoid muscle, warmth to touch, small knot at injection site.
Product Expiration Date issue/expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 0900am; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 09Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 33-year-old patient received BNT162b2 (BNT162B2), on 12Jan2023 at 09:00 as dose 1, single (Lot number: FP7138, Expiration Date: 30Nov2022) at the age of 33 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "cervical cancer" (unspecified if ongoing), notes: Onset Date: age 28. There were no concomitant medications. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 12Jan2023 at 09:00, outcome "unknown", described as "Product Expiration Date issue/expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 0900am".  Additional Information: Product was Undiluted. Product was stored when excursion occurred in Fridge (2 -8 degree C). Maximum temperature reported / measured during excursion was Max 5.5 degree and minimum was Min 5 degree. Complete temperature data during storage at customer location was Attached. Pfizer delivered to this location. Upon follow-up (09Feb2023), Expired Pfizer vaccine on 30Nov2022 was given on 12Jan2023 at 09:00am. No adverse event contacted Pfizer for guidance was told vaccine was good no further instruction needed.
Pt passed out in check out area approx. 10 min after adm. of GARDASIL. Pale but conscious. Vitals stable 110/60 P 58, sat up without lightheadedness & stood within few minutes. Pt drank fluids in waiting area, felt better.
Information has been received from a registered nurse (R.N) concerning a 26 year old female patient with a history of egg white allergy as a child, and no drug allergies or reactions, who on 14 Jan-2011 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 666987/1016Z, exp date 22-NOV-2011). Concomitant therapy included oral contraceptives (unspecified). The R.N reported that after receiving the first dose of the vaccine, on 15-JAN-2011 the patient experienced a severe topical allergic reaction. The patient broke out in a severe rash. The rash was red, bumpy, itchy and irritated. The rash covered the patient's hand, arm and legs. She had some rash on her forehead. The patient used some hydrocortisone cream on the rash. The R.N stated that the patient had never had an allergy to yeast and had not had any issues with vaccines in the past. There were no laboratory test performed. On 17-JAN-2010, when the patients contacted the physician's office she was improving. The patient sought unspecified medical attention. Follow up information has been received from the registered nurse indicating that on 14-JAN-2011 at 16:00 the IT recruiting patient was vaccinated intramuscularly in the right deltoid. On 15-JAN-2011 the patient broke out in red, bumpy, itchy, irritated rash. The patient used hydrocortisone cream and rash started to improve on 17-JAN-2011. The patient recovered on 17-JAN-2011. It was reported that the patient did not require emergency room/doctor visit. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.   Clinical course: Reportedly, the patient received anti-viral COVID 19 Treatment with Paxlovid from 18Jul2022 to 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 minutes after arm pain. Next day arm pain, joint pain, muscle aches. Took Tylenol for pain. On day 8  noticed small blister/pustule  at injection site when I scratched arm, it broke open, Redness, warm to touch, NO fever. Symptom's continued for 10 days. Contacted PCP via patient portal on 10/22/23. Was advised of allergic reaction on 10/23/22. PCP recommended antihistamine. Took Claritin. Joint pain, Muscle aches, arm pain not as severe.
(R) ARM PAIN, PARESTHESIA, LIMITED  (R) SHLDR MOTION DUE TO PAIN x3d.
Immunization received WED 4/14/10. Following day 4/15/10 right deltoid very red, swollen, extremely painful. Temp increase to 102.3, responded to TYLENOL. On Fri 4/16/10, temp increase to 101.3, redness increase, very painful. Sent to Urgent care, started on KEFLEX 500mg po TID. On Mon 4/19/10, redness increase, continue febrile. Back to MD, Dx = severe reaction. Continue ATBX. Apply ice.
Early August  '21 pt had fatigue for 3 days and his wife was sick for more than a week.  Quarantined but never covid tested. he got the covid antibody test a few weeks later which was positive.  Then got the Johnson & Johnson vaccine September 30 and a couple weeks later at  Air Force Base shortly before PCS'ing to patient, noticed dyspnea on exertion about 14 or 15 minutes in the hard workout whereas usually can go 20 minutes or longer with no problem.
arm is so painful she cannot even sleep; arm from elbow to the top of the shoulder was black and blue; it travels from the upper arm to her neck; COVID arm; inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful), INSOMNIA (arm is so painful she cannot even sleep), SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 019B21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM and Statin for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful). On an unknown date, the patient experienced INSOMNIA (arm is so painful she cannot even sleep), SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm). At the time of the report, PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful), INSOMNIA (arm is so painful she cannot even sleep), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm) had not resolved and SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue) had resolved.            Patient took lot of vitamins no treatment medication was given
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medicines were reported. It was reported that if the patient should get the booster again or any testing done.
shortness of breath; sore arm; rapid heart beat; tightness of chest; Second dose scheduled 41 days after first dose; fever; Diagnosed with asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat) and CHEST DISCOMFORT (tightness of chest) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ASTHMA (Diagnosed with asthma). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (Diagnosed with asthma), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), TACHYCARDIA (rapid heart beat), CHEST DISCOMFORT (tightness of chest), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 41 days after first dose) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Patient received DTAP IM in left deltoid. Patient developed 2.5x5 inch redness on deltoid with warmth. Small blisters also developed.
Pt recv vax on 3/24/99; on same day pt exp swollen/ bruised/ knot at vax site
Patient woke up with hives and itching. Says she gets hives about once a year, but this was from the zoster vaccine. Took some BENADRYL. The hives she gets once a year go away with BENADRYL and sometimes needs prednisone.
I had a huge wave of fatigue and a slight fever.; Really bad sore arm.; throbbing headache; I got warm again with a slight fever; I had a huge wave of fatigue and a slight fever/really tired/tiredness came on; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and experienced just sore arm and slight warmth. On an unspecified date in Mar2021, the patient had a huge wave of fatigue and a slight fever/really tired/tiredness came on, really bad sore arm, throbbing headache and got warm again with a slight fever. Patient stated, I just got my second shot of Pfizer Vaccine on 21Mar2021. Will there be any clinical trials of tring out a third dosage? I heard the company is looking into trying out a third shot of it seeing how it would react of an immune response I might be interested in doing it possibly. Patient stated my second dose I noticed side effects more than first. My second shot about 16-18 hours in (unspecified date in Mar2021), I had a huge wave of fatigue and a slight fever. Really bad sore arm. Then the next day had to call off of work had a throbbing headache when I woke up and just really tired and out of it for about 36 hours. I took a Aleve 12 hour relief that helped some after I woke up the day after shot but then I got warm again with a slight fever and tiredness came on. But after this went away, I felt fine on Tuesday March 23rd and returned back to work. Therapeutic measures were taken as a result of adverse events, Aleve 12-hour relief. The outcome of all the events was recovered on 23Mar2021.  No follow-ups are needed; information about lot/batch number cannot be obtained.
I have a fever today; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I have a fever today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 02-Jun-2021, the patient experienced PYREXIA (I have a fever today). At the time of the report, PYREXIA (I have a fever today) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 003J21/2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Fluarix (Lot-D7AE5, route-Intramuscular and dose- 0.5ml.) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Flu Fluarix.   On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. The patients did not  experienced any symptoms and did not seek for medical care.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Non-significant follow-up, reporter fax number added.
Information received on 26MAR2015 from a consumer. A 39 year old male experienced migraine-like headaches following the administration of BIOTHRAX. Around May or June of 1995, patient believes he received seven doses of BIOTHRAX. He stated that all doses were administered two weeks apart. He reported he experienced an immediate adverse event which consisted of a knot on his right arm. In 1996, he began to experience constant migraine-like headaches which persist still. He has tried a number of therapies (not specified) none of which helped. he has had medical work-ups that included two spinal taps (June 2014) and numerous computed tomography scans (CT) and magnetic resonance imaging (MRI) (dates not provided) all of which were reported as negative. Patient noted that spinal taps made headaches worse. He stated that he has not been hospitalized for the headaches; however, he also stated that the headaches could be nearly incapacitating at times and that he did receive a 30 percent disability from work because of the headaches. Patient also reported currently experiencing occasional muscle aches, which he attributed to getting older. Treatments included number of unspecified therapies. Medical history included hypertension and exposure to tuberculosis (TB). Concomitant medications included isoniazid for exposure to TB. Relevant laboratory/diagnostics: Numerous CT scans and MRIs dates not provided. Two spinal taps, the last in June 2014. All reported as negative. Medical records have been requested. Additional information is expected.
Left arm has red area bout 4 inches in diameter that is warm to touch. Pt. advised to ice and MOTRIN or TYLENOL for comfort.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 09-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by the healthcare provider in a hospital. On an unspecified date, subsequent to patient's inoculation, the patient was treated by healthcare provider for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
22NOV96 onset fever 101-PM of 21NOV;today c/o chills, pain in both knees, lt ankle & neck plus ache all over;has been taking ibuprofen w/o relief;encouraged to see local MD if sx bothersome;
When patients 15 minute wait was done, she was advised she was ready to go as her recommended time was finished. Pt felt nauseous as she stood up and Vomited. Pt stated she developed a sudden stomach discomfort when she stood up. Pt Vomited twice within 15 minutes. Provider was immediately called and examined Pt. Vitals were taken and provider prescribed Pt Ondansetron 8 mg and recommended she is examined by ER if not feeling any better.
Dose 2: Chills, body ache, headache  by 10:00pm (13.5hrs after vaccination 01/07/2021),  severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021