chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
Consumer wants to receive her second dose today which is day 47; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer wants to receive her second dose today which is day 47) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer wants to receive her second dose today which is day 47). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer wants to receive her second dose today which is day 47) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
New heart palpitations , occur randomly at rest and exercising.  New high blood pressure spikes ,randomly at rest and exercising.  New headaches,random occurence of different level intensity.  Random blurry vision. This is a new symptom
Woke up the 10th with fever up to 103 but by late evening it was down to 99. While I was falling asleep I started to get itchy in different parts and it caused a bad night of sleep. By 7am on the 11th my broke out in hives all over my body and I went to the ER.  I was told to isolate for 48 hours and take Benadryl every 6 hours and Zyrtec once a day. Today is 12/1/2022 and I am still experiencing itchiness and closing of throat (this only had occurred twice when I did not take Zyrtec. I was told symptoms may last up to a month.  It's been 22 days
This spontaneous report as received from a pharmacist refers to a 79 year old male patient. On 01-SEP-2013 the patient was vaccinated with ZOATAVAX, injections, 0.65 ml, subcutaneously; lot number # J003796, expiration date 28-JUN-2014. On 01-SEP-2013 the patient had developed a flushed face and sinus congestion within two to three hours of receiving the dose of ZOSTAVAX. He had been coughing and had trouble swallowing, his tonsils were swollen and he was diaphoretic at times. The episodes of diaphoresis and difficulty swallowing lasted for 48 hours after receipt of the dose of ZOSTAVX. A significant amount of sputum which he produced caused him to use an entire box of facial tissue over the course of the 48 hours. The patient sought medical attention  wrote a letter to the pharmacist. No treatment was given for the adverse events. The outcome of flushed face, significance of the amount of sputum, tonsils were swollen; coughing and sinus congestion was unknown. The relatedness between vaccination with ZOSTAVAX and events was not reported. The pharmacist was requesting a lot check for ZOSTAVAX (lot # J003796, exp 28-JUN-2014) since two other patients had also reported adverse effects since receiving ZOSTAVAX of this lot number. Reports from the same source (# 1309USA002794; #139USA002846). Additional information has been requested.
Almost passed out in shower with low blood pressure; Almost passed out in shower with low blood pressure; Started to experience severe allergies; Severe muscle weakness (especially in left arm); Soreness; Fatigue; Cramping muscle; Recurring swelling/tenderness at injection site; Recurring swelling/tenderness at injection site; Chest pains; Gastritis; Diarrhea; Nausea; This is spontaneous report from a contactable other healthcare professional (the patient). A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 2613) via an unspecified route of administration in left arm on 13Apr2021 12:30 at age of 30-year-old at single dose for COVID-19 immunisation. Medical history included lyme disease from 2018 and gastritis from 2019. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At one and a half weeks after first dose, the patient started to experience severe allergies which is not typical for her. Currently since the two weeks since the vaccine the patient had severe muscle weakness (especially in left arm), soreness and fatigue, cramping muscles, recurring swelling/tenderness at injection site, chest pains, gastritis, diarrhea, nausea, and almost passed out in shower with low blood pressure. The events onset date was 22Apr2021 09:00. No treatment received for the events. Nasal Swab/COVID-19 Active Infection RTPCR/TMA (SARS-CoV-2 RNA, Qualitative NAAT) was negative on 23Apr2021. The outcome of the events was not recovered.
Nasal Swab  Positive; Nasal Swab  Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: ek9231), on 18Jan2021 as dose 2, single (Lot number: el3249) and on 06Oct2021 as dose 3 (booster), single (Lot number: ew0183), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Oct2021 as dose 1, single (Lot number: 3pn2b), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Nov2021, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2021) Positive, notes: covid test type post vaccination. This Report was about covid vaccine. Patient received other vaccine in four weeks. The other vaccine product was for flu. Patient had tested with COVID test post vaccination by nasal swab.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Information has been received from a physician concerning a "9 to 10" year old patient who was vaccinated with a dose of VARIVAX (Merck). It was reported that "the patient experienced nerve pain and then shingles" in "the week of 05-APR-2010". The patient received unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
About 7 days after thee second dose of vaccination,patient complains of rash and itching to arm.  Classifies as mild.  Patient has taken diphenhydramine po and hydrocotisone cream to assist with symptoms.
soreness in neck it became stiff;aching all over body, sore throat, stuffy nose;flu like sx appeared;
Sore throat; Congestion; Coughing; headaches; fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year old female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN; Dose number: 1st dose), via an unspecified route of administration in unspecified site on 14Mar2021 at 15:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had penicillin allergy. The patients concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 13: 00, the patient experienced sore throat, coughing, headaches, congestion and fever. The clinical outcomes of events sore throat, coughing, headaches, congestion and fever were recovering at the time of reporting.   Information about lot number cannot be obtained. No further information expected.
Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased.  Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain
Stiff, painful left neck for 24 hours. Very stiff, very painful upper arm for 60 hours. Feverish, chills, loss of appetite, nausea for 60 hours.  Not sure if ongoing joint pain in right hip has been exacerbated by shot. Subsequently have had ongoing indigestion / heartburn which has become increasingly worse no matter what I eat. Still have the indigestion and heartburn nearly daily.
Arm itched like crazy; Their doctor told that the shot was lower than where it is normally; Arm was a little sore in the injection site; arm become red; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally), VACCINATION SITE PAIN (Arm was a little sore in the injection site), VACCINATION SITE ERYTHEMA (arm become red) and VACCINATION SITE PRURITUS (Arm itched like crazy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011ZLOA) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Cholesterol. Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for Atrial fibrillation, SIMVASTATIN for Cholesterol, VITAMINS NOS (ICAPS PLUS [VITAMINS NOS]) for Eye disorder NOS, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, LUBIPROSTONE (AMITIZA), VITAMIN D NOS and CALCIUM for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally), VACCINATION SITE PAIN (Arm was a little sore in the injection site) and VACCINATION SITE ERYTHEMA (arm become red). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm itched like crazy). On 09-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally) had resolved. On 18-Feb-2021, VACCINATION SITE PAIN (Arm was a little sore in the injection site), VACCINATION SITE ERYTHEMA (arm become red) and VACCINATION SITE PRURITUS (Arm itched like crazy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable The doctor told that the shot was lower than where it is normally given, and the caller think it was subcutaneous.   This case was linked to MOD-2021-015972 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non-significant follow up appended
Approx. Aug.9,2022 I began feeling tenderness in my left calf.  I was aware of the tenderness but thought I had bumped my leg or otherwise caused a superficial bruise.  Over the course of 10 days... discomfort increased and the tender area increased in size... moving from about 2" above my ankle to just below the back of my knee.  By this time, it began to hurt when I stepped on that leg.  I tried to get in to see my PCP but there were no available appointments for 10-14 days.  On Aug. 23, I went to urgent care.   The physician who treated me at this facility ordered an Ultrasound to confirm or rule out a blood clot.  Results were positive and showed I had a  superficial blood clot that was 17 cm long in my calf, extending from above my ankle to the back of my knee.  I was put on a 45 day course of Pradaxa 110 mg 2 caps /day.  I saw my PCP on 9/12 for a follow up visit.  Dr. wants me to have a second US to confirm that the clot is being absorbed.
Since receiving the vaccine, I have had significant pain in the upper arm/shoulder area and tingling in my fingertips. The pain limits my range of motion in my left arm. It has been several weeks since I received the injection and the pain has never subsided. The pharmacy recommended I take Ibuprofen for pain and inflammation, but only temporarily helps.
My latest menstrual cycle lasted about three weeks, typically, my period is predicable, once a month more or less, and last about 7 days; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12May2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jul2021, the patient experienced her latest menstrual cycle that lasted for about three weeks. Typically, her period was predictable, once a month more or less, and lasted for about 7 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event latest menstrual cycle that lasted for about three weeks was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LOST MUSCLE; ARTHRITIS; LACK OF CONTROL; SICK; Booster; This is a spontaneous report received from contactable reporter (Physician).  A female patient received bnt162b2 (Batch/Lot number: unknown) as dose 3, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "LOST MUSCLE"; ARTHRITIS (non-serious), outcome "unknown", described as "ARTHRITIS"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "LACK OF CONTROL"; ILLNESS (non-serious), outcome "unknown", described as "SICK"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Additional information: *On an unspecified date, the patient was administered with Covid-19 vaccine for Covid-19 immunization at unknown dose and route of administration. The patient was sick shortly after taking the Covid-19 vaccine booster.* *On an unspecified date, the patient developed arthritis and had lost muscle.* At the time of this report, therapy with isavuconazole (CRESEMBA) was ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient missed her second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Red, Itchy patch ~ 4" diameter (R) deltoid where MMRV was given
Pt. had syncopal episode immediately after HPV given. Pt. became pale, non-responsive for 1-2 seconds. No treatment except legs elevated. Syncopal episode reoccurred approximately 20 min. later. Pt. discharged after about 1 hr with stable gait, alert - oriented x 3.
Site: Bruising at Injection Site-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Severe, Additional Details: 5 mins after administration of the vaccine, pt starting slumping and waking up several times. She was moved to the floor with knees up, but it did not change her status. 911 was called and she was taken to the ER. She was responsive, but kept fainting and waking up every few seconds. She was not confused. She was able to tell the date and personal information verbally while awake. Paramedics came in and her blood pressure was around 170/95, O2 normal, and blood sugar normal.
This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of injection site warmth (1st dose received on an unknown date, refer case US2021AMR263517). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site warmth and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site warmth and sickness were unknown. It was unknown if the reporter considered the injection site warmth and sickness to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The shots were not so hot, either. Especially the second one was sick as a dog. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR263485:same reporter.
I have a large red itchy spot at the injection site. It has been there for a week. It is hot to the touch, slightly tender, and large.
Redness/warmth to arm surrounding injection site; hardness (firmness) surrounding injection site; Fever, muscle aches, headache
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site swelling. The patient was treated with Antihistamines and Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced excessive redness, tenderness, and swelling in the same arm where she received her SHINGRIX vaccine. There was no fever. The symptoms were began the next day, worsened by 2 days after administration, and started to improve starting 4 days after administration. The symptoms was resolved since then, but the exact date was not known. The patient was advised to take antihistamines, and was also prescribed antibiotics in case of infection. The patient was out of state and therefore did not visit doctor's office, and all post-vaccination follow-up was done over the phone. The reporter was consented to follow up.