chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle and arm pain; Muscle and arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Muscle and arm pain".  Additional information: Patient got the 2nd dose of the Pfizer COVID vaccine a month ago and was having muscle and arm pain. She did not wish to provide an address, email or date of birth and did not have time to complete report as she was at work. She stated she would call back later. No further details provided. She did not have the lot or expiration to provide today (at the time of report).  Follow-up attempts completed. No further information is expected.
TD given at 10:55pm on 05/08/2002. Swelling on left arm at site of injection approximately 4.5cm in size. Pt instructed to use ice on left shoulder for 20 mins three times a day.
Pt reports noticing reaction the day after administration. Red, raised area approx 6cm in diameter noted at site of injection. BENADRYL 50mg PO given x1 6/13/10 and x1 6/14/10. Pt reports induration is warm and "itchy" but has not increased in size since appearance.
Information has been received from a pharmacist referring to his mother, a 84 year old female patient. The patient's pertinent medical history was not provided. There were no drug reactions or allergies. Concomitant therapy included warfarin (blood thinner). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L024129 with expiration date January 2017) single dose 0.5 ml dose, subcutaneously. On 29-OCT-2016, the patient experienced "cellulitis on her bicep". The patient contacted the pharmacist to seek medical attention. Unspecified treatment was given for the adverse event. No lab diagnostics studies were performed. At the time of the report, the outcome of the event was reported as recovered. Upon internal review, cellulitis on her bicep was determined to be medically significant. Additional information has been requested.
improperly stored vaccine administered to one patient; no adverse effect; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On an unknown date, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis, lot # R017799 and expiration date 19-DEC-2019 (strength, frequency, and route of administration were not reported).         The patient experienced no adverse events. It was reported that the temperature excursion was at a temperature of 9.5 F during 11 Hours 59 Minutes; no previous temperature excursions were reported. Digital datta logger was involved.
3 episodes of fainting; Flu like symptoms; Chest tightness; Sore and tender upon swallowing food; Muscle aches on right arm; fever; fatigue; A spontaneous report was received from a consumer concerning a 45-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, fever, fainting, muscle aches, flu-like symptoms, chest tightness, and sore throat.  The patient's medical history, as provided by the reporter, included childhood asthma and seasonal allergies. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient had fatigue by the end of the day following vaccination.   On 29 Jan 2021, the patient presented fever and 3 episodes of fainting. She had muscles aches on her right arm, flu-like symptoms, chest tightness, and sore/tender throat area upon swallowing food. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events was not reported.; Reporter's Comments: Further information has been requested as there is limited information regarding the events, particularly the event of syncope and chest discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Upon wakening this morning pt reports  L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.
Patient states she began experiencing drawing on the left side of the face 6-7 days following her second dose of COVID-19 Moderna vaccine and has continued to have these episodes approximately three times per week.  She explained the drawing effect felt similar to a muscle cramping on the left side of the face and it would sometimes cause her left eye to be difficult to keep open.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I took Benadryl before this dose per my allergist. About 3 minutes after the dose I felt a little light headed and dizzy that shortly resolved. About 10 minutes after that, I became light headed and dizzy again along with chest tightness, palpitations and an itchy throat. My heart rate was in the 110s. My symptoms would be on and off. I received more Benadryl in the ED with no resolution. I then was given an epi pen and prednisone. After this the itchy throat and light headedness resolved. I was observed in the ED for a total of 4 hours. I was discharged with 4 days of prednisone and 2 days of Benadryl.
i administered  the bivalent bood, I should of gave the second monovalent from primary series
Patient said her arm was red and had pain on her arm 2 days after receiving shingrix vaccine. She went to visit her primary physician and they diagnosed it as injection site infection and gave her antibiotic.  Patient called Friday (3/17) to inform of her infection. she if feeling better not. She does not have redness but have little pain
Fatigue; tried to rehydrate; fever 100.3 that lasted for 3 days; Chills; This is a spontaneous report from a contactable consumer reported for herself that. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 69 years). The patient past medical history and concomitant medication was not reported. The patient is calling to order Sildenafil for her mother for her mother's heart failure. She wanted to report a reaction she (the caller) had to the COVID vaccine. The caller confirmed the details provided by the transferring agent. The caller had a mild reaction to the COVID 19 vaccine. She hears about reporting side effects in the recording. It was the Pfizer COVID vaccine. She got both Pfizer doses: first shot: 19Apr2021, ER8733, 31Jul2021, right arm; last shot 10May2021, ER8729, 31Jul2021, left arm She got both doses at (address withheld). On an unspecified date the patient experienced side effects after the second dose. She had a fever 100.3 that lasted for 3 days. She had chills that lasted for 3 days. She just tried to sleep it off and drink it off. She just tried to rehydrate. The fatigue lasted a couple of days. These just happened after the last dose. She went to the internist recently, and her numbers were really good. She has no diabetes. Her numbers were all well under everything. Her husband and 99-year-old mother got both COVID vaccines the same day as her, and neither one of them had a reaction to either dose. Her husband is a big baby, so she is glad he didn't. Two of her former coworkers had the Moderna vaccine and had the same reaction. She thought it was funny because they all worked together for so long. She doesn't want to do a report for them. The patient underwent lab tests and procedures which included body temperature: 100.3 on an unspecified date and investigation: were good on  has no diabetes. were all well under everything. The event outcome was recovered on an unspecified date.
After my 2nd dose and now also after my 3rd dose I experienced disruptions in my period cycle. I have been tracking my period for years using an app. My cycle is consistently between 26-28 days long. After my vaccine booster my cycle shortened to 21 days for two months in a row now. After my second shot, my cycle also shortened for several months.
Pt achy, tired-low grade temp off & on; started 3 days past vax; Seen by MD 28OCT91 started on Amantadine; Called 1 wk later, still ill but better; 21NOV91 called pt, illness resolved;
July noticed heart rate had been abnormal. Previous from vaccine never had any heart abnormalities. Throughout day heart rate is all over the place. Pounding at some times. Chest feels tight.
PT was injected with 0.3 ml of undiluted pfizer booster shot, staff were immediately notified. Per protocol PT was informed of the issue and informed of reactions and told to seek medical attention if she feels she is having a reaction. She was watched for fifteen minutes and vitals were checked a second time vitals were still normal and were charted.
Left arm swollen and red, hot to touch, fever of 101. 1/24/07 13x16 cm area of redness, slightly swollen but 1355 not tense. Left upper arm
Patient received the Moderna vaccine. About 5 mins after receiving the vaccine patient started to have seizures. Patient had episodes of seizures off and on for several minutes. Patient was taken to ER for further treatment.
Nausea, vomiting, abdominal pain, headache, body aches, Headache started within 2 hours of receiving vaccine. Nausea, vomiting, abdominal pain, body aches and headache the day after. Given ZOFRAN. Today 11/9/2018 is starting to feel better.
This spontaneous report as received from a physician refers to a 11 years old male patient. On an unknown date the patient was vaccinated with GARDASIL, route, dose and lot # unspecified. Concomitant vaccines included DTAP and MENACTRA. The patient after lying for fifteen minutes upon getting up to stand fainted. Upon gaining conscious the patient's pressure was taken and was normal (No specific measurement given). The patient remained at the office another thirty minutes where he was monitored closely. The patient appeared to be completely recovered and was allowed to leave after thirty minutes. Additional information has been requested.
Patient got vaccine on 12/19/15 and had reported swelling, pain in arm near injection site about 6 days after Boostrix (tdap) vaccine was given. Patient went to get seen by physician on 12/26/15 and was given a antibiotic. She did not know the name of antibiotic given to her. However, after being on the antibiotic for 3 days she stated she felt better and the swelling went down.
she is getting thrush in her mouth; her left arm was sore (at the injection site); nausea; her left armpit lymph nodes were swollen; shivering; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) (batch number 276570, expiry date 30th June 2021) for prophylaxis.   On 25th September 2020 17:00, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2020, the patient received FLUCELVAX QUADRIVALENT (intramuscular). In September 2020, 9 hrs after receiving Shingrix, the patient experienced injection site pain, nausea, enlargement of lymph nodes and shivering. On 28th September 2020, the patient experienced oral thrush. The action taken with FLUCELVAX QUADRIVALENT was unknown. On an unknown date, the outcome of the injection site pain and enlargement of lymph nodes were recovering/resolving and the outcome of the nausea was unknown and the outcome of the shivering was recovered/resolved and the outcome of the oral thrush was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, enlargement of lymph nodes, shivering and oral thrush to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix intramuscularly on left deltoid. The patient also received Flucelvax quadrivalent shot intramuscularly on right deltoid at the same visit. The patient had the lot number and expiry date for the flu shot but not for the Shingrix. Around 02:00 on 26th September 2020, the patient woke up with nausea and left arm was sore at the injection site and left armpit lymph nodes were swollen also was shivering. The patient stayed in bed on 26th september 2020. On 27th September 2020, felt better and got up and did some things. On 28th September 2020, was nauseated again and said it look like was getting thrush in mouth. The injection site soreness was still sore but was about 75 percent better. The lymph node swelling had gone down but was still touchy. The reporter consented to follow up.
Weakness - per group home recieved covid vaccine 1 week ago -staff states has been getting worse since then
Redness, rash injection site 10-15 mins after shot. Scattered lesions (red, flat) chest & back. Removed Band-aid, cool compress injection site. Monitor x 15+ mins. redness, rash, lesions resolved. Vital signs WNL. Denies itch, trouble breathing.
Narrative: Headache, Myalgia, Arthralgia, Chills, Malaise.
On 04/15/2022 I received my Covid-19 Vaccine. On the evening of 01/31/2023 I was experiencing sore throat, headache, muscle ache, fatigue, congestion. After reaching out to the doctor I was diagnosed with Covid. Symptoms lasted 8 days. lingering cough and permeant lung damage.
4/23/19 redness noted to injection sight and below the injection site of right arm, 4/25/19, redness increased and started to have "red/pimple looking bumps" to elbow, forearm and wrist to both arms accompanied with itching.  Medicated with Benadryl and cold compresses.
0.3ml undiluted Pfizer Peds vaccine given.  No adverse reaction for the patient.
pt rcvd vax; pt did not sleep at all during eve of shots; seemed like pt was on drug & very wired; pt cried next day & would not eat; mom called RN; she said not to worry as long as pt not crying; pt did not eat & died in afternoon;
Experienced leg pain in upper right thigh for a period of approximately 18 hours. Symptom of pain similar to a "Charley Horse" in right quadricep. Not severe but very noticeable. No treatment received. Did not report to medical personnel.
PAIN IN THE ARM; FEVER; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 27 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 21-NOV-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 21-NOV-2021, in the afternoon the patient had pain in the arm (from the shot), fever, and tiredness (Dose number in series 2). She felt like it was normal side effects and don't want to be contacted or take this further. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, tiredness and pain in the arm was not reported. This report was non-serious.
The spontaneous case, initially received from other non-health professional (consumer) on 16-Jan-2018, concerning 74-year-old, elderly, female patient. The patient's current conditions included Hashimoto's, migraines and depression. The patient was allergic to egg. It was reported that, exposure to egg caused pain in the calf of the patient. The patient's concomitant medications included ARMOUR thyroid, SYNTHROID, progesterone capsule, estrogen patch for an unknown indication. On 11-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid (left arm), batch number: 195241 and expiry date: 30-Jun-2018). On the same day of vaccination in the evening, the patient had deep pain in right calf muscle about the size of a nickel. No treatment medications were given to the patient. The patient went for physical therapy on 23-Jan-2018, which helped a little from pain. The patient recovered from the event (deep pain in right calf muscle). The reporter assessed the case as non-serious. Follow up report received on 27-Feb-2018: The patient's current conditions (Hashimoto's, migraines and depression). Batch number (195241) and expiry date (30-Jun-2018) was added. The outcome of the event was changed from not recovered to recovered. The narrative was amended accordingly.
LOW GRADE NAGGING HEADACHE ON AND OFF BUT NOW NOT LETTING GO; LIGHT NAUSEA ON AND OFF; DID NOT GET OUT OF BED; EXHAUSTED THAT COULD NOT  MOVE THE BLANKET; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for headache.  On 07-APR-2021, the subject experienced did not get out of bed. On 07-APR-2021, the subject experienced exhausted that could not move the blanket. On 16-APR-2021, the subject experienced low grade nagging headache on and off but now not letting go. On 16-APR-2021, the subject experienced light nausea on and off.  Laboratory data (dates unspecified) included: Chemotherapy (NR: not provided) unknown, and Radiation therapy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not get out of bed, and exhausted that could not move the blanket on 09-APR-2021, and had not recovered from low grade nagging headache on and off but now not letting go, and light nausea on and off. This report was non-serious
Large, fist-sized circular rash near injection site; exacerbated Carpal Tunnel-like symptoms in are
Starting around 9 am the following day, Feb 9th, I began to have body aches with chills and a headache. This lasted until 8:30 pm. I still had a headache the next day, Feb 10 but once I took Ibupropfen the headache went away.
Patient returned to pharmacy two days later stating her injection site had become infected. Red area on arm noted by pharmacist.
Dizziness, Tachycardia, felt dizzy/lightheaded/tachycardia immediately after vaccine Narrative:  was sent to ED for further observation (no treatment given)
Papules on left leg at injection site and surrounding site 5 cm patch no hives no redness no swelling no itching.
No additional adverse effects reported; the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse, referring to a 12-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously (strength, vaccination scheme, anatomical site of injection were not reported; lot number S032352, expiration date: 14-OCT-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects reported.  On an unknown date, the vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.9F) for 2 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.
fell over and died of heart attack; fell over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "fell over and died of heart attack"; FALL (non-serious), outcome "unknown", described as "fell over". The patient date of death was unknown. Reported cause of death: "fell over and died of heart attack". It was not reported if an autopsy was performed. Clinical course: the reporter reported that I just heard on the news today that the doctor (not clarified) who was 27 years old a doctor in the prime of her life running a Triathlon nothing wrong with her she just fell over and died of heart attack. She had two Pfizer shots and a booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: fell over and died of heart attack
First dose was 4/22/2021, general dr visit on 5/12/2021 showed radical heart beat. Second dose on 5/20/2021 became very ill, uncontrolled heartbeat, hospital admission that same day. He passed away the morning of 5/23/2021. I am his daughter, POA/Executor and was his designated health care director and caregiver.
Immediately following vaccine patient developed hives on her leg which resolved very quickly.  No further vaccines given.
Pt claims in intensive are for 1 and 1/2 weeks with renal and respiratory failure.