chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tues. 1-25-11- Itching at site. Wed. 1-26-11 redness & pain at 4 p.m. (just finished skiing). Thurs. 1-27-11 Redness and swelling extending from rt. elbow to rt. shoulder hot to touch painful. No fever. Fri. swelling lessened. Mon- 1-31 Back in school. Sm. knot at site.
Patient presented to the pharmacy on 10/19/21 with redness, swelling, itchiness and patient complained of warmness at injection site to left arm.
Back stiffness; Neck has terrible crick in it after second vaccine dose; Can't turn head its very painful after second vaccine dose; Muscle in shoulder blade in the back is sore after second vaccine dose; Right arm is sore after second vaccine dose; Low grade fever after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Back stiffness), MUSCULOSKELETAL STIFFNESS (Neck has terrible crick in it after second vaccine dose), HEADACHE (Can't turn head its very painful after second vaccine dose), MYALGIA (Muscle in shoulder blade in the back is sore after second vaccine dose) and MYALGIA (Right arm is sore after second vaccine dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Back stiffness), MUSCULOSKELETAL STIFFNESS (Neck has terrible crick in it after second vaccine dose), HEADACHE (Can't turn head its very painful after second vaccine dose), MYALGIA (Muscle in shoulder blade in the back is sore after second vaccine dose), MYALGIA (Right arm is sore after second vaccine dose) and PYREXIA (Low grade fever after second vaccine dose). At the time of the report, MUSCULOSKELETAL STIFFNESS (Back stiffness), MUSCULOSKELETAL STIFFNESS (Neck has terrible crick in it after second vaccine dose), HEADACHE (Can't turn head its very painful after second vaccine dose), MYALGIA (Muscle in shoulder blade in the back is sore after second vaccine dose), MYALGIA (Right arm is sore after second vaccine dose) and PYREXIA (Low grade fever after second vaccine dose) outcome was unknown.            No concomitant medication listed. Treatment details were not provided.   This case was linked to MOD-2021-074516 (E2B Linked Report).; Sender's Comments:  MOD-2021-074516:First Dose
This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient,who subcutaneously vaccinated a dose of ZOSTAVAX (lot # was unknown)0.65 ml on 16-JUL-2012. The patient called" the pharmacy on July 18,2012 to report that starting on the evening of July 16,2012,she developed a rash at the injection site,that is continuing to grow." Pharmacist reports that " the patient reports that the rash is approximately 1-1.25 inches in diameter". "The patient also reports experiencing morning headaches since receiving ZOSTAVAX". The patient had a prior history of morning headache, the patient sought medical attention through calling pharmacy. The outcome of developed a rash at the injection site and morning headache was reported as not recovered/not resolved. The relatedness for developed a rash at the injection site and morning headache was unknown for ZOSTAVAX. Additional information is not expected.
fever/his highest fever is 101.5; chills; This is a spontaneous report from a contactable consumer (patient's wife). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 at 11:45 (lot number: EN6207; expiry date: 03Jul2021) at the of 67-years-old, as dose number unknown, single, for Covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included amlodipine besylate; hydrochlorothiazide; clomiphene citrate; tadalafil taken for unspecified indications, start and stop dates were not reported. On unspecified date in Mar2021, the patient experienced chills. On 19Mar2021, the patient experienced fever, his highest fever was 101.5. Outcome of the event his highest fever is 101.5 was not recovered, while for the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient inadvertently given the wrong Moderna covid-19 presentation. Client is scheduled to come back in and be revaccinated with the correct presentation.
10 minutes after administration, patient report a tickle in her throat which led to a intermittent dry cough
pt recvd vax & became limp & pale;resp easy;lungs clear;p/about 15mins, color was much improved, tone improving;p/another 25min pt was alert, active, good tone, good skin color;reporter felt pt was breath-holding & fainted
During injection there was leakage of liquid from between the needle and syringe - patient did not receive a full dose
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 02-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Approximately 48 hours after receiving the vaccine, i developed what may  be described as "Covid Arm": A warm, red large circle surrounding the injection site that was tender to the touch and itchy at times. Additionally, I developed a hard mass under the skin at the injection site. The redness and itchiness lasted about a week. The redness increased with touch and after showers. The itchiness slighlt subsided with topical cortisone. The pain/tenderness surrounding the hard mass lasted about 12 days. I'm currently 13 days out from receipt of vaccination and continue to have the hard mass under the injection site.
Adverse event, fever and pharyngitis initial letter mailed to you 9/24/02. Throat culture now positive for strep, group A, so not a vaccine reaction at all, just a coincident infection.
On December 17 I woke up feeling poorly. I took a home Covid test and it was positive. On Monday morning I went to clinic to have that result confirmed. It was confirmed that I had Covid. I use some over the counter, cold and flu preparation?s. The symptoms were primarily headache, fatigue, nausea. I didn?t really have any fever this go around. I had Covid last December and it was much worse.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a medical office manager. This case involves a 28 years old male patient who experienced swelling, redness and tenderness in left arm, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included TUBERSOL for Tuberculin test (date not reported). On 27-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA; expiry date: 13-Jun-2020 via intradermal route in the left forearm. On an unknown date¸ the patient developed a non-serious tenderness in left arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date ¸the patient developed a non-serious redness and swelling in left arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was inflammation in left arm, tenderness in left arm and swelling in left arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for swelling in left arm, as Recovering / Resolving for tenderness in left arm and as Recovering / Resolving for inflammation in left arm.
Difficulty walking; Severe muscle and bone aches all over his body; Severe muscle and bone aches all over his body; This is a spontaneous case, initially received from other non-health professional (consumer) via Company (reference number: SEQ19-06865) on 20-Nov-2019, concerning a 79-year-old, male patient.   The patient's relevant medical history included previous influenza vaccines without a reaction.  The patient's concomitant medications were not reported.  On 13-Oct-2019, the patient was administered unspecified INN Flu Vaccine [Influenza virus vaccine polyvalent, anatomical location: arm, dose, route of administration, batch number and expiration date: not reported] as protection against seasonal influenza.    On an unspecified date in Oct-2019, reported as 3 to 4 days after receiving the vaccine, the patient experienced severe muscle and bone aches all over his body.   On an unspecified date, the patient had difficulty walking, due to severe muscle and bone aches.  At the time of this report, the patient did not recover from the events of walking difficulty, muscle ache and bone pain.  The reporter assessed the case as non-serious and did not provide causality assessment to unspecified INN Flu Vaccine.  Company Comment: The patient experienced gait disturbance, bone pain and myalgia after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Advanced age (79) may have contributed to development of the events. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced gait disturbance, bone pain and myalgia after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Advanced age (79) may have contributed to development of the events. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu) and RASH ERYTHEMATOUS (had a big red rash/Moderna arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like had the flu). On unknown date, the patient experienced RASH ERYTHEMATOUS (had a big red rash/Moderna arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu) and RASH ERYTHEMATOUS (had a big red rash/Moderna arm) outcome was unknown. No concomitant medication were reported. Patient took the first booster dose of the Moderna COVID-19 vaccine and felt like had the flu. Also reported that, 4 days later, patient had a big red rash. Patient googled that, and referenced it as Moderna arm.
Acute Myocardial Infarction in the setting of nonobstructive coronary artery disease (angiography 3/30/2021)  due to Acute MYOCARDITIS proven by cardiac MRI (3/31/2021)
Excruciating migraine lasting 4-5 hours with tight throat and diarrhea the next day.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received CERVARIX. On an unknown date, the patient received CERVARIX. On an unknown date, 20 days after receiving CERVARIX, the patient experienced swelling arm, injected limb mobility decreased and nervous. On an unknown date, the outcome of the swelling arm, injected limb mobility decreased and nervous were recovered/resolved. It was unknown if the reporter considered the swelling arm, injected limb mobility decreased and nervous to be related to CERVARIX. Additional details were received as follows: This case was received via hotline. The age at vaccination was not reported. The reporter stated that she searched in the internet and found a patient that developed swelling arm (which was injected) and that arm could not lift up, after receiving CERVARIX. The patient saw a doctor, and the doctor told she was nervous, and no action was taken. The symptoms were resolved by themselves. No other information was provided. The reporter refused to follow up. This case has been linked with case CN2017GSK177485, reported by the same reporter.
Pt developed an injection site reaction characterized by redness, swelling and itching. She also experienced pain under that arm.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was neg;
Sore arm starting the day of the vaccine Headache, body aches, sore/swollen lymph nodes under armpit starting the day after the vaccine
High fever; chills; sweats; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old male patient received the second dose of BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 08Jan2021 at single dose in the left arm for an unspecified indication. Medical history included high blood pressure and allergy to coconut. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. Historical vaccine includes BNT162B2 received via intramuscular on 11Dec2020 14:00 ("also reported as 12Dec2020 14:00) at single dose (first dose) in the left arm for COVID-19 immunization. On 09Jan2021 07:00, the patient experienced high fever, chills and sweats. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the events was not recovered.  Information regarding lot/batch number has been requested.
Typical delayed hypersensitivity reaction, started 7-8 days after vaccination. Vaccination site is red swollen, warm and itchy. I have applied Benadryl spray.
pt recvd vax;devel local pain, inflammation, redness, swelling & warmth at inject site & fever of approx 100 which lasted for 3 days;also exp dysfunction of arm;
Shot at 5:20 pm. - slept well.  Rose at 7:30 am.  At 10 am started feeling very cold.  Could not get warm.  At 2 p.m. took a 325MG Tylenol.  Slept from 10 to 3.  Felt so much better after that.
Severe deep muscle pain redness and blotches on site of shot and surrounding area. Fever ranging from 100.2 to 102 Degrees for 36 hours. Severe weakness for 36 hours.
This spontaneous report as received from a physician via a company field representative refers to a 14 year old female patient. On 22-JUL-2014 the patient was vaccinated with the first dose of GARDASIL, injection, (dose, frequency, route, lot # and expired date were not reported). Concomitant therapy was not reported. After injection on 22-JUL-2014, while having blood drawn, the patient fainted. The patient sought medical attention by being in doctor's office. The patient had to be given oxygen. None lab diagnostics studies were performed. The therapy with GARDASIL was not discontinued. The patient had fully recovered on 22-JUL-2014. The reporter considered the event to be medical significant because the patient needed to be given oxygen. Additional information has been requested.
Mom reported a 6 months well child check that pt got fever 105 axillary 30 minutes after getting injection. She was seen in ER with no other source for fever found. No other symptoms besides at 4 month well check fussiness, not treated besides Tylenol, fever lasted 4 days.
Hives covering entire body, itching especially of hands and feet, redness of hands, swelling and redness of feet.
Information has been received from a licensed practical nurse concerning a female patient who on unspecified dates was vaccinated with the 0.5 ml first, second and third dose of GARDASIL. There was no concomitant medication. On an unspecified date, the patient received her third dose of GARDASIL and developed a quarter sized lump on her arm at injection site. The patient sought unspecified medical attention. As of 23-DEC-2009, the lump had been reduced to the size of a dime. No lot number was provided. Follow up information was received from a licensed practical nurse. It was reported that the 19 year old patient on 17-DEC-2009 was vaccinated with a third dose of GARDASIL at 15:00. The patient stated that the injection site was swollen and sore to the touch or if she would bump her arm. At the time of reporting, the patient had recovered. Additional information is not expected.
After the first mandatory dose of influenza vaccine, annual healt check up revealed platelets of 13,000 Since then I have been under Drs care for ITP
Initial report received on 22-October-2013 from a health care professional. A 30-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number UT4722BA) at delt (route of vaccination was not reported) on 21-Oct-2013. On 21-Oct-2013, after receiving vaccine the patient experienced 2" in diameter, red, hot, tender to touch, localized reaction and temperature 99.5F. The events were ongoing at the time of this report. List of documents held by sender: none.
Menstrual bleeding (off cycle); This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual bleeding (off cycle)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual bleeding (off cycle)). At the time of the report, MENSTRUAL DISORDER (Menstrual bleeding (off cycle)) had not resolved. Not Provided          Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
I did experience some itching the evening I received the vaccine, but it only lasted a couple of hours. The swelling died down slowly over about 5-6 days. Day 6 (Wednesday) I could feel slight pain at the injection sight if I touched it. Thursday morning I didn't feel anything. Thursday  afternoon (Day 7) about 4 pm my arm started itching. By the time I left work at 7:30 pm it was red and swollen and warm to the touch.  Day 8, Friday, I woke up and it was very itchy and warm. I have applied Benadryl cream and some cold compresses throughout the day. It is still warm and itches, but is not as firm as it was this morning.
Tachycardia, pain/cellulitis at site, leukocytosis.
Patient received Moderna booster 1 on 12/17/21 and received Moderna booster 2 on 04/2/22 - 15 days earlier than recommended
Injection site soreness, red, hot to touch, itchy. Dr. advised BENADRYL and cool compress. Could be normal reaction.
headache, tiredness, muscle pain, the chills so cool I had to put the eclectic blanket on.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2013, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/28/21 lot# EL9261;  Pfizer 5/19/21 Lot# EW0183
This vaccinee, post vax, developed systemic lupus erythematous after receiving influenza vaccine, typhoid vaccine, meningococcal vaccine, tetanus vaccine and Immune serum globulin. He had not received any drugs known to induce SLE prior to vaccination. Treatment regiment included corticosteroids, cyclophosphamide, hydromycholoroqune and azathioprine. He continued to experience residual symptoms for up to 7 years of follow-up. Per doc no 199371, annual follow up, no further information received as of september 2001.
SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body.  On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY