chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given Proquad and Varicella together. No adverse reactions noted. Pt was observed x 30 minutes and mother was advised to monitor.
PT COMPLAINED OF SHORTNESS OF BREATH AND DIZZINESS APPROX 24 HOURS AFTER RECIEVING INJECTIONS.  HE WAS SEEN AT AN URGENT CARE FACILITY AND THEN FOLLOWED UP WITH US ON 09112008.  AT THAT TIME THE SYMPTOMS HAD SUBSIDED.
Left thigh noted to be red & warm to touch.  Red area measuring 15cmX8cm.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   Reporter did not allow further contact
Felt arm was numb in region of injection. This occurred 10 days after second injection. Condition lasted for 3 days. I visited a local hospital.
I experienced all the common side effects: sore arm, fatigue, fever, chills, body aches within the first 12 hours of receiving my second dose of  the Moderna shot. I passed in and out of consciousness 4 times during the early hours of Wednesday morning, September 8th resulting in a fall in my bathroom onto the tile floor. I have severely injured my left knee. I cannot bend my knee and have constant pain in it. I have had a x-ray and will have a MRI to see if the meniscus or MCL is torn.  If my husband hadn?t caught me I passed out when he did I would have further injured myself and likely hit my head.
Tested COVID19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Polymerase chain reaction: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Within three hours my upper left arm was very sore, but the level of discomfort progressed rapidly. By that evening any movement was so painful, that I had to move my arm with my right hand.  I would say that the pain was greater than the post-op pain following my total hip.  Also my upper arm was swollen, warm and red.  By the next morning, with the benefit of a pain medication, I was able to move my arm a little.  The swelling and redness was increasing, and moving down my arm. 48 hours after the shot I was seen at an immediate care center, by then I was able to lift my arm, but still had some discomfort.
Received Pfizer-BIONet COVID vaccines on 12/26/20 and 1/18/21.   On 4/18 /21 developed body aches, headache, and nasal congestion.  Tested positive for COVID.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. No medical history was reported. On 08-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, dose route not reported). No concomitant medication were reported. On 08-APR-2013, an area on a patient's arm from her elbow toward her upper arm became tender and pink after receiving ZOSTAVAX. The pharmacist stated that the area on the patient's arm extended above and below the injection site and remained pink and tender for 4-5 days. The patient was instructed by an unspecified person to take ibuprofen as treatment. It was unspecified if the patient sought medical attention. The patient recovered approximately on 12-APR-2013. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration on 19-aug-2021. Concomitant medication was not provided  Treatment information was unknown
2 Vaccines received (pneumococcal polysaccharide in left upper arm and 3rd of Hepatitis B in right upper arm) on Friday 9/19 @ 4P.  Both arms were sore at point of injection.  Pain increased throughout evening, particularly left arm.  Extremely restless sleep.  Sat 9/20 awoke with more pain in left arm, a little decrease in right arm.  Right arm pain almost completely gone by Tues 9/23.  Sat 9/20 evening discovered enflamed area on inner side of upper left arm.  Morning of Sun 9/21 confirmed were slight case of shingles.  Pain in arm decreased by Mon 9/22 evening, still slightly present Tues 9/23 morning.  Redness has decreased to slight pink, sensitive to touch.
Since my injection my hip pain at night us such that I cannot sleep more than 45 minutes at a time. Since I got the vaccine I have not slept more than 3 hours a night or in a 24 hour period. Yesterday July 8, 2021 was the first time I have slept for six hours during the night.
Patient reported redness and swelling at the injection site along with nausea, vomiting and fever
I was diagnosed with shingles a moth later.  On the lower right side of my back. Swollen lymph nodes on the right groin area.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7 year old daughter who, at the time of administration, experienced nasal congestion and later a sore throat.  The pt received a dose on 12/20/03.  The reporter indicated that the pt had no medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/2003.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On the day of administration (12/20/03), the pt, as reported by her mother, experienced nasal congestion (nasal congestion).  Two days later, on 12/22/03, she developed a sore throat (pharyngolaryngeal pain).  On 12/23/03, both the nasal congestion and sore throat persisted.  No additional information was available at the time of this report.
Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,
Patient woke up 1/3/21 with a sore mouth that burns and has skin peeling inside. Patient tried to do a hydrogen peroxide oral rinse that worsened the pain. Patient woke up at 2:00 am 1/4/21 with worsening pain and bigger rash inside of mouth.
3 hrs after vaccine - vomiting, diarrhea, fever-102.6, dry heaves. Runny nose, cough, eye matting, vomiting, loose stools, fever 100 degrees continuing after 3 days.
This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs).  A contactable Pharmacist reported for a patient of unknown age and gender who received PREVNAR 13, at single dose on unknown date for immunization and Epinephrine. Relevant medical history and concomitant medication were not reported. The patient had an allergy at some point to something he got at the dental office that had epinephrine in it. It was not an anaphylactic reaction, it was more of a side effect. He had a fast heart beat from the epinephrine which is expected. The caller was just concerned of the polysorbate in the PREVNAR 13. Pfizer is a marketing authorization holder of Epinephrine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Epinephrine has submitted the same report to the regulatory authorities. No follow up attempts are possible. No further information is expected.; Sender's Comments: Current information is limited for fully meaningful assessment;  Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that allergy is related to PREVENAR 13 administration might not be fully excluded. Fast hear beat is attributable to epinephrine being a treatment for allergy.
Narrative:  Patient got hives after getting imms. Went to ED. Was given steroid and noted to be improving. Today is her last day of steroids. She states hives have gone away. Aside from some restlessness she is experiencing from the steorids, she is doing well. She states she will decline all vaccines from now on.
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director, offered everyone a dose of 0.25ml out of the new unopened vial.
Rash appeared on infant's abdomen, upper limbs and face. It was red, light and flat on 11/11/02 at 18:00.
Woke up at 5am with arm pain that got worse and so bad and started to move into Chest I went to wife who thought I was having heart attack. Dry heaved twice then went to hospital. Did EKG and tested for other issues but all came back normal.
Developed a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COUGH (Developed a cough). At the time of the report, COUGH (Developed a cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was prescribed steroids for his cough. Patient enquired if he can take steroids as treatment for cough post Moderna vaccine shot. Concomitant medications were not provided.  Patient responded follow-up denying the relation between the event cough and Moderna vaccine. He also denied to fill the adverse report form due to his age.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Pneumonia; Flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who had pneumonia and flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient had serious event pneumonia  (unknown latency)  This event was assessed as medically significant.  On an unknown date the patient had non-serious event flu (influenza) (unknown latency).  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events; Sender's Comments: Sanofi Company Comment dated on 19-DEC-2022: This case involves an unknown age and unknown gender patient who had pneumonia and flu after receiving vaccine INFLUENZA VACCINE.  Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed
Feels terrible; Did not sleep last night; Neck is killing them; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), INSOMNIA (Did not sleep last night) and NECK PAIN (Neck is killing them) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007Z21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Feels terrible), INSOMNIA (Did not sleep last night) and NECK PAIN (Neck is killing them). At the time of the report, FEELING ABNORMAL (Feels terrible), INSOMNIA (Did not sleep last night) and NECK PAIN (Neck is killing them) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications was not provided by the reporter. Treatment included antibiotics and stopped.
Fever, muscle aches, severe headache lasting for 24 hours.  On 2/13/2013 armpit of arm where vaccine was administered was swollen with inflamed lymph node.
I?ve experienced much heavier bleeding during my menstrual cycle along with large clotting.
Information has been received from a pharmacist concerning an adult female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.56 ml.  On approximately 18-JAN-2009 the patient experienced nauseous and minor rash.  On an unspecified date the patient recovered.  The patient sought unspecified medical attention.  No further information is available.
Received Varivax 4/27/99 at doctors office. Now has chicken pox disease.
Case number PHEH2012US022820, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 with the follow-up received from other healthcare professional on 17 Dec 2012. This report refers to 23 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11071, expiry date: Dec 2013) in the left arm at a dose of 0.5 ml, intramuscular on 05 Nov 2012 at 11:56AM. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported. Follow-up received on 17 Dec 2012: Updated vaccine batch number, site of vaccination and time of vaccination.
A RN / gave / just the adjuvant of the Shingrix vaccine; A RN / gave / just the adjuvant of the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, patient was just the adjuvant of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Within 24 hrs. of MENACTRA vaccine, pt developed fever (102 degrees), joint pain, fatigue, anorexia. Took ibuprofen 400 mg to reduce fever. Pt. telephoned clinic 4/8/10 to report reaction - fever absent, joint pain and fatigue continue.
Moderna Vaccine 01/27, 2021 Lot No. 041L20A Left Arm. February 3, 2021: Woke up with baseball-like swelling of left upper arm. Huge red rash. Pain. Was very afraid, but felt better when finding an article on-line by MD who also had this and did research and found that 0.8% of people had this during trails. (Covid Arm/delayed curaneous hypersensitivity). This lasted 5 days, treated with lots of ice. Lots of itching. February 24, 2021:  2nd Dose Moderna Lot No. partially covered by black marker on my Covid-19 Vaccination Record Card Right Arm Vaccine at 10:40 AM. Felt fine until evening. Then: Violent shaking of whole body Excrutiating headache Whole body pain Slight fever No sleep that night/freezing with wintercoats and many blankets February 25, 2021: On and off shaking of body Still bad headache Still body pain No fever Could not stand without holding on to the wall or furniture Uneasy light sleep that night February 26, 2021: Extreme weakness and headaches. February 27 Covid arm on right side (injection side). Swollen, huge red rash. Pain. This lasted until March 1,2021.
Five days post vaccination the patient was participating in a cross country meet. While running, the patient lost consciousness and needed to be rushed via ambulance to the emergency department. Patient stated he had no abnormal feelings leading up the the syncopal event. Patient's mother stated he was unconscious for 20 minutes, but she was unable to confirm. Also, stated patient vomited multiple times en route to the hospital. Treatment was performed in the emergency department, so I am unaware of exact therapies.
I was on a trip in another country and another person was coughing, on day three I developed a sore throat my test was positive as was the original person who was coughing. My symptoms were sore throat and headache for two days no respiratory issues. I isolated for seven and returned home well with no symptoms.
Booster; When she got the booster dose the expiration date of the vials is beyonddate. The HCP who administered the vaccine wrote a different expiration date on thevaccination card.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FT8757) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "When she got the booster dose the expiration date of the vials is beyonddate. The HCP who administered the vaccine wrote a different expiration date on thevaccination card.".  Additional information: Patient wants to check the expiration of the lot number. She provided the Lot number FT8757, she said that the Lot number is not clear and she wants to verify the expiration date. When she got the booster dose the expiration date of the vials is beyond date. The HCP who administered the vaccine wrote a different expiration date on the vaccination card.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 4/14/99; on 4/15/99 pt exp LA area of erythema  &induration, tender lt axillary node
patient complained of metallic taste, light headedness, feeling faint, numb face, initial trouble breathing. almost fainted but did not. Called paramedics. Patient recovered and was cleared to leave
got both shots about 1 year ago, had a breakthrough case/suspected Vaccination failure; breakthrough case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both shots about 1 year ago. The patient experienced breakthrough cases. The patient had a breakthrough case last month from the date of reporting and it was not as severe as the others, refer case US2021AMR243458. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation was unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243458:same reporter, other episode
Large area of redness, warmth and hardness with pain present within 24 hrs of vaccination.
p/vax pt exp a horrible varicella rash w/lesions over the entire body;also exp fatigue, h/a & a fever of 101;pt sought unspecified medical attention;
about 4 days p/vax pt exp swelling in feet;later pt gained 1lb/day in water;pt was hospitalized w/30 lbs of water weight/nephritis/nephrotic synd;pt states is better but still has nephrotic synd
none known.  Mother notified of duplicate varicella given by 5 p.m.
States that he woke up on 07/16/10 @ 10:00 AM with Sx of sweating off/on until 07/19/10. Woke up with a headache on 07/16/10 and was constant until 07/20/10. Woke up with a fever on 07/16/10 and had a fever every day until 07/19/10 with the highest being 103.5 pm 07/17/10 and on 07/18/10. Nausea started 3 days later on 7/18/10 and lasted for 15 minutes.