chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse via company representative and refers to a currently 17 year old female patient (daughter of the nurse). Patient's medical history, concomitant therapies or drug reactions/allergies were not reported. On 25-FEB-2009, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). Other suspect therapies included an unspecified meningococcal vaccine and an unspecified Tdap vaccine, received on the same day. On 27-APR-2009, the patient was administered with her second dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). On 27-AUG-2009, the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, dose and route of administration not provided). On an unknown date in 2010 (reported as 6 to 8 months after the last dose of GARDASIL), the patient started to experience cold and numbness in her feet and was diagnosed with Raynaud's syndrome. On an unspecified date (reported as recently), the patient was also diagnosed with lupus. The outcome of lupus and Raynaud's syndrome was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, lupus was determined to be medically significant. Additional information has been requested.
She had 10 days of intermittent fevers and fatigue. She had a negative Covid test. Had labs done and had elevated liver enzymes. Tested positive for Mononucleosis. About a month later her liver enzymes were normal again.
Headache, Sedation, INJECTION SITE PAIN Narrative:  Other Relevant History:
Sick All Day; Low Grade Fever; Chills; headache; Fatigue; Arm swollen and puffy at the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick All Day), PYREXIA (Low Grade Fever), CHILLS (Chills), HEADACHE (headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ILLNESS (Sick All Day), PYREXIA (Low Grade Fever), CHILLS (Chills), HEADACHE (headache), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm swollen and puffy at the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date at an unspecified dose and frequency. On 01-Feb-2021, ILLNESS (Sick All Day) had resolved. At the time of the report, PYREXIA (Low Grade Fever), CHILLS (Chills), HEADACHE (headache), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm swollen and puffy at the Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter.
The patient has complaint of soreness in his shoulder that has persisted from time of injection. It is worse in the morning and gets better throughout the day. He has been using a pain cream, and that has helped. He also said that when he wakes the pain is on both sides and then subsides to his right shoulder. The patient denies any arthritis, and his doctor ruled that out as well.
The same day post vax, the pt experienced dizziness, nausea, abdominal cramping, aching, and malaise.
Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
1 day after vaccination - chills, fever, headache. 5 to 7 days after vaccination - inguinal lymphadenopathy and penile edema (Physician description)
Information has been received from a certified medical assistant (CMA) concerning a 4 month old male who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. Additional information has been requested.
Anaphylactic reaction after first Moderna Vaccine dose; A spontaneous report was received from a pharmacist concerning a female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The pharmacist reports the patient developed an anaphylactic reaction with no other details. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed anaphylactic reaction, was considered unknown.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant. The event occurred at unknown time after received their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Patient came in for the flu and pneumonia vaccines, pt had gotten both in the past and pt had a previous stroke leaving the (R) side paralyzed: both vaccines were given 1 inch apart in the (L) arm. About a few moments after the shot the pt complained of chest pain. Ambulance was called & pt taken to ER.
Patient complained that 3 days after getting the flu shot she had tightness , red, swollen, and painful right upper arm. There were little flat rashes that were not itchy . Patient took Tylenol for the pain. Her arm is getting better after 3 days and is going back to normal.
About 20 hrs after vaccination had flu symptoms temp 102,9, chills, dizziness, fatigue. Felt better on Sunday. Monday night started having severe joint pain in both knees and right ankle.  Woke with 103 temp. Developed a rash and itching over my entire body. Still having severe joint pain.
Began to notice chills around bed time, along with severe headache and muscle weakness.  Continued through the night and as of this writing is continuing.  FYI, I had COVID 19 in January 2021.
Initial misuse report received from a healthcare professional on 24 January 2013. A patient (No information was provided regarding the patient) was administered an expired dose of MENOMUNE. No adverse event was reported. List of documents held by sender: none.
45 min after vaccines  , patient started  laughing for no reason , throwing his goose and says fly fly , he acted  like a  high mood person , lasted  for  couple hours before he is back to him self
autoimmune myositis, fasciitis, anemia, chronic autoimmune disease.  Patient developed symptoms in ipsilateral arm about 3 weeks postvaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing.  07/09/2008 Office notes received from Rheumatologist from 9/7/2007 to 4/03/2008 with DX: Myositis/Fasciitis L arm.   Pt developed L shoulder pain and decreased ROM in 8/2007 which has persisted. Pt then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. PE (+) for TMJ pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the L forearm. Pain upon dorsiflexion of L wrist. Swelling noted on L forearm. Started on Pred.  Much improved by 10/11/07 with Pred taper scheduled. Increased pain with decreased pred. Dose increased and Methotrexate started. Episode of inflammation L leg (ankle and shin pain) 4/2008.
Body feeling achey, hungry, later developed chills, headache behind the eyes, fatigue, fever
Has diffuse maculopapular lesions on thorax and upper extremities consistent with generalized vaccinia.  No systemic symptoms at this time.  No pustules. Had general malaise for 3 days ending yesterday, otherwise feels fine.  Vaccination site normal.
Ear pain; Sore Throat; This spontaneous case was reported by a pharmacist and describes the occurrence of EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Dec-2020 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) to be possibly related.    No concomitant information provided. No treatment information provided.   This case was linked to MOD-2020-001825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: The reporter information, patient identifiers, event details and vaccine information were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
No adverse effect reported; one patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.    On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R023499 with an expiration date on 13-FEB-2020 and lot# R026722 with expiration date on 17-MAR-2020 (dose, route and site of administration were not reported) indicated for prophylaxis, which were reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) (lot# and expiration date was not reported).  The nurse did not have the specific lot and expiration date of administered vaccine to the patient, but it was one of the listed above.  No adverse effect reported.       The administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) experienced two temperature excursions, one on 12-AUG-2019 and the other one was on 13-AUG-2019 for a time frame of  -14°C Celsius degrees to -10 °C (-11.91 °C) for 8 hours, as recorded by a data logger.   There were no previous excursions reported.
detached retina; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETINAL DETACHMENT (medically significant), outcome "unknown", described as "detached retina".  Clinical course: It was reported that, the patient had a detached retina, the Pfizer vaccine and no other medical reason doctors could find for a detached retina.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported serious event Retinal detachment cannot be excluded for the suspect product BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
VAR vaccine (R) arm, local reaction 15cmx45cm Red, Denies pain.
11 year old, felt dizzy, diaphoretic low blood pressure after MMR given. Heart rate low she did faint but was arousable. BG 77. Placed supine with legs elevated. Given low flow oxygen. Vitals monitored. She recovered. Soda given to increase blood sugar. No S/s of hives, swelling or shortness of breath. No difficulty swallowing.
patient presented with redness, swelling near injection site. site was marked and patient counseled to apply cold compresses and check in with physician if not resolving in a few days
Circular rash appeared on 1/12 with induration - tender. 1 day later, became itchy.
I had a fever, I threw up three times, had a head ache, and could only breathe in and out like this (exhale, stop, exhale, stop, exhale, stop, inhale stop, inhale, stop,  inhale, stop) for like an hour or two. I was on a scale, from 1 to 10,  it was a negative one and I almost went to the hospital.
Headache, shivering , fever, fatigue. My fever spiked at 102 degrees. my symptoms lasted for 36 hours.
I was unaware that there was latex in the syringe when the vaccine was administered. Over the period of two weeks I developed pain at the injection site, nausea, fatigue, and lymphedema in my breast. It took approximately six weeks to figure out and track back the cause to the flu shot and the latex. Treatment was Benadryl and ranitadine.
Right upper arm - erythema, edema and warmth, nontender Benadryl q 6 degree pm, 1 cc to arm
This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. On 18-MAR-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous. Dose, dose number and lot number were not reported. The physician reported that the patient developed shingles after vaccination. The patient sought medical attention via a phone call. The outcome of shingles was reported as not recovered/not resolved. Reporter causality assessment was not provided. Additional information is not expected.
pt recvd vax 16SPE94 & devel h/a, chills, crying spells w/in hrs p/vax; pt returned to office 19SEP94 w/presistant sx;
my face started to feel tight, feeling as through I was getting a sore throat, lips and tongue started tingling.   All symptoms were minor and lasted about 3 hours.
Nausea vomiting fever fever chills body aches migraine. Fatigue. Weakness
This case was reported by a consumer via call center representative and described the occurrence of shivers in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivers. On an unknown date, the outcome of the shivers was recovered/resolved. It was unknown if the reporter considered the shivers to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that, after taking the vaccine she had shivers for three nights and then the shivers stopped.
Per mom, post vax, at approx. 11:00, the pt took 1 oz of formula and fell asleep. She was awakened at approx. 16:00 and she refused to eat. She started crying non-stop at 17:30 to 19:30, and then fell asleep at 19:45. At some time this evening, her temperature climbed to 103.2F and she was taken to ER. In ER she was vomiting and was given suppositories at ER. On 8/30/01, she was taken to a pediatric doctor and blood and urine samples were taken. She was given a shot of Rocephin at this time. Both legs were red and swollen at injection sties. On 8/31/01, she was taken back to the doctor because of continued diarrhea and vomiting. Another shot was given; mom is not sure what it was but she thinks it was Rocephin. On 9/1/01, mom states she took some Pedialyte but pushed nipple back on formula. She had less diarrhea and vomiting today. On 9/2/01, the baby took 12 oz of formula today. No Pedialyte offered. but less diarrhea and vomiting than yesterday per mom. On 9/3/01, mom felt she was "turning around" for the better by today. The way the baby acted, ate and slept, she was better. On 9/5/01, she was seen again by the doctor for a check-up. Baby was back to "normal" per the doctor and the mom.
Extreme sore throat on Saturday (two days after the shot).   AS of today (4/21/21) her throat doesn't hurt doing the day but hurts at night.   Patient has an appointment with her physician  on 4/22/21 (was already scheduled).
Severe,debilitating pain in arm that received injection.  Pain concentrated in neck and down arm ending just below elbow joint.  Treated with heat and Vicodin (Ibuprophen offered no pain relief).  Pain still mild/moderate at time of submission of this report (9 hrs post injection)
After the first few days, I was tired as I knew I would be. Then I started getting dizzy and having heart palpitations. I normally work out a lot and I couldn't even walk around the block. I got very dizzy and felt like I was going to pass out. That's what it has been so far. I get heart palpitations and I get exhausted every time I exert energy. It doesn't seem to be getting any better. It just seems to be getting worse. I did call the doctor on Wednesday and they say saw me on Thursday. They ran a lot of lab work and everything seems to be normal so far. I will be following up with them.
Immediate flushing, red face, hard time breathing, chest pressure , dizziness.   Pharmacist gave Benadryl tablet.  Symptoms eased after a few minutes.
MMR vax given 15APR onset painful knees approx 1MAy; unresponsive to NSAIDS;  referred to rheumatologist who felt it was not vax related; eval by MD was chondromalacia patella; h/a, achiness w/some swelling; cyanosis; peripatellar erythema
had, headache, body aches, chills ,GI upset, heartburn,  sweats the next day. then 2 days later had loose stools,  day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
pt recv vax 24MAY95 & 16APR97 pt devel a moderate case of chickenpox;it was reported that pt had pox on every eyelid & mucous membrane;
1 of 4 pts vaxed w/Td vax exp an inject site react of erythema & induration; pt recovered;
After the last of the vaccines were administered, the pt slumped over in the chair, his body became rigid and he appeared to have a seizure. After the seizure, he was unresponsive to ammonia inhalant, verbal and tactile stimulation for about 5 minutes. Paramedics called and he was taken to the ER.
Left upper arm with erythema, warm, lymphadenopathy, firm.  Follow up - Patient last name needs to be correcte4d. Record updated.
Pt complains of flu like symptoms and "feeling awful" for 12 to 36 hours after receiving the shot. Also states she has a sore arm with a "welt" at the site of injection for 4 days after receiving injection.
Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face Higher than normal blood pressure  Sensations started earlier in the day on Saturday.  On Sunday at 1pm, she went to the hospital and the symptoms stayed until 6pm.  She was sent home from the hospital with diagnoses of parasthesia and numbness. Sensations started again earlier today, Wednesday the 27th.  Called the doctor and said there isn't much they can do because they don't know much about the vaccine.
Itching and rash arms, chest, back 20 mins after seasonal flu vaccination. Treated w/BENADRYL 25 mg PO.
Something that people are allergic to in a regular flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic to vaccine. The reporter did not consent to follow up. This case has been linked with US2020AMR193688, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193688:grandson's case
1st shot: the following morning felt like I had a cold.  symptons over by noon  2nd shot: felt good and got sleepy early and am sleepy the next day, sore arm for 24hrs then all good!
Fever; Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free. On 05-Nov-2021, the patient experienced EPISTAXIS (Nose bleeds). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, EPISTAXIS (Nose bleeds) was resolving and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
Narrative:  Pt, is a 65 y.o. FEMALE who presents noting she got her "pneumonia shot" in her left arm earlier this week. Since then has had hive / swelling in left arm around area of shot. gradually improved with benadryl no swelling of lips, tongue. no difficulty breathing. gradual in onset. moderate. Patient was also treated with Solu-Medrol
Information has been received from a physician concerning a patient who was vaccinated with Pneumovax 23. The physician reported that the patient had a headache. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.