chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient took first dose on 30Mar2021 and second dose on 20Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Psoriasis.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            In March 2021, the patient experienced not taken prescription due to taking vaccines/patient took the covid booster shot and did not want to take humira. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 30-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 20-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna, on 20-Oct-2021, patient received 3rd dose covid-19 vaccine manufactured by moderna, primary reporter declined to be contacted.   No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
My son was given this WITHOUT MY PERMISSION. I found this record in 2019 in transferring records. This incident caused my son two emergency room visits, seizures, anaphylactic episode with profuse vomiting, face swelling, throat closing, and triggered PANS disorder and mast cell activation syndrome to worsen in my son causing many, many doctors appointments to calm.  I do have documentation in correspondence with his integrative doc and ER records.
an improperly stored dose of GARDASIL 9 was administered; No adverse effects; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On an unknown date, the patient received improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952, expiration date 14-JUN-2020, dose and route of administration were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature of below 36 degrees Fahrenheit (32.1 degrees Fahrenheit) for 8 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects.
Patient daughter called today about an allergic reaction to the Shringrix vaccine her mom received on 11/29/19. She has red spots on her body and face. I asked her did she experience any difficulty breathing and she said no. I told her to contact her Dr. and we would follow up on the following day.
Itching, redness, swelling, ice pack placed on injection site oral prednisone and cortizone shot.
Chills; This is a spontaneous report from a contactable consumer. A unspecified aged female patient, received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in May2021 the patient experienced chills. It was unknown whether therapeutic measures were taken as a result of reported event. The clinical outcome of the event chills was unknown, at this time of this report.  No follow up attempts are needed; Information on lot/batch number has been requested.
expired Ipol vaccination had been given today, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00533950) and transmitted to Sanofi on 24-Mar-2021.  This case involves a patient (unknown age and gender) who was administered an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot R1V25, expiry date: 13-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Expired Ipol vaccination had been given to consumer. Patient wants to know if it needs to be given again. Expiration 13 Mar 2021 Additional Description of event Adverse events :Caller states that she has no additional information.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented to Health Department on 11/05/2012 and has complained of right arm pain (upper and lower forearm) with movement of extremity.  Also pain with pressure to area and unable to sleep on that side.  No visible swelling, inflammation, redness.  Area of 3 cm bruising noted below deltoid but states area of pain is in deltoid region.  Patient denies trauma to area.
Information has been received from a health professional concerning a 12 month old female with a penicillin allergy and no other medical history who on 6/21/06 in the PM was vaccinated IM previously reported S IV in the right thigh with a first doe of MMR II/Varicella vaccine (lot #652233/0844R). There was no concomitant medications. There was no illness at the time of vaccination. On 6/22/06 the pt developed right thigh swelling. It was previously reported there was no adverse event. Unspecified medical attention was sought. No lab test were performed. The pts outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
pt has swelling at the deltoid muscle and warm to the touch.  recommended benadryl and to use a cold compress
Patient asked for her blood pressure to be checked approximately 10 minutes after receiving her COVID vaccine.  Reports a history of hypertension.  Has been prescribed an unknown blood pressure medication but has not taken the medication for "a long time."  Denies SOB or headache when asked.  Blood pressure recorded as follows: 1:10pm 178/119 Pulse=83 O2 Sats=98 1:15pm 185/120 1:20pm  198/125  1:25pm 155/112 1:26pm 157/111 Suggested patient go to ER for follow-up.  She agreed.  Her employer transported her to Hospital at approximately 1:40pm.
Body aches- 24 hours; joint pain- 24 hours; lymph node swelling under arm and across breast - 2 weeks; chest and head congestion -24 hours
On June 5th while running a race I experienced extreme fatigue, overheating, jaw pain, and shortness of breath. I thought I was suffering from heat exhaustion, but after several days, I was still short of breath and experiencing tightness in my chest. It continued to worsen, making it difficult to breath while walking, and eventually just sitting. I was told by my doctor report to the ER on June 14th. I was admitted that day due to elevated troponin levels. I had an EKG, chest x-ray, and ultrasound of the heart. On June 15th I had a cardiac catheterization. No blockages were found. I was sent home, but continued to experience shortness of breath and tightness in my chest. I went back to the doctor who was concerned about a pulmonary embolism. I had at CTA scan which showed no clots. The symptoms continued. On June 21st I went back to the doctor, who scheduled a pulmonary function test. I had that test on June 24th. It indicated that my lungs had some "blockage" (sorry, I don't know the exact terminology). I was given a prescription for Symbicort. I also had a follow-up visit with a cardiologist on the 24th. They have concerns about myocarditis and have scheduled me for a cardiac MRI.
1/12/21 am - woke up with severe headache, pressure behind my eyes, dizzy and chills.  Was unable to work that day 1/12-19/21 - extreme fatigue with intermittent dizziness and mild headache 1/19/21 - woke up with same severe headache and pressure behind my eyes that I experienced on 1/12 2/10/21 - had same type of headache and pressure behind my eyes as previously, only not quite as severe 2/11/21 - discussed symptoms with our employee health nurse and she advised to fill out this form
Sore, red, swollen upper arm. ?COVID Arm?  Painful, itchy, splotchy inflamed rash-like shape.  Tired
This spontaneous report as received from a health worker refers to a 4 months old patient. The patient's pertinent medical history and drug reactions or allergies were not provided. On 14-AUG-2012, the patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # and exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information is not expected.
developed hives within an hour; This is a spontaneous case received from a contactable consumer from a Pfizer-Sponsored Program.   A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. According to the reporter, the patient received second dose of vaccine and developed hives within an hour and has not gone away. The outcome of the event was not recovered.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, vertigo, lightheadedness, mild headache, nausea, chills, body aches, loose stool.
Patient reports her heart racing. She reports having history of anxiety and is anxious. EMS assessed patient and her EKG was normal. Patient refused to be transported to ER and was cleared by EMS.  BP = 178/102 HR = 125
Felt sick; Bad rash; Injection site got swollen; Numbness in right side of face; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), HYPOAESTHESIA (Numbness in right side of face), RASH (Bad rash) and VACCINATION SITE SWELLING (Injection site got swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt sick), HYPOAESTHESIA (Numbness in right side of face), RASH (Bad rash) and VACCINATION SITE SWELLING (Injection site got swollen). At the time of the report, ILLNESS (Felt sick), RASH (Bad rash) and VACCINATION SITE SWELLING (Injection site got swollen) outcome was unknown and HYPOAESTHESIA (Numbness in right side of face) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details included Benadryl after the first dose adverse event.   This case was linked to MOD-2021-314623 (Patient Link).
arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via call-center (Reference number- 00342292) and transmitted to Sanofi on 02-Nov-2020.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 36-years-old female patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.
Swelling in her lower left arm, as well as her glands; Swelling in her lower left arm; felt a Sensitivity under her left arm pit. / felt like a "nerve sensitivity"/ Sensitivity in lower left arm, as well as glands; Sensitivity under her left arm pit/ felt like a "nerve sensitivity", and it only hurt when she stretched her left arm; Muscle Aches in her left arm; This case was reported by a consumer and described the occurrence of swollen glands in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR043313).   On 27th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 27th January 2021, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On 29th January 2021, the patient experienced increased skin sensitivity and axillary pain. On 15th February 2021, the patient experienced swollen glands and swelling arm. On 1st February 2021, the outcome of the myalgia upper extremities was recovered/resolved. On an unknown date, the outcome of the swollen glands, swelling arm and increased skin sensitivity were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the swollen glands, swelling arm, increased skin sensitivity and myalgia upper extremities to be related to Shingrix. It was unknown if the reporter considered the axillary pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix in left arm and she experienced muscle aches in her left arm for five days. Approximately 2 days after receiving the vaccine, the patient felt a sensitivity under her left arm pit which felt like a nerve sensitivity, and it only hurt when she stretched her left arm.  Till the time of reporting, the patient was experiencing sensitivity and swelling in her lower left arm, as well as her glands.  The patient was referred to a physician. The reporter did not consent to follow up. All information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043313:1st dose, same reporter
8/7/21  I noticed rashes and hives around injection site that went away the same day. 8/7/21 7p.m. I experienced strong headache and arm pain. Headache went away the same evening but severe arm pain started and lasted until the late evening on 8/9/21. 8/8/21 and 8/9/21 I was having nausea off and on that went away.  I though previously described side effects are fairly common and did not raise any alarms but my next symptom got me little worried so I decided to write the report. 8/9/21 in the evening I felt knife like stabbing pain between my breast towards left breast (3 times for a second ) that went away. Next day I had little discomfort between breast day but today I feel ok. Please let me know if I should pay a visit to cardiologist since they are warned me in the waiver about potential heart problems. Thank you.
Redness and soreness and a lump on front of left arm below and towards the body from where the shot had been given. The redness and soreness extended down into the top of the top and right side of the arm pit.  Symptoms were first noticed the afternoon after receiving the shot. A visit to the Dr. office the next day. Dr. was puzzled by the reaction, suggested taking Benadryl that night and the next night which I did. She was not sure if it was an allergic reaction or an infection. She also gave me a prescription for Doxycylene if the redness and soreness did not go away. The redness has gone away. the lump has reduced although is still there and less sore.
Initial consumer report received on 10 Mar 2010: This patient received FLUVIRIN (batch number unknown), unknown dose, intramuscular on 28 Nov 2009. On an unknown date, two weeks later after vaccination in Dec 2009, the patient experienced rash on arms, armpits, and legs and got itchy, 3 to 6 hours after consumption of shellfish, beer, steak, beef, and milk. It was reported that the patient experienced the above reactions whenever the patient consume any of the above-listed foods and beverages. It was reported that the patient had never experienced this reaction's prior to receiving the vaccine, and that the patient was able to consume these items prior to receiving the vaccine without any reactions. The outcome of the events was reported.
Within 24 hours developed Fatigue. Then developed benign positional vertigo. Symptoms resolved after 3-4 days. But BPV returned again on 4/15, 6 days after vaccination .
After my vaccination I experienced clamminess and fatigue.  I was given a drink of juice by the nurses and I felt ok afterward. Now I'm experiencing heart palpitations and cold hands and feet.
During the 15 minute observation period, patient started to have shortness of breathe and became flush coloring
Lethargy; Mild headache; chills; Mild soreness; Restlessness followed; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via unspecified route of administration in the right arm on 16Mar2021 at 09:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient had no medical and known allergic history. Concomitant medication included glucosamine (MANUFACTURER UNKNOWN), one a day for men at the age of 50 plus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient had experienced mild soreness, 11 hours later at 22:00 severe chills which were strong enough that the patient could not carry a glass of water without spilling it and restlessness followed. On 17Mar2021, next day the patient experienced lethargy and mild headache which continued in the evenings for 2 days. The Patient did not receive any treatment for the events. Event had not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes for the events chills, was recovered on 17Mar2021 at 02:00, lethargy and mild headache were recovered on 19Mar2021, restlessness and soreness were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Covid-19; Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035f21A, 024M20A and 032M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-May-2022 to 02-May-2022 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021). On 15-May-2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021) outcome was unknown.            Company comment- This spontaneous concerns a 66-year-old female with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 6 months and 4 days after the third dose of mRNA-1273. Inappropriate schedule of vaccine administration was noted in the case (19 days between dose 1 and 2). No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. report.   This case was linked to MOD-2022-577163 (Patient Link).; Sender's Comments: This spontaneous concerns a 66-year-old female with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 6 months and 4 days after the third dose of mRNA-1273. Inappropriate schedule of vaccine administration was noted in the case (19 days between dose 1 and 2). No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. report.