chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of retinal bleeding in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 4 to 5 years before the reporting date). On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th December 2018, 1 days after receiving SHINGRIX, the patient experienced retinal bleeding (serious criteria GSK medically significant), eye hemorrhage (serious criteria GSK medically significant), eye floaters and headache. On 18th December 2018, the patient experienced blurred vision and visual impairment. The patient was treated with Aspirin and TYLENOL. On 18th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the retinal bleeding, eye hemorrhage, eye floaters, blurred vision and visual impairment were not recovered/not resolved. It was unknown if the reporter considered the retinal bleeding, eye hemorrhage, eye floaters, headache, blurred vision and visual impairment to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left deltoid. The nurse reported that she experienced headache the next morning when she awoke around 7 am and she took an Aspirin. The patient had a few dark squiggly lines in her eye. The patient had a headache again on 16th December 2018 and she took TYLENOL and it resolved. On 18th December 2018, 4 days after receiving vaccination, the patient had dark squiggly cobwebs or floaters in her left eye from 5:30 to 7 am and it was blurry and hard for her to see out of that eye. The patient went to an ophthalmologist and he claimed that she had a retinal bleed or hemorrhage in her eye. The ophthalmologist told her that blood was causing the floaters which was obstructing her vision. The patient felt like the left eye was underwater and she cannot see out of it. The patient was planning to return for a follow-up doctor appointment on 28th December 2018. The reporter was a nurse and does 24 hour nurse shifts. The patient also reported that she was healthy and had a 105/69 blood pressure with no previous issues. The reporter had consented to follow up and had provided physician's contact details.
Expired vaccine was administered.  Expired June 24, 2023.  The expiration on the syinge was printed as "23JUN24" and was interpreted as June 23, 2024.
Patient had tenderness and pain at the time of the vaccine on 1/31/21.  On  2/1/21, patient woke with severe headache in morning which persisted throughout the day; also had fatigue and body aches, found it  hard to move arm , the site was inflamed and swollen . Patient napped all day. Today, 2/2/21 patient's  left arm pain is mild and getting much better; headache, body aches, and fatigue have gone away.
pt recvd vax & devel t102 in evening & exp some type of sz was brought into hosp adm overnoc;
This case was reported by a physician and described the occurrence of a injection site reaction in a 2 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This case was initially reported by a nurse who stated that two patient's experienced an injection site reaction following the administration of Infanrix, however, identifiers were only provided for one patient. On 8/26/04, the patient received the first dose of Infanrix in the right thigh. On 8/26/04, the patient also received injections of poliomyelitis virus vaccine and Haemophilus influenzae type B conjugate vaccine in the left thigh. Immediately following the administration of Infanrix, on 8/26/04, the patient experienced redness and swelling at the injection site on the right thigh. The event resolved approximately 10 minutes later. The reporting physician considered the event to probably be related to vaccination with Infanrix.
A consumer report has been received, concerning a 23 year old male patient, height: 78.0 inches; weight: 205.0 pounds. No concomitant medication or relevant history was provided. On 27-Sep-2012, the patient received nasal FLUMIST. On 28-Sep-2012, 27 hours after administration of FLUMIST, patient's body was covered in hives, started with minor hives on elbows and stomach rapidly spread over entire body excluding genitalia. The patient was treated with BENADRYL, ZANTAC and prednisone. The action taken with FLUMIST was unknown. At the time of reporting, the event of body covered in hives was improving. The report was considered to be non-serious by a company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 01-Oct-2012 from consumer: country of case changed, reporter information updated, patient's DOB, height and weight, date of vaccination, event onset date provided, outcome added as recovering. Narrative was updated. Corrected report 17-Oct-2012: New reporter added with reporter type Patient, as the consumer was reporting about himself.
On 07-15-21 we had a nurse vaccinating for Pfizer at one table and a nurse vaccinating for Janssen at another table. Each table keeps their vaccines in color coordinated boxes that is assigned for each vaccine being administered. At approximately 12:20PM the nurse who was vaccinating Janssen closed her pink box labeled J&J and stepped away 6 feet from her table to speak to the service representative that was checking in our patients. Unbeknownst to us, the nurse vaccinating Pfizer walked to the other table and grabbed vaccines from the pink box labeled J&J and took them back to her station and put them into her clear box. There were a total of 2 vaccines taken from the Janssen box. At approximately 12:45PM the nurse vaccinating Janssen returned to her table and noticed that two vaccines were missing from her box. The other nurse then proceed to give her one back. The nurse vaccinating Janssen immediately brought the syringes to a supervisor for disposal. Based on the timeline we have compiled a list of patients that were vaccinated by the nurse who took the Janssen vaccines. Patient was to receive his second dose of Pfizer but now based on the above instance we are unsure if he was given Janssen. Administration has been made aware of the instance and one of our MDs notified the patient.
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something.  (I had already had lunch and a snack).  That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired.  I had some problems catching my breath when climbing stair and  and at one point felt hot and clammy.  Headache was better.
Pt. recieved 1st dose of Moderna vaccine on 5 Feb and presented to the ED with new onset AFIB & abdominal pain on 5 Feb.  Patient was discharged on 17 Feb.  Home course unknown
Back pain; Knee pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache). At the time of the report, BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Reporters causality of events with Humira was no reasonable possibility.  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
Dizziness, Myalgia, Fever, SkinRash, NauseaVomiting, Palpitations, Tachycardia, Tingling throat, lips, tongue. Lip swelling. Severe arm pain at site, sore throat, nasal congestion
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 19-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Day after the dose was administered: Fever of 99, pain/soreness/swelling at site of injection, tiredness Two days after the dose was administered: Fever of 101, pain/soreness/swelling at site of injection, tiredness, headache, aches Three days after the dose was administered: pain/soreness/swelling at site of injection, tiredness, aches
Extreme swelling and pain in both hands. Left eye lid swelling. Intense ongoing headache. Hives on head and stomach.
Breakthrough case admission after 2 vaccines Pfizer 3/31/21 Lot# Ew0150;  Pfizer 4/21/21 Lot# Ew0169
High fever (102.6 F oral), chills, nausea/vomiting, headache, anorexia, fatigue, (L) deltoid induration at vaccination site. Seen in urgent care clinic 3/14/14 and 3/15/15. Follow up with MDs on 3/17 and 3/19. Pt reported nausea started 3/13. Dizziness 3/12 at night. Tx: Pt received IV fluids, ZOFRAN, ice/heat to injection site.
Patient had 2 doses of Pfizer COVID vaccine, on 1/23/21 and 2/13/21.  Patient was hospitalized for COVID symptoms starting 9/24/21 and remains hospitalized today, 9/27/21.
As the patient's Dad drove drove down the street after leaving the clinic, he observed patients eyes roll back and her head slumped. He raised her head and she aroused. He reports that she was unresponsive for 15-20 seconds. He immediately returned to the clinic. Patient was ambulatory and oriented. Her color appeared pale. Her hands were clammy. RN asked her to sit and elevated her feet. Patient reported that she had eaten only crackers and Muddy buddies for lunch. RN gave her 2 granola bars and a glass of water followed by Cran/grape juice and a bag of peanuts. Vital signs were taken q 15 minutes and patient was observed for 30 minutes. She appeared to recover fully.
Site: Pain at Injection Site-Medium, Additional Details: Pt came into pharmacy march 4 2023 complaining of pain at injection site from shot given in september.  Had appt with primary care Dr. referred to orthopaedic md pt would like follow up
Pt recvd Engerix-B series (3 doses) & pt reported as being a "nonresponder" plan to "administer additional doses";
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No Known allergies. On 29May2022 patient received other medication in 2weeks it was Tylenol stopped on 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
lightheaded for 2-3 weeks; sore under armpits (lymph nodes); The pain at times is bad; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW6200) on 19Mar2021 at left arm for COVID-19 immunisation. Medical history included high cholesterol and allergies: Sulfar, penicillin. Historical vaccine included 1st dose of BNT162B2 (lot EL9262) on 26Feb2021 at left arm for COVID-19 immunisation with adverse event lightheaded and dizzy. Concomitant drugs included ibuprofen, simvistatin, paracetamol (TYLENOL) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was lightheaded for 2-3 weeks, sore under armpits (lymph nodes) which was still effecting her 2 weeks after the second dose was administered. Event resulted in Doctor or other healthcare professional office/clinic visit and no treatment was received except paracetamol or Ibuprofen for pain. She was concerned about this because it was affecting her life and job. The pain at times was bad (She used heating pad to relieve pain). The patient reported lightheaded, dizzy and pain underneath the arm pits, she guessed in the lymph nodes. She was curious as to how long those lymph node pains were going to be around because sometimes it's so painful that she thought she was having a heart attack but people say - No, that's lymph node which is going into your breast. She was concerned about how long this was going to be happening to her or what she was supposed to be doing. Covid test with nasal swab on 17Mar2021 was negative. The patient had complete blood count, urine analysis, Lipid Panel for Cholesterol. The outcome of the events was not resolved.
approximately 10 minutes after receiving the vaccine patient suddenly felt flushed and hot, noted a headache and wanted to lie down on the floor.  Patient was transported to ED.  Patient stated headache not out of the ordinary for her as she has chronic migraines.  patient given Normal Saline IV, Fioricet for headache and zofran for nausea.  Patient discharged from ED with no further issues.
Patient received an unknow COVID-19 vaccine of either Moderna or Janssen outside of the 6 hour window of vaccine vial puncture. Incident was discovered after patient left facility. Patient was called once incident was discovered the same day. Patient was followed up on 30 hours after vaccination as well. Patient stated he had a non-severe diarrhea and sore all over that he did not need to treat. Patient was given facility after hours phone numbers to contact if other symptoms occurred and was instructed to call 911 if emergency occurred.
A little bit of fatigue the 2nd time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little bit of fatigue the 2nd time) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029120A) for COVID-19 vaccination.     The patient's past medical history included Flu.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, 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 experienced FATIGUE (A little bit of fatigue the 2nd time). At the time of the report, FATIGUE (A little bit of fatigue the 2nd time) outcome was unknown.            No concomitant medications were reported. No treatment medications was provided   This case was linked to MOD-2021-381236, MOD-2021-381265 (Patient Link).
Sudden onset of tachycardia and heart dysrhythmias. On or around Monday September 27th while lying in bed I felt my heart skip a beat and then has some tachycardia. On Friday October 1st while driving my heart again went into tachycardia and I was seen in the ER and upon arrival my heart rate was 172 and my BP was elevated and I was told by the ER staff that they believed I had a run of SVT. Had another episode on 10/08/21, 10/09/21 and 10/21/21. I made an appointment with a cardiologist and he has diagnosed it as AV nodal re-entry tachycardia or PSVT.
Sensation of heat; Tenderness; Head pressure; Head pain; severe migraine; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (severe migraine), FEELING HOT (Sensation of heat), TENDERNESS (Tenderness), HEAD DISCOMFORT (Head pressure) and HEADACHE (Head pain) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MIGRAINE (severe migraine). On 20-Jan-2021, the patient experienced FEELING HOT (Sensation of heat), TENDERNESS (Tenderness), HEAD DISCOMFORT (Head pressure) and HEADACHE (Head pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. On 19-Jan-2021, MIGRAINE (severe migraine) had resolved. On 20-Jan-2021, FEELING HOT (Sensation of heat), TENDERNESS (Tenderness), HEAD DISCOMFORT (Head pressure) and HEADACHE (Head pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Advil.    This case was linked to MOD-2021-029505 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on the 27-Apr-2021, Patient endorsed to feeling fine, and requested no further follow-up.
severe headaches at the back of my head with neck pain since I took the vaccine till today 4/26 Nausea  occasionally Tiredness occasionally
A report has been received from a physician via medical representative concerning an 8 year old, female patient. The patient's concomitant diseases included mild upper respiratory (viral) symptoms at the time of the vaccine. Concomitant medications were none. On 19-Feb-2013 the patient received nasal FLUMIST. She received previously FLUMIST, without any adverse event. The patient experienced severe rash which started on 24-Feb-2013 and urticaria. Her rash appeared firstly on her abdomen and lower back. The patient responded to BENADRYL, but the rash reappeared on her shoulders and face. She was treated with BENADRYL again. The action taken of FLUMIST was not applicable. The patient recovered from the event of rash on 26-Feb-2013 and the outcome of the event of urticaria was unknown. The event of rash was considered to be non-serious by the reporter. The event of urticaria was considered to be non-serious by company physician. The event of urticaria have been identified by the company physician from the source document and added as adverse event. Summary of follow-up information received by AstraZeneca/MedImmune 06-May-2013: Patient initials corrected. The event as reported term of Rash over her back changed to Rash. Event onset- and stop date was provided. (From 24-Feb-2013 to 26-Feb-2013). Start date of FLUMIST completed as 19-Feb-2013. Lot number was provided. Concomitant disease added as mild upper respiratory (viral) symptoms at the time of the vaccine.
I had threatened preterm labor at 32 weeks of pregnancy. This was my 4th pregnancy and had never had issues with preterm contractions previously. At delivery I ended up with a c section at 39 weeks and a placental abruption was noted. My baby has extensive macular stains (stork bites) on her face. Shortly after birth she was diagnosed with laryngomalacia.
Imediate pain within 10 minutes of injection, still unresolved.  Diagnosed by chiropractor with localized myositis in her left arm.  Inflammation causing arm to be over an inch larger than her right arm.  Applies heat 2-3 times a day and is continuing to receive treatment by chiropractor.  Pain continues, especially when she lifts her arm.  At least 5 others with same symptoms received same lot at a small flu clinic.
1 day of local erythema of skin approx 10 cm in diameter, no induration.
Case previously recorded as MA2009-4602. Case report received from a physician via MedCom, on 18 NOV 2009. 21 month-old male patient was vaccinated S-OIV FLUVIRIN (batch no. 102044P1 ) i.m. on 18 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. MedCom reference no.: NA09-008466.
A non-serious spontaneous report of fever, cough and nasal congestion has been received from a consumer concerning her child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for the patient. On an unknown date, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion. The outcome of the events of fever, cough and nasal congestion was resolved. Additional information was received on 15-Apr-2011 and incorporated into the narrative: Outcome of the events, reporter confirmed that the patient did not experience any late occurring adverse events.
I was around someone who tested positive for COVID-19 on 12/20 but did not realize she was sick. ON 12/21 I began having a bit of congestion. I tested positive for COVID-19 on an at home test on 12/23. My symptoms got progressively worse over the next few days. the 24th and 25th were the worse of the symptoms. I was prescribed on 12/27 or 12/28 an antibiotic although I had already began to feel better to prevent a secondary infection.