chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; PREVNAR 13 on 10/2018, (exact date was not specified), PNEUMOV AX 23 on 02/2019 (exact date was not specified), and PREVNAR 13 on 7/26/2019.; This spontaneous report was received from a male patient of unknown age who was also a dentist. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  The patient reported that he received pneumococcal vaccines on the following dates: on an unknown date in October 2018, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR); on an unknown date in February 2019, pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and on 26-JUL-2019, again pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (lot number, expiration data, route of administration, anatomical location, dose and frequency were not provided). No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown.
Initial report received from healthcare professional on 15 JANUARY 2013. A 64-year-old female patient, who had no pre-existing physician diagnosed allergies, birth defects and medical conditions, had received a dose 1 of ADACEL (batch number C4251AA, route of administration was not reported) in left deltoid and an intramuscular dose 1 of PNEMOVAX (other manufacturer, batch number 0225AE) in right deltoid, both vaccines were received on 04-JANUARY 2013. The patient had no other illness at the time of vaccination. On 09 JANUARY (5 days after vaccine administration) the patient experienced left arm redness, heat, pain, and felt lump. On 14 JANUARY 2013 the pain came back intensely from her arm to her clavicle. Patient was experiencing hurts with movement and patient was comfortable at rest. Patient had no longer redness, lump or heat on unspecified dates. The patient had received aspirin for a couple days (dose unknown) and pain medication (trade name and dosage unknown) as corrective treatments. The laboratory investigations/relevant diagnostic tests were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Red blotches @ site ice pack applied Rash in back wt based BENADRYL given
An expired 2nd dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the manufacture date of expiration) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the manufacture date of expiration) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 168 doses/vials were given for LOT 048C21A. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Chest pain; Pleurisy; discomfort in his chest (not in the lung) in the bone muscle around the lung, it feels like he has been punched right in the cardiac plexus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 79-years, on 07Apr2021 10:20 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included ongoing moderate to mild asthma that sometimes bothered him when he tried to sleep and maybe wheezed a bit and he had to use inhalers during the day as he cannot go to sleep if he got a wheeze; diabetes 8 or 10 years ago and he took Insulin for it; he was allergic to aspirin. Family History included that his mother had rheumatoid arthritis. The patient's concomitant medications were not reported. No additional vaccines administered on the same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021, next day (08Apr2021) he started to have discomfort across his chest like a hernia starting on the left (he started to have chest discomfort, like a hurting across the chest starting on the left and now on the right), after being checked on a medical place he was informed that he has Pleurisy, they did a chest X-ray and then they sent the information to the hospital to have a doctor look at it so he had to wait a half hour. Mentioned they wanted to put him on pain medication but he declined because he was allergic to aspirin and he only took Tylenol. He described the sensation as: a discomfort in his chest (not in the lung) in the bone muscle around the lung, it felt like he has been punched right in the cardiac plexus, now was a minor discomfort that won't go away. He cancelled his appointment to receive the second dose of the vaccine (due tomorrow) and wanted to know if he should receive the second dose at all. The patient also experienced Chest pain that started on 08May2021, but now it had shifted, and it was more on the right side. First he noticed it on the left then it moved under his sternum and now almost all of it is on the right side. The pain got up to a certain point and then it had stayed the same. Sitting he isn't feeling it but when he got up out of the chair it was worse. Seemed to be worse when he moved from a relaxed position like getting out of bed. Events of Chest discomfort and Pleurisy resulted in "Physician Office Visit". Events outcome was not recovered.
9 days after receiving the moderna vaccine I started to feel my left arm which was used to administer the vaccine start to itch and it feels hot in the spot where they put the needle. As the day progressed I began to notice that the same spot started to turn red and swollen. By the evening the spot started to spread on my upper left arm and it was sore, sensitive to the touch (I could not lay on it) and it looked like a rash. Its uncomfortable and itches a lot around the area. In the area where the needle was administered it feels hard like a ball. On Monday 1/11/2021 I went back to the clinic to report the issue. They drew a circle on the arm and prescribed antibiotics which is called SULFAMETH/TRIMETHOPRIM for seven days and I have to take it twice a day. This evening the red mark/rash has spread out of the circle which the doctors drew on and I haven't felt any type of relief yet. I have a follow up appt on 1/14/2021
Patient went to ER with pain, swelling of Left arm-was unable to move left arm-pain medication was no helping with pain Also was having numbness distally in fingers. ER report stated that thought it was Deltoid bursitis. Was seen by primary physician on 2-2-18, primary physician thought it was more of an severe localized reaction to injection and not bursitis.
Cancer patient was laid out for 2 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Cancer patient was laid out for 2 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Cancer patient was laid out for 2 weeks). At the time of the report, BEDRIDDEN (Cancer patient was laid out for 2 weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-091960 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091960:Same reporter, different patient
Patient fainted immediately after she was given vaccine (needle was removed from arm); she was braced by her father and myself as she fainted. She regained consciousness immediately following. She was fine after having some water and sitting for 10-15 minutes.
Pt developed red, dry rash on neck, trunk, and right wrist within 2 days of receiving vaccine.
Mother reports her daughter came home after working at daycare from 6-12 "wiped out", had a slight fever c/o backache, headache.  No soreness at injection sight.  Given extra strength tylenol - also c/o weakness.  Mom says eyes appear glassy.  Advised to see physician if symptoms perisit.  7-19-06 when telephoned to check on her, she was at work.
Moderna Monovalent was given as dose #3, instead of bivalent dose. As of today, 02/08/23, there have been no reports of adverse reaction by parent/guardian.
he is fully vaccinated and boosted and still get the virus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he is fully vaccinated and boosted and still get the virus) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he is fully vaccinated and boosted and still get the virus). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (he is fully vaccinated and boosted and still get the virus) outcome was unknown.            No concomitant drug information was provided.  It was reported that patient was fully vaccinated and boosted with Moderna vaccine, however patient still got virus. Patient had already finished the Paxlovid therapy and was enquiring when to take a covid-19 test.   Reporter did not allow further contact
began with body aches in the knees, took Tylenol and went to bed @9:30pm. Woke up @12:30am with chills, a headache, soreness in the injection site, and body aches in the neck, back and legs.  Got up and tried stretching and drinking water. Stoped drinking water when I felt nauseas. Did not throw up. Took Ibuprofen and melatonin before falling asleep about 30 minutes after taking the medication. Woke up @3:00am and chills were gone, only left with pain in the knees and injection site. Wasn?t able to sleep until around 4:45am. When I woke up @7:45 am, I still had slight pain in the knees, I took Tylenol @10:45 am. Pain was on and off throughout the day. I took a hot bath, that helped the pain tremendously. Fatigue throughout the day. After sleeping the day after the shot, all symptoms are gone, only soreness in the injection site.
Approximately 3 months after my booster shot (3rd shot) I tested positive for COVID. I experienced the following symptoms: Chills, Headache, Sore throat, Body Ache, Cough, Shortness of Breath, Fatigue and Chest Pain. I used an inhaler to ease my chest pain and shortness of breath and took Tylenol but it did not improve my situation, so I called my doctor's office and I was referred to get Paxlovid for 5 days and it did help me to get better but my shortness of breath and fatigue remained for a month.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06May2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19; Negative, notes: prior negative test result. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient reports pain in arm started the day after injection. Patient has used up to 600mg of ibuprofen every 6 hours and up to 1000mg of acetaminophen three times a day for pain. Currently still complains of constant shooting pain and nausea. Has taken two doses of ondansetron 8mg for nausea.  Has not seen physician for physical exam yet.
This spontaneous report as received from a Licensed Practical Nurse referring to 4 patient of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates, the patient was vaccinated with improperly stored PROQUAD (lot # M031944, expiry date: 27-DEC-2017; lot number: M041083, expiry date:04-APR-2018) for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -11.7 °C for 40 hours 28 minutes. Previous temperature excursion was reported to have occurred on an unknown date. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005581:
fever; A report was received from a nurse concerning a 36 years old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced fever.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the nurse administered the mRNA-1273 vaccine to a patient. The patient spiked a fever about 8 hours after vaccination. Fever only lasted for a few hours and resolved at night.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, fever, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, fever.; Reporter's Comments: This case concerns a 36-year-old, female, patient, who experienced an expected non-serious event of Pyrexia. The event occurred approximately 8 hours after first dose of mRNA-1273. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
error in administration- have not been able to confirm with patient if they are having any symptoms. Vaccine was administered without any diluent
parents states baby began crying @ 8PM & was continually crying until 11PM-cried several hr;low temp (not taken);recovered w/o any problems
Large injection site reaction developed day of second injection dose and persisted for 5 days. Swollen, red, and tender, itchiness also present. Reaction covered most of upper arm, treated supportively with benadryl, topical steroids, cold compress, ibuprofen. Less severe reaction was seen after first dose, but was delayed 7 days post injection.
I suffered a stroke on March 19, 2021 that effected my  Occipital and Temporal Lobes on the right side of my brain. The primary symptom was almost total and complete blindness. Taken to emergency room, made a stroke alert, tPA cleared clot, spent 5 days at the hospital.
Narrative: 43 YO F with PMH GAD, PTSD, migraine, and multiple allergies reported anxiety, nausea, diaphoresis, bilateral hand tremors, and headaches upon administration of Dose #1 COVID vaccine on 3/16/21. Patient was transported to ED where symptoms resolved after one dose of PO ondansetron. After Dose #2 on 4/6/21, patient reported feeling "woozy", hot, and had a headache. Symptoms resolved after 30 minutes with no intrvention.
This case was reported by a other health professional via sales rep and described the occurrence of local swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown. It was unknown if the reporter considered the local swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by a Certified Medical Assistant (CMA). This case was reported by other healthcare professional, who herself was the patient's mother. The patient experienced a lump (huge swollen spot) on her arm after receiving BEXSERO. The sales representative did not have further information regarding patient identifiers, product details or information regarding the event. Attempt to contact the other healthcare professional was unsuccessful and a voicemail was left to return call back to GlaxoSmithKline Medical information for follow up reporting purposes.
Info has been received from a woman in a medical office concerning a 65-year-old male with coronary artery disease and hypertension who on 11/21/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #643890/0679M-diluent vial), in the left deltoid. There was no illness at the time of vaccination. On 11/22/2002 the pt had left arm swelling and hot, achiness, fever and nausea. Subsequently, the pt recovered on 11/25/2002. Follow-up info reported that the pt "did not follow-up with clinic after reactions." No further info is expected.
Case number PHEH2013US021738 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to left deltoid on 28 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). No adverse event was reported following the medication error. He was revaccinated on 26 Jul 2013.
Information has been received from a physician concerning a 30 year old female who has never had chicken pox who was vaccinated with the first dose of varicella vaccine on an unspecified date. It was reported that the pt developed massive induration. The reporter stated "titers still not at protective levels." and inquired "should pt get dose #2?" Upon follow-up, it was reported that the injection was given at the local health dept on an unknown date and that the pt reported the "massive induration" around 01/17/2001. Additional info has been requested.
After shot one on 4/11 I developed an allergic reaction skin rash on both arms and the thighs of both legs. I saw the doctor on 4/29 and was prescribed a steroid cream to help my body get rid of the rash. After my vaccine on 5/2, the rash flared hours after injection and became more prevalent and itchier.
Mother called to report that child developed fever and feeling of rapid heartbeat on 02-12-2012. She took child to Emergency Room on 2-12-2012. Child was evaluated and discharged. Child saw Dr. on 02-14-2012 for continued rapid heart rate. Child was referred to a cardiologist and has an appointment on 03-01-2012. Heart rate 131.
Approximately 5 hrs after receiving the shot patient had bad flu symptoms.  Nausea, cold chills, throwing up and aching all over.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
got shingles; This is a spontaneous report from a Pfizer  via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles after her first dose on Apr2021. The patient was scheduled to receive her second dose on 08May2021. However, she wants to know if she should wait until the shingles were gone or just receive the second dose. The patient was given with Pfizer medical information team's (PMI) phone number and she said that she would call later. It was reported that no unaddressed medical questions referred or forwarded to Medical Information team. The outcome of the event was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient experienced arm and joint pain developing on Thursday July 22nd. Those symptoms went away by July 23rd. The patient woke up with severe pain in his side on Monday July 26th. He went to the emergency department and was diagnosed with pleurisy.
Pain, distal from shot red rash warm to touch, and per pt she isn't able to lift arm.