chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad i could hardly walk to the bathroom; Stiffness in her legs; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number: US-AMGEN-USASP2021177227), license party for ENBREL.  This non-serious spontaneous report (USASP2021177227) was reported on 13/OCT/2021 by a consumer and involves a female patient who experienced could hardly walk to the bathroom [mobility decreased], stiffness in her legs while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Pfizer Biontech Covid-19 Vaccine (tozinameran). The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in 1995. On an unknown date, the patient reported after receipt of the second Pfizer COVID 19 vaccine, she experienced such stiffness in her legs so bad she could hardly walk to the bathroom. The patient noted treating herself with turmeric and the stiffness was resolved. The outcome of the event musculoskeletal stiffness was reported as recovered/resolved. The outcome of the event mobility decreased was reported as unknown. The event musculoskeletal stiffness was resolved on an unknown date. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events mobility decreased and musculoskeletal stiffness. The causal relationship between the events mobility decreased, musculoskeletal stiffness, Enbrel, and Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided. Patient had a second booster dose of Moderna vaccine. It was unknown if the patient had allergies to any medications, food and other products. The vial had not undergone any temperature excursion issue. The vial was initially stored in refrigerator on 11-Apr-2022. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up received contains no new information.
painful left shoulder; joint pain; could not lift arm; Nausea; nausea feeling; Dizzy; dizziness; unwell feeling; tiredness; muscle pain; some chest pressure in her breathing; This is a spontaneous report from a contactable consumer. An 87-year-old female patient (reporter's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 15Mar2021 (Lot Number: En6204) (at the age of 87 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included COPD. The patient's concomitant medications were not reported. On 15Mar2021, the patient experienced a painful left shoulder, could not lift arm, nausea, and dizzy. The patient called the doctor's office and made an appointment. She discussed her nausea feeling and dizziness and was prescribed meclizine hydrochloride (12.5 mg tablet) which helped her feel better. Nausea feeling was under control after the second day. On unspecified dates in 2021, the patient experienced an unwell feeling, tiredness, muscle pain, joint pain, and some chest pressure in her breathing that went away after using some oxygen. After a few days, the patient seemed ok and the symptoms were minimal after that. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
received the second dose after it underwent a potential temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion). On 26-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. Treatment information was not provided.
2 days p/vax pt vomiting & had diarrhea, & lethargic;pt seen by MD kept for observation for 24hr; given fluids;recovered completely;
Received flu shot on August 28th, 2013. Came into store the week of December 15th, 2013 saying there is possible nerve damage due to receiving the vaccination.
Fatigue, pain at injection site, bloating, gastric pain, diarrhea.
soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my arm) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in my arm). At the time of the report, PAIN IN EXTREMITY (soreness in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
I had the soreness in the left arm (to be expected) after the injection.   But then days went by and I noticed my arm was still super painful near the injection site, causing pains down my arm and limited motion and painful movements that have continued to last for months.   The pain has been severe enough that I have not had full use of my arm for months (it is now June 18, 2021)  , certain motion are extremely painful  and I can not sleep well at night due to the pain.   I also have trouble performing certain usual tasks that were part of my daily life (trouble lifting, sewing, driving with left arm...)
3/12 (day of #2 vaccine) typical warm, slightly swollen injection site on RIGHT deltoid. 3/14 LEFT arm had shooting pains from deltoid to fingers that would clench involuntarily (similar symptom as with #1 vaccine)             Intensely itchy skin developed over entire body late in day. Intensity increased to burning sensation, extreme fatigue, mental               fog, and inability to fall sleep. This lasted all night until about mid-day 3/15. 3/16 Symptoms began to subside. 3/17 Close to normal .... I hope!
Moderna COVID-19 Vaccine. Reaction began that same night with redness and swelling, tenderness, itchy, possible rash.  By today, February 10, the redness and swelling has moved down towards the elbow.  Still sore and feels warm to the touch and still itchy.
Patient received J+J vaccine 3/8/2021.  Patient then received Pfizer vaccine as listed here on 7/30/2021.
Patient fainted and regained consciousness in 45 seconds, did feel weak and fatigued.  Patient left with a family member after feeling better.
She got her vaccine, started around 7:30 and 8:00 AM next morning started off with a headache, and then chills, then a fever.  When she got up to go walk every bone and joint in her body was aching, difficulty walking, and fingers were hurting.  She went to the bathroom, started taking Tylenol.  Then she had started up with a cough and now it's like a post nasal drip cough and spitting up phlegm.  She has also been nauseous ever since then.  She broke out with a bad rash around the injection site, got real real red, but is lightening up today.  Very itchy nose.  She also has weakness, everything she tries to do is a task.  Her breathing is like light winded, has to take a deep breath to try to breath, also maybe due to the nausea and the weakness.  She has been taking Alka Selzer plus cold and cough.  She contacted the pharmacy who told her that they were going to report her symptoms to the CDC, and is reporting herself as she is having more symptoms and how long are they going to last.    She has been breaking out into sweats and woke up last night drenched and had to change the sheets as they were soaked as well.   She has also been having severe pounding headache, and when she coughs she has to hold her head as the headache is so bad, and moving her head in the bed is painful as well.
Rash at site / symptoms / not as severe this time; Fever for 3 days / symptoms / not as severe this time; Tired / symptoms / not as severe this time; Not feeling my best / symptoms / not as severe this time; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (1st dose received in 30th November 2020 and the patient experienced Injection site rash,injection site pain, injection site swelling, fever, chills and fatigue refer case US2021030909).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site rash, fever, fatigue and feeling unwell. Rechallenge with Shingrix was positive. On 3rd December 2020, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the injection site rash, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that second vaccination still had side effects; fever for 3 days, rash at injection site, tired and not feeling her best. The patient reported that the symptoms were not as severe this time and recovery was about 7 days this time. The patient did not go to doctor regarding the side effects.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030909:Same reporter
Patient received ZOSTAVAX sub-q on left upper arm and developed a large raised, warm, red area of inflammation that was painful to the touch.
Narrative: Patient received second shot and writer noted patient to not be answering questions, staring at this writer, no loss of consciousness. Episode lasting less than five minutes. Patient has no recollection of receiving shot or conversation with writer while receiving shot. Patient was alert and oriented after the episode Provider called to assess, Patient was sent to ER, patient transported with LPN staff. Patient did not want to looked at, and jumped out of wheel chair and left. Provider wanted to check Keppra levels, but patient refused.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 48-year-old, adult, female patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, batch number: 252235, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported). At the time of the report, no adverse event was reported. This case 201804658 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): Description to be Coded was changed from 'extra dose administered' to 'overdose' for the event verbatim "Received 1.5 ml dose instead of 0.5 ml". Narrative and case comment was amended accordingly.
Adult dose Age 12 and older given to 8 yr old. Mom has been notified.
On 6/22/23 the patient was 15 years old and received a dose of MCV4 vaccine. Her records indicated that she previously received doses at the ages of 5 and 10 years of age. The dose given on 6/22/23 was not needed according to CDC guidance.
TOOK LAST DOSE OF VIVOTIF THAT WAS FROZEN; A spontaneous case report was received from a consumer on 24-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201910-000818 (PVX2019-2655; husband) and PVX201910-000819 (PVX2019-2658; wife) were created and cross-linked in the database.   This case (PVX2019-2655) described a male consumer who "took last dose of Vivotif that was frozen" (PT: Product storage error), while being on Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, on 18-Oct-2019, he took last dose that was frozen.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable US-PaxVax Berna GmbH-PVX201910-000819:
9 1/2 x 7cm red area (L) Thigh. DTaP and Varicella given on 6-19-09.
Itching at injection site; Rash at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with MULTIVITAMIN [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 03-Feb-2021, VACCINATION SITE PRURITUS (Itching at injection site) had resolved. On 04-Feb-2021, VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.   Reporter did not allow further contact
Pt. had allergic reaction Redness/Rash - started next day after vaccine given warm to touch Getting better now, going away Redness spread down the arm
feeling unwell; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell) and PYREXIA (fever). At the time of the report, MALAISE (feeling unwell) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment products were not provided.
6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. Then 6 hours later I woke up with a swollen face, swollen eyes, welts, and hives. It burned and itched. I called the EMT and a doctor said I was not having an anaphylactic shock, but some sort of allergic reaction. He gave me a cortisone bill and proscribed an antihistamine. I took 50 mg. of cortisone for two days with 10mg. of an antihistamine. It subsided a bit, but at night, I swelled up again. Today I went to the doctor and got a cortisone infusion.
Narrative: COVID infection following COVID vaccine series 01/13, MODERNA, dose #1 02/10, MODERNA, dose #2 08/17 pt cc: rhinorrhea exposure: unknown 08/18 COVID swab, result: detected
Presented with chest pain and acute shortness of breath, found to have bilateral sub-segmental PE with LLE DVT, treated with UF Heparin. Hospitalization ongoing (day 3).
I had gone to the doctor for a diabetic check-in and the doctor was concerned that my heart rate was too high, she said it was tachycardia. The lowest it got was 118. I thought it was just stress. She advised I cut back on caffeine and follow up in a month. I cut back on my coffee and soda. I had a pulse oximeter that I would check myself periodically and did not notice anything unusual but at the follow up she gave me a Zio heart monitor for a week. During that week I had 38 Tachycardia episodes with the highest over 200. She is currently getting me a referral for an electrophysiologists for follow up.
I found that the first shot I had a sore arm for about two or three weeks; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I found that the first shot I had a sore arm for about two or three weeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146398 Same patient, same vaccine but different doses with different events;
fever 104-106 w/in 1hr of vax, dec appetite-gave Ibuprofen  q 6hr & sponging x 3 days;
On 10/15/2021 I started getting a cold. It started with teeth pain, pressure in ears and sinuses, and ears clogged. I took Tylenol every 2 hours. It went into my sinuses more. It was really scary because usually then it goes into my lungs.  Somebody at my office tested positive for Covid so I decided to get tested on 10/15/2021. My test came back positive. I received the monoclonal antibody infusion last Friday and I feel much better. My ears are still clogged but I kept if away from my lungs. I also lost my sense and smell. Earlier that month I was dealing with some vertigo.
Left arm at injection site is swollen, painful and itching a week after the injection. It had been fine for the last 5 days.
Skin felt hot, but no fever at that time. fatigue, nausea for about 2 hours. Later that same day, exactly 24 hours after vaccine, got cold chills and fever of 101.0 that lasted for about 2 hours. Night of the vaccine:  Arm pain at injection site was very bad, could not lay on left side the night before.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Weakness-Severe, Additional Details: pt was mostly unresposive and turning white and motionless; throat closing up; no other choice but to give the epi-jr shot; after administering the shot the patient started to feel better but we decided to still call 911 to be on the safe side
7/5/2011 I felt dizzy, weak and headaches. 7/6/2011 at noon I started to have hives. 7/7/2011 more hives, swollen fingers and burning sensation on fingers, and also headaches, dizzy. Went to a doctor. Today I see they just get worst as days go by.
Within 30 minutes, odd metallic taste in mouth. Is still present next day.  Sore arm worsening. No treatment needed.
Insomnia.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included unspecified prescribed medicines. The patient had no known allergies to medications, food or other products. On 11May2021 at 00:00, the patient experienced insomnia. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sudden change change in heart function, followed by light headed-ness, and vision fading to black. Nearly lost consciousness. Continued feeling of slight light headedness/impairment up to now (about 6 days since the shot).
Large welt at injection site that is very tender and swollen, like half a golf ball size. Slightly sore throat, wheezing and muscle soreness and fatigue.
Burning and swelling at injection site, general malaise and fatigue, fever, stuffy nose, sneezing, and light headedness. Has continued from the morning 8am til now and still continues thus far.