chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experienced severe muscle pain in her neck, back an lower legs, along with nasal congestion; fatigue; She experienced severe muscle pain in her neck, back an lower legs, along with nasal congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 43-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0168) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (FIRST DOSE- 11May2021, Lot- EW0167), administration date: 11May2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Jul2021, outcome "not recovered", NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown" and all described as "She experienced severe muscle pain in her neck, back a lower leg, along with nasal congestion"; FATIGUE (non-serious) with onset Jul2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia.  Additional information: Patient reported that, after receiving the Pfizer Covid 19 Vaccination series she experienced severe muscle pain in her neck, back and lower legs, along with nasal congestion. Patient stated that she experienced so much muscle aches on neck and lower back, fatigue she has never had before, states it has just gotten worse. Patient stated she going to work and everything it got really bad, due to the pains she had to start seeing orthopaedic doctors and chiropractors, just using muscle and pain killers, states it is overwhelming, state to do this she has had to stop working. Patient wants to know now that it is time for her booster, she is hesitating and wants to know if she should get the booster, states she is looking for guidance on the booster shot when she has experienced these effects from the other vaccines. States she couldn't walk properly because of this, had to start using a cane. She says she spoke to someone previously, and this affected her job, family, and emotional. Patient asked if the booster can be Moderna? Asking if there have been any reactions from the Moderna after taking the Pfizer.  No follow-up attempts are possible. No further information is expected.
Arm started getting painful, then on Tuesday 8/27/13 arm was red and indurated, and felt hot. Continued to be sore. Seen in office 8/28, arm is still red, painful and redness is now going further down arm all redness in on the inferior aspect.
High fever, chills, body aches, joint pain, muscle pain, nausea, upset stomach, abdominal cramps, brain fog, fatigue, weakness
Had severe headache, chills with body shakes, fever, body aches, dizziness, fatigue, and painful arm at injection site that lasted for 24 hours after second vaccine on the 13nth of March, 2021.
Sharp Stabbing pain in neck and arm; Sharp Stabbing pain in neck and arm; This is a spontaneous report received from contactable reporter (Pharmacist).  A 34-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2022 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), 0.3 ml single for COVID-19 immunisation. Vaccination facility type was reported as pharmacy. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot FA7484 , expiration Sep2021, Intramuscular injection in left arm), administration date: 06Aug2021, when the patient was 34 years old, for COVID-19 Immunization, reaction: "She was fine with the first two doses"; BNT162b2 (dose 2, single, lot FF2588 , expiration Dec2021, intramuscular injection in left arm), administration date: 27Aug2021, when the patient was 34 years old, for COVID-19 immunization, reaction: "She was fine with the first two doses". The pharmacist said that first two doses were the ones that had to be reconstituted. The patient did not experience adverse event following previous vaccinations. It was unknown if patient received prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: NECK PAIN (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 13Mar2022, outcome "not recovered" and all described as "Sharp Stabbing pain in neck and arm". The patient did not undergo relevant tests.  Clinical course: Patient told her that this was debilitating.  She was a law official and had to move constantly. Every time she had to use her arm, she could feel the pain. Sharp stabbing neck and arm pain unknown time. She just said it happened after she got it and she did not specify if same day or next day (as reported). Patient will probably go to the doctor. At the time of this report the event did not result in emergency room or physician office visit.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Considering the plausible drug-event temporal association, there is a reasonable possibility that reported events were related to BNT162B2 vaccine administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
This is a spontaneous report from a contactable physician. A 66-year-old female patient received PREVNAR 13, batch/lot number and expiration date), via an unspecified route of administration in left deltoid on 02Jul2018 at a single dose as precautionary. The vaccination was done in pharmacy. There were no relevant medical and concomitant medications. The patient experienced cellulitis post injection on an unspecified date. The outcome of the event was not recovered. The event was assessed as related and medically significant. The patient visited physician's office due to the event. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Based on a temporal association, a causal relationship between the event cellulitis post infection and pneumococcal 13-valent conjugated vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
frustration; missed, irregular period; does not feel anything anymore when she is ovulating; light menstrual flow than the usual; sore arms/body aches; fever of 101 degrees Fahrenheit; This spontaneous case was reported by a health care professional and describes the occurrence of MENSTRUAL DISORDER (light menstrual flow than the usual), MENSTRUATION IRREGULAR (missed, irregular period), OVULATION DISORDER (does not feel anything anymore when she is ovulating), FRUSTRATION TOLERANCE DECREASED (frustration) and MYALGIA (sore arms/body aches) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (sore arms/body aches) and PYREXIA (fever of 101 degrees Fahrenheit). On 11-Apr-2021, the patient experienced MENSTRUAL DISORDER (light menstrual flow than the usual). On 12-May-2021, the patient experienced MENSTRUATION IRREGULAR (missed, irregular period) and OVULATION DISORDER (does not feel anything anymore when she is ovulating). On an unknown date, the patient experienced FRUSTRATION TOLERANCE DECREASED (frustration). At the time of the report, MENSTRUAL DISORDER (light menstrual flow than the usual), MENSTRUATION IRREGULAR (missed, irregular period), OVULATION DISORDER (does not feel anything anymore when she is ovulating), FRUSTRATION TOLERANCE DECREASED (frustration), MYALGIA (sore arms/body aches) and PYREXIA (fever of 101 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
On 4/4/22 that evening and the next day I had a mild elevation in my temperature, I felt fatigue, chills and a little achy. I had a little soreness at the site of the injection, but no swelling or redness.  It lasted about 36 hours. On 6/22/2022, it started with a little dry cough.  That night I had a scratchy throat. The next morning the cough was worse, the throat was worse, and I started feeling achy and generally sick. On 6/23/2022 I took a at home antigen test, and it was positive.  I called my doctor, and he prescribed me Paxlovid. It took me around 4 or 5 days to completely recover.
Prickles on the surface of both forearms, but only after cycling. Within a few hours after cycling, then the prickles shrink back, and the skin is smoother. I've been treating the skin area with a cream called, Cortizone-10, Ultra Moisturizer. Five times since May 30th I have gone cycling, and all five times after cycling I see the prickles. They look just like the story from this lady, post-vaccine,
Day 1 after receiving vaccine he started to notice redness on face and fatigue. Day 2 woke up face was swollen and eyes almost swollen shut and hot, started taking benadryl and sleep most of the days. Denies SOB. Day 3 continue benadryl, zyrtec and pepcid. Day 4 came to PCP as it's gotten worst. Swelling of bilateral ears, face, and forehead.
Pt presented to ED 2/28/2, had COVID vaccine at approx 11AM. Generally feeling unwell, "it feels like my throat could close up. My mouth feels sort of numb." Speaking in full sentences with no apparent distress. Denies SOB. Took benadryl prior to arrival. Given IV famotidine in ED. Discharged home.
joint pain; muscle pain; Headache; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on 20Feb2021 09:30 at single dose for COVID-19 immunization. Medical history included degenerative arthritis, seizure disorder diagnosed when she was young, hip replacement from 2005 (the left hip was replaced in feb2005 and the right hip was in dec2005), and allergic to iodine dye. Concomitant medications were not reported. Patient previously took codeine and experienced allergy. Her husband and her both got the pneumonia and flu shot either late 2020 or early 2021, and they gave only half the pneumonia shot, they did not give full amount and said that they had to come back the same time next year to get the rest of it. On 20Feb2021, typical side effects happened later that day evening, it was a headache, then next day (21Feb2021) it was a headache and she did have joint and muscle pain, it all subsided. Outcome of the events was resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Slight increase in having trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product REMODULIN for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BOSENTAN for an unknown indication.   On 05-Jul-2018, the patient started REMODULIN (Intravenous) 0.0926microgram/kg. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA. At the time of the report, DYSPNOEA outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported   Reporter did not allow further contact
Client presented with LUE warm, swollen 5" diameter; client states she felt ill 4/16-17/2015, but did not call provider or CHD.
Child came in office to recieve Bivalent booster and was given 0.25 mL, should have been given 0.5 mL - will return in 2 months for full dosage.
Body aches on the 23rd. Shingles:  04/25 started beginning of shingles outbreak. Painful areas on right side face. On 4/27 these areas became blisters. 04/28 diagnosed with Shingles at ARC. Started antiviral at 1pm same day. Treatment still in progress.
Starting 07/13/2022, in the evening, I became extremely congested and started coughing and sneezing. I though it was allergies. The next day the symptoms worsened and I could feel sinus drainage in the back of my throat and I had a sore throat. I upped my allergy protocol thinking it was again just a bad case of allergies. On 07/15/2022, I had an appointment with my allergist and got allergy shots. I took an at home COVID-19 test on 07/13 and 07/14 in which both were negative. I felt rotten after the allergist appointment. I took my temperature and it was 99.1 and I never run a temp over 97. I decided to take another at-home COVID-19 test which came back positive. I called the allergist's office to let them know they had been exposed to COVID. On Saturday 07/16/2022, I contacted my PCP to get PAXLOVID but they said they couldn't prescribe it unless they saw me on Monday but I knew that would be outside of the window I should take it. I called multiple pharmacies to see if they could prescribe it but they said they had no protocol for that. At this point, I was concerned because I hadn't had asthma issues in years and I was having to use my albuterol inhaler a lot due to a "heaviness" feeling in my chest and difficulty catching my breath. I called my allergist back to see if they'd prescribe it and they prescribed PAXLOVID. I started taking it that same day. I drank lots of fluids and slept a whole lot. By 07/20/2022, I started feeling better and my fever went away. At one point I had a fever of 102 but unsure when. Also, I experienced chills, fatigue and headache. I started feeling considerably better after that and on 07/21/2022 I actually got out of bed, with a mask, and  actually felt hungry. PAXLOVID gave me a very metallic taste in my mouth and I think that was part of the reason I was avoiding food. By Friday, I almost felt completely normal with only a cough remaining. I was able to run errands and get my allergy shots. Today I am good other than a cough and yesterday I tested myself again and was negative (07/26/2022).
No adverse effects.  Resident received Covid booster #2 on 8/9/2022 and was not eligible for this booster yet.
Patient is a 72-year-old female with a past medical history significant for hypertension, schizophrenia who presents to our facility today for abdominal and chest pain. History obtained by patient's son at bedside. Per patient's son, patient developed chest pain, cough and decreased appetite last week and was taken to Hospital on 1/14/22 where she was diagnosed with Covid pneumonia. Patient was discharged home. Over the past 2 days, patient has had progression of her chest pain as well as right-sided abdominal pain. Patient son further states patient has had approximately one week of diarrhea for which patient has been wearing pull-ups. Patient further has not been eating over the past 2 days. She is vaccinated for Covid. Further history and ROS is limited as patient will intermittently respond yes and no to questions.
Mild dizziness and headaches from day of injection, improving daily, no LOC/syncope, no treatment prior to being seen today, suggested tylenol/ibuprofen for headaches and hydration
Terrible ear ache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EAR PAIN (Terrible ear ache) 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 24-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EAR PAIN (Terrible ear ache). At the time of the report, EAR PAIN (Terrible ear ache) had not resolved. No concomitant medication was reported.  No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-651165 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651165:Wife case, same reporter
Flubok flu vaccine was administered to a person less than 18 years old. Pt should have received an age appropriate vaccine like Fluzone instead.
No additional AE; expired dose of MMR-II at her doctor's office.; This spontaneous report was received from Pharmacist who is also the patient (no age or gender reported).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot #W034714, expiration date reported as 10-OCT-2023, but upon validation set as 18-OCT-2023, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (Expired vaccine used), the patient experienced No additional adverse event.
The Patient is a 4 year old male.  Source of patient information was mother. Afebrile. Patient says his upper arm hurts but does not seem to be in a lot of pain. Bandaid still in place over injection site removed. No erythema or swelling around the injection site but there is an area of mild induration and mild erythema that does not seem tender extending from lower edge of the site of the bandaid almost down the antecubital fossa. There is no erythema or induation around the actual puncture site but a rather large area as described dependent to it. I suspect this might be a reaction to the bandaid, although it is latex free. Possibly the injected serum diffused distally to the injection site and he had an allergic reaction. Child will be prescribed an antibiotic and also Benadryl. Mom advised to apply ice packs 4 times per day and one was applied in the clinic.
Severe dizziness out of nowhere. Worst vertigo I?ve ever had.  Started at 3:30 on 2/6/21. I thought I?d have to go to the ER, except I couldn?t stand up without falling. Just as quickly as it came, it stopped at 8:35 p.m. that same night.
On November 12, 2007, patient received in her left deltoid region, a Boostrix injection, Glaxo Smith Kline, lot number 52b016BA, expiration date of 03/30/09.  Patient and mother report she had soreness and redness of the left arm within 2 days of the injection.  She presents today, 11/24/07 with a complaint of left arm hurting after the shot with tingling off and on.  Physical exam revealed equal strength in hand grasps bilaterally.  Upper left arm range of motion painful.  Flexion of deltoid exhibited pain.  Patient reports she had used 800 mg of Ibuprofen without relief.  She continues to perform activities of daily living such as washing dishes and school activities.  She did report she dropped a book when she was handed a book. Treatment recommended today - Ibuprofen 600 mg every 6 hours.
Like the previous dose, I had my second dose on right side this time on 7/14/2021. I noticed the swelling the next morning about 11:00. My right lymph node on my clavicle swelled. I also noticed pulsating lymph nodes were swelling and behind my knee on the right side. No pain just pulsating. I have not yet followed up with doctor because I had COVID. Both swollen lymph nodes on clavicle are still present and pea like and both moveable.
It started out I had diarrhea feeling crampy so I went in and laid down I woke up later but had fallen out of bed without realizing, my daughter checked on me out of routine and had my neighbor check on me who I told to call the emergency squad they took me to the local hospital.
Worried about getting the same or worse side effect for the 2nd dose; Vomiting; Diarrhea; Really sick; Swollen arm; Sore arm/Painful arm; Area below injection site was a little lumpy; Area below injection site very hot; Area below injection site was really red; Area below injection site very sore; Hives; Arm hurting; Black and blue injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea) and ILLNESS (Really sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE DISCOLOURATION (Black and blue injection site). On 18-Mar-2021, the patient experienced URTICARIA (Hives), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Really sick) and VOMITING (Vomiting). On 24-Mar-2021, the patient experienced ANXIETY (Worried about getting the same or worse side effect for the 2nd dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CEFALEXIN at a dose of 500 mg. At the time of the report, URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea), ILLNESS (Really sick), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE DISCOLOURATION (Black and blue injection site), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Soreness in four inch diameter region surrounding injection site - began on 3/3/2021 and lasted four days.  On 3/05/2021 I observed a four inch long by 3 inch wide red area on upper left arm, about three inches below the injection site.  That area was slightly warm to the touch and was itchy.  As of this date, 3/10/2021 the redness of the area is substantially less but still noticeable.