chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No problems at initial time of administration. 46 hours after, patient reported muscle pain at the injection site that reaches in her neck.
Development of right brachial plexitis.  Injection given 10/24/2007.  Symptoms developed ~ 1 wk later.  Neuropathic pain nonresponsive to treatment.  Empiric course of high dose steroids ~ 3-4 wks after onset.  EEG & NCS confirm brachial plexitis.  Pt seen by neurology, no history of trauma.  Continuing pain but improving.  03/10/2008 Consult letter dated 12/4/07 received from PCP with DX: Probable Right Brachial Neuritis. Pt reported significant aching in R arm following DPT in August 2007.  Pt then received Flu shot in L arm on 10/24/07.  Following this pt developed severe R arm pain, immobilizing the arm to minimize it. ROM intact. Fasciculations noted in the region of the tricep.  Sleep disrupted 2' to pain. PE WNL except decreased pinprick in the distribution of the R axillary nerve and 1+ DTRs at the R biceps and brachioradialis. 03/11/2008 MR received from neuro consult (see above) 12/4/07 with c/o R arm pain following flu shot. 1/20/2010 Still with persistent brochial pleats right arm; symptoms are less prominent however.  Persistent pain from brochial plexitis on the right. Expected time to resolve> 6months.
Got extremely hot after and ended up passing out about 6 minutes after receiving  the 1st dose of the vaccine.  I began sweating and my skin was very red. However I also had not had any food up to this point and believe it may have been caused by my sugar bottoming out. I left after about an hour under observations. It has been about 2 hours since the shot and I still feel light headed and a little fatigue.
I had a hoarse and froggy throat after traveling. I tested to be cautious as I had been exposed to COVID-19 and did not want to give it to my husband. I tested positive immediately. I called my doctor who decided that because of my immune system that Paxlovid would be the best medication for me. Right after starting the Paxlovid my vision was affected, I could not see twelve feet in front of me. I thought I may have something on my glasses so I cleaned them and I still could not see. I also thought it may be COVID-19 so I took two my doses and my vision got worse. I stopped taking it after the third dose. After a day and half off of the Paxlovid my vision returned to normal.
pt recv vax; arm very sore, red, 3" diam raised, warm spot;
Symptoms began 1/16/2021, rash started around my breasts, abdomen and back that then spread to my groin, legs, feet, arms and hands. Target looking, redness and some blisters. Rash is severely itchy and burns.
April 6 giant  hives covering entire body.  Extdreme itching, Sores of the lips,,
On 5/16/07  received Tdap, #1Hep A, #1HPV and MCV4. On 5/17/07 she felt itchy all over especially her neck area. On 5/18/07 she woke up with a itchy/painful rash from the neck down. Father denies any problems with previous immunizations. Denies ingesting or having contact with anything new. Father has appled Flucocinolone Acetonide 0.025% cream to the rash area a couple of times since it developed. Recommended MD and advised to stop using the Flucocinolone Acetonide 0.025% cream (it had not been prescribed). Father states that he is taking his son to their family doctor.
Sore arm, body aches, chills, headache  30.5 weeks pregnant
She got a Covid vaccine Pfizer at the Health Dept on Dec 18th in her L arm. Within 30 minutes, she felt tingling going down her L arm and in then she felt tingling on the L side of her face. Muscle aches, fatigue and chills lasted about 33 hours. On the 22th she had L leg weakness when she got out of bed, this lasted just a few seconds until she "worked it out." Later, she developed a sinus type headache.  She developed muscle aches on 25-26th, she went to have a covid test that was negative.   The L side of her face is tingly and her L jaw is sore--she describes it as feeling like she has had a novacaine injection for dental work since 4pm yesterday.
Shingles Virus.  Third Day of rash. Dr. (dermatologist) put me on Antiviral and my GP (internist Dr.) gave me gabapentin and Tylenol with Codeine,  upped the amiltryptilene to 50mg.  So far pain is very bearable. I suspect and hope that this is a mild case.
This spontaneous report as received from a regulatory associate (also reported as health care worker) refers to a 85 year old female patient. On 19-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J006242, expiration date 03-AUG-2014, dose, route not reported) for vaccination. On 19-OCT-2013 the patient experienced the area of injection was "swollen, red and hot". The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Fainted at 5:30am immediately after vomiting and bowel movement. Chills and assumed fever began around 1:30am.
Patient felt very lethargic; Bones hurt so bad; experienced body aches for 2 weeks,bodyaches from shoulders to fingers, Body aches from knees to toes; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Patient felt very lethargic), MYALGIA (experienced body aches for 2 weeks,bodyaches from shoulders to fingers, Body aches from knees to toes) and BONE PAIN (Bones hurt so bad) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Latex allergy and Multiple sclerosis (since she was 14 years old). Concomitant products included ARIPIPRAZOLE (ABILIFY), BUSPIRONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 27-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced LETHARGY (Patient felt very lethargic), MYALGIA (experienced body aches for 2 weeks,bodyaches from shoulders to fingers, Body aches from knees to toes) and BONE PAIN (Bones hurt so bad). On 11-Dec-2021, LETHARGY (Patient felt very lethargic), MYALGIA (experienced body aches for 2 weeks,bodyaches from shoulders to fingers, Body aches from knees to toes) and BONE PAIN (Bones hurt so bad) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was provided.   This case was linked to MOD-2022-502652 (Patient Link).
After 15-20 minutes had passed from time of vaccination, my heart had runs of palpitations that passed quickly. This happened 3 times the night of vaccination. I felt anxiety ridden the entire night. I woke in the morning with feelings of severe anxiousness which dwindled over the morning hours turning into extreme malaise/fever/fatigue/body aches and etc. which lasted the rest of the day.  I did not seek help for this but would of had the palpitations, awareness of breathing quicker and general uneasiness/anxiety persisted or worsened.
Patient received a single dose of the Moderna vaccine from our facility on 8/10/21 after having received a single dose of the Janssen vaccine from another facility in March of 2021.  She was closely monitored after receiving the Moderna vaccine and did not experience any adverse effects.
Menactra (MCV4) administered 5/16. Noticed erythema, slight induration and swelling 5/18. Slight ecchymosis around site.  Erythema extends approx 8cm in diameter, roughly circular. No SOB/fever/ataxia.  Feels well. No TTP.
Lump under the right arm; Pain; 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 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jul2021 10:42 (Lot number: SA7485) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: at about 10:30am in the right arm, Lot: SA6780), administration date: 08Jul2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Little swelling and tenderness at the", "Little swelling and tenderness at the". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Jul2021, outcome "unknown", described as "Lump under the right arm"; PAIN (non-serious) with onset Jul2021, outcome "unknown", described as "Pain". Therapeutic measures were not taken as a result of lymphadenopathy, pain.  Additional information: Caller has a lump under the right arm. She wants to know if this side effect is associated with the vaccine. Response: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Off label disclaimer provided before giving out the following information. Informed caller warm compress can help alleviate some effects of a lump. Continue to asses the lump in size if it progresses or doesn't resolve within 10 days please consult your HCP for more information. Caller also wants to know what can she do to alleviate the pain. Reporter seriousness for lump under right arm was unspecified. No other Products. Additional Information for Other Conditions included had for many years Investigation. Caller reporting on the Pfizer COVID 19 vaccine and who explains that she got her last dose yesterday, 29Jul2021 and is concerned because she has a lump under her right arm. Caller has questions on this side effect. Event: the lump was noticed about 15- 20 minutes ago. First dose: Given on 08Jul2021 at about 10:30am in the right arm, Lot: SA6780. No NDC or expiry. Second dose: given on 29Jul2021 at about 10:42am, in the right arm. No NDC or expiry. After the first dose she had no problem, just a little swelling and tenderness at the injection site that lasted about day and a half. She has done no treatments, she just noticed the lump. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Did any AE(s) not required a visit to emergency room and physician office. No prior vaccinations (within 4 weeks). AE(s) following prior vaccinations was none. No relevant tests. Patient's Medical History (including any illness at time of vaccination) was hypertension.    Follow-up attempts are completed. No further information is expected.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298536, 2018SA298573, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298573 (same reporter). This case involves a 70-year-old age patient (gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a single 5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Persistent tinnitus in left ear that started a couple hours after getting 2nd dose of Moderna covid-19 vaccine.
Soreness in arm that rapidly came on roughly 10 hours later, but subsided significantly following 24 hours after the shot was given. All soreness subsided within 3 days.   Sudden sensitivity to light developed about 26 hours after the shot was given. This side effect remained for about 8 days afterwards and still has some very slight residual effect (now 12 days after).
fussy @ babysitter all day;started crying @ 6:30PM & cried all noc;wouldn't eat-couldn't quiet child;called MD said to offer pedialyte & up dose of APAP;took little pedialyte-quieted down 530AM & OK next day;
Headache for 5 days straight. Advil and Tylenol do not help. Exhaustion. Lightheaded and nauseous at times today.
pt not given any APAP, fell asleep p/inj;woke up crying-never walked on leg p/shot;woke-up 10x15cm sl reddened, sl induration, warm grew on rt upper thigh @ site of inj, sl tender to touch;dx probable tissue rxn to site;
Large red patch near injection site with redness, swelling, and heat; Chills; Body aches; Headache; Malaise; Fever
injection site pain; Chills; Mild fever (99.5F); Feeling more tired than normal; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 51-years-old male patient received BNT162b2 (Solution for injection, Lot No: EN6203; Expiration Date: Jun2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication(s) included alfuzosin (ALFUZOSIN) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported.The patient experienced injection site pain, chills, mild fever, feeling more tired than normal on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on. Event took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Following 1st dose of vax pt experienced pain @ inject site; Following 2nd dose vax experienced prolonged pain & tenderness @ inject site;
tiredness; Fever; chills; headache; body ache; light headed; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Feb2022 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "fatty liver disease" (unspecified if ongoing), notes: other medical history: fatty liver disease. Concomitant medication(s) included: METFORMIN; CELECOXIB; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 01Apr2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Mar2021, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "tiredness"; PYREXIA (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "body ache"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "light headed"; DIZZINESS (non-serious) with onset 23Feb2022 14:30, outcome "recovering", described as "dizziness". The events "tiredness", "fever", "chills", "headache", "body ache", "light headed" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of fatigue, pyrexia, chills, headache, pain, dizziness, dizziness. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Treatment received for the adverse event was Tylenol. No follow-up attempts are possible. No further information is expected.
Presents to PCP 3/13/13 at 1614. Large swollen area to right & left thigh lateral to injection site. Treated with AUGMENTIN. Swelling >10 cm on both legs. HIB >15 cm, DTaP >10 cm.
I don't know whether this would count as an adverse event but 2 weeks after receiving my 2nd booster (4th vaccine injection), I developed a cough, runny nose, significant palpitations, and fatigue with muscle aches that lasted 3 days. The palpitations were so frequent that it was hard to sleep.  I still have the cough and occasional palpitations as of May 3rd.  I took a Covid test (PCR) which was negative.  I saw Urgent Care (Dr.) on Monday 4/25/22 who ran an EKG and did a Chest x-ray.  My lungs were clear and my EKG was normal except for a PVC. He thought I was having multiple PVCs and referred me to a cardiologist who placed me on a Holter monitor for 2 weeks (I'm still wearing it so I don't have results).  As of today, the PVCs are much reduced but still occurring and I still have a cough but not frequently.
Pediarix given 11/24/2005 IM. Large reddened patch next day over injection site right thigh 11/25/2005 given children's Advil, Biaxin 125 mg BID 1/2 tsp x 7 days.
Pain, swelling and super hot in left arm, muscle aches, fever, fatigue, headache, itchiness, severe dizziness, rash or hives not sure which one on my lower left leg
On 3-18-11 in the morning, patient woke with a very itchy arm. In spot where Varicella vaccine was given was red, swollen, and hot area. After school on 3-18-11, patient complained of even itchier, red, swollen, and hot spot on arm. Mom put on BENADRYL cream and gave ice pack to put on. Mom may give anti-inflammatories.
When the vaccine was given, the patient had a sensation go down his chest and his arm became weak. It bled quite a bit. After the vaccine was given he continued to have weakness in his left arm and pain. His range of motion is also diminished. He is still experiencing the weakness in the whole arm and pain in the shoulder.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 08-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Was given varicella vaccine on 3/3/17. The next day, it was reddened, swollen and sore. It continued to spread and on 3/6/17 it is approx 7cmx10cm, red, painful and warm to the touch.
First my arm where I was injected started to hurt more and more, then my back started to hurt that night. The next morning I woke up all my muscles and joints hurt similar to when a person gets the flu, as the day went on I developed a worsening headache, dizziness, malaise, then that night I had a temperature of 101.5. I'm not sure if this is the worst of it because I am reporting this as it is happening, but it's the worst reaction I've ever had to a vaccine.
Mom called 3 days after vaccines administered, stating client had a rxn to vaccines.  Mom states client developed hives, facial swelling, RA red and warm to touch.  Mom did not take client to urgent care or ED, and did not state when rxn started.  Mom has not returned calls to follow up on onset time and duration, unsure if client is still having s/sx's.
paralysis; Excruating leg pain; 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 PARALYSIS (paralysis) and PAIN IN EXTREMITY (Excruating leg pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (paralysis) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Excruating leg pain) (seriousness criterion medically significant). At the time of the report, PARALYSIS (paralysis) and PAIN IN EXTREMITY (Excruating leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CONCOMITANT INFORMATION NOT PROVIDED  TREATMENT INFORMATION WERE NOT PROVIDED  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Red, swollen area where pt was vaccinated and warm and hard to touch--looks like a cellulitis.
Swelling of tongue, throat and numbness in lips - 30 min after shot - subsided after 10 minutes with no intervention Swelling of tongue, numbness in lips, tingling all over the body - 24 hrs after shot - subsided with Benadryl 102 fever, severe back ache, neck pain 24 hrs after shot Dizziness, mild vertigo and ear pain- 48 hrs after shot - still have 4 days after shot
Information has been received from a certified medical assistant concerning two patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 16-FEB-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03296, 0711USA03297). Additional information has been requested.