chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number D9ZH7) for prophylaxis.   On 27-APR-2023, the patient received Shingrix. On 27-APR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 The Shingrix was reconstituted using sterile water and administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date was reported. The reporter consented to follow up via email. The Shingrix was reconstituted using sterile water and administered to a patient, which led to wrong solution used in drug reconstitution.
Week after shot my arm started to itch. and my injection site was raised and kept itching. I tried not to scratch it.
Information has been received from a registered nurse concerning a 10 month old female who on 04-NOV-2011 inadvertently was vaccinated with the third dose of ROTATEQ (lot number not reported). No adverse symptoms noted. The follow-up information has been received from the registered nurse concerning the patient who at 10:00 AM on 07-NOV-2011 orally was vaccinated with the third dose of ROTATEQ (lot number 16572, a not valid number) by public funds at public health clinic/hospital. The nurse reported that no adverse events. The patient did not perform any relevant diagnostic tests or any illness at time of vaccination. The patient did not have any adverse events following prior vaccination. The patient did not have any pre-existing allergies, birth defects or medical conditions. Additional information is not expected.
The leg receiving the DTaP became red and swollen 24 hours after shot. By 48 hours, the redness had moved laterally out from the injection site. The thigh was red and swollen and hot; 5-6" diameter.
Immediately extreme pain at site. The injected medicine pooled at two sites under the skin and red dots and swelling at site for several days. Next day tiredness swept over my entire body like a wave and stayed and then the next day weakness and more tiredness, then full blown sickness headache, pain joint, stuff nose, cough severe and I mean extreme Exhaustion!! Went back to the Doctor's office four times.
Injection site tenderness, injection site swollen and hard, mild headache. Adverse event is currently ongoing. Acetaminophen given. (Note: reporting patient is also a pharmacist; AE was not reported to the physician.)
Patient developed urticaria (hives) on body 24 hours after getting vaccines PENTACEL; ROTATEQ, Hep B and PREVNAR 13.
non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine; Rash; Mild swelling of the throat; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported same events for 2 patients. This report is for 1st of 2 patient.   A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, propylene glycol via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 17Dec2020 at 2:50 pm, PharmD, Clinical Pharmacy Manager, shared with the reporter that two employees had non-anaphylactic allergy reactions to the Pfizer BioNTech COVID-19 vaccine, this patient is one of them. She reported rash and mild swelling of the throat. They suspect it was a reaction to propylene glycol and will be doing skin testing. The action taken in response to the event for propylene glycol was unknown. The outcome of events was unknown.   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-2020501257 same reporter/drug/event, different patient
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
Got a pain in left arm; got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Got a pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 29-Jan-2021. Past adverse reactions to the above products included Allergic reaction with Pfizer.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Got a pain in left arm). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer as1st dose on 29-Jan-2021, then got the Moderna Covid-19 Vaccine as 2nd dose on 03-Nov-2021) had resolved. At the time of the report, VACCINATION SITE PAIN (Got a pain in left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
having a little bit of pain in the middle of her chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "having a little bit of pain in the middle of her chest".  Additional information: Patient states it was the BioTech or something like that, it was for the pandemic. Patient clarifies further she finally decided to get the vaccine for the COVID pandemic and she has concerns regarding the paperwork she received after the shot. The operator she was speaking with told that she should speak to a nurse. She clarifies she did not have a reaction or anything, she is just concerned with what she read in the paperwork she was given. She is hoping someone can put her mind at ease. Patient having a little bit of pain in the middle of her chest and she did read about myocarditis and their being a concern with heart problems. However, this all may be in her head because she was thinking about it a little bit. Patient states she also is out of shape and was playing with her baby, lifting her up, the day before the vaccine, so maybe she pulled something in her chest, who knows. The patient had not experiencing anything crazy, she will keep an eye on it. The paperwork talks about side effects. Patient mentions on the bottom right it says revised 23Aug2021. A little down the top, under the side effects the last sentence reads: These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. That is why she was hesitant to get the vaccine to begin with. Patient does not know if she should get the second dose or not.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Shoulder pain rotator cuff pain can?t move my arm very well extreme pain it?s been over a week still have the pain in my shoulder and rotator cuff down my arm
Client stated she received the Hep B vaccination in the health department on 7/18/17. She did not notice any immediate reactions at the time the dose was given. This was the clients 1st shot of the series. However, on 7/19/17 she started experiencing symptoms of itching, pain, and rash. She noted from the VIS that pain at the injection site could be a reaction. However, the pain radiated to her neck and she began to get a rash on the same arm that the injection was given. The client rubbed cortizone cream on the affected areas and also took Benadryl. She stated that both have helped alleviate the symptoms. When reporting adverse event to the health department, a red rash was noted on the inner aspect of the arm. Client reported this event on 7/24/17.
Pt had a vasovagal reaction abut 5 mins. after administration. Pt responded immediately to verbal commands. She was oriented - kept pt until her mother came to pick her up (30 min-approx)
PATIENT CAME IN TODAY, COMPLAINING SHE IS BARELY ABLE TO MOVE HER RIGHT ARM WITHOUT SIGNIFICANT PAIN. SHE LIFTS ARM WITH LIMITATION, AND SLOWLY, BUT IT HURTS. JOINTS AT ELBOW HURT, NECK IS SORE, AND RIGHT SIDE OF TORSO IS SORE AS WELL. RECOMMENDED FOLLOWING UP WITH MD.
a sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program . A 64-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from an unknown date (Lot#: not provided) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got a sore arm after received the Pfizer vaccine on an unspecified date, there is no any other issue with it. Event outcome was unknown.  Information on the lot/batch number has been requested.
Pt recd 2nd Hep B vax 25JUL89 & on 29JUL89 devel cystitis, fever, flu-like sx, malaise, diarrhea, nausea & joint pain;
Pt states after receiving 1st Anthrax shot, he started experiencing muscle aches, fatigue, sore throat more frequently and ears seem to be plugged.  Follow up 10/25/2000: "Received Anthrax adverse event follow up form....nothing written."
Temperature 103 degrees F. since 7pm on 2/12/21. Vomited three times on 2/13/21. Uncontrollable chills. Lightheaded.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-SEP-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
This was patient's description of signs and symptoms (she is MD): Around 5 pm that evening, developed a localized reaction See message below: -about 5:30 pm yesterday started developing a lot of pain, tenderness in deltoid. figured it was just the usual post injection fluvax-like tenderness  -by evening-> warmth and firmness/edema of entire deltoid muscle and  pain and dec ROM of entire deltoid and a 4x4 cm erythematous maculopapular rash on overlying skin  -Took tylenol without relief last night  -could not sleep last night due to pain, swelling and increase in area of firmness/edema., Deltoid firm but extending over entire muscle with pain/tenderness into axilla and across anterior shoulder tendons radiating into biceps/pec  Could not even doze on that side  -this AM, erythematous patch gone but still with firm edema involving deltoid/ tendons of anterior shoulder, axilla. Injection side warmer (per me and employee). Afebrile. Feel a little yucky but able to eat oatmeal fine.  I can only abduct my arm actively to 90 degrees -- limited by pain. trouble pulling up pants and wiping (ie internal rotation)  If employee does passive ROM he can get it above 90 deg and can rotate and get it higher almost to over head but it is painful and a bit limited. took tylenol/ibuprofen
No adverse event. Pfizer Bivalent vaccine was given on 1/4/23 after only 1 dose of Pfizer Monovalent vaccine given by Pharmacy on 11/25/22. Patient did not present her COVID vaccination card and said she needed a covid booster for her work.
left  hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my ears (on the collar bone)  , heavy overflowing Menstrual cycle , lump in my left breast.  headach
WITNESSED FALL S/P FIRST DOES PFIZER, ALOC X1 SEC, PARAMEDICS CAME, SX RESOLVED, REFUSED TRANSPORT, HOME WITH MOTHER.
parent reported pt crying inconsolably;started 2PM 6/30/99;high pitched cry;T97.4;parents took pt to ER but left before seen-pt doing better;
Patient presented with chest pain.  Troponins were elevated.  Echocardiogram revealed decreased left ventricular systolic function with an ejection fraction of 30-35%, MRI was consistent with myocarditis.
Dizzy; Vertigo; Sore everywhere; Fever; Chills; This is a spontaneous report received from a contactable consumer (Patient). A 54-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included breast cancer 4 years ago. The patient was allergic to dairy and tape. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizzy, fever, vertigo, sore everywhere and chills on 27Mar2021 16:00. The treatment was not received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3x3 Erythema and swelling 3x3  demarcated area and associated achiness and tender at the injection site  No warmth. . The employee states " the swelling is resolving"
After second dose of moderna  vaccines, patient started to feeling naussea and ten minutes later she felt better.
Red whelp with fever and itching 8 days later snd another on 9th day after.... covid arm
myalgia, arthralgia, senositis joints w/ knee effusion 3 to 5 days, h/a; treated 3-5 days;
Patient should have been given a booster dose and instead he received a full third dose of Moderna because he marked that it was his second dose.
Patient received DTap, IPV, MMR and PPD on 8/4/03. Next day, 8/5/03, the patient developed fever (100 degrees F) at night. He had right arm erythema/warmth/swelling. He also developed redness and puffiness around right eye. Mother called doctor and was told to give Benadryl, gave 2 dose of Benadryl. Patient visited clinic on 8/6/03. Doctor recommended to give Benadryl ever 6 hours. Pt was assessed on 8/8/03 again. Right arm now resolved.
Arm was sore immediately after injection.  Red, sore lump in arm below injection site was noticed a few hours after receiving the vaccine. Several hours later it felt warm to the touch.  24 hours after vaccine noticed fever, chills, body ache, and headache. At that time I drank a lot of water, took acetaminophen and went to sleep. The next morning I felt better but arm was still red, and warm to the touch. Lump  was still there but is speeding out, larger in diameter but smaller in depth. Lump on arm continues to be warm to the touch and spreading out 3 days later. Approximately 4? in diameter.
NOSE BLEED WITH BIG CLOT WHEN BLOWING NOSE; SINUS TYPE HEADACHE; TIREDNESS; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201921A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prevention of covid-19. No concomitant medications were reported. On 07-APR-2021, the subject experienced stomach cramps. On 07-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced sinus type headache. On 10-APR-2021, the subject experienced nose bleed with big clot when blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed with big clot when blowing nose on 10-APR-2021, stomach cramps, and tiredness on 08-APR-2021, and sinus type headache on 11-APR-2021. This report was non-serious.; Sender's Comments: V0:  This 53-year-old male patient sho reported nose bleeding with big clot of blood when eh blew his nose 3 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient also reported stomach cramps and tiredness on the day of vaccination and sinus type of headache 2 days after vaccination.  The patient denies any history of headache.  The patient recovered from the events.  No other details reported.   Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Woke up with discomfort/pain in my breastbone area.  It spread to my esophageal tube (extremely tender), a couple hours later my throat became strep-like sore, could not take a full breath, and throat swelling impacted my ability to talk clearly.  About 12 hours later, I had facial swelling.  One full day later, a chain-like rash appeared on my arms, chest, thighs, and feet.  Each subsequent day is spread to a new body part (but never occurred on my face),  I had to take Benadryl EVERY 4-5 hours to keep everything at bay.  Three days into the event my neck and torso skin were extremely painful to touch.  Most days since, I am exhausted and get winded easily.  Today is 30MAR21 and it's happening again as it began on 21MAR21.  I took two Benadryl in the hopes I will not have to go to ER again.
Vaccine record mis-read and repeat vaccines (Kinrix, MMRV) administered.
18 days post vax the pt developed a varicella like rash from head to toe that consisted of greater than 50 lesions and a fever.  The reporting physician felt that varicella like rash was not related to therapy with varicella virus vaccine live. Two additional pts had similar experiences following exposure to varicella virus vaccine live.
Wife reported swelling at the injection site, redness, and hot.  She denied any shortness or breath or difficulty breathing related to the vaccine
Large, red rash developed which is warm to the touch and itchy. The area measures 4inx2in where vax was given.
Papulovesicular lesions-scalp/upper back and chest. Prescribed Zovirax.
her dermatologist says that his mom is also having problems with pain in her shins & feet after getting the Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her dermatologist says that his mom is also having problems with pain in her shins & feet after getting the Moderna Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her dermatologist says that his mom is also having problems with pain in her shins & feet after getting the Moderna Vaccine). At the time of the report, PAIN IN EXTREMITY (her dermatologist says that his mom is also having problems with pain in her shins & feet after getting the Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Nine days post vax pt began having rash on right inner arm which spread to cover her entire body by the next day. Erythematous morbilform rash looks like a rash from the measles. Pt had a temperature of 99.3. Rash covering all of her body from the top of her head down to legs.
pt recvd & exp lightheadedness, dizziness & passed out; further details have been requested;
pt came into clinic 10/22/99 & had a swollen upper lip;given solumedrol which resolved problem;
Patient received her second dose of Pfizer as scheduled. She was not 16 yrs of age.  Paperwork reflected she was 16 yrs old.  Confirmed with mother/legal guardian over the phone that the birthdate was incorrect and she was underage to receive the Pfizer vaccine per the CDC guidelines and to verify the encounter/error with her pediatrician.
Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, Temperature started at 11:30, shot was given at 4:00 pm. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving, retching. Her doctor prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Outcome of event for fever was recovering; body aches and dry heaving was not recovered and for the other events it was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
2-3 days after administration of MMR, PCV, Hep A, and varicalla vaccines, pt developed diffuse hives and irritability.
About 24hrs after the vaccine my arm at the injection site swollen and was very painful. A 102 fever, chills, body aches and pain which developed all over and all lasted about 3 day and subsided on its own. I reached out to the Teladoc who advised I take Tylenol which did help for the arm pain but nothing else.