chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In July 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose of permanent prevention and protection against shingles and zoster related conditions. On or about 04-AUG-2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
severe lower back pain; , the pain is been so bad that I couldn't walk, I have to crawl to go to the bathroom; I can't walk; I am walking with a cane right now, because I still get back spasms; I am walking with a cane right now, because I still get back spasms; This is a spontaneous report from a contactable consumer (Patient reported for self). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number and Expiry Date: Unknown), via an unspecified route of administration on 26Aug2021 as dose 1, single for COVID-19 immunisation. The patient reported, (on unspecified date) starting yesterday at 4 clock in the afternoon patient had severe lower back pain; the patient stated "the pain is been so bad that I couldn't walk, I have to crawl to go to the bathroom and today is the pain is subsided a bit but I am walking with a cane right now, because I still get back spasms." Patient was not concerned about that so much as the second dose which is schedule for September 16th, patient was told that this second dose that the side effects are more severe so patient queried if it was possible for patient to push up second dose until the 20Sep. Patient hung up abruptly hence details could not be probed,limited information was available over the call. The outcome of the events was unknown.  Batch/lot number not available for vaccine [BNT162B2]. Follow-up attempts are completed and no further information is expected.
At 1635, RRT activated when client (57 y/o F) called recovery nurse c/o feeling itchiness all over her body, and c/o throat pain. She was already under closer monitoring as she has had a reaction during her first dose 21 days prior. Vaccinated at 1608 on the L arm. Has had severe anaphylaxis in the past for PCN. BP ? 170/90, HR ? 72, RR ? 18, Pain ? 3/10. Head to toe assessment completed. No PMH. Took Benadryl after getting the vaccine in anticipation of possible reaction; client brought own supply of medication. Monitoring period extended to ensure client?s condition to improve but decided at 1702 to leave despite still noting the throat pain. She left the vaccination clinic ambulatory.
Left hand/arm pain - unable to grasp objects, called PMD - on 12/2/07 - advised to use warm compress and take ibuprofen. Visited PMD on 12/3/7. No change in condition. 2nd PMD visit on 12/13/07 - Rx Ibuprofen 600mg BID and 300mg Neurontin TID given by doctor. 1/9/08-records received-12/3/07 seen for C/O left hand very weak and having a hard time picking up things. Impression:peripheral neurtiis. 12/13/07-C/O pain left hand, cramp of fingers. Weakness, numbness and tingling.  1/9/08-non-compliant patient, did not return for follow-up.
Patient complains of soreness and redness at site of injection. No shortness of breath, or difficulty breathing. No rash.  Patient to place icepack at site of injection and to seek medical attention if symptoms persist or worsen.
At 09:30 am I passed out losing conscious for a few minutes. The next day I was fine made a virtual appt with a doctor(he wasn't sympathetic) stated that this is something that may happened after taken a experimental drug.
Information has been received from a physician concerning a 62 year old healthy female who in March 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In June 2008, the patient was diagnosed with aplaestic anemia, after presenting with anemia, thrombocytopenia, and Absolute Neutrophil Count (ANC) under 500, with a bone marrow biopsy consistent with that diagnosis. The patient was noted to be anemic on a blood draw in April (done in anticipation of blood donation). At the time of this report, the outcome was unknown. Upon internal review, aplastic anemia was determined to be an other important medical event. Additional information has been requested.
Fatigue; A spontaneous report was received from a consumer concerning, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the event, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the fatigue.   No laboratory details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional called to report that several patients had reported pain at the injection site after receiving SHINGRIX. No more information was obtained at the time of call.
Arm intensely aching and tingly from clavicle to finger tips for 2 days post shot.    Lymph nodes in left arm pit extremely sore and swollen along with inside of arm being very sensitive to the touch - going on 6 days.    no treatment sought - just advil and heat
Vaccine was given to 16 year old employee. Mother was in attendance at the time. No side effects have been reported to date.
Pt reports 2-3 days after getting the vaccine she noted Hives on her left arm to her left hand.   They lasted for 2-3 days.   She just reported it today when she came in today for Shingrix #2.  It was not given.   she did also get a Tdap in the right arm the same day.  The Shingrix was given in the left arm.
rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash". This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash". Additional information: Reporter stated her son 11 years old, received the Pfizer Covid 19 vaccine, several days after it was administered, he started with a rash that progressively got worst. One week later, he has a terrible rash all over his entire body. She was looking for information on what is considered a severe allergic reaction, since she is getting conflicting information from the FDA website and her son's pediatrician.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shots given 8/12/02. Dimple and hard spot noted on right lateral thigh on Monday 8/26/02. No pain, redness noted. Visited MD 8/30/02 to diagnose problem.
A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that 21 month old male vaccinee inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300029.
Tested positive for covid; Tested positive for covid; congestion; fever; sore throat; occasional cough; running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: EN6203) at the age of 46 years as DOSE 2, SINGLE and administered in arm left, administration date 21May2021 (Lot number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). The patient had no allergies. The patient had no other vaccines within 4 weeks. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "congestion"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovering", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "recovering", described as "occasional cough"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Covid test after post vaccination: Home kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, oropharyngeal pain, cough, rhinorrhoea.  No follow-up attempts are possible. No further information is expected.
patient received Pfizer as a second dose; 15 YO patient received Moderna as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose). On 06-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose). On 08-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 YO patient received Moderna as a 1st dose) had resolved. On 06-Jan-2022, INTERCHANGE OF VACCINE PRODUCTS (patient received Pfizer as a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported
Vaccinated on 16 July in left upper arm. Following day area is red, swollen, and itching. Slight discomfort. No systemic sx. The next day area increased in size approx. 3x6 inches. Warm to touch. No problems with previous immunizations. Is taking acetaminophen and ibuprofen, and antihistamines. All symptoms resolved within a couple of days. Symptoms: Edema, unspecified, Pruritus, unspecified, Toxic erythema.
For about 15 minutes, I could not think or compose a sentence.  It did not hurt.  I was just confused and disorientated while a friend stayed on the phone with me until it passed.  This happened shortly after my vaccine, and it was frightening.  Never had this experience before.
Hospitalized with COVID-19 a month after COVID-19 vaccine. Had fever, chills, congestion, sore through, cough, shortness of breath, chest pain, fatigue, and headache.
Change in behavior, child unable to sleep through the night.  Crying for no obvious reasons.  4 days later and still waking up in the middle of the night, crying with no discernable cause.
SWEATING A LOT; COUGHING; CONGESTION; LOTS OF MUCUS; FELT SICK; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A12A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-MAY-2021, the subject experienced sweating a lot, coughing, congestion, lots of mucus, felt sick. The action taken with covid-19 vaccine  was not applicable. The outcome of the sweating a lot, felt sick, coughing, congestion and lots of mucus was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Approximately 3 weeks after my 2nd dose vaccination, I experienced the following symptoms: Shoulder pain (Left side). I had a cortisone shot for treatment and have an upcoming MRI appointment to determine what is happening with my shoulder.
back pain/soreness in his lower back/had bad lower back pain; injection site pain on his arm that traveled to his shoulder; joint pain/injection site pain on his arm that traveled to his shoulder; nausea; had a sore left arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in his left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included PTSD (Post-traumatic stress disorder), anxiety, is a disabled veteran, has had different cancers, had stage III lung cancer, brain surgery and brain cancer before the Covid vaccine. The patient's concomitant medications reported as he had great medicines and was doing good that. The patient reported that on 23Jan2021 he started having a lot of back pain/soreness in his lower back. He stated on the day he received the injection, he experienced injection site pain on his arm on 19Jan2021 that traveled to his shoulder. He also reported having nausea and joint pain since the vaccine on 19Jan2021. Patient stated that his arm was sore where he got the shot, had a sore left arm on 19Jan2021. Stated day before yesterday (23Jan2021) noticed travelled down arm. Stated that he had bad lower back pain, he never had back pain before. Stated that it hit him all at once the day before yesterday (23Jan2021). The outcome of the events was unknown. Serious reported as no.  Information on the lot/batch number has been requested.
Pt devel frequent period of nausea w/general malaise; 26MAY91 felt exhausted, constant nausea, & pain in RUQ area; Was able to palpate liver; Discussed sx w/MD on 27MAY91 did not advise being examined;
Immediately after administration of second dose of the COVID vaccine, patient had severe swelling at injection site.  Pain extended across shoulder and up to L neck.  Patient was monitored- the following vitals are immediately after the injection: HR 69, sats 98%, BP 210/91, 193/101, 214/97.  Patient taken to ED as a precaution and monitored for over an hour.  BP at 1406: 218/111, BP at 1431: 197/84, and BP at 1549: 172/81.  Patient discharged from the ED - no worsening symptoms and no medications administered.  Patient reports the same reaction occurred after her first vaccine dose, but not to this degree, and it occurred several hours after the vaccine.
Interchange of Vaccine products; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: Tested negative for two days after paxlovid treatment ended; (Aug2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID-19 Treatment from 20Aug2022 to 25Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itchy bumps/Now the outbreak is on stomach, chest, left arm, and both legs; This is a spontaneous report from a contactable other Health Care Professional (Patient, self-reported). A 54-years-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiry dates were not provided), via an unspecified route of administration, in Arm Right, on 05Feb2021 08:30 AM (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation and experienced itchy bumps on 20Jan2021. The patient did not receive any other vaccine within 4 weeks of the vaccine. The patient reported that Singular itchy bumps within 5-7 days after the initial injection, these shows up on stomach area and left leg on 20Jan2021. They started to dry up, however, after the second dose (as prescribed) and after 5-7 days another outbreak. Now the outbreak is on stomach, chest, left arm, and both legs on an unknown date in Feb2021. Patient underwent, nasal swab test on 12Jan2021, 26Jan2021, 10Feb2021 and 16Feb2021 respectively; resulted as negative on all dates. No treatment was received for the event. Outcome of the event was reported as not recovered.  Information on the lot/batch number has been requested.
pt recv 1st dose varivax & subsequently pt devel a macular rash w/some arthralgia & joint swelling
Within 1 hour or receiving vaccines he started vomiting.  No ill contacts and wasn't ill at time of visit.  No reactions with other vaccines prior to this visit.
Very painful at time of injection and I commented to my dad very high on shoulder and painful. Unusual pain for wks got some better with ADVIL - but pain continued. I endured it for months but will not heal. I went to my family doc. and later to therapy - I'm currently on 2nd rehab trip. First I experienced pain at the time of the injection, which I have never experienced before and I also noticed how high the shot was given in my shoulder. I have experienced some soreness after previous flu shots but it usually lasts a short period of time. This time my shoulder was very sore and it hurt to raise my arm so I started taking ADVIL and it would get some better until I use it and then it will get worse for weeks. After months of this cycle I visited my family doctor I told him I did not know how I hurt my shoulder I mentioned I had a flu shot in that arm and he dismissed that thought and I agreed that sounded odd. He did a standard x-ray and said the thought I had fluid issues related to my bursa and bursitis. He prescribed CELEBREX which I took for a while but it bothers my stomach so I stopped taking it. He also later agreed that physical therapy may help so I completed my first session and saw some improvement. So now I am going to my second session with little improvement. Looking back I am sure my problem is related to my flu shot and I fear I will need surgery and not be able to work for an extended period of time. I went to the pharmacy by my home where I received the shot to make this report and the nurse said she had never filled out an Adverse Reaction Form and she called her supervisor in my presence and they agreed to call me but as of today they have not.
PAIN INJECION AREA, SWELLING INJECTION AREA,INCHING.