chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over her body/itchy rash all over her; feeling flu-ish; joint pain/sore and joint issues; fatigue/tired; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL9266 and Expiration date: May2021) via unknown route of administration, administered in left arm on 02Mar2021 as dose 1, single (age at vaccination 66-year-old) for COVID-19 immunisation. Patient medical history included seasonal allergies (since child) from an unknown date and unknown if ongoing. Patient received no concomitant medications. On 03Mar2021, patient experienced a rash all over her body/ itchy rash all over, joint pain/sore and joint issues, feeling flu-ish/ feeling like she had the flu, and fatigue/tired. Patient stated that she had shoulder surgery on 19Mar2021, and the second dose was scheduled for 30Mar2021. Patient wanted to know what to do about the second dose of the vaccine. Patient mentioned that she might take prednisone to treat her rash. The outcome of feeling flu-ish was unknown and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
DVT in right leg with multiple PE?s bilaterally. Treatment: oral Xarelto
Information has been received from a physician concerning a 7 year old pt who on 08/08/1995 was vaccinated with a dose of varicella virus vaccine live. On 12/05/1998 the pt experienced a case of breakdown varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no tx or hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01873 and 0409USA1875 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Ct. given BOOSTRIX (Tdap) instead of ADACEL Tdap). BOOSTRIX is approved for use thru 18yrs old. No adverse effects reported. Medication errors.
Heavy, abnormal uterine bleeding, home temperature reported as 103 off and on x 2 days. Fever resolved, bleeding currently persisting.
Pt. states received vaccine 05/01/2021 shortly after 05/06/2021 started experiencing symptoms of fever, muscle/joint pain, pressure headaches, dizziness, fatigue, and nauseous. No physician's visit noted. Still experiencing symptoms on/off. Plans to visit a local physician if symptoms persist.
L03.90 - Cellulitis E11.9 - Diabetes D72.829 - Leukocytosis A41.9 - Sepsis
Fever; It's gotten bigger, pinkish, kind of a rash but not really a rash; Soreness all over, generally rotten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome of event (s) changed from unknown to recovered.
Initial medication error report received on 01 OCTOBER 2013 from a health care professional (nurse). A 20 months old unknown patients whose gender, medical history and concomitant medications were not reported,, received a dose of FLUZONE (route, lot # and site of administration was not reported) on an unspecified dare. Nurse gave expired dose to 20 months old patient. Lost of documents held by sender: None.
I received Pneumovax 23 Vaccine which I have had before in 2008 and 2013. I had no problems before but when I got it this time, I started feeling a very sore arm, rash, diarrhea, fever of 102-103, chills, body aches, fatigue, and headache. For about 4 and a half days I couldn?t move. I talked to my doctor, and he gave me Benadryl. My arm still had a rash on my left arm, fatigue, and fever keeps going up and down.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 24 months old female patient who supposed to vaccinated with a 0.5ml dose of PENTACEL (lot C5529AA and Exp. Date 04-OCT-2019) but only received the PENTACEL Hib component that was diluted with sterile water via unknown route in the right thigh on an unspecified date. The patient's medical history not reported and concomitant medications included PROQUAD and HEPATITIS B VACCINE for Immunization. It was an actual medication error case due to inappropriate reconstitution technique. No reported side effects. 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. List of documents held by sender: none.
back spasms with both shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (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: MUSCLE SPASMS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "back spasms with both shots". It was unknown if therapeutic measures were taken as a result of muscle spasms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness; Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Fever (got to 102.2 degrees); Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy, food allergy (Gluten), and allergy to some antibiotics. Concomitant medications included paracetamol (TYLENOL), hormone replacement therapy (MANAFACTURER UNKNOWN), thyroid (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 21Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. 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. On 11Apr2021 at 11:00, the patient experienced Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness. The patient did not receive any treatment for the events. On 11Apr2021, the patient underwent body Temperature measurement and the result was 102.2 degrees (UNSPECIFIED UNITS). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to a child patient of unknown age. On 13-MAY-2013, the patient was vaccinated with an expired dose of M-M-R II (Lot # 670623/0664AA, expiration date 04-MAY-2013). No adverse effect was reported. Additional information has been requested.
Booster; Itchy plagues; developed spotty areas that itch all over my body, most on the left side, around 10; developed spotty areas that itch all over my body, most on the left side, around 10; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 16:00 (Lot number: FE3592) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OZEMPIC taken for weight decreased, start date: Oct2020 (ongoing). Vaccination history included: Bnt162b2 (2nd dose, Time: 5 pm, Anatomical Site of injection: Left upper arm, Route of Administration: Intramuscular, Batch/lot number: EL3248), administration date: 12Jan2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months", "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months"; Bnt162b2 (Dose: 01, Time: 5 Pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: EK9231), administration date: 22Dec2020, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021 16:00, outcome "unknown", described as "Booster"; PLAGUE (medically significant) with onset 2021, outcome "not recovered", described as "Itchy plagues"; RASH MACULAR (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "developed spotty areas that itch all over my body, most on the left side, around 10". Therapeutic measures were taken as a result of plague, rash macular, pruritus included OTC hydrocortisone. relevant tests and specific tests were none. Clinical course as follows: The only reason patient thought it may be related to the vaccine is that after her booster that area became extremely itchy + with almost a plaque. That spot has gone but others are still there largest gone largest area is 2 cm x 2cm. Itchy Plaques was reported as Not Serious.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation and Plague, and BNT162B2.  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.,Linked Report(s) : US-PFIZER INC-202101495494 Same patient/Vaccine, different event, different vaccine dose
4hrs post vax developed v, d 6x each between 6PM & 7AM; no fever, febrile sz, arched back legs stiff no clonus, eye dilated & "empty look", ? lt cheek & lt arm twitching;
Tested positive for COVID on Jan 24, 2022, developed bronchitis on Jan 27,2022
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
PT STATES HER THROAT WAS SWOLLEN WHEN SHE GOT HOME ALSO HER EYES BECAME SWOLLEN THE NEXT MORNING WITH DISCHARGE
I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October6, 2022.  3 days ago I realized my left  hand ( monkeypox vaccination shot arm) swelled up and became quite boated. Very scary. It tingled and hurt. This never happened before.  Yesterday, Urgency care sent me to ER. After X-ray, sonogram and blood draws, concussion that there was no blood cots.  It was probably reaction from having the two vaccine just days apart. I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October 6, 2022.
Left shoulder pain (sharp pain). Loss of range of motion in left arm. Pain in deltoid muscle (L) upon movement (ranges from sharp to dull); no pain on rest. Weakness in left arm; no fever; no rash or redness at injection site.
going to the bathroom quite a bit; stomach soreness/stomach pain; numbness in her tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2022 (Lot number: PJ9943) at the age of 78 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Unknown manufacturer), for COVID-19 immunization. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "going to the bathroom quite a bit"; HYPOAESTHESIA ORAL (non-serious) with onset 24Mar2022 12:30, outcome "unknown", described as "numbness in her tongue"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach soreness/stomach pain".
Elevated H, Heart Rate 130 Plus, Severe Dizziness, General Weakness, Headache, Nausea, Shivering.
Headache, Arthralgia, NauseaVomiting TINNITIS Narrative:
I went from feeling completely normal to almost falling over and shaking. I was told my BP was really high. I was approved to go home after my BP was normalized. I was completely exhausted from that point and I went to straight to bed when I got home. I sleep until the next day and was completely fine the next. The same thing happened with 2nd dose.
It was reported that an infant rec'd DTaP (manufacturer unknown) along with his 2nd dose of Prevnar in early 3/01. The infant developed a nodule at the DTaP injection site and experienced irritability and vomiting. At the date of this report, he recovered form irritability and vomiting; the injection site mass persisted.
Rec flu vaccine on Sat 10/8/16 next day Sun dev a rash that was initially itchy but after itch stopped rash spread. Did not need to scratch rash-no itching on day of visit which was 10/12/16-rash spread to involve trunk, neck, prox extremities. Small flesh color flat topped papules. (7.5 mm size each) densely distributed but not confluent over trunk, prox extreme, neck-no excoriation (no fever).
Heachache, chills, fever, muscle aches, fatigue, soreness at injection site
C/O chills and fatigue; Injection sites with painful swelling, erythema, and warm to the touch.
Fever, extreme dehydration, kidney infection, extreme lower body pain (back, legs, joints) requiring emergency room visits as directed by my primary physician on November 1 and on November 5
The night the vaccines were administered (8/16/22( patient started complaining of "heart pain." Mother took patients temperature was 100.0 F. Patient was given Tylenol Q4H until patient was seen in office on 8/17/22 around 9 am. Initial presentation in office was tachycardia (140-150) and a fever of 99.8. Patient was given 7.5 mL of Tylenol in office. After 30 minutes patient heart rate reduced to 120 BPM.  Patient tolerated medication in office and effectively had HR reduced to a normal range. Patient instructed to follow-up in ER if symptoms returned.
pt recv vax & cried unusual for 3+ hrs w/only 1-2mins bread during that time; p/APAP given p/3hrs, crying stopped shortly thereafter
Per dad about 10 mins. after receiving immunizations she became pale and fainted for about 1 min. When she woke up she was drowsy, vomiting, HA. Pt was referred to her PCP for eval of having a history of syncope episodes. Dismissed home is stable condition.
Patient did not have any adverse effects or symptoms following administration.; one dose of PROQUAD was administered following temperature excursion.; This spontaneous report was received from a practice administrator and refers to a 4-year-old patient of unknown gender. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The patient's concurrent conditions, medical history allergies and drug reactions were not reported.   On 23-MAY-2022, the patient was vaccinated with improperly stored one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot #W002784, expiration date: 24-JUL-2023, (strength, exact dose, dose number, route and site of administration were not provided) for prophylaxis (product storage error). The vaccine was stored at - 4.6 degree Celsius (C) for 4 hours 16 minutes and 0.2 C for 7 hours 46 minutes. No previous temperature excursions were reported. The patient did not have any adverse effects or symptoms following administration (no adverse event).
Rec'd 5th DTaP, 4th IPV on 07/30/02 in L ant thigh. On 07/31/02, developed some erythema and edema, then by 08/01/02-increased redness, edema. L ant high with more erythema, taut, edema, 19.5cm x 15cm. Thigh diameter more than 1.5cm over that of R. Cellulitis. Augmentin 400/5 1/1/2 tsp BID x 13d.
A DPT administered on 7/30/14 to Rt thigh; By 7/31/14 Rt thigh markedly swollen - this is our second similar reaction in last two months.
A little blood came out of my arm/ mnimal amount of blood; Vaccine was running over my arm; Vaccine was running over arm; Vaccine was running over arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood), UNDERDOSE (Vaccine was running over my arm), DEVICE CONNECTION ISSUE (Vaccine was running over arm) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 004C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM from 01-Jan-2020 to an unknown date for Cholesterol.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood), UNDERDOSE (Vaccine was running over my arm), DEVICE CONNECTION ISSUE (Vaccine was running over arm) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm). On 05-Jun-2021, UNDERDOSE (Vaccine was running over my arm) and DEVICE CONNECTION ISSUE (Vaccine was running over arm) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (A little blood came out of my arm/ mnimal amount of blood) and EXPOSURE VIA SKIN CONTACT (Vaccine was running over arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were provided. No treatment was provided. Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information included- Concomitant medication with details was added and event outcome was updated.
no other AE; Caller reported an AE for MMRII. The caller said an expired dose was administered on 7/28/2023 to a patient. Confirmed no other AE occurred and the product did not have any temperature excursions prior to administration. AE letter sent to provided. N; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 28-JUL-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) (lot # U022318, expiration date 15-JUL-2023; strength, frequency, and route were not reported) for prophylaxis. Confirmed no other adverse event (AE) occurred and the product did not have any temperature excursions prior to administration.
in the early morning  hours both of my hands went numb and caused tremendous pain for about 2 weeks.  The symptoms were the same as the flare-ups I have had throughout the years with carpal tunnel: however, I had not had any carpal tunnel symptoms for over a year and had not done anything unusual to cause my carpal tunnel issues to act up.  Secondly, my IBS symptoms appeared in t he early morning as well and were very painful.  In two months before the booster I did have an IBS flare-up BUT nothing at the time of the booster.  I still have residual side-effects of carpal tunnel and IBS's that I have not been able to kick BUT in much, much, less pain.  I did go to my gastrologist and to a hand surgeon.  Both seemed to think this was an inflamatory response to the booster.
Severe discomfort  from shoulder to elbow with minimal movement of entire Rt. arm. Symptoms started the evening of vaccines. 10/08/2008 hives started in arm.
pt devel erythema & swelling from rt shoulder to finger tips;pt was seen in clinic given antihistimines & antiinflamatories
Received at 9am.  Continued arm pain so at 10pm I took Tylenol. Then by 11pm I had shakes, fever 100.4 after Tylenol, weakness all over, massive headache, dizzy, and nausea.  I tried to tolerate and wait it out by 11am 1:6/2021 I felt some what better. Fever gone. Headache continues.