chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states pain at injection site L Deltoid 5/30/17 PM. Thru out day 5/31/17 pain and burning increased. Redness stretched from outer deltoid area inside arm down to elbow. Pt. used ice on sites. 6/1/17 AM pt. presented at pharmacy we sent her to Dr. Prescribed MEDROL DP and clindamycin.
experienced bleeding last night, when she is not even scheduled to have her menstruation yet; Vaginal bleeding; dizziness; waves of nausea; tiredness; chills; feels hot and cold a lot/hot flashes or cold a lot; had cramps similar to that of menstrual cramps; felt like she had a fever; This is a spontaneous report from a contactable consumer (Patient). A 29 years old female patient received the 1st dose of BNT162B2 (the Pfizer-BioNTech Covid-19 Vaccine, Batch/lot number: ER8729) on 09Apr2021 on left arm at single dose for covid-19 immunization. Medical history was not reported. She took a lot of medications, antidepressants and antianxiety meds, states she told the facility where she got the vaccine about these. Until now, she said she is still experiencing dizziness, waves of nausea, tiredness, and chills. She said she feels hot and cold a lot. Last night (14Apr2021), she said she had cramps similar to that of menstrual cramps. She said she has not had cramps ever since she started being on an Intrauterine Device (IUD) and birth control. Consumer also said that she experienced Vaginal bleeding last night (14Apr2021), when she is not even scheduled to have her menstruation yet. She wants to know if this is a normal reaction to the vaccine, and if it is normal that she is still having the symptoms even after almost 7 days since receiving the vaccine. Caller states she gets dizzy a lot, waves of nausea, and felt like she had a fever, hot flashes or cold a lot. Had to call out of work on the weekend. Last night was really weird for her, was having cramps, like menstrual cramps, has an IUD and takes birth control and went to the bathroom and she was bleeding, even if she was supposed to have her period it wouldn't be the time she was supposed to be having it, called her Gynocologist to let them know. Dizziness gets worse during the day, nausea comes in waves, tries to sleep through the day, the more she sleeps the better she feels. Does not know if this is an allergic reaction. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
At first I just started to feel a little nausea and some dizziness.  Later my face and top of my head and upper chest flushed some and had a  headache, the headache went away on it's own relatively quickly.   The next day I felt a little rough, but I have read that the second dose has much higher side effects, and since I have a blood issue, it's concerning.
NEUROPATHY  10/1/2022 & 10/11/2023  --  RECURRENCE OF SAME SYMPTOMS
arm pain, knot on left arm for 3 days, fever lasted 2-3 days, headache, fatigue, blood clot in lower left leg. Was prescribed a blood thinner, swollen arm, inflammation in previous energy places.
About 24' after vaccines given, pt had 2 separate episodes of jerking of arms & head twitch to side with mouth open. The jerking happened q5 sec and lasted 15 min. No LOC. Temp 100.6, Tylenol given after 1st episode. Gave 3 days of Tylenol yesterday. Pt up more at night. By 4/15/20 morning pt was back to normal. No episodes. 99' temp.
Symptoms of injection site reaction including pruritus, swelling, and soreness. Patient describes as small in nature and uncomfortable, but not painful.
No adverse reaction reported by mother of patient.   Moderna covid 19 age 6 month- 5yr  pink cap 0.2ml was given instead of the Moderna covid 19 age 6 month-5yr blue cap.  At the time of injection we were not aware there were two different presentations for Moderna covid 19 bivalent for ages 6months- 5yrs.  We contacted the manufacturer today and reported the event and received current guidelines to be able to administer this correctly moving forward.
Information has been received from two registered nurses concerning a 4 year old male with no known drug allergies or past medical history, who on 03/02/1998 was vaccinated with the first dose of Varicella virus vaccine live which the patient received subcutaneously in the right arm, and the third dose of oral poliovirus vaccine. Originally the one nurse reported that on 03/21/2001, the patient experienced 50 or more lesions over all his body Unspecified medical attention was sought No treatment had been ordered. In follow-up, another nurse reported that the patient had approximately 50 lesions on his abdomen and back on 04/01/2001. This nurse reported that the patient recovered.  The registered nurse also reported on the patient's sibling who had an experience following vaccination with Varicella virus vaccine live, Additional information is not expected
Numbness, sharp shooting pain when arm is rotated or lifted from fingers to jaw, muscle and nerve pain, knot in arm, four months and still has no relief
Chest pain after 1st dose that lasted three days. No adverse reaction after 2nd dose.
allergic reaction; Lips swollen; hands, wrist had bumps; other vaccine same date vaccine date 21May2021; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21May2021 (Lot number: EW0179) at the age of 16 years as dose 2, single and administered in arm right, administration date 21May2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIP SWELLING (non-serious) with onset 22May2021, outcome "recovered with sequelae", described as "Lips swollen"; INFLAMMATION (non-serious) with onset 22May2021, outcome "recovered with sequelae", described as "hands, wrist had bumps"; HYPERSENSITIVITY (non-serious) with onset 12Jun2021 15:00, outcome "recovered with sequelae", described as "allergic reaction"; PRODUCT USE ISSUE (non-serious) with onset 21May2021, outcome "unknown", described as "other vaccine same date vaccine date 21May2021"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21May2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "lips swollen", "hands, wrist had bumps", "allergic reaction", "other vaccine same date vaccine date 21may2021" and "inappropriate schedule of vaccine administered" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lip swelling, inflammation, hypersensitivity.  Additional information: Patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that Next day after getting vaccine, the patient experienced Lips swollen, hands, wrist had bumps. After taking him to the ER he took Benadryl everyday since 12Jun2021 because he got the allergic reaction, he was advice by doctor because if he got a steroid shot it would defeat the purpose of the vaccine.   No follow-up attempts are possible. No further information is expected.
A 1 inch needle was used and I believe a 1.5 inch needle should have been used due to patient size.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse via Medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 in between doses. The person who tested positive has not yet received the second dose. The patient tested positive for COVID-19 after receiving the first dose of BNT162B2 on unspecified date. The outcome of the event was unknown.  information on about lot/batch number has been requested.
Tendon pain; Aches; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in an 85-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Increased and 99 (High) Increased.         No concomitant medication was provided.  No treatment medication was provided.
PATIENT IS A 16 YEAR OLD FEMALE WHO RECEIVED A COVID PFIZER BOOSTER BY MISTAKE. PT WAS NO AWARE THAT BOOSTER WAS APPROVED ONLY FOR 18 YEARS AND OVER AND FILLED OUT THE FORM WITH THE REST OF HER FAMILY.  PARENTS WILL CONTACTED AND THEY WILL CONTACT HER PRIMARY CARE DOCTOR. PATIENT IS DOING WELL WITH NO SIDE EFFECTS
rapid heartrate, drop in bp, sweating, turned pale, mild nausea, warmth throughout the body
Patient ran fever.  She had a sore spot at injection site.  She had large red spot on same arm & red spots on chest & breast.
enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2022 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Johnson and johnson (Dose: 01), administration date: Sep2021, for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 24Mar2022, outcome "unknown", described as "enlarged heart". The event "enlarged heart" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was put on a heart monitor on Tuesday that she just got off of today. They did tons and tons and tons of test, CT scans, bloodwork, EKGs, 14 tests that had came back and she doesn't know how many were done. She went in on Tuesday and had no idea of those results from Tuesday. She was perfectly healthy. She worked in food prep in the healthcare industry and she was told it was time to get a booster. After a second shot side effects after the second shot might be more intense than the ones experienced after the first shot. These side effects were normal signs that the body was building protection and should go away within a few days. If received a booster shot so far, reactions reported after getting a booster shot were similar to those after the two dose or single dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects, and overall, most side effects were mild to moderate. However, as with the two-dose or single-dose primary series, serious side effects are rare, but may occur.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On 1/18 developed fever 102.5, upon waking, around 8am.  Fever climbed to 103.5 in the afternoon. Acetaminophen 1000mg  taken and fever dropped to 102.5 in evening of 1/18. Severe night sweats and chills at night of 1/18 and 1/19, 1/20.  Was advised by employer to go to ED due to elevated fever >12hrs. Pt declined due to cost of ED visit.
administered with expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-314567, MOD-2021-314573, MOD-2021-314570, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Additional source document received contains NNI.
Pt was very anxious about receiving the vaccine. Immediately after receiving Pfizer, Pt complained of being itchy everywhere and started vigorously scratching her arms, legs, neck and back. No visible reaction was noticed on the skin. Pt was given 25mg Benadryl PO. Within a minute the Pt described feeling "better" and stopped scratching. Pt then complained of a headache that was causing blurred vision in the right eye, which she mentioned was her aura for her seizure disorder. Pt's vital signs were WNL. Pt refused all further interventions, including EMT.  Pt was observed for 40 minutes and left at 1:30 with her wife stating she felt "good enough to go home"
Vaccine licensed through age 12 was administered to a 16 year old child. No adverse side effects experienced.
pain/ pain in the left arm; pain in the left arm started to get worse and now the pain involves the whole left arm, radiating to the left shoulder; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2019, immediately after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine intramuscularly into the deltoid muscle of the left arm. Post vaccination the patient started to experience pain almost  immediately. The patient stated that gradually the pain in the left arm started to get worse and at the time of reporting the pain involved the whole left arm, radiating to the left shoulder.   No additional information was provided. The reporter consented to follow up.
2ml of normal saline was used to reconstitute the vaccine instead of the recommended 1.8ml. No adverse effects identified.
Extremely sick the first day; Dizziness; Diarrhoea; For the next five days I was only tired; Vomiting; Achy joints; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19) and FATIGUE (For the next five days I was only tired) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), FATIGUE (For the next five days I was only tired), VOMITING (Vomiting) and ARTHRALGIA (Achy joints). At the time of the report, ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19), VOMITING (Vomiting) and ARTHRALGIA (Achy joints) had resolved and FATIGUE (For the next five days I was only tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided. Patient had tested COVID-19 positive after 4 months of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non-Significant Follow up
pt recv vax 1MAY95 & 9MAY95 pt devel a fever of 101 & a mild, erythematous, papular rash on face, trunk & exp fussiness;tx APAP;
The patient did not experience any symptoms; reconstituted with 0.5 ml of sterile diluent, rather than the entire deliverable volume in the vial of diluent; This spontaneous report has been received from a phlebotomist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 18-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, subcutaneous, lot # R030612, expiration date 23-OCT-2020, prophylaxis; Strength and frequency were unknown) that was reconstituted with 0.5 ml of sterile diluent, rather than the entire deliverable volume in the vial of diluent (product preparation issue). The entire vial of  varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted and was administered. The patient did not experience any symptoms.  This is a non-valid case due to lack of patient identifier.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO (batch number 157101, expiry date unknown). in August 2016, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The reporter's clinic had a patient who was vaccinated around 11th August 2016 that had severe pain at the injection site. The patient ended up going to the emergency room. The reporter agreed to follow up. This case is 1 of the 8 cases reported by the same reporter.
large painful swollen lymph nodes in armpit.  They have lasted almost a week so far.  I am seeing my general practitioner on 11/11/2021 for care and evaluation.
Initial and follow-up information has been received from a physician concerning a 36 month old male (reported as 3 year old) with a history of eczema and never had chicken pox and was not exposed to chicken pox who in 2009 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). The patient also had eczema before vaccination and was treated with corticosteroids (unspecified) "steroids" and antihistamines periodically (steroids and antihistamines also reported as concomitant medications). In August 2010, the patient experienced a zoster rash and resulting in hospitalization on 30-AUG-2010. He was discharged after a few days. The lab diagnostics studies reported as "isolated". At this time of reporting, the outcome of zoster rash was unknown. Additional information has been requested.
Tingling/numbness in left hand and some tingling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 14:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient had no allergic to medications, food, or other products. 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 06Apr2021 at 14:45, the patient experienced tingling or numbness in the left hand and left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event tingling or numbness in the left hand and left arm was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Client reports had "bad fever", like hot flashes x 2days, some flu like symptoms that lasted 15 days. After shot on 8-30-10 also c/o arm aching ((L) arm) up to 2 days ago.
ill; fever; flu symptoms; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (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: MALAISE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "ill"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "fever"; INFLUENZA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "flu symptoms"; ILLNESS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "sick". The lot number for bnt162b2 was not provided and will be requested during follow up.
consumer reports pt recvd vax 20APR94 & w/in 24 hrs, exp an inject site react @ the DT site; 3cm area of induration & erythema, hot to touch & appeared as a large white welt w/a red center; 21APR office visit-treated w/cold compresses;
After receiving moderna vaccine administration, we requested pt to wait at least 30 minutes prior to leaving the pharmacy. After 30 minutes, we came back to give the pt her vaccination card and as soon as she stood up, she fell slowly onto the floor and started having seizure (pt didn't hit her head per technician on scene) around 3:50 pm and became unconscious for a few seconds. She was able to answer our questions when she woke up, but was confused of where she at. She continued to call out random names.  We called the ambulance and assisted her while she was on the floor.  She had another seizure 5 minutes after the first seizure and became unconscious again for a few more seconds. After she woke up, we placed her on her side and monitored her pulse rates and her breathing while on the phone with 911 personnel.  The paramedic came 10 mins after the call. Pt had a history of seizure (she wore epileptic tag around her neck). Pt was taken by paramedic to the nearest hospital for further observation.