chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination site pain; Injection site redness; Vaccination site swelling; fever; Rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling), PYREXIA (fever) and RASH (Rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro).    On 15-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Vaccination site swelling). 16-Mar-2021, the patient experienced PYREXIA (fever) and RASH (Rash). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), INJECTION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown and PYREXIA (fever) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up was received included allergy and  newevents
first shot 03.02.21 - slight body aches and nausea second shot 03.30.21 - paralyzed arm and extreme pain.  9 days later can move arm, still lots of pain from arm, back and neck.
Swollen lymph notes in both armpits, Swollen left breast with red rash and lump
At 4:00 p.m. I experienced mild chills, and a "raspy" throat.  By 6:00 p.m. I had nasal and sinus congestion, and couldn't breath through my left nostril. At 9:00 p.m. all of these symptoms were still present, so I decided I had a cold and called in sick to work for the next day.  I slept poorly, congested and mildly chilling/low-grade fever.  When I arose at 9 a.m. I felt slightly better, ande my symptoms impoved gradually and were gone by late afternoon.
Patient was inadvertently given a 4th dose of Pfizer COVID-19 Vaccine.  Patient's State vaccine record did not reconcile with the database, so the third dose did not transfer to the database, therefore, the database only showed patient received two doses, however, after further investigation, patient was given four doses: 2/16/2021, 3/9/2021, 10/20/2021 and today 12/6/2021.  When physician ordered what was thought to be the 3rd dose, patient indicated they had only had 2 doses.
prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited non-serious case received from a pharmacist.   This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (lot: UT6695LA, expiry date: 30-Jun-2020) via unknown route in arm NOS, on an unknown date.   It was an actual medication error case due to vaccine underdose and Exposure via skin contact. It was reported that prefilled syringe leaked around hub when plunger was pushed down in syringe, leaking vaccine onto patient's arm. No note problems with product prior to administration.  It was also a case of syringe issue.   At the time of this report, no adverse event was reported.  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.
Second vaccine: rash break out between his knees and ankles on both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Feb2021 12:58 (Lot number: EL9262, Expiration Date: 03Feb2021) at the age of 76 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease", start date: Jun2011 (ongoing), notes: Diagnosed 6-7 years ago; "BPH", start date: Sep2014 (ongoing); "ASCAD", start date: May2005 (ongoing); "Hyperchol", start date: May2005 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE , Dosage text :30mcg/0.3mL, left arm, Time: 14:53, Anatomical Site of injection: Deltoid Left, Route of administration: Intramuscular, Batch/Lot Number: EK4176), administration date: 13Jan2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: RASH (non-serious) with onset 09Feb2021, outcome "recovered", described as "Second vaccine: rash break out between his knees and ankles on both legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling in regards to the Corona Vaccine.The caller explains the withheld hospital told him to give Pfizer a call and report what he  asked them about. Caller states he got the first shot in January and second one on 03Feb2021. Six days after the second shot in February, he had a rash break out between his knees and ankles on both legs. The rash did not itch and never bothered him at all. He never had a rash of any kind like that in his life. He didn't know whether it was from the vaccine or it was just a coincidence or what. He states the rash went away within 4 or 5 weeks, it never once bothered him. Caller mentions the Lot number for the second dose has even smaller print than the first one. He states he guess eyeglass companies make them use small print. He confirms the expiration date was the same date he received the vaccine, 03Feb2021.   No follow-up attempts are possible. No further information is expected.
Begin to feel tingling and some numbness in left arm. Moved over into right also. About an hour after shot feeling chest tightness, winded with activity. Tingling stopped within an hour but tightness and breathing continued Did not feel bad enough to worry We but did not feel good for several days. Continue to have feelings of not being  able to get deep breath. Have been in contact with my physician about issues. Have never been bothered with vaccines before but did not feel right pretty quick after this one.
The next day post first vax, the pt developed hives that spread all over her body. He was treated with diphenhydramine for 24 hours and albuterol nebulizer treatments every 4 hours for 24 hours. Follow-up information reported that the hives resolved 24-35 hours later.
Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 10-year-old son who experienced an "awful" tasted, watery eyes and gagging. Product was administered on an unspecified date. The reported also noted that the product did not come out as a spray, rather it squirted out. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced taste (dysgeusia), eyes watery (lacrimation increased) and gag (retching) in Nov-2003. No additional information was available at the time of this report.
Swelling at site no warmth at site several hrs after inject. No itch. No systemic s/s.
Wife called me today stating her husband had started getting chills this afternoon, dry heaving, a fever, and pain near his spine at the bottom of his back. She stated he did not have soreness of the injection site or redness. Wife then stated patient had cancer previously and is in remission. I suggested the patient get in to see the doctor immediately. Although these symptoms may be a result of a vaccination, they could also be the result of other illnesses that need to be evaluated by a physician.  Have not heard result or outcome at this time. Wife was taking patient to get evaluated.
Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose. The vial was punctured more than 12 hours after first puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Both patients administered booster dose on 8.30am and 8.31am 07-Dec-2021. Expiration: 12:08am 07-Dec-2021   This case was linked to MOD-2021-405923 (Patient Link).
Patient's spouse reports to vaccine clinic on 2/2  for his second dose.  He brought his wife's card with him.  He reported that she "died in her sleep two days after the first shot."  After consulting with our physician leaders, it was advised to enter this into VAERS .
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/09/2021, 03/08/2021, and 08/25/2021. They had a symptom onset of approx 10/08/2021 with shortness of breath. They presented to emergency department on 10/09/2021. They were admitted to hospital from the emergency department and tested positive for COVID-19 upon admission. Their condition rapidly deteriorated and the individual was transitioned to comfort care only. They died on 10/10/2021.
patient said she got an itchy rash around the circumference of her left arm (injected arm) 3 days after receiving the injection. The rash formed a band around her arm. Injection site was very swollen, red, hot  and painful. She said the rash  itched for 2 weeks. It self resolved. She did not go get it looked at or report it until after the rash disappeared.
approx 10 of 100 pts who recvd Engerix-B exp fever, etc; 1 pt exp t102, diarrhea, chills & abdo cramping; body aches, abdo cramps, nausea, vomiting, urticaria, t99, h/a, nervous stomach;
The patient experienced flu-like symptoms the next day, but also muscle spasms. The muscle spasms continued to worsen over the next few days, until on 10/3 the patient said they could not move at all. The muscle spasms lessened after that, but continue to occur.
quite sick from the second dose; Ragging headache; fatigue; bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache). At the time of the report, ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age. No concomitant medications were reported. No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: The outcome of events were updated to recovered. The reporter did not allow further contact.
FluMist Quadrivalent was given 1 day past expiration date. Vaccine expired on 12/07/2021. Was given on 12/08/2021.
1: "covid arm", very painful was on fire, below the injection and round to the front of the arm.  Started on the night after the injection and pain lasted for two days.  Still itching on the fourth day. 2: High fever, woke up on Friday morning at 6 am with a 100.4 fever.  It started to rise, and went up to 102.9.  I took some Tylenol and the fever went down back down to around 100, but then went up again after it wore off.  This continued until 12 pm on 18 April, when the fever finally broke.
sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned she received the Pfizer-BioNTech COVID-19 Vaccine Dose 1 and reported to have had a sore arm. She got the second dose and reported having sore arm and severe headache. She took ibuprofen (2 capsules at 4:30AM, 2PM and 3PM after the shot) and eventually the headache resolved. The caller asked if it was okay to take ibuprofen or this would have compromised the vaccine. The caller asked whether she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She received the response which included the interim  guidelines note that, & quot; Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms was not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses was not available at this time.& quot;  If she was the patient, she should discuss that with her healthcare provider. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: ROTATEQ (route: oral, lot # N007759, expiration date 24-OCT-2019 or lot # N022173, expiration date 15-MAR-2019, exact dose details were not reported) or VARIVAX (lot# N020016, expiration date 17-JUL-2019 or lot #N019133, expiration date 22-JUN-2019, route of administration and exact dose details were not provided) for prophylaxis. The vaccines were stored in the refrigerator at -1.2 degrees Celsius for 5 minutes and in freezer at the temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. There was previous temperature excursion in the freezer in temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. It was registered by the data logger. No adverse events were reported. This is a non-valid case due to unspecified patient. Telephone call was made on 01-NOV-2018. The reporter stated she would find the requested information and fax the patient identifiers and dates of vaccination. This case was initially considered as non valid, upon receipt of follow-up information on 09-NOV-2018 the case is valid as the patient identifiers were added. Follow-up information was received from the medical assistant on 09-NOV-2018. It was reported that none of the patients were vaccinated with VARIVAX. The 6 month old patient was vaccinated with ROTATEQ on 08-MAY-2018.
Headache, Fever, Chills and swollen injection arm Narrative:  Other Relevant History:
The pharmacist who gave me my vaccine flicked the syringe that contained my covid vaccine three times to expel air.  This flicking risks inactivating the vaccine or degrading the quality.
Fever of 104; Jaw pain; Chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer) from a Pfizer sales representative.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever of 104"; PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain"; CHILLS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had fever of 104 within a week of her COVID vaccine. The high fever led to jaw pain from the chills that accompanied her fever. The fever lasted 2-3 days before resolving. The patient was afraid to receive the bivalent booster because of her previous experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore throat(lasted about 5 days), feverish, fatigue  Congestion for over three week
Throat is scratchy; Feeling nauseous; Extremely horse voice; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 2021 as a single for covid-19 immunisation. Medical history included allergy to plants from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity, morphine, and experienced drug hypersensitivity. She also has allergies with codeine, morphine, and penicillin. On an unspecified date the reporter stated that her throat was scratchy, feeling nauseous, had extremely horse voice. She took Benadryl and seemed to be okay. She had a similar reaction with other products. Therapeutic measures were taken as a result of throat is scratchy, feeling nauseous, extremely hoarse voice. Outcome of the events was recovered on unspecified date in 2021.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
9/24/21 pt brought to ED via EMS after being found unresponsive by pt's husband; pt in cardiac arrest; CPR/ACLS performed; ROSC 2 x while en route to hospital; experienced cardiac arrest again in ED; CPR/ACLS performed for greater than 1 hour; still had asystole/PEA rhythm; 9/17/21 pt had a positive COVID test; pt then had a previous admission to the hospital with COVID pneumonia, UTI, and acute on chronic renal failure; was dc'd to home 4 days later
8/1 6:30 pm - Fever (103 temple, 100.9 underarm),  - vomiting - runny nose - Resp rate: 36 bpm  7:20 pm - Administered Motrin (5mL) - Fever (102.5 temple and forehead) - Glassy eyes  8/2  8 am - Temple 103.5, leg 100.7, underarm 101.6 8:41 am - Administered Motrin (5mL)  10:25 am - Temple: 98.5, forehead 99.4  12:45 pm - 97.6 temple - No appetite for lunch  1:30 pm - Administered Tylenol (5mL) Nap: 1:50 pm - 4:05 pm  4:15 pm - 100.2 temple, 98.7 forehead  6:20 - 103.3 temple, 101.1 forehead - Lethargic - Breathing labored - Administered Motrin (5mL)  6:36 pm - 103.9 temple - Catatonic on sofa - Sensitive to light  7:15 pm - 103.6 temple - Possible rash? - Doesn?t want to walk - says tired - Crying uncontrollably - Administered Zyrtec (5mL) - Still photosensitive   7:45 pm - pepped back up - 103.3 temple  8/3   1:55 am - 104.6 temple - Administered Motrin (5mL)  7:45 am - 104.8 temple, 102 underarm 8 am -  - Administered Motrin (5mL)  10:45 am - 100.1 temple - Administered Tylenol (5mL)  3:55 pm - 101 temple, 100 forehead - Administered Motrin (5mL)  7:00 pm - 99.9 temple - Administered Tylenol (5mL)  8/4 8:30 am - 104.9 temple - Lethargic and photosensitive  - Administered Motrin (5mL)  8/4 slept until 10:45 am Fever broke? Very sweaty  11:50 -  - Administered Tylenol (5mL)  2:30 pm - Administered Advil (5 mL) - 98.2 temple  4:45 - wailing, inconsolable for about 30 mins  - Ate some dinner ~6:30  7:50 pm - 98.4 temple - Administered Tylenol (5 mL) - Wailing from 7:15 until sleep  9:30 am - 102.1 temple, 100 forehead - Administered Motrin (5mL) - Didn?t eat breakfast   12:40 - ate lunch!! - Small rash spreading on face - 97.5 temple and forehead - Administered Zyrtec (2.5mL)  7:30 - administered Motrin (5 mL) - Fever up - 102 - Rash: small red pamphlets on legs and arms and face 8/6 10:35 am - no fever!! - No appetite - Full-body rash , no itching  Rash was still present on upper thighs 8/8, fully resolved by 8/9.
Itchy inside of mouth; thick tongue feeling; Itching all over body; rash under arm of injection; 3" itchy red welt in front of underarm on right side/hives on left thumb; headache; backache in middle of back; tired; nausea; light headed; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 62-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration in right arm on 12Mar2021 10:30 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took codeine, morphine and erythromycin, Known allergies: codeine, morphine and erythromycin. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccination and patient did not receive any other medications in two weeks. Patient did not have COVID-19 prior vaccination and since vaccination patient has not been tested for COVID-19. The patient experienced itchy inside of mouth, thick tongue feeling, itching all over body, rash under arm of injection, 3" itchy red welt in front of underarm on right side/hives on left thumb, headache, backache in middle of back, tired, light headed 12Mar2021 11:00. Patient did not receive any treatment for the events. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Received DTAP, IPR, MMR & VARIVAX IZ on 2-19-09.  Came in 2-21-09 to clinic to have PPD read.  Left upper arm red, swollen, tender & hot to touch