chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is hot to touch; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills). At the time of the report, FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Complained of feeling hot 5 minutes after injection. Patient then had upper respiratory stridor with SOB. I put patient on 4 l nc. Lungs sounds were clear. Stridor resolved after 5 minutes. Sats were always in the high 90's with no tachycardia. Respiratory rate between 20-24 till stridor resolved. When home visit was finished patient on O2 at 4 l nc and c/o no SOB. Lungs clear, denies SOB. I called patient at 14:40 for recheck and he states he feels fine and has been off oxygen this afternoon with no SOB.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that on 21-SEP-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L006382, expiration date 25-MAY-2016) (Dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected because the pharmacist declined to provided patient's or physician's information at this time.
I had swelling on my fingers joints. My right ring finger still has theses swelling. Fever and  puffiness in my armpit.
Had severe hip and lower back pain; Had severe hip and lower back pain; Had edematous feet and ankles; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200), via an unspecified route of administration in right upper arm  on 24Feb2021 at 13:30 (at the age of 69 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received Shingles vaccine and experienced symptoms feeling heat. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer Suspect. On 26Feb2021, two days after receiving the first dose patient experienced severe hip and lower back pain, an inflammatory like response, had edematous feet and ankles. When it was time for the patient to receive the second dose Pfizer Covid 19 Vaccine, the sever hip and lower back pain and the edematous feet and ankles kind of disappeared and it was okay after the third week.  She considered not getting the second dose Pfizer Covid 19 Vaccine because of the symptoms, but then the symptoms disappeared.  She said she needed to finish the remainder.  She would say she pretty much recovered, pretty much almost totally recovered. Had edematous feet and ankles seemed like recovered from it. She didn't have swollen feet or ankles after that. The hip pain and back pain ended up going, called primary physician and ended up going to a person who specializes in hip issues. No family medical history relevant to adverse events was provided and no relevant tests were performed. The events resulted in a visit to physician office. The outcome of the events was recovered on an unspecified date in Mar2021.  Information on Lot/Batch number was available. Additional information has been requested.
Extreme swelling in upper arm, hard, hot and some redness. Severe pain radiating into back shoulder blade when moving or not; Some itchiness, watery eyes and fuzzy throat. Nausea, unusual drowsiness,  chills.
Within 6 weeks of receiving my first dose, I experienced shingles outbreak. Also, I have not had a period consistently for a number of years and a month and a half after the dose, I began menstruating again and it has now been 6 months of monthly menstruation. My period has returned each month and is ongoing.
Patient received 2 doses of Pfizer covid vaccine on 3/19/2021 and 4/16/2021. She tested positive for covid on 6/8/2021. Her symptoms started on 6/3/2021 and included fever, cough, chills, loss of taste/smell, diarrhea, headache, and congestion/runny nose.
Right deltoid-almond size red, swollen, hard, painful lump when approved. 10/18/06 AM when woke up -then area became blistered. Then came down with fever blisters, nose, lips, stuffy head, nose, head congestion. Primary care physician told her never to get flu shot again.
Nausea; Hot, heat upper arm, chest and upper back; Rash upper arm, chest and upper back; Arm swelling elbow to shoulder; This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number JC9EM, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml. On an unknown date, 3 hrs after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced nausea, swelling arm, feeling of warmth and rash. The patient was treated with triamcinolone acetonide (Kenalog). On an unknown date, the outcome of the nausea, feeling of warmth and rash were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the nausea, swelling arm, feeling of warmth and rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Medical Assistant. The age at vaccination was not reported. The reporter stated that, the patient experienced nausea, arm swelling elbow to shoulder, hot, swelling, heat rash upper arm, chest and upper back. The kenelog was given as treatment for swelling, and swelling resolved after kenelog on day 2 or 3.
Right hip pain with limp, exam findings consistent with transient synovitis, resolved after 36 hours with scheduled NSAIDs
The patient has a history of cholangiocarcinoma currently receiving chemotherapy. He presented to the ED on 2/6/23 with weakness, confusion, cough, and difficulty breathing. A COVID PCR test done in the ED returned positive. He was admitted to the hospital 2/6/23 - 2/9/23. Discharge diagnoses include sepsis, generalized weakness and metabolic encephalopathy secondary to COVID-19 infection, and suspect CAP, among other diagnoses. He did not require supplemental oxygen during his admission. He was started on paxlovid, however there were no indications for steroids. The patient's most recent COVID booster was administered 7/12/22.
Child given wrong vaccines. Given HPV, Fluzone 12/11/07 1140 AM.
3 years since first Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st Shingrix shot 3 years ago since the time of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter asked if he/she should just get one more shot, or start over and get two more shots. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix , which led to incomplete course of vaccination. The follow up would not possible, as no contact details were available.
syncope, found unresponsive/ second episode; sore arm; mild fatigue; This case was reported by a nurse via sales rep and described the occurrence of syncope in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2021, the patient received the 1st dose of Shingrix. In September 2021, 12 hrs after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), pain in arm and fatigue. On an unknown date, the outcome of the syncope, pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the syncope, pain in arm and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The nurse reported that a friend of wife called her to report that she received the Shingrix vaccine on 12th September 2021. The patient had sore arm but otherwise reasonably well except for mild fatigue until about 12 hours later when she had syncope, found unresponsive by husband (a physician) in bathroom. Followed by second episode as he was getting her back to bed, to which she was slow to recover from and he briefly considered calling ambulance but changed his mind after she awoke fully. The reporter stated that patient was willing to speak to GSK about this incident which she found to be very alarming. This case is linked with the case US2021AMR196420, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196420:same reporter
2/13/22- Transfer to Hospital for acute hypoxic respiratory failure and chest pain.  Found to have a acute saddle pe without obstructive shock with large clot burden on CT. WBC-17.4 Started on Heparin drip. Bedrest, IV cefepime, and IV doxycycline. 2/14/22p Patient is confused, currently on 2L via NC  o2 sat 94%. Left leg tender and more edematous larger then the right. Heparin increased to 14ml/hr due to APTT being 58.   2/16/2022- Tested Covid + today.  Heparin drip d/c started Elliquis. Increased confusion Head CT -No intercanial hemorrhane or mass effect. Moderate periventricular supraventricular chronic microvascular ischemic disease.  Altered mental status could be secondary to dementia vs. 2/16/2022- Pneumonia. 2/17/2022- Pt is O2 sat on RA, 96% no supplemental oxygen needed. 2/18/22- IV antibiotics transitioned to PO cefdinir, doxycycline and lasix.  2/19/22- Maintaining oxygenation on RA. 2/21/22- Finish course of antibiotics, titrate Elliquis. stable discharged to home . Follow up with Neuro outpatient.
This spontaneous report as received from a consumer refers to her son, a 18 years old male patient with allergy for sulfa drugs. The patient's medical history included wisdom teeth removal. The patient was vaccinated with dose 1, 0.5 ml GARDASIL intramuscularly (IM) in March 2012, as part of a 3 dose series of injections. Lot number was not reported. The patient used no concomitant medications. After the first 2 injections the patient did not experience any adverse event. On 28-SEP-2012 the patient received the third and final dose of GARDASIL 0.5 ml IM (lot # not reported). On 02-OCT-2012, after the third injection, the patient developed pain in his upper right abdomen. He also mentioned his throat was bothering him and he did not want to eat because of the irritation. The reporter had not spoken to the patient's doctor yet, but planned to do so. No treatment was provided for the events. At the time of report the patient had not recovered. The relatedness for the events was not reported for GARDASIL. Additional information has been requested.
Woke up day after flu shot with increasingly blurred/worse vision, by noon only able to make out large shapes no print. Seen by optometrist.
Several days after receiving this second dose of the vaccine, I started getting a bumpy, itchy, red rash that looked like mosquito bites even though it was February. My doctor at the time insisted it was insect bites. After several months, many lab tests, four doctors and one biopsy later, it was determined I had hives. I still have hives after all these months. I am able to keep them in check with a quadruple dose of Zyrtek daily.
pt recv vax MAR96 & in 1996 pt exp negative antibodies;a titer was done in 1996 w/negative results;
On 12/6/16 pt had temp 100.5 with back/neck pain, TYLENOL given by father. On 12/7/16 T. 103, coughing and ER visit. Treated at ER with antibiotic. Pt better 12/8/16 with no fever.
Pt was given DTAP and Polio injections in both thighs she was fine when they were given and when they proceeded to the checkout the little girl passed out immediate attention was given and the on call doctor followed up with that family the next day.
Patient was very sick after vaccine administration. Patient's wife reported chills, fever,malaise, and severe pain. Patient went to the ER and received care then was discharged the same day.
hard time sleeping after getting the first shot of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (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: SLEEP DISORDER (non-serious) with onset 14Feb2021, outcome "unknown", described as "hard time sleeping after getting the first shot of the vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are needed; No further information is expected.
Hive (local) rxn to immunizations (L) thigh 5 x7 cm. DaPT, IPV, given on LT.
automatic itching; red rash almost instantaneously; hot flushes/flushing/flushy feeling/hot flushing feeling; immediate rash to the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FK9729, Expiration Date: 21Jun2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose:02), for COVID-19 Immunization, reaction(s): "No adverse event".  The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "automatic itching"; RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "red rash almost instantaneously"; HOT FLUSH (non-serious), outcome "recovered", described as "hot flushes/flushing/flushy feeling/hot flushing feeling"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "immediate rash to the injection site".  No follow-up attempts are possible. No further information is expected.
Hives, mainly around the torso appeared a few hours after the shot. Hives were gone by morning but reappeared each night and began to increase in intensity and duration after a week. Doctor consultation one week after the shot. Received prescription for Methylprednisolone 4 mg. Seems to be helping.
Patient presented with a 4 day history of headache.    Presented for care and had CT scan which identified a subacute infarct in the L occipital lobe.
Sl. red raised dime size area, adjacent pink raised oblong area anterior to each of these a smaller, lighter faintly red irregular area. Instructed to give ZYRTEC.
Mother brought her daughter in @ 1630, with a nodule on left leg about the size of a quarter. I referred her to PCM as W/I. Patient didn't seem to have anything else wrong. No treatment, mild expected reaction.
Patient hospitalized beginning 8/14/2021..Symptoms:altered mental status, respiratory distress; Nonrebreather mask; BiPAP setting above 90%; Treatment: dexathasone and remdesivir, Vancomycin and Rocephin. Hospitalization ongoing in CCU.
Migraine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown". Follow-up attempts are completed. No further information is expected.
Child returned to have ppd checked. Grandma said R leg red and swollen. Pt examined by PCP 15x15cm erythematous area around Dtap site.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. The reporter reported that he had seen many injection site reactions in unspecified patients who received ZOSTAVAX (dose, lot#, dose# and route not reported) on unspecified dates. He reported that the injection site reactions were "mostly quarter-sized rashes that got red and raised, but some progress to a '2x4 area' around the injection site. Sometimes the injection site areas turned 'red and ugly-looking', but the injection site reactions usually went away in approximately a week." He was not certain if he had seen any vesicular rashes, but he stated that many people told him that they develop a rash after receiving ZOSTAVAX. He was not able to recall any specific persons, nor did he think that he would be able to recall any specific instances in the future. The outcome of rash was not reported. Additional information has been requested.
2in x 1 1/2in. erythematous raised rash surrounding injection site. No pain, mild tenderness. Placed on BENADRYL q 6 hours x 24 hours then q 6 hours prn. (R) thigh - PCV 13.
This spontaneous report was received from a healthcare worker refers to a 78 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 09-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L018503, expiry date 16-MAR-2017 (dose, route and site of administration were not reported). The patient did not take any concomitant medications. On 10-MAR-2016, she experienced generalized weakness and could not lift her arm. There were no lab diagnostics studies performed. The outcome of the events was unknown. The patient sought medical attention via calling the physician's office. The relatedness between the events and suspect therapy was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd vax & 2 wks p/vax devel transverse cervical myelitis, in retrospect, it was recognized that pt probably had MS for many years undiagnosed;
Muscle weakness, pain, cramping.  No change with D/C statin or addition od CoQ10
sore throat; eye aches; difficulty sleeping; Extreme fatigue; body aches; chills; headaches; Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping) and FATIGUE (Extreme fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer/BioNTech (Dose Number: 1  Batch/Lot No: EN6201  Location of injection: Arm Right  Vaccine Administration Time: 11:15 AM) on 26-Feb-2021, Pfizer/BioNTech (Dose number: 2 Batch/Lot No: EW0187 Location of injection: Arm Right  Vaccine Administration Time: 02:30 PM) on 27-Aug-2021 and Pfizer/BioNTech (Dose number: 3 Batch/Lot No: EN6208 Location of injection: Arm Right  Vaccine Administration Time: 11:45 AM) on 19-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer/BioNTech, Pfizer/BioNTech and Pfizer/BioNTech. Concurrent medical conditions included Drug allergy (Unknown drug).    On 30-Mar-2022 at 2:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022). On 18-May-2022 at 11:00 AM, the patient experienced OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. The patient previously received a COVID-19 Vaccine. It was unknown that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had treatment for COVID-19 (unspecified). Device Date: 21-May-2022
Left deltoid red, swollen, hot to touch, raised, a little firm, center white; about size of small orange; a little tender to touch.
COVID-19 INFECTION; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 155 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced covid-19 infection. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be void: y based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000175739
Received Pfizer vaccines on 8/17, 9/7/21 Tested positive for COVID by PCR on 11/25/21 admitted to the Hospital on 12/15/21 d/t acute pain/pain crisis, underlying relapsed multiple myeloma.
Red face and neck, itching, felt extreme heat sensation, nausea, high blood pressure, chills, muscle spasms to left leg, and headache. Took Benadyrl. Side effects have resolved.
A significant lump appeared in Left armpit (injected arm).  It is soft and squishy, tender to the touch.
Swollen, tender lymph nodes under left armpit. Arm rash 4 inches surrounding injection site on arm. Tender injection site. All symptoms occurring 48 hours after injection and persisting through the time of this report.
Left deltoid red, swollen, warm to touch, temp 99.1. Went to urgent care for evaluation and to r/o cellulitis. ARNP stated symptoms were delayed reaction to vaccine. Applied ice and took Aleve and symptoms resolved in 2-3 days.