chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose; The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN and CARVEDILOL for Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose). At the time of the report, PYREXIA (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) and CHILLS (The only thing he got previously is a 24 hour reaction of fever & chills, maybe, after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication were reported.   This case was linked to MOD-2021-411018 (Patient Link).
Extreme pain, muscle spasms, could not walk, high temperature, headache for 24 hours, wobbliness and difficulty walking, winded, lack of clarity next day
Arm  was swollen; Arm was red, red, red; Arm was hot like it had fever; Itchy; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy) and PYREXIA (Fever) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Patient had an original pfizer series and a booster of a monovalent vaccine prior to a bone marrow transplant. In the Summer of 2022 (August), he had a bone marrow transplant and was advised to repeat the entire Covid vaccination series. He was given a monovalent moderna vaccine on 9/2/22 and came back on 10/11/22 to get his 2nd monovalent dose. The pharmacist on duty saw his vaccination card and past hx of primary series, and gave a Moderna bivalent booster instead of a 2nd dose of moderna monovalent.   He returned to get a booster recently and that's when the error was noticed. Patient reports no adverse events
10/2: Severe left upper arm pain radiating into left shoulder, unable to raise left arm occurring approximately 4 hours after administration 10/3: Clinic visit: persistent (L) upper arm pain without erythema, edema or induration @ injection site (Left deltoid muscle) unable to raise arm d/t pain: Hydrocodone/acetaminophen 7.5 mg/325 mg prescribed for pain control 10/4/19: Telephone follow-up: Mild improvement in left upper arm pain - still requiring narcotic pain medication for pain control. Patient report 0 edema, erythema or induration at injection site
This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a 35-year-old female patient. On 26-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly in left deltoid. AFLURIA was drawn up from a vial and placed into one of the syringes. When administering AFLURIA, the syringe came apart and only half of the dose was administered to the patient. Some of the vaccine leaked onto the patient's arm. No adverse effects reported.
Same day post vax, the pt developed a rash on arms and chest. The pt visited the local ER. A Tissue biopsy was performed and diagnosis of erythema multiforme was made. A dermatologist confirmed the diagnosis. No further vaccinations performed.
Information has been received from a consumer concerning his 3 month old son with no medical history and no drug allergies, who on 06-DEC-2007 was vaccinated with a first dose of PedvaxHIB. Concomitant suspect vaccinations included Rotateq. Other concomitant vaccinations included Pediarix. Subsequently, "about a day or two post vaccination" on approximately 08-DEC-2007, the patient was fussy, did not want to eat, was cramping up, and was vomiting. The patient did not have a bowel movement for 3 days. It was also reported that the patient had not really eaten for two days and was still throwing up. The patient was given Pedialite and was taking some of it down but not much. The physician was contacted. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  3/5/08 Seen in pcp office 12/13 & 12/14/2007 for viral gastroenteritis.  On 12/14 referred to ER.  PCP called ER on 12/14 but unclear from pcp notes whether patient admitted or released.  PCP not available at this time.  Will request hospital/ER records.  No further visit until well child vs for vax 2/2008. PedvaxHib 0437U, Pediarix AC21B124CA, Rotateq 0236U and Prevnar B08700D.  3/19/08 Reviewed ER medical records of 12/14/2007. FINAL DX: Vomiting Records reveal patient experienced vomiting, irritability, decreased oral intake, decreased UO x 3 days.  Exam revealed sunken fontanelle & dry mucous membranes.  Tx w/IVF & antiemetics.  D/C to home to f/u next day w/pcp. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow-up information has been received from a consumer concerning his 3 month old son with no medical history and no drug allergies, who on 06-DEC-2007 at 11:00 was vaccinated intramuscularly with a first dose of PEDVAXHIB (OMPC) (Lot# 656522/0437U). Concomitant suspect vaccinations included a first dose of ROTATEQ (Lot# 656390/0236U) administered by mouth. Other concomitant vaccinations included a first dose of PEDIARIX (Lot# AC21B124CA) administered intramuscularly, and a first dose PREVNAR (Lot# B08700D) administered intramuscularly. Subsequently, "about a day or two post vaccination" on approximately 08-DEC-2007, the patient was fussy, and was cramping up. On 11-DEC-2007 at 18:00 the patient was vomiting and had decreased po intake. The patient did not have a bowel movement for 3 days. It was also reported that the patient had not really eaten for two days and was still throwing up. The patient was given Pedialite and was taking some of it down but not much. The physician was contacted. The patient was seen by the physician on 13-DEC-2007 and went to the emergency room on 14-DEC-2007. No laboratory diagnostics were performed. On 14-DEC-2007 the patient recovered from vomiting and decreased po intake. At the time of the report, the outcome of the patient being fussy and cramping up were unknown (previously reported as the patient had not recovered). No product quality complaint was involved. Additional information has been requested.
A PCV-13 was ordered, but a PPV-23 was given on 10/30/15. Parent notified, pt is well and appt scheduled for tmrw for correct vaccine.
Information has been received from a registered nurse concerning a 36 month old male patient who had alpha-galactosidase prior to getting vaccinated, and who sometime last week, on approximately 15-AUG-2011 was vaccinated with a 0.5ml dose of MMR II (route, site, dose and lot number not provided) and on the same day received a dose of VARIVAX (route, site, dose and lot number not provided), a dose of INFANRIX and a dose of HIBERIX. The registered nurse reported that within 15 minutes of vaccination, the patient experienced an anaphylactic reaction. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, anaphylactic reaction was considered to be an other important medical event. Additional information has been requested.
Dtap 7/26/06 @11am L thigh-site swollen and bright red area >1 inch-also pink area L lower abd-swollen and very painful-sent to LAH ER. DX with L leg cellulitis and lymph node enlargement. Rx Keflex 250/5mg 1 1/2 tsp bid.
4/13/2018: Right breast pain & feeling of heaviness. Had to hold up right breast. 4/14/2018: Rash outbreak on right side of breast & under arm pit. 4/15/2018: I called hospital advice line & spoke to a nurse at 10 pm, Painful breast & rash area. 4/16/2018: Got phone consult with Dr., I sent photos of rash via email, 4/18/2018: Got Rx for NORCO & Naprosyn for pain cuz OTC analgesics not helping. Sent more photos as rash increasing. Dr. said it definitely looked like shingles  4/20/2018: Reported to GlaxoSmithKline spoke to RPh that I got shingles from the SHINGRIX vaccine. I had called GSK on 4/16/2018 to report effects.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In January 2014 (exact date not provided), the patient was vaccinated with the first dose of PNEUMOVAX 23 given intramuscularly (dose, lot #, batch #, expiration date and indication not provided). On 23-OCT-2014, the patient was inadvertently administered a second dose of PNEUMOVAX 23, intramuscularly (dose, lot #, batch #, expiration date, indication not provided). No adverse effects were reported. Additional information has been requested.
Large red hard knot at injection site. Redness approximately 2 inches long 1 inch wide, warm to touch, itchiness, headache. Headache started at approximately 2-3 hours post shot. Red, hard knot began the next day and lasted approximately a week. Also chills and extreme fatigue began the next day which lasted a day and a half.
My left arm has become red and swollen and In Pain in an area where the vaccine was administered.
This case was reported by a pharmacist via call center representative and described the occurrence of axillary lymph nodes enlarged in a 66-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included PNEUMOVAX 23. On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th July 2018, several hours after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged. On 29th July 2018, the outcome of the axillary lymph nodes enlarged was recovered/resolved. It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to SHINGRIX. Additional details were provided as follows: On 27th July 2018, the patient received PNEUMOVAX 23. The patient received SHINGRIX in the left arm. The patient developed an enlarged axillary lymph node on the same arm as the vaccine was given within 24 hours that lasted for 2 day and currently resolved.
Lightly sore arm; Slight headache; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 Immunisation. The medical history of the patient included rheumatoid arthritis (RA), fibromyalgia and Hashimoto's thyroiditis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), REMICADE, all for an unspecified indication. The patient was allergic to MEDROL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 11:00, the patient experienced lightly sore arm and slight headache. The patient did not receive any treatment for the events. The clinical outcome for the events pain in arm and headache were not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Patient states experiencing painful, warm, red area that is radiating to elbow. Patient states not experiencing blisters or fever, but thinks it is getting worse as of 09/23/2016 AM. Pharmacist recommended patient call primary doctor for evaluation.
Nasuea, dizziness/lightheadedness, weak in legs, chills starting approximately 24 hours after 1st dose of vaccine
His heart is being squeezed, she thinks may be its Myocarditis; Felt like someone was squeezing his heart; Still feeling bad; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program  support.  A 48-year-old male patient received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 21Sep2021 15:00 (Batch/Lot number was not reported) (at the age of 48-years-old)  as DOSE 1, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient had no prior vaccination within the last four weeks. On 21Sep2021, the patient went to get his first dose of the Pfizer covid 19 vaccine and an hour later, felt like someone was squeezing his heart. The patient was still feeling bad. The reporter stated that  the pharmacist said it was all in his head, she did not refer to doctor or anything. It has been twelve hours and it was a constant feeling. The reporter stated that her fiance (patient) did not have a health care provider and they would have to seek ER or urgent care. The reporter states obviously this was an effect from the vaccine and asked if there was any coverage that is provided. This was something they were not expecting. The reporter stated that patient has been feeling like his heart is being squeezed, she thought may be it's myocarditis, she was not quite sure do she needed to make a report of this, she also wanted to know about if Pfizer has any assistance risk precast associated for taking treatment.  The reporter informed that reason for her call was  mainly because they had called to  pharmacist at the (Withheld) where he got the vaccination and he forced him that he did not  need to seek medical assistance nor for and that was all in his head, reporter just wanted to put it out there because Pfizer told reporter that he should be taking medical assistance, whereas the pharmacist saying otherwise so this is like a huge concern especially given that the vaccine is so new so what is the thing we should do and are the pharmacist are even been trained on telling patients what to do after administering this product.  Reporter stated further that her reason to call to figure out what we need to do, she was not calling just to report the fact that he was having issue, and wanted to know what the next step was. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
more than 6 months since his first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 6 months from reporting date.).   On an unknown date, the patient received 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 details were provided as follows: This case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if it was still ok to get his 2nd dose. The reporter did not consent to follow up. No further information was reported.
Rash from shoulder to elbow on the right arm for about 1 week. Slight swelling and very itchy.
Headache, Myalgia, Arthralgia, Fever, Chills Narrative:
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL. No concomitant medication was reported. On an unknown date medication error was reported that patient may have received an expired dose of GARDASIL and no adverse effects reported. She stated that the dose could have been administered up to ten days after expiry. She stated that she is unsure if it was given, and she stated that she had no specific information. The outcome of the medication error was unknown. Additional information is not expected.
11/6  Pt to ED via EMS with c/o high blood sugar. Hx of diabetes and hasnt eaten in 2 weeks. Pt chest x-ray showed bilateral basilar interstitial airspace opacity, left more than right. 11/8 Dx COVID Pneumonia,  Steroids and anticoagulation to be started.
Pt w/ hx of seizure cleared to have Flu vaccine by PCP & neurological okayed if pt seizure free x 4 weeks & PCP okayed. PCP prescribed Flu shot. Pt reported approximately 4 (+) wks after receiving shot that she had seizure (Grand Mal) 4 days after receiving Flu shot & wondered if shot caused seizure.
Immediately after the injection I felt dizzy for approx. one hour. Experienced severe itching and mild pain at injection site one week after injection. I had a red area about the size of an apple. Telephone conversation on 3/16/2021 with family physicians' office resulted in treatment to use TRIAMCINOLONE ACETONIDE CREAM, .1% twice a day. Cream reduced itching for approximately 4 to 5 hours after each application.
dizziness, lightheaded, nausea did not lose consciousness. called 911 at pt mom request Paramedics checked BP, breathing. Patient left pharmacy on own power w/Blessing of paramedics
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD lot # L019996 with expiration date: 02-DEC-2016 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Initial report received on 11/3/2005 from a consumer. A 77 year old female patient who was currently taking Zestoretic, Toprol XL, 200 mg, Tricor, 160 mg and Synthroid 0.1mg at the time of the vaccination had received an administration (route site not reported) of Fluzone SV 2005-2006 USP lot number not reported on 9/21/2005. The next day she complained of muscle soreness, weakness and joint pain. The patient fells it is very severe in nature. She was evaluated by a physician and was prescribed methylprednisolone which slightly improved her conditions. The patient had some unspecified diagnostic testing completed to rule out rheumatoid arthritis. The patient had not recovered from these events at the time of the report. Follow up information received on 1/13/2006 from the patient. Per the reporter, the patient stated she developed muscle weakness and soreness the day after receiving an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1806AA, in the left deltoid on 9/21/2005 at 15:30. After seeing three doctors she was diagnosed with polymyalgia rheumatica. The patient was taking Norvasc at the time of the vaccination. It is unknown if the patient recovered from these events at the time of this report. Follow up information received on 1/24/2006 from the patient. The patient reported that the day after receiving an injection of Fluzone, she woke up aching like she had the flu. She traveled and a pre planned trip from 10/13/2005 to 10/20/2005 and reported that she was in great pain and could not sleep at night. She was seen by a physician who prescribed Advil, which did not improve her symptoms. She reported that she had to be assisted out of chairs, the bus, etc. and that by the time she returned home she was home bound until she saw a rheumatologist and received the diagnosis of poly myalgia rheumatica. She reports that she is now taking prednisone and had had to add Norvasc to control her high blood pressure. It was not reported whether she has recovered from the events. Due to the new information provided on 1/24/2006, this case is being upgraded to serious (OMIC).
Itchy red bump/rash around injection site; Itchy red bump/rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration in left arm on 12Feb2021 at 18:30 (at the age of 34-year-old) as single dose for COVID-19 immunization. Medical history of the patient included seasonal allergies. Concomitant medications/other medications in two weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate [LO LOESTRIN FE], cetirizine hydrochloride [ZYRTEC], montelukast sodium [SINGULAIR], naproxen sodium [ALEVE] all taken for unspecified indications. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Sulfa drug on an unspecified date and experienced allergy. Patient previously received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EJ9262) via an unspecified route of administration in right arm on 21Jan2021 at 18:15 as single dose for COVID-19 immunization. On 13Feb2021 at 22:00 patient experienced Itchy red bump/rash around injection site. No treatment was received in response to the event. Outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
arm pain; fatigue; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (patient, reported for self). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that with her first dose of the vaccine, she just had arm pain and fatigue which they (doctor) said was normal.The clinical outcome of the events was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100912728 same patient/drug, different event/dose