chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of vaccine products; Diagnosed with Covid-19; Diagnosed with Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Comments: Diabetic. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Mar2023, outcome "unknown" and all described as "Diagnosed with Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "diagnosed with covid-19" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no prior vaccinations (within 4 weeks) and no family medical history relevant to adverse events. Had total of 3 or 4 vaccines, 1 was Monderna, did not have dates, NDC, LOT, EXP for these vaccines with her at this time. Has information on vaccine card. Felt like they got everything, got really sick. Was sicker than a dog. Her husband, not so much. Caller declines to complete report on husband, stating everything was the same except for the degree of illness. Fully vaccinated, got primary series, boosters and, got Covid-19. Clarified that caller was diagnosed with Covid prior to taking the Paxlovid. Were both taking some meds, were told to stop taking one while on Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145996 Same product and event, different patient;
Headache; Nausea; Light headedness; Fatigue; Metal taste; Swelling and numbness whole arm/hand; Swelling and numbness whole arm/hand; Pain x4 days; Lung inhale feels abnormal; Face hot/flushed; Low grade fever; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266) dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) (at the age of 49-years-old) as DOSE 2, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Patient medical history included chronic bronchitis (not currently active though) from an unknown date and unknown if ongoing. Patient concomitant medication(s) included rosuvastatin (ROSUVASTATIN) 10 mg, ergocalciferol (VIT D), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), Multivit and ubidecarenone (COQ 10), all were taken for an unspecified indication, start and stop date were not reported for any. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 16:30, the patient experienced headache, nausea, light headedness, fatigue, metal taste, swelling and numbness in whole arm/hand, pain x4 days, lung inhale feels abnormal, face hot/flushed, had low grade fever and had deep pain in armpit, elbow, hand and breast area. On 03Apr2021, the patient underwent lab tests and procedures which included body temperature which was found to be low grade. The patient did not received any treatment for the events. The outcome of events was not recovered.    No follow-up attempts are needed. No further information is expected.
Symptoms showed up one at a time.  Arm soreness was gone by Tuesday. Tuesday night with right upper back dull pain. Headache, chills, swollen lymph nodes to neck and left armpit, body ages, fatigue,  multiple bruising to both legs associated with soreness and pain. Went to ED 0300 am Thursday. 2 liters IV bills plus IV Toradol. Had minimal relief at the time so released with Tylenol #3.  Takes pain away but comes right back once med wore off. Added Ibuprofen. Helps but pain comes back with bad chills and headache.
The vaccine was administered on 09-21-2017. On 09-22-2017 the patient became ill; experiencing diarrhea and vomiting. Her caregiver came to the retail pharmacy, and picked up EMETROL and IMODIUM over the counter; symptoms persisted. The evening of 09-22-2017 the patient went to an urgent care facility; it was determined she was dehydrated and was sent to the hospital. She was admitted to the ER, and was treated with IV fluids and ZOFRAN. She was released from the ER the same evening, 09-22-2017. The patient has been well since her release from the ER.
Left lymph node under arm was sore and swollen, as well as lymph node on my collar bone, which has lasted for 3-4 days.
fever over 102, erythema, swollen at injection site, fussy, lethargic
lump at injection site; swelling under arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE SWELLING (swelling under arm of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE SWELLING (swelling under arm of injection). At the time of the report, VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE SWELLING (swelling under arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
This spontaneous report as received from a physician refers to a patient of 22 years old (current age) who had a positive PAP smear for HPV, on preventative exam, after patient had received first dose of GARDASIL (route, dose, frequency unspecified) (lot # and exp date unknown) in 2009. Concomitant therapy included unspecified birth control pills. Physician believed patient completed GARDASIL vaccination series. Patient has not had sexual contact. The patient did not seek medical attention and no treatment was given to the patient. Additional information has been requested.
With in 30 minutes of Modern booster shot, I felt  dizziness and equilibrium off.  I did not feel this for the 1st or 2nd shot.
much stronger side effect,typical side effect; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (much stronger side effect,typical side effect) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (much stronger side effect,typical side effect). At the time of the report, IMMUNISATION REACTION (much stronger side effect,typical side effect) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant details were reported.  Patient had a much stronger side effect, typical side effect than her husband, but after more than 2 days it was gone.  No treatment details were reported.  Reporter declined providing information regarding the side effects because they were so minimal.   This case was linked to MOD-2022-578357, MOD-2022-578384 (Patient Link).   Reporter did not allow further contact
Large lymph node by ear, about 5 cm, resolved in 7-10 days
Awoken at about 6am the following morning with rapid heart rate. After 24hrs B.P. at 172/92 pulse 96 (very high for me). Feeling of Deep, Icy Cold, Blueish hands and Feet. Rash on face and upper chest, no appetite. Nov. 20, Rapid heart rate again, loose bowels, dizziness, winded on exertion. 11/22 (Nov.) Leg pain. Dec. 07, early am rapid heart rate, Fatigue, rash that comes and goes. Nov. 20 (1 week later) BP Still high 150/85 pulse 80. Dec. 04 (3wks from shot) woke 8am with palpitations all day fatigue, slightly dizzy. Intermittent facial flushing. Dec. 13 Finally Feeling better. Stopped nightly Benadryl. (2 maximum / 24 hrs.)  *No treatment from Doctors- PCP said to go to E.R. if shortness of breath occurs.
two of her patients are breakthrough cases; two of her patients are breakthrough cases; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This consumer reported similar events for two patients. This is the second of two reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history included blood pressure abnormal and diabetes mellitus. The concomitant medications for patient were not reported. The consumer's daughter (physician) working in ICU stated that two of her patients were breakthrough cases who had conditions such as blood pressure and diabetes. These two were in critical conditions and they had to be put on ventilator. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070268 same  drug/reporter/events, different patients
pt awoke 1AM was fussy; father picked pt up & pt stiffened, eyes rolled back, began trembling & jerking; color became pale w/blueness around mouth; skin became cool & clammy-made a strangling noise & seemed to be having problems breathing;
only more severe redness to face, both sides of hands. Redness appeared on throat and arms 2nd day; Redness appeared on throat; very flushed; heated face and top and bottom of hands; Very hot touch to skin; Extreme itching on top and bottom of hands/extreme itching on the back; Extreme itching on top and bottom of hands, swelling; Extreme itching on top and bottom of hands, swelling and inflamed; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 13:00 (at 50-years-old) as a single dose for COVID-19 immunisation. Medical history included unconfirmed COVID infection in early Mar2020 to Mar2020; migraines and gastroesophageal reflux disease (GERD) reported as minor, both from unknown dates and unknown if ongoing. Concomitant medications included plecanatide (TRULANCE), lansoprazole (PREVACID), colecalciferol (D3), turmeric (curcuma longa rhizome), and fish oil, all from unknown dates for unknown indications. Prior to vaccination the patient was not diagnosed with COVID-19, had not received any other vaccines within 4 weeks of the COVID vaccine, and had no known allergies. It was reported that 4 days post-vaccination, also reported as 14Apr2021 at 12:30, the patient was very flushed and heated face and top and bottom of hands, further reported as very hot touch to skin. The patient experience extreme itching on top and bottom of hands, swelling and inflamed as well as extreme itching on the back. Two hours later, nausea and vomiting. The events resolved with 1 tablets of diphenhydramine hydrochloride (BENADRYL) after 6 hours. The same symptoms happened the next day only more severe redness to face, and both sides of hands. Redness appeared on throat and arms second day, with more nausea and vomiting. The patient went to the emergency room for treatment. The patient was treated with anti-nausea medications mixed with diphenhydramine hydrochloride in an intravenous (IV) solution. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
On Friday after 7 hours of receiving vaccine I was nauseous, had chills, my arm at the injection site was very sore and I couldn?t sleep for about 24 hours. My symptoms were gone within 24 hours of receiving vaccine. However my symptoms came back on Wednesday at 4pm (5 days after receiving vaccine). My arm was all of the sudden sore again and hot to touch. I had chills, couldn?t sleep through the night, and was nauseous for another 24 hours.
Patient presents generalized fatigue for approximately one week.  Patient has associated sore throat, headaches and shortness of breath with exertion.  In the ER patient had a Temp of 101.6° was satting 95% on room air.  Patient tested positive for COVID-19 and was admitted as she did not feel comfortable going home.  Patient's urinalysis was significant for UTI.  Patient placed on ciprofloxacin for three days with lactobacillus as bowel prophylaxis.  Following day patient was doing well afebrile and ready to discharge home.
THE DAY OF THE VACCINE WITHIN A COUPLE OF HOURS PATIENT EXPERIENCED A GENERAL ACHE, SWELLING, REDNESS. BY EVENING, IT GOT PROGRESSIVELY WORSE.  SHE HAD TROUBLE MOVING HER ARM BY THE TIME SHE WENT TO BED.  SHE HAD SOME NAUSEA AND DIZZINESS THE NIGHT OF THE VACCINATION.  THE DAY AFTER THE IMMUNIZATION, SHE SAID THERE WAS A RED RING THAT WENT MORE INTO HER AXILLARY AREA FOR A FEW DAYS.  A FEW DAYS LATER, THE SYMPTOMS SUCH AS REDNESS AND SWELLING RESOLVED, BUT PATIENT STILL COMPLAINS OF REDUCED MOVEMENT RESTRICTIONS STILL APPROXIMATELY 45 DAYS LATER FROM INITIAL VACCINATION.  PATIENT DID NOT SEE A MEDICAL PROVIDER OR PHARMACY UNTIL THE DATE OF THIS REPORT.  AS A PHARMACIST, I SUGGESTED SHE HAVE HER ARM EVALUATED BY A MEDICAL PRACTITIONER THAT CAN EVALUATE FURTHER AND ALSO SUGGESTED LIMITED ICE THERAPY.
Pt presents w/rash & warmth at site of varicella vaccine and urticarial rash on his chest.
Swollen arm; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.
Eight - ten hours after the vax, pt developed night sweats and fever for two nights. Aches and numbness of the right shoulder muscle only continuous over several weeks lessened to only evenings and now only it arm is used quite often. Pt denies weakness in right arm or hand and denies numbness anywhere else.
The condition was treated by an emergency room physician whom I do not know the name of. I had a fever the week of October 6th, 2022. On October 13th, 2022, I went to get tested for COVID-19 and it was negative. 2 days later my temperature went up to 101. October 16, 2022, I went to the hospital. I had a spot on my lung. In the emergency room they did a chest x-ray and diagnosed me with a spot on my lung that looked like pneumonia. They gave me amox and discharged me. They told me to go home and cough up the congestion. After about a week my temperature was back to normal. I was still tired for at least a month and felt beat up.
Headache, Myalgia, NauseaVomiting, chills, tired. Narrative:
Information has been received from an investigator regarding a 12 month old male who received his fourth dose of study vaccine on 4/29/03 as part of the clinical trial, "A Phase III, Randomized, Double-Blind, Multicenter Study to Compare the Safety and Immunogenicity of a 9-Vlent Pneumococcal, Meningococcal Serogroup C Conjugate Combination Vaccine Buffered with Succinate to the Non-Buffered Formulation in Healthy Infants." Concomitant therapy included Hib-Titer, Varivax, and MMR vaccines On the morning of 5/3/02, he had a fever of 101.7 deg F and was given Tylenol. That afternoon, he experienced a febrile seizure and was taken to the emergency dept. An electrocardiogram, x-ray and other unspecified laboratory tests were performed with unknown results. He was discharged with instructions to take Motrin around the clock. On 5/5/03, he was seen by his primary medical doctor. His temperature was 100.8 deg F and had two red spots on his face. The physician noted that the red spots were not varicella. The event end date was reported as 5/6/03. This event was considered medically important (OMIC). The investigator considered the febrile seizure (not expected per the investigator brochure) to be "probably not" related to the study or concomitant vaccines. The medical monitor considered the event to be "possibly related" to the study vaccine as well as to the concomitant vaccines.  A 15-day follow up report received 6/14/2003 adds no new info. A 15-day follow up report received 7/31/2003 adds: (At ER on 05/03/2002): A chest X-ray revealed no segmental infiltrates or significant pleural effusions. Laboratory tests results revealed a white blood cell count of 5.4 K/uL. An electrocardiogram and a urine analysis were performed with unknown results.
No additional adverse events; administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot number U006485 has been verified to be a valid lot number, expiry date 26-FEB-2023), and  1 improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U002400 has been verified to be a valid lot number, expiry date 22-JAN-2023) (strengths, doses, frequencies, routes of administration, and anatomical locations were not provided) both vaccines indicated as prophylaxis.  The measles, mumps, rubella and varicella (oka merck) virus vaccine live (M-M-R II) was stored at a temperature of above 8 degree Celcius (C) (8.8C) for 1 hour 27 minutes and 0 seconds; above 8 C (8.SC) for 6 hours 39 minutes and 0 seconds, above 8 C (8.8 C) for 8 hours 45 minutes and 0 seconds; above 8 C (10.7C) for 11 hours 42 minutes and 0 seconds; above 8 C (9.83C) for 18 hours 48 minutes and 0 seconds; above 8 C (9.5 C) for 14 hours 10 minutes and 0 seconds, and above 8 C (9.OC) for 9 hours 24 minutes and 0 seconds. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored a t a temperature of  -14°C up to -10°C (-13.1C) for 18 minutes; and -14°C up to -10°C (-11.9C)  for 21 minutes. There was no previous temperature excursion.  No additional adverse events were reported.     9.5 Fahrenheit (F) for the time frame of 35 minutes. There was no previous temperature excursion.  No additional adverse events reported.
Around 03JAN2023 I woke up with a sore throat and head congestion I had chills but no fever I treated with Tylenol and Mucinex when no improvement I called my Doctor and I had taken a COVID-19 was taken and the result was negative.  06JAN2023 I saw my Doctor and a Strep test was negative, they prescribed a Flonase nasal spray and an antibiotic.  I felt better within a couple of days after that. They thought it was probably a virus that was currently going around,  once my COVID-19 test was negative they started me on an antibiotic.
Extreme Fatigue;  Achiness all over body, particularly back of arms; pain in joints, particularly ankle joints, soreness in arm (expected this) and 102.9 temp
SHAKES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 227 pounds, and height was not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, and chills on 10-APR-2021, and had not recovered from fever, headache, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a other health professional refers to a 9 week old female patient. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-OCT-2017, the patient was vaccinated with ROTATEQ lot # N005617 expiration date OCT-20, orally via a bottle nipple cap (strength and dose # were not provided) for prophylaxis. The patient received all the vaccine, according to dose, in the plastic squeeze vial. This administration allowed the patient to receive all of the vaccine without coughing, sputtering or drooling out the vaccine.