chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Something in her bladder; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISCOMFORT (Something in her bladder) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLADDER DISCOMFORT (Something in her bladder). The patient was treated with NITROFURANTOIN (MACRODANTIN) for Bladder discomfort, at an unspecified dose and frequency. At the time of the report, BLADDER DISCOMFORT (Something in her bladder) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they had 2 doses of the Moderna vaccine and was ready for their booster shot but the patient was presently taking Macrodantin with nitrofurantoin, substituted for the Macrodantin.  Upon call back, the patient's husband answered and was hard of hearing. It was reported that the patient had an examination a couple of days ago, and their husband was not sure exactly what it was. It was a test. Something in patient's bladder and the antibiotic was a precaution from their doctor. The patient had only taken it for a couple of days, and they had to insert something to check their bladder and they prescribed this antibiotic so there wouldn't be any problems with that. The patient was having the booster shot next week.   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Follow-up received contains no new information.
I had diarrhea in the morning and then my symptoms progressed to include chills, body aches, lightheadedness, and fatigue. The injection site was also very painful. When I woke up this morning, I didn?t have any symptoms other than a little bit of fatigue and slight soreness in the injection site.
I noticed the arm pain like you know I cannot use them; it got little bit swollen; I noticed the arm pain like you know I cannot use them; it got little bit swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed., MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "I noticed the arm pain like you know I cannot use them; it got little bit swollen".  Additional information: Consumer stated that "The reason I am calling is I had fourth booster shot Friday and I have arm pain. Can I take Aspirin". Consumer stated, "I noticed the arm pain like you know I cannot use them and I have pain but not severe pain and it got little bit swollen and I want to know if I can ice it. Can I put ice on it". When confirm the shot as Pfizer COVID-19 shot: Consumer stated, "Yes. that is with, that was Pfizer."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm become red swollen and warm to touch. Approximately 4 in. by 2 in.
Body aches; Fatigue; headache; Chills; This is a Spontaneous report from a Contactable Consumer (patient). A 47-years-old male patient received bnt162b2 (BNT162B2; lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion) second dose, via an unspecified route of administration on 04Feb2021 15:00 at SINGLE DOSE for covid-19 immunization, vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. Patient had no Known allergies. Historical vaccine included first dose of BNT162B2 for covid-19 immunization on 14Jan2021. The patient experienced body aches, fatigue, headache and chills, all on 04Feb2021 20:00 with outcome of recovered. No treatment was received.  Information on the lot/batch number has been requested.
11/25: Mild Sore arm at injection area; 11/26: Got increasing generalized myalgias; Muscles were weak; Felt very tired; 11/27: Symptoms stronger; added fever. Took Tylenol; 11/28: Added feelings of numbness/pins&needles on the legs and all over his back (and scalp according to ER note)  Says couldn't move out of bed readily due to an uncomfortable sensation 'halfway between tickle and pain'. Felt dehydrated. Temps to 102 in spite of tylenol.  By that night, temps to 103.5 in spite of tylenol so went to ER as above. After ER: 11/29: Felt exhausted, muscles very sore; 11/30: Felt exhausted, muscles very sore; 12/01: Felt exhausted, muscles very sore; 12/02: Muscle soreness fading to a stiffness feeling instead. Felt cycles of energy and no energy; 12/03: Improving, but still some aches, and still feels like tires more easily. No urine changes.  No rash.
I'm nursing, breastfeeding my son.  My son started throwing up at 9pm  the Thursday following my second dose.  He threw up for 4 hours straight.  Wouldn't eat or drink anything and could keep anything down.  He was 14 months old at the time.
real bad periods of tachycardia and sob; real bad periods of tachycardia and sob; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in left upper deltoid, administration date 04Apr2021 (Lot number: EW0150) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dry eyes" (unspecified if ongoing); "GERD", start date: 18Sep2018 (ongoing); "Lyme", start date: 18Sep2018, stop date: 18Oct2018. Concomitant medication(s) included: FISH OIL taken for dry eye; LUMIGAN; VITAMIN D3; VITAMIN B COMPLEX. The patient had no prior vaccinations within 4 weeks but received a Flu shot in Oct2021. The patient reported having "real bad (severe) periods of tachycardia and shortness of breath (SOB), after receiving the 1st dose. The patient spoke to the doctor and told her that this was not an immediate response as this happened 4 or 5 hours later, and the patient thought it was more like an adverse reaction. It was real bad with the 1st dose, and mild with the second dose. With the first one, she was seriously considering running to the emergency room (ER), it kicked and then calmed down, it kicked in and calm down, it was like a cycling kinda thing, and then it finally go away. She said she got the vaccine like about 2  in the afternoon. She later stated it kicked in like 2:30, then 7:30/8:00. She was like yikes, woah, and it kept happening. It would calm down and then come again. She told her husband that she was having a crazy rapid heart beat, and shortness of breath and if continued would need to go to the Emergency Room. She decided to wait it out and just drank a lot to hydrate and it then calmed down. The patient reportedly had a cardiology consult. The patient asked if she should get the booster dose in light of the side effects she experienced. The patient did not require the emergency Room because it calmed down. At first, she thought she was going to. She was concerned now about getting the booster. Now everyone is aware of the Adverse Events and making people aware and unsure if should get the booster, this not an allergic reaction, but more an allergic reaction. Therapeutic measures were not taken as a result of tachycardia. The event "real bad periods of tachycardia and sob" and "real bad periods of tachycardia and sob" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Swollen and red are (circular) in (R) thigh about 6-7 cm major diameter warm-Local reaction to immunization -warm compresses -Benadryl -Keflex R/O cellulitis
Pt recvd vax 8JAN93 & approx 4 hrs p/receiving vax exp shooting pain in shoulder & swelling of arm, neck & clavicle; no further details were provided;
Injection site reaction- erythema, warmth and swelling 3cm induration, non tender to palpation and not pruritic.
I started out being very fatigue with a headache, head cold with congestion. I dealt with this for two days then went to Urgent care.  I tested for COVID-19 and the results were positive. The day I tested my throat was extremely sore. I was prescribed Paxlovid and albuterol inhaler, and Benzonatate. In about five days later I tested negative but to this day I still have congestion.
Headache, body/joint aches, fatigue, brain fog, loss of appetite, body rash
PT WAS WAITING AFTER VACCINE AND PHARMACIST NOTICED HIM DROP HIS CELL PHONE ON THE GROUND AND HIS EYES CLOSE.  PHARMACIST WENT OVER TO HIM TO SEE IF HE WAS RESPONSIVE.  TOOK A LITTLE NUDGING AND THE PATIENT RESPONDED AND SAID "I JUST FELL ASLEEP."  IT LOOKED LIKE MORE OF A FAINTING SITUATION THAN JUST NODDING OFF.  PT DENIED FEELING DIZZY AND SAID HE WAS JUST TIRED. UNKNOWN IF IT WAS VACCINE RELATED OR NOT.  PT MONITORED FOR ABOUT 40 MINUTES AND WAS FINE.
This spontaneous report as received from Novartis (MFR # PUS2103US109430) refers to a 65 year old female patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23. Reporter stated that originally patient thought she got influenza vaccine. However, they later discovered that she only got the PNEUMOVAX23 shot. Arm was really numb and couldn't lift it. Influenza vaccine was not administered. The outcome of events was unknown. The original reporter was an officer manager. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8787), in left arm and on 23Apr2021 as dose 2, single (Lot number: EW0172) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Known allergies: several, too numerous to mention" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Sep2022) Negative, notes: tested negative; (05Sep2022) Negative, notes: tested negative again; (09Sep2022) Positive, notes: postive COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was treated with Paxlovid from 29Aug2022 to 03Sep2022 for Covid-19.
By parent report, pt developed significant swelling and redness involving right shoulder near injection site extending to right chest, upper arm, and right cheek. Went to Hospital on 8/22 for evaluation. Discharge paperwork indicates cellulitis, treated with oral CLINDAMYCIN and to return next day. Patient and mother returned to Hospital on 8/23. Discharge paperwork indicates to discontinue CLINDAMYCIN, diagnosis of dermatitis and prescription for cetirizine. Pt presented for follow-up today at her primary care provider's office, 8/24. Presents with swelling over right shoulder and erythema extending from right shoulder to upper right arm, and right chest. Mother shows pictures of site over time -- much improved, though still demonstrates significant swelling and erythema. Given improvement, plan today is to apply cold packs to site over next 2-3 days, discontinue cetirizine (was not helping to reduce itch), take one dose of diphenhydramine before bed (6.25mL).  Appt made with primary care provider for 8/28 for follow-up.
Information has been received from a 34 year old female medical assistant with no drug reactions or allergies and no medical history who has been giving ZOSTAVAX  (Merkc) injections for 1 year. There was no concomitant medication. On approximately 27-SEP-2010 (reported as "3 weeks ago"), she began to experience "itchy throat" when she reconstituted the ZOSTAVAX (Merck). The "itch throat" took approximately 20 minutes to resolve. The patient reported that she was wearing latex gloves when she administered ZOSTAVAX (Merck). Whenever she would administer the ZOSTAVAX (Merck), she would get red and develop an "itchy throat". The other medical assistant had had to take over giving this vaccination to patient. The patient also reported that she got a tingling sensation in her throat that usually cleared up about 20 minutes after she administered the vaccine to a patient. This had happened the past couple of times. No lab diagnostics studies were performed. At the time of the report, the patient had recovered from "tingling sensation in her throat" on 18-OCT-2010 and recovered from "itchy throat" on an unspecified date. the patient did not seek medical attention. This is one of the reports from the same source. No further information is available.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter was a pharmacy manager/director for a national health plan. The reporter indicated anecdotally' that he had heard increased occurrence of or more significant injection site reactions (pain, soreness) with SHINGRIX. The reporter also stated that the chief concerned wasn't of impact to patients from a reaction but would this be something that would prevent a patient from receiving the second dose.
Patient came into office for his first covid vaccination. I was unsure about giving this to a 13yr old and speaking with Dr., the pt did get the vaccine. We had heard kids 12 and up could get the vaccine, so I had Dr. go into room and inform patient about the side effects and to call 911 if he had any complications.  He was also asked if he had any fevers or reactions to immunizations, He was foreign speaking and was given the moderna injection 0.5 ml. in his Left Arm.  Pt did sit for 10-12 min before leaving the room to get scheduled for his second dose. Finding out hours later that we do not give the moderna to kids. I will have Dr. call pt and inform him that his next dose will have to  be at the health dept. to get his 2nd vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-JAN-2009 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a clinic (by an unspecified health care professional), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-JUN-2016, the patient was treated (by an unspecified health care professional) at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 22-JUN-2016, the patient sought subsequent treatment at a medical center for ongoing and worsening symptoms, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. On or about 18-NOV-2016, the patient was again treated at the medical center for new and progressive outbreaks of shingles. The patient has been prescribed valacyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Day 4 (April 30) After 2nd vaccine dose: chest pain started and continued through the night. . Day 5 (May 1) after 2nd dose: chest pain intensified.  Visit Urgent Care where EKG abnormal, chest X-ray okay.  Sent to ER on basis of abnormal EKG.   At ER (still day 5 (May 1) after 2nd dose) echocardiogram normal. EKG abnormal. Blood labs showed elevated Enzyme Troponin (7-8ng/ml). Admitted to hospital.   Started colchicine 0.6 mg 2x/day.  Troponin levels continued to rise and elevated to 12 ng/ml within 24 hrs from start of meds. Took another 36  hrs to bring Troponin down to 6 ng/ml.   Sent home May 3 where continued Meds.
This spontaneous report as received from a registered nurse (R.N.) refers to a 24 year old female patient. The patient was allergic to banana. The patient's medical history included migraines. On 24-JAN-2013 the patient was vaccinated with GARDASIL (lot # not reported) (dose 1, strength and total daily dose not reported). On 10-APR-2013 the patient was vaccinated with GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dose 2, strength and total daily dose not reported). Concomitant therapies included NORDETTE. It was reported that no adverse event was reported with the first dose of GARDASIL. And the patient developed a stabbing abdominal pain, flu like symptoms and dizziness following the second dose of GARDASIL. The nurse reported that the stabbing abdominal pain, started on 10-APR-2013 and lasted for 3 days (the patient could not eat due to the stabbing abdominal pain), and recovered on approximately 13-APR-2013. The flu like symptoms and dizziness started on 10-APR-2013 and lasted for 9 days, and recovered on approximately 19-APR-2013. The patient did not seek medical attention, but reported the stabbing abdominal pain, flu like symptoms and dizziness to the nurse on 18-JUN-2013 during a routine office visit. No treatment was given. Lab diagnostics studies performed were reported as none. Additional information has been requested.
After receiving the vaccine client stated shat she feels dizzy.  Vital signs obtained by EMS  Bp 113/78, O2 sat 100%, Blood sugar 118. Client states she feels better.  Client discharged home by EMS.  Client advised to call EMS if symptoms worsen.
left arm pain, swelling,  Red Rash spread down to the arm and hot to touch for 4 days..
Left arm became reddened.  Denies warmth, pain, swelling, hardness of the left arm.  Recommended icing it and taking either Tylenol or ibuprofen for any discomfort.  Follow-up with provider if worsens or no improvement.
Small fever, sore throat, and general malaise; Small fever, sore throat, and general malaise; Small fever, sore throat, and general malaise; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in left arm on 05May2021 17:00 (at the age of 33-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug Store. The patient medical history was not reported. The patient had no allergies. Concomitant medications (within 2 weeks of vaccination) included fish oil, arginine hydrochloride (L ARGININE [ARGININE HYDROCHLORIDE]) and vitamin c/e. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 17:30 the patient experienced small fever, sore throat, and general malaise. Small fever, sore throat, and general malaise lasted for 18-24 hours after vaccination. The outcome of the events was recovered on an unspecified date in May2021.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021 at 4:58 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Not Provided      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.; Sender's Comments: This report refers to a case of Expired product administration, for mRNA-1273, lot #: 014M20A, with no associated AEs.
sneezing; Sniffles; cold; congestion; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion). The patient was treated with LORATADINE (CLARITINE) for Congestion nasal, at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion) outcome was unknown. Not Provided          No concomitant medication was reported.
He developed a rash over most of his body (not head) that was itchy the first day so he took BENADRYL- he had the shot 1 week previously - it went away after 3 days.
Patient received the vaccine on Friday morning and is experiencing some redness, warmth and hardness in the right arm near and around the administration site.