chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/9 at 1120: TC from pt. Did have a fever for a couple days. Did not take temp. Injection was in L arm. Arm got swollen and hot and swelled up and now is moving down his arm. There is some swelling around elbow. It is still hot and red. Pain is lessening.
RAPID HEART RATE FOR 6-8HRS; DIFFICULTY BREATHING; HOT FLASHES; MUSCLE AND JOINT PAIN; UNABLE TO SLEEP; DIZZINESS; DIARRHEA; INTENSE CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced rapid heart rate for 6-8hrs. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced muscle and joint pain. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced dizziness. On 2021, the subject experienced diarrhea. On 2021, the subject experienced intense chills. On 2021, the subject experienced nausea. On 2021, the subject experienced headache.  Laboratory data included: Heart rate (NR: not provided) 90bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate for 6-8hrs, difficulty breathing, hot flashes, muscle and joint pain, unable to sleep, dizziness, diarrhea, intense chills, nausea, and headache on 2021. This report was non-serious.
The "adverse event" was that I got Covid in February 2023.  I took Paxlovid, and I did have a rebound.  (I tested positive for about 5 days, negative for about 4, positive again for 3 or 4 days, and then negative again.  All those tests were at-home rapid tests.). I'm still recovering (on March 14, 2023); I can't do nearly as much exercise as I used to yet.
receiving 3rd dose of Moderna instead of flu shot; Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A., 049E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot). At the time of the report, PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot) had resolved and PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-340958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: follow-up received: Added event.
Modern COVID-19 Vaccine EUA - side effects fever, headache, sinus pain, body ache, fatigue from 2:00am 04/26/2021, fever broke at 9:00pm 04/26/2021, headache, sinus pain, body ache fatigue stopped at 5;00am 04/27/2021. Fever varied from 99.9 to 101.3.
Information has been received from a registered nurse concerning a 2 month old male with no pertinent medical history who on 23-JAN-2008 was vaccinated PO with his first dose of ROTATEQ. On 03-FEB-2008 the patient experienced diarrhea that lasted all month. On 27-FEB-2008 the patient experienced positive stool cultures for rotavirus. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
I have shingles and I have never had it before; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 13:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 13:00, the patient experienced shingles which the patient never had before. The adverse event resulted in emergency room/department or urgent care. The patient received antibiotic (unspecified) as treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Very tired, became very emotional (weepy), had a long cry after got upset about something, rested, then limbs felt very heavy.
rash on stomach; unable to breathe; Coughing; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207; Expiration Date: 31Jul2021; NDC number: unknown) via an unspecified route of administration on 12Mar2021 at 10:00 (at the age of 54-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect, prior vaccinations (within 4 weeks) and additional vaccines administered on same date of the Pfizer suspect were reported as none. No investigation assessment was reported. The patient received covid-19 vaccine on 12Mar2021, she was fine and did not had any problems. On 14Mar2021 she was unable to breathe and was coughing. She took Benadryl and it helped. On 15Mar2021 she had a rash on stomach. It was not a big rash, there were 3 dots and it looked like a triangle. She was unsure if the rash was an insect bite or from the vaccine. The adverse event did not require emergency room or physician office visit. Relevant tests were not reported. The outcome of the event rash was not recovered and for all other events was resolving.  No follow-up attempts are possible. No further information is expected.
Gradually got worse after the shot.  Pain on the upper shoulder and when he lifts his arm to insert arm in sleeve or fix his belt he is in pain.
I was having a scratchy throat, so I took a COVID-19 Home Test, and it was negative. The next day I woke up with slight fever of 100.8 took Tylenol and called my PCP but they wanted to do a virtual appointment, so I went to an urgent care. The urgent care did not test for COVID-19 but did for influenza and strep and both were negative, so they sent me home with amoxicillin and an antibiotic shot. I took a nap and woke up and by that night I had a fever of 104. I had my husband bring me some soup and I could not taste it, so I had him bring me a test and I took a home test again and it was positive, I called my doctor's office back and the clinic back where I was seen and then i went to the ER. They tested again for flu, strep, and COVID and it was positive. They gave me a breathing treatment, ibuprofen and an inhaler to take home and then sent me home. On the 22nd I called to my PCP they put me on Paxlovid. My husband and son ended up positive for COVID-19 as well. I finally tested negative on December 26th.
MI Ft very dizzy th morning after the shot . I had a slight headache in my left temple. I then blacked out and fell to the floor. I do not remember falling , and becoming conscious while on the floor. I have no idea how long that I was there before waking.. I had a slight bruise to the back of my head.This happened only once.
Feeling weak a day or so; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak a day or so) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Pain. Concomitant products included AMLODIPINE for Blood pressure, PRAVASTATIN for Cholesterol, MELOXICAM for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced ASTHENIA (Feeling weak a day or so). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Feeling weak a day or so) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-388204, MOD-2021-388272 (Patient Link).
3 to 4 months following vax pt became pregnant;pt had a miscarriage;pt felt that the miscarriage was not caused by hep B
Information regarding PREVNAR 13 was receive from a healthcare professional regarding a 4-year-old male patient who experienced difficulty walking due to leg pain and leg pain. The patient received a dose on an unspecified date. MEDICAL HISTORY: Therapy regimen changed. Past therapies included 4 doses of PREVNAR, given on unspecified dates. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: On an unspecified date in either Mar or Apr-2010, the patient received a dose of PREVNAR 13 and subsequently experienced difficulty walking due to leg pain. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
On 4/6/00, pt developed vomiting and diarrhea, she was seen by the vaccine provider.
sick for 3 weeks; heavy congestion; congestion in her chest; nose cold; cough; headache; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with BENZONATATE ongoing since an unknown date for Cold, at an unspecified dose and frequency.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a nurse practitioner concerning an 8 year old male pt who on 03Oct96 was vaccinated with a dose of varicella virus vaccine live. On 19Apr04 the pt presented to the office with less than 50 lesions on his trunk. Unspecified medical attention was sought. No product quality complaint was involved. It was reported that another pt (WAES0405USA01113) experienced chickenpox after vaccination with varicella virus vaccine live. Additional information has been requested.
It was reported that a 46 year old female patient received Typhim VI, an IPOL and a Menomune A/CY/W-135 vaccinations on 01/31/01 reportedly a day after the injections the patient developed pain in her shoulder and arm around injection site, numbness in her fingers. She was seen by her family physician who told her it was a "protein reaction" and treated her with Flxeril and Celebrex. The symptoms are still not resolved. From additional correspondence received on 03/09/01, it was reported. "Patient was asked to call us about condition -but did not.' Additional patient, vaccine, vaccine administrator and responsible facility information was provided.
11/06/2001 at 10:30 pm the patient developed hives on her abdomen, neck, back, arm, and legs. The vaccine area was not affected. The patient was treated with Benadryl.
Patient was administered vaccine into left deltoid.  Patient had vaccine previously without incident.  Patient had left deltoid and tricep pain that profounding worsened.  Pain wakes patient from sleep.
She had her first Moderna COVID vaccine 9/7/21. She felt a little achy for the next 24 hours afterwards. 9/9/21 she got home from work, was up on the deck, looked out "and I just felt a little disoriented, my vision was delayed a little." She drove herself to volleyball, played with some difficulty due to her vision. The next day her vision got worse - "I don't even know how to describe it, I wasn't dizzy necessarily but that was the closest thing I could come up with." She worked that day. 9/11/21 (Saturday) she woke up "and I couldn't walk well, I was super off balance, I needed help walking." She noticed her pupils were different sizes for a few hours that day. She didn't go to work that night. Sunday 9/12/21 her girlfriend noticed some nystagmus when she was looking to the left. By Monday 9/20/21 she had up and down double vision and went to the ER. MRI head revealed multiple areas of FLAIR hyperintensity oriented perpendicular to the ventricles and an enhancing area of FLAIR hyperintensity in the body of the corpus callosum. CSF studies notable for mild lymphocytic pleocytosis with normal protein and positive oligoclonal banding with elevated IgG and IgG index concerning for MS. She was treated with 1mg methylprednisone for 5 days (9/21-9/25) with mild improvement of diplopia and gait instability. She saw a neuromuscular specialist at a local HCF 9/27/21 who diagnosed her with relapsing remitting MS.   The only neurologic episode Pt recalls previous to this was an episode of vertigo for about 1 week a few years ago that was mild and resolved on its own. Per Dr.'s report Pt has been having idiopathic hives on and off for about a year, did see an allergist and a rheumatologist who found her to have a mildly positive ANA with a titer of 1:80, nucleolar pattern.
5/19/21 patient is noted to have a red circular area approx 3 inches in diameter. The center of this circle is dark bruised. This red circular area is not hardened or raised. Vital signs within normal limits. No other signs or symptoms noted or reported. Consumer appears in no distress and denies chest pain, shortness of breath or trouble breathing.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 04-Apr-2011 which confirmed that the patient did not report any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
On 12/18 feeling congestion and stuffy nose was able to go work that night as well 12/19. Then on 12/21 realized lost taste/smell went to get test for Covid  results positive. As of 12/23 still haven't gain taste/smell. I had to miss 10 days of work.
Fatigue, malaise, aches and pain. Mainly at injection site. Just took sick leave for the day.
Fairly sore arm day of and day after injection (though did not interfere with daily activity).  Approx. 8 days after injection, noticed red patch (approx. 3"x4") below injection site.  This  rectangle had surprisingly straight edges and occasionally itched slightly.  Six days later the rectangle is approximately the same size, but has lost its very straight edges, and has paled in color.   Perhaps 10 days after the injection, some swelling was noticed in the left armpit and an intermittent discomfort like a dull pencil poking a particular spot in the armpit was experienced. The armpit swelling/discomfort lasted about 3 days.
Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thursday rash had spread to legs, back, and neck. Pruritic rash that is tender to touch. Diarrhea began Thursday, 4-5 episodes in 1 day. Fatigue also began Thursday. Has tried 25mg benadryl on Wednesday and Thursday with no relief. No fever.
Nausea after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea after receiving the first dose) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (Nausea after receiving the first dose). At the time of the report, NAUSEA (Nausea after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown", described as "Breast tenderness". Additional information: Reason for no lot number of Pfizer Covid vaccine reporter unwilling to complete the report. The patient had no other products. Investigation assessment was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Initiation of consistent, bilateral tinnitus, beginning three days following vaccination.  Tinnitus has continued, increasing in intensity since 1/5/22.  Tinnitus has interfered with ability to concentrate and work, resulting in canceled freelance contracts/client relationships and loss of work.  Hearing test was completed by audiologist, with no signs of hearing loss.
Patient received Tdap and 3rd Hep B vaccine After 1 mo patient complained of falling down (2/10/08) The next day he bagan to experience mid dorsal back pain and foot numbness, hand numbness and weakness in arms and legs  Dr referred him to a neurologist who diagnosed Guillain-Barre' syndrome.
Patient tested positive for COVID 7/27/21 by PCR test. She is fully vaccinated.
10/16 - tender arm, 10/17- tender arm, chills, threw up 10/18-tender arm, 10/19 tender and red arm
Flu like symptoms, no fever.  Just achy and tired with mild headache.  Injection site is red, slightly swollen  and slightly tender to the touch.
Moderna Covid-19 Vaccine (EUA)  Swelling of right foot and leg started last evening around 10 pm.  I elevated the foot when going to bed  and some swelling  was reduced.  At this current time , 2-2-2021 at 6:15 pm, swelling is back and slight burning in foot .
No adverse effects reported.; one dose of improperly stored PROQUAD was administered to the patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 13-NOV-2019, one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S017251, expiration date: 01-DEC-2020; strength, frequency and route were unknown) for prophylaxis (product storage error). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.1 degrees Fahrenheit) for 1 hours 10 minutes. There was previous temperature excursion in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (14.5 degrees Fahrenheit) for 1 hour 25 minutes. The digital data logger was involved. No adverse effects reported.
myocarditis; This is a literature report for the following literature source(s): "A report on short-term follow-up cardiac imaging and clinical outcomes of myocarditis after coronavirus disease 2019 vaccination".  A 12-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: elevated; Echocardiogram: left ventricular ejection fraction 64 percent, notes: no regional wall motion abnormality, normal diastolic function; left ventricular ejection fraction 65 percent, notes: no regional wall motion abnormality, normal diastolic function; Ejection fraction: 64 %; 65 %; Electrocardiogram: ST elevations in inferior leads, notes: on presentation; Resolved ST-T wave, notes: changes; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: edema patchy subepicardial late gadolinium, notes: enhancement; Small focal late gadolinium, notes: enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;