chrisvoncsefalvay/vaers-outcomes huggingface dataset:
like flu symptoms; feeling unwell; has no energy; has no appetite; Can't do anything; felt like had fever but don't; tired and exhausted; little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu symptoms), MALAISE (feeling unwell), ASTHENIA (has no energy), DECREASED APPETITE (has no appetite) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything) in an 84-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like flu symptoms), MALAISE (feeling unwell), ASTHENIA (has no energy), DECREASED APPETITE (has no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), PYREXIA (felt like had fever but don't), FATIGUE (tired and exhausted) and NAUSEA (little nauseous). At the time of the report, INFLUENZA LIKE ILLNESS (like flu symptoms), MALAISE (feeling unwell), ASTHENIA (has no energy), DECREASED APPETITE (has no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), PYREXIA (felt like had fever but don't), FATIGUE (tired and exhausted) and NAUSEA (little nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administered adjuvant portion only without reconstituting with the lyophilized portion; Administered adjuvant portion only without reconstituting with the lyophilized portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered adjuvant portion only without reconstituting with the lyophilized portion) and inappropriate dose of vaccine administered (Verbatim: Administered adjuvant portion only without reconstituting with the lyophilized portion).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that she realized that this morning she administered a dose of the Shingrix adjuvant portion only without reconstituting with lyophilized portion. The reporter reported that this was their second dose in the series. The reporter stated that at the time of reporting the repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. Only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
For about 2 weeks before July 11, 2022,  I noticed my balance and leg strength were deteriorating.  At about 5am on July 11, 2022, I woke up with severe vertigo.  Was hospitalized for 3.5 days to rule out stroke, etc. Was diagnosed with "vestibular neuritis." Since then I have had continuing balance and leg strength issues. Have seen my PCP, a neurologist and physical therapist to deal with these issues. But it appears I likely have permanent nerve damage in some of the nerves that control balance. Permanent return to my previous health situation appears unlikely, I will probably be dealing with these issues for the rest of my life.
Patient felt dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for about 30 seconds in the vaccination chair. Vitals were taken. BP was 90/55. EMS was called
New vial of pfizer bivalent was punctured at 1pm on 10/11/22.  All 6 syringes from that vial were filled and placed back into the fridge.  2 prefilled syringes were left over night in the fridge and were NOT wasted.  At 7:30am on 10/12/22 one of the "old" vaccines were given to a patient.
Started with a bad headache for a few day (still ongoing). Now I have to focus super hard to do any type of work. During conversations I stumble over my words and I have to correct myself a lot. It's like a super bad brain fog.
I received my first shot of Moderna on 4/9/21. On 4/22/23, I experienced the worse case of vertigo. It lasted two-three weeks. The room was spinning and I was throwing up. Prednisone was prescribed to get rid of it. I will be receiving my second shot on 5/28/21. It was delayed because I've been on Prednisone for a while.
painful swelling of one or more lymph nodes; tennis ball sized knot in the arm; achy; pain and slight swelling at the injection site; pain and slight swelling at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: EN6203 and Expiry date: Unknown), dose 2 via an unspecified route of administration, on 05Mar2021 at 10:45  as 2ND DOSE, SINGLE for covid-19 administered in Arm Left immunization. Medical history included osteoarthritis, fibromyalgia, asthma and allergy to several foods. The patient did not receive any other vaccine in 4 weeks. Patient was not covid positive prior vaccination. The patient previously took celebrex and experienced Celebrex. Historical vaccination included the patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date: Unknown), on 06Feb2021 at 10:45 am for COVID-19 immunization . On 05Mar2021 at 18:00, the patient experienced pain and slight swelling at the injection site, tennis ball sized knot in the arm and achy on 06Mar2021 and painful swelling of one or more lymph nodes on 07Mar2021. It was reported that on evening of injection (Friday) the patient had pain and slight swelling at the injection site. The next day (Saturday), she had a tennis ball sized knot in the arm which was slightly achy but not really painful. When she woke up on the second after the vaccine (Sunday) she noticed a somewhat painful swelling of one or more lymph nodes under her left arm extending slightly into her left breast. A hot shower has alleviated some of the swelling and pain so far. she expected this would ease up in the next few days. If it does not, she would seek medical advice. No treatment was given for the events. Patient was not tested for covid post vaccination. Outcome of the events were resolving.   No follow-up attempts are possible. No further information is expected
Patient experienced extreme redness and swelling at injection site during the night she got the vaccine (12/28/18). She had muscle pain throughout her entire body. When she woke up the next day she had extreme vertigo and could not function. She experienced rapid heart rate, chest pains and palpitations and the dizziness became worse during 12/19. She went to the ER where they gave her IV fluids and also a dose of ketorolac 30mg IV push and was discharged. She was still experiencing vertigo and went to her doctor on 1/2/19 and there she received another steroid shot. Patient did not experience full recovery until 1/8/19.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age, gender and demographics. Patient's current condition and medical history was not reported. On 05-SEP-2014, the patient was vaccinated with PNEUMOVAX23 injection (dose and units not provided), lot # J004080 (expiration date: 22-AUG-2014), intramuscularly for an unknown indication. No concomitant medication has been reported. On 05-SEP-2014, the patient received expired dose of PNEUMOVAX23. On an unknown date in September 2014, the patient experienced no adverse effects. There was no product quality complaint involved. The outcome of the events was not reported. Additional information has been requested.
Fever of 101.8 with chills from 230p-10p. APAP 650mg orally given x1. Monitored x48hours at 3p.
INJECTION SITE PAIN Narrative:  68 YO male reported injection site pain after his first covid19 vaccine dose on 2/4/2021. This ADR was reported on 2/24/2021 when he returned for the second dose. Symptom self-resolved.
A few days after the vaccine early in the morning hours I woke up with extreme nausea and vomiting up undigested food that had been eaten 12hrs earlier. And my stomach and flank pain begin at that time.  Over the next few days, I noticed further slowing of my gastric motility so I reached out to my PCP because I couldn't get in to see my Gastrologist. I also noticed changes in my vomiting and bowel movements with further pain in the stomach and flank area. My PCP started me on 12.5mg of Promethazine as needed to help try to elevate the symptoms. I take Motergitiy for the motility issues but that may have to be changed. I have been referred to a Specialty clinic for further evaluation.
Onset of fever 102F, continued subjective fevers x 4 days, measles-like rash started 6/16/14 on chest and spread to face, then arms, then legs.
Received both vaccinations via IM to Left deltoid on the afternoon of January 18th, 2023 at 3pm.  The father reported the next morning on Thursday January 18th there was redness and Friday January 19th there was itching and swelling of the left arm.  Father reported that skin was intact, no openings and reported no bruising was present.  Father took child to the doctor on Friday January 19, 2023.  Doctor prescribed Bendaryl, which was taken for two days.  Last dose administered on Saturday January 21.  Symptoms have resolved with no further issue.
18 hours after injection, patient described fever of 102.5 degrees, chills, shakes, and nausea.  All symptoms resolved within 24 hours.
Patient developed itching and rash on vaccination arm within 5 minutes of the shot. He has no known allergies.No previous reactions to vaccinations. The rash and itching intensified over the next 30 minutes. Benadryl was given (50mg) orally at 35  minutes post shot. Paramedics were called and arrived 5 minutes after giving benadryl. Patient's was stable, BP was high but patient refused to be taken to hospital.
Symptoms of covid began 4 days post-vaccine; congestion, cough, body and head aches, tired, chills, lost smell and taste Contacted my physician after positive covid test  who prescribed 10 days azithromycin,  vitamin C and D, zinc and pulse oximeter readings 3x/day
SORE THROAT; CHILLS; JOINT PAIN; NAUSEA; FEVER; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, chills, joint pain, nausea, fever, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, nausea, fever, headache, muscle pain, joint pain and chills was not reported. This report was non-serious.
headaches; nausea; trouble vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as Dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "trouble vision".  No follow-up attempt are needed. Information about lot/batch number cannot be obtained.
Feeling crappy; Chills; Pain in joints; Arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was very sore). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints). At the time of the report, PAIN IN EXTREMITY (Arm was very sore), FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065246:Husband case
DIFFICULTY BREATHING BEGINNING AT 11:00 AM AND WAS SEEN IN A URGENT CARE FACILITY. BY THE TIME I GOT TO THE URGENT CARE I WAS HOARSE, REDNESS TO FACE AND UPPER CHEST AREA, FAST HEART BEAT IN THE 120'S, AND DIZZINESS.
Patient reports feeling warm, nauseous, thirsty and clammy before lowering herself to floor.  Episode occurred 15 mins after vaccination.  Symptoms improved after lying down.
On the same day as injection, there was some redness at injection site, but no itching. 9 days after injection, injection site is redder, painful, and itching enough to where it interfered with sleep.
County Public Health the vaccine to Police/Paramedics to give to homebound individuals in  County. One family was unreachable by phone but the Police/Paramedic team went to the home as it was on the list. Vaccine was given to person under the age of 18. Telephone call to the parent of the case but no answer.
came in 2 days later to have arm checked d/t rxn;lt deltoid had a large, red, blotchy area 6cm x 6cm;area hot & tender
on 4/10/21, I had severe and sudden onset of vertigo. I was taken to the hospital via ambulance and hospitalized for 3 days. For the next few months, I had constant dizziness and nausea. One day it just suddenly stopped. A final determination of cause was never determined as my symptoms were inconsistent for months.   When I discovered a coworker had the exact same experience I did after having the COVID vaccine, and another had similar experiences, and we were all vaccinated at the same event and time, I felt it necessary to report it as a possible side effect from the vaccine.
Pain at site, shivering, chills, burning, fever 101, headache, weakness. Fever gone by morning; other side effects gone by evening, other than arm still sore. I did not seek medical treatment.
Lingering headache on the day prior to injection.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, asthma, anaphylaxis, seafood allergy, peanut allergy, allergy to nuts (Tree nut), pollen allergy, allergic to cats, allergic to dogs, allergy to animal dander (Pet dander), house dust mite allergy (Dust mite allergy), allergy to molds, cockroach allergy and allergy (Weeds). Concomitant medications included meningococcal vaccine b (MANUFACTURER UNKNOWN) dose number 02 in the left arm on 27Apr2021 for an unspecified indication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 12May2021 at 07:30, the patient experienced lingering headache on the day prior to injection. Patient also stated she had to take pain medicine for relief. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with pain medicine, names unspecified. The clinical outcome of the event lingering headache on the day prior to injection was recovering   No follow-up attempts are needed. No further information is expected.
feeling energized since 1 hour after the injection, and dry mouth started 3 hours after.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and a health professional concerning a 43 month old male who on 5/9/06 was vaccinated with a dose of varicella virus vaccine live. On 5/9/06, within one hour of vaccination, the pt experienced a severe allergic reaction. He was noted to have erythema and generalized itching. There was no respiratory distress. He returned to the pediatricians office and received epinephrine, Benadryl and prednisone. This was noted to be an intervention to prevent serious criteria. He did not require hospitalization. The events improved after treatment. The pt was stable at the time of the report. He received a skin testing which was positive for an allergy to gelatin. There was no product quality complaint. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
Small spot of shingles on my lower back; Small spot; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient had a small spot of shingles on her lower back broke out the day after receiving Shingrix.
tingling; numbness; slight ache; A spontaneous report was received from a consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling, numbness, slight ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) tingling, numbness, slight ache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling, numbness, slight ache was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at13:17, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Janssen COVID-19 Vaccine EUA Strong headache 7 hrs after shot; lasting over 24 hours Fever 9 hrs after shot; lasting 18 hours Brief nausea lasting 3 hrs upon waking up the next day Aches lasting 12 hrs upon waking up the next day
Patient received vaccine Friday am- That evening had 101.9 temp- Lasted through Saturday afternoon. Sunday started with hives.
Information has been received from a certified medical assistant concerning a 78 year old male with no pertinent medical history and no known allergies, who on 15-JUN-2006 was vaccinated intramuscular in the deltoid with 0.5 ml of Pneumovax 23 (lot # 651321/1036P). Concomitant therapy included lovastatin and phenytoin (DILANTIN). It was reported that at the time of vaccination, the patient had "no problems". The medical assistant stated that the injection was one of the last two doses administered from this lot. Subsequently, on 15-JUN-2006 the patient experienced excruciating pain in the arm without redness or swelling and stated that he "could not life his arm". Unspecified medical attention was sought. The patient was told to take anti-inflammatory medications to help resolve the symptoms. The patient was to be followed by his physician. The patient had a previous vaccination of Pneumovax 23 in 1998 but was not administered at the same practice, therefore little information pertaining to this vaccination was available. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.