chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
[Tested positive for] Flu; Tested positive for Flu; This is a serious spontaneous case, reported by other healthcare professional and initially received on 18-Feb-2019, concerning a 08-year-old, child, female patient.  On 23-Oct-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose, route of administration, batch number, anatomical location and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient was tested positive for Flu. The patient was feeling much better after taking Tamiflu (oseltamivir phosphate).  The outcome of the event was recovering.  Follow-up was received from the reporter on 19-Feb-2019: Added treatment drug Tami?u (oseltamivir phosphate) in the product tab. The outcome of the event (influenza) was changed from not reported' to recovering'. The narrative was amended accordingly.; Reporter's Comments: An 8-year-old female patient was tested positive for flu, unspecified period of time after receipt of Flucelvax QIVc. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event flu, company assessed the causality as unassessable. The company assessed the event (Flu) as serious (medically significant).
Reported feeling flushed within 5 minutes of inoculation. Benadryl 50mg oral given. Reported feeling fine after 30 minute monitoring.
Severe arm pain, chills, severe fatigue, headache, stomach ache, rash over neck, chest, shoulders and upper back.
Red rash; Swelling on arm; Hot to touch; Itching; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ZOSTER IMMUNOGLOBULIN (shingles shot). Concurrent medical conditions included Drug allergy (Naproxen). Concomitant products included RALOXIFENE HYDROCHLORIDE for Bone disorder NOS, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) for Mineral supplementation, FISH OIL for Nutritional support, CYANOCOBALAMIN (B12 1000 SR) and BIOTIN for Vitamin supplementation.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch). On 21-Mar-2021, RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The events were treated with over the counter with cream.   This case was linked to MOD-2021-109657 (Patient Link).
This spontaneous report was received from a register nurse concerning a 24 year old patient on an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015, batch number H017436. On 01-APR-2014, patient was the patient was vaccinated with M-M-R II (route was not reported) lot # H017432, expiration date 20-SEP-2014. Co-suspect and concoimitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were adminsterde to 10 patients. The clinic has contacted the patients and 3 out of 10 patient had received an additional dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1404USA014293, 1404USA012494, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
FELT ACHY; LOW GRADE FEVER; TIRED; COVID-19; This spontaneous report received from a consumer via other manufacturer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUL-2022, the patient experienced covid-19 (dose number in series 2). On an unspecified date, the patient experienced felt achy, low grade fever, and tired which lasted just for a day and a half (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, low grade fever, and tired, and the outcome of covid-19 was not reported. This report was non-serious.
after receiving a dose of Rotarix regurgitated it; after receiving a dose of Rotarix regurgitated it; This case was reported by a nurse via call center representative and described the occurrence of regurgitation in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L5G93, expiry date 27th August 2021) for prophylaxis.   On 22nd June 2020, the patient received Rotarix lyophilized formulation (oral). On 22nd June 2020, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation and accidental underdose. On an unknown date, the outcome of the regurgitation and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation to be related to Rotarix lyophilized formulation.  Additional case details were reported as follows: The patient after receiving the dose of Rotarix regurgitated it, happened on the same day as reported. The reporter consent to follow up.
I have had bronchitis since my early 20's, an annual event.  This year no different.  I started having issues breathing in the beginning of November 2021 and thought it was in relationship to an oncoming brochitis.  I did get bronchitis later in the month and received medications in December 2021.  I continue to have a breathing problem and am short of breath post bronchitis.  I have never ever had these symptoms in the 30 years I've had bronchitis.  I now take oxygen, as well a prescribed inhaler and have bouts nearly daily of being out of breath.  The only change in my life is getting the vaccination, of which I now believe I will have a breathing issue the rest of my life.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 06-AUG-2014 the patient was vaccinated with 0.5ml dose of PROQUAD (Merck) (injection, lot# and dose number were not provided), which had undergone a temperature excursion, subcutaneously. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Mumps vaccine 4/12 in right upper arm and right arm hurt from time of injection and upper arm felt tingling from site to elbow and stiffness, also 4/13 did not feel well. Felt feverish, didn't take temp, fatigue took Tylenol ES x 1, no further doses. 4/14 feels better T97.8, continues to have tingling and stiffness in upper right arm injection site. Site appears red and is warm and slight swollen. No pusticle at injection site.
Patient complaining of upper arm swollen and red. When she presented to us the severity was hard to notice but she says it was worse yesterday.
Received TDaP shot. Developed localized swelling, redness, itching. Reaction localized only. Pt anxious as never had reaction before to a vaccine. Notified office 8/31.
I had my period start 2 days later and it was a normal cycle but my next cycle was not. On 12/24/2021, my menstrual bleeding was so heavy I was considering going to the ER. I did not because I did not want to be exposed to Covid. I was wearing double pads and going to the bathroom every 15 min. If I was later than that, I was bleeding through everything onto my clothing. I have never experienced blood clots anywhere near that size previously. At first I had was wearing a tampon and it pulled out a blood clot the size of a plum. The bleeding continued at this rate for 5 - 6 hours. My period continues to be heavy for 2 days. I was very weak and light headed for about 4 days afterwards.
On an unspecified date, the patient received unspecified flu vaccine (lot number not reported). On an unspecified date, the patient developed sore arm after receiving the flu vaccine. The outcome was not reported.
Information has been received from a 72-year-old female with hypercholesterolaemia and an allergy to LIPITOR (muscles aches all over body, the muscle aches resolved when the medication was discontinued-years ago) who in April 2007, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). In July 2007, the patient developed pain in her right side. The distribution of the pain was from the right side of the torso, at waist level, radiating round to the middle of her back. The patient's physician suspected a possible case of shingles. No rash developed. The patient was referred for a renal ultrasound, which was negative. The pain resolved 6-7 weeks after onset with treatment. A product quality complaint was not involved. Additional information has been requested.
Chest pain 12 hrs after Pfizer COVID-19 vaccine,  continued intermittently for 3 weeks.  Feeling of excessive tiredness.
Patient came in with a cough and nasal congestion for 2 weeks. Performed a COVID-19 swab. Next day patient results came in positive after vaccine was given.
extremely itchy palms/bottoms of our feet; pretty exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose number unknown (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 series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "extremely itchy palms/bottoms of our feet"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown", described as "pretty exhausted".  Additional information: Reporter stated, her husband and reporter both got the Pfizer Bivalent Shot (Clarified as: COVID-19 Vaccine Bivalent). They got that on Wednesday and both of them ended up within 24 hours, of extremely itchy palms and extremely itchy bottoms of there feet, last for couple of hours, kind of weird, never had that before. They were both pretty exhausted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine had expired w/ expiration date of 06/30/2021.  Patient experienced no reaction or ill effects.
it hurts all from her waist down; Almost like a charley horse; wakes her up in the middle of the night; felt sick for a few days; felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk; feeling weak in her legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MUSCULAR WEAKNESS (feeling weak in her legs and knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCULAR WEAKNESS (feeling weak in her legs and knees). In May 2021, the patient experienced GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk). On an unknown date, the patient experienced PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night) and MALAISE (felt sick for a few days). At the time of the report, GAIT DISTURBANCE (felt like she couldn't walk, she started hobbling around/ first thing in the morning it's hard to walk), PAIN (it hurts all from her waist down), MUSCLE SPASMS (Almost like a charley horse), SLEEP DISORDER (wakes her up in the middle of the night), MUSCULAR WEAKNESS (feeling weak in her legs and knees) and MALAISE (felt sick for a few days) outcome was unknown.            Patient was reported that after the second dose, the patient felt sick for a few days.  Then in April patient started feeling weak in legs and knees.  In mid-May patient really felt like couldn't walk, started hobbling around and never thought it could be from the vaccine until visited  a pharmacist.
I have been having an increase in headaches almost daily after receiving the first dose of the covid vaccine. I am not sure if it is related or not but was told by my scc to fill out a pearl
Patient received 2nd Moderna  COVID Vaccine today via the right deltoid.  Immediately upon receiving the injection she complained of warmth running down her arm and into her hand.  She then complained of numbness to the  same extremity.  Within the next 2 minutes she stated that  numbness started in her right leg, as well.  The CRNA onsite came to assess her.  It was then noted that she developed some swelling to her right foot. Patient was then taken to the emergency room for observation.
The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece.  Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump.  Day 4 or 5 the color changed to purple and the lump had decreased.  It took about a week for the lump to go away.  I still have a discoloration on my arm where the vaccine was given.  It looks a bruise but no pain.  The whole time the area blanched well.  The first dose I had on my left arm and the next day I had a small welt with redness.  I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose.  My doctor put me on a antibiotic as well with the second round of steroids.  My asthma is a little better but not at my baseline.
Developed dizziness, chills, fever, nausea & vomiting w/ diarrhea.  PHENERGAN on hand for nausea.
This spontaneous report as received from a pharmacist refers to a 66 year old male patient with an allergy (or other drug reaction) to unspecified quinolones. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant mediation was not specified by the reporter. The pharmacist stated that the patient saw his unspecified healthcare provider on 24-AUG-2015 (reported as today) and he was diagnosed with shingles but the rash had scabbed over so the pharmacist was sure that the patient had it for awhile (start date of the event was not specified). It was also reported that the patient developed shingles on an unspecified date, after receiving ZOSTAVAX. It was not specified if any treatment was given for the adverse event. The outcome of herpes zoster was reported as not recovered/not resolved. Causality assessment between the adverse event and the therapy with ZOSTAVAX was not specified. Additional information is not expected as the reporter did not wish further contact.
Patient developed a red/itchy rash within 24 hours that progresed the next day. Patient treated with atanoy and prednisone
left arm was sore; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810 and expiration date was not reported), intramuscular on arm left on 06Feb2021 at 11:00 as single dose for Preventative (COVID-19 immunization) in hospital. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not administer additional vaccines on same date of suspect vaccine. No relevant tests were reported. It was reported that she got first shot of COVID vaccine on 06Feb2021 (Saturday). She was fine, she just had a sore in left arm Saturday night (06Feb2021). She was due to get the first shot on Tuesday 02Feb2021 but due to the snowstorm she had to get the shot on Saturday instead. The appointment for her second shot was scheduled for 23Feb2021, stated this was four days before the 21-day guidance and she inquired if this was ok. She stated that it was just like getting a flu shot, she occasionally got a sore arm for a couple of hours. She had been getting one for 24 years. She did not have the name or lot number for the flu shot she had received. She declined for any treatment of the event. She did not visit emergency room or physician office. The outcome of the event left arm was sore was resolved on 06Feb2021.
Patient was given 3 vaccines. As she was leaving with mom, she stated that she felt sick. Mom brought her into bathroom where she collapsed. O2 saturation was 67%. Patient had mental status changes, became very tired. O2 was applied and vital signs done every 15 minutes for 1.5 hours until she was stable. She left clinic in good condition.
Patient experienced pain in right shoulder, lower back, arms, both leg (especially more severe pain on right leg), and lower right abdomen. Patient complained hard to get out of bed in the morning. Patient tried TYLENOL, and it helped a little bit but not much. Patient is still in pain as of 10/9/18.
Initial literature report received on 01 Nov 2010: This patient with chronic obstructive pulmonary disease participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 20, and 80 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient, who had a history of COPD, had 4-fold increase in titer value and tested positive for seroconversion of B strain. Therefore this patient was considered as an LCI case of Influenza B. The outcome was not reported.
Pt. developed (R) sided Bell's Palsy approx 1 mo following Zoster vaccine. He also had recent influenza vaccine (approx 2 wks) (unsure if connected).  10/23/07 Reviewed ER medical records which reveal patient experienced right posterior ear pain, HA & right facial weakness/numbness x 2 days.  Unable to close right eye & has increased right eye tearing.  Tx w/antivirals, steroids, eye lubricant.  D/C to pcp f/u. FINAL DX: right sided Bell's palsy. 10/23/07 Received vax record.  1/18/08 Provider states that patient did not receive flu vax there in 2007 but in 2006.  Pharmacy where received zoster confirmed received flu vax there 10/12/07.