chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; chills; fever; diarrhea; cough; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIARRHOEA (diarrhea), COUGH (cough) and ASTHENIA (weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever), DIARRHOEA (diarrhea) and COUGH (cough). On 15-Mar-2021, the patient experienced ASTHENIA (weak). On 15-Mar-2021, CHILLS (chills), PYREXIA (fever) and DIARRHOEA (diarrhea) had resolved. At the time of the report, COUGH (cough) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This spontaneous case, initially received on 30-Sep-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 20-SEP-2016 to 20-SEP-2016. Dose regimen: 0.5 ml as one single dose, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse event description: On 20-Sep-2016, the patient was administered influenza vaccine with a 5/8 inch needle (special circumstances: drug administration error without adverse event). The reporter is concerned that it may have not reached the muscle in the patient. Reporter comment: The healthcare professional classified the event as a medication error.
BP 180/110, HR 140.  Baseline is BP 110/70, HR55.  Slowly returned to baseline but with dizziness and lightheaded symptoms for the remainder of the day.
Case number PHHY2015US006721, is an initial spontaneous report from a consumer (also patient) received on 16 Jan 2015. This report refers to an adult female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date in 1999. On an unknown date after the vaccination, the patient experienced Guillain-Barre syndrome (GBS). The outcome, seriousness and causality were not reported. Seriousness assessment of Guillain-Barre syndrome was upgraded based on NVS-IME list. The patient was further vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 02 Dec 2014 and experienced Guillain-Barre syndrome (see case: PHEH2015US001456).
Patient was administered a dose of Pfizer 0.3 mL monovalent instead of the Pfizer 0.3 mL bivalent vaccine. Pharmacist drew up the wrong vaccine type. No adverse reaction from patient was observed.
3 itchy red spots at "my" inguinal region near lymph nodes/ this rash developed further covering full body,centering around inguinal and armpit areas, legs too/ diagnosed as by "my" dermatologist as gianotti-crosti syndrome, caused by vaccine shot.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to dust mites and pollen. 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. On 19Apr2021, after 3 days of first Pfizer vaccine shot, the patient developed 3 itchy red spots at her inguinal region near lymph nodes. On 24Apr2021, on 8th day, that rash developed further covering full body, centering around inguinal and armpit areas and legs too. On 25Apr2021, on 9th day, the patient went to see urgent care. On 26Apr2021, 10th day, the patient saw her family doctor and confirmed it was caused by COVID-19 vaccine and prescribed medicine and cream. On 27Apr2021, on 11th day,  it was diagnosed as gianotti-crosti syndrome by her dermatologist, caused by vaccine shot. The patient reported that she was recommended to take the second shots by both family doctor and dermatologist, so she went to receive her second shot 3 weeks later, on May7th as planned. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures taken as a result of the reported events included treatment with cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL), clobetasone cream (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN) on unknown dates. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 3 itchy red spots at inguinal region near lymph nodes, full body rash on inguinal, armpit areas and legs and gianotti-crosti syndrome were resolving at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are possible. No further information is expected.
Lower body weakness; Neck pain; legs couldn't stand; Inability to walk; Weakness of legs; terrified of the BOOSTER.; Head pain; Fever; Body pain/Severe body aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk) and MUSCULAR WEAKNESS (Weakness of legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 8077727399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive.). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), ANXIETY (terrified of the BOOSTER.), HEADACHE (Head pain), PYREXIA (Fever) and MYALGIA (Body pain/Severe body aches). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (Lower body weakness), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), HEADACHE (Head pain) and PYREXIA (Fever) had not resolved and NECK PAIN (Neck pain), ANXIETY (terrified of the BOOSTER.) and MYALGIA (Body pain/Severe body aches) outcome was unknown.            Patient height was 5'2" and weight was 220. No treatment medications were reported.   This case was linked to MOD-2021-338873 (RA Linked Report). This case was linked to MOD-2021-023159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains Updated suspect product details. Added new events and concomitant medications and patient medical history. On 05-Oct-2021: Follow up received on 06 oct 2021 contains NNI.; Sender's Comments:  MOD-2021-338873:Dose 2
Chill Narrative: 77 YOM reported headache, nausea, and chill following his first dose of Covid-19 vaccine on 1/29/21 that lasted for 1 day.
On the 11th she noticed in the evening that the injection site was hard. Over the next few days she noticed the hardness spreading around the injection site towards her body. (Right arm) On the 15th around 10pm she did not feel well. Arm hurt and hardness had spread approximately 5" top to bottom and around the arm in a band at injection site; with burning sensation in the fingers, numbness and tingling across arm. 11pm the room was spinning and she could not stand. She was able to sit up onto the edge of bed. She said her heart was pounding as if she was running a marathon but we had been only lying in bed watching TV. I felt her chest and she had a severe wheeze In her upper chest but was taking in shallow breaths easily. By 11:30pm I had gone out to start the car to take her to the ER and I came back inside right away and she was slumped over unconscious. She was out for about 5 minutes. Her pulse was faint and she was completely non responsive. When I got her to wake up she was confused and could not move any body part independently except her fingers which she could move with great effort. EMTs came and took her to ER. She lost 2 years of memory through the next day. She also sporadically lost up to 6 years of memory in waves it would come and go.
5-21-14 OV for cholesterol screen. Pt reports that "flu shot you gave me" caused reaction. Swollen lips/throat. States did OK with regular dose. She could not give onset of reaction after shot. Also hx of allergy s/s x yrs and found was Lisinopril.
8 days after vaccination my left arm at the injection site became intermittently itchy.  There was very little bruise left and a grape sized area of very slight redness.  The morning of day 9 post vaccine  I noted a new 3 inch circular, red, raised area that was hot to the touch.   There was minimal pain, just a little itchiness.  The raised, red area persisted for 2 days and then began fading.
Extreme fatigue 1 day after second dose. I'm a physical and health trainer and have not been able to workout or train anyone 1 day after the second dose.
No adverse event; More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.) and NO ADVERSE EVENT (No adverse event) in a child female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Apr-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that On 10-Dec-2022, the patient received first dose of moderna vaccine and batch number was reported as AS1414B. Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023. It was not believed that the freezer had not gone out of range during this time however it was also not known if the freezer went out of range during this time. The freezer does had an alarm on it that had not gone off since April 13, 2023.
Patient stated that they had never received a COVID vaccine, and a primary/monovalent Pfizer vaccination was given on 10/7/22. The patient came in for a second dose and the patient's daughter stated that the patient had received 3 previous vaccines. So, the patient should have received a Booster/Bivalent dose and not the first in the primary series.
maculpapular rash over neck, face, chest, back, & stomach w/onset approx 2 wks p/administration of MMR vax; afebrile; c/o mild joint stiffness & pain;
Patient presented to the ED on 2/28/21. She was admitted on 3/1/21. Another ED visit on 3/4/21. On 3/14/21 she presented to the ED and was subsequently hospitalized. These visits were within 6 weeks of receiving COVID vaccination.
I put ice on my arm after the shot. By bedtime (9pm) I was achy which I have had before from the flu shot and I took 500mg naproxen. I couldn't sleep after 1.5 hours and took one TYLENOL #3. I woke up around 5am from pain and tenderness in my left armpit, as well as the return of generalized aches. I finally got up at 6:15am and took another 500mg naproxen. My generalized aches are ebbing, but my armpit still hurts. I don't think the lymph node is particularly swollen, but it is tender in addition to just hurting even when I don't touch it.
p/vax whole body very sore & stiff day 2-3 p/vax;day 5 pt 1st noticed a sl swollen 2" red area;stated did not have redness prior to this day;sore & stiff body gone p/2 days;
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX,(lot number, expiry date and route was injection). Concomitant medications were not reported. On an unknown date, the patient had shingles twice since the administration of the vaccine. The outcome of the event was unknown. The patient medical attention (saw the doctor). Additional information has been requested.
Report number 20000181921 described the occurrence of possible degenerative joint disease in a 67 year old male receiving Lymerix for prevention of Lyme disease. The vaccinee has no known drug allergies. The vaccinee has no history of arthritis, Lyme disease, gout, psoriasis, or Crohn's disease. The vaccinee has no family members with rheumatoid arthritis or Lupus. Concurrent medical conditions include chronic obstructive pulmonary disease, polycythemia, cerebrovascular accident, hypertension, back surgery, and bilateral knee repair for meniscal tear. In May 1999 IM and June 1999 IM, the vaccinee received the first and second doses of Lymerix, respectively. Rheumatologist reports that subsequently, the vaccinee experienced pain in all his joints except the distal interphalangeal joints. The metacarpophalangeal joints were a little tender on exam. The exam was mostly unremarkable. There was no swelling. The vaccinee claimed he had intermittent swelling and pain but none were found. There were no warm joints on exam. Thee was a small effusion in the right knee, too small to tap. The rheumatologist stated that this effusion could be due to degenerative joint disease. The rheumatologist noted some loss of range of motion to the right knee. The vaccinee also complained of abnormal sensations in his legs. He reported that it started as pain but had progressed to a numbness. He could no identify when this had started. He was referred to a neurologist. No treatment was given. The rheumatologist saw no joint changes indication arthritis. There were no erosions and no inflammatory changes. The most recent information, received on 6/14/2000 reports the outcome of the event as unresolved. In a statement of injuries, the subjects attorney alleged that the subject suffers and has suffered form joint pain, swelling, cramping, headaches, flu like symptoms, fatigue, numbness, paralysis, possibly memory loss, decreased activities of daily life, rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix.
Arm hurt; Diarrhea; Knees hurt; Was cold; Mild fever; Felt a little like balance was off; she calls it being fuzzy headed and she felt a little lightheaded; she calls it being fuzzy headed and she felt a little lightheaded; So tired I don't want to do anything; Can't remember words/difficulty remembering words worsened; Can't remember words/difficulty remembering words worsened; This is a spontaneous report from a contactable consumer or other non hcp. An unspecified age female patient received 2nd dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Expiration date: unknown), via unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for covid-19 immunisation. The patient medical history included difficulty remembering words from an unknown date. Concomitant medications were not reported. consumer stated that on unspecified date, the patient experienced arm hurt, diarrhea, knees hurt, was cold, mild fever and except knees hurt, patient feels normal and fine on next day (15Mar2021) and the top of her neck and the back of her head felt a little like her balance was off, it being fuzzy headed and she felt a little lightheaded. Consumer reported that it goes a little while, then she gets the fuzzy headed feeling, then she was fine.  Consumer reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. consumer reported that the fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she does not want to do anything.  consumer reported that the next day, she would be good to go again.  consumer reported that sometimes she would push herself and do things anyhow, but she does not feel like doing anything. Consumer reported that she was a senior, and most seniors have a problem where they cannot remember a word then blink and can think of it.  consumer reported that her bother was about problem remembering words was getting worse, from her baseline after she received the Covid-19 vaccine, but it has stayed the same since originally worsening from baseline and around the same time that her fuzzy or lightheaded feeling began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient hasn't received 2nd dose because of vaccine site shut-down; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down). On 19-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because of vaccine site shut-down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.   This case was linked to MOD-2021-229317 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 20-06-2021 and contains no significant information.
This spontaneous report was received from a 68 year old male patient reporting on himself. The patient's concurrent conditions included a metastatic malignant melanoma diagnosed in approximately 2006, reported as "12 years ago". The patient had no drug reactions/allergies. On an unspecified date in 2008, the patient was vaccinated with PNEUMOVAX 23 dose 1 as vaccination from pneumonia (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, as after the first PNEUMOVAX 23 dose, the patient started ipilimumab for metastatic melanoma. On approximately August 2017, reported as "8 months ago", the patient was vaccinated with PNEUMOVAX 23 dose 2 as vaccination from pneumonia (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. No lab diagnostic studies were performed. The patient sought unspecified medical attention. At the reporting time, the patient's outcome was unknown.
Pt immediately had elevated heart rate and anxiety following first injection. Pt noted off-schedule bleeding Dec 20th, lasting 2.5 weeks. This off-schedule bleeding has continued and worsened in frequency after second injection, which was given 01/20/22 (Moderna lot #0417a1A given at pharmacy). The patient reports daily bleeding starting 02/14/22 that has not stopped. Additionally, she reports significant hair loss starting mid Jan, as well as frequent hot flashes and night sweats. She has not had thiss issue before, is on same OCP which has not had dose changed nor pills missed or late start, and has had negative lab testing.
Severe eczema flare ups over face, scalp, and entire body. Dishysdrotic eczema on feet.
Child became weak (had trouble holding head up) and eyes crossed, 5 days, post vax of 6 month vaccinations of DTP/Hib3 & OPV3. Final dx: Cerebral Palsy.
Hollow Talk; Loss of hearing after the second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included BUDESONIDE for Colitis, WARFARIN SODIUM (COUMADIN) for Seizures, VITAMINS NOS, PROBIOTICS NOS, CLONAZEPAM and MONTELUKAST for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination). At the time of the report, DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) outcome was unknown.            Concomitant medication includes Lobotrixine, Totermine, Antrictalis. Treatment information was not provided. Doctor tell her that there was nothing wrong whit her ears.
pt was taking morning shower;mom heard pt make strange wailing cry;pulled open shower curtain just as pt collapsed;pt was unconscious about 30 sec;when pt awoke, pupils were unequal;examined in ER & by peds;both exams nl;leg hurt, h/a
Patient had a brief episode of severe vomiting and nausea, chills and malaise lasting 24 hours.  She feels fine now - no treatment was necessary.
NauseaVomiting FATIGUE, INJECTION SITE PAIN Narrative:  Other Relevant History: