chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever; Body aches; Injection site pain; Nausea; This is a spontaneous report from a non-contactable other hcp (Patient). A 23-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 19Feb2021 13:30 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, gastroparesis and fructose intolerance from an unknown date and unknown if ongoing. No other vaccine was given within four weeks. Patient Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), fluticasone propionate, salmeterol xinafoate (ADVAIR), bifidobacterium infantis (ALIGN) and daily vitamin taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on unspecified date as single for COVID-19 immunization. On 20Feb2021 at 01:45 the patient experienced high fever, body aches, injection site pain and nausea. (Reporter felt like she had COVID again, although she knows this is not the case) after her second dose. She experienced hardly any side effects after her first dose. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
The day after vaccine, Pt reports low grade fever, body aches, fatigue and chest pain. Did not seek medical help at the time. Call placed to office on 7/28/17 at 09:30.
Hives that are itching red and raised and started on arms in middle of night that seemed to dissipate and have returned to the legs mostly on the thighs, but also lower legs and a bit on the arms today, which is 5/2 in the morning. It seems strange that it is occurring a full week after the 2nd shot, but I've never experienced anything like this so attribute it to the vaccine.
Meningoencephalitis; transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "weight loss" (unspecified if ongoing); "Night sweats" (unspecified if ongoing); "Paresthesias in her lower extremities" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ENCEPHALITIS (medically significant) with onset 28Jan2021, outcome "unknown", described as "Meningoencephalitis"; MYELITIS TRANSVERSE (medically significant) with onset 28Jan2021, outcome "unknown", described as "transverse myelitis". Adverse event summary reported as generalized tonic-clonic seizure evening of 1st injection. Initially, awake and responsive, then disorientation. Bilateral multifocal pneumonia. Dx. meningoencephalitis. Intubated. Quadraplegic but able to follow commands with her eyes and mouth. Over previous six months, wt loss, night sweats and one week of paresthesias in her lower extremities. Felt that some neurological decline started prior to vaccination. Diagnosed as meningoencephalitis. The patient underwent the following laboratory tests and procedures: CSF glucose: 59; CSF protein: 145; CSF red blood cell count: 14; CSF test: GS 2+ WBCs, no orgs; CSF white blood cell count: 14% PMNs, 76% lymphs, 10% Monos; Gram stain: Negative; Magnetic resonance imaging spinal: longitudinally extensive transverse myelitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This is a Literature report. Based on the currently available information, including the evaluation of the safety profile a reasonable possibility that the reported adverse event "Meningoencephalitis"; "transverse myelitis are associated to the administration of the suspect drug BNT162b2 (BNT162B2),  cannot be completely excluded in this patient. The impact of this report on the benefit risk profile of the Pfizer product and is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response will be promptly notified to regulatory authorities, Ethics committees and Investigators as appropriate.  ,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event and different patient;
Started running a fever of around 102.  This continued until around 4:00 AM on 9/2/2013. Reported no other symptoms.
Pt was administered the SHINGRIX vaccine. It was given in the left arm SC instead of deltoid IM pt said her arm was sore.
A pharmacist reported that a pt received Tetanus Toxoid as a child and subsequently developed an allergy. As of 10/12/00, no further information was available.
Heart started racing/palpating, glanced at clock- 12:23PM roughly 30 minutes after getting the vaccine. less than a minute later I lost my hearing in both ears, throat started to close and started to wheeze/gasp for air.  Started to pull over to right shoulder of hwy and call EMS 12:25 could not breathe at all and began to panic having small child in back seat. dialed EMS but cannot breathe at all. 12:26 blowing cold ac in my face and finally caught a small breath. Slowly felt throat loosen a little and began gasping for air.  12:28 sweating profusely, able to breathe, still cannot hear anything out of left ear, regained hearing in right ear.  Chest is tight and hurts, severe headache, lump in throat feeling.  12:30 I decide against 911 and drive home. Stayed in bed with family home. Still no hearing in left ear, chest pain, tightness in chest, heart palpitations.
Had Varivax at Peds 5/4/98 Lot# 0262M, Pt has chicken pox now.
Tinnitus; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  No treatment medications provided   This case was linked to MOD21-071007 (Linked Report).; Sender's Comments:  MOD21-071007:
Received work place flu injection into L arm. Immediately on administration I said it was very high. The RN advised that it was in the deltoid and that pushing in the vaccine was harder and she had only had about 2 single doses be this way. I took picture of injection site - looks about 2 cm below shoulder. I had pain with injection and then within 2 h noted loss of range of motion with being unable to reach back to get toilet paper off back toilet, more pain with crossing my arms to remove shirt and unable to raise arm up completed. This continued to next day so I saw a provider at Sat clinic and advised what happened. I showed her where injection went in and she said shoulder higher so did not think it went into shoulder. I had about 50% improvement in initial pain by Mon but have continue to have a burning sensation all around my rotator cuff. Achy and dull pain with using arm and this pain has interrupted my sleep. Pain and weakness from underarm/back arm. I have flu injection yearly and have never had this reaction. I have never had a shoulder issue or pain such as this. I plan to see my own primary care provider next week if it is not resolving.
Fever, Chills with local lymphodenopathy (marked) resolved 07/18/02
Flu-like symptoms; Extremely bad headache; Armpit/glands in shot arm very sore; Armpit/glands in shot arm very sore; This is a spontaneous report from a contactable consumer, the patient. A 43-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 left arm on 22Feb2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroidosis. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Feb2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 23:00, the patient experienced flu-like symptoms for 24 hrs (no congestion), extremely bad headache and armpit/glands in shot arm very sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events flu-like symptoms was resolved on 24Feb2021; while that of the events extremely bad headache and armpit/glands in shot arm very sore were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Noticed vesicular rash around vaccination site.  Then started noticing red colored papules on trunk and extremities
Entire Lt upper arm to just below the elbow swelled, became red, hot and hard to touch with red streaks from injection site to mid-forearm. Tx'd with Benadryl and Keflex.
Notice lumps in left side/center of left breast within two weeks of JNJ COVID-19 vaccine during breast self-check exam at home.  The site was also very tender to the touch and remained sore after touch.  Attempted to schedule my annual mammogram on 4/2/21;  I was directed by radiology scheduler to PCP to confirm whether I would need a diagnostic versus screening mammogram due to what I was detecting.  I went to my PCP to  inquire about symptoms on 4/7/21.  By that time, the lumps and soreness was much less detected.  I was advised to schedule a mammogram at least 6 weeks post-vaccination.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 2nd March 2019, the patient received the 1st dose of SHINGRIX. On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced pain and erythema. On 5th March 2019, the patient experienced swelling, skin warm and injection site bruising. On an unknown date, the outcome of the pain, erythema, swelling, skin warm and injection site bruising were unknown. It was unknown if the reporter considered the pain, erythema, swelling, skin warm and injection site bruising to be related to SHINGRIX. Additional details were provided as follows. The patient received SHINGRIX in the left deltoid. The next day of vaccination the patient had soreness that was more than expected normal she stated to pharmacist. The patient also had redness below the injection site, so she marked the redness. The area of redness was larger, swollen and hot. The area of redness was about 5.5 inches down from the injection site itself. The reporter stated there was bruising at the site.
Breakthrough COVID infection. Asymptomatic. Routine screening on admission. Positive test collected 08/14/2022.
rash by her collar bone; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 301358A), via an unspecified route of administration, administered in Arm Right on 29Sep2021 14:00 (at the age of 85-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included arthritis, breast cancer female (The caller is immunocompromised with breast and bone cancer), blood pressure, bone cancer, immunocompromised. Concomitant medication(s) included atenolol 50 mg taken for blood pressure, start and stop date were not reported; letrozole 2.5 mg taken for breast cancer, start and stop date were not reported; lovastatin 10 mg taken for blood cholesterol, start and stop date were not reported; calcium carbonate (TUMS [CALCIUM CARBONATE]) taken for mineral supplementation, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; gummy vitamins. The patient previously took amoxicillin and experienced rash, bnt162b2 dose 1 on 22Feb2021 (Lot number and Expiration date: Unknown) and dose 2 on 15Mar2021 (Lot number: EM9809, Expiration date: 30Jun2021) for covid-19 immunisation (received both doses at the age of 84-year-old), received flu vaccine on 13Sep2021. The caller is immunocompromised with breast and bone cancer. Prior Vaccinations (within 4 weeks) includes Flu vaccine, the high dose for seniors received on 13Sep2021.The patient experienced rash by her collar bone on 30Sep2021. The rash was on the right side of the caller's body. The outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.
PAIN ON BONES AND JOINTS  IN THE ARM THAT 2ND DOSE WAS GIVEN NEARLY A MONTH TO DATE OF THE VACCINE GIVEN  PAIN HAS BEEN ONGOING FOR OVER A WEEK
Information has been received from a female patient of unknown age referring to herself. No pertinent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown). There was no concomitant medication reported. On an unknown date, the patient had a "terrible itch on scalp and back" and was later diagnosis with shingles after ZOSTAVAX. The outcome of shingles was unknown. Causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week.  Sleeplessness was worse each night, with inablilty to sleep even with 50 mg of Benadryl and Valium.  Did sleep about  two hours a night with those meds but continued to be wide awake all day also.  My body felt like it hadn't slept but was unable to do so.  These symptoms left me suddenly with a severe chill and the brain fog litarally lifted and was gone.  The next week following developed mild red itchy skin that comes and goes on hands and torso and that symptom persists.  I am now able to sleep.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 11Apr2021 as dose 2, single (Lot number: ER8729) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 20Dec2021 as dose 3 (booster), single (Lot number: 032H214), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: I got test positive on day 1 and start Paxlovid on day 1; (18Jul2022) Negative, notes: I got a negative test on day 6; (21Jul2022) Positive, notes: positive test on day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient got test positive on day 1 and start Paxlovid on day 1. She finishes the 5 day Paxlovid does to treat Covid. She got a negative test on day 6 but got a positive test on day 9 and start to have symptoms again on day 9. Antiviral details: Product was Paxlovid and started on 13Jul2022 and stopped on 17Jul2022. Indication was treatment of covid-19.
Swollen & painful lt leg, feverish & difficulty walking.  No known allergies, 5th DTP, no prior problems
I had a very early miscarriage; This is a spontaneous report from a contactable consumer reporting for herself.  This pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date after the first vaccine shot the patient had a very early miscarriage. The outcome was unknown.  Information on the lot/batch number has been requested.
On the night of 04-27-04, the patient patient stated that she had a fever, cold sweats, headache and red skin on her face. Patient returned to the Health Center on 04-29-04 and was taken to a hospital emergency room by EMS.
Fever; Chills; Nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) outcome was unknown.            No concomitant and treatment medications were reported. On 25-Apr-2021, the patient experienced fever, chills, nausea and muscle pain.   This case was linked to MOD-2021-406387 (Patient Link).
Moderna Bivalent booster administered morning of Tuesday December 20th, 2022. Immunization Information System reports patient already received Moderna Bivalent booster on 09/22/2022.  Patient?s vaccine history was searched in prior to vaccinating today, but he was mistakenly sent to the nurse to get vaccinated again anyway. Patient was instructed to be observed by staff 15 minutes post-vaccine, and returned to work where he would be under the observation of others.  The facility?s supervisor was notified and advice on how to proceed was given. Patient was notified within 30 minutes of error. Patient reported feeling ?ok so far.? Patient was advised that common symptoms of vaccine administration may happen post-vaccination, and to seek help from PCP if patient felt necessary, as well as go to ER in case of an emergent event post-vaccination.
Pfizer COVID-19 Vaccine EUA  Patient became sweaty and hot and felt like his right arm was tingling got to the medical obs. Patient was monitored for a total of 30 minutes.  Patients vital remained stable. Reported improvement in symptoms prior to being discharged.
On October 11, 2020, I received a second dose of Shingrix and a 2020 flu vaccination. Later that evening and into the next day, I experienced a low-grade fever, chills / shivering, and myalgia. Fever and chills resolved that evening. Myalgia has lessened but is still present. Arm where injection was administered is very sore. Based on available literature, I know these are known side effects but feel they should still be reported.
Patient received expired vaccine. Office will call Pfizer to determine stability and revaccinate if recommended.
Quarter sized reddened, swollen area @ inj site with soreness which began the evening of 10/18/99 and laster through 10/19/99.  Administered children's Advil and used cool cloth to area.
Within 24 hrs of MCV vaccine, pt developed erythema and edema measuring 12cm x 9cm, hot to touch, 4 cm distal to injection site.
Narrative: 89 yo had received covid vaccines on 1/14/21 & 2/11/21. Pt died on 6/4/2021 in his home after hx of prostate cancer & secondary malignancy of bone, Likely death is unrelated to covid vaccinations.
No additional adverse events reported; a dose of ROTATEQ was administered during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 7 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 18-DEC-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # 1684149, expiration date was reported as 21-JUN-2021, but upon internal validation established as 25-JUN-2021) 2 ml orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 8.5 degree Celsius for a time frame of 3 minutes. Data logger was not involved. There were no previous temperature excursions. No further adverse event (AE) information was provided.
Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a dose of Gardasil at another practice. The patient developed an outbreak of genital warts after receiving the Gardasil. The time frame was unknown between the vaccination and the outbreaks. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 16-MAY-2011 at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed BACTROBAN, valacyclovir, and prednisone for management of his persistent and painful symptoms. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient was in for flu vaccine, tolerated well, pt sitting on table had just finished shot administration. MA and mother of pt. were discussing interactions; pt. fainted and fell off bed; Emergency response team called and Nurse and PA evaluated pt. Instructions for fainting and concussions given. Dx w/vasovagal episode and instructions to monitor pt. and ice head given by nurse.