chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was in bed for 2 weeks. She could hardly move around; Since taking first vaccine, was ill for several weeks; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (had for about 6 years), hypertension from Apr2021 and ongoing, ongoing depression (had since teenager), nephrectomy from 06Jul2020 to an unknown date, ongoing blood cholesterol, ongoing hypersensitivity. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity from an unspecified start date and ongoing; pravastatin (PRAVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; venlafaxine hydrochloride (EFFEXOR) taken for depression from an unspecified start date and ongoing; losartan potassium (COZAAR) taken for hypertension from Mar2021 and ongoing. Caller reported that she got the first shot at 9:30 in the morning at work. She had an appointment at 14:00 with the diabetes specialist. It was about a 20 minutes drive. Caller said that about 10 minutes into the appointment, she had to cut the appointment short and call her son to come get her. She was in bed for 2 weeks. She could hardly move around. Then for the last week before the second shot, she was better but it persisted. It was reported that since taking first vaccine, was ill for several weeks (29Mar2021). She was scared to get the second shot. She had seen her doctor. Treatment was received for the event since taking first vaccine, was ill for several weeks (illness) was to drink plenty of liquids and rest. Outcome of the events were reported as unknown.  Information regarding the lot/batch number has been requested.
Patient with 3-day history of bilateral red itchy eyes that are tearing. He has a darker red spot on his left lateral sclera. He has no fevers cough labored breathing eye trauma vision changes or any other related concerns. He has a chronic pupillary abnormality of his left side
Enlarged Lymph node in neck, right side lasting 8 weeks +. No pain, discomfort, or inflammation.
24 hours after the injection I got swollen eyes. This is exactly what happens to me when I use a product (lotion, soap, etc.) so I?m assuming it?s my immune response. The swelling mostly went away 24 hours after onset (48 hours after shot).
THERE WAS NO ACTUAL ADVERSE EVENT.  PATIENT WAS GIVEN THE UNDILUTED PEDIATRIC VACCINE (0.3ML) DOSE INSTEAD OF THE ADULT DOSE.  I FOLLOWED UP WITH THE PATIENT 24 HOURS LATER AND THEY SAID THEY FEEL FINE AND DIDN'T HAVE ANY SIDE EFFECTS.
About a month after my J&J Covid vaccine I started having tingling/cold feelings in my feet and hands, my feet felt they were breaking a cold sweat it was very mild about a 2 on a scale from 1-10. I also noticed a lump on top of my right foot. The lump has been diagnosed since as a ganglion cyst. Since May 1st I have had peripheral neuropathy in feet and hands and it has since spread to my legs and arms. When I first went to the doctor they did not think my symptoms were from the vaccine so I have been waiting for things to clear up. I have another apt with my doctor next week to discuss my symptoms. I was also diagnosed with a heart murrmur at that initial visit with the peripheral neuropathy. I do not know if the vaccine is related to my symptoms. I have never had either issue before and with in the first 12 hours after my vaccine I felt so sick for about an hour like my blood was boiling in my body.
1/13/2021, 10:30: Birthdate and consent was given by parent to administer vaccine to patient, DOB-6/27/2006. Patient was given a pediatric dose of Pfizer, 0.2mL, for his Booster. Vaccine was labeled correctly as (PEDS) Pediatric Pfizer dose (0.2ml). Patient should have received a full adult dose of Pfizer vaccine, 0.3mL.
SICK; PAIN; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sick, and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and pain was not reported. This report was non-serious.
Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms  lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again.  I had no reaction to 1st dose.
Case number PHEH2014US016971 is an initial spontaneous report received from a physician on 21 Aug 2014. This report refers to an 18 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) intramuscularly on 27 June 2008. He was again vaccinated with MENVEO on 10 Jun 2011 and on 20 Aug 2014 (batch number: A14203). No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Sore left arm, dizziness & vomiting X 1 day.  C/o achy feeling & stuttering (resolved).
Information has been received from a physician concerning a 17 year old male who on 19-JUN-1996 was vaccinated with a first dose of MMR II.  On 08-JUN-1998, the patient was vaccinated with a second dose of MMR II (routes, site and lots number were not reported).  The patient's fever count was 82 and his parotitis count was 100.  On 13-NOV-2009 the patient's serum immunoglobulin M was negative, serum immunoglobulin G was 3.56 and serum amylase was 89.  On 13-NOV-2009 the patient was diagnosed with mumps.  On 14-NOV-2009 the patient experienced right parotitis.  The patient was afebrile.  The outcome for mumps was not reported.  Follow up information has been received concerning the 17 year old male patient who on 19-JUN-1996 and on 08-JUN-1998 was vaccinated with the first and second doses of MMR II (route and lot # unknown), respectively.  On 28-NOV-2009 the patient experienced mumps (he was diagnosed on 01-DEC-2009).  The patient was afebrile and had R parotitis.  On 01-DEC-2009, a first blood work was performed with a result of IgM was <1:10, IgG was 5.01 and serum amylase test was 178.  At the time of the report the patient's outcome was unknown.  No further information is available.
receiving covid booster/having more discomfort and swelling; receiving covid booster/having more discomfort and swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 75 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Sep2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown booster, single 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, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), DISCOMFORT (non-serious), outcome "recovered" and all described as "receiving covid booster/having more discomfort and swelling". Therapeutic measures were taken as a result of swelling, discomfort.  Additional information: Patient reported some time around Sep2021 receiving covid booster. She was off of Xeljanz for 9 days for the booster as instructed by MD. During time off of Xeljanz, she reported having more discomfort and swelling. After getting back on Xeljanz, the symptoms went away.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Headache, Myalgia, Fever, fatigue, tenderness at injection site Narrative:
NOCOVER> 1   HEALTH  SYSTEM LABORATORY Chart Review Copy                                                             (64 yrs) PT CLASS: Inpatient CSN:  DEPT:   PATIENT STATUS: Discharged GENDER: male BED:    ORD DR:    AUTH DR:    Results Covid-19, Flu, RSV by NAA     Contains abnormal data Covid-19, Flu, RSV by NAA Order:   Status: Final result    Visible to patient: No (inaccessible)    Next appt: 03/30/2022 at 09:15 AM in Radiology   Specimen Information: Nasopharyngeal; Swab    0 Result Notes    Component Ref Range & Units   Influenza A Not Detected Not Detected   Influenza B Not Detected Not Detected   RSV Not Detected Not Detected   SARS-CoV-2 (COVID-19) by NAA, Micro  Not Detected Detected Abnormal        Narrative   Methodology: Nucleic Acid Amplification(NAA)/Polymerase Chain Reaction(PCR)   The SARS-CoV-2 (COVID-19) test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for laboratories certified under Agency to perform high complexity testing. This test has not been FDA cleared or approved.  Specimen Collected: 01/29/22  5:11 PM Last Resulted: 01/29/22  6:05 PM   Order Details    View Encounter    Lab and Collection Details    Routing
Pt recv vax on 2/25/98; on the same day pt exp swollen thigh from knee, crying unrelieved by Tylenol and hot to touch.
Left arm numbness and tingling with pain and tingling in the distribution of the radial nerve, starting at injection site and shooting down arm to thumb. 9/24/07-records received for DOS 8/20/07-Impression: numbness secondary to vaccine administration, possible neuropraxia. C/O numbness of thumb and outside aspect of left arm 15 minutes after receiving Menactra in left deltoid region.Numbness progressed initially and has stabilized. Denies weakness.
PATIENT WAS SITTING IN OBSERVATION AREA WHEN HE BECAME DIAPHORETIC AND PALLOR, STATED HE FELT HOT AND FLUSHED. PT WAS FAINT BUT DID NOT LOOSE CONSCIOUSNESS. HOWEVER PATIENT WAS LOWERED TO THE GROUND, CLOTHES LOOSED.  PT WAS MONITORED FOR AN ADDITIONAL 30 MINUTES WHERE SYMPTOMS RESOLVED PATIENT WAS THEN RELEASED HOME TO SELF CARE
12 year old complains of pain and swelling to Right upper arm x 1 day. Patient mother stated that he went to a friends house the night of vaccine. When he returned home the next day she noticed swelling and redness to site, upon visual examination right upper arm was swollen and warm to touch, cool pack was applied to site and  patient was referred to urgent care to rule out cellulitis and if any antibiotics are needed. Patients mother verbalized understanding
Rash over entire body with itching. Dr called this office and gave details about possible adverse reaction from immunization - (Child seen by Dr - Rx for rash given today). 1 wk ago rash, fussiness, crying and itching.
pt states severe headache, redness and red spots at injection site,  soreness and muscle spasms in arm and down right side of back, pt called pharmacy 01/08/22 pm and asked if anyone else had reported such symptoms said she had headache with first dose but not this severe, i recommended she call her physician and meantime hydrocortisone at injection sight along with ice and continue tylenol or ibuprofen
Pt vaccinated with DTP/OPV felt hot, acting limp, weak, & eyes rolled back, temp 104.8(R).
Non-Stop ringing in ears. Sometimes very loud; Neck pain; Feeling of heaviness on back of neck; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN) of 50mg; from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PA156051) via an unspecified route of administration in the right arm on an unspecified date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced non-stop ringing in ears. Sometimes very loud, neck pain and feeling of heaviness on back of neck. No therapeutic measures were taken for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of non-stop ringing in ears, neck pain and feeling of heaviness on back of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Covid-19 vaccine administered and patient experienced an adverse reaction: EPINEPHrine (Epipen) administered and 911 called and Ambulance transport  Patient came into clinic stating she has some tingling after first Moderna Vaccine, did not escalate. Second Moderna vaccine patient stated they had anaphylaxis 35 mins after getting the vaccine as seen in note from ED on 4/27/2021. Today, patient got the 3rd dose of the Moderna vaccine at 10:05am, patient started to feel tingling in her throat and tongue swelling about 10 mins after vaccine administration. I observed patients mouth and was not able to see throat and tongue was swollen. Patient denied difficultly breathing and swallowing, chest pain, dizziness. EPI pen was given in her left anterior lateral thigh @10:17am. Patient was monitored closely and 911 was called. After 5 mins patient stated that the swelling was persistent and slightly worsening. Tongue did appear slightly more swollen; however, EMS had arrived to transport patient to hospital. Patient stable throughout encounter. Care was transferred to EMS.
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling.   The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
Rash appeared at the injection site of PREVNAR 13 after 24 hours, later it spread to the other parts of the arm. Arms are sore, painful and difficulty in lifting the arm. Headache and fever for 2 days after receiving vaccine. Mild rash at the injection site of SHINGRIX. Disappeared after few days.
Rash at site. Mom first noticed 24 hrs after administration of vaccine. No treatment needed.
24 hours after shot, Pt. presented with a fever of 102. Pt. felt like flu symptoms, chills, aches, fever. 48 hours after shot, Pt. developed stomach ache, loss of appetite, fatigue. Injection area swollen and red, area was hot, itchy and painful, also headache.
8/29/21  Admitted to the hospital for shortness of breath and cough. Tested COVID + on 8/24/21.  Had a lengthy hospitalization requiring mechanical ventilation.   Expired from COVID/ARDS on 9/23/21.
tinnitus started a week after the first dose in June 4; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus started a week after the first dose in June 4) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu Vaccination. Past adverse reactions to the above products included Ear infection with Flu Vaccination. Concurrent medical conditions included Tinnitus.    On 04-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022,  after starting mRNA-1273 (Spikevax), the patient experienced TINNITUS (tinnitus started a week after the first dose in June 4). At the time of the report, TINNITUS (tinnitus started a week after the first dose in June 4) had not resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient had tinnitus for one year but not cured.  No treatment medications were reported.
Had covid in October. Felt like she did when she had covid. Painful joints, gross fatigue, no appetite, sore arm, low grade temp. No energy.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 6 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Treated for breast cancer until May2022; "Allergies" (unspecified if ongoing), notes: Known allergies: yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had Paxlovid from 19Dec2022 to 23Dec2022 as COVID 19 Treatment.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
No adverse effects reported; Patient was vaccinated with a dose of improperly stored GARDASIL 9; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-US-009507513-1907USA007468: US-US-009507513-1907USA007439: US-US-009507513-1907USA005368: US-US-009507513-1907USA005362: US-US-009507513-1907USA010550: US-US-009507513-1907USA010552: US-US-009507513-1907USA010553: US-US-009507513-1907USA010554: US-US-009507513-1907USA010555: US-US-009507513-1907USA010556: US-US-009507513-1907USA010557: US-US-009507513-1907USA010558:
fainted. Felt light headed then asked to lay on the floor, we supported her as she briefly seemed to pass out for not more than a few seconds. She quickly began to respond to us, her blood pressure was 135/65  86 she began to perspire. PT felt better after a few moments talking to us and drank a couple glasses of water that we provided. at 11:05 her blood pressure returned to 105/65 63 she stayed for 30 minutes eventually standing and walking outside the pharmacy, she declined a ride offer and drove herself home
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 8 to 10 days, my arm became very itchy with a lot of redness and swelling. It was uncontrollably itchy, hot and swollen. It lasted for about 5 days. I took Benadryl and Advil.
Husband reports that within 24 hours, patient was extremely weak and had fainted x2 in the home. She continued to feel weak for a total of 48 hours post vaccination.
8.5x8.5cm area of increased erythema and warmth left upper extremity.
Rash (Redness) around the area of injection  plus eching  six day after adminsteration
No adverse event; Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) 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 EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.).    Concomitant medication details not reported by the reporter. Pharmacist stated that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD. The lot number of the vaccine is AS7173B, the date it was pulled out of the freezer was 24-Apr-2023. 4 doses were administered on 25-May-2023 and 2 doses on 26-May-2023 Treatment details was not reported by the reporter. This case contains information about 1st patient out of 6   This case was linked to US-MODERNATX, INC.-MOD-2023-726808, US-MODERNATX, INC.-MOD-2023-726807, US-MODERNATX, INC.-MOD-2023-726806, US-MODERNATX, INC.-MOD-2023-726805, US-MODERNATX, INC.-MOD-2023-726799 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726808:Patient 6 US-MODERNATX, INC.-MOD-2023-726806:Patient 4 US-MODERNATX, INC.-MOD-2023-726805:Patient 3 US-MODERNATX, INC.-MOD-2023-726807:Patient 5 US-MODERNATX, INC.-MOD-2023-726799:Patient 2