chrisvoncsefalvay/vaers-outcomes huggingface dataset:
localized erythema; Face with little blotches; Face was puffy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face was puffy), ERYTHEMA (localized erythema) and RASH MACULAR (Face with little blotches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SWELLING FACE (Face was puffy) and RASH MACULAR (Face with little blotches). On an unknown date, the patient experienced ERYTHEMA (localized erythema). At the time of the report, SWELLING FACE (Face was puffy) had resolved and ERYTHEMA (localized erythema) and RASH MACULAR (Face with little blotches) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-064222 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-064222:First dose
Information has been received on 06-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 07-APR-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster, or shingles. The patient has been prescribed continued dosages of valacyclovir for management of her painful condition. 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.
20SEP97 sz that lasted 3hr as per mom sz started 11PM;pt felt warm teeth clenched;911 called pt not responsive) taken to ER stayed 2noc;had another sz in ER tx w/sz med & APAP kept for observation;
Pt. examined and vaccinated on 12/23/08 for well visit - normal exam. Pt found by parent in crib morning of 12/24 apneic - SIDS is preliminary cause of death - coroner's report not available.   2/2/09 Received Autopsy Report which states COD as sudden unexplained death in an infant & manner of death as undetermined.  2/2/09 Autopsy report also states patient experienced cold s/s.  Last seen by PCP on 12/23/08 for vaccinations, had been given Tylenol x 3 doses.  Was fed & had been placed in crib face down w/head turned to side & 2 blankets on.    2/4/09 Received PCP office & vaccine records. Records reveal patient in good health on 12/23/08 w/only dry patchy areas on legs & back & left eye turning intermittently.
did pass out; This spontaneous report was received from a Licensed Practical Nurse and refers to a 15-year-old male patient. No information regarding his pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date in January 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for cancer prevention. It was reported that he "was OK" after vaccination. On 02-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration reported as injection (exact dose, lot # and expiration date were not reported) for cancer prevention. On 02-AUG-2019, the patient passed out after receiving his second dose of the vaccine. He did not eat any food prior to receiving the vaccine. As soon as the office personnel gave him food, he was fine. The outcome of the event was reported as recovered on 02-AUG-2019. The reported stated that, the passing out was an adverse effect after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Therefore, the event was considered to be related to suspected vaccine.   Upon internal review the event of pass out was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA008190:
Began getting fussy and irritable. Developed fever overnight into 3/9/2014 and had a fever off and on through the day with help from Tylenol. Spiked a fever of 104.1 at approx 2:30am on 3/10/2014 and had crying fits that lasted hours and seemed to be in a great deal of pain. Mom remembers a similar chain of events occurring after patient's first dose of the flu vaccine in November 2013. This most recent shot was a booster. Mom questioned the doctor about the initial reaction before patient received the booster shot. The Doctor did not seem to believe that it was an adverse reaction.
Nasal drainage; body pain; nausea; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nasal drainage), ARTHRALGIA (sore shoulder), PAIN (body pain) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0252264) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). On an unknown date, the patient experienced RHINORRHOEA (Nasal drainage), PAIN (body pain) and NAUSEA (nausea). On 25-Jan-2021, ARTHRALGIA (sore shoulder) outcome was unknown. At the time of the report, RHINORRHOEA (Nasal drainage), PAIN (body pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received vitamin C as a treatment,
Migraine, shoulder/back pain and states went to ER and treated for bell's palsy. Went to ER 3/19/21 per patient
patient received 0.5ml dose of Moderna. He experienced fever, chills, aches/pains and vomiting.
Narrative:  Patient COVID positive despite 3 doses of COVID vaccine. Admitted 1/14/2022 and discharged same day. per Provider: Patient was found to be Covid positive however did not really have any symptoms and was requiring no oxygen. Patient needs no treatment regarding this peer.
Had no noticeable symptoms until 34 hours after the second dose.  Although, in retrospect, I realize I had some "brain fog" during the day after the injection.  Day after the vaccine:  9pm I went to bed with terrible chills. Could not get warm, nor stop shaking. Awoke in the night needing to use the bathroom. Lifted my head and was so dizzy I began vomiting. Could not get out of bed and walk downstairs to the bathroom. On the day of the vaccine, I was at my normal body temperature of 96.6.  My temperature when I awoke was 102.9.  I was drenched in sweat.  I lay back and tried to sleep.  My breathing was very strange. I was taking deep breaths and as I exhaled my breath came out in squeaks and rattles. It was frightening.  Remained in bed and could not break the fever the next day. Very tired and feeling sick.  Chest hurt if I laughed or coughed due to the severe shivering the night before. That night I had the severe chills again. Still had the fever. Upset stomach. Exhaustion.   The fever continued the next day with some ups and downs - but never down to normal.  I did not feel fully recovered from the vaccine side-effects until about 10 days after the shot.
Pt received first  dose of Moderna Covid Vaccine in left arm; approximately 1345 Patient was sitting in waiting area  when pt verbalized that he was experiencing swelling of the tongue and having difficulty breathing. Patient could be observed with profuse sweating. Epi Pen x1 0.3 mg IM was administered  patient's right thigh, Emergency department immediately notified by medical staff and ER physician and Nurse arrive in approximately 3 minutes to assess patient. Pt transferred to ER for further care and observation.
1 day following vax, pt devel swelling, redness and tenderness at inject site. 2 days post vax, pt devel morbilliform-type rash on her trunk, arms & thighs. Rash described as "What you'd see with Amoxicillin."
Patient came in for Moderna covid booster appointment; and accidentally received both Flu shot and Moderna covid booster; Patient had received a flu shot previously on 10/11/2021
She got her vaccine, she felt the pinch of the needle and that was it, soreness.  She walked over to the viewing area, and she started clearing her throat all the time, then she started getting itchy on her chest, and she started breaking out in hives, her breathing became shallow/different, tight in her chest, her throat was definitely tight and clearing her throat.  She felt light headed, and her hands were shaking.  Somebody monitoring her saw the breakout of the hives and was pulled over by what she thought was a doctor behind a screened in area where he put a pulse oximeter on her finger, told her to take deep breaths, listened to her chest, and to see her stomach which was also broken out into hives.  She was getting a little dizzy, more difficulty breathing, the clearing of the throat was more, and he administered oxygen.  She also had tingling in her hands, and she also had a time sticker on her for the 15 minute interval, and was past that 15 minute time mark about 30 minutes or so.  She stayed on a gurney in this area, and thought that it would be reported.  She believes that the person was a doctor from the hospital.  She was given water.  About 1/2 hour later the hives started to subside, her hands were shaking less, and he told her that she had a very severe allergic reaction and he did not recommend a 2nd vaccine.  She remembers scheduling the next shot immediately after the shot and did not go to it.   She was sent home, was told to take large amounts of non-drowsy antihistamines.  She does not remember getting anything or given anything for the reaction.  Recommended her to take cinnarizine, and if she did not get better to go to the ER if she did not have any trouble breathing.  She was well enough that he was comfortable for her to go home.  When she got home she felt like flu-like symptoms, felt like she got hit by a truck.  Her bones hurt, she had a low-grade fever for 2 days following the vaccine.  Her arm hurt at the injection site, there was a large puffy swollen area around the injection site.  She was emotionally upset, and didn't feel good.  She was crying which she is not normally like this, no appetite, her body hurt.  She was taking Ibuprofen, had no more hives, but did have a headache, just felt bad.    She saw her doctor for routine visit and informed her of the events, and she informed her that she should not get anymore vaccines.  In December of 2021 she wrote her a medical exemption letter for not getting anymore vaccines.    They called to remind her of the vaccine, and she informed them of the AE, which they did not have any documentation of this.
Arm pain at injection site 9 days after the injection starting in morning of 18Apr2021. Did not limit arm motion, but pain was enough that it prevented me from doing normal activities and impossible to ignore, probably 6 on pain scale.; Arm pain at injection site 9 days after the injection starting in morning of 18Apr2021. Did not limit arm motion, but pain was enough that it prevented me from doing normal activities and impossible to ignore, probably 6 on pain scale.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, bipolar ii disorder (reported as bipolar II). The patient had environmental allergy, latex allergy (reported as Latex sensitivity). Concomitant medications taken within two weeks of vaccination included bupropion (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) fluticasone (MANUFACTURER UNKNOWN) and multivitamin; all from unknown date for unknown indication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00. Did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale. 650mg Tylenol eased pain, but pain returned about every 4 hours. Pain was gone by next morning (19Apr2021). Therapeutic measures were taken as a result of arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00; did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale and included treatment with Tylenol 650mg 3x on 18Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm pain at injection site nine days after the injection starting in morning of 18Apr2021 at 10:00; did not limit arm motion, but pain was enough that it prevented her from doing normal activities and impossible to ignore, probably 6 on pain scale. 650mg Tylenol eased pain, but pain returned about every 4 hours. Pain was gone by next morning (19Apr2021) was resolved on 19Apr2021.   No follow-up attempts are needed. No further information is expected.
m.d. rpt after 2nd dose of vax pt exp a high fever of 103 to 104. pt sought unspecified medical attention
This spontaneous report as received from a Pharmacist refers to a 37 year old female patient. The patient's concurrent conditions or medical history were not reported. On 23-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial, lot # reported as J006107 with expiration date 17-MAY-2015 (dose, route and anatomical location not reported). No adverse effect was reported. Additional information has been requested.
2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; 2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 at 12:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included: PROTONIX, ADVIL and unspecified MULTIVITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Administration location: left arm, Route of administration: intramuscular), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction" and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955 ; Administration location: left arm; Route of administration: intramuscular, administration date: 08Apr2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 12:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) both with onset 22Dec2021 at 05:00, outcome "recovered" (22Dec2021), and both described as "2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning". Therapeutic measures were taken as a result of axillary pain and lymphadenopathy.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for reported events included advil (patient reported to feel okay after approximately 3 hours after taking advil).
Patient reported feeling dizzy and numbness in the right arm. EMS was called , he was able to walk away with EMS out of the pharmacy / store.
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and referred to a patient with unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status of recombinant human albumin [rHA]) subcutaneous injection, frequency reported as 1 dose, lot #X009733, expiration date: 02-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional AEs were reported (No adverse event).  The storage temperature was 29 Fahrenheit with time frame of 4 hours 30 minutes. There was no previous temperature excursion.
Right upper thigh very painful red swollen and hot to touch - golf ball size.  Began two days after immunization.  Was given Keflex and Benadryl.
writer did not dilute the vaccine as needed for peds dosing, pt got twice the amount of vaccine recomended
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in your right upper arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in your right upper arm). At the time of the report, PAIN IN EXTREMITY (Pain in your right upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Spontaneous urticaria flare ups starting 1-2 months after 2nd dose.
12/03/2003 @ 11:53, presented to ER with throat swelling, neck pain for several hours; mild difficulty swelling, no dyspnea.  Rash-macular over cheeks, no hives.  Given per mouth Benadryl/Ibuprofen.  ? Reactions as 2 days later, but thought should be reported.
Admitted to ICU on 11/2/21 for worsening resp failure, COVID+. Currently requiring HFNC.
stuffy nose, sinus congestion, left ear feels full starting on 10/30/21
Injection site soreness; Injection site redness; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2X7, expiry date 29-JUL-2023) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix. On 30-MAR-2023, 2 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site soreness) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt date:30-MAR-2023. The public health nurse reported that a patient experienced injection site soreness and redness after the first dose of Shingrix was administered 28-MAR-2023. The symptoms started two days later.  The reporter did not consent to follow-up.
very sleepy for 6hr;approx 3hr 20min p/vax while sleeping on side mom noted funny breathing w/gray lips & very pale;also limpness & w/o good response to surroundings;911 called & then in 5-10min w/stable VS;pt examined in MD ofc 1hr later;
p/vax pt devel inj site rxn characterized by swelling, redness, pain & warmth which extended to wrist;pt considered this to be an allerg rxn;tx w/hydrocortisone cream & ATB;redness persisted;
Didn't receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure high.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose). On 11-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication not provided
Immediate swelling of injection site; appeared to be flushed; stated she "didn't feel right"; complained of some tightness in her throat; she is a pharmacist as well and we discussed NOT immediately administering an EPI PEN.  She requested the liquid Benadryl option I suggested.  I administered 25mg liquid Benadryl and within 5 minutes she was feeling better.  I kept her for observation for 45 minutes and continued to monitor her all day.  She felt "dizziness/drowsiness" which was attributed to the Benadryl.  No further complaints of allergic like reaction after Benadryl was administerd.