chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided. On 13-FEB-2019, the patient was administered 1 dose of RECOMBIVAX HB (lot # R006746 with expiration date 09-NOV-2020; strength, dose detail and route was not provided) and 1 dose of PEDIARIX (unknown manufacturer) (Inappropriate dose of vaccine administered) for prophylaxis. No adverse effects. The causality of the events was not provided.
Low grade fever lasted for 24 hours. Aching joints and chills. And a headache lasting for 24 hours.
Information has been received from a pharmacy student concerning a patient who during the week of 28-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The pharmacy student declined participation in the program.  No further information is available.
mouth seems to have swollen up, my lips, my tongue feels like sand paper. My mouth feels like I've been gurgling with gasoline. and it is painful to brush teeth.  Still have rash from the 1st shot on my shoulder. My lips are chapped.
Information had been received from a lawyer regarding a case in litigation. It was alleged in litigation that a female was administered two vaccines, PNEUMOVAX23 and AFLURIA on 15-APR-2013 at a pharmacy. The patient sustained severe side effects including shoulder, chest and headache. The pain radiated to her fingers and she was referred to a physiatrist. Information had been received from a claims representative of the pharmacy where the patient had been vaccinated. It was alleged that the patient was administered two vaccines in the same right arm, PNEUMOVAX23 and AFLURIA and sustained severe side effects such as: inflammation, severe pain in the shoulder, chest and headache. It was alleged that pain radiated to her fingers and she was referred to a physiatrist. Information had been received from a lawyer and claims service representative for a pharmacy regarding a 53 year old female non-smoker with asthma and diabetes. On 15-APR-2013, the patient visited a pharmacy to buy some medicine and was offered vaccination services. The patient was administered PNEUMOVAX23 (lot# H015749, expiration date 08-JUN-2014) and AFLURIA (lot# reported as 08149211A, expiration date 30-JUN-2013). Both were injected simultaneously on the right arm, intramuscularly. Both the lawyer and claims representative noted that this was an incorrect determination as they should not have been injected on the same arm. A previous interview was not completed either. As a consequence, the patient developed a strong discomfort on her right side, inflammation swelling on her arm, strong pain on her shoulder, chest and head, and pain that reached to the fingers of her right hand. Days after, her arm condition worsened as it turned red all over and also got swelled. The patient called the pharmacy on 17-APR-2013 and was attended by a pharmacist who indicated that the administration of both vaccines on the same arm was not an appropriate one. The pharmacist oriented the patient to go to her physician so that he could call the pharmacy and have the patient's diabetes drugs to be dispatched for free. On 18-APR-2013, the patient visited her physician who in turn called the pharmacy. The physician concluded that indeed, the patient should have not received both vaccines simultaneously on the same arm since among other things a proper determination of its reaction was not possible. Physician prescribed CIPRO 500mg and nabumetone 750mg. Physician recommended that the patient rest from 18-APR-2013 during which time the patient was absent from her job. On 22-APR-2013, physician reevaluated the patient who authorized her to return to work on 23-APR-2013 and to continue with her medications. Once back at her job, the patient started to feel discomfort when she tried to grab using her thumb, index and middle hand fingers, and this discomfort continued intermittently. On 01-JUN-2013, the patient was examined again by her physician and referred to a physiotherapist for evaluation. The diagnosis was "right radial nerve palsy". Upon internal review, right radial nerve palsy was considered to be medically significant. Additional information has been requested.
The reporter of this case also reported another event for this patient which is captured in 2014SA145945. Initial spontaneous information received on 17 November 2014 from a health care professional (physician). A male child, age of event not reported with a history of an allergic reaction to FLUZONE in 2013 at the age of 3 years, was vaccinated on an unknown date with IPV, DTAP and MMR, manufacturers, batch, route and site of administration were not reported. On an unreported date since 2013, the patient experienced an allergic reaction. The patient had an allergy skin prick test on an unreported date which was positive to MMRV, gelatin and +/- to neomycin. Laboratory tests and treatment details were not reported. No further details were available at the time of this report. The patient outcome is unknown. Documents held by sender: None.
Initially, I only had pain in my arm. The next morning, I had chills and a fever. After I ate, I started experiencing excruciating stomach pain every time  I ate. That lasted until 3/23, when it just suddenly stopped.
History of fainting with blood draws. RN helped pt to lie down on cot, pt C/O tunnel vision felt like going to pass out. Code Green called paramedics assessed BP132/88, HR 95, RR 18. Pt felt much better, kept in observation for an additional 30 minutes.
COVID Vaccine Breakthrough Case  J&J Dose 1 3/25/21   COVID Positive 11/16/2021  11/17/21: History is obtained from patient as well as by personal review of records.  Patient is a 77-year-old lady with remote history of stroke.  Presented to emergency department with history generalized weakness and difficulty in ambulation. She was so weak that she has to call EMS 3 times in last 2 days to get her out of chair. Patient denied focal motor weakness.  No focal sensory loss.  Denied double vision or other visual problems.  No difficulty with swallowing.  No difficulty with speech.  Reported being exposed to  SARS-CoV-2.  Reported having nonproductive cough.  She had pulse ox of 89% during evaluation in emergency department on room air.  Was kept on oxygen supplementation.  She had received  J & J SARS-CoV-2 vaccination in March 2021.  11/18/21: Patient is a 77-year-old female who was admitted on 11/17/2021 with COVID positivity, mild hypoxia, and urinary tract infection.  Patient also reported generalized weakness.  Patient was admitted to the medical floor was started on IV antibiotics.  She did not require any supple oxygen.  Today the patient reports she is feeling much better.  She is ambulating in the room independently on my exam.  She is requesting to go home.  We discussed the Agency safe at home program, and the patient was agreeable.  We also discussed home physical therapy, and the patient was agreeable to that as well.  The patient's urine culture showed 3+ organisms, and recommended recollect.  I have ordered the same, and we will obtain the before she goes home today.  Patient denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  She will be discharged home today.
Pt accidently received and extra dose of Moderna bivalent booster vaccine, within 2 weeks of receiving a Pfizer booster vaccine. Pt only developed fever at night of the vaccine and experienced fatigue and achiness the following morning. all symptoms were controllable by Tylenol extra strength according to pt.
first shot on Sept / 2020 /missed the second shot; This case was reported by a consumer via SHINGRIX interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to ask if he or she could still take the second shot after almost a year. The follow-up would not possible as no contact details were available.
Covid19 breakthrough.  1st vaccine received on 02/13/2021.  75 y/o PMH CAD, DM, Non-Hodgkins lymphoma on Rituxin, Rheumatoid arthritis.  Pt tested positive for Covid 1 week ago and was having high fevers at home.  Pt presented to the ED with c/o worsening SOB, Cough and diarrhea.  Room air sats 88%, placed on O2 at 4L NC, CXR suggests PNA.  Pt started on steroids and Baricitinib and already on hydroxychloroquine.
Patient came in on October 19 around 8:30 am and stated that since he got the vaccine in September 19, he cannot lift up his left arm when he got the Comirnaty 2023-24 SDV.  He was asked if it was swollen but his arm is not swelled up but he stated that it is internal.  Patient was consulted to go to his primary physician for follow up in regards to the adverse event to his left arm.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 16, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced persistent headaches and achiness, blood in her urine and aching around her kidneys on an unspecified date. She took Tylenol due to hurting so bad, feeling achy and having headaches. Therapeutic measures were taken as a result of persistent headaches and achiness. The patient underwent lab tests and procedures, which included rapid test for the virus: unknown result and urinalysis: unknown result. Physician office visit for the events; with outcome of unknown.
had routine blood drawn for a routine check-up , they couldn't get it in the arm that I had my shot in, tried different arm and they really had a hard time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: POOR VENOUS ACCESS (non-serious), outcome "unknown", described as "had routine blood drawn for a routine check-up , they couldn't get it in the arm that I had my shot in, tried different arm and they really had a hard time ". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264532 Same reporter, product, and event; different patient
stroke; so weak/so weak, which has never happened; did not feel safe/pretty bad state/felt bad every single day; shaky; arm was really really sore; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 038B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm was really really sore). On 24-Dec-2021, the patient experienced TREMOR (shaky). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), ASTHENIA (so weak/so weak, which has never happened) and FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day). The patient was hospitalized on 26-Dec-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), ASTHENIA (so weak/so weak, which has never happened), FEELING ABNORMAL (did not feel safe/pretty bad state/felt bad every single day), PAIN IN EXTREMITY (arm was really really sore) and TREMOR (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 507 (High) 507. On an unknown date, Blood iron: depleted (Low) depleted. On an unknown date, Blood magnesium: depleted (Low) depleted.         Concomitant medications were not reported. Treatment medications were not reported. Company Comment This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
off balance with nausea and vomiting that started 3 days post vaccination with Zostivax.   Symptoms resolved after 24 hours
Moderna Vaccine Covid -19. Pt had shortness of breath with tight feeling in throat. Pt was treated with IM Epinepherine 0.3mg, and 50mg Benadryl IV. Pt was transported to hospital for observation.
This a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation; and influenza vaccine, via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the co-administration with flu vaccine had shown to cause decreased immune response to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. They inquired what was the required spacing to avoid this. Outcome of the events was unknown. Information on the batch number has been requested.
tested negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (tested negative for antibodies) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (tested negative for antibodies). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (tested negative for antibodies) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Symptoms of lips feeling numb and wheezing in chest. Felt a little short of breath.
All symptoms started around the 11/27/2022 Coughing Runny nose Fever Headache Nausea Sore Throat Laryngitis  Doctor prescribed via email messages Azithromycin 250 MG tablets (quantity of 6) on 12/12/2022. From onset of symptoms, it has taken at least 5 weeks to get over most of the symptoms.
began within a month of second dose. skin feels different--rougher. little spots show up, turn red, with a bump or not, and then some scab, some don't, and then they heal and go away over 4-7 days. Most are the size of pencil eraser or a little larger.  Kind of spread when they heal.  They keep popping up.  I sometimes don't have any or don't notice, then 4-9 show up in various places within a few days of each other. Sometimes they itch but usually not. The doctor did not really do anything.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. It was stated that on  10-AUG-2015, the patient received the first dose of GARDASIL (does, route of administration, lot number and expiration date were not reported) and at the time of the report the patient would like to received a second dose of GARDASIL. No other suspect or concomitants therapies were reported. No adverse symptoms were reported. Additional information has been requested.
Severe leg cramps. Temporary paralysis of both legs. Intense pain in both legs and feet. Several episodes lasting approximately 10 minutes
The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.
couldn't move; was unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk) in an 80-year-old male patient 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 30-Aug-2021, the patient experienced MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk). At the time of the report, MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced "stuff like that" on 30-aug-2021  No Concomitant drugs were reported. No Treatment information  were reported.
~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min.  Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea.  Taste alterations resolved that day.  Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020.  Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath.  Symptoms peaked on day 8, then I woke up feeling great on day 9.    Minimal reaction to dose #2.
Raw throat and bronchial on morning of April 2. Felt pretty good on April 3. Night of April 3, woke up with temperature of 100, severe aches and starting to cough up phlegm. Have had fever til current date/time.  Now am coughing up yellow crud and mu lungs are starting to hurt. I don't see the lung stuff in the adverse effects and am concerned I should get tested for COVID.
The following day on 9/3/2021, I experienced a bloody nose for almost 3-4 hours. I was sitting at my home office desk when blood started heavily dripping from my right nostril.  I was not exerting myself and was well hydrated.  I have not had a bloody nose in more that 30+ years. The bleeding finally stopped after I put an ice pack on my nose.  The next day, 9/4/2021, in the morning around 8:30am, my nose stated to bleed again while I was sitting at my desk. The bleeding was not as heavy and stopped within the hour.  Secondly, my right thumb and index finger involuntary started to twitch and pulsate when I was at a resting state. It was very visually noticeable when I was watching tv and trying to get to sleep. It started on 6 days after my shot and lasted for 4 additional days.
This case was reported by a nurse via call center representative and described the occurrence of ERYTHEMA in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, 2 days after receiving DTaP vaccine, the patient experienced ERYTHEMA, inflammation and pain to be related to DTaP vaccine. Additional details were provided as follows: This was all the information the reporter had on this event.
redness of eyes; redness of body and my hand; Stiffness of neck; flushing; Tingling; chills; Thickening of skin; feeling hot; Numbness in hand; Pain; Rashes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), OCULAR HYPERAEMIA (redness of eyes), ERYTHEMA (redness of body and my hand), HYPOAESTHESIA (Numbness in hand) and MUSCULOSKELETAL STIFFNESS (Stiffness of neck) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chemical sensitivity (Allergic to Quinines.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Pain) and RASH (Rashes). On 23-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in hand), SKIN HYPERTROPHY (Thickening of skin), FEELING HOT (feeling hot) and CHILLS (chills). On an unknown date, the patient experienced OCULAR HYPERAEMIA (redness of eyes), ERYTHEMA (redness of body and my hand), MUSCULOSKELETAL STIFFNESS (Stiffness of neck), FLUSHING (flushing) and PARAESTHESIA (Tingling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN (Pain) and RASH (Rashes) had resolved and OCULAR HYPERAEMIA (redness of eyes), ERYTHEMA (redness of body and my hand), HYPOAESTHESIA (Numbness in hand), MUSCULOSKELETAL STIFFNESS (Stiffness of neck), SKIN HYPERTROPHY (Thickening of skin), FEELING HOT (feeling hot), FLUSHING (flushing), PARAESTHESIA (Tingling) and CHILLS (chills) 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 information on concomitant medications reported. The patient reported "medicines" used for pain and rashes following first dose as a corrective treatment   This case was linked to MOD-2021-241151 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up appended. patient demographics added. Allergy to Quinines added. Events: Red/itchy eyes, chills, prickling/tingling sensation,Numbness,feeling hot, flushing. Added. Events outcome is unknown. Benadryl was added as treatment for rashes