chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing near-constant muscle pain throughout the body to varying degrees. There are days when it is debilitating, and days when it is manageable. This includes forearms, biceps, hips and thighs and does not include any joint pain; This includes forearms, biceps, hips and thighs and does not include any joint pain, it is specifically limited to muscles and tendons.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 17:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indication from unknown start date and unknown if ongoing. The patient had no known allergies to medications, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266) via an unspecified route of administration in the left arm on 22Feb2021 at 13:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, after receiving second shot, the patient experienced near-constant muscle pain throughout his body to varying degrees. There were days when it was debilitating, and days when it was manageable. This included forearms, biceps, hips, thighs and did not include any joint pain. It seemed specifically limited to muscles and tendons. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 21Mar2021, the patient underwent SARS-COV-2 RNA, QL, RT PCR and the result was Negative. On 22Mar2021, the patient underwent (Nasal swab) Rapid Test and the result was Negative. On 12Apr2021, the patient underwent (Nasal swab) SARS-COV-2 RNA, QL, RT PCR and the result was Negative. The clinical outcome of the events constant muscle pain throughout the body, tendon pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
arm became very red, warm, sore, itchy, stared about four hours after shot and was still sore six days later. Also had a fever of 100.9 at night for 3 nights ands was tired and felt achy, have never had a vaccine do this before and not sure I want the second one.
No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified) and meningococcal acyw conj vaccine (carrier unspecified).  On 10-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012355: US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Mother reports next day, pt had red, swollen area at left arm injection site about 30mm, warm to touch. Child playing, active, acting normal self, no other rash seen or any respiratory symptoms. Mother instructed to take child to see physician and call back. No call back.
At 9:40 started to feel like my heart was racing, a weight on my chest, pain in my left chest area. Called nurse when I got to work, and they recommended going to ER. Was light headed when walking, slight headache, and chest pain moved between left chest, left arm, middle of chest.
The night of getting booster shot, I did not sleep well. I noticed my ears were ringing or buzzing constantly. I started to not feel well. The next day and night 1/5/2022, I had the usual tired/achy/chills as with previous Moderna vaccine shots. Ringing/buzzing in my ears persisted. 1/6/2022 the ringing/buzzing continued but other symptoms improved. The ringing/buzzing continued or persisted and has not gone away. It is there 24/7.
Information has been received from a 27 year old female with an allergic reaction to antibiotics who on 13-MAR-2007 was vaccinated with a first dose of GARDASIL.  On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL.  There was no concomitant medication.  It was reported that the patient had three shots of GARDASIL and experienced a seizure disorder during sleep on 27-OCT-2007, 10-NOV-2007, 01-JAN-2008, 31-JAN-2008, 23-FEB-2008 and 03-APR-2008.  Unspecified medical attention was sought.  The patient had a computed axial tomography, diagnostic laboratory tests, electroencephalography and a magnetic resonance imaging performed.  The results were unknown.  At the time of reporting the patient had not recovered.  Upon internal review the event seizure disorder was considered to be an other medical event.  No additional information is available.
Narrative:  Patient was administered a 0.25 mL dose on 10/28/22 when the patient told the RN that she was immunocompromised. The nurse and nursing manager was advised to have the patient come back and administer a 0.5 mL dose, per the CDC recommendations on incorrect vaccine doses. The patient came back in to the clinic on 11/3/22 and the patient was again administered a 0.25 mL dose, instead of the 0.5 mL dose which should have been given. The nursing staff and nurse manager were made aware of this by pharmacy. The CDC does not have recommendations about what to do if the incorrect half dose is administered twice. Due to the patient being immunocompromised from chronic oral corticosteroid use pharmacy recommended the patient coming back for a full 0.5 mL dose. We also told the nursing staff at the clinic that the provider and the patient will need to have a discussion about whether they will want to repeat a bivalent booster dose.
Patient in hospice; A spontaneous report was received from a consumer concerning a male patient of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, patient in hospice.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, patient in hospice.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, patient in hospice was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
pt recv vax OCT95 & a titer was drawn, & it indicated that the pt failed to seroconvert;In APR95 pt recv booster dose of varicella vax;
herpes outbreak; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0169) via an unspecified route of administration, administered in right arm on 08Jul2021 between 1-2pm (age at vaccination: 21-Year-old) as DOSE 1, SINGLE for Covid-19 immunization from Vaccination Clinic through the hospital. Medical history included herpes simplex from an unknown date and unknown if ongoing (when she was younger, she had herpes simplex virus. She has not had an outbreak since she was 15 or 16). There were no concomitant medications. Patient had no adverse event following prior vaccinations. She had received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 17Aug2021 (Lot Number: FC3181) as Dose 2, Single for Covid-19 immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On unspecific date in Jul2021, after first dose the patient experienced herpes outbreak. On an unspecific date the patient underwent lab tests and procedures which included herpes simplex test: positive for herpes via vaginal swab. The event resulted in Physician office visit not in emergency. Therapeutic measures were taken as a result of herpes outbreak. The outcome of the event was resolved on an unspecified date in Aug2021.  Follow-up attempts are completed. No further information is expected.
7/2/22 pt taken to hospital with worsening SOB, poor appetite, hypotension, hypoxia (87% O2 saturation on RA); placed on O2 supplementation; CTA chest showed bilateral multifocal pneumonia; positive COVID test; transferred to different hospital and admitted; given Decadron, Remdesivir, ABX; O2 requirement increased requiring NRB; placed in CCU; respiratory distress despite 100% BiPAP; intubated; mechanically ventilated; pt's condition continued to decline and he passed away in the hospital
Headache everyday for a month after the vaccine.  Took Tylenol for pain.  Pain at base of skull.  Would hurt, at times so bad felt like I was going to vomit, but didn't.  Then it would go away for a while then return.  Was like this on and off everyday for a month.
REDNESS,SWELLING,WARMTH,PAIN WITH MILD ITCH AT THE INJECTION SITE ON THE LEFT UPPER ARM (LATERAL)SINCE 09:00PM ON 08/16/07. BODY TEMP WAS 100.0F(A) AT 09:00PM, WHICH RESOLVED BY ONE DOSE OF TYLENOL(160MG/5ML)1TSP. Possible cellulitis vs. vaccine reaction. Treatment: Augmentin
Patient reported that she had very little reaction initially from the vaccine. She said that about 3-5 days after she received it, the injection site became very itch. The injection site swelled in an area that was about the size of a golf ball and became hard around the site of injection.  It also became red and developed a rash that covered a larger area. It has now been 10 days since injection and she is first reporting these symptoms now. She says it has gotten a little better, but she is still experiencing symptoms.
Weakness in my legs, hard breathing, bad digestion, sleepless, constipating, anxiety, depression, swollen stomach especially by my right side where the liver and gallbladder is located. Want to let you know that in 2001, 2002 years I did not have any side effects. I don't know why I have side effects with this flu shot.
Hives on legs noted 5 hours after flu vaccination; resolved spontaneously after 1 hour.
high fever 102.6 for 24 hours , severe body aches 24 hours  , long lasting Tinnitus ever since my fever broke
She missed to take her fourth dose of Vivotif which was due on yesterday; Spontaneous report received on 22DEC2020.  A female consumer reported that "she missed to take her fourth dose of Vivotif which was due on yesterday" (PT: Product dose omission issue). She was receiving Vivotif for immunisation. It was reported that the consumer had taken the first three doses of Vivotif as per the schedule but missed to take the fourth dose of Vivotif which was due on 21DEC2020. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.
Case number PHEH2013US019472 is an initial spontaneous report received from a nurse on 13 Sep 2013. This report refers to an adult (in between 20-29 years) male patient. He received only MenCYW liquid conjugate component of MENVEO (batch number: M12024) intramuscularly, without being reconstituted with MenA on 12 Sep 2013. No adverse event was reported following medication error.
Onset of rash 5/20/13. Seen that day - a few papules on face and chest. Seen again 5/22/- many more papules/vesicles in different stages. Pink papules, vesicles on erythematous base, some crusted.
Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination. Also, fatigue, the day after the vaccine. The injection site pain decreased but still ong; Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination. Also, fatigue, the day after the vaccine. The injection site pain decreased but still ong; Injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ew0178), via an unspecified route of administration, in right arm on 15Jun2021 (age at vaccination: 58 years) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known drug allergies. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient was now not diagnosed with COVID-19. On 16Jun2021, the patient experienced injection site pain radiating into the entire deltoid area of the right arm started the day after vaccination and fatigue, the day after the vaccine. The injection site pain decreased but still ongoing. Since the vaccination, the patient was not tested for COVID-19. No treatment received for reported adverse events. The outcome of event fatigue was reported as resolved on an unknown date in 2021 and for other events were reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Patient presented to local hospital on 09/04/2021 with c/o SOB and weakness; with a PMH significant for Leukemia, CAD, Type 2 DM, HTN, HLD. Patient was diagnosed with COVID one week prior to hospitalization. Also c/o fevers, diarrhea, nausea, and decreased oral intake, SOB with nonproductive cough. In the ED patient was placed on oxygen and given IV fluids. CXR showed patchy bilateral infiltrate's. EKG showed sinus rhythm without acute ischemic changes.  Patient also received Decadron in ED. Patient was admitted to hospital. Patient was intubated on 09/12/2021 and expired on 09/18/2021.
Confirmed clinical vaccination failure; Confirmed COVID-19 Infection; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: grass allergy, alcoholic, smoker, and gout. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 at 14:00 for prophylactic vaccination. Concomitant medications included allopurinol for gout.  On 11-APR-2021, the patient experienced body aches, fatigue, headache, joint aches and low grade fever (dose number in series 1). On 2021, treatment medications included: ibuprofen, and paracetamol for joint aches. The patient recovered from body aches, joint aches, low grade fever, headache, and fatigue on 11-APR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: unknown) dose was not reported, 1 total, administered on OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects which includes headache, sore throat, fatigue, post nasal drip, nasal congestion and cough (confirmed clinical vaccination failure, and confirmed covid-19 infection) (dose number in series 2). Patient did not experienced fever, shortness of breath and loss of taste/or smell. On 22-JAN-2022, the patient underwent Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213856. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed. This case, involving the same patient is linked to 20210832866.; Sender's Comments: V0- 20220145974 -Covid-19 vaccine ad26.CoV-2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt received dose on or at 1035 am.  At 10:40 he stated he felt hot and dizzy.  He proceeded to pass out and slide out of chair to floor for a couple of minutes. He was easily aroused. He was AAOx4. Voiced no pain or difficulty breathing. VS within normal limits. EMS contacted as precautionary measures. He was assessed and released by EMS to go home at 1110 am.
No additional AE; Medical assistant reported that a patient received additional VARIVAX.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was properly vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (MMR II) (strength, dose, route of administration, lot # and expired date were not provided) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) (strength, dose, route of administration, lot # and expired date were not provided); however on 26-APR-2022, the patient received another dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (Extra dose administered) (valid lot #U026207, expiration date: 24-AUG-2023) for prophylaxis (strength and route of administration were not provided) which was reconstituted with a sterile diluent (valid lot #T015779, expiration date: 02-DEC-2022). No additional adverse events were reported, no further information was provided.
Persistent hives all over body with significant redness, itching and  discomfort particularly at joint sites secondary to swellinG; mild to moderate pain over hive sites
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of RECOMBIVAX HB (lot 007558 with expiration 1o-NOV-2016; lot#/batch# was reported as L010896 with expiration 12-NOV-2016;  dose, frequency and route were not reported) which has been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Rash, lips swelling, increase cough EpiPen X2, Benadryl PO, Albuterol neb.
Strong headache, fever, chills, body aches, vomiting, diarrhea, dizziness, tiredness
It bled a little, right away I felt jittery. Later that night I got chills, and I had to change my shirt twice because I was drenched in sweat.  The morning I had a head ache and just felt achy, my arm was very painful. I was able to sit down and run some errands. I was feeling sick like when you have flu. The 26th I felt the same, the 27th I felt the same and my arm was hurting and the injections site was red and very big. On the 28th I decided to go to the Urgent Care. The Dr told me I had an infection on my arm, he gave me an antibiotic shot for the infection and another shot for the pain. I continued taking antibiotics and Benadryl and was feeling much better by Wednesday and my arm swelling went away. I had Covid in October and Urgent care saved my life, I love going there.
unknown number of patients received improperly stored VARIVAX on unspcified date; No additional adverse effect reported; This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S036636, expiration date 14-NOV-2021 (dose and route of administration were not provided) for prophylaxis. Administered doses of the suspect vaccine experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (7.97F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. Varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No additional adverse effects reported.  This is a non-valid report due to the lack of the patients identifiers.
74 years-old female with pmhx significant for ESRD on HD, COPD, HTN, HLD, OSA (BiPAP at home) presents 07/06/21 to after completing full HD treatment with worsening SOB/fatigue x 4 days, family members at home tested positive for COVID, she states they have been isolating at home. Required 3-4L of O2 on presentation. Patient received a 5 day course of Remdesivir and 10 day course of Decadron.