chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has her 2nd dose appointment on 05March2021, it would be 45 days after the 1st shot) outcome was unknown.            This case was linked to MOD-2021-027923, MOD-2021-041951 (Patient Link).   Reporter did not allow further contact
Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN620U), dose 1 via an unspecified route of administration, in left arm on 04Mar2021 11:30 (at the age of 78-year-old) as 1st dose, single dose for covid-19 immunisation. Facility type reported hospital. Medical history included breast cancer. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies reported to dairy, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), monascus purpureus (RED YEAST RICE), probiotics, vitamin D [vitamin D nos]. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04Mar2021 at 15:00, the patient experienced tingling in arms and legs, red, swollen ear lobe and rosacea. The patient received treatment of benadryl for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Rash on back(Erythematous); Swelling on Injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back(Erythematous)) and VACCINATION SITE SWELLING (Swelling on Injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling on Injection site). On an unknown date, the patient experienced RASH (Rash on back(Erythematous)). At the time of the report, RASH (Rash on back(Erythematous)) and VACCINATION SITE SWELLING (Swelling on Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had tenderness under left armpit/neck and right arm (not so much); middle ear infection; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; lymph nodes swelled under left arm and throat/neck; This is a spontaneous report from a contactable consumer. A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 2, single for covid-19 immunisation. The patient medical history includes included seasonal allergy, lactose intolerance, autoimmune thyroiditis, thyroid cancer, colitis ulcerative, menopause, sinusitis from an unknown date and unknown if ongoing and lymphadenectomy from 2005 to an unknown date and 3 main lymph nodes in neck removed in 2005. Concomitant medication included levothyroxine sodium (TIROSINT), liothyronine sodium (CYTOMEL), mesalamine (MESALAMINE), estradiol (ESTROGEN) taken within two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 1, single for covid-19 immunisation. The patient has not taken any other vaccine in four weeks. The patient stated that 3 days after my 2nd dose my lymph nodes swelled under left arm and throat/neck on 14Feb2021 and Had tenderness under left armpit/neck and right arm (not so much), developed middle ear infection with left ear swollen shut/pain ear and minor swelling on neck/face on 11Mar2021 (02:00). Treatment received with 4 drops 2X day for 7 days of Ciprodex. Ae resulted in Emergency room visit and patient had 3 main lymph nodes in neck removed in 2005 due to thyroid cancer. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and has been tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test and the result was negative on 04Mar2021. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Labial herpes; Ocular headache; A spontaneous report was received from consumer on 16NOV2020.  The consumer (unknown gender and age) experienced labial herpes (PT: Oral herpes) and ocular headache (PT: Headache) while being on therapy with Vivotif for immunisation. The consumer asked "is it possible that in the days following taking the three doses I experienced a labial herpes and an ocular headache?". Action taken with Vivotif with respect to the reported events was unknown. The outcome of reported events was unknown.  Company Comment: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.; Sender's Comments: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.
Temp of 101.2, crying out in agitation / discomfort. treated with PRN Tylenol.
Swelling in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swelling in the armpit). At the time of the report, LYMPHADENOPATHY (Swelling in the armpit) had not resolved.     No concomitant medications were reported.  Treatment details was not provided.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.
Patient is not having any adverse reactions, but he did receive 2 Fluad vaccines. The first one was administered on September 27th and then the second one on October 10th. We are reporting to make y'all aware. If there are any adverse events, we will update or resubmit. Thanks
when inj was administered the connection between the syringe and needle was not secure. A few drops of the vaccine leaked from the connection. Only a partial dose was administered. When attempting to remove the needle, the syringe came completely off Narrative: when inj was administered the connection between the syringe and needle was not secure. A few drops of the vaccine leaked from the connection. Only a partial dose was administered. When attempting to remove the needle, the syringe came completely off the needle. The needle had to be separately removed from the arm.
Was having a normal healthy pregnancy and my water broke 5 days after having the seasonal flu shot and H1N1 shot and had my baby 3 months early at 25 weeks and 5 days. 12/08/09 Hospital records received for DOS: 10/30/09-11/03/09 G1 P0 presented with premature rupture of membranes at 25 weeks gestation; c/o crampiness, clear fluid leakage; cervical dilation 12/09/09 Antepartum records received for DOS 08/21/09-10/19/09
Post vax 1st Anthrax, at 15:30, about 01:00, the pt woke up with chills and shaking. Approximately around 02:00 he had vomiting until he had the dry heaves and had diarrhea until around 04:30.
have a ball between under their armpit and their chest on the left side; felt hot; spent most of the time asleep; like having the flu; headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN MASS (have a ball between under their armpit and their chest on the left side), FEELING HOT (felt hot), SOMNOLENCE (spent most of the time asleep), INFLUENZA (like having the flu) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.
When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
I felt okay after the shot but the next morning, while walking my dog, I had a severe dizzy spell. It felt like my blood pressure plummeted and I saw stars and even felt I was walking unevenly for a few steps. It happened one more time while I made my way home where I had my husband take my blood pressure (it was 88/60 as I recall, low even for me) I laid down a few minutes and felt fine and decided to go on with my day. For a few hours nothing happened. Just after noon I started to get a headache. By 3:30 it was so severe I had to lie down. I was nauseous and a little bit dizzy (but nothing like in the morning). Other friends who'd been vaccinated with Moderna reported an "ice pick headache" so I didn't think anything of it. I eventually took some caffeine and when the nausea was really bad I went out in the sun to see what that would do. By dinner time I felt halfway decent again. I had a slight headache on and off for about four days. I didn't think anything of it, just assumed it was a natural side effect.
No adverse event; 7 doses of Moderna monovalent vaccine administered after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry).    It was unknown if the patient received any other vaccines 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  The vaccine had been frozen with no known temperature excursion before being thawed today for administration. The vial was initially stored in the refrigerator on 27-Feb-2023.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-710742, US-MODERNATX, INC.-MOD-2023-713027 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-710742:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter
Patient was given the incorrect vaccine. She received her first dose of Moderna on June 19 and her second dose of Pfizer on August 25.
Flush feeling, Shaking/Tingling hands/arm/back , Dizziness, Dry mouth
pt had URI sx & T100.5;had well baby visit on that day & did not appear ill;immun given & approx 8hr later had staring spell w/lack of responsiveness for about 3min;spell ended abruptly & pt cried;
Complains of constant itching all over his body.  States has small "bumps" all over his back. (sample/ biopsy taken and results note ectopic dermatitis)
heart attack; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 27-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a heart attack. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of heart attack was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of heart attack to be disability.  Upon internal review, the event of heart attack was determined to be medically significant.
At 0835 client received the modern vaccine.  0842 client complained of feeling lightheaded.  Client was pale.  Client was placed in wheelchair and taken to post-vac area for vitals and observation.  Father with client at time of incident.  0844 client was placed in position with feet up in the wheelchair.  Client had verbalized during receiving any vaccine she usually has the same episodes and usually brings chocolate chips to eat to prevent this.   0853 BP: 90/60 P: 73 Sp02:99 RA.  0858 pt moved from floor to sitting position.  pt denied any dizziness upon ambulation. BP:92/62 P: 65 Sp02 100% RA.  pt denied any further issues A&O x4.  Symptoms resolved approx 16 min after initial episode.  Father will be driving patient home.  No further treatment needed, pt left 09:15.
fever; didn't feel well; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and did not feel well on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complete numbness of vaccinated arm; Coughing; Vomiting; Headache; Muscle pain/Muscle soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 20Aug2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received halperidol (MANUFACTURER UNKNOW) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 27Jul2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 20Aug2021, the patient experienced complete numbness of vaccinated arm, coughing, vomiting, headache, muscle soreness and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events complete numbness of vaccinated arm, coughing, vomiting, headache, muscle soreness and muscle pain were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The HCP stated that 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.   On 01 Apr 2022, the vial was initially stored in the refrigerator and thawed on the day of use. The administration was spread out throughout the end of March to the beginning of April.  The vial did not undergo any temperature excursions.  Treatment information was not provided.