chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Pharmacist reports the administration of an expired dose of PNEUMOVAX 23 [ Lot: U010533; Exp:10/29/2022] to a patient on 03NOV2022.; This non-valid spontaneous report was received from a pharmacist, referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-NOV-2022, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U010533, expiration date reported and validated as 29-OCT-2022) as prophylaxis (expired product administered). No additional adverse event reported (no adverse event). Caller confirmed vaccine was not involved in a temperature excursion and was stored in the recommended storage range until administration.  This case was considered non-valid due to the lack of patient's identifiers.  Follow up information has been received from the pharmacist on 01-DEC-2022. The patient was a female. This follow up made the case valid due to providing patient's identifier.
VACCINES ABOUT 2:30PM. BABY STARTED CRYING "NON-STOP" ABOUT 3PM - NOT NORMAL CRYING. VOMITED A FEEDING AT ABOUT 6:45PM, STILL CRYING. MOM PHONES DOCTOR AND ADVISED TO HAVE BABY EVALUATED IN E.D. TONIGHT. CRIED TOTAL 4-5 HOURS WAS FINE WHEN E.D. PHYSICIAN SAW HER.  1 5YR OLD BROTHER, NEVER ANY PROBLEMS W/ VACCINE.
Rec'd vax on 13MAR91 as per mom child was irritable 24 hrs later & began developing redness & a lump @ inject site; Came in on 18MAR91 had a red hard lump 4 1/2 x 2 1/2cm
Information has been received from a physician concerning a patient who was vaccinated with the rubella virus vaccine live (second generation). The physician reported that the patient's mother reported that the patient's had a "bad experience with the rubella vaccine". The outcome of the patient's "bad experience" was unknown. Additional information has been requested.
Patient received his flu shot (FLUARIX QUAD) on 9/27/18 as normal and said he felt worse this year than usual. He said he usually feels "kind of yucky for a couple days but nothing too bad." This time the patient said he had a lot of fatigue with it, starting while he was still in the store the day of the injection and it lasted for a good week. He also said he experienced a headache with eye pressure and a few days later it moved to a headache in the back of his head and down to his neck. He reported this to me this afternoon (10/7/18) and he just wanted it on his record that he had an adverse event and he was also going to notify his PCP so it would be in his record there as well. He was feeling better. He said he would still get one next year because it would be a lot worse with his medical conditions for him to get the flu than what he experienced. He just wanted us to know and have it on his profile.
Arm was warm, didn't redden until later and continued to spread over about 4 days until I went to Urgent Care. Antibiotics-which was taken off by the doctor at urgent care, high dose advil, benadryl, ice pack.There is very little information out there on NOMID and the PNEUMOVAX vaccine and apparently my provider missed it.
Sore arm at injection site, Muscle aches, Diarhea, Headache. No treatment.
social problem; blisters; round circle on her back; circle got bigger and painful; circle got bigger and bigger and it was itchy and painful; shingles; nausea; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in mid January 2020 and had no problems).   On 27th June 2020, the patient received the 2nd dose of Shingrix. On 27th June 2020, 6 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced nausea, headache and fever. On 7th July 2020, the patient experienced shingles, rash, pain and pruritus. On 16th July 2020, the patient experienced blister. On an unknown date, the patient experienced social problem. The patient was treated with valaciclovir hydrochloride (Valtrex). On 28th June 2020, the outcome of the nausea, headache and fever were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, blister and social problem were unknown and the outcome of the rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus and blister to be related to Shingrix. The reporter considered the nausea, headache, fever, rash and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix around noon and by 6:00, she had a fever of 102 degrees, a headache and was nauseous.   19 days after the patient had blistered. By the time she woke the morning and all symptoms had resolved.   The patient noticed a round circle on her back and sent a picture to her doctor who advised her to keep an eye on it and report if anything further developed.   The circle got bigger and bigger and it was itchy and painful.   The patient again sent a picture to her doctor who said it was shingles and prescribed Valtrex.   She took her 1st dose of Valtrex at 5:00pm and the area was blistered and did not hurt. The reporter consented to follow up.
5 days after 1st Covid-19 vaccine given he noticed that he had an enlarged right Pre-Auricular & Right neck lymph nodes that were not present prior to 1st Covid-19 vaccine.
Patient started to complain about hives and itching on torso and chest area after approximately 30 minutes post immunization.
pt recvd vax; c/o numbness in lt arm; onset 1 1/2 hrs p/ inject;also c/o dizziness, associated w/ numbness; referred to clinic for f/u;
Patient felt tired; Patient developed a cold sore; Fever of 99.0 degrees Farenheight; Patients received the 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (Patient developed a cold sore), PYREXIA (Fever of 99.0 degrees Farenheight), FATIGUE (Patient felt tired) and ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Cold sores.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose). On 20-Nov-2021, the patient experienced PYREXIA (Fever of 99.0 degrees Farenheight). On 21-Nov-2021, the patient experienced ORAL HERPES (Patient developed a cold sore). On an unknown date, the patient experienced FATIGUE (Patient felt tired). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Patients received the 0.5ml dose) had resolved. At the time of the report, ORAL HERPES (Patient developed a cold sore), PYREXIA (Fever of 99.0 degrees Farenheight) and FATIGUE (Patient felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-403029 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Secondary reporter Information was added.
Woke up day after 2nd vaccine with severe front spinning head over heels feeling and still experiencing this every morning when I wake up 6 months later
Low grade temp, swelling @ injection site within 2 hours.  Temp & swelling resolved but, persistent pain & tenderness @ site of infection with decreased ROM.
Extreme Fatigue Disoriented  Imbalanced Memory Loss Inability to  perform daily tasks
Left upper arm cellulitis, RX with KEFLEX 500 mg tid X 10 days.
11/09/12 c/o tenderness (L) upper arm after flu vaccine injection on 11/07/12. Red, mild swelling, warm area of mid lateral outer arm. MOTRIN 400mg PO Q4 hours PRN moderate pain. Seen by APRN.
Patient states she experienced DELAYED swelling of eyes, DELAYED difficulty breathing, along with runny nose/eyes, congestion, pain in arm,  fever, and headache.
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time.  Face returned to normal in 90 minutes. Scalp in 2  1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
shaking that She thought of like having seizure; feverish feeling; troubled sleeping; joint pain; achy feeling; tiredness; only had one experience; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (troubled sleeping), TREMOR (shaking that She thought of like having seizure), VACCINATION COMPLICATION (only had one experience), ARTHRALGIA (joint pain) and MYALGIA (achy feeling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, SPIRONOLACTONE, LOSARTAN, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION COMPLICATION (only had one experience). On 18-Mar-2021, the patient experienced FATIGUE (tiredness). On 20-Mar-2021, the patient experienced INSOMNIA (troubled sleeping), ARTHRALGIA (joint pain) and MYALGIA (achy feeling). On 21-Mar-2021, the patient experienced TREMOR (shaking that She thought of like having seizure) and PYREXIA (feverish feeling). On 20-Mar-2021, FATIGUE (tiredness) had resolved. On 21-Mar-2021, TREMOR (shaking that She thought of like having seizure) had resolved. On 22-Mar-2021, INSOMNIA (troubled sleeping), VACCINATION COMPLICATION (only had one experience), ARTHRALGIA (joint pain), MYALGIA (achy feeling) and PYREXIA (feverish feeling) had resolved.            The patient was advised by primary care doctor to report these events as the side effects that occurred several days after the injection. The patient has not experienced any more side effects since the first experience. The patient consented to healthcare provider followup.  No treatment information was provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow-up- Event added, first dose information was added, updated start and stop dates of events, and changed the primary regimen of the vaccine.
Pt recvd Hep B vax 7MAY91 & immediately following the 1st dose, pt exp massive fatigue, vomiting, achiness, t101, could not sleep; tx not administered; vomiting & fever persisted x 3 days;
11/9/04: 2am awoke with fever of 101.7 ax and crying: fevers off and on all day. Temp increased to 104.9 at 3:30pm on 11/9: saw doctor within one hours. Home with antipyretic instructions. No other meds.
Pt recd vax 4NOV92 & w/in 24 hrs following vax devel a high fever up to 103; w/in 3 hrs of vax pt devel flushing, tachypneia & was sl listless;
I have been on depo for decades and have not had a menstral cycle. I am current up to date on depo shot and the sat after the inj done on tues, I started cramping and had what I am assuming to be a period. lasting only 3 days and subsided
patient wasn't feeling well; Feet were swelling every day; Feet and Legs feel hot; Skin on her legs is weird, somewhat like a burn; Feet turned very red, like on fire red/redness spread to both of her legs; Toes turned purple on the back side; Dizzy for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet were swelling every day), ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs), SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced DIZZINESS (Dizzy for a couple days). On 29-May-2021, the patient experienced ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) and SKIN DISCOLOURATION (Toes turned purple on the back side). In June 2021, the patient experienced PERIPHERAL SWELLING (Feet were swelling every day), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn). On an unknown date, the patient experienced MALAISE (patient wasn't feeling well). The patient was treated with PREDNISONE for Adverse event, at a dose of 20 mg once a day; PREDNISONE ongoing since an unknown date for Adverse event, at a dose of 20 mg once a day and PREDNISONE for Adverse event, at a dose of 20 mg once a day. In June 2021, DIZZINESS (Dizzy for a couple days) had resolved. In July 2021, PERIPHERAL SWELLING (Feet were swelling every day) had resolved. At the time of the report, ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) had resolved and SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot), SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) and MALAISE (patient wasn't feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything came out fine.         No concomitant medications were given by the reporter.  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.; Sender'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.
headache leading to severe migraine extremely elevated BP for patient up to 200/100 resolved with extra dose of BP meds patient is on after a couple of hours
Vaccine was stored improperly upon arrival to facility. Patient has had no adverse symptoms due to receiving the vaccine.
The first dose  I was sick for 4 days. I immediately felt dizzy, tingly lips and lightheaded. I began to run a fever that day and had a headache for a week after. My 2nd dose was 45 days after the first.  I experienced tingly lips, some arm pain. Later the Sam?s day I began to feel extremely tired. The next day I woke up feeling sore all over and a few hours later had a fever and horrible headache. My headache has not subsided, although it?s not as painful I still feel sore and achy on the right back lower part of my head.  Today, 5/30/21 I have been experiencing pain along my shoulders, back of neck and the back of my head. It?s been 15 days since my 2nd vaccine.
Swollen, sharp pains in right tonsil. Pain is intermittent, tends to come and go within hours, and started one day after administering Dose 2 of the COVID vaccine and still persists. White spots were also seen above both tonsils. No medical treatment was sought, since I could still go about daily life normally.
NOT HIMSELF; FEELING TIRED; .This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced not himself, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired and not himself was not reported. This report was non-serious.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5mlSD-PFS LLokw Tip) (lot # L019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 576 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional information received as follows: The age at vaccination was not reported. The reporter would like to report an adverse reaction to meningitis vaccine MCV4. The reporter asked if he or she could report it through email or need to call. The reporter was asking for the contact number.
She got a shot in the morning yesterday and she said she went to work out. All evening, her hips and waist area hurt. I asked her if it was more of muscle or bone. She said she couldn't tell. Today, she feels 100% BETTER.
About 40 minutes after vaccination, pt experienced some chest cramping on over the right breast that radiated upward.  There were 4 cramps that stopped when she got home.  She was experiencing some dizziness as well.  Pt was going to drink water and daughter will monitor symptoms.  Pt is elderly and walks with a walker. It is possible she strained while getting out of the car or moving around. The chest cramps subsided.
Low fever of 100 starting 5 hours after dose. Fever resolved once aleve and later tylenol were taken at 11 and 14 hours after dose, respectively. Fatigue and muscle pain still present as of writing, 27.5 hours after dose.
37 week Intrauterine fetal demise diagnosed on 9/22/21. Patient had first dose 8/16/21 followed by mild COVID disease two weeks later. Then second dose 9/7/21. Her pregnancy was also complicated by morbid obesity and gestational diabetes
Blurred vision began 4 hours after vaccination, lasted throughout evening.  Incident gone as of March 26 AM.
Swelling at the injection site; Redness at the injection site; Pain at the injection site; area is oval in shape and tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site pain and tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain, redness, and swelling at the injection site. The patient also stated that the area was oval in shape and tender to the touch, it was not resolving. The patient was inquiring about treatment recommendations. The reporter was provided medical advice disclaimer. Spoke from Shingrix frequent asked questions (FAQs). The reporter was referred to HCP.  No additional details were provided. The patient provided permission to contact HCP. The reporter consented to follow-up.
pt recv vax 10APR96 & about 1 1/2 min p/vax pt exp tenderness in arm like got hit by an elephant;could not sleep or rt arm;felt very tired & exp malaise;no migraine was noted;no dx work-up was conducted;
pt recv vax 22AUG96 & 10SEP96 pt exp a rash w/an eruption of 36hr duration;pt recovered from sx & exp no further problems;
Stated left arm became very sore for several weeks after administration and still is sore at this time. Did not complain of redness, just pain.  Pt already has limited use of arm, and did not notice any additional loss of mobility in arm. I recommended she talk to her physician.
giving the shot in the bone, and not in the muscle (too high); This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) in a female patient of an unknown age 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 an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving the shot in the bone, and not in the muscle (too high)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
My arm got red and swollen about the size of a silver dollar, then it turned brownish, I got 101 fever, bodyaches, really bad headaches. My arm was really bad for 3 to 4 weeks.  Now I'm getting yeast infections and broke out on my back patchy rash on left side at my waist. I have never been prone to yeast infections my entire life.
Right ankle brushed against it burned on contact and burn followed up the vein 4 inches-developed into 1+pitting edema all along the shin and same for the Left leg 1+ pitting edema along the shin only-burning got worse over the next 2weeks and went to Urgent Care -Dorsalis pedis and posterior tibialis pulses are strong -feet warm and dry- Burning intense in right calf-had to ask RN for Methylprednisolone pack to stop the burn. within 90 minutes of medication the burning stopped the edema did not. Have never had pitting edema. THis is now 6 weeks - went to store and bought Diurex OTC and edema not pitting anymore and almost gone now.