chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022).    Concomitant product use was not provided by the reporter.  Vials did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706651 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-706651:Master case - 1st adult patient MODERNATX, INC.-MOD-2023-706901:2nd adult MODERNATX, INC.-MOD-2023-706942:Master case - 2nd adult patient
BRUISED PURPLE SPOTS AROUND INJECTION SITE; BODY ACHES; LEFT ARM SWELLING; LEFT ARM SORENESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, diabetes, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced left arm swelling. On 30-MAR-2021, the subject experienced left arm soreness. On 31-MAR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced bruised purple spots around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised purple spots around injection site, and had not recovered from left arm soreness, body aches, and left arm swelling. This report was non-serious.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after 2 vaccines Moderna 4/28/21 Lot# 006C21A;  Moderna 5/26/21 Lot# 027C21A
Twinrix #3 given too soon. #3 dose given 6 months after #1 but only 3 months after #2.
IN AND OUT OF BED FOR TWO DAYS; COLD; HOT; RASH ON ARM AT INJECTION SITE; NAUSEAS; MUSCLE ACHE; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE) and NAUSEA (NAUSEAS) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE). At the time of the report, MOVEMENT DISORDER (IN AND OUT OF BED FOR TWO DAYS), NASOPHARYNGITIS (COLD), FEELING HOT (HOT), VACCINATION SITE RASH (RASH ON ARM AT INJECTION SITE), NAUSEA (NAUSEAS) and MYALGIA (MUSCLE ACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.
About 15 minutes after first dose I felt like I couldn't breathe and my chest was hurting and very tight. My heart felt like it was pounding and my husband tool my heart rate using an arm pulse/no reader. It read 116. It stayed around for a few minutes. Then I got very dizzy and felt off and like I was going to pass out. My chest felt weird and he checked again and this time read"low". After about two minutes this resolved and I felt okay. We checked again a few minutes later and it read 102. It continued to improve and within an hour dropped down to 90 and then 88 about 1.5 hours after.  That same evening I started having pains in my chest and then pain urinating. The next morning, which was today, I had a lot of pain urinating and a lot of blood was in my urine. I've never experienced this before.
Started with head aches, flu like symptoms and progressed into allergic reaction (swelling, hives, anaphalaxis), numbness in limbs and face.  Poor hand eye coordination and fogginess.
Initially cold/flu symptoms within 12 hours, then developed vertigo that has taken about 6 weeks to resolve.  This is the 3rd time that I can remember that I've had vertigo very closely associated with timing of flu shot.
Very heavy period. So much so that when changing my pads there was actual weight (feeling of heaviness) because it was so full of blood. Never have I ever completely filled a pad to the very brim/edges of the fabric. This "filled pads" happened repeatedly for several days.
between the time she was covid positive; between the time she was covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient said she got her first dose and between the time she was covid positive she said that she is scheduled to have the second dose this Thursday the 28Jan. Caller was asking if she could get the second dose even though she is a covid positive she said that she will be out of quarantine today (26Jan2021). The outcome of the event was unknown.  Information about lot/batch number has been requested.
Tick bite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EM9809) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPOD BITE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Tick bite". The event "tick bite" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthropod bite. Additional information: The patient was scheduled for her 2nd dose of the covid vaccine on 31Mar2021. On Monday, 22Mar2021, the patient had a tick bite. The tick was discovered on Monday, 22Mar2021. Reporter tried to get the tick out of the patient but could not get it all. Patient went to a walk-in clinic, and the doctor there took all of the tick out. The doctor prescribed her doxycycline to take for 14 days. The doctor at the walk-in clinic suggested that the patient should delay her second dose of the covid vaccine until 5 days after she has completed the doxycycline. The doctor at the walk-in clinic made it seem like she did not think the doxycycline would hurt the second dose of the covid vaccine, but the doctor believes that patient could possibly have more symptoms after the second dose of the covid vaccine. Clarified as, that the patient may experience stronger or negative side effects from the second dose of the covid vaccine. Reporter was querying about this. The reporter would also like to know if there was an interaction between the covid vaccine and Doxycycline, an antibiotic.  No follow-up attempts are possible. No further information is expected.
Received Tdap on 9/7/07. Symptoms of ache, fever, stiff neck, HA and vomiting onset 9/8/07. Diarrhea, continued HAR onset 9/9/07 through 9/12/07. Severe HA on 9/13/07.
Patient stated that she received a seizure. She has never had a seizure before. It lasted about 30seconds. Patient stated that she did not go to the Dr but she did reach out to her PCP to let her know what happened.
This spontaneous report was received from a medical assistant, referring to a 25 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 05-MAR-2018, the patient was vaccinated with an expired dose of GARDASIL 9 lot M011840, expiration date 01-FEB-2018, for prophylaxis (strength, dose, route and frequency were not reported). The vaccine did not have temperature excursion. No adverse effects reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients. The patients medical history and current conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose and frequency unknown) (Lot # and expiry date not provided). No adverse events were reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter and linked to case # 1411USA009296. Additional information has been requested.
Hope you're well!  I had my first Covid vaccine a couple of weeks ago.  I received the Pfizer vaccine at a pharmacy.  All was fine, however, last week I got a bit of a sunburn on my left upper arm.  After a couple of days, I developed a rash on my left bicep.  I didn't think much about it until it started to spread down my arm and to the right bicep and forearm.  I received the vaccine in my right arm.   Now I'm wondering if the vaccine is contributing to this rash.  I'm supposed to be getting my second covid vaccine early next week, but I'm wondering whether I should wait until the rash is gone.   As you know, I've got a lot of allergies and my reactions typically tend to be delayed.  Please let me know what you think.  Thanks so much!   BTW, I'm also wondering if I can get my second vaccine through a different provider.  The pharmacy that I went to was filthy.  I would rather not return there for my second dose.
Extremely swollen injection site. Red, painful.  Fever. Fatigue.  Extremely swollen, painful lymph nodes on same side under arm.
Rash on face, vomiting, fever, nausea, chills, headache  Vomiting stopped after 10 hours, other reactions still present 28 hours after vaccination
His arm is in agonizing pain; He has been bed ridden for the last 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  An elderly male patient 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 of Covid-19 Vaccine, manufacture unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "His arm is in agonizing pain"; BEDRIDDEN (non-serious) with onset Jun2021, outcome "not recovered", described as "He has been bed ridden for the last 3 days".  Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Swap. Caller has an elderly gentleman friend who received his 2nd dose of Covid vaccine about a month ago. She called to check on him and he has been bed ridden for the last 3 days and his arm is in agonizing pain where he received the vaccine. She is wondering why, after a month, is he just now having reactions and how long could this last. Relayed information and transferred to (withheld). Faxed. Caller did not want to provide any information.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine at 2:30pm, started to feel lightheaded approximately 5 minutes after vaccine was administered. She was given water, and measured BP every 2 minutes. Patient states her blood pressure is normally very low, her mom agreed. First reading 80/52mmHg, second 87/58mmHg. Patient's mother called her PCP and patient started to feel better. Patient was completely coherent the entire time-answering questions and able to describe her symptoms with great detail, but closed her eyes a few times and said she felt dizzy. Dr stated she would call her back shortly. Patient left pharmacy and asked us not to call 911 or first responders. She will follow up with her doctor via phone and decide at that time if she will get her second vaccination.
Approximately 1 hour post vax, pt experienced dizziness, numbness spreading from thighs to upper arms, feeling as though she was going to pass out, nausea, loose bowels and shakiness.  All symptoms came in waves, waxing and waning for approximately 7 hours.
Blancing, erythematous rash with petchiae on trunk, back, left arm for 24 hours
varicella lesions on scalp, face & abd;tx zovirax x 5 days;
On 10/19/2005 child woke up with swelling on neck at jaw line. Also had fever.
One cm firm mass below the dermis on the left leg, non tender, no change in skin temperature or color.
TC to Client and spoke with patient. Patient received COVID 19 vaccine on 6/30/2021, at 1400. Around 11:00 pm, on 6/30/2021 symptoms started, feeling warm, chills, sweats, headache, body aches, joint pain, brain fog, dizziness, lightheaded, slight coughing episodes, swollen lymph nodes. Per patient, had one time episode of vomiting, having abdomen pain and mild diarrhea. Per patient, some symptoms have subsided, no follow up for medial treatment and has not taken any medications. No underlying medical condition, but is a former smoker, as of two weeks now. PHN recommend that Client follow up with PCP and to call 911 for medical emergency. Patient verbalized understanding information provided by PHN.
He was supposed to get the Covid vaccine 6 mos - 4 years and he received the covid vaccine for 5-11 years.  He didn't have any adverse reactions.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding their concomitant medications, pertinent medical history, drug reactions or allergies was provided. On an unknown date, patients were vaccinated with ZOSTAVAX vial 19400 plaque-forming units (PFU) (lot#, expiration date, dose, were not provided), concomitantly with PNEUMOVAX 23 (lot#, expiration date, dose, frequency: unknown). No adverse events were reported. Additional information is not expected, as the reporter did not wish further contact.
A sore arm; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date were not provided), unspecified dose via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for a couple of days and the key was to be well hydrated beforehand. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Patient had Moderna as first dose and received Pfizer as second dose. No symptoms or sign of adverse event. Patient received Pfizer as a second dose instead of Moderna.
This spontaneous report as received from a nurse refers to a approximately 4 months old male patient with no pertinent medical history. The patient was vaccinated with dose 1, dose 2 and dose 3 RECOMBIVAX HB on 27-OCT-2011, 27-DEC-2011 and 14-MAR-2012, respectively. There was no concomitant medications. The nurse reported that the patient was administered the first dose of RECOMBIVAX HB (lot number and expiration date were unknown) and did not experience any problems. When the second dose of RECOMBIVAX HB (lot #: 670231/1155AA, expiration date: 17-DEC-2013) was administered, the patient experienced extremely sore leg all the way down his leg. When the third dose of RECOMBIVAX HB (lot #: 669599/0231AA, expiration date; 14-OCT-2013) was administered, the patient experienced extremely sensitive leg with a macular papular rash all the way down his leg. The nurse did not know how long after the second and third doses that the adverse experiences occurred. The patient was seen by his pediatrician. No treatment information was reported. No lab diagnostics studies were performed. The nurse reported that the patient did recover from the adverse experiences after the second and third doses but she did not know how long it took the patient to recover. The nurse noted the patient experienced similar reactions with PENTACEL and PREVNAR. Additional information has been requested.
she feels body soreness and difficulty moving at a fast pace; she feels body soreness and difficulty moving at a fast pace; It just that my muscles are too weak. It was 'like it is after half a mile of swimming'; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9262, expiry date was unknown) via an unspecified route of administration, on 26Jan2021, at single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient reported that she received first dose of vaccine Tuesday. She did not feel sick or as if she has the flu per her report. She felt body soreness and difficulty moving at a fast pace in Jan2021. She would like to know if it will be okay for her to get the second dose of vaccine. Patient stated that my muscles are too weak in Jan2021. Patient also reported that, I have no fever, I have no cough, I don't feel sick. It just that my muscles are too weak. It was 'like it is after half a mile of swimming' (not clear over the call). I was reading all the papers and it says that it is normal as of one of the symptoms. I was just wondering how long it will take to be that away." No treatment was given to the events. Outcome of the events was reported as unknown.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain, with outcome of unknown. Therapeutic measures were taken as a result of pain. The patient took Tylenol 4 and tramadol. She wanted to know if it's ok to take pain medications. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
redness; hot to the touch; swelling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced redness, hot to the touch, swelling, and "it's getting bigger," at the injection site on an unspecified date. She stated it was then the 4th day of experiencing the side effects and paracetamol (TYLENOL) wasn't working. She asked if she could take an antihistamine instead. It was further reported that she was having redness from the COVID vaccine. It was day 4 and it was very warm, and she took just paracetamol and cold compress aren't helping it.  The redness started on third day. Outcome of the events was unknown.  No follow-up attempts are possible; no further information expected.
couldn't stop shaking uncontrollably, stiff neck, shaking, for 1 hour
She reports having hot flashes and flushing of the skin.  This has been going on for the past 2 weeks.  When she feels warm or hot, her temp is normal and her husband says her skin feels normal.  Does appear a little flushed though.
Patient had fever, hot, chilled, headache, dizzy and fatigue. Arm pain 3 days after receiving GARDASIL.
Mom called 09/22/2005 stating patient ended up in ER 09/20/2005.  According to Mom patient had a headache 2 hours after immunization on 09/16/2005.  On 09/17/2005 had low grade temperature, headache and light and sound sensitivity.  09/18/2005 headache continued and sensitivity to light and sound.  08/19/2005 no change continued headache etc.  09/20/2005 at 07:10PM complained of right hand finger being numb, right ear felt like it was burning - had pain back of head and head felt too heavy to hold up.  Complained of double vision and slurred speech.
About 5 days after receiving the injection pt noticed redness and itching in that area. Pt has 11 x 6.5 cm hive like area rt upper arm and warmth. Pt given Allegra 60 mg one bid
pt recvd vax & devel rash; swollen glands; dental problems & swollen knees; 6sep94 cont to c/o knee joint pain; tx w/ advil per MD;
Fever 101F, Chills, Shivering, Isolated Muscle Twitching, Slight Headache that lasted about 4-6 hours.
Reported to emergency room with dizziness, heart palpitations, rapid heart rate, hoarseness and blood pressure 204/197.
pt recv vax & 11 days post vax pt devel h/a, swelling behind the ears, neck pain & intermittent tenderness to the touch for 2 days;2wk post vax pt devel swelling in both knees, diff bending & walking along, finger swelling, achiness wrist;