chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
I had a cough that would not go away after my vaccine, prior to my delivery it went away but came back in November and has not gone away and my delivery went from normal vaginal to C section my recovery is going well but it has gone to my chest and throat. Doctors feel it could be allergies, I have had allergies since living in this area and this cough has persisted and gone on this long. I have tried different treatments and medicines and have narrowed it down, allergens that keep the cough going. Delivery date was reported, weight was seven and one half pounds.
Child presents today with bilateral swelling of hands, associated with itching and wheals on the arms and back.
Woke up at 6:00 AM with a headache throughout the day she had difficulty breathing. She felt like she was breathing quick. She had some tingling in her hands and feet. She received 1 dose of VALIUM in the ER which resolved the trouble breathing. 1 dose of ibuprofen did not help with the headaches, she developed a fever of 102.6F while in the hospital.
Hospitalized 10/19/2021; COVID-19 positive 10/19/2021; fully vaccinated  Assessment and Plan COVID 19 Pneumonia Acute Hypoxic Respiratory Failure  Presenting symptoms: SOB, cough, fever. COVID 19 detected by PCR: 10/19/2021. Symptomatic day: 4 CXR pending Received Decadron 6mg oral, Remdesivir in ED. Current oxygen saturation 91%, oxygen requirement 3L NC Severe Respiratory isolation Dexamethasone 6 mg oral daily 1/10 days Remdisivir day 1. Will need daily CMP monitoring for liver and renal toxicities. Daily labs CBC with differential, CMP, D-dimer  Monitor Ins/Outs Continuous pulse oximetry and telemetry  VTE prophylaxis with Lovenox  10/21/2021 note: Patient hypotensive, tachypneic with oxygen requirement increased to 10L intermediate flow. Reassessed patient at bedside. He reports that he feels the same as this morning with shortness of breath at rest and frequent cough. He is not feeling lightheaded or dizzy. Recheck bp of 106/60 RR 20 Procal level indicates very low likelihood of bacterial infection. Continue to monitor. Consider repeat CXR if symptoms worsening 10/24/2021 note: Assessment/Plan COVID 19 Pneumonia Acute Hypoxic Respiratory Failure  Presenting symptoms: SOB, cough, fever. COVID 19 detected by PCR: 10/19/2021. CXR as above Severe Respiratory isolation Oxygen requirement: 9L NC Dexamethasone 6 mg oral daily 4/10 days Remdisivir day 4. Will need daily CMP monitoring for liver and renal toxicities. Daily labs CBC with differential, CMP, D-dimer  Monitor Ins/Outs Continuous pulse oximetry and telemetry  VTE prophylaxis with Lovenox   COPD No increased sputum production or purulence, do not suspect acute exacerbation at this time. - Continue home inhalers dulera, spiriva - Scheduled albuterol q4h
Moderna COVID-19 Vaccine EUA  Severe arm soreness at site of injection in the left shoulder with inability to lift the left arm above 90° for 2 days following the injection.  Still mildly sore today and not full range of motion resolution.    Mild headache and chills for about one hour approximately 6 hours after injection.   Global muscle stiffness the evening of the date of injection.
This spontaneous report as received from a nurse refers to an unknown number of patients with unknown age. The patients' medical history and drug allergies were not reported. On an unknown date, patients were vaccinated with M-M-R II, 0.5 ml, (lot # and expired date were not reported). Concomitant therapy was not reported. Nurse mentioned that M-M-R II that was received by the patients was improperly stored in the fridge by being exposed to light for about 3 months. No adverse effects reported. Additional information has been requested.
diarrhea; low grade fever (99.5); chills; Fatigue; brain fog; vomiting; This is a spontaneous report from a contactable other hcp (health care professional, patient reported for self). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on 30Jan2021 (batch/lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 58-years-old). Medical history included hypothyroid from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins/minerals and herbal remedies all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient had known allergy of Clindamycin. Patient did not have covid prior vaccination. facility type vaccine was reported as other. It was reported that nine days after the vaccination on 08Feb2021 at 17:00 pm the patient experienced vomiting (multiple episodes) then diarrhea, low grade fever (99.5), chills, brain fog. Diarrhea and brain fog lasted 3 days. It was further stated as fever was 2 days, vomiting was just first evening, fatigue first 2 days following vaccine, then felt okay until 8th day. The patient underwent lab tests and procedures which included body temperature which showed low grade fever (99.5) on 08Feb2021, nasal swab PCR test and nasal swab rapid test which result was negative on 09Feb2021. The patient tested for covid post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient was recovered from all the events on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash on legs, moved to arms, face-ears turned red & were warm to touch, eyes swelled (Mongoloid look), blotchy face-hives on neck & head; given DPH & taken to MD;
Fridge temp went out of range by 4 degrees overnight sunday due to storm, facility closed on 1/17. Vaccines were administered to patients in the morning
syncope, vasal vagal symtpoms, sweating, paleness for about 1 minute
This spontaneous report as received from a physician refers to a 12 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with his first dose of GARDASIL (0.5 ml, intramuscularly, Lot# unspecified) on 07-AUG-2012 and second dose (Lot#, dose, route unspecified) today, on 19-OCT-2012. There was no concomitant medication. It was reported that after the first dose vaccination, patient had developed a rash localized to his right anterior upper thigh on an unknown date in 2012. The lesions were papular/pustular at the onset of the rash but were now red, papular lesions. The lesions were slightly pruritic. The physician had diagnosed the rash as Gianotti-Crosti Syndrome. The patient had sought medical attention via office visit. No lab diagnostics studies performed and no treatment was given for the event. The outcome of gianotti-crosti symptom was reported as not recovered/not resolved. Additional information has been requested.
swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (swelling of lymph nodes) in a  patient of an unknown age and gender 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 LYMPHADENITIS (swelling of lymph nodes). At the time of the report, LYMPHADENITIS (swelling of lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Following vax, the pt developed a pustule at the site of the injection. The next day a knot developed about 2 cm below the injection site and it was red and warm to the touch. The pt experienced tenderness around the knot and under the left arm. The pt denies a fever. The pt took Tylenol and was using warm packs at site on arm.
I have started very sharp pains on my breasts and my breasts became very dense and bigger after 2 weeks of the first shot, pain still continues after 19 days of the 2nd shot, also after 2 weeks of the second shot I started my period eventhough it was not due till another 2 weeks so in between bleeding started . It has been 3 days so far medium flow my period hasn?t stopped yet.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 08-JAN-2013, the patient was vaccinated with expired GARDASIL. Lot number was reported as 0331Z with an expiration date of 20-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of vaccination with GARDASIL that had an expiration date of 20-NOV-2012 is unknown. No further information was available. Additional information has been requested.
Patient states that the next day she was very weak, nauseated, tired, and occasional trouble breathing. Her arm was also sore but that was not her primary concern. I suggested she seek immediate medical attention for the trouble breathing - she did not feel she needed to do so. I also encouraged her to check with her MD regarding the symptoms. I called her later that day and she was feeling a little better.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, in her facility where she works at there has been temperature excursions with her freezer. It has been happening for weeks since April 2022.   The storage condition at the time of the excursion was frozen. The vial with lot number affected were 065K21A and 045L21A. The maximum or minimum temperatures reached were as follows maximum: 30 Fahrenheit Degrees and minimum -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The reporter does not have the information on date vial(s) moved from freezer to refrigerator. The vials currently stored in frozen state. On visual inspection no changes were observed in any vaccine state. The Proposed desired Use by Date was not reported.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Beyond the expected adverse symptoms I had (chills, headache, lots of pain at injection site) The longest and most unpleasant adverse event has been tenderness and pain of my armpit - of the arm where I was injected with vaccine. I do not feel any swelling of lymph nodes. Its been almost 7 days and this symptom has persisted. The area feels very sensitive and tender. The way I move my arm or hand causes pain of my armpit as well.
side effects continuously; aching glands - armpits, groin; feeling of cramping in my feet; tight calves; aching backs of knees; aching glands - armpits, groin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves) and ARTHRALGIA (aching backs of knees) in a patient of an unknown age and gender 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 17-May-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 VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin). At the time of the report, VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Patient received PNEUMOVAX vaccine during office visit on 7/17/2014 and then developed pain and swelling around the injection site. On 7/20/2014, patient called her physician complaining of persistent fever, redness and swelling around the injection site. The physician advised the patient go to ER. Patient was admitted to the hospital for cellulitis of upper arm, SIRS and abnormal liver function tests (patient does not have history of alcohol abuse or hepatitis). The patient was treated with IV antibiotics (vancomycin, levofloxacin) and IV fluids.
ACUTE PULMONARY EMBOLISM HYPOXIA 2/18/2022 -- RECURRENCE OF SAME SYMPTOMS
Large area (13 cm x 12 cm) of warm erythematous itchy skin around vaccine site.
Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities
This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose in the arm for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had redness in his/her arms where the shot was (given). The patient inquired if this was a normal case if you get a shot and had redness in the arms where the shot was (given). He/She also wanted to know if that was an injection or a reaction to pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
6/20/19 mom stated baby had fever 104.5 and rash started. She then called insurance advice line and was told to give Tylenol and motrin. Mom states fever 101 on 6/23/19. Then 6/24/19 went to Urgent Care because rash was worse, temperature 98.2. Dr notified of event and ask mom to take picture and follow up appointment made for 6/26/19
Information has been received from a medical assistant referring to a 3 year old male patient. There were no pertinent medical history, drug reactions or allergies. On 16-NOV-2015, the patient received a delayed routine vaccination with one dose of M-M-R II (lot # L011528, expiration date 03-APR-2017, 0.5 ml, subcutaneous). There was no concomitant medication. Shortly after the vaccination on 16-NOV-2015, the patient developed an itchy tongue and two "bug-bite like marks on his face". The patient was given TYLENOL and BENADRYL as treatment. Then shortly after administering the TYLENOL and BENADRYL, the patient developed swollen eyelids and was having difficulty breathing. He kept grunting like it was hard for him to breathe. EPIPEN was then used and the patient was taken to the hospital for further observation. The patient was not admitted to the hospital and was released at about 11:00 PM on that night. No lab diagnostics studies were performed. At the time of report, the patient's eyelids were still a little swollen but the other events were resolved (reported as "otherwise he was good"). The causality between the events and M-M-R II was unspecified. Upon internal review, the events were considered to be medically significant. Additional information has been requested.
Onset of fever chills muscle aches 24 hours from injection. Txd with Ibu/tyl antihistamines
rhabdomyalgia & myositis are reported in a pt NOV93 & approx 3 wks p/vax exp onset of myositis affecting muscles of arms, legs & back;  30NOV93 sed rate=100, CPK=14,000 & hematocrit=29; pt was hospitalized on 30NOV93
It was very itchy rash appeared on my chest; It was very itchy rash appeared on my chest; This is a spontaneous report from a non-contactable consumer(patient, reported for herself).  A 56-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on an unspecified date as a dose 1, single (at the age of 56-years-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced an itchy with in top of their breast one hour after taking BNT162b2.The patient reported that she put a cream on and they went away on an unspecified date and the rash was on chest after taking the vaccine and something concern about or should they take a second dose or not. On an unspecified date the patient experienced very itchy and it went away but bloody not bloody, but it was very wet. The reporter never had any rash on her right chest the right side of breast, the other side didn't have. The consumer reported that 3 weeks ago, the patient was just wondering what was that a period or a rash, it was very itchy rash appeared on her chest, then she put medicine on it some Hydrocortisone cream but then it went away. The patient received treatment for the events. The outcome of the events was recovered/resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had received booster dose from us at Pharmacy on 12/02/2021 at the 0.25 ml dose after having received a J&J vaccine earlier in 2021. Pt's mother signed up pt for an additional Moderna vaccine believing that she needed a second dose and an additional dose was administer on 01/24/2022 as though it was a second dose for the pt at the dose of 0.5 ml.
Shortly after receiving the first dose of moderna vaccine the patient described facial redness, itching, and rash. On exam, she did have facial redness but I did not appreciate rash.  Regardless, she was given diphenhydramine 50mg x 1. She endorsed some benefit from her symptoms. Vitals remained normal throughout including 02 sat 98%.
pt recvd vax 22APR92 & 16JUL92 exp pain of an arthritic nature in rt shoulder; pain in the rt shoulder seemed to shift to lt shoulder; 13JAN93 there was cont pain w/inc intensity & crepitation w/limitation of abduction; loss of strength;
Achy back, legs like flu; Achy back, legs like flu; Achy back, legs like flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 30Nov2021 (Lot number: FF8841) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL (ongoing); ADVIL taken for headache; FLINTSTONES (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Site and Route of injection:, Anatomical site of injection: arm, Batch/Lot number: EW0161), administration date: 19Apr2021, when the patient was 53 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Site and Route of injection:, Anatomical site of injection: arm, Batch/Lot number: EW0173, odd feeling of having fluid in my armpit), administration date: 10May2021, when the patient was 53 years old, for Covid-19 Immunization, reaction(s): "odd feeling of having fluid in my armpit". The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 01Dec2021, outcome "recovered" and all described as "Achy back, legs like flu". Therapeutic measures were not taken as a result of back pain, pain in extremity, influenza like illness. No follow-up attempts are possible. No further information is expected.
9OCT91 laryngitis w/dry, hacking cough, low grade temp x 1 wk; 16OCT91 productive cough, thick yellow sputum, dyspnea; 20OCT91 severe resp distress adm to hosp x 6 days sputum smear pneumococcal/strep dx flu/pneumonia;
Red blotchy rash about 2 inches in diameter at injection site. Noticed it on day 7  aster vaccine. Not itchy as of now.
arrived at the post vaccination section with her EpiPen, stating she has a history of allergies; she was under observation for 30 minutes. About 25 minutes into her observation time, she complained of dizziness that lasted less than 15 seconds?no shortness of breath or breathing difficulties. After 30 minutes, the client verbalized not having any sign of vaccine reaction.
Caller stated she had soreness; Really bad allergies for spring and summer with the pollen have gone away; she started having an eye twitch/Eye Twitching; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 12:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. Medical history included bipolar disorder from 2001 and ongoing, pancreatitis from 2003 and pollen allergy. Family medical history included Alzheimer's and heart disease. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and VITAMIN D NOS (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported.  Caller stated she had two side effects, one good thing and one bad thing, Caller stated she was usually sick this time of year but caller stated her allergies went away specifically mentioning pollen but now there was nothing. She noticed this on 12Apr2021. Caller stated she had soreness but no headache after the vaccine but two days after the vaccine she started having an eye twitch on 10Apr2021. Caller stated it did not last all day and was periodically and lasted for 3-5 minutes. Outcome of allergies went away and eye twitch was not resolved. Outcome of soreness was unknown.  No follow-up attempts are needed. No further information is expected.
Received shot Fri, over weekend area became red, hardened approx 3" diameter. Sore. Taking MOTRIN ,warm compress to area. States area smaller this am, 8-8-11.