chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 4:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.93.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pruritic papular skin eruption starting in her occipital scalp but over the succeeding days/weeks this extended to areas on her trunk and extremities; Itching; injection site skin reaction; only mild arm discomfort; This is a spontaneous report from a contactable physician (Patient's Husband). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19, solution for injection), via an unspecified route of administration, on 25Mar2021  (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Physician reported that, approximately 7 days following inoculation, his wife began developing a very pruritic papular skin eruption starting in her occipital scalp, but over the succeeding days/weeks this extended to areas on her trunk and extremities. She had very little, if any, injection site skin reaction (only mild arm discomfort). They consulted with a local dermatologist (3 weeks after onset) and a clinical allergist/immunologist (6 weeks after onset). The dermatologist advised to get the second dose and thought this would resolve with time, the immunologist advised against a second dose but also thought it would resolve with time. Over time, the eruption has cleared in many areas but new has emerged in other areas and now over 4 months later she still has some areas of involvement, albeit the itching is less than before. She had no prior history of any kind skin disease or atopy. There was some thought this was a T-cell activation syndrome of some sort, but he thought it would have resolved by now. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
One day post vax the pt developed a four inch, red, raised band around the entire circumference of the right upper arm, which ached dully. There was no pruritus. Symptoms resolved after a few days. The most recent information reports the outcome of the event as resolved.
The day after receiving the Pfizer Bivalent vaccine, I woke up and I was running a fever of 102.5. I was experiencing a lot of body ache and chills. As the day went on, I developed a very bad sore throat, earache and started to feel congested. By 11/21/2022, the congestion was worse and I was experiencing headaches and sinus pressure. I went to a walk in clinic and they tested me for Covid, Flu and Strep, which were all negative. They felt as though I had an upper respiratory infection. They prescribed me a Z-PAK and it did not help much. I contacted my doctor and he gave me a round of steroids and antibiotics. I followed up with him 12/13/2022 and I was feeling better at the appointment, but I could still tell that it was hanging on. He took me off one of my nasal sprays to help the drainage and I am supposed to keep him updated about my symptoms.
Muscle soreness at injection site; Flu-like symptoms; chills; body aches; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy. Concomitant products included ramipril, metoprolol, simvastatin, metformin, iron (Iron Supplement), acetylsalicylic acid (Aspirin) and ascorbic acid (Vitamin C Supplement).   On 22-MAR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 23-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site muscle pain (Verbatim: Muscle soreness at injection site), influenza-like symptoms (Verbatim: Flu-like symptoms), chills (Verbatim: chills) and general body pain (Verbatim: body aches). On 23-MAR-2023, the outcome of the injection site muscle pain, influenza-like symptoms, chills and general body pain were resolved.   It was unknown if the reporter considered the injection site muscle pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site muscle pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 20-Jun-2023 The patient had muscle soreness at injection site. Flu-like symptoms for 24 hours, chills and body aches. Follow-up not possible as no contact details provided.
Inappropriate route of vaccination; This spontaneous report was received from a pharmacist and refers to a currently 57 years old female patient. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On 17-MAY-2019 (also reported as 17-MAY-2009), the patient with an unknown Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccination history, who had measles antibody negative, mumps antibody test negative, and rubella antibody negative (no blood titer)  was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant Human albumin (rHA), one dose of 0.5 mL, intramuscular (Inappropriate route of vaccination) for prophylaxis (lot number R036580 with expiration date on 17-DEC-2020). The vaccine was given with properly store sterile diluent (lot number S005076 with expiration date on 05-NOV-2021). It was reported that the patient received treatment for the adverse event. However, no medical attention was sought. The outcome of the event inappropriate route of vaccination was unknown also reported as not recovered (discrepant information).
tiredness; head ache; swollen lymphnodes; arm pain; joint pain; fever; This is a spontaneous report from a contactable consumer (patient's parent). A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15May2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her son received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on last 15May2021. On an unspecified date, the patient had experienced severe reaction like tiredness, headache, swollen lymph nodes, arm pain, joint pain and fever. She was asking if he would experience this again in the second dose. The second dose was scheduled on Saturday, 05Jun2021 but they missed it. She was asking if her son can still take the second dose. The seriousness of the events repoted as non serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
no antibodies; This spontaneous report was received from a pharmacist and refers to a 40-year-old female. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On unknown date, the patient was vaccinated with an unspecified "MMR vaccine". On 5-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient "had titers done which showed she had no antibodies" (the event of antibody test negative). At the time of reporting, the outcome of the event was not reported.  The causal relationship between the event of antibody test negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
On 5/30/2011 he received his first doses of three vaccines: smallpox, anthrax and typhoid (VICPs). On 6/13, post vaccine day 14, he developed "firm vesicular eruptions on flexor surfaces of both knees and elbows with minor itching." Diagnosed with erythema multiforme on 6/15 by Dermatology. Treated with Prednisone for 2 weeks. Had mild rebound rash and resolved around 7/12.
Patient presented to the pharmacy questioning possible adverse reactions to the COVID vaccine. After a little discussion with a technician, I was summoned to evaluate the patient. Patient received the 1st dose of COVID vaccine on 2/11/2021; she reported significant arm tenderness in the arm that received the inoculation, however, she reported the soreness was improving. Patient's left arm appeared red & warm to touch. Although it did not appear inundated and lacked tracking, I encouraged patient to contact her primary care doctor's office for evaluation. Patient followed my recommendation and I consulted with the provider. The conclusion was made that patient appears to be having an immune response to the vaccine yet. Dr also consulted with RN (immunizations)  and she reported this reaction has not been uncommon 5 dose post-vaccination. Patient was instructed to apply cold compresses now and again after receiving the 2nd dose. We do not believe any contraindication exists for the 2nd dose at this time, and patient is encouraged to receive the 2nd dose on 3/11/2021 as scheduled.
Pt vaccinated with TTOX developed 10 cm redness & swelling. Given Lidex cream
PATIENT RECEIVED HIS HEPATITIS A VACCINE YESTERDAY.HE HAD NO OTHER ISSUES GOING ON WITH HIM AT THAT TIMEFRAME.  FOLLOWING THAT APPROXIMATELY 1 HOUR LATER HE STARTED HAVING ISSUES WITH GRUNTING/DIFFICULTY BREATHING.  THIS IS ALSO ACCOMPANIED BY A INCREASED TONE THROUGHOUT HIS BODY.  NO DEFINITE SEIZURE ACTIVITY NOTED.  THIS LASTED SEVERAL MINUTES BUT LESS THAN 10 MINUTES.  HE HAD ANOTHER RECURRENCE OF THIS 1 TO 2 HOURS LATER.  I ADVISED HIM ON THIS IS SOME SORT OF REACTION TO THE HEPATITIS A VACCINE.  WE WILL FILL OUT A VAERS REPORT.  TREAT WITH BENADRYL FOR NOW.
Pt developed a flushed feeling and dizziness shortly after recieving the vaccine. She was visibly pale and needed to recline in her seat. BP noted to be 110/60, HR: 75, SP02 99%. She recovered within minutes and symptoms completely resolved. She elected to driver herself home. and did not require EMS services.
Flu, chill, unsteady, and have 3 red hives on left arm.
No adverse effect. Patient was given by mistake, the second dose of different COVID vaccine Manufacturer.  Patient was observed for a total of 40 minutes after the vaccine was administered. No s/e observed.  We contacted manufacturer. for information in regards adverse effects and recommendation to continue with series.  Spoke with the Medical information department. They informed us, there is not available interchangeable data in regards wrongfully administration of a different COVID vaccine manufacturer. At this point they recommended that patient does not get additional doses. He completed his COVID vaccine series, he should just monitor for any symptoms. According to manufacturer department; symptoms are not different than the symptoms reported for other COVID vaccines. Patient should  monitor for usual possible symptoms related to COVID vaccine. Side effects that have been reported in a clinical trial with the Moderna COVID-19 Vaccine include: ? Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness ? General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
Fever, full body muscle and joint pain, very bad headache. These all mostly cleared within 48 hours. Some muscle / joint pain still
nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.; After the injection a bit of liquid came off of the vaccination wound; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound) and DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLONAZEPAM (CLONAZEPAM AUDEN) and BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.). At the time of the report, ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound) and DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-265748 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: no new information received. On 07-Oct-2021: Non-Significant followup  information included no new information
pt recv vax & devel joint pain in the arms,feet,knees & ankles;no other info was known as of reporting date;
Patient called me describing a red, baseball-sized circle at area of vaccination. not raised, and not especially painful. Told patient that it should resolve on its own, but if it progresses to seek consult of her PCP.
Information has been received from a registered nurse, concerning a female patient (age not specified) who in September 2007 was vaccinated IM with the first dose of Gardasil, and on 16-Nov-2007 vaccinated IM with the second dose of Gardasil (lot # not provided).  There was no concomitant medication.  On 17-Nov-2007, "after she was given the second dose," the patient developed a rash and hives, as well as pain and itching in the palms in her hands.  She contacted the department of health.  Treatment included Benadryl.  At the time of this report, the outcome of the events was not recovered.  Additional information has been requested.
This spontaneous report as received from a physician refers to a 15 year old female patient with acne and no drug reactions or allergies. On 22-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #L040164 exp date 20-FEB-2018) intramuscularly. On 27-APR-2016, the patient received the second dose of GARDASIL 9 (lot # reported as L048459 exp date 22-FEB-2018) intramuscularly and the first dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). Concomitant therapies included tretinoin, azelaic acid, TRI-SPRINTEC and minocycline. The physician reported that on 29-APR-2016, the patient developed swelling and extreme pain and tenderness in her bilateral axillary areas. The patient was unable to lift either of her arms due to the intensity of the pain and tenderness. The patient visited the physician on 02-MAY-2016, at which time she burst out crying due to the intensity of the pain and tenderness in her axillary areas upon palpation. The patient's vital signs taken at the visit were: temperature of 38.2 degrees C (fever), blood pressure 104/60, respiratory rate 16 and weight 51.7 kg. It was unable to be clarified whether any of these values (besides temperature) were abnormal for the patient. The physician drew patient's blood on 02-MAY-2016 to have complete blood count and basic metabolic panel performed (results were pending). The patient was treated with ibuprofen. At the time of the report, the patient had not recovered. Extreme pain and tenderness in her bilateral axillary areas and unable to lift either of her arms were considered to be disabling by the physician. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 15:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a physician regarding a 33 year old Adult female patient. Patient's pertinent medical history included pulmonary embolism and pre-diabetics. No concomitant medications were mentioned and she had no known drug allergies. On 25-MAR-2019 the patient was vaccinated with GARDASIL 9, intramuscular for hpv pre (prophylaxis). Other suspect therapies included tinidazole (TINDAMAX) administered for bacterial vaginosis on 25-MAR-2019. On an unknown date in 2019, the patient complained of urticaria. Patient went to an unspecified emergency room and was given diphenhydramine hydrochloride (BENADRYL) and was sent home. Patient seek medical attention. No laboratory diagnostics were done. The outcome of urticaria was unknown. Causality assessment was not reported.
Narrative:  COVID infections following completion of COVID vaccine series 01/21/21 COVID vaccine dose #1 02/10/21 COVID vaccine dose #2 03/02/21 Preop COVID test - COVID NEGAVTIVE 07/25/21 Pt reports general body aches, headaches, chills, fever (temp 100.3), diarrhea, mild dry cough, and decreased appetite x2 days; CXR wnl; COVID POSITIVE; treated with NS, ibuprofen and discharged home with rx for albuterol, DM/guaifenesin, vitamin C, vitamin D, acetaminophen, ibuprofen, zinc 07/26/21 Pt reports cough that keeps him up at night and continued muscle pain; rx given for melatonin, benzonatate 07/28/21 Pt reports worsening and very painful headaches; advised to go to ED but adamantly refused 07/29/21 Pt reports headache is improving, loss of taste/smell 08/03/21 Pt reports cough is nearly resolved and is improving; met CDC criteria for resolution
The left upper arm had considerable area of inflammation and erythema and even induration towards the superior aspect of the reddened area.  It extends from just immediately below the shoulder to immediately above the elbow on the left side.