chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 10:55, 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.
the worst high fever; congestion; craziness in stomach; This is a spontaneous report from a contactable consumer or other non-healthcare professional (the patient). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: not reported, expiry date: not reported ) via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04May2021, the patient experienced worst high fever, congestion, craziness in stomach and he was scheduled to get the second dose 10May2021. He wants to know if he can still get the second dose and what lymphadenopathy is. The patient underwent lab tests which included high body temperature on 04May2021.The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose 2 one month after dose 1; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 16th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter called on behalf of the patient. She stated that, the patient was not immunocompromised but was inadvertently given Shingrix dose 2 on October 16th, 2021, one month after dose 1 which was given on 18th September 2021), which led to shortening of vaccination schedule. She had questions about what to do next and was advised accordingly.
I received the second dose of Pfizer COVID-19 vaccine on Friday, July 23. The next day I woke up with extreme fatigue, dizziness, headache, and aches. On July 26, I received a call from Walgreens stating that I was given a higher concentration of the vaccine due to a dilution error.
tired; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) at the age of 56 years 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: FATIGUE (non-serious) with onset 24May2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset 24May2021, outcome "unknown", described as "headache".  Additional Information: The patient was only experiencing headache and tired, he was doing better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.
24 hours after vaccination, client experienced pain, redness, swelling from left deltoid down to elbow. No fever associated. The pain was excruciating that client ended up to ER. Client was put on Ciprofloxacin for 10 days.
Inflammation in the face; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLAMMATION (Inflammation in the face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history  is provided and concomitant drugs are provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the face). At the time of the report, INFLAMMATION (Inflammation in the face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Headache (turned into a migraine), extremely drained of energy, lack of appetite, and felt off all day (4/9/21). The next morning (4/10/21) felt the same as the day before, however, had several episodes where I would get really light headed, dizzy, and nauseous. Went to Home Depot at 2:15pm (4/10) and while there my vision blurred and started to fade, I had ringing in my ears and couldn?t hear out of the right and barely was able to hear out of the left. I got very nauseous and I couldn?t breath. I managed to sit on something and put my head between my legs that helped. Fortunately my step- dad was with me and helped me outside while I could barely see and hear and he stated I was very pale. I was having a hard time talking or being conherent. Once outside the symptoms slowly cleared over about the next 6-7 hours. At 4:45pm my mom decided to take me to the doctor but the walk in had just closed and I went to the ER. They stated I had elevated d-dime and did a chest CT scan  to check for blood clots around 7:30pm (I believe not sure exact time) doctor stated they came back clear but when asked if he suspected that the episode and symptoms were due to a dissipated blood clot he would not directly answer it. I overheard him dictating his notes and he started he beloved as such. I have never experienced anything like this before. I still felt drained, headache (migraine), occasionally dizzy, and lack of appetite (4/11/21, 4/12/21) and still currently feel the same drained, migraine, lack of appetite, and occasionally dizzy.
Patient received Flumist on 10/6/06. Approx 15-30 min after administration he began to experience a headache that progressively became worse by later that afternoon. Patient experienced headache for 1 1/2 weeks. Headache was described as dull but disturbing. Patient had to take extra strength Tylenol four times a day for 1 and 1/2 weeks to relieve pain.
Painful, tender and sore right ankle; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Painful, tender and sore right ankle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 005C21A) for COVID-19 vaccination.     The patient's past medical history included Ankle sprain (severe sprain to right ankle but it healed completely) in 2012.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Painful, tender and sore right ankle). The patient was treated with NAPROXEN at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and Physical therapy (Physical therapy 2-3 times a week) for Arthralgia. At the time of the report, ARTHRALGIA (Painful, tender and sore right ankle) had not resolved.            No concomitant medications were provided.  Additional treatment details include acupuncture and ice pack application.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Event outcome updated, treatment information added
Patient vaccines administered, MA noted hive like rash to right thigh after Prevnar given (only vaccine given in that thigh).  Doctor assess patient immediately. Noted a splotchy hive like rash distal to the area of the right thigh where injection had been given. There was  no respiratory distress, no cough or wheezing. The reaction appeared localized as did not spread to the other body parts.  Order for 1.25 mg/kg dose of oral diphenhydramine  given by LVN. Patient was observed for full resolution of hives which occurred within 5-6 minutes of dose administration. Child departed with mother in stable normal condition without rash/hives.
Redness around the injection site; Pain; Chills a fever of 100; Chills a fever of 100; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (Chills a fever of 100), CHILLS (Chills a fever of 100), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 29-year-old male 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 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (Pain), PYREXIA (Chills a fever of 100), CHILLS (Chills a fever of 100), MYALGIA (Muscle aches) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). On 15-Feb-2021, PYREXIA (Chills a fever of 100), CHILLS (Chills a fever of 100), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had not resolved.            No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Elevated temperature, flu-like symptoms, nausea, headache.  Received a total of four rabies vaccines on 6/19, 6/22, 6/26 and 7/3/2012 as well as rabies immune globulin on 6/19/2012.  Received all four vaccines in left deltoid, per patient request.  On 7/31/2012, called to report left arm weakness and difficult raising arm.
Sneezing, intermittent cough, congestion, body aches, fatigue, loss of appetite.
This is a spontaneous report from a non-contactable consumer who reported for herself. This female consumer reported that on 10May2012 she received 1 dose of PREVNAR 13. On 15May2012 she felt very tired. On 17May2012 and on 18May2012, she experienced mild intestinal upset early morning. From the evening of 18May2012 to 20May2012, she was still very tired and lethargic. On 21May2012 at noon she experienced headache and slight nausea so, she decided to go to the physician who diagnosed an unspecified infection. Treatment provided was an antibiotic. She is still not recovered: on 23May2012 she felt sick, on 25May2012 she had swollen glands and sore throat. She felt fine but she was still on antibiotics and taking ADVIL COLD AND SINUS each day. She has not a lot of appetite. No follow up attempts possible. No further information expected.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION . At the time of the report, IMMUNISATION REACTION  outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
sensation of heat/burning in feet @ night;9-10hr p/vax;4-5hr p/similar feeling in hands & @ lips next morning;these s/s persisted through that next day & secondary following dose;
lt eye started shooting to center & down when tried to look up w/eye;not noticed until p/vax given;it got worse for several weeks;pt limped & c/o leg hurt;dx poss double elevator palsy in lt eye;later dx Brown's synd;
An 11-year-old female patient with no past medical history, had received a first dose injection of MENACTRA (route/site and lot number unknown) on 02 July 2008 and three days later, on 05 July 2008, she developed a low grade fever (temperature not provided) that persisted until 08 July 2008. On 21 July 2008, the patient again developed a low grade fever (temperature not provided) with a headache, achiness and a decreased appetite which continued at the time of the report. She had been evaluated by her physician on an unknown date; results of that evaluation were not provided. No further information was provided.
Injection site red, itchy, sore, and swollen 9 days after injection.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received  on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Severe canker sores all over inside of mouth and lips; This is a spontaneous report received from a contactable consumer, the patient. An 80-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on 22Feb2021 at 09:30 (at the age of 80 years) as a single dose for COVID-19 immunisation. Medical history included white blood cell count low (recently diagnosed with low white cell under doctor care for that). Concomitant medications included Apixaban (ELIQUIS), amlodipine (MANUFACTURER UNKNOWN), solitol (MANUFACTURER UNKNOWN) Atorvastatin (LIPITOR), multi vitamin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the first vaccine the patient experienced severe canker sores all over inside of mouth and lips. The patient did not receive any treatment for the events. The patient stated that severe canker sores all over inside of mouth and lips, highly inflamed swollen area around lips after first shot and now second shot on 24Feb2021, happened two days after each shot. The clinical outcome of the event severe canker sores all over inside of mouth and lips was not resolved at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
He is feeling, his bone inside the body cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: 301358A) at the age of 12 years 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: FEELING COLD (non-serious), outcome "unknown", described as "He is feeling, his bone inside the body cold.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patient's who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, the patient had pain with the injection. The reporter did not consent to follow up. The reporter stated that it was just something she heard. The reporter does not even know if it was for patients that received the product at the hospital she works.
74 yo male patient s/p Pfizer vaccination: dose 1 on 1/30/21, dose 2 on 2/20/21, and booster dose on 8/17/2021. Past medical history significant for living donor renal transplant on immunosuppression with rapamune and cyclosporine, T2DM, HTN, HLD, primary hypothyroidism, gout, anemia, and obesity who presented on 8/26 with 4 days of nausea, vomiting, diarrhea, and dry cough who was found to be positive for COVID-19, despite being fully vaccinated. On admission Infectious Disease was consulted and he received remdesivir for 7 days and dexamethasone for 10 days. He required up to 15L high flow nasal cannula this admission. He had elevated d-dimer measurements this admission and on 9/2/21 CTPE was ordered...
LIGHT HEADED AND DIZZY; CHILLS; DIARRHEA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced light headed and dizzy. On 08-NOV-2021, the patient experienced chills. On 08-NOV-2021, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headed and dizzy, chills, and diarrhea. This report was non-serious.
Narrative: Patient received Moderna COVID vaccines on the following dates at this facility: 1-22-21, 2-19-21, 10-13-21. Patient was admitted for COVID pneumonia on 2-27-22 and discharged on 3-3-22.