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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.19.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-APR-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-MAY-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022 at 5:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Mar-2022 at 5:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  The patient received booster dose on 07 Mar 2022.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
swollen face; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 09Mar2021, as first dose, single dose for COVID-19 immunization. The patient medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. One day later, on 10Mar2021 the patient woke up with a swollen face. She explained her face was getting better, but it started to swell again. She mentioned that she has thyroid issues and sometimes wakes up with a swollen face, but her sister recommended for her to report the event. She also mentioned she spoke with her endocrinologist who has her on Benadryl every 8 hours and recommended her to monitor her symptoms, and to go to the emergency room if needed. She asked if her symptom was reported as a side effect to the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case previously recorded as MA2009-5490. Initial case report received via Med Com from a health care professional on 20 NOV 2009: A 3-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1008143P) on 19 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008634.
Influenza vaccine - manufacturer/lot number unknown 11/06 8:45 a.m. (appointment time) staff administered flu shot 11/06, early evening:  Extreme pain that lasted for 3 nights/days.  When I reported this the following week when I was called by staff with blood work results, I was told that this year's shot hurt more than usual.   Pain continued for 5 weeks, both at rest and especially during some movements as well as weakness/inability to function properly.  Unable to lift a gallon of milk or get dressed or undressed properly.  12/12 When I brought it up when I was called again with blood work results, the nurse took it seriously and scheduled me an appointment for the following Monday 12/16  My primary evaluated me and concluded that a tendon was probably hit with the flu shot based on where it was hurting.  She prescribed me oral steroids and physical therapy.  Also had x-ray done which came back with no issues.  Then I got a call a couple of weeks later to check on my arm/shoulder and was asked to hold off on physical therapy because steroids might be enough.  12/22 I came down with a sickness and was given stronger steroids to calm down my asthma, which masked my arm/shoulder pain longer 01/12 - arm / shoulder pain returned so I proceeded with physical therapy  02/17 - saw orthopedic dr who diagnosed me with impingement syndrome of left shoulder and bursitis of left shoulder
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 328 hours, with the lowest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given 0.2mL of undiluted Pfizer  Covid-19 (5-11). Error was noticed 2.5 hours later, Parent was called and given potential adverse effects to be aware of (local and systemic), and to call pediatrician for follow-up if needed.  Will follow-up. No documented adverse events at this time.
Patient's last menstrual period was 02/12/2021  Estimated Date of Delivery: 11/23/21  Cough   Nasal congestion
Slower breathing patterns; Swollen lymph node in my neck; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY RATE DECREASED (Slower breathing patterns) and LYMPHADENOPATHY (Swollen lymph node in my neck) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced RESPIRATORY RATE DECREASED (Slower breathing patterns) and LYMPHADENOPATHY (Swollen lymph node in my neck). At the time of the report, RESPIRATORY RATE DECREASED (Slower breathing patterns) and LYMPHADENOPATHY (Swollen lymph node in my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
PT waked up to the front of the observation room c/o feeling faint and fainted she was out for about 30 seconds upon waking her up we tried to sit her up and she became very pale PT was sent out 911 for observation
Headache, Myalgia, Fever, Chills, runny nose, back ache Narrative:
Pt had swollen lips and redness around injection site  the next day after receiving the vaccine.
A Fever of 100-104 that lasted five days. On the sixth day she broke out in hives on her back, chest and face. Hives lasted roughly five days.
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on the lot/batch number has been requested.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4453553-00. A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for rheumatoid arthritis. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious), outcome "recovered". The action taken for adalimumab was unknown. The reporter considered "Covid-19" and "urinary tract infection" related to BNT162b2. Causality for Humira (Adalimumab) was given as the reporter's causality for the event(s) of Urinary tract infection and COVID with Humira (Adalimumab) was a reasonable possibility. The reporter's assessment of the causal relationship of "Covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "Covid-19" and "urinary tract infection" related to BNT162b2. Clinical course: Patient did not have any known allergies. Patient did not have relevant medical history. Patient did not take concomitant drugs. On unknown dates, the patient experienced urinary tract infection and COVID. On unknown dates, urinary tract infection and COVID resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Daily dose was given as Citrate free for Humira (Solution for injection in pre-filled pen) (Adalimumab). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events. The case will be reassessed once new information is available.
Back injury; This is a spontaneous report from a consumer (patient) from a Pfizer-sponsored program . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 22Jan2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient received both doses of the vaccine on 22Jan2021 for his first dose and his second dose on 19Feb2021 (4 weeks apart). He mentioned that he had a back injury in between the doses on an unspecified date in 2021, and he took anti-inflammatory and pain killers for 2 weeks. He stopped the medication 60 hours before taking the second dose. His main question was how these medications might affect the efficacy of the vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This initial spontaneous case was received on 18-Oct-2017, from other non-health professional, concerning a 21-year-old adult female patient. The patient had a history of dairy sensitivity and was not on any concomitant medications. On 21-Nov-2011, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 1100401 (as reported), anatomical location, expiry date: not reported). On the same day, after receiving the vaccine, the patient developed overall allergic reaction. The patient also experienced nausea, vomiting and cramping. She was sick for 3 days. The patient also experienced stomach issues, pain and general discomfort. On 20-Oct-2017, the patient took the FLUVIRIN vaccine again and had no problems. On 24-Nov-2011, the patient had recovered from the events allergic reaction, stomach issues, pain and general discomfort and sickness. The outcome of the other events was not reported. The reporter assessed the events as non-serious. Significant follow-up received on 27-Oct-2017: It was confirmed that, no medications were taken for the events. The patient confirmed that the allergic reaction was not due to any other factor. The patient had no problems with vaccination on 20-Oct-2017. Narrative amended accordingly. Follow up received on 18-Oct-2017 from the reporter: Added events (nausea, vomiting and cramps). Amended narrative accordingly.
Patient received pfizer booster (3rd dose) felt faint and fell off her chair. Patient has no recollection of falling off the chair. Patient was lowered and placed in supine position feet where then elevated. Patient was given water and crackers. Patient stated "she did not eat anything today". 911 was called EMT took blood glucose was 97 after crackers were eaten. Heart rate was 79, Pulses 3+ equal and bilateral, O2 99%. Patient was responsive and orientated. Patient resumed seated position with in 10 minutes and refused additional care by EMT.
Just felt tired; Minor aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EN6201) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 10Feb2021, outcome "recovered", described as "Just felt tired"; PAIN (non-serious) with onset 10Feb2021, outcome "recovered", described as "Minor aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Initially, flu/viral (sore throat, cough, nasal congestion, fever, etc.) beginning on evening of 3/31.   Also fatigue with severe dizziness, unsteadiness).  All progressively worsened over course of one week.  Viral symptoms, today, are improving.    Neuro symptoms have worsened in intensity.  These include:  significant headache on left side of my head that is different from migraines.   Also, right arm and leg weakness with electrical, shooting pain.  Currently taking Gabapentin an opioids and not getting any relief.   Weakness has caused several falls.  Using a walker.  Feel like I?m not functioning properly mentally (word finding and wrong words, just not alert to perform simple tasks).   April 4. 2021:  Virtual video call (limited to viral symptoms).  Told to obtain higher level of care.     Went to local urgent care and had rapid flu and Covid nares swab.  Provider called inhaler in to pharmacy for wheezing.    Transferred  to local emergency room for higher level of care.   Had PCR for multiple viruses.  Positive for rhinovirus/enterovirus.  Normal chest x-ray.  Told I had a ?cold? and needed no further medical care..   None of the neurological symptoms were evaluated.  Received a shot of Imitrex for headache.
pain in arm; still having trouble raising her left arm/couldn't life her arm; couldn't life her arm to do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INJECTED LIMB MOBILITY DECREASED (still having trouble raising her left arm/couldn't life her arm) and INJECTED LIMB MOBILITY DECREASED (couldn't life her arm to do anything) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and Wellbutrin XR for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), INJECTED LIMB MOBILITY DECREASED (still having trouble raising her left arm/couldn't life her arm) and INJECTED LIMB MOBILITY DECREASED (couldn't life her arm to do anything). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), INJECTED LIMB MOBILITY DECREASED (still having trouble raising her left arm/couldn't life her arm) and INJECTED LIMB MOBILITY DECREASED (couldn't life her arm to do anything) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She states she is concerned about getting the second dose of the vaccine because she heard the second dose is even worse than the first and is afraid, she will not be able to use her arm at all
He experienced a breakthrough case of COVID-19 with a cough, vomiting and runny rose.
Mental fogginess; Clammy feeling; Body Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Mental fogginess), COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Nerve damage.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Mental fogginess), COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, General body pain and Clammy, at an unspecified dose and frequency. On 20-Feb-2021, COLD SWEAT (Clammy feeling), PAIN (Body Aches) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Mental fogginess) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood Pressure pill, nerve damage pill.
The patient reported to me today (29 days after the vaccine) that he had severe bruising over the entire deltoid area and that he still has pain on the spot where the vaccine was given. The bruise was dark at first but is getting lighter (it was yellow today when I examined it). He said that it still hurts when he touches the area where the vaccine was given. He reported a low fever in the days following the vaccine, but the fever is gone now. There was no visible swelling today, just yellow bruising over the entire deltoid area today. He says that it is improving, but was concerned because it has been so long since he received the vaccination.