chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to an unspecified amount of patients of unknown age and gender. It was reported that an unspecified number of RECOMBIVAX HB vaccines were administered to unspecified patients on unspecified dates. RECOMBIVAX HB was involved in an unsupported temperature excursion in August 2013 (reported on 26-FEB-2013). No further information was available. The case is linked to 1302USA012759, 1303USA007275 and 1303USA007279 which respectively describe unsupported temperature excursion of VAQTA, ROTATEQ, Oral and GARDASIL. Additional information has been requested.
Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever up to 100.9 even on Tylenol.   Symptoms were more than moderate.  Had to alternate Tylenol and Advil every 3 hours for fever.  Arm soreness started just hours after shot and hurt even when arm was stationary.  Other symptoms started overnight and lasted through the next night.  Received shot We?d at 4:30 and took until Friday for major symptoms to subside. Still with some congestion, runny nose and tiredness as of today (Friday).
PT VACCINATED IN CHAIR. PT LEANED FORWARD AND BECAME INCOHERENT. PT ASSISTED TO RECLINING CHAIR AND FEET ELEVATED. PT BECAME ORIENTED TO PERSON, PLACE, AND TIME. PT GIVEN SNACK AND WATER. PT MONITORED. VITAL SIGNS WNL. NURSE PRACTITIONER ASSESSMENT WNL.
8x8 raised red, warm area over R deltoid.  Slightly tender to touch.
One day post vax pt started itching and redness. Three post vax right arm was slightly reddened, warm, indurated and swollen.  Anterior to injection site. Pt was treated with Benadryl.
No additional AE reported; an expired dose was administered to a patient on 12/20/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 20-DEC-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (0.5 ml/ once, lot#: t021327, expiration date: 14-NOV-2022; strength, and route of administration were not reported) for prophylaxis (expired product administered). No adverse effects were reported. No additional adverse events (AE) were reported (no adverse event).
rash to arms, legs, and back with itching; This is a spontaneous report from a non-contactable nurse.   An 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on an unspecified date at single dose intramuscular for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported since an unspecified date after vaccination rash to arms, legs, and back with itching, lasting 2 weeks. Patient took Benedryl twice daily for relief. The patient recovered on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Pt mentioned to staff RPH on 10-5-09 who in turn told me to call her on 10-6-09. Pt said she had pain or soreness in her right arm prior to getting the shot but it turned into extreme soreness/pain after getting the flu shot. She said she chose the right arm because her right arm was already bothering her so she figured she'll get the shot in her right arm as well, that way she have "one good arm". She said, she gets soreness in her right arm because she has a bone spur- calcific tendonitis. She saw orthopedic Dr and received DARVOCET and CELEBREX on 10-5-09.
Developed Bells Palsy 3 days after administration of flu vaccine. R side of face affected. Treated with medrol dose pack and acyclovir. 10/15/07-received vac record and statement from reporter-patient developed Bell's Palsy 3 days after flu shot, treated with acyclovir and medrol dose pack per her father a physician.
Post vaccine in monitoring area, reported feeling hot and anxious. Fell out of chair and hit forehead on floor.  Witnessed by staff. No loss of consciousness. Post fall. Immediately alert and oriented x3. Vitals within normal limits. PERRLA.  Neuro exam normal. no swelling at site of impact. No dizziness reported. Ice pack applied. Denies pain. Advised to follow up with emergency room if anything changed.
break thru covid case Tested positive for covid-19 july 15 2021 at local hosptial
my face started to get red; my cheeks were swollen; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262, expiration date May2021), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got her first injection yesterday at 5pm. At 7pm, her face started to get red and her cheeks were swollen. At 1:30AM, she took some Benadryl. The outcome of the events was unknown.
Patient was vaccinated with Typhoid inj. and Yellow Fever vaccine on 6-19-14 and developed a cold sore on his tongue on 6-20-14. C/O minimal nausea, no vomiting, afebrile and sore was gone in 1 week. Sanofi Pasteur R.N. aware and says possible immune response to 'live vaccine.'
Case number PHEH20015US021291 is an initial spontaneous report from a health care professional received on 15 Oct 2015. This report refers to a male patient of an unknown age. The patient was vaccinated with BEXSERO (batch number: 148901, expiry date: 30 Sep 2016) along with FLUZONE (other manufacturer, batch number: not reported) on  an unknown date. After vaccinations, he experienced falling sleeping and diarrhea. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Very sleepy and tired; Very sleepy and tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired). At the time of the report, SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. The reported stated her husband did well for first 3 weeks before the event began.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-060416 (Patient Link).
Patient developed swollen lymph nodes and redness in the axilla beginning on 10/31/2021 after vaccination. She received a half-dose booster shot. She says it started as redness at the injection site and spread down her arm and into her breast area on the side she received her vaccine on. It was not painful. She says it is improving but not completely resolved yet.
tested positive for COVID with symptoms; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient's husband). The consumer reporter similar events for two patients. This is the second of two reports.   A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in left arm on 30Jan2021 15:00 as single dose for COVID-19 immunisation. The patient has no medical history and concomitant medications. The patient received her first dose of COVID-19 Vaccine on 30Jan2021. On 12Feb2021, the patient experienced symptoms of being tired and started with sore throat. The patient went to the doctor to get checked and she was tested for COVID-19 on the same day. The patient tested positive for COVID-19 on both the rapid test and PCR test on 12Feb2021. The patient developed other symptoms of cough with some mucus with it but not much. She has no fever and no body aches. She does not have a sense of smell or taste. The patient thinks she has pink eye in both eyes. When she wakes in the mornings she feels stronger but as the day goes on she gets a little bit more symptoms, a little bit of a headache. Nothing major. Has been taking oxygen levels which have all been in the high 90s. Body temperatures taken have all been within normal range. They cancelled her second dose which was scheduled for 20Feb2021. The patient was vaccinated on a racetrack. The events required a visit to the physician's office but was not hospitalized. The outcome of the events was reported as not recovered.; Sender's Comments: Linked Report(s) PFIZER INC-2021196167 same reporter and vaccine, similar events, different patient
3/30/2023 I started felling unwell in the evening and it came on rapidly with a headache, body ache and a bit of a sore throat. I had difficulty sleeping and remaining asleep. I felt much worse in the morning. I had a slightly elevated temperature of 100. On 3/31/23 I took an At Home COVID test which was negative. I thought I had a cold. I proceeded as if I was not infected with COVID. I had a very bad night's sleep, had difficulty staying asleep. My throat became much more sore with difficulty swallowing and clearing my throat all night long. In the morning of 4/1/23, I was feeling much worse. My temperature was 103.3, I began taking Tylenol. I took an At Home COVID test and it was positive. I called my insurance nurse line to find a place to get treatment, unable to see my doctor. I went to the Urgent Care to see a doctor. I had another positive COVID test and was prescribed Lagevrio. I began taking the 5 day supply that morning. For the next two and half, three days, I rested and took the Lagevrio and Tylenol for fever. I drank liquids. I didn't eat very much during those first two days, just fluids. I had three very bad nights with an inflamed and infected throat and difficulty breathing. By 4/4/23 I was beginning to feel a little better. I did not have headache or a fever. The pain and inflammation in my throat was reduced. My general feeling of being unwell and fatigued was abating somewhat. The next day, I felt even better. Yesterday, I had completed my 5 days of taking the Lagevrio. On 4/4/23 I tested positive for COVID with an at home COVID test. Since yesterday I have been feeling 75% to 85% recovered.
On 4/29 - I felt fatigue and pain on left arm, on 4/30 i started feeling shortness of breath. on 5/1 I started to have more flu like symptoms sneezing coughing runny nose sore throat body aches and a fever. All the flu like symptoms continued until 5/5 when they started to clear up.
Rash on both arms and stomach; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: unknown), intramuscular (left arm) on 13Jan2021 at 01:45 at a single dose for COVID-19 immunization. Medical history included known allergies. The patient is not pregnant. Concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and had not tested post-vaccination. The patient experienced rash on both arms and stomach on 16Jan2021 at 09:30. No treatment administered for the event. The event had not resolved.
Pfizer BioNTech Covid 19 vaccien  Ringing in left ear started 1/27/21 intermittently for a few days and then started ringing nonstop and continues nonstop as of current. Significant vertigo, nausea and occasional headache. ENT appointment scheduled 4/13/2021 with Dr.
Covid infection; Covid infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 16 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jul2021 as dose 1, single (Lot number: 1C005A), on 24Jul2021 as dose 2, single (Lot number: FE1510) and on 05Feb2022 as dose 3 (booster), single (Lot number: FN0087) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2022, outcome "not recovered" and all described as "Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Vaccine expired 07/12/2022 (3 days earlier). Pfizer notified. They have stability data for 2 days after expiration. Form submitted to Pfizer so they can determine if their suppliers have additional stability data. Doctor does not recommend revaccination. Parent informed.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In October 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In January 2015, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Headache, stiff neck, stiff back, fever (night sweats), nausea, loss of appetite, shortness of breath, chest pain.
TOOK LAST DOSE 2 WEEKS LATER THAN THE SCHEDULED TIME; This spontaneous case (PVX2019-970) was received from a pharmacist on 23-Apr-2019. It describes a male consumer who "took last dose 2 weeks later than the scheduled time", while being on Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif and forgot to take the last dose for 2 weeks. He took the doses on 3-Apr-2019, 5-Apr-2019, 7-Apr-2019, and 21-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took last dose 2 weeks later than the scheduled time" was unknown.  Company's Comment: The causality of the event "took last dose 2 weeks later than the scheduled time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose 2 weeks later than the scheduled time" was considered as not applicable.
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 52-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced 15 or 20 years ago). On 27th July 2018, the patient received the 1st dose of SHINGRIX In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site reaction and pain in arm. On an unknown date, the outcome of the injection site reaction and pain in arm were unknown. It was unknown if the reporter considered the injection site reaction and pain in arm to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The age at vaccination can be 52 or 53 years. The reporter was the patient's father who received the 1st dose of SHINGRIX and experienced injection site reaction including arm soreness and pain. The reporter also stated that, the patient did not have redness but had arm pain that was moving down into the fingers at the time of reporting. This case was linked to case US2018136222, reported by the same reporter.
Patient had this vaccine administered on 1/28/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported. Per manufacturer, administration not recommended past 31 days + an additional 14 days of temperature excursion. Per manufacturer, patient will need revaccination. No minimum time interval for this revaccination.
Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.
R upper arm red 3 1/2x 4, warm to touch, sl. firm 5/16/03. Mom used ice and Benadryl.
pt recv vax 25MAY95 & 17JUN95 pt exp rapid pulse & a feeling that something was going on inside body that had no control over;feeling progressed to joint pain in legs (hips,knees,ankles);also exp itchiness in palms & feet,thrombocytopenia
Chest tightness and pain like closing in, face flushed, redness of eyes, severe pain at lower back like shooting pain. I can't move due to the pain. Some difficulty of swallowing, blurry vision for few minutes
Patient noted malaise fever, chills night of injection. Following day rash began on face. Patient evaluated November 5. Diagnosed with upper respiratory infection and cough. Provided albuterol inhaler and prednisone taper.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 82.76. No concomitant medication was reported by reporter. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021 and beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021, respectively. Product moved to clinic on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a brand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
pt recv vax 6OCT95 & OCT95 pt exp major decrease in energy level, dizziness & lightheadedness all day;16OCT95 pt fainted & was w/o energy all day;physical exam & lab eval on 19OCT95 revealed no other illness;
beginning of 3rd week after vaccination, head to toe redness/rash burning and itching... flushed head to toe happens intermittently last an hour. She takes benadryl and it resolves within an hour.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient in her 70s received PREVNAR 13, intramuscular, on an unspecified date, at 0.5 ml single, for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced pain and achiness in arm and severe cellulitis both on an unspecified date. The patient went to the doctor who prescribed BACTRIM. Outcome of the events was unknown. The reporter assessed the events as medically significant and related to pneumococcal 13-val conj vac (dipht crm197 protein). The information on the lot number has been requested. Sender's Comments: Current information is limited for fully medical assessment especially lack of details on the location and nature of cellulitis, site for vaccination and the time frame between the vaccination and the onset of the events. Considering the plausible time association, the technique issue during the vacation with PREVENAR 13 might have played a contributory role in triggering the occurrence of pain and achiness in arm and severe cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2017512487 same reporter/drug/event different patients.
Received 2nd  Covid vaccine yesterday at 2 pm; Signs/symptoms started around 11 pm last night; Was feeling fine then suddenly a "rush" over her body; Fluttering got worse in her chest, hx of chronic fluttering; Chest tightness, Shortness of breath, her HR and BP went up-- blood pressure was 140/95, pulse was 92, nauseated and felt like she achy all over and like she was going to just pass out; Lasted for a little while last night; Today doesn't feel like she will pass out but still doesn't feel well; Current signs/symptoms: HR 99; Fluttering in her chest that she feels is worse than her normal; Chest pain rated at 6/10- not radiating; Shortness of breath that she feels is a little worse than her normal; Soreness all over her body; Nauseated; Chills, slight headache; BP is normal today she states; RN referred patient to ER today due to s/s.