chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded.  Case will be re-assessed upon the additional information provided. 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.
Started not felling good; Blisters on face; Cold sores/Fever bilisters; Redness legs/Redness feet; Swelling legs/Swelling feet; Achy; Tired; Felt feverish, but no fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet) in a 40-year-old female 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 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever). On 21-Aug-2021, the patient experienced FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet). The patient was treated with IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet), PERIPHERAL SWELLING (Swelling legs/Swelling feet), PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include steroid and anti-viral medication.  Concomitant medication was not provided.
It was reported that a pt (5 of 13) received a Fluzone SV '00-'01 vaccination on 17 Oct 2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
Chills; Not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Not feeling good".  Additional information: Patient received first dose of the Pfizer vaccine on Friday and was told not to take any Advil and completely forgot and took couple of doses of Advil and "camkingi" (word not clarified) that have ruined the vaccine now. When paraphrased the concern, consumer stated, "Not Tylenol Advil. Patient was told to avoid Advil and should take Tylenol and forgot. Patient have been having chills, not feeling good and couples of doses of Advil between 03Apr2021 and 04Apr2021 and suddenly remember that patient was not supposed to take it. Patient asked was that going to ruin the efficacy of the vaccine or was it okay because patient reading the articles, they are saying it was perfectly ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine on 6 Jan 2010. On 7 Jan 2010 pt started having swelling, redness and fever of 102.9. Went to ER-given steroid injection on 8 Jan 2010. 8-9 Jan, site grew down to elbow. ER called pt back + was given Rocephin + Cindanycin. Since ABX's, swelling went down, pt has returned to good normal. Dr DX was cellulitis.
No adverse event; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    No concomitant medications were reported.  No symptoms were reported.  No additional doses, medications, or treatments were given.
10/26/2006 smallpox vaccination by vaccinia innoculation. Pt reports 1 wk F NS 4d multifocal pustular eruptions upper torso, gluteal area, UE/ LE. ROS otherwise negative.  No conjunctival findings. HR 75. COR PULM unremarkable. Lesions as described, only original innoculum site on LUE with eschar. Bilateral axillary LN L>R. No relevant PMHx or family Hx. Apparently spouse healthy. No children.  Our clinical impression was generalized vaccinia, low severity. Discussed role of contact precautions at home and at work, avoidance of patient care, monitoring for superinfection with both patient and his PCM.  Patient subsequently evaluated by Dermatology. They felt rash more consistent with vaccination folliculitis. Appreciated their evaluation and reference. However, in setting of LN on R as well and systemic sx (F NS) may be a mixed syndrome, or atypical GV. No change to our recommendations. Patient has excellent following and we remain available for urgencies or questions.
Patient received bivalent Covid vaccine as first dose in series instead of monovalent. No symptoms or adverse reactions
Client presented for flu vaccination and was vaccinated without incident. No history of problems after a vaccine in the past. Immediately after being vaccinated she became very pale and complained of being lightheaded.  No rash, no hives or difficulty breathing. BP 80/50; HR 60. Cool compress given and orange juice to drink.  School nurse was brought in to sit with client and observe her. 10 minutes later BP repeated and was same at 80/50 and color had improved and client reported feeling better. Client was released to the care of her mother with instructions to seek medical help if symptoms reoccurred or worsened. Nurse also recommended client be vaccinated in the future at her family doctor.
Hard, swollen, red, and painful several hours after injection. At home patient self administered hot compress. She called around 4pm to report her symptoms. Patient came into the office to be evaluated. Dr. looked at the injection site and noted that injection was given in the correct place and the correct medication was given. Vitals were normal. She was advised to go home and use cool compress. She returned to the office the next day and was sent to ER due to being allergic to several antibiotics, in hope that they could administer and watch her. She was having bright, hot redness down her arm with pain into her wrist. She was sent home with an oral abx that she did not take. Patient came in the next day and the redness, swelling, and pain and reduced.
Redness; Swelling; Hot; Hard lump; Hard lump; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hot), MASS (Hard lump) and INDURATION (Hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   This case was linked to MOD-2021-128176, MOD-2021-128305, MOD-2021-128576, MOD-2021-128649,  INC.-MOD-2021-128643 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-128176: MOD-2021-128305: MOD-2021-128576: MOD-2021-128649: INC.-MOD-2021-128643:
Felt I was on steroids; Totally dehydrated; Threw up; Chills; Both arms sore; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up), CHILLS (Chills) and MYALGIA (Both arms sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up), CHILLS (Chills) and MYALGIA (Both arms sore). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up) and CHILLS (Chills) had resolved. At the time of the report, MYALGIA (Both arms sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient did a CAT scan and blood test.   This case was linked to MOD-2021-127380 (Patient Link).
Headache; Tired; Arm was more sore; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 24Feb2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fluticasone propionate; salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX); both from an unknown start date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Feb2021 at 05:00, the patient experienced headache, tired and the arm was more sore that day than the previous day. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, tired and the arm was more sore was not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
itching of both palms and both of feet; Itching of both palms of hands that gradually got worse; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching of both palms and both of feet) and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J212A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced PRURITUS (itching of both palms and both of feet) and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching of both palms and both of feet) had not resolved and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. It was stated that patient went to doctor who did not prescribe anything as per patient.
This spontaneous report as received from a certified nurse practitioner who is a nurse midwife refers to a 19 year old female patient with no known drug reactions/allergies and no other pertinent medical history. On 26-JUN-2013 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular (site and lot number not provided). There was no concomitant medication. On 26-JUN-2013, the patient fainted after being administered the GARDASIL, this happened in the physician's office. It was given oxygen to the patient as a treatment for the adverse event. No lab diagnostic tests were performed. HCP office sent the patient to the emergency room at a local hospital. The HCP office was not sure if patient would stay overnight at the hospital. The outcome of the patient was reported as recovering. The causal relationship was not reported. Additional information has been requested.
axillary swelling on right side; nipple soreness  (both); injection site still itchy, red and swollen
This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On 08-JUL-2016 (also reported as today), the patients were vaccinated with expired doses of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information is not expected as the reported did not wish to be contacted.
5 days after vaccine, began abdominal pain and a day later diagnosed with appendicitis and had appendix removed
Pt became pale, diaphoretic, reported dizziness and vomited several times after receiving the vaccines. He vomited for about 5 minutes, stayed pale and sweaty for about 30 minutes. VS were taken at symptom onset and BP slightly elevated at 130/78, but normal 10 min later. Blood glucose normal. After being told he could leave, ~30 minutes later he had another episode with the aforementioned sx about 3 minutes after. VS were taken, normal again. Pt's symptoms resolved ~20 min later and pt was wheeled out to car just in case, informed to eat a meal and drink lots of water.
Acute appendicitis with no perforation, abscess or gangrene. Laparoscopic appendectomy was successful
Employee had nausea, throat tightness, dizziness and chest tightness approx. 20 min. post vaccination. She stated, "I get nauseated after receiving the flu shot each year." She was given IV Benadryl and transported to Emergency Room via stretcher. Hospital is adjacent to another Hospital.
I broke out in hives but have never done so before in my adult life. I had not eaten anything strange nor left my house in 2 days. After taking some Benadryl, I was fine. No need to go to a doctor.
Information has been received from a legal firm regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury based preservative thimerosal. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up information was received on 6/28/02 in the form of immunization records. It was reported that the patient was vaccinated with a first dose of hepatitis B virus vaccine on 5/30/97; a second dose on 9/12/97; and a third dose on 12/29/97. Other immunizations included poliovirus vaccine on 5/30/97, 9/12/97, and 10/21/98l diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 5/30/97, 8/6/97, 10/14/97, and 10/21/98; haemophilus B conjugate vaccine on 5/30/97, 8/6/97, 10/14/97, and 6/16/98; MMR on 4/20/98 and varicella viru vaccine live on 4/20/98. The patient was also administered tuberculin purified protein derivative on 4/20/98 and 6/29/99, both with negative results. Follow up information received on 5/1/03 reported that the patient received injections that were alleged to contain thimerosal on the following dates: 5/30/97, 8/6/97, 9/12/97, 10/14/97, 12/29/97, 4/20/98, 7/16/98, and 10/21/98. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events (OMIC). No further information is available.
3/25/04: seen in clinic with history of MMR, Varivax, HIB vaccines given on 3/1/04. 1 week later began multiple/clustered red papules on left thigh at site of varicella vaccine. Today 8 vesicles, one beginning to rupture. No other papules on body. Yesterday, child awake wit bright red discrete-confluent macular rash on face. Today face rash fading. Few similar eruption on trunk and arms. She is happy, afebrile, active, eating and sleeping well as of today's visit.
the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of FLUZONE HIGH DOSE QIV due to this event with no reported adverse event; Initial information was received from on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 87 years old female patient who received the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] due to this event with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2022, the patient received influenza quadrival a-b high dose hv vaccine at a dose of 0.7 ml once (lot UJ926AB, expiry date - 30-Jun-2023) (formulation: unknown) via intramuscular route in the right deltoid for immunization and reported vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of influenza quadrival A-B high dose hv vaccine due to this event with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of fluzone high dose qiv due to this event with no reported adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Moderate axillary swelling and tenderness, same side as injection. Onset 1/9/21, no treatment sought as of now.
PATIENT CAME IN TO THE PHARMACY ON SATURDAY AFTER RECEIVING THE VACCINE ON THURSDAY. SHE STATED THAT THE AREA WHERE SHE RECEIVED THE VACCINE WAS VERY SWOLLEN AND HARD. SHE WAS ALSO VERY ITCHY. SHE WENT TO URGENT CARE, AND THEY SAID SHE MAY BE ALLERGIC TO NEOMYCIN AND GAVE HER A TOPICAL STEROID.
This spontaneous report was received from a consumer regarding his daughter, a 15 year old female patient with no pertinent medical history reported. In December 2009 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported), (dose and route not reported). The reporter stated that the patient received the second dose of GARDASIL on 25-MAY-2013. No adverse effect reported. Additional information has been requested.
Entire spinal com Lumpish aching and severe headaches from cervical one to skull
Pt received the Hep-B vaccine and had moderate to severe swelling and tenderness at the injection site on 3/2/02. By 3/4/02, the swelling and pain decreased and the pt made a good recovery.
Primary symptom was nasal congestion and sinus congestion along with a runny nose. I also had a slight headache, a little fatigued. It felt like a head cold.
Reaction - Red and swollen, warm to touch, itching - currently not as red, swollen, not itching Treatment - ice pack, ibuprofen, allegra, hydrocortisone.
On 10/2/22, my blood pressure went up about 10 points. I waited until Tuesday, and took it again, and it was still high. That is when I decided to go to the doctor, and they prescribed HCTZ along with raising my Metoprolol. If it doesn't get lower, they are going to double my mediation. My doctor is going to check up with me in about 10 days.