chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was still kind of chilly/ Chilliness; Resting heart rate dropped to 63; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer (patient) reported for herself that: A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown) via intramuscular route of administration on arm right on 30Mar2021 at 08:15 (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. Patient relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Obese and date is unknown. She said she is obese in the sense of being overweight but is not severely obese. ongoing cardiac disorder (She is on a lot of pills for her heart). Family medical history was unknown. Patient didn't had other vaccines before and no other vaccines within four weeks. Patient didn't had AE prior vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): No previous. The patient's concomitant medications were not reported.  On 30Mar2021 after couple of hours (09:30-10:00) patient experienced still kind of little chilly/ Chilliness and notice while resting her heart beats per second has gotten down to like /heart rate dropped to 63. Patients want to know what number would be too low for resting heart rate. She is not going to say sometimes she doesn't feel chilly but did notice it after getting the vaccine. She did low impact cycling for 30minutes to warm up and her heart rate up and now heart rate at rest is 78. While resting she is monitoring (around 70). She does not usually see it in the 60's unless she is asleep. Patient took lot of pills for heart this morning and didn't know if they were relevant or not. Patient didn't require ER or physician's office. The patient underwent lab tests and procedures which included heart rate: 63 on 30Mar2021 (heart rate at rest is 78. But it had dropped to 63). The clinical outcome of the event heart rate decreased recovering while chilly was unknown.   PSCC Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites, along with phone, with hours of 8a-8p, Monday-Friday, 9a-3p, Saturday and Sunday, prior to transfer, in the event of disconnection.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2016US027044 is an initial spontaneous report from a healthcare professional (pharmacy student) received on 14 Oct 2016. This report refers to a 64 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 29 Sep 2016. On 30 Sep 2016, the patient experienced rash lasted 12 days. The outcome of event was reported as unknown. Seriousness and causality of the event were not reported.
1-15 vaccination About 4 hours later, sat down for dinner and knee started to hurt. Started to get bigger and bigger; squishy. I knew there was fluid on the knee. It was very painful, swollen. I happened to be going see the pain doctor for monthly check up 1/22 prednisone 1/25 MRI; PT, pain doctor, able to prescribe prednisone.  *Effusion of the knee for 2 weeks.  *1996 I had middle meniscus surgery on that knee.
difficulty in breathing; dizziness, light headed; A spontaneous report  was received behalf of Consumer concerning a 84 Years-old elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, light headed and difficulty in breathing.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event as difficulty in breathing which considerable as seriousness and admitted in the hospital.   On an unknown date, the patient experienced the events as dizziness, lightheaded.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of the events difficulty in breathing and dizziness lightheaded was UNKNOWN; Reporter's Comments: This case concerns an 84-year-old female who was hospitalized with a serious unexpected event of dyspnea along with NS unexpected dizziness and lightheadedness. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient called to report difficulty taking deep breaths (chest felt tight), coughing, pain with deep breaths. Pain was felt mostly in upper back. Urged patient to directly go to ER or urgent care for evaluation and treatment.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 1092 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Injection site became very red, swollen and hot to touch. Patient states had lethergy, sore throat, very itchy at site, aches in arm, nasal congestion, tightness sensation in arms, puffy eyes.
Pt c/o redness, swelling, "lump at" injection site 7 ours after injection.
pt recvd vax & exp vomiting,high fever,malaise,arthralgia,& myalgia;pt was seen by MD who treated w/Tigan & APAP;
Narrative: 89yo male with hx of idiopathic pulmonary fibrosis, copd, htn, hdl, low thyroid, afib, on blood thinner died on 7/7/2021 at outside facility. No information provided on pt's death. Pt had received covid vaccines on 1/16/2021 & on 2/13/2021. Likely pt's death not related to vaccinations given long timeframe btwn death & vaccinnations.
No adverse event; 5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose; 2nd primary dose was administered prior to the recommended interval of 4 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks).    No concomitant products were reported.  it was reported 2 different incidents with administration errors. No treatment drugs were reported
Developed fever(100.3 F) and headache 10 days AFTER my second dose. I did not have these symptoms with the first dose or immediately after the second dose. The fever and headache lasted around 12 hours and went away without any further treatment.
Significant fatigue - Notable in 91 year old lady, with associated fall - Began day following injection and persisting at least three weeks later
One week after the vaccine, I had severe pain in both my calves. This persisted for 5 days and it hurt to walk. Then, on September 1, my hands and feet had pins and needles and went partially numb. The pins and needles feeling then moved up my leg. After many tests and a lumbar puncture, Guillain-Barré syndrome was confirmed.
hearing loss in her left ear; trigeminal neuralgia; vocal cord paralysis; debilitating pain; debilitating pain; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered intense facial and neurological pain and was diagnosed with trigeminal neuralgia. The patient also suffered hearing loss in her left ear and vocal cord paralysis. The patient's injuries were permanent in nature, and she experienced frequent outbreaks of debilitating pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered all the events to be disability.  Upon internal review, hearing loss in her left ear was determined to be medically significant.
All my joints have turned pink, mostly on my hands, and legs. I do also have Alopecia and arthritis , I feel my joints have been discolored, possibly from my second Covid shots.
Neutropenic fever - Initially treated with cefepime and vancomycin, scaled back to cefepime alone with treatment response observed. He also had inflammation and low-grade cellulitis of both great toes with ingrown toenails.  This was evaluated by podiatry and he had revision of both great toe toenails.  The lesion on the arm is covered by an absorbent Mepilex type of dressing draining well now showing no signs of inflammation. He shown a complete return of his platelet count is white count he had a nadir of 0.7 but now has returned to 0.9 and with the clinical improvement he will be discharged on 5 more days of IV antibiotics. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a office manager on behalf of physician assistant refers to a patient less than one year old (gender not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot number and expiry date were not reported) reconstituted with sterile diluent (DILUENT MRK) (strength, dose, frequency, route, lot number and expiry date were not reported)  for prophylaxis. The patient received the VARIVAX before the patient was one year of age on an unspecified date (drug administered to patient of inappropriate age). Officer manager refused to answer additional questions. No adverse effects reported. Additional information has been requested.
my eyes started burning, stinging and burning; my eyes started burning, stinging and burning; achy; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (my eyes started burning, stinging and burning), EYE IRRITATION (my eyes started burning, stinging and burning) and PAIN (achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT nasal spray), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMINS [VITAMINS NOS] and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (achy). On 04-Mar-2021, the patient experienced EYE PAIN (my eyes started burning, stinging and burning) and EYE IRRITATION (my eyes started burning, stinging and burning). At the time of the report, EYE PAIN (my eyes started burning, stinging and burning), EYE IRRITATION (my eyes started burning, stinging and burning) and PAIN (achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received included No New Information.
mom of infant came down w/varicella (chicken pox) 3 days p/child got shot;no other known contacts
Intermittent soreness and pain at the left arm of injection site; This is a spontaneous report received from a contactable physician. A 31-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on an unspecified date in 2021 (at an age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Two months after the vaccination on an unknown date in 2021, the patient experienced intermittent soreness and pain at the left arm at the site of vaccination. The patient was not treated for the reported event. The clinical outcome of vaccination site pain was not resolved at the time of report.  Information on lot/batch number has been requested.
after recv vax pt exp muscle aches, irritability. unable to sleep well 2 nights. also have lump in arm at inject site & lymph nodes are affected under that rt arm.
Medication administration error.  Patient was supposed to receive pediatric dose of Pfizer vaccine 0.2 mL . Instead, patient received 0.25 mL booster dose of Moderna on 11/12/2021 at 10:30 am. I immediately noted error as soon as I finished administering the vaccine and spoke with patient's parent immediately about the incident. I recommended that the patient wait 30 minutes for observation.  I then immediately called to report occurrence to a health agency. We were advised to let parents know about the error, have them wait 30 minutes,  and advise them that we would be in contact for information and guidance regarding the second dose of the vaccine once we receive instruction from the CDC's standpoint.  Patient was under our observation for 30 minutes post-vaccine administration and had no signs or symptoms of adverse reaction. Gave  health agency contact information and phone number to patient's parents to call with any additional questions or concerns and verbalized that we would be in touch to give further guidance on the plan for the second dose.
Patient reported tingling of upper lip, dry throat, sensation of bumps on skin of arms (though not visible to observer)
Patient reports within 15 to 20 minutes she experienced head pain in the back of head/neck, nausea, vomiting, abdominal pain, weakness, pale skin, pain in injection site, fever, Chills, severe pain on the right upper arm, pain with movement of right arm.
Patient became vaccinated with J&J on 3/20/21. Patient recently had SOB with activity and for the last 2 to 3 days has been having trouble walking about 30 feet. Patient is currently admitted since 12/27/21
Pt became diaphoretic, then "passed out and began twitching motions in his head and neck." Pt became very pale. Blood pressure fell to 90/60, 3 minutes after the event; lowered his head; gave him orange juice; pt rested until recovered.
1 st dose- 5 hours after given experienced - cold to lower extremities , and hands. Followed by night sweats during the night. Following day some discomfort at injection site, and muscle pain to left side of body, mostly in gluteus . Fatigue lasts 2 day after injection.  2nd dose- at time of injection sensation of warmth in right arm with pain to site. 6-7 hours later joint pain in hands, injection arm elbow, and right knee, some dizziness. During night increased pain in injection site, continued joint pain, new symptoms muscle pain in gluteus and lower calf's all left side. Around 4 am woke up with extreme headache, nausea, and joint/body stiffness. Symptoms subsided through the day, by evening around 7 pm only some joint pain, and injection site discomfort. Fatigue remains.
Patient has a large area of erythema, warmth and tenderness on her left upper arm. No discrete fluctuance. This was the site of her flu vaccine injection.
w/in 15 mins p/vax car driving home, grandmother described pt as foaming @ the mouth, eyes rolling back in head, apparently non-responsive; upon return to clinic aprox 1130AM; pt partially responsive to voice, crying a times, limp & drowsy;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, more than 20 years ago, an employee received a of RECOMBIVAX HB series (also reported as the name and manufacturer of the hepatitis B vaccine were unknown) (lot number and expiration date were not reported) (dose, frequency and route not reported). No other co suspect or concomitant medications were reported. It was reported that right now the employee had low hepatitis b titers. The outcome of low hepatitis b titers was reported as not recovered. This case is related to MARRS cases 1303USA011314, 1303USA014014. Additional information has been requested.
pt recv vax 19JUL95 & upon awakening 20JUL95 pt exp nausea w/o vomiting, lightheadedness, dyspnea, rt leg cramps & pain in the lt arm & shoulder;seen in ER dx viral infect or rxn to vax;
Patient noticed a red, swollen area on the same area as the 2 vaccines were administered. However, it did not occur until the day after the vaccination. It also was not in the same spot as the injection site. It was further down her arm, towards the elbow. She did not come to me until Monday afternoon. She said the site was not any larger than last night. I advised her, after talking to my clinical coordinator, so check with her doctor just to see if he would like to check it out also. She indicated she would do that tomorrow, if it was not better.
Pt was given her 4 month routine vaccines. Together with her twin sister. Pt had a mild reaction her ankles and calves with erythematous papulae. Scattered. No urticarial lesions. No resp distress. Pt was smiling and happy. Mild papular rash reaction had resolved within 30 minutes.
I and my husband had Pfizer covid-19 shot the same time and within the same week we both was labeled with having a stroke. Mine was a T.I.A. 3 days after my shot I had slurred speech that lasted about 30 minutes. After that time everything was O.K. with me. The store I had my shot is pharmacy.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient had no pertinent medical history. On 09-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot# and frequency were unknown. On 09-JUL-2014, the patient developed a red, raised, itchy area on her arm near the injection site after receiving ZOSTAVAX. Patient sought medical attention via phone call to pharmacy. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-OCT-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not reported). On 12-DEC-2011 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot# were not reported). The patient has not yet received the third dose of GARDASIL at the time of this report. The patient did not report any adverse experiences. Additional information has been requested.
Extreme headaches over 2 1/2 week period, 2 ER visits,  blurred vision, bilateral,  numbness and tingling in right hand,  CNS Vasculitis, Stroke
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, sickness, fever and weakness. On an unknown date, the outcome of the influenza-like symptoms, sickness, fever and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, sickness, fever and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and got very sick, fever (101.4 degree F), flu-like symptoms for 5 days and at the time of reporting she was very weak. The patient asked should she get the 2nd dose in 2 months and would she get as sick. Lab Comments: Lab test performed on unknown date.
Failure of the vaccine to prevent Herpes zoster infection. Onset of typical episode of shingles involving the facial nerve on the left side.  Pain over the left scalp, orbit, cheek.  Typical lesions on eyebrow and cheeks.