chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer, Case. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on April 1 to April 8, 2022 from lot number 084J21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccine administered on April 9 to May 11, 2022 from lot number 084J21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. We are working on contacting the patient and recommending re-vaccination. No ill effect post.
Administered (PEDS) Pfizer dose w/o dilution. Unable to reach family.
Severe lower back and Kidney area pain. Using Aspirin, Motrin, Naproxen taken from onset daily as needed and continuing at present, now some 2 weeks later.
Case number PHEH2014US013869 is an initial spontaneous report from a medical assistant received on 09 Jul 2014. This report refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: M13054) intramuscularly on 08 Jul 2014. On the same day, post vaccination, she experienced localize swelling and increased temperature at the injection site. She returned to clinic to report these adverse reactions. Seriousness, outcome and causality of the events were not reported.
My Dr ask me to write all my symptoms down..its a long list: headaches, muscles hurt ache, can't use, can't see like I could before, balance issues, memory issues, can't yell project my voice, don't have strength in muscles, bones pop and crack, fatigue, muscle feel like they are on fire or arthritis/ joints hurt, trouble remembering what things are even when looking right at the item, sensitive to cold,and light at times, kidneys hurt, after walking my muscles get stiff and I can't move, balance issues dizziness, rash that comes and goes, gained weight and couldn't lose, now losing and can't gain..lost 2 lbs from yesterday sensitive spots..neck back.shoulders hips, skin itches, sleep issues...can't sleep then that's all I wanna do, loss of appetite, other days can eat all day and never full but still losing weight. Had to go to a chiropractor cause I could not walk, was bed ridden for the month of June and July did not leave my bedroom. Went to the Dr July 5th 2013 cause of my eye sight went black in my right eye. He is sending me to a neurologist. Took them forever to respond back to get an appointment. I see them in September on the 6th....treatment is on going. Believe it may be fibromyalgia.
Stiff neck, both sides; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 13:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) and multivitamin, all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 14Jan2021 at 12:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced stiff neck, both sides and headaches. These events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of stiff neck and headache and included treatment with Tylenol (MANUFACTURER UNKNOWN), heat and massage. The clinical outcome of the events stiff neck and headache were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Myalgia, SkinRash, Rash, raised red area at injection site Narrative:
the spike/adapter broke into 2 parts: a top and a bottom; he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown , single (Lot number: HA3217, Expiration Date: Mar2025) and as dose number unknown , single (Lot number: HF5020, Expiration Date: Feb2025) for immunisation, Device Lot Number: F655, Device Expiration Date: 01May2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the spike/adapter broke into 2 parts: a top and a bottom"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side". Additional information: The diluent leaked out when the plunger was used, and they now have no diluent to go into the vial and they do not have the sterile diluent product and she is asking for replacement. The pharmacist was putting it together for the system to insert the diluent to mix and the spike did not go into the rubber, and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side. Verified that no patient was administered the Abrysvo vaccine with this issue and they reconstituted another one that was in the same package. Based on follow-up on 09Nov2023, it was reported that "The pharmacist who was mixing the product said the spike/adapter broke into 2 parts: a top and a bottom. She tried to plug them back together before adding the diluent, but it leaked out the side. They longer have the adapter pieces. She threw them away". Causality for "the spike/adapter broke into 2 parts: a top and a bottom" and "he spike did not go into the rubber and it locked but did not plunge into it so they used the diluent and it all leaked out and came out of the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.  Follow-up (15Nov2023): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2023): This is a follow-up report from Product Quality Group, new information included: event medical details added, this case was reassessed as Reportable for device part.  Follow-up attempts are completed. No further information is expected.
How long do the side effects last?; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not reported.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked how long do the side effects last. The reporter consent to follow up.
9:05 AM on 2/10/21 - Fever of 101.3F  with lethargy;  emesis x1 followed by  Respiratory distress (O2 sat 90% room air, RR 40); HR 115 regular rhythm; decreased breath sounds with rales upper lobes and no breath sounds at base; tranferred via EMS to local hospital ER where received 2L fluids and admitted to care of hospitalist service with primary diagnosis of "adverse effect of COVID-19 vaccination and possible pneumonia."  Presenting hypotension improved with fluid bolus  and Zosyn IV was started empirically.
Narrative:  Patient's wife called to report that patient developed a rash/ red raised area on the left ear lobe. Denies SOB, swollen lips/tongue/face.
sore arm; muscle soreness, like an ache "on and off" and then it went away; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; picking things up and dropping things; having a tingling feeling off and on but that went away; some weakness to her hand on the side of her injection; tired; Pain at the injection site; feel discomfort at the injection site; This is a spontaneous report from a contactable consumer (patient).  This is the first case out of the 2 cases. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, muscle soreness, like an ache "on and off" and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, picking things up and dropping things, having a tingling feeling off and on but that went away, some weakness to her hand on the side of her injection, tired and feel discomfort at the injection site. Reporter was asking "Is this something that happens to other people?" Reporter reported that she received her second dose of the Covid vaccine on Apr18 and from the time she got the injection she started having a sore arm. Reporter reported having muscle soreness, like an ache "on and off" and then it went away. Reporter reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. She had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group. The first vaccine dose was not painful, but the second shot was more painful and may have been given with a larger needle. She went on to report that "she had 5,6,7 days where I was picking things up and dropping things" and reported having a tingling feeling off and on but that went away. Reporter also reported having some weakness to her hand on the side of her injection. Patient had Soreness to her arm, tiredness and pain at the injection site. There was no product complaint reported. The clinical outcome of all the events were unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient
night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
I was having shortness of breath, weak, dizzy, and felt like passing out and vomiting. My hands became tingly and sweaty, I was taken to the emergency room.
Neck stiffness and headaches. 11/12/07 above pt was advised to see her regular MD for further eval and tx.
RED RASH (STARTED ON FEET AND STOMACH BUT NOW EVERYWHERE)/ ITCHY/ ALLERGIC REACTION SOMETHING; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, hydrocortisone, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. This report was non-serious.
10/18/18 Mother reported child had fever (mother did not have thermometer), numbness in legs, pain down his spine and pain in his arms. Nurse advised mother to have child seen by MD today. 10/19/18-Nurse called and spoke with mother. Mother reported child was seen in hospital ER on 10/18/18. Mother stated child had lab-work which was negative for mono and UTI and additional lab-work which were also negative. Temperature at time of ER visit was 100.4 (Mother had given child TYLENOL 30 minutes prior). As per mother, child was diagnosed with HPV vaccine side effects. Child was discharged home with instructions to take TYLENOL alternating with MOTRIN. Child has no abnormal symptoms today and attended school.
NOSE BLEEDS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleeds. This report was non-serious.
Dry heaves started within 4 hours: every 15 minutes for 9 hours:  I tried Pepto bismal but it didn?t help. I found an anti nausea pill from a previous surgery which was able to stop the dry heaves. Chills Horrible debilitating headache non stop Aches, pain, fatigue
Developed redness and swelling around injection site the next am. Increased in size to 12cm diam by 2pm today (9/27). Moderate tenderness and warmth to touch, T 100.6. 9/28/06 hospitalized for IV antibiotics. Varivax given 8/25/06 DC DX: Right thigh cellulitis. Status post varivax injection for DOS 9/28-9/29/06. 9 year old with 3 day history of right thigh swelling 1 day after receiving varivax vaccine in right thigh. Temp at home 101. Erythema and tenderness soon followed was seen in ER that night and received RX of Keflex. Had 2 doses of Kelfex but erythema and tenderness continued to increase. Returned to ER received 1 dose IV Clinidamycin. Had been afebrile no nausea or vomiting. Admitted and received IV clindamycin. Marked improvement in morning with decreased tenderness/erythema. Remained afebrile. After 2nd day of Clindamycin borders of erythema had receded and erythema had reduced to pink blotches. DC on 10 day course of Clindamycin. No labs or diagnostics tests were ordered.
Metallic taste in mouth within 1-2 min after receiving shot (tasted like sucking on pennies).  Lasted approximately 5 minutes.  Warm feeling in face/head, almost like I was blushing. Onset at same time as metallic taste, lasted no more than 5 minutes.
AT first only sore arm and fatigue. Second day extreme fatigue. Third day cough, congestion. Fourth day productive cough, fever,  headache (I get them often anyway), continued for 6th day then I got  laryngitis and  for 3 days (along with continuing other symptoms) and then an ear problem started - tooting and echoing sound in left ear -  (today 4/21 - echoing is still present) when I speak and when someone speaks to me. Saw an ENT - 4/19, MD - an ENT for that.She gave me AFrin nose spray, antibiotics, and Flonase to take.
Pt given DTaP, HIB, IPV, Prevnar 4/30/03. 5/1 T 102.1, inconsolable crying. Seen by Dr who Dx with febrile rx to vaccines. Lasted til 5/2.
Chills; Headache; Muscle aches; Intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician). An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Not available/provided to reporter at the time of report completion) administration date: Aug2021 for COVID-19 Immunisation, reaction(s): "Chills", "intense fatigue", "headache", "muscle aches", Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Not available/provided to reporter at the time of report completion) administration date: Sep2021 for COVID-19 Immunisation, reaction(s): "Chills", "intense fatigue", "Headache", "muscle aches". The following information was reported: CHILLS (non-serious) with onset May2022, outcome "recovered" (2022), HEADACHE (non-serious) with onset May2022, outcome "recovered" (2022), FATIGUE (non-serious) with onset May2022, outcome "recovered" (2022), described as "Intense fatigue", MYALGIA (non-serious) with onset May2022, outcome "recovered" (2022), described as "Muscle aches". It was unknown if therapeutic measures were taken as a result of chills, headache, myalgia, fatigue.  Additional information: It was reported that patient experiencing 1 day of chills and 5 days of headache, muscle aches and intense fatigue beginning the day after receiving her first booster (3rd Pfizer vaccine shot), 8 months after completing her primary vaccination course of two doses of the Pfizer COVID-19 vaccine. On the sixth day after receiving her booster shot, she awoke feeling normal with all symptoms resolved. She had experienced similar symptoms 1 day after each of the two doses of Pfizer vaccine that lasted only for 1 day each during her primary vaccination sequence of dosing. Facility type vaccine was unknown. It was unknown if patient received other vaccine in four weeks. It was unknown if patient has taken other medication in two weeks. She was not tested COVID positive prior to CIVID vaccination and was not tested positive post vaccination. It was unknown whether patient had any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have a autoimmune disease the vaccination activated it which caused a stroke. I was put on eliquis which was not affective so medication was changed to clomadine.
Slept 3 hrs. after immunizations woke and screamed for 8 hrs. No temp, no redness or induration.
Injection site pain and swelling same day. work to high fever, body aches, chills, injection site pain and swelling, chills
This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23(lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to the female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. She was vaccinated with improperly stored doses of VAQTA. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. Sender's Comments: US-009507513-1801USA004018.
Patient called on 10/13/23 to report that her arm was hurting, was red, was swollen, was itching, and felt warm to the touch. She said it had progressively gotten worse since she received her vaccine on 10/10/23. I told her to ice the area periodically, to watch to see if the red area grows, and to apply anti-itch cream (i.e. hydrocortisone) if it kept itching. I told her to follow up with her doctor for guidance on Monday 10/16/23 if she was still having trouble.
Hives all over the body; body aches; pain at the site of the injection on left arm; tiredness / fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN (LEXAPROFEN) and ALPRAZOLAM (XANAX) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue). On 29-Mar-2021, the patient experienced URTICARIA (Hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) was resolving and PAIN (body aches), VACCINATION SITE PAIN (pain at the site of the injection on left arm) and FATIGUE (tiredness / fatigue) had resolved. 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.