chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a lot of joint pain; muscle pain; she can barely walk; she puts pressure it hurts horrible; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 05Feb2021 (at the age of 80 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated, "she was calling because she got her vaccine shot Friday her second one and on 06Feb2021, Saturday she got lot of muscle and joint pain in her left, she means her right leg at the top, and it's so terrible that she can barely walk on it when she puts pressure it hurts horrible, and she don't know what to take for it. She stated, "Yeah it terrible the pain, she can't even walk, it been since she put pressure on it, and it's been since Saturday when she got the shot, Friday, if this was abominated, it was the second one that was bothering her. Department role and responsibility of the department was told to the consumer. She stated, now this pain, won't this pain go away, oh it's terrible. she was 80 years old and she can barely even walk. She needs to talk to somebody that can tell her what to do to help this so that she can start walking. She would like to know if there's anything she can do. She would like to know how long these symptoms will last. The outcome of events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Pain started immediately after injection of Shingrix on the left arm, and has continued since then, but has improved in the last day. Some swelling was noticeable on and around the injection site on the first day (10/24), and since then it has been progressing distally and medially. The injection site is not painful anymore but the area just distal and medial to it is red, warm and painful to the touch, and slightly swollen. Today (10/28), the redness extends for about 5 inches
No adverse event.  Error in administration.  Patient given pediatric dose of Covid vaccine (0.3 mL/10 mcg)
12 hours after injection angioedema of lips. 108 hours 4 1/2 days after sever angioedema of scrotum.
The LVN did not see that the patient had already received their COVID-19 bivalent booster since the information was documented at the back of the COVID-19 vaccine card and inadvertently administered the vaccine to the patient. The patient was observed for 5-10 mins post-vaccination. They were stable and did not exhibit any concerning s/sx that would have warranted additional medical attention. A follow-up call was conducted on 1/31 to check in on the patient and they said they were "fine" and aside from the arm soreness and body aches, no other concerning symptoms.
Patient appeared very anxious & verbalized nervousness prior to vaccines.  Three vaccines given without difficulty.  Patient was standing & talking to her mother when she fainted to the floor without apparent injury.  She did complain of a headache for about 10-15 after incident.  Staff remained with patient until she felt better (about 20 minutes).  Client left clinic with her mother & sister.
mild body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (mild body aches). At the time of the report, MYALGIA (mild body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adver se effects were reported; The patient inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same time.; This spontaneous report was received from a pharmacy student regarding a 12 month patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On 29-JUL-2019, the patient was vaccinated inadvertently (overdose) with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R030604, expiration date 23-OCT-2020, and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S002498, expiration date 23-JUL-2020  both vaccines for prophylaxis (strength, dosage, frequency and route of administration were not reported). No adverse effects were reported.
swollen right arm; rash in the right arm; she fainted; flu like symptoms; fever; tiredness; itchiness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (she fainted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and FATIGUE (tiredness). On 03-May-2021, the patient experienced SYNCOPE (she fainted) (seriousness criterion medically significant). On 07-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE RASH (rash in the right arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness in the right arm). At the time of the report, SYNCOPE (she fainted), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PRURITUS (itchiness in the right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE RASH (rash in the right arm), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given a dose of the COVID vaccine that had been drawn up the day prior and not disposed of
pt recvd vax;2 days later had inject site redness for 3 days;sxs subsided;2 wks later exp ha;was seen by MD;sxs had not subsided
soreness under her arm pit; Huge swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node). At the time of the report, AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node) 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.   No concomitant medication details was reported. No treatment medication details was reported.
Itchy and tingling skin, which later turned into allergic rash on arms, neck, chest and back. Later symptoms of dizziness, brain fog, neuropathy, hot flashes.
Patient reports next morning woke up with painful skin on leg with large oblong rash 5-6 inches long and 3-4 inches wide that lasted for 2 days.
8:00 pm Fever, Chills, Body Aches.  2/3/21- 8:00am- Sore Muscles, Fatigue, headache. In the middle of the night I had night sweats. 2/4/21- 7:30 am brain fog, and swelling and redness near the injection site.
Day following vaccine, patient experienced generally feeling ill as well as arm swelling, turning red, and being itchy and painful.
Developed 2 "welts" - itchy erythematous lesions in area of VARIVAX vaccine on left leg - dev. over past 24 hours about 8 days after vaccine.
No advers effects reported; 2 improperly stored doses of PROQUAD administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R080798, expiration date reported as 22-APR-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from -9 degree celsius to 8 degree celsius (2.62C), during 4 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.  Lot number R080798 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.; Sender's Comments:  US-009507513-1907USA015729:
Intussusception of small bowel - presented 10/13/20 to Hospital ED with lethargy, vomiting, and no bowel movement x 2 days.  Diagnosed with intussusception in ED on abdominal US and was reduced successfully with air enema.
Pain and aches in left foot; Difficultymoving toes and walking.; Pain is moderate, but quite uncomfortable; Pain is moderate, but quite uncomfortable; around 5-6 on pain scale.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 18Apr2021 at 12:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included asthma, allergy to dust, molds and seasonal allergies. 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 COVID vaccine. The concomitant medications included salbutamol sulfate (ALBUTEROL SULFATE), fluticasone propionate (FLONASE) and unspecified allergy pill (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. On 18Apr2021 at 14:30, the patient experienced pain and aches in left foot, difficulty moving toes and walking, pain was moderate, but quite uncomfortable; around 5-6 on pain scale. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and aches in left foot, difficulty moving toes and walking and pain was moderate, but quite uncomfortable was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient came to ED with shortness of breath and cough.  Patient was admitted for Covid and treated with remdesivir.
could not lift arm;extreme pain;h/a, T102;fine, solid rash @ site of shot;spread down arm-had pneumonia shot in rt arm where pain & rash began;flu shot in lt-rash on this arm also;
Information has been received from a physician concerning a 4 year old male pt who was vaccinated with pneumococccal vaccine 23 polyvalent and 24 hours, post vax, the pt developed a fever of 103F. The pt sought unspecified medical attention. Additional information has been requested.
SERONEGATIVE RHEUMATOID ARTHRITIS; TEMPORAL ARTERITIS; This spontaneous report received from a patient via a company representative concerned a 70 year old female of an unspecified race and ethnicity. 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: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On an unspecified date in MAR-2021, 10-14 days after receiving the vaccine, the patient experienced severe left temporal headache for a few days, followed by intense low back pain. She was evaluated by a doctor 01-APR-2021 or 02-APR-2021 and diagnosed with temporal arteritis and given high dose prednisone. Symptoms had persisted for 21 months. On an unspecified date, patient had also been diagnosed with seronegative rheumatoid arthritis. Laboratory data (dates unspecified) included: MRI (Magnetic resonance imaging) diagnosed with rheumatoid arthritis, sero-negative, with joint erosion in hands and fingers. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporal arteritis, and the outcome of seronegative rheumatoid arthritis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221212413- Seronegative rheumatoid arthritis.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.]
Says shot did not hurt but 5-10 mins later he said he felt dizzy and his arm started to hurt (the arm which he received the injection in). His blood pressure and pulse rate dropped very low. 911 was called. By the time the EMTs arrived his BP and PR were normal.
After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of administration; tired; her arm was a little sore; the girl got a rash of the diameter of a lemon on her inner thigh, next day on both legs; This is a spontaneous report from a non-contactable consumer (patient grandmother). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 20May2021 (age at the time of vaccination 17-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included allergic to sulfa drugs. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient concomitant medications were not reported. It was reported that after receiving the shot patient experienced after receiving the shot she experienced the "covids bullseye", a circle on her arm at the site of administration, tired, her arm was a little sore. On Saturday, the patient got a rash of the diameter of a lemon on her inner thigh, so the reporter told her to only use sunblock, next day (Sunday) both legs were covered in a rash. Reporter looked on the Pfizer's website and saw that rash was reported in 0.001 percent of people who had the vaccine. Also, on Sunday, reporter took the patient to the doctor but he was not there, so she called a service (reporter did not elaborate on this) and a person told them that the rash could be from a serious disease called "petechiae rash" and told them to take patient to ER where she got the shot. Once in the ER, they told them that it was not the serious condition "petechiae rash" but that it was a "rash" and that they had never heard before of anybody experiencing a "rash" after the administration of the vaccine. Reporter wanted to know if "rash" has been reported as an adverse event of the Pfizer's COVID-19 vaccine, how long after the administration of the vaccine appears and how long it lasts. She would also like to know if we can call the facility to let them know that "rash" was reported as a side effect of the vaccine, since she was upset because she does not understand how someone in the ER does not know that "rash" was an adverse reaction and they had them thinking for a couple of hours that patient could be suffering of a serious disease. Reporter does not want someone else to go through this situation. Reporter mentioned that in the ER told them to wait 2 days and give Benadryl to patient, so she wanted to confirm if this was the right treatment for patient and if she should wait those 2 days to see if the rash was gone before she calls the doctor. Reporter wanted to know how long after the administration of the vaccine the rash appears and how long the rash would last. The outcome of the event was unknown   No follow-up attempts are possible. No further information is expected.
Cold sweats; swelling in the arm; large welt at the injection site; tiredness; body aches; headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache. Therapeutic measures were not taken as a result of the event(s). The events did not result  in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events of  cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Injection site is very sore; Been in bed since 2 last night/feeling very not well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well) and VACCINATION SITE PAIN (Injection site is very sore) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site is very sore). At the time of the report, VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well) and VACCINATION SITE PAIN (Injection site is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Reddening of cheeks, progressively worsened.  By 8AM on 12/29 the rash had spread all over the body.
Patient called to report adverse reaction the day after vaccine administration. Patient stated injection site redness and swelling as well as a fever and malaise. She said those symptoms progressed to weakness and pain in her arm at approximately 1 hours after vaccine. All continued the day after her vaccine, with some improvement in pain. Patient described pain as "almost unbearable" at approximately one hour after vaccination and that she could "barley move her arm by evening".
Patient was administered Moderna 0.5mL as second dose instead of Pfizer. No adverse events were reported.
In the middle of the night he woke up not feeling well and the parent went to give tylenol and the patient passed out.  They took him to the ER and he was administered fluids and he began to feel better.
Information has been received from a licensed visiting nurse concerning a 17 year old female who on 16-JUN-2007 was vaccinated with her first dose of Gardasil, 0.5 mL injection (Lot # 658556/U). After her first dose of Gardasil, on 17-JUN-2007 the patient developed bruising the size of a baseball on her right arm around the injection site. On an unspecified date the patient recovered from bruising around the injection site. On an unspecified date the patient received her second dose of Gardasil on her left arm and did not report any bruising. It was reported that the patient sought medical attention in the office. PQC was not involved. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills, Joint Pain, Headache, Myalgia, Fever, Nausea Narrative:  Used OTC ibuprofen and acetaminophen
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient felt queasy shortly after shot. Per patient, proceeded to restroom and experienced vomiting. Patient stayed whole 15 minutes for observation. Pt stated dizziness and that she was a little "out of it", but feeling better towards end. Temp monitered at end was 98.3F. Other possible factors: Slight bleeding at injection site which was staunched with cotton ball. Pt was aware of bleeding.