chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUARIX (Route: IM Body Site: Right Deltoid Lot No:379TF).   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable. This case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the non-serious unexpected event of malaise and non-serious expected event of headache. The events occurred  1 day after booster dose of mRNA 1273 vaccine. The rechallenge for third dose is not applicable as no additional dose is expected. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report   This case was linked to MOD-2021-370222 (Patient Link).; Sender's Comments: This case concerns a 42-year-old, female patient, with no relevant medical history, who experienced the non-serious unexpected event of malaise and non-serious expected event of headache. The events occurred  1 day after booster dose of mRNA 1273 vaccine. The rechallenge for third dose is not applicable as no additional dose is expected. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA (Food and Drug Administration) guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no know adverse events.
It was sore at the injection site for a day and one half.  Everything was totally normal until the 8th day after my shot. I then noticed a dime sized red spot that itched near the injection site. The next day the redness had spread above and below the injection site    And I felt a dull ache in my upper arm
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, injection site pain, fatigue Narrative:  Employee reports injection site pain/discomfort, headache, ("migraine"), chills, body aches, joint pain (in shoulders, arms, neck), "tiredness," nausea, and diarrhea. Reports has history of migraines, therefore had topiramate at home. Reports took Tylenol 1000mg once and topiramate 50mg once. Reports migraine is no worse/no better than ones experienced in past. Left work and went home early on date of report (day after receipt of vaccine).
Information has been received from a pharmacist referring to a male patient of unknown age. The wife of the patient reported this adverse event to the pharmacist. Patient's concurrent conditions, concomitant medication and medical history were not provided. ON 28-MAY-2015, the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot # and expiry date were not provided). "Three to four days later", on approximately 31-MAY-2015, the patient broke out in an unspecified rash under of his under arms. The patient then had unspecified neck and back pain (since an unspecified date of 2015). The patient had sought for medical attention by his wife speaking to pharmacist. The events were improved with unspecified therapy. The pharmacist reported that the patient was recovered and the rash had gone away (on an unspecified date of 2015). Additional information has been requested.
next morning had large welts, hives on back, extremely itchy.  on R side of back & shoulder about size of quarter to half dollar.  Lasted at least one week.  Had bleeding from scratching, but no infection.  Resolved in one week
Increase in squamous cells w/central hyperkeratosis, Actinic keratosis, & Seborrheic Keratoses. (07/20/2021) Cryosurgery on face
Within 2 hours of getting the vaccine, I developed a severe migraine, fever(100.1-100.4), chills, dizziness, extreme body aches, nausea and was very weak. Once the bulk of the symptoms subsided, a little under 48 hours after the vaccine was administered, I was able to resume to my daily life. I still have a lingering migraine, arm pain, body aches and a low grade fever of 99.9 now almost 72 hours later, but it is bearable unlike the immediate 48 hours following the vaccine. Over-the-counter medications usually take the edge off of my migraines, though they didn?t even come close to helping the one I currently have. I have been rotating Tylenol and ibuprofen since developing the side effects.
Arm swelling below site of injection with rash. Swelling moving down arm now at mid- forearm. Nausea and slight headache.
16 Year old received a 0.5ml Moderna booster after a complete 2-dose series of Pfizer. Only Pfizer has received authorization for boosters for 16 year olds.
Sick; Can't walk; Legs don't work; Never felt something like this before; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before). At the time of the report, ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment information was provided.
landed in the ER with one man having a BP around 220; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERTENSION (medically significant), outcome "unknown", described as "landed in the ER with one man having a BP around 220". The event "landed in the er with one man having a bp around 220" required emergency room visit. Clinical Course: Reporter stated that after she got it in October, her blood pressure has not been right since. It fluctuates with the highest reading at 220 but will hang around 187 (146 was lowest she can get it), said she had called before and was referred to CDC. Caller asking can the shot affect blood pressure. States she talked to 2 other people who experienced the same thing. Reporter stated she has had all Pfizer covid 19 shots and date of last booster: 24Oct2022. Stated she has talked to many people about this; 2 other people she talked to landed in the ER with one man having a BP around 220. States she called Pfizer right after this happened. She can only find 2 other people that this happened to. All she knows about the two people that experienced this too was that one and the other was a female from but lives in. One of them went to the ER. Reporter does not have any further information to do reports on them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201360920 Same reporter, same product, same event, different patient;US-PFIZER INC-202201361209 Same reporter, same product, same event, different patient;
received doses from vials that had been in the refrigerator past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from vials that had been in the refrigerator past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   reporter stated that she was not aware about any adverse event from the storage issue No relevant concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-363768, MOD-2021-363754, MOD-2021-363739, MOD-2021-363716, MOD-2021-363737, MOD-2021-364236, MOD-2021-364598, MOD-2021-364962, MOD-2021-364355, MOD-2021-364754, MOD-2021-364515, MOD-2021-364819, MOD-2021-364949, MOD-2021-364896, MOD-2021-364896, MOD-2021-365131, MOD-2021-365093, MOD-2021-365022, MOD-2021-364989, MOD-2021-364286, MOD-2021-364885, MOD-2021-364926, MOD-2021-365177, MOD-2021-364809, MOD-2021-363781 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up received contains non significant information added in inarrative supplement.
my arm where I got the vaccine is hard and painful to the touch; my arm where I got the vaccine is hard and painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch). At the time of the report, VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information were not provided.
Swelling and warmth of site, fevers, dizziness, chills, nausea.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The physician reported that the patient "years ago" had a titer drawn an unspecified time after receiving VARIVAX (lot #, dose, frequency and administration route unspecified) which resulted negative. Action taken with VARIVAX was not applicable. The outcome of the event was not reported. The reporter did not provide the causal relatiobnship of the event and VARIVAX. Additional information has been requested.
Itchy, swollen toes progressed to elbows within the first few days. The rash slowly began reaching her knees, ankles and thumbs. This lasted for about one week. There were days with minimal presence of a rash but then it returned initially on the elbows and the backs of heels/achilles tendons. Over a course of 2 weeks, the rash has flashed up in various areas for a few days at a time. Today (5/9/21) there is swelling and redness on her feet (bottoms and sides) and her fingers. There is a tingly sensation with movement and her skin feels tight to move. She is due to have second vaccine in 3 days.
Area of warmth and induration progressing from 0.25 cm x .5 cm small hematoma on 4/28/16 to 3 cm x 2 cm on (L) thigh anterolateral aspect in 4 weeks (5/19/16). Follow up is 6/2/2016.
Heart palpitations, Throat closing up, Sore arm Took Benadryl to manage allergic reaction.   Red, hot rash on arm that is still ongoing (10/22/2022)
Twenty minutes after taking Vivotif, developed facial tingling followed within 5 minutes by shortness of breath (difficulty breathing), anaphylatic event.  Husband is a physician and he treated the problem without hospitalization.
Lost focus; Extremely dizzy; Weak; A spontaneous report was received from a consumer, concerning a 52-year-old female patient, who received Moderna's COVID-19 Vaccine and felt extremely dizzy, weak, and lost focus.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, three hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025J208) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient became extremely dizzy, weak, and lost focus. The patient was taken to the emergency room (ER) and was so weak they had to put her in a wheelchair. Unspecified tests were conducted at the ER but nothing was found and the patient was sent home. Treatment included diazepam, although it was not confirmed.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, extremely dizzy, weak, and lost focus, was unknown.; Reporter's Comments: This report refers to a case of 52- year-old female patient who experienced events of extremely dizzy, weak and lost focus 3 hours after administration of mRNA-1273, lot # 025J208, Expiration date-unknown. Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiological factors, a causal association cannot be excluded.
This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effects on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. A patient described in this article had a lack of the skin reaction indicating vaccine activity. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A patient had what the authors described as a non-take, or a lack of the skin reaction indicating vaccine activity. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. The reporter indicated that five patients experienced this event; however, they are not presently identifiable. Additional reports will be generated if identifying information is provided.
light headed shortly after shot, had nap with odd dreams woke up went to sleep three hours later. about 4 am i was awake but could not move at all.all i could do is make small sounds untill someone could shake me and the rest of me was fine.
Roughly 25 minutes after receiving the vaccine, I experienced numbness in my face (both sides).  It lasted approx. 1.5 - 2 hours.  No treatment was sought as there were no issues with breathing.  The feeling returned to normal on its own.
Dtap was given instead of Tdap. Provider was notified. Mother was notified. No reactions reported by mother.
Fever 101.6; Severe body aches; Pressure in joints, head, eyes; Tylenol every 4 hours
redness, swelling, heat, soreness in injection area. Called Peace Health on 11/10 they told me to come in at 3:00pm they wanted to look at it they asked me to report and felt it would continue to improve, use ice or heat whatever makes it feel better along with advil I took Benadryl several time as well.
Body aches; Mild fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 13Mar2021 15:30 (at the age of 41-year-old) in the left arm, as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient was allergic to meloxicam. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccination. The patient was not tested for COVID-19, prior to the vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), CENTRUM MULTIVITAMIN started on an unknown date for an unknown indication. The past drug history included meloxicam (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. On 22Mar2021, at 07:00 after 9 days of vaccination, the patient experienced body aches which increased through the day, that night the patient developed mild fever and chills. It lasted one more day and then symptoms disappeared. These events resulted in doctor or other healthcare professional office/clinic visit. On 23Mar2021, the patient underwent a nasal swab and PCR test just to rule out any possibility and the result was negative. TYLENOL (paracetamol) was taken as treatment for the events body aches, mild fever and chills. The clinical outcomes of the events body aches, mild fever and chills were resolved on 23Mar2021 (lasted for one day as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
During the past year, I started to be less mobile. I could not turn my head, my back would not bend and I became very ill with a fever and chest and joint pain. The stiffening started shortly after the last shots and the fever began 5 months after the last shot. My fevers lasted almost 3 months. I went through many tests to try to find out what was wrong. 7/23/02 Hospital d/c summary notes add diagnosis of anemia. 8/22/02 Review of more complete hospital records indicates additional symptom of exertional dyspnea.
Likely bursitis of shoulder according to her PCP. Patient is experiencing pain and numbness. She is also experiencing immobility.
Localized area of redness & itching at injection site approx 6 hrs after inject. increased swelling and redness throughout night. Woke up 10/18/13 with larger area of redness, swelling and "heat". Patient was brought in to the office and examined. No shortness of breath, difficulty breathing or problems with airway - reaction is more localized to injection site.
Information was received on 11/21/03 provided a PQ reference number for Acel-Imune; no new safety information. The reported lot number for Hib-TITER (M240LL) is not a valid lot number. A quality assurance investigation could not be performed due to incorrect product identification. Information was received on 10/16/03 provided a PQ reference number; no new safety information. Information was received from an attorney concerning a 15 month old male child who received his fourth dose of Acel-Imune vaccine in the left arm on 7/30/98. Concomitant vaccines included his first dose of Hib-Titer vaccine administered in the left arm as well as his first dose of MMR administered in the left arm. Relevant medical history was not provided. Indication for Acel-Imune vaccine was immunization. Product was administered on 7/30/98. Dose regimen was 1 dose 1 time per day (IM). Concomitant medications were not reported. The reporter indicated that the child was diagnosed with autism after his MMR vaccination on 7/30/98. At the age of 3 years, the child developed violent tempers, did not talk, and he ate inedible items. This event was considered medically important (OMIC). No additional information was available at the time of this report.
Received vaccine along with FLUVIRIN on 10/8/13. Came into pharmacy on 10/17/14 with swollen, warm arm. Advised to go to hospital. Was right arm FLURIVIN was cause.
pt states that she only had sore arm after the vax but by the end of the day she had fever and chills then started hyper ventilating.  Her fever rose while she sleeping  to 101.  Next day pt still had 100 fever with chills.  She did not have any appetite and was nauseated.  Pt had the same symptoms the next day.  On  the third day pt had a 102.8 fever.  She took Tylenol and used cold compresses.  2/8/2021 pt states her temp was back to normal and went to see her PCP  and was instructed to go home, rest and drink plenty of fluid.  Pt was feeling better on 2/9/2021 so went to work but developed another fever 99.5 w/ fever chills.  She came home from work and slept.  She still has a low grade fever at this time.
Extreme dizziness, pain in shoulder, neck, arm (right).  Tingling in right hand and wrist.
1st Shingrix vaccine given 2 pm-urinated 10 x during the night., 2nd Shingrix vaccine given 7 pm, urinated 10 x next morning within 6 hours. Felt tingly all over the way I've heard that Shingles feels and had to go to bed. 2nd Shingrix 2/27/2020, urinated 10 times
itching rash, angioedema, throat tight & sore, dysuria, soreness, facial swelling, urticaria, also asthma;  low grade fever;