chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Little rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE RASH (Little rash at the injection site). At the time of the report, VACCINATION SITE RASH (Little rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment was medication reported   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received and  Added patient demographics.
3 hrs after vaccination - chills, shaking, h/a, couldn't move arms, legs, clammy, eyes rolling in back of head, decreased orientation. EMS called, taken to ER. While in ER, arms started to move. Legs wouldn't move. Admitted to hospital.
Information has been received from a nurse concerning an 11 year old male who's mother called 24 hours after the patient was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a 2 inch circle of bumpy redness around the injection site area and skin was hot to the touch. The patient's 2 inch circle of bumpy redness around the injection site area and skin was hot to the touch persisted. Unspecified medical attention was sought. Additional information is expected.
PATIENT RECEIVED 1ST DOSE 3/18/2021. On 03/20/2021 patient states she had an allergic reaction where her throat was very tight and had some difficulty breathing and swallowing. Two days later on 03/24/2021 she had huge blisters on both lips and her nose.  Patient states her nose and lips felt numb.  She states lips were three times the size.  Last week on 03/28/2021 her whole body started itching from head to toe.  The vaccine site was very inflamed and she had huge welts on her chest area and belly and lots of burning.  Patient has a tele visit with Dr. on 3/30/2021 and was prescribed prednisone and benadryl.  Patient states she has no history of any allergies whatsoever.
The adverse event was a vaccine administration error-- not the PCP's fault as they did not have the immunization record for the second doses. The Child did not have any reportable symptoms.   Vaccines invalidated due to repeats:  HEPB, HPV9, and TDAP.  Not validated or unvalidated: 3rd dose of Varicella vaccine
Rapid heartbeat; Palpitation; Arm sore/soreness on her arm; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heartbeat), PALPITATIONS (Palpitation), PAIN IN EXTREMITY (Arm sore/soreness on her arm), HEADACHE (Headache) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptoms lasted until  first two weeks of January 2021) from 27-Dec-2020 to January 2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore/soreness on her arm), HEADACHE (Headache) and FATIGUE (fatigue). On 31-Mar-2021, the patient experienced TACHYCARDIA (Rapid heartbeat). 31-Mar-2021, the patient experienced PALPITATIONS (Palpitation). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) at an unspecified dose and frequency. On 31-Mar-2021, TACHYCARDIA (Rapid heartbeat) and PALPITATIONS (Palpitation) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm sore/soreness on her arm), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received and added patient medical history, lab data, treatment drug and new event.
asthmatic; tightness in my chest; fever; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (aches), ASTHMA (asthmatic) and CHEST DISCOMFORT (tightness in my chest) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second 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 01-Feb-2021, the patient experienced PYREXIA (fever) and PAIN (aches). On 03-Feb-2021, the patient experienced ASTHMA (asthmatic) and CHEST DISCOMFORT (tightness in my chest). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthmatic, at an unspecified dose and frequency. On 03-Feb-2021, PYREXIA (fever) and PAIN (aches) had resolved. At the time of the report, ASTHMA (asthmatic) and CHEST DISCOMFORT (tightness in my chest) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant information was not provided.
8/13/21: Patient is a 46-year-old female presenting to emergency room today for further evaluation of urinary frequency, hesitancy, malaise and fever that started 3 days ago. She reports she is fully vaccinated for COVID-19 denies any sick contacts however she does work at skilled nursing facility as a CNA. Diagnosed with viral sepsis, COVID-19, metabolic acidosis, pancytopenia secondary to COVID-19 8/16/21: Patient discharged Home. Note: Received first dose of Pfizer vaccine on 12/30/2020 and second dose on 1/19/2021.
Nausea,  no appetite  &  little or no taste to food or liquid except water
Patient described pain at 10/10. Couldn't lift arm and has been like this for a few days; pain wasn't relieved with ibuprofen or Aleve.
Slight swelling, reddened area approximately tennis ball sized, tactile warmth, pain. Mom advised to apply cool compress & inform us if it worsenes.
Moments after receiving vaccination in the pharmacy, patient collapsed in the pharmacy waiting area and was unconscious for about 2-3 minutes. EMS was called for and arrived about 5 minutes after patient fell. He was very diaphoretic and clammy. According to EMS glucose, blood pressure, and heart rate were all normal. He declined to go to hospital for evaluation and remained in the pharmacy for about 20 minutes after EMS left to regain his strength. His wife was with him at the time.
Left arm swelling and redness @ injection site. Temperature 101.4, chilling.  Lymph node swelling in axillary region on 11/14/2021 and injection site area is hot to touch.
developed covid arm immediately after injection. Raised, very itchy, hot to touch, very painful, rash is circular and big.
five day with fever of 101-102, headaches, body aches, etc. but most noticable was 7 days later when I realized my hearing in my right ear was nearly non existent and tinnitus way up and hearing very echoy.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400079.
Crazy swelling in glands under arm painful difficulty in lifting up left arm that received flu shot.
Swelling in groin and face, severe itching all over body, began 24 hours after injection. Continued urticaria in weeks following. Allergist found high antibody levels in blood work, referred to Endocrine. Endocrine diagnosed with Hashimoto's, and Pernicious Anemia after blood work.
Patient presented to COVID vaccine clinic with CDC card. On the CDC card it had dates of Moderna 2/19/21 and Moderna 3/24/21, making them eligible for first booster. Patient stated she did not receive these doses so registration noted them to be entered as historical in database. When I went to enter them, there was multiple COVID vaccine administrations in there - even without entering these so said historicals I reached out to the local DOH and was told to submit VAERS report.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy; her arm was hurting bad yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 09:30 (Lot number: FC318) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: FA7484, Anatomical Location: right arm), administration date: 20Jul2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Her arm hurt". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 12Aug2021, outcome "not recovered" and all described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PRURITUS (non-serious) with onset 12Aug2021, outcome "unknown", described as "On her arm where the shot is, she has a knot there and it has a red circle around it. It is on her left arm. It feels itchy"; VACCINATION SITE PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "her arm was hurting bad yesterday".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect: No. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Prior Vaccinations (within 4 weeks): No. Any AE(s) require a visit to: Emergency Room: No, Physician Office: No. Investigation Assessment: No. Relevant Tests: No.  No follow-up attempts are possible. No further information is expected.
Patient fainted 3-4 minutes after receiving vaccine. Came to immediately. Refused any treatment.
Information has been received from a physician via a field representative. The reporter totally reported 4 patients of unknown age and gender: 2 were teenagers, 1 baby and 1 child whose age could not be determined but was described as immunocompromised. It was reported that one of the 4 patients received 2 doses of (Oka/Merck) VARIVAX. The immunocompromised patient had only one dose of (Oka/Merck) VARIVAX. The dose for the other 2 patients was unspecified. It was reported that 3 out of the 4 patients each developed shingles, including the immunocompromised child; the fourth patient developed unspecified reaction to the vaccine (it was unspecified what specified symptoms or reaction the patient developed, however the patient did developed). The physician did not define how long past the (Oka/Merck) VARIVAX the adverse events happened. One of the adverse events happened in December 2015 and another in February 2016. The time of the other 2 adverse events was unspecified. This report referred to immunocompromised child who developed shingles (the other 2 patients who developed shingle was captured in MAARS#1603USA004656). This is one of several cases reported from the same reporter. Additional information has been requested.
Pt initially called her doctor to let him know about the reaction and he let patient know that her reaction is a somewhat "normal" reaction.  Pt stated that the area around injection site was raised, red, warm to touch, and itchy.  Pt was not upset or worried after speaking to her doctor, but felt that she should let us know.
Muscle pain, tender to touch, Limited range of motion x 4 weeks. Treating with Ibuprofen and gentle stretching.
jaw bone bilateral area of face "jolting sensation" and then right side of lower back  tingly, kinda like when foot falls asleep. Have not seen a doctor
12 month old female patient received Pentacel vaccine /NO AE; Initial information received on 29-Jun-2020 regarding an unsolicited valid non-serious case from a other Health care professional (physician assistant).  This case involves a 12 months old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided. On an unknown date patient received concomitant medications which included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A).  On 19-Jun-2020, the patient received a fourth series of 0.5 mL once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ057AA, expiry date: 07-Nov-2020] via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was reported that, on 19-Jun-2020, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and should have only received HIB dose so consumer received 4th dose of IPV before 4 years of age and DTaP 3 months early (inappropriate schedule of product administration).  At the time of report, there were no adverse event symptoms.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
With the first dose on 8/13/21 my left knee, hip, and shoulder hurt. I also had some tightness in my upper chest/neck area. These symptoms lasted for 1 to 2 hours. Took Advil to help symptoms. With the second dose 9/3/21 I have had some itching through my fingers and legs. This lasted for about 1 hour.
Fever; Chills; they gave the shot way below the Deltoid muscle between the shoulder and elbow,; painful; red swollen arm; red swollen arm; A spontaneous report was received from a pharmacist (United States) on behalf of her parents. This case is in regards to one parent who was also a 69-years-old, female patient. Please note, the other parent is documented in a linked case (MOD-2021-031649). This 69-year-old female patient received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced: they gave the shot way below the deltoid muscle between the shoulder and the elbow (incorrect route of product), painful (pain in extremity), red (erythema), swollen arm (peripheral swelling), fever (pyrexia) and chills.   The patient's medical history was not reported.   Concomitant product use was not provided/unknown by the reporter   On 26Feb2021, the reporter states she took her parents to receive the Moderna shot. The patient received her first dose of Moderna's COVID-19 vaccine (mRNA-1273, lot number was not provided/unknown to the reporter) for COVID-19 prophylaxis. It was noted that the vaccine was administered way below the deltoid muscle between the shoulder and the elbow as stated by the reporter. Later that day, the patient developed painful, red, swollen arm which continues to be on-going.The patient also went on to develop fever and chills but it is not reported when the onset of these symptoms were.   Treatment for the events included Tylenol which was noted to be not helpful.   Action taken with mRNA-1273 in response to the events was not reported.   No causality assessment was provided by the reporter.   The outcome of the event, painful, red, swollen arm was reported as not resolved. The outcome of the event fever and chills was not reported.; Reporter'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.
Possible GBS 48 hours post injection. Inpatient 12/2-12/13 for back surgery. Discharged to Hospital. Rec'd 2009 H1N1 vaccine 12/15 with onset approx. 48hrs later. Readmitted to hospital 12/24/2009. Discharged to rehab facility 1/1/10. Patient has regained use of upper body and has limited used of lower body but is recovering.
Delayed reaction, swelling to left eye area around 24 hours post-vaccination. No bilateral eye swelling or additional swelling to the face/airway edema. No difficulty breathing.
Alcohol intoxication without complication and behavioral health admission. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Per pt she started to feel lightheaded, nauseous and have ringings in the ear about 5 minutes after the vaccine. Pt tearful, brought over to the observation area in a wheel chair and placed on cart.   First set of vitals @ 1753 : BP: 115/73 HR: 80 SPo2: 98%   Pt given water.   Second set of vitals @ 1758:  BP: 118/76 HR: 82 Spo2: 100%   Pt states she is feeling better and head of bed brought to 90 degrees.   Last set of vitals @ 1805: BP: 111/72 HR:84 SPo2: 98%   Pt states she is feeling better. Reminded to keep up with fluids. Feels okay to go home at this time.
My arm was sore for about a day or two and I felt really tired. I ended up testing positive for COVID in January 2022.
Sore arm initially, then 11 days later sore arm, redness and swelling.  Side of stomach, above hip, sore and tender to touch.  Pt states having fatty liver dx, and went to the emergency room for blood work and CT scan, which didn't reveal any abnormalities.
Rash (pruritic) and swelling distal and medial to the vaccination site that continued to migrate distally over the course of a week.  Treated at home with topical antihistamine cream and oral antihistamines.  Incremental resolution each day after the first two days, 95% resolved by day 6.  Adverse event did not prevent any ADLs.
No ADR Dose was administered after improper storage and handling of the vaccine Local Pharmacy dispensed the vaccine to the facility for a clinic. The facility was incorrectly informed that they could store the vaccine in their refrigerator overnight and administered the next day. No temperature monitoring being done so not clear whether the vaccine was exposed to a temperature excursion.
Fever; Every bone is aching; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had been in bed, had a fever and every bone was aching. The patient underwent lab test which included body temperature: fever on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PAIN IN INGROWN ARMPIT HAIR; THROAT MUCUS; ALLERGIES; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pain in ingrown armpit hair. On 31-MAR-2021, the subject experienced throat mucus. On 31-MAR-2021, the subject experienced allergies. On 31-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in ingrown armpit hair, pain at injection site, throat mucus and allergies was not reported. This report was non-serious.
Client took one pill Feb 4, 2019 no reaction. Took second pill on Feb 6, 2019 in the evening. On Feb 7/2019 in the afternoon, she started to feel "unwell, itchy". By 2/7/2019 in the evening client reported she took a bath and noticed a rash 5 -10 hive like red spots. She was very itchy and took BENADRYL. At midnight she woke up having a difficult time to swallow and had a really low pulse she stated at bout 40. She took more BENADRYL and called to report the reaction in the morning 02/08/2019. Public health nurse called her doctor and asked she be seen. Client states she had a bad reaction to tetanus 10 years ago and went to the hospital for it.