chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a fever; A sore arm near the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 14-Sep-2022 at 5:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 15-Sep-2022 at 12:00 PM, the patient experienced PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site). The patient was treated with ACETAMINOPHEN for Fever and Vaccination site pain, at an unspecified dose and frequency. In September 2022, PYREXIA (I had a fever) and PAIN IN EXTREMITY (A sore arm near the injection site) had resolved.            Patient received booster dose.  No concomitant medication was reported.
Pt reported a bruise  about 4-5 inches under the injection site on the same arm. (EMT) was notified. After speaking to administrator, it was determined that the bruising was on the arm prior to patient receiving the injection.
Severe soreness, redness, bruising, swelling to injection site that started the day after vaccine was administered.  Diagnosed with cellulitis and treated with antibiotics.  Also fever up to 104.2 that stared about 26 hours after vaccine was administered with eyes burning, chills, extreme fatigue,  clear runny nose and some cough. Body aches. Fever up and down for 9 days with fatigue and body aches.
2 1/2 hrs p/vax pt became enraged, out of control & then spoke incoherently while in a trance-like state; pt slept brielfy & woke up in hysterics w/c/o being cold & stomach pains; pt went to ER & cont w/incoherent speech;
I was sick with a fever, body aches, chills, and headache starting 12 hours after and ending 48 hours after vaccine was given. I have continued to have a headache ever since the vaccine was given, and cannot get rid of it. I am now on day 5 after the vaccine and I still have a headache.
ran a fever and had aches, similar to flu.  by the time I woke up on Saturday am was back to normal
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (did not experience any side effects when she had the 1st injection). On 16th January 2019, the patient received the 2nd dose of BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced fever, nausea and unwell. On an unknown date, the outcome of the fever, nausea and unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, nausea and unwell to be related to BEXSERO. Additional details were provided as follows: This case was reported by the consumer for her daughter. The age at vaccination was not reported. Yesterday from the reporting date, the patient received the booster of BEXSERO and then a couple of hours later she had a high fever, suffered nausea, and was ill. She The patient did not experience any of these side effects when she had the 1st injection. At the time of this report, on the second day of vaccination, she still had a slight temperate and still nauseous. The reporter was seeking advice how long the side effects last as their doctor advised it could be 3 to 7 days.
Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 32L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Pt presented on 3/12/2020 (the day after vaccine was given) with red, very warm, somewhat firm skin, about 5-6 inches up and down, and about 3 inches wide on left deltoid. Pt was prescribed Clindamycin for left arm cellulitis. Pt presented the following day 3/13/2020 with increased erythema and induration about 10cm by 6cm. Cont'd Clindamycin, Benadryl, Ibuprofen, and cool compress as needed.
Client received her Moderna Covid vaccine dose 2 lot #: 027C21A and expires 7/1/21 at approximately 1:05pm. PHN noticed client had mask down and asked client to cover her nose, since she was waiting for her mother to get medical consult.  Client then reports she "just feels really hot." PHN  observes client is alert and oriented x4 and reports no dizziness, no shortness of breath, no blurred vision, and no chest pain. At 1:15pm, vitals are: blood pressure: 160/100, heart rate:81 and unable to get oxygen saturation due to long acrylic nails. Client reports not taking any medications, no known allergies and only has history of rosacea. PHN  alert Lead PHN to come assist with client who is having a reaction. PHN  assesses client and observes flushed face and rash on upper back and front neck area.  Client reports to  that she feels "lightheaded", PHN  asks  RN to get gravity chair and switch client to gravity chair. Client able to transfer herself to anti-gravity chair by herself. PHN  offered client Benadryl and client accepted. Client reports she can get family to pick her up.  At 1:18pm,  PHN  provides client with oral Benadryl 50 mg.  Vitals are heart rate: 81 and blood pressure: 170/100. Client reports she feels "hot", her head "feels weird" and she feels like her "heart is racing."  RN assists by fanning client. RN takes over vitals blood pressure: 180/130 at 1:20pm and client reports feeling hot everywhere. While PHN  is assessing client PHN activates 911 at 1:23pm.  At 1:25pm, client reports she feels "throbbing in her head and chest", "heavy breathing", "lightheaded" and PHN  notes flushed face. Vitals are: Blood pressure:180/120 heart rate:86 and oxygen: 98%.  Fire department arrives at 1:29pm and assumes care.  At 1:34pm client was wheeled out of facility on gurney and was taken to hospital.
Administration of wrong vaccination. Child received  0.3mL of grey top Pfizer 12+ vaccine  instead of 0.2mL of orange top pediatric Pfizer formulation.
Information has been received through the pregnancy registry from a certified nurse midwife concerning a white female with no medical history who tested negative for varicella antibodies before vaccination was vaccinated on 2/11/02 and 3/6/02 with a first and second dose of varicella virus vaccine live (639682/0576L). There were no local reactions at the vaccination site, varicella symptoms nor herpes zoster symptoms post vaccination. The pt reported that she was injected with the vaccine two days into her pregnancy. She had no adverse events but was concerned about the effect on the fetus. Her LMP was 1/19/02. On 3/19/02 a dating ultrasound was done and was 6 4/7 weeks. On 5/28/02 a MSAFP showed "costrun" normal limits. On 6/7/02 the results of an anatomy screen ultrasound were normal with no anomalies seen. Medications used during this pregnancy included prenatal vitamins 1 tablet every day from March to November and Celexa 20mg during the first trimester for PMS. On 11/11/02 the pt delivered a normal live born 9lb. 8oz. female. There were no congenital anomalies, complications or abnormalities. There were no complications during pregnancy. The pt had a primary c-section for cephlo-pelvic disproportion and arrest of descent and it was also noted that there was meconium in the amniotic fluid. There was no feature of congenital varicella zoster syndrome noted. Additional info is not expected.
Pt came in on 01/08/2002 with swelling of left thigh. Red. prickly rash resembling a heat rash, no warmth to touch. Tender and hardened.
Body aches; Head aches; Generally not feeling well; This is a spontaneous report from a Pfizer sponsored program  received from a contactable other healthcare professional and a non-contactable pharmacist. A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose number unknown, single for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR 11mg) on 03Feb2021 at 11 mg. Medical history and concomitant medications were not reported. Patient reported to pharmacist that after having the COVID vaccine she had body aches, headaches and generally not feeling well while taking tofacitinib citrate and COVID vaccine. The action taken with tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Immediately after Hep-B Shot: Burning hot face, tingly feeling in face; Sore injection site; Generally unwell. After a few days: Sore arm; Tingly/pins and needles in fingers on the arm of injection site. January 2018: Sore arm; Tingly/Pins and Needles in fingers/hands; Extreme back pain - knots along sciatica; flu-like sickness. Feb 2018: Mouth ulcers - 4 or more; Achy elbows (both arms); Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. March and April 2018: Hair loss, Mouth ulcers 4 or more; Achy elbows (both arms); Achy Knees - feet throbbing when standing still - big toes turning blue; Tingly/pins and needles in both hands; Tiredness; Sun/heat sensitivity. May 2018: Same as March and April; Numbness in face - 2 days; Fatigue lessening. June 2018: Same as March and April: Hair loss lessening; Fewer mouth ulcers (2); Wrists/hands ache.
Headaches, Extremely fatigue . I slept 18 hours .  06/25/2021
Patient is not having an adverse reaction. Patient had received 2 doses of Sinovac vaccine. Second dose was 4/29/21. Patient requested a booster dose of Janssen in order the return to another country. Booster was administered based on information that from CDC that if patient received a vaccine that is not authorized or approved by FDA may receive any FDA-authorized or approved vaccine 28 days following last dose on non-authorized vaccine. Filing report based on guidance of clinical coordinator due to lack of clear guidance surrounding boosters and vaccine not-authorized by the FDA.
A few hours post vax the pt developed hives mostly on the arms, and was itching all over. Pt was seen by a physician and Benadryl tablets were prescribed. The outcome of the event was not reported. Additional detail indicated that the pt had hives; red, raised on wrists, forearm and one side of neck. The pt denied shortness of breath or difficulty breathing. Symptoms resolved after two days.
Fully vaccinated, not eligible for booster.   COVID symptomatic breakthrough infection with inpatient hospital stay.   35 w pregnant.  Not in labor and baby showing no distress.
Throbbing inner corner left eye burning and tearing, redness, ?? blurred 2-3 days.
Pt recvd 1st dose of Hep B vax 26AUG91 & 24 hrs post vax devel hives on face & chest; hives subsided over next 24 hrs but fingers of lower extremities appeared swollen & pruritic; dx DPH; also devel swelling of lower lip; contacted MD;
Fever to 101.3, chest tightness, chills, nausea, heart racing, aching in multiple joints, no rashes.
About 30-40 min after receiving PEDIARIX, PREVNAR, ROTATEQ, and ACTHIB, mom said baby was not responsive. No color change noted, but baby was difficult to arouse. Vitals were stable, never desated. Back to baseline when came to.
Moderna COVID?19 Vaccine EUA  Itchy, red, hot, hard welt at site of injection that showed up suddenly 8 days post-vaccine. Arm was sore for two days with red welt present for 5 days post-vaccine, but the welt subsided and did not itch until it showed back up on day 8.
Redness and swelling on both legs. Ibuprofen 100 mg every 6-8 hrs.
Potential subcutaneous administration; a bump suddenly appeared on her left deltoid at the injection site; patient started to bleed more than normal; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number ZS3D7, expiry date 08-OCT-2024) for prophylaxis.   On 11-OCT-2023, the patient received Shingrix (subcutaneous, left deltoid). On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Potential subcutaneous administration). In OCT-2023, the patient experienced injection site swelling (Verbatim: a bump suddenly appeared on her left deltoid at the injection site) and skin bleeding (Verbatim: patient started to bleed more than normal). The outcome of the injection site swelling and skin bleeding were not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling and skin bleeding to be related to Shingrix.     It was unknown if the company considered the injection site swelling and skin bleeding to be related to Shingrix.   Additional Information: GSK receipt date: 12-OCT-2023 The pharmacist requested data following potential SC (subcutaneous) injections of Shingrix.  HCP (health care professional) stated that patient started to bleed more than normal, and a bump suddenly appeared on her left deltoid at the injection site.  HCP called EMS (emergency medical service).  No sign of anaphylaxis and patient not on blood thinners. The reporter consented to follow up.
This spontaneous report has been received from a medical assistant via company representative regarding a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were unknown. Approximately in 2012 (reported as 5 years ago), the patient was vaccinated with GARDASIL injection (dosing details were not provided) for Human Papillomavirus (HPV) prevention. Reporter mentioned that the patient became sick after receiving the vaccine at the office. She required medical attention and had to be airlifted to an unspecified hospital from the office. It was unknown if it was the first, second or third dose in the GARDASIL series. Outcome of the event was unknown. Causality assessment was not provided. Reporter considered the event to be serious due to hospitalization. Additional information has been requested.
Headache; Fever; Nausea; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/lot number was not provided) via unspecified route of administration, administered in arm left on 25Mar2021 12:00 (Age at vaccination: 29 years old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient had no allergies to medications, food, or other products. The patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19, since the vaccination, the patient had not tested for COVID-19. The patient did not receive, any other medications within 2 weeks of vaccination. On 28Mar2021, patient experienced fever, nausea, chills and headache. Patient had not received treatment for the adverse event. The outcome for the events was recovered on an unspecified date.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Next day excrutiating pain in opposite arm from shoulder to elbow then including forearm and eventually spreading to wrist and finger bones. Mostly on r side but also on side of injection. Felt beaten with a hammer and joints out of socket.  Fingers were hot and swollen, skin was tight. Unable to lift arm or bend/straiten
After receiving the Moderna vaccination  I received a rash  over my left arm. I also experienced a fever of 102.7  for 30 hours. I also experienced headaches and could not move. I was very weak, fatigued and exhausted.  It was also very hard to lift my arm the headaches continued for a week.  A couple of weeks later my throat was numb the soft pallet of my mouth was inflamed and I noticed a rash as well. It gave me a sensation of choking  at night. To this day I am still experiencing the choking sensation.
58 year old white male who received Influenza vaccine 10 days prior who developed non-painful swelling of left ankle that has persisted. pt has had influenza vaccine from various manufacturers without side effects. Non painful arthritis. Probably post infections. As per acknowledgement letter: arthritis resolved on own after 6 weeks
Pt came from a doctor office with a prescription for cephalexine 500mg. She experienced cellulitis and inflamation at the site of vaccine injection given to her 10/4/16.
Hives on legs and torso and they were multiplying; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic on an unknown date and ongoing. Concomitant medications included dulaglutide (TRULICITY) for diabetic from an unknown date. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient hives on legs and torso and they were multiplying. Therapeutic measures were not taken as a result of these events.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives on legs and torso and they were multiplying was not recovered at the time of this report.   The patient later received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:MOD-2022-646512: Master case
1.5 weeks post covid vaccine, started to have postmenopausal uterine bleeding.
Menstrual spotting late afternoon/early evening day after vaccine. Menstrual period started on time 2 days later. Spotting is unusual for patient.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication was provided.
Patient reported chest pain for 2 days and intermittent jaw pain after receiving his second Pfizer COVID vaccine on 4/22, and presented to the ER on 4/25 with a headache and emesis. An ECHO was performed and LVEF was 45%, and an EKG showed possible ST elevation. Per the Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine study there were no reports of STEMI being an adverse effect. Given the patient's ejection fraction of 45%, there was likely a prior medical condition the patient was unaware of and may have precipitated the STEMI rather than the vaccine . Hospitalized for 2 days and diagnosed with pericarditis.