chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician.  A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020.  Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
On 12/19/18, 3 minutes after receiving PNEUMOVAX and while she was receiving the flu vaccine, the patient began to have acute onset shortness of breath, so I was called out of another patient room to re-assess. She was notably flushed, tachypneic, satting 88% on room air, lungs clear, tachycardic with regular rhythm. I requested my attending physician Dr. to assist me with management at this point. She stated she had to go to the bathroom, as she was having acute-onset diarrhea. She was helped to the restroom by MA and had profuse diarrhea, she subsequently felt too weak to get off the toilet, and was then assisted to the floor. While patient was helped to the bathroom, EMS was called for concerns for anaphylactic shock. Dr. and Dr. accompanied the patient in the bathroom. Vitals were re-obtained which showed BP 70/40s with weak distal extremity pulses. Two rounds of epinephrine injection 0.3mg given at 11:31 am on R) thigh, another dose of Epinephrine given at 11:36am on L) thigh administered by Dr. epinephrine Lot No. 7FM427; Exp Jan 2019. Benadryl PO 50 mg x1 was also given, and O2 4L NC was started. EMS arrived, and she was still alert and able to answer questions, though with slowed mentation and complaining of diffuse abdominal pain. Given concern for anaphylactic shock, she was emergently transported to the ED by paramedics. At Hospital ED, she received a dose of 10 mg dexamethasone IV and famotidine 40 mg IV, though vital signs were stable upon arrival. She was prescribed an epipen at the time of discharge from the ED. She was diagnosed with anaphylaxis and discharged home in stable condition. She returned to our clinic 12/31/18 for follow-up, and was notably in stable condition. She was referred to an allergist for formal testing, though it is presumed her anaphylaxis was likely secondary to either the PNEUMOVAX vaccine (which she received first) or the flu vaccine (which she received second). I suspect the reaction was more likely secondary to the PNEUMOVAX vaccine, as her symptoms of feeling short of breath started just prior to her receiving the flu vaccine, and she has received the flu vaccine 4 years ago with no adverse effects.
Blister at the side where HEPTAVAX was given with headache for a few hours.
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was administered M-M-R II (dose, frequency and lot number were unknown) intramuscularly. No adverse effect was reported. Additional information has been requested.
This is a spontaneous report from a non-contactable physician. This report was received via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms for 3 days following vaccination on an unspecified date with outcome of unknown. The reported event was considered non serious. No follow-up attempts are possible, information about batch number cannot be obtained.
Appendicitis; COVID-19; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of APPENDICITIS (Appendicitis) and COVID-19 (COVID-19) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-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 02-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant) and COVID-19 (COVID-19) (seriousness criterion medically significant). The patient was treated with Surgery (appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) The result was positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided. The patient was tested before having an appendectomy.; Sender's Comments: Based on the mechanism of action of mRNA 1273, event Covid 19 is unlikely related to the Vaccine.Very limited information regarding the event Appendicitis have been provided at this time. No further information is expected.
Headache and vomiting since she had a Janssen yesterday. Took some tylenol @1700 without relief. Denies chest pain, difficult breathing.
Fever, rash on chest, back, neck, (R) arm, warm to touch, sensitivity reaction.
4/29/21 patient reported rash, swelling, and itching at injection site (left deltoid)
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: Patient reports that the symptoms started the morning after she received the vaccine. She slept part of the day but felt very lightheaded and was throwing up a lot, so she called an ambulance and was treated with IV fluids in the ED. She reports a full recovery as of today, 6/28/2021.
I had typical flu symptoms for 36 hours after the vaccine, 101 fever, aches, and headaches.  Then I was fine for a week.  I exercised hard on Saturday, 9 days after getting the vaccine, and the symptoms returned.  They were much worse though.  I had a 103 fever for 9 days and severe headaches.  I still get headaches, which I rarely had before.  I took a covid test during that time and it was negative.
first GARDASIL 9 vaccine 2 years ago; This spontaneous report was received from a pharmacist who was reporting on 26-year-old male patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2018, also reported as 2 years ago, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (exact dose , lot number, expiration date, route of administration, anatomical location and strength were not provided) for prophylaxis. He did not receive consecutive doses yet (inappropriate schedule of vaccine administered), reported wanted to know if the patient needs to restart the series.
Pain in the collar bone and near the breast; soreness; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the collar bone and near the breast) and BREAST PAIN (soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX), SERTRALINE, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), CETIRIZINE, SIMVASTATIN and PANTOPRAZOLE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced BONE PAIN (Pain in the collar bone and near the breast) and BREAST PAIN (soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Pain in the collar bone and near the breast) and BREAST PAIN (soreness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Second dosing regimen added. Action taken updated from unknown to not applicable. Preferred term updated for pain. Outcome updated.
Ancillary  lymph node swelling and pain starting on day 5 after injection given, followed by a red, warm hive-like rash all around the injection site on day 7. Photos taken.
Mom called office 9:10 am 6/29/09 regarding Hepatitis A shot received in office on 6/26/09 - States child developed fever- 102 degrees Saturday 6/27/09 - 06/29/09 - Fever didn't occur til 6/27/09 pm along with rash to trunk and back. Has been treated with TYLENOL for fever.
No Adverse Event; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. Case 02428709 filed. AE cases 02428861, 02428862, 02428865, 02428779, 024288; This spontaneous report was received from an other health care professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUN-2023, the patient was vaccinated with dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot #W031810, expiration date: 05-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.     Administered dose of vaccine experienced the temperature excursion (product storage error). There were no additional adverse events reported (no adverse event).
Pain after shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comments; This case was reported by a patient via interactive digital media. The reporter stated that he/she had pain after shot. Additional supportive information: Follow-up would not possible, as no contact, details were available.
A non-serious spontaneous report of "gave the H1N1 vaccine to a 54-year-old" was received from a health care professional concerning a 54-year-old female. On 29-Oct-2009, the patient received single dose H1N1, Intranasal. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Information has been received from a physician concerning a 14 year old female who on 28-JAN-2011 was vaccinated with a dose of GARDASIL (therapy route and lot # not provided). On 29-JAN-2011 the patient experienced swollen lymph nodes underneath her arm. Vaccination with GARDASIL was reported to be continued. Adverse event improved after a week of onset. Patient sought unspecified medical attention. At the time of reporting, the patient' status was recovering. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was sitting upright then fell over to floor unconscious for 5 seconds, he slowly recovered Paramedics checked on him but he didn't want to go. He was fine
Pain on face, severe, area of trigeminal nerve; Pain on face, severe, area of trigeminal nerve; Pain on face, severe, area of trigeminal nerve from his ear to lower jaw; Pain on face, severe, area of trigeminal nerve from his ear to lower jaw; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, 1 day after receiving Shingrix, the patient experienced facial pain, trigeminal neuralgia, ear pain and jaw pain. On an unknown date, the outcome of the facial pain, trigeminal neuralgia, ear pain and jaw pain were not recovered/not resolved.   It was unknown if the reporter considered the facial pain, trigeminal neuralgia, ear pain and jaw pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by patient's wife. The patient received Shingrix 2 days ago and the day after he started experiencing pain on the right side of his face.  At the time of reporting, it was more severe and follows the area of the trigeminal nerve from his ear to lower jaw on the right. Additional Supportive Information: The follow up would not possible as no contact details were available.
This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) in approximately September 2009 "three years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that currently the patient had shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
Severe pain at injection site, started immediately at time of injection.  Site continues to be very tender to touch and painful to move arm. Taking Ibuprofen and also recommended ice to area PRN.
10 days later rash devel all over body;raised red;sore throat;malaise for approx 2 days
Information has been received from a certified medical assistant concerning one adult female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot #660717/0224X). Subsequently, the patient experienced an injection site reaction. At the time of reporting the patient was recovering. The certified medical assistant reported that last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up, the medical assistant reported that the patient was female and was vaccinated on 13-OCT-2008. In October 2008, the patient experienced a sore arm and a rash that could be attributed to the injection. Subsequently, the patient recovered from the sore arm and rash. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patients' hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the center and was released. This is one of several reports received from the same source. Additional information has been requested.
Arm swelling from shoulder to elbow, tight redness and hot to touch. Brought to ER 11/10 for difficulty breathing. High fever.
Pt developed throat tightness, coughing and itching several minutes after her vaccination. She reports that she had similar symptoms after her first dose of Moderna on April 16. She did not notify the vaccinator of this at our site. She states she discussed this with her doctor several days prior and was told it was ok to proceed with her second dose. She premedicated with Benadryl prior to arrival. No rash noted on inspection and no definite signs of anaphylaxis. BP 140/86, SP02 97%, HR 79. Transport to the ER was recommended for extended observation period but the patient declined. She stated that her symptoms were resolving when she drove home after appx. 35 minutes of observation.
injection site is red 9cm down my arm, warm to the touch, itchy,  and sore
PAIN FROM THE JAB WAS HORRIBLE; SO SICK COULDN'T DRIVE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced pain from the jab was horrible, and so sick couldn't drive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the so sick couldn't drive and pain from the jab was horrible was not reported. This report was non-serious.
Chills, fever, nauseated, vomiting, red, hot and swollen at injection site.
Vomiting, falling , walking into walls, turning into a rash that developed slowly overtime. Eventually being diagnosed as erythema multiforme.
The next day after the vaccine. the injection site was swollen about the size of a golf ball. It was hot to the touch and kept getting bigger day by day. By the 4th, it had spread over my whole upper arm.  I went in on the 5th to see a doctor.
Flu shot given 1PM Sunday 9-4-11. Pt. broke out with lg. whelping rashes on legs, arms, trunk. Large red skin eruptions, swelling. She went to MD was given steroid cream & shot.
Patient experienced syncope shortly after receiving vaccine while standing.  Patient fell and remained on ground per advice of EMTs who arrived and escorted via ambulance for evaluation due to the patient experiencing nausea and vomiting upon rising back up.
Swollen arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
One week after vaccination, patient awoke with intense generalized itching  (she described as a "internal burning itchiness" that was "all over").  She saw no rash or hives.  Continued for remainder of night, difficult to sleep.  Next day her husband found what he described as a few "faint, non raised patches of very light hives" on the patient's back.  She looked more carefully and found a few small similar patches on both arms and legs.  Treated with OTC lotion, CeraVe Itch Relief Lotion from store.  Patient says 12 hours after onset that the "insane burning/ itching has subsided for now."  Patient reports no new foods, clothing, washing machine detergent, illnesses, or other exposures.  I am a physician, and the patient called me (her brother) to ask me whether this was a known side effect of the Janssen COVID vaccine.  I did not see this described in the FDA advisory committee data package, but just a general reference that urticaria would be an expected side effect to a vaccine.
Throat tightening, BP 203/109; HR 80, RR 18, 100% RA; Prior to D/C 17mins later BP 179/104; HR 75, 100% RA.  No additional information provided.  Provider indicated that the patient was stable and released from the vaccination site with a recommendation to f/u regarding elevated BP.
Found pt crying for over 4 hours about 18 hours, post vax. Pt doing better at time mother brought baby in; bright and burning arm.
Death  3/31/2021 Causes of death listed on death certificate: 1) Cardiac arrest  2) covid 19 pneumonia
1 day after vaccine administration, leg was sore 2 days after vaccine a erythematous area surrounded site of administration. It measured 9cm x 7.5 cm.
Tongue turned bright red, became swollen and sore.  Took Benadryl.  Resolved in 3 to 4 hours.
20Nov90 pt vax w/ hepta B; Dec90 devel amenorrhea for 2 months. Resumed menses Feb91.
Blacked out around 2 am while trying to walk to the bathroom. Legs began to feel weak and I became extremely nauseous, the room became black and then came to while on the floor. Room was still black and had ringing in the ears. Symptoms lasted approximately two minutes.  On Sunday, two days after the vaccination a rash around my torso developed as well as some tightness in chest. The rash resembles that which occurs when I have reactions to antibiotics.