chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered pharmacist concerning an approximately 56 year old female patient with no drug reactions or allergies. Current condition of the patient included Hepatitis C. The patient had a previous history of shingles. On 02-AUG-2013, the patient was vaccinated with dose of ZOSTAVAX (lot number and expiry date reported as J001694 and 08-MAY-2013 respectively, dose and route unspecified). Concomitant medications included an unspecified pain and anxiety medication. On 05-AUG-2013, the patient developed itchy and painful blisters all over after receiving ZOSTAVAX. Some of the blisters were on the face of the patient. The patient sought medical attention (contacted pharmacist). No treated was provided. No lab tests were performed. The patient was not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
I went to the ER because I had a very bad headache that was in the front of my face, behind my eyes, but it usually starts at  by my neck and head, either one side or the other. I also had this squeezing under my ribcage. They did an EKG, which was normal and then told me to see a cardiologist. It took a while to get in, but I had my ECHO today and the Stress Test is scheduled for June 1st.   Last week, I started getting sticking pains in my joints and it's random. It lasted for a couple days, but I haven't had any since then. My headache is gone, but I still get the squeezing feeling from time to time.
Employee describes experiencing flu-like symptoms that began the morning after vaccination (1/27/21). She called out of work for 2 days. She rested and drank fluids and was able to return to work 3 days post-vaccination.
First was a lump on the throat 30 minutes after getting the shot and it has not yet went away. Not sure if that counts as shortness of breath but I was still able to breath. It is 3 hours after when the first symptom started. Also within that time, extream tiredness,  severe headache and no energy. I didn't take any medication for the side effects but did take a nap.
skin issues; 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 SKIN DISORDER (skin issues) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (skin issues). At the time of the report, SKIN DISORDER (skin issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.
The patient received her 1st Covid 19 vaccine at 11:05 in her left arm. She waited in the parking lot for 30 minutes until 11:35pm due to allergies to Bees, ASA, Beta Blockers, PCN, Sulfa and Steroids. She came back in the parking lot at 11:44am and reported that she started having right sided face swelling and chest tightness. O2 sats 95%, HR 88 and BP 140/82. EPI auto injector x 1 administered at 11:48 am in her right thigh. 11:51 am O2 sats 97% and HR 70 and pt reports her chest was feeling better. 11:57 O2 98% and HR 68, 138/80 and pt check her blood sugar and it was 121. 12:08 EMS arrived and the paramedic reported her lungs were clear and her BP  was 128/68. Pt refused transport to the hospital and said she would rather go see her PCP. RN called and scheduled her an appt with Dr at 1:00pm. 12:29 O2 92%.
A report received from a health care professional on 06Dec02, concerning 30-40 vaccinees who experienced tapioca like objects in stools, mild fatigue, nausea and vomiting after receiving Fluvirin between October and November 2002. On 17Oct02 and 24Oct02, staff members at a long term care facility received Fluvirin and on 07Nov02, the residents at the facility received Fluvirin. Between 20-22 Nov02, 30-40 vaccinees experienced tapioca like objects in stools, mild fatigue, nausea and vomiting after receiving Fluvirin. The family members of the affected staff members also experienced the same symptoms. Tests on the stools, water system and other relevant equipment around the facility were negative for virus, parasite and bacterial contamination. The reporter indicated that the Fluvirin vaccine vials were left at room temp overnight, and then subsequently stored in a refrigerator until administration. The vaccinees have not yet recovered at the time of reporting. The reporter has assessed the relationship of the vaccine to the event as possible.
Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine). At the time of the report, IMMUNISATION REACTION (Patient had a bad reaction after getting first shot of the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
This spontaneous report as received from a certified medical assistant refers to a 21 year old female patient with allergy to sulfonamides and no pertinent medical history. On 07-AUG-2006, the patient was vaccinated with the first 0.5 ml dose of (merck) VARIVAX (Lot # not reported) SQ and on 07-AUG-2006, received the second 0.5 ml dose of (merck) VARIVAX (Lot # reported as 0245F, expiration date 07-AUG-2006) SC. The medical assistant reported that o 22-APR-2013, the patient experienced negative antibody titers. The patient did not receive treatment for the adverse event. The outcome of negative antibody titers was unknown. Additional information is not expected.
12/29/22 presents to ED for "shortness of breath". PMHx of "afib on warfarin, Pulmonary HTN, CHF"
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 12/30 COVID swab, result: detected 02/01 COVID swab, result: NOT detected 08/03 pt cc: exposure: unknown 02/01 CXR IMPRESSION: No radiographic evidence of acute cardiopulmonary process.
no documented reaction to receiving this vaccine; vaccine exposure, freezer left open; This spontaneous report has been received from a registered nurse and refers to 4-year-old male patient. The patient had no known allergies, no listed medical conditions and no illness at the time of the vaccination. His concomitant medication included diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).   On 17-DEC-2020, the patients was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) T023917 has been verified as a valid lot number, expiration date reported as 09-JAN-2022, first dose, via subcutaneous route in right arm for prophylaxis (exact dose was not reported). The excursion was due to the freezer was left open. It was reported that the vaccine was ok to use. It was unknown if the digital data logger was involved. The patient had no documented reaction to receiving this vaccine.; Sender's Comments:  US-009507513-2012USA008918:
This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced muscle weakness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the muscle weakness, exhaustion and influenza-like symptoms were unknown. It was unknown if the reporter considered the muscle weakness, exhaustion and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter reported via chat. The age at vaccination was not reported. No information about lot or expiry was available. The pharmacist reported that the patient stated that she had all of the side effects from a dose of SHINGRIX and experienced muscle weakness, feeling exhausted, and like she had the flu. She felt so terrible that she did not want another one. Pharmacist stated, the patient did not receive the vaccine at her facility.
8-27-12: Received call from Cl. c/o's pain/soreness in LD area. Advised Cl to use cool packs to area & massage area. If no improvement call Dr - voices understanding. 10-4-12: Cl calls office & c/o's soreness in LD area - stated she had called her Dr. & he said maybe a nerve had been hit. Required no Tx.
The night following my vaccination I ended up with a fever of over 100 degrees Fahrenheit and also suffered from a severe headache and sore throat. The fever and headache subsided after 24 hours, but the sore throat and ulcers on my gum line remained for the next 3-4 days. 9 days after I had gotten the vaccine, I started suffering from what I thought was a significant MS relapse. The left side of my face went numb and started drooping, my legs went completely numb, and my vision went blurry.
Eyes hurt, fever ranging 100.4-102, sore neck, feels like the flu.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 06-JUL-2018, the patient was vaccinated with a dose of VARIVAX for prophylaxis, lot #M032358 and expiration date 05-JUL-2018 (strength, dose, frequency and route of administration were not reported) (expired product administered). No adverse effects were reported.
patient felt tingling senstation in lips with slight swelling after fifteen minutes, which the swelling stopped in lips but the tingling sensation traveled to the tongue. after 1 hour the tingling remained in the tongue but the lips no longer tingled. referred patient to seek urgent care or ER if the tingling sensation spread and persisted
Information has been received from a registered nurse concerning a 9 year old patient (gender not provided) who was vaccinated with the second dose of Varivax. Subsequently within days after being give the second dose the patient experienced injection site irritation. Additional information has been requested.
Client called office on 8/23/21 c/o "skin itching all over with tiny red bumps" appearing the following day after vaccination. Denies any other sx, however, client did state that he had trouble swallowing at one point the following day after sx began, but states he had not had any further instances of dysphagia. Advised client to notify his PCP and follow up in PCP office if warranted.  Followed up with client on 8/25/21 via phone call and client states "red bumps are almost gone"  and itching has resolved. Denies c/o any additional sx . client states he did not contact PCP as advised on 8/23/21  and declines need to do so at this time as well.
Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023; No adverse event; Patient received an expired dose from lot number 043H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 043H22A and AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) 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 event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023).    Concomitant medication not reported. The vial did not undergo any temperature excursions. Vial size was 2.5 ml Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730851:same reporter with diffrent patient
Pt. reported left upper arm swollen and hot to touch. Took Band Aid off around 10 AM 10/4/13 and it got worse.
redness, swelling, hot. Swelling and redness extended to a patch approximately 4 inches by 8 inches on arm. Some pain, lots of itching, rash appearance.
VASOVAGAL SYNOPE, PATIENT PASSED OUT AND FELL TO THE FLOOR (STANDING AFTER VACCINATION)
Chest tightness with wheezing, reactive airway, fever (up to 102), localized swelling, localized heat, localized redness, pain in the shoulder, minimal cough.
I got cramps in the right calf; muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 44-years old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included ubidecarenone (Q10), ergocalciferol (VIT D), ascorbic acid (VIT C), cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. No Allergies to medications, food, or other products. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunisation. Couple days after the second shot, on an unspecified date in Apr2021 (Reported as 05Mar202116:00) in her left arm, she got cramps in the right calf and she started to had joint pain in her right elbow and muscle pain that extended down her forearm. No treatment received for the adverse event. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007M20A) for COVID-19 immunization. No medical history reported. On Feb 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash). The patient treated with Cortisone at an unspecified dose and frequency. At the time of the report, erythematous rash (red rash 4 inches across) and pruritic rash (itchy rash) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. Most recent follow-up information incorporated above included: On Jul 21, 2021: Attachment provided. Reporter contact information updated.
Information has been received from a certified medical assistant concerning a 20 year old female patient with polycystic ovarian syndrome, depression, asthma and insulin resistance, and no known drug reactions or allergies who on 16-SEP-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL (lot# 660618/0572X). Concomitant therapy included ZOVIA, GLUCOPHAGE, spironolactone, XANAX, PROZAC, trazodone HCl and METADATE. The medical assistant reported that the patient experienced rash all over her body a week after getting vaccinated (approximately 23-SEP-2008). On 11-NOV-2008 the patient received the second dose of GARDASIL (lot# 661044/0548X) and reported the rash. On the night of 11-NOV-2008 the patient had trouble breathing and fainted. On 12-NOV-2008 the patient experienced 2 seizures at school and went to the emergency room and was hospitalized. During her hospitalization, the patient had 8 to 10 seizures and was transferred to the intensive care unit. On 18-NOV-2008 the patient was released because she was seizure-free. On the weekend of 22-NOV-2008 the patient was admitted to the hospital because of more seizures. She was still in the care of the hospital. Rash all over her body, trouble breathing, fainted, and seizures were considered to be other important medical events. Additional information has been requested.  12/31/08 Reviewed hospital medical records of 11/12-11/14/2008 FINAL DX: possible pseudoseizures vx seizure disorder Records reveal patient experienced fever, chills, felt unwell after HPV#2, 0548X, received 11/11/2008.  Had cold sore on day of vaccination.  Had witnessed tonic-clonic seizure activity w/tongue biting, loss of consciousness, & postictal confusion. Neuro consult done & tx w/antiseizure meds.  ICU stay.  D/C to home w/neuro & psych f/u.
pt recv vax & 7 to 8 days p/vax pt devel a rash consisting of small papules localized in elbow regions;rash on rt elbow was the size of a half dollar, & the rash along lt elbow had the appearance of a streak;
muscle aches; joint pain; fatigue; fever; chills; flu like symptoms for 36 hours , States the symptoms were" in and out; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by patient.  Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) for Menopause.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 36 hours , States the symptoms were" in and out), MYALGIA (muscle aches), ARTHRALGIA (joint pain), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) had resolved.            Treatment was given hydration after 1st and 2nd dose symptoms. Other concomitant product included unspecified Calcium supplement.   This case was linked to MOD-2021-396654 (Patient Link).
Itchy skin; Rashes all over the skin and appear specially at night; Patient is 32 weeks pregnant and received Moderna booster dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin), RASH (Rashes all over the skin and appear specially at night) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 040B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and LEVOTHYROXINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose). On 31-Dec-2021, the patient experienced PRURITUS (Itchy skin) and RASH (Rashes all over the skin and appear specially at night). On 18-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 32 weeks pregnant and received Moderna booster dose) had resolved. At the time of the report, PRURITUS (Itchy skin) and RASH (Rashes all over the skin and appear specially at night) had not resolved.            No treatment medication was reported.
pt recvd vax 23OCT95 & devel erythema approx 2cm below the inj site (14cm x 13cm in diameter);pt has not yet recovered as of 26OCT95;
After giving vaccines, patient appeared tired and laid back in chair and passed out, then patient started seizing for less than a minute. Patient began talking to us that she's okay and then several seconds later it occurred again. Afterwards, she needed time to rest and she was sweating. Patient became okay after taking rest and drinking water. She was also accompanied by her husband/boyfriend.