chrisvoncsefalvay/vaers-outcomes huggingface dataset:
never took her back for the second dose;   This literature marketed report as received from an other health professional referring to a female patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.       On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, route and dose details were not provided) for prophylaxis.         The patient's mother had never taken the patient back for the second dose of vaccine as there was so much going on it had been forgotten about long enough (inappropriate schedule of product administration).  A copy of the published article is attached as further documentation of the patient's experience.
Sunday afternoon she felt tired, slept and took day off on Monday.  Felt better on Tuesday and Wednesday.  Wednesday evening felt bad again, chills, fatigue, temp 99.4.  Normal for her is 97.  Chills, fatigue, nausea. Left chest pain like a bruised chest. Headache slight. Achy feeling.
PATIENT RECIEVED VACCINE AFTER THE BEYOND DUE DATE. THERE WAS NO REPORTED SIDE EFFECTS. PFIZER WAS CALLED ABOUT THIS.
Hurts like you know what; This non-serious 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 24-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts like you know what). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2nd shot yesterday (the day before reporting). And patient stated that hurt like you knew that.
No additional adverse effect reported; on 2/10/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-FEB-2020 ,the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112, expiration date 18-OCT-2020 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effect reported. No product quality complaint. The vaccine experienced multiple temperature excursions below 2 degrees Celsius (1.28C) for 2 hours and 30 hours. There was no previous temperature excursion. There was data logger involved.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients ), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients ), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  On 06-Oct-2021, vaccine was moved to fridge. It was reported that the vaccines were shipped in refrigerated temps and then re-frozen for storage once arriving the facility. The vaccine was partially thawed/liquid and underwent temperature excursion for maximum of 4 hours.   No Treatment medication reported.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 on an unspecified date (lot #659485/1715U). Subsequently the patient experienced severe arm pain, tingling, numbness and swelling on an unspecified date. No cellulitis reported. The outcome was unknown at the time of reporting. Follow up information was received concerning a 37 year old male patient with asthma and allergy to penicillin and E-MYCIN who was intramuscularly vaccinated with the first dose of PNEUMOVAX 23 at 9:00 on 04-NOV-2008 into the right deltoid. ON the same day the patient also was intramuscularly vaccinated with the first dose of FLUARIX into the right deltoid. There was no illness at the time of vaccination. At 11:00 on 04-NOV-2008 the patient experienced severe arm pain and required emergency room/doctor visit. No treatment was given. The reporter considered this case was due to FLUARIX not PNEUMOVAX 23. The outcome was not provided. Follow up information was received concerning the male patient who experienced severe arm pain with numbness and tingling on 04-NOV-2008. He recovered from severe arm pain with numbness and tingling on unspecified dates. This is one of several reports from the same source. Additional information has been requested.
Rash confirmed to be Varicella-vaccine strain 2 weeks after 1st dose of vaccine
Vaccine administered after being in fridge for 31 days. Patient remained in clinic for 15 min after injection. No reaction noted while in clinic.
less than 5min p/vax pt became unconscious, apneic & had a brief 1min focal sz involving face & eyes;hypotensive, pulse 50;airway opened, sent by amb to ER;pt weak & dizzy;dx vasovagal faint;
New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and "newsensitives to face cleansers".  The patient's medical history was not provided. Concomitant product use included face cleansers.  On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with "epinephrine quite a few times along with steroids and ranitidine". On 09-Jan-2021, the patient went to the hospital two more times for "breathing issues", however she was not admitted. On 10-Jan-2021, in the morning, the patient had "passed out" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are "bright red" and "burns".  The patient also experienced new sensitivities to the face cleansers she has used for over 12 years.  Action taken with mRNA-1273 in response to the events were unknown.  The events, anaphylactic shock, was considered newsensitives to face cleanser" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health District, per guidance from the Department of Health (DH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
This spontaneous report as received from a nurse concerning a 22 year old female patient. On 28-MAR-2013, the patient was vaccinated with GARDASIL dose 1. (Lot number, dose and route not reported). On 02-APR-2013, the patient was vaccinated with GARDASIL dose 2. (Lot number, dose and route not reported). On 04-JUN-2013, the patient was vaccinated with GARDASIL dose 3. (Lot number, dose and route not reported). The patient had not recalled first dose of GARDASIL, prior receiving the second and third doses of GARDASIL. No adverse effect. Additional information has been requested.
redness, tenderness, and warmth present to right delt surrounding area of vaccine that appeared 4 days after vaccination and day 11 is still present but improving. pt has been putting benadryl cream on site
pain in arm; allergic reaction in left upper arm; edema; itching; developed bump around shot/progressing bumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps). The patient was treated with HISTAMINE at a dose of 1 dosage form and DEXAMETHASONE SODIUM PHOSPHATE (CORTICOIDEX) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Oral Histamine and Corticoid cream were taken as Treatment medications.  Patient was also applying cold compress. Patient scheduled for second dose next week at the time of reporting and the doctor suggested performing adjuvant testing to see if she has some type of allergic reaction.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received which contains no new information.
Pt returned to clinic apprx. 15 minutes after receiving vaccines below with c/o hives, sensation of tongue thickness, and some hoarseness. Sxs relieved by Benadryl 50mg IM. Pt transferred to ER for monitoring.
Have been sick; Wrist has swelling in it/left knee has swollen up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) 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 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up). At the time of the report, ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up received on 06 SEP 2021 contains NNI.
At approximately 7:00pm on 7/7/2021, I started to show signs of an anaphylaxis reaction. Those include: lip swelling, facial swelling, moderate difficulty breathing, anxiety, and severe diarrhea. Since it was late in the evening, I treated with an Albuterol inhaler, which provided very little relief. On 7/8/2021, I went to Urgent Care and was given a course of Prednisone, starting at 60mg and tapering down. Lip and facial swelling and diarrhea continued to be moderate to severe. On 7/9/2021, my breathing condition improved while still on 60mg of Prednisone. Facial and lip swelling continued. Additional diarrhea continued, but not as severe. On Sunday, 7/11/2021, as I reduced to 40mg of Prednisone, my condition deteriorated starting at 10:00am. Facial and lip swelling worsened, there was quite a bit of difficulty breathing and more diarrhea. However, I started to feel a lump in my throat as well. An on-call nurse asked me to take 25mg of Benadryl-- which I did. On 7/11/2021 at approximately 3:00pm, I went to the Emergency Room. O2 Sat levels ranged from 88 % to 95% and my BP was in the normal range. At 5:00pm, I was given additional Prednisone orally to increase that daily does to 60mg. I remain on a tapering dose today-- at 40mg and decending.
Swollen lips for 5 weeks straight, lesions in the mouth, hives all over the body. I received prednisone and methylprednisolone. I even went into anaphylaxis and was rushed to the ER and given epinephrine. I, now have over 20+ new allergies that I have never had before.
Severe rash at site. Moderna # 025J20A, Continuing Pain thereafter. Second dose Moderna #028L20A January 20, 2020. Great and debilitating pain muscular and at joints. Rx Methylprednisone on February 9, Six day: six, five four, Three, Two and One tablets , 4mg. Relief to fourth day when symptoms reappeared. Patient is in extreme pain.
rash, center to left side of back; rash became very itchy; pain in arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraines.   On an unknown date, the patient received the 1st dose of Shingrix 50 µg. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, fatigue, localised rash and itchy rash. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the localised rash and itchy rash were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, localised rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had a reaction after her first dose of Shingrix that was given into her left arm.. Immediately after the injection she experienced pain in her arm and fatigue which lasted 2 to 3 days.  Five to six days after the vaccine, she developed a rash on the center to left side of her back under her bra area.  A day later the rash became very itchy.  The patient reported she had a history of migraines (unrelated, prior to receiving Shingrix) which might have contributed to her fatigue . The reporter chose to remain anonymous and did not want to provide her name, DOB (Date of birth), address, phone or any other identifying information.  The reporter was not able to collect lot or expiration date of the vaccine given because when the patient found out that GlaxoSmithKline was unable to give medical advice for her rash, she disconnected from the call. The reporter did not consent to follow-up. GSK note- there was discrepancy in the reported information about time to onset of rash and itchiness. In structured field it was reported as 5 and 6 days respectively but in narrative it is stated like rash appeared five to six days later. TTO for these events captured as per structured fields. Similarly event outcomes captured according to case narrative.
Left side facial swelling, redness, bumps. Improved within 4 hours. Left cheek bone still swollen and red after taking 2 Benadryl. (Have not had any facial filler or anything done to my face what so ever)
Student received 1st H1N1 vaccine 2 weeks prior. Student did not exhibit adverse symptoms.
pt noted large ecchymosis on lt upper arm during late evening 4NOV97;ecchymosis below hep A inj site approx 3inch diameter & extends to prox biceps;inj site ecchymosis;ecchymosis visible until approx 24NOV97;
felt pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (felt pain at the injection site) 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 VACCINATION SITE PAIN (felt pain at the injection site). At the time of the report, VACCINATION SITE PAIN (felt pain at the injection site) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Treatment information was not provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15 Jul 2021 contains non-significant information.
Severe pain in right arm up to shoulder immediately. January 14, 2022 diagnosed with bilateral PE Clots
Information has been received from a physician concerning a baby boy who was vaccinated with a second dose of ROTATEQ (Lot number unknown) and one month after receiving it, he experienced intussusception. At the time of report, the patient had recovered from intussusception. Upon internal review, intussusception was considering to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-JUN-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 248 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Widespread cutaneous reaction, scattered wheals/erythematous, acute urticarial reaction, began approximately 7 hours after immunization; cleared by 48 hours. Rx given hydroxyene 1/2 teaspoon every 8 hours PRN.
client received the 1st dose of Moderna COVID vaccine at 1:33pm.  Client reported to EMT  that she felt chest tightness. PHN joined team shortly after to assist. Upon arrival client was grabbing chest area with right hand. Client alert and oriented, EMT began vitals as PHN did assessment. Vitals: blood pressure:167/96, oxygen: 98% and pulse 56. Client was answering questions. Client answered having chest pain, tingling sensation to left arm, mild shortness of breath. Client leaned forward grabbing chest and stated pain was stronger. At 1:39pm, PHN called 911. Client reported no relevant medical history and no current medications. Per client only follows up with any provider as needed. At 1:43pm client reported having some tongue tingling, dizziness and headache. At 1:45pm client reported numbness to left arm. Paramedics arrived at 1:46pm and assumed care. Client declined to go to hospital, paramedics left at 1:51pm. Client stated she felt better, PHN gave ER precautions. Client would be leaving accompanied by husband. At 2:02PM client left facility with a steady gait
Patient given Hep A adult vaccine instead of Hep A pedi/adolescent vaccine.  Report filed, Patient's  guardian notified, state notified,  PCP and management notified.
This spontaneous report as received from a 76 year old female consumer (reporting on herself). On 03-JUL-2013 the patient was vaccinated with a single dose of ZOSTAVAX (Lot # not reported) (dose not reported, injection route). Concomitant therapy was not reported. On 08-JUL-2013, the patient experienced a rash after receiving the ZOSTAVAX vaccine. The patient did not sought medical attention. The outcome of rash after receiving the ZOSTAVAX vaccine was reported as recovering. Additional information is not expected.
patient received an expired dose of Engerix B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   On 30th December 2022, the patient received Engerix B. On 30th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The licensed practical nurse (LVN) reported that, the patient received an expired dose of Engerix B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B beyond the expiration date, which led to expired vaccine used.
The day after receiving the second Moderna vaccine for Covid-19, my taste and smell (which I had lost when infected with Covid-19 in January 2021), became disrupted. My smell and taste were changed so that most things smelled/tasted like melted/burned plastic mixed with something metallic.  Also, due to the severe change in diet, my stool was mostly mucus with reddish tints for three and a half weeks until I was prescribed steroids form my doctor (Prednisone).
pt mom's stated pt legs & feet (both limbs) were swollen; pt fussy; knot @ site of inject;