chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache sweating, SOB, severe neck/body spasm, redness, nausea Narrative:  PREVIOUS REPORT on 1/13/2021: Original report was classified as severe from an ER visit. Today patient returned to ER c/o: his skin has noticeably turned red (chest and fate), hot and cold flashes, nausea, terrible headache (photo/phonophobia), clammy, severe neck (body spasms) similar to Sunday's reaction but today was worse. Also general malaise. LABS: COVID-19 negative Flu-A PCR negative Flu B PCR negative RSV PCR negative chest films and cbc wnl treated with ibuprofen 800mg and dark room patient denied CT of head at this time as HA was resolving-discharged from ED
Reporting side effects to first dose of COVID-19 vaccine. In addition to a sore arm, I also experience a headache, tiredness and fatigue x2 days.
The patient experienced an itchy, macular papular rash on her arms, back and chest.
temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed, a nurse administered the vaccine before they learned that it was not a good vaccine/no AE; temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed, a nurse administered the vaccine before they learned that it was not a good vaccine/no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  This case involves a 16 years old male patient who received a 0.5 ml dose vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AA and expiry date: 04-Apr-2021)  via intramuscular route in the right arm, on 12-Dec-2019.  The patient's past medical history, medical treatment(s), treatment(s) and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (FLU VACCINE VII) for Immunisation; and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Immunisation.  It was of actual medication error case due Incorrect product storage and product shipment delay. It was reported that temperature excursion caused because the Menactra was delivered 1 day late/longer than it was supposed to be. A patient administered the vaccine on 12-12-19 to a patient before they learned that it was not a good vaccine and they were told it needed to be discarded.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
had a hoarse, scratchy voice, actually lost her voice briefly about an hour; had a hoarse, scratchy voice, actually lost her voice briefly about an hour; scratching throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), APHONIA (non-serious) all with onset 29Mar2021, outcome "recovered" (29Mar2021) and all described as "had a hoarse, scratchy voice, actually lost her voice briefly about an hour"; THROAT IRRITATION (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "scratching throat".  Additional Information: It was reported that the reporter's wife received her 1st Pfizer vaccine dose yesterday and had a hoarse, scratchy voice, actually lost her voice briefly about an hour after patient received the shot. Then it just went away. Reporter asked, was it ok if she gets the 2nd dose? Patient had a scratching throat kind a lost her voice for a little while, about an hour after patient injection for her first injection and patient was wondering will that side effect should impact or whether or not patient got her second injection or not. Patient asked should she go ahead to get the second injection couple of weeks later or not?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a 69-year-old female patient regarding herself. Current conditions included allergy to aspirin and an unspecified disorder of thyroid. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously in the right arm. Other suspect therapies included AFLURIA (lot#, expiration date and route not reported) administered on the same date. Concomitant medications included DILTIAZON. On an unknown date in 2008 the patient got 2 bumps on her neck. She stated she continued to get these usually on the right arm where the vaccines were given. She described them as red, warm lumps that do get a white head. After they pop, they healed up. Treatment was not rendered for the events. It was unspecified if any lab diagnostic studies were performed. Patient sought an unspecified medical attention. The outcome of the reported events were unknown. Causality was not reported. Additional information has been requested.
I was suppose to get my second shot in march; Headache above eyes; Muscle Pain; Joint Pain; Fever 101 F; Fatigue; Nausea; creepiness in the Stomach; Insomnia; Annoying dreams; Aches in the back of head and Neck; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (creepiness in the Stomach), INSOMNIA (Insomnia), ABNORMAL DREAMS (Annoying dreams), PAIN (Aches in the back of head and Neck) and PRODUCT DOSE OMISSION ISSUE (I was suppose to get my second shot in march) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (creepiness in the Stomach), INSOMNIA (Insomnia), ABNORMAL DREAMS (Annoying dreams), PAIN (Aches in the back of head and Neck), HEADACHE (Headache above eyes), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever 101 F), FATIGUE (Fatigue) and NAUSEA (Nausea). On 09-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was suppose to get my second shot in march). On 17-Feb-2021, ABDOMINAL DISCOMFORT (creepiness in the Stomach), INSOMNIA (Insomnia), ABNORMAL DREAMS (Annoying dreams), HEADACHE (Headache above eyes), PYREXIA (Fever 101 F), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN (Aches in the back of head and Neck), PRODUCT DOSE OMISSION ISSUE (I was suppose to get my second shot in march), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications was not provided. Treatment information not provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow up document attached. Added new event. Denied consent for follow up
Sore arm and a month later intermittant throbbing pain daily and nightly.  Still continuing to this date of 11/03/2013.  Have tried heat as well as Aleve and Advil to no relief as well as heat.
Information has been received from a consumer concerning a 13  yr old female who was vaccinated with a dose of varicella virus vaccine live. Within the last month, in Mar 2005, the pt experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a consumer concerning her daughter, an 18 year old female without pertinent medical history and allergies to Cecore, amoxicillin and sulpha who was vaccinated with a dose of GARDASIL in May or June 2009 and "about 5 weeks ago" approximately on 07-SEP-2009 respectively. Concomitant therapy included YASMIN, CYMBALTA and ADDERALL. The reporter mentioned that on approximately 14-SEP-2009 "4 weeks ago" after the patient received the second dose of GARDASIL she started experiencing difficulty breathing and tingling sensations in her arms and legs. It was also reported that "about a week ago" approximately on 07-SEP-2009 the patient was hospitalized for 24 hours because her blood pressure and her pulse were erratic (pulse at 150 to 160). The reporter mentioned that her daughter was still having tingling, as well as joint and muscle pain and she does seem to able to get in a comfortable body temperature (she was either cold or really hot). The patient sought unspecified medical attention. Follow-up information was received from an office Manager who reported that the patient received on 20-MAY-2009 the first dose of GARDASIL (Lot # 661953/1130X) and on 26-AUG-2009 the second dose of GARDASIL (Lot # 661952/1129X). The reporter also mentioned that the patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. Additional information has been requested. 10/29/09:  Emergency Department records received for date of service 10/5/09.  Dx:  Narrow complex tachycardia Assessment:  Presents with dyspnea, described as mild.  No cough, sputum production, fever or chills.  No chest pain or discomfort. Tachycardic. Pleural effusion and pulmonary embolism ruled out. Admitted to hospital.
Patient had extreme sweating episodes for 1 week after administration. Patient did say that he had received steroid shot the next morning before. ZOSTAVAX but had not told us or checked the box indicating he had received steroids.
Seizure-like activity with rigid body, snorting, followed by unresponsiveness for 20 seconds.
Fever, body aches especially back, tired, headache. Fever for about 3 hours.  Aches about 24 hrs, tired about 24 hours, headache about 8 hours
sore arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3247, expiration date: unknown), via an unspecified route of administration at the age of 83-years, on 13Jan2021, at 0.3 mL, single dose (dose number: 1) for COVID-19 immunization. The patient's medical history and concomitant medications were none. It was reported that she had no issues with the first vaccine except a sore arm on an unknown date in 2021, got first vaccine on 13Jan2021, sore arm lasted a couple of days, states it was not too bad. The outcome of the event was unknown.
Off label use  [but is not immunocompromised]; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use  [but is not immunocompromised]) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced OFF LABEL USE (Off label use  [but is not immunocompromised]). In August 2021, OFF LABEL USE (Off label use  [but is not immunocompromised]) had resolved.            No concomitant medication was mentioned. No treatment medication was mentioned.  It was reported that patient is not immunocompromised and may be because patient is married to someone who is immunocompromised as he is a lot older and because of that she received the third dose.
This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a male patient (his or her grandson) almost died from a PREVNAR shot. No follow-up attempts are possible. No further information is expected.
Felt tired for about one day after his first vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired for about one day after his first vaccination.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired for about one day after his first vaccination.). At the time of the report, FATIGUE (Felt tired for about one day after his first vaccination.) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-372255 (Patient Link).
cold; developed hives; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cold and developed hives. The patient was asking if the events were normal and how long they last. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A nurse reported that a male pt inadvertently received a triple dose of Cholera vax. Subsequently, the pt developed an injection site reaction characterized by pain and redness which persisted as of 6/10/99. This is 1 of 2 pts from this facility who experienced this event following receipt of Cholera vax.
This case was reported by a physician via sales rep and described the occurrence of contact dermatitis in a 17-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, several days after receiving BEXSERO, the patient experienced contact dermatitis, folliculitis and rash. On an unknown date, the outcome of the contact dermatitis, folliculitis and rash were unknown. It was unknown if the reporter considered the contact dermatitis, folliculitis and rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's parent reported that the patient had rash on his legs few days after vaccination with BEXSERO. There was no rash near the injection site and no fever as well. The physician felt it was folliculitis or contact dermatitis. The patient's parents were concerned it was related to BEXSERO.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 12:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 12:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.61  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was stored on cooler 1, on 03-Nov-2021, Excursion duration At 8 AM: 36, 9 AM: 36, 10 AM: 36, 11 AM: 35, 12 AM: 36, 1PM: 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt reports having been positive for COVID x approx 2 weeks @ home; brought to ED with worsening SOB, weakness and cough; HX:  CADBG, prostate CA, thyroid disease; hernia repair; on HF NC with O2 sats 89-90%; started on dexamethasone; AHRF; DNI/DNR; condition worsened significantly; pt went into respiratory arrest and died in the hospital
Patient went home, before bed he started to feel chest tightness and throat tightness. After that resolved he woke up with worsening hives on flanks that spread over the next 3 days down legs and up trunk.
Patient admitted inpatient on 11/13/22 with COVID symptoms and tested positive. Patient also experiencing suspected marginal abruption of low-lying placenta based on clinical symptoms.
Patient came into the pharmacy on 10/3/18 with rash on his left elbow region and forearm, that is itchy. Occurring approximately one week ago which would be 9/26/18 per patient. Patient had his second dose of the SHINGRIX vaccination on 9/13/18 on his left arm. Patient was told to be seen by his provider.
First dose: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Aug2021 13:30 (Lot number: EW0177) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: he already had COVID before. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "unknown", described as "First dose: sore arm".  Additional Information: Description of complaint: The caller confirms he is a Pfizer Employee calling on behalf of himself. The caller mentions he tried to do it on the website but it wouldn't take. He is calling in regards to the COVID-19 vaccine. He clarifies that he had the vaccine on 15 or 16th of last month. He is still experiencing inflammation in his joints, he is very sore and he has a hard time moving without pain. The caller states everything has subsided except for his hips and legs. He is taking a pretty significant amount of anti-inflammatories every day which may last a day but the next it come back. He clarifies the pain comes and goes, but it comes more than it goes. It's hard to walk. He clarifies it's uncomfortable to walk. He has been thinking maybe it would go away as he is taking anti-inflammatories. He has been to the chiropractor, massage therapist trying to work it out but the the pain is just sticking with him.  Follow-up attempts are completed. No further information is expected.
Moderna COVID-19 Vaccine EUA: On 12/30/2020,  I just had slight tenderness/soreness at the injection site. On 1/5/2021, I noticed tenderness under my left arm pit. On 1/6/2021, I felt itching on my left arm at the injection site--the injection site looks raised, bumpy, and welt-like.  On 1/6/2021, I placed Cortisone cream on the injection site and following instructions to report side effects. I will continue to monitor.
This is an initial spontaneous report from a contactable nurse. This female nurse reported similar events for three different patients. This female Pfizer Sales Representative reported on behalf of a nurse for the second patient who was administered PREVNAR 13 injection unknown dose as a single shot at unknown time on an unknown anatomical site on an unknown date. Relevant medical history was unknown. Relevant drug history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccines taken within the last four weeks were unknown. In Sep2012 after taking the single shot of PREVNAR 13 the area around the site of injection was warm to touch and had redness and swelling around the site of injection. The patient was administered PREVNAR 13 as a single dose. Relevant lab data was unknown. At the time of the report patient was not on PREVNAR 13 as it was given as single dose. At the time of the report clinical outcome of the above mentioned events were unknown. Follow-up (19OCT2012): Follow-up attempts completed. No further information expected.
Severe Body pains, sweating, swollen lymph nodes under left arm. Took Tylenol every 4 hours for pain which helped slightly.
Child awoke early morning with very high fever and had a seizure. Mother called 911 and EMS came and took him to ER. Was given Tylenol and IV Fluids in ER. Dx with Febrile Seizure due to Vaccine.
Patient had Moderna #1 COVID-19 vaccine this morning in office. Due to history of anaphylaxis to PCN she waited for 30 minutes following injection. Near the 30 minute mark she reported having generalized itching, more pronounced in palms of hand and left ear. She denied lightheadedness, tongue itching/swelling, SOB, N/V/D, abdominal pain. No prior reaction to vaccinations in the past.  She was evaluated by myself and was in no acute distress. She had swelling and itching of left external ear and redness and itching to her palms. No rash was noted. Lungs CTA.    Patient was monitored in office for 30 minutes following reaction. She was given 50mg Benadryl po and 20mg Pepcid po. Ice pack applied to left ear for itching and swelling. Vitals remained stable throughout visit. Patient felt comfortable leaving, husband drove her. I spoke with her via phone four hours later and all symptoms had resolved other than fatigue.  BP 140/70, Pulse 93, O2 99%, Temp 97.7F