chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 75 year old female patient with breast cancer. No drug reaction/allergies were reported. On 30-OCT-2013, the patient was vaccinated with her first dose of PNEUMOVAX23, (lot # H022280, Exp date 16-JUL-2014), intramuscular in the left arm, (dose and indication not reported). Concomitant therapies included ARIMIDEX. On 31-OCT-2013, the patient experienced pain and a nodule at the injection site. On 01-NOV-2013 the injection site became red, warm and swelling extended up to her shoulder from her elbow. She was diagnosed with cellulitis. She was given AUGMENTIN and consequently developed a clostridium difficile infection which required hospitalization at an unspecified hospital. The outcome of the events was unknown. The patient sought medical attention by saw in office. Additional information has been requested.
Narrative: Patient developed difficulty breathing approximately 3 minutes after administration of Janseen covid vaccine. Nurse administered Epi-Pen with patient reporting respiratory relief. Nurse did not report hives or tongue swelling. Patient was taken to the ER for further evaluation.
The family came to the Covid clinic on 6/26 for pt's second covid shot. The order was pended by me (an RN), and signed by the doctor on duty. I gave the shot for the Moderna Bivalent (pink top) 0.2 ml which is incorrect and an under dose according to the new guidelines. The pt should have received moderna bivalent (blue top) 0.25 ml. Moderna does not scan so the lot number was manually entered therefore not recognized by the system to be incorrect for the order that was put in.  A notice was placed, Provider has been notified.
Covid 19 monovalent vaccine was given instead of Covid 19 bivalent vaccine.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reaction, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of VAQTA (doses and routes of administration were not provided) lot # M036459, expiration date: 18-JAN-2018 and lot # M047658, expiration date: 28-AUG-2017. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA013231: US-009507513-1704USA013229: US-009507513-1704USA013737.
Arm that received vaccine developed large amount of swelling all the way down to elbow. Lump that developed that was about the size of a grapefruit, and was hot to the touch. Swelling peaked approximately 36-40 hours after shot. We used ice packs, Benadryl and ibuprofen to relieve discomfort. The reaction occurred over a weekend and we did not seek medical consultation.
diarrhea; This is a spontaneous report received from a Pfizer sponsored program . A Contactable consumer (patient his wife) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2; Solution for injection), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 03Mar2021 for Covid-19 immunization. It was reported he mentioned that his wife had a reaction with Pfizer vaccine like diarrhea in Mar2021, and he added that he experienced a pain in his arm where the vaccine injected. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349483 Different patient, same drug, different event
Lot #00244 Pneomovax vaccine administered on 9/30/09 in left deltoid. Within 2-3 hours after administering vaccine client developed a large area of redness & swelling about 4 by 6 inches - client  here today 10-1-09, for ZOSTOVAX - referred per Dr. 10/2/09 TC from client. She saw Dr was ordered Keflex 500mg 4xday for 10 days. Advised for return for ZOSTAVAX post all meds done.
Dose 1-3: Moderna Vaccine and dose 4 Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "Lymphocytic colitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "contact dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Dogs" (unspecified if ongoing); "Known allergies: Cats" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). Concomitant medication(s) included: LIALDA; FLUOXETINE; DUPIXENT; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OXYBUTYNIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Erethromycin, reaction(s): "Known allergies: Erethromycin"; Tamiflu, reaction(s): "Known allergies: Tamiflu"; Formaldehyde, reaction(s): "Known allergies: Formaldehyde". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Dose 1-3: Moderna Vaccine and dose 4 Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took a round of Paxlovid after testing positive for covid; Positive, notes: I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Reported as, patient took a round of Paxlovid after testing positive for covid. Patient symptoms had gone away, but she continued to mask. On the fourth day after finishing the Paxlovid, her symptoms reappeared. She tested positive for Covid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
at about 1730 pm on 12/30/2020 patient experienced chills.  He took 1 Tylenol tab 500 mg.  He went to bed and in the am the Chills had subsided.
heart was beating fast; shallow breathing similar to when she had COVID; thought she was having panic attack; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack). At the time of the report, HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: Heart was beating fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack). At the time of the report, HEART RATE IRREGULAR (heart was beating fast), HYPOPNOEA (shallow breathing similar to when she had COVID) and PANIC ATTACK (thought she was having panic attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Heart rate: Heart was beating fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Patient developed R inguinal adenopathy (1cm x 2) on 11/13/21.  On 11/14/21 she developed an erythematous papular rash on the R lower extremity and a few similar lesions on her chest and back.  Was seen by urgent care and told rash were bites.  Was seen at on  11/15 CBC, BMP, CRP drawn, all WNL.  The lesions on her legs became purpuric on 11/19/21.  Seen again at on 11/22, inguinal adenopathy decreasing in size, labs repeated including UA which showed microscopic hematuria.  At no time did she have fever.  No abdominal pain, no joint pain, no headache, no itching. BP 93/62--normal   Given lower extremity rash and microscopic hematuria, we are calling this HSP but it is a very soft diagnosis.  The feeling is that this is vaccine related, whether it be HSP or just a purpuric rash.
big red spot on her right arm; itchy; warm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash) 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.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash). At the time of the report, ERYTHEMA (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information included a cream for rash.
As expected, I had flu like symptoms starting at 10pm the night of the 2nd shot lasting 36 hours (chills, body aches).  After two weeks, I woke up on 2/26/21 (2 weeks after 2nd shot) with spots on both legs (lower half ).  About 10 on each leg.  Spots started out the size of bites but did not itch or hurt but right ankle felt hot and swollen.  Over the next two days, spots got bigger (about the size of a quarter) and more red.  Skin was tender to the touch.  Both ankles were not red, hot, swollen.  On 3/1/21,  I visited the dermatologist because the swelling had not gone down and the skin was still very tender.  They took a biopsy and had me do blood work, still waiting for results but they are guessing it is Erythema Nodosum casued by the vaccine.   It is now 3/9/21 and the spots have gone to bruises and are fading but the ankles/feet are still very swollen (even with compression socks and elevation), hot and painful.
Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.
pain/Achy all over/Stabbing pain like a knife throughout her body; low grade fever but went up to 100.6 degrees; Chills; Couldn't walk, loss of balance; Headache; Neck pain; Tremors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain/Achy all over/Stabbing pain like a knife throughout her body"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever but went up to 100.6 degrees"; CHILLS (non-serious), outcome "unknown"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Couldn't walk, loss of balance"; HEADACHE (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "Tremors". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was not sure she has the right department. Product was Pfizer Covid vaccine booster, latest vaccine She got it Tuesday morning. She states that she was recommended to take this vaccine by a family member who was a doctor, also had these reactions with the previous Pfizer Covid vaccines, but this time they are more severe. Patient reclarify some details as she was speaking very quickly, clarified information as So much pain, so sick she was crying and had a low-grade fever but went up to 100.6 degrees Fahrenheit Chills Tremors Stabbing pain like a knife throughout her body Couldn't walk, loss of balance Achy all over Headache Neck pain. Patient states hat her husband had some of these bad reactions from the Pfizer Covid vaccines, she did not specify which reactions, patient states her husband has not gotten any booster yet. Patient states she did not see information anywhere that showed any severity, she will talk to her physician to see if maybe her husband should take the Moderna vaccine next time instead of the Pfizer vaccine. Patient declines to complete a report. She just wants to find out if these effects are the usual reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201264913 similar report from same reporter;
Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced flu. (It was reported that the only time in his life he got the flu was the one year he got a flu shot.) Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Pt received Pfizer vaccination 1st dose at 1125. Pt was in observation area and complained of an itchy throat, mouth, arms and legs at 1138. No facial swelling noted. No hives or rash noted. VS at 1125:  BP 96/60,HR 72, O2 sat 98%, RR 14. VS remained stable. Given Benadryl 25mg PO at 1154. At 1214 pt stated that her throat stopped itching, her mouth still itched.  Her arms no longer itched and her legs still itched. NP assessed pt at 1220. Pt voluntarily left at 1223.   Had history of seasonal allergies (did not take allergy medicaitons prior to vaccination appt)
1-10-12 4 cm induration, tender, red, hot (R) arm. 1-11-12 2 cm induration, no redness, no tenderness.
Light headedness; Headache/stabbing pain at the front of her head near her temples; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FE3594) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: Unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Light headedness"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache/stabbing pain at the front of her head near her temples". The events "light headedness" and "headache/stabbing pain at the front of her head near her temples" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, her 17-year-old daughter received the Pfizer Covid19 Booster shot on 22Dec2021, 2 weeks later her daughter developed headache, light headedness which is intermittent at the beginning then progressed to constant headache. It described as stabbing pain at the front of her head near her temples. it only improves slightly for few hours and then it will go back to intense pain. It was also stated, they were seen 2 neurologists, they were in the emergency room twice, they had multiple testing done. Upon follow-up (16Feb2022) Updated information Included: Reporter address, Lab Test, Dosage Regimens (Lot Number), Event onset Date. It was reported that, it started 7Jan2022 and by 27Jan2022 has not left. States she has had CT, MRI and MRA and just did last night an overnight EEG that they don't have the results for. She relays the pain is the front of her head near her temples and it was a stabbing pain. States it was a 4 when she takes some meloxicam medication and a couple hours later is back to a 7 or 8.  No follow-up attempts are possible. No further information is expected.
dehydrated; body ache; fever, chills, and body ache, and pain in the muscle where vaccine injected; fever, chills, and body ache, and pain in the muscle where vaccine injected; pain in the muscle where vaccine injected; tired all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Muscle sore" (unspecified if ongoing); "Body ache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DEHYDRATION (non-serious), outcome "recovering", described as "dehydrated"; PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "body ache"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 30Nov2021, outcome "recovered" (01Dec2021) and all described as "fever, chills, and body ache, and pain in the muscle where vaccine injected"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "pain in the muscle where vaccine injected"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovered", described as "tired all day". Therapeutic measures were taken as a result of pain, pyrexia, chills, vaccination site pain, fatigue.  Additional information: Patient took 2 ibuprofen every 4 hours to manage symptoms and was extremely tired all day. Symptoms disappeared today, 01Dec, when patient woke up. Patient was muscle sore from working out on Saturday, 27Nov, which patient believe exacerbated patient's body ache symptoms. patient was not similarly affected after first two doses of Comirnaty. Patient was also dehydrated and had to drink a lot of water, which may have improved patient's symptoms. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd booster dose of vax on 25JUL93 & 13SEP93 pt seen by MD w/fever & swelling of the parotic glands; No further details were provided;
Severe bruising underneath left arm and down left side onto breast and torso. Swollen underneath arm and in armpit. Sore under vaccinated arm. Bruising began on Saturday (vaccine was given on Thursday) presenting as dots and rope like down the arm and under arm. Bruising on breast and torso appeared on Monday.
The patient received her first Moderna vaccine 6/15/21. She started to feel pain and discomfort radiating from her shoulder toward her neck on 6/23/21. She stated that her shoulder also feels "a little swollen" but no redness or inflammation is visable on the skin. The patient was seen in the ER 6/24/21 . X-ray of shoulder, neck and chest and Strep test were done. Dr told pt her lymph node in neck was swollen.  Dr told pt it was possible the vaccine cause the pain in should/neck and swollen lymph node. She was told to return to ER or see PCP if the pain did not resolve in 5 days.
noc sweats,chills, fever, warmth/redness @ site;all lasted 3 days following administration;
Large, indurated erythematous area around the site of injection.  Painful - worst symptoms at approximately 36 hours post injection.
Patient had received 1st dose approximately on 03/24/2021, 2nd dose on 04/14/2021. Pt was noted with swollen lymph nodes at the clavicle where he was seen 04/13/2021 for a virtual appointment for further eval.
RIGHT LEG BEGAN TO SWELL AND BECOME VERY TENDER AND RED EVENTUALLY SWELLING TO 10 INCHES. PT WAS VERY FUSSY, IRRITABLE AND IN SIGNIF.PAIN. THIS SIZE OF SWELLING PERSISTED FOR 10 DAYS
bilateral arm redness, swelling, and soreness Benadryl 25mg every 8 hours PRN x 1 day
Information has been received from a registered nurse concerning a female was vaccinated with two doses of RECOMBIVAX HB (manufacturer unknown). Subsequently the patient experienced developed hives on two occasions after the both doses. The patient was seen by a physician. The patient recovered on an unspecified date. Additional information has been requested.