chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 2 hrs of injection - extreme fatigue Within 8 hrs - fever/chills/nausea/body aches/lightheadness, arm became so stiff/sore that I could barely lift it  It has been 48 hrs and the chills have stopped Treatment - Acetaminophen, drinking lots of water, bed rest (24 hrs)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Panic disorder" (unspecified if ongoing); "obesity" (unspecified if ongoing); "ptsd" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 30Jun2022 to 04Jul2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fatigue; Malaise; chills; fever; muscle soreness; headache; joint pain; rash; This is a spontaneous report from a contactable consumer or other non hcp.     A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included food allergy ongoing, known allergy eggs Concomitant medication(s) included pregabalin (LYRICA); hydrocodone bitartrate, paracetamol (NORCO); cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) duloxetine hydrochloride (CYMBALTA; meloxicam (MELOXICAM); camphor, eucalyptus spp. oil, levomenthol, Mentha spp. oil (RELI BALM). The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, The patient experienced fatigue, malaise, chills, fever, muscle soreness, headache, joint pain, rash on 26Feb2021 16:00 with outcome of unknown.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
1 week after getting shot, 2 weeks of bad headaches, fatigue, woke up during the night and I couldn't hardly turn over because of pain. Pain when raising arms, weakness and pain in legs. It has been 5 months since the shot and I am in a lot of pain everyday. My whole life has changed. Some days I get up feeling like I have been beat with a bat. Never had this before the PREVNAR 13 shot. I hope this is not permanent.
Pt admitted to facility due to acute hypoxic respiratory failure, tested positive for COVID-19 on 8/19/21
Three days after the patient received the Shingrix vaccine, she felt very ill, no fever, had cold sweats, muscle soreness all over her body, red rash approx 2 finger widths wide located 2 inches below her injection site, and general cold/flu symptoms. The patient was not sure if she was experiencing an adverse reaction from the vaccine or also had contracted a cold. Symptoms were managed with acetaminophen and ice pack for her arm. The symptoms resolved on the 4th day. No additional medical treatment was sought. She wished to report the event.
The side effects started almost immediately with dizziness and headache.   I then started to feel pain in my arm and nausea. By the morning (I work nights), I was vomiting profusely and continued to vomit the next two days. I had chills and fever, difficulty breathing, horrible headache, diarrhea for two more days, and my lower back and hip joints hurt to the point of making walking difficult. I could not afford to take time off work and had to work with pain in hip joints and lower back pain for two days. I was feeling better after the sixth day, but will not return for my second dose. I should have gone to the emergency on the second day, I was too sick to make a call.
Bells palsy; Soreness; Neck pain; A spontaneous report was received from a consumer concerning a 44-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness/ pain, bells palsy/ facial paralysis and neck pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced soreness, bells palsy , and neck pain. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, soreness, bells palsy, and neck pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inconsistent ability to taste (not at full capacity in weeks), and a ranging feeling of static or something similar in various parts of the mouth (possibly due to tongue numbness)
sever lymphadenopathy in left underarm 3inch lump, body aches, headache, fatigue
This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patients were inadvertently vaccinated with improperly stored ZOSTAVAX (lot #, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
8 years old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number YC97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 29-Jun-2022. Reporter's Comments: The physician assistant reported that an 8 years old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive Information: The 8 years old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
approx 1hr p/vax pt had a dull h/a on both of hip joints for aobut 30-36hr;
The patient had her 1st Moderna shot on 03/19/2021 and was  scheduled to come in on 04/16/2021 for her 2nd shot.  When calling to reminder her for her 2nd shot, she stated that she already recieved her 2nd Moderna dose on 04/09/2021.  She states she got the date confused and came in 1 week early.  This is only 21 days after her first dose.  The patient denied any adverse reactions after her 2nd dose.  The clinic on 04/09/2021 was only scheduled for second doses and it is still unclear how this patient got past the front desk check in process.
Redden & swollen @ inject site (lt deltoid) approx, 3 X 4cm;pt very irritable
Client was vaccinated with 0.2 ml of un-reconstituted Pfizer pediatric vaccine.  Client was observed for > 30 minutes, no adverse signs or symptoms noted during observation period and no complaints from client.
Felt a gripping sensation around her rib cage that radiated down her body/gripping feeling on the side of her body where it started at the rib cage(breastbone) and went all the way down; Felt a gripping sensation around her rib cage that radiated down her body/gripping feeling on the side of her body where it started at the rib cage(breastbone) and went all the way down; Felt the back of her throat was swelling/having a little swelling in the back of her throat; This spontaneous case was received on 11-Feb-2021 reported by other health professional (nurse) to Agency (reference number: SEQW21-00462) with additional documents received on 16-Feb-2021 reporter to Novartis (reference number: NUS2021US022355) and on 22-Feb-2021 reported to Agency (reference number: SEQW21-00682) by same reporter and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 19-Dec-2014, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, anatomical location, route of administration: not reported) for influenza prophylaxis. The batch number reported was 1412001 and expiry date reported was May-2015.  On the same day, within a half hour after receiving influenza virus vaccine polyvalent, the patient experienced a reaction. The patient felt a gripping sensation around her rib cage that radiated down her body and felt the back of her throat was swelling, this was not an anaphylactic reaction. This was also reported as, the patient felt this gripping feeling on the side of her body where it started at the rib cage(breastbone) and went all the way down, which eventually did subsided. The patient also experienced having a little swelling in the back of her throat and not severe where she wasn't able to breathe. The patient was advised to not receive another flu vaccine. The patient was going to see an allergist.  On the same day, after half hour, the patient recovered from the events.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed chest pain, pain and pharyngeal swelling on the same day after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. On the same day, after half hour, the patient recovered from the events. Causal relationship for all other events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed chest pain, pain and pharyngeal swelling on the same day after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. On the same day, after half hour, the patient recovered from the events. Causal relationship for all other events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Two days after pt. got vaccine, had intractable nausea and vomiting and abdominal pain
Pt was inadvertently given FLUMIST when at 29 3/7 weeks gestation in pregnancy.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX (batch number T5242, expiry date March 2019) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the arm. The healthcare professional reported that the patient had redness on arm basically a big rectangle from shoulder to elbow along with pain at the injection site. The redness lasted for 1 week with a slightly pinkish discoloration that resolved fully a few weeks later.
Fever as high as 103 for 36 hours.   Right arm sore for 24 hours.  Large swollen lymph node on R collarbone.  Painful for 48 hours, continues to be largely swollen.
a real sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "a real sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional Information: The patient received first Pfizer COVID-19 injection and not having any side effects except for a real sore arm. She treated the sore arm by taking Tylenol but it did not help. Eventually, the soreness in the arm went away. The consumer is scheduled to get her second injection of the Pfizer covid-19 vaccine but has not received it yet. If she gets a sore arm again, she plans to take Aleve to treat it instead of Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congestion, little sore throat  no horrible, slight headache but I haven't had medicine for it, tiredness. Overall hasn't been bad. My PCP put me on covid medicine today.
Excruciating sharp pains in middle of back, swollen in middle of the back and their is a not there.  Pain shoots up neck when trying to sleep. When applying pressure their is pain.   Has been going on since the first vaccine.
vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267336 same reporter.  This case involves 42 years male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid but have been deemed not suitable for use.  Patient past medial history, vaccination, treatment and family history not reported.  No other vaccine was given.  It was a case of actual medication error due to Product storage error.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  At the time of report 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 holder's 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.  Documents held by sender: none.
Patient states that about 12 to 13 hours after she received her shingles and flu shots, that she woke up in the middle of the night with fever (105), chills, trembling, body aches and pains.  Patient states that she was freezing with fever.  The fever came down to around 99.5 the next day, but patient was very tired and experiencing aches and pains.
1/25/13 Fri Local reaction at each site - pt. advised to take BENADRYL & apply cool packs to each site. 1/28/13 Mon Areas of redness & swelling have gotten smaller - child did attend school today.
Guillain-Barré syndrome - chronic progressive weakness and numbness since March after receiving J&J vaccine Complete loss of vibration lower extremities bilaterally, pinprick sensation diminished up to mid calf level Loss of reflexes in lower extremities and painful dysesthesia Differential included axonal variant of CIDP, or subacute inflammatory demyelinating polyneuropathy
This spontaneous report was received from a medical assistant, concerning an 11 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 26-JUL-2018, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis (vaccination), but might have possibly not received the full dose. It was described that when the syringe was being withdrawn from the patient, there was visible liquid leaking out of the syringe (underdose). It was also reported that the patient vomited for unspecified reason (vomiting) but did recovered a few minutes later that day and was fine to go home; so there was no need to seek medical attention. It was unknown if any treatment was given for the event or if any laboratory diagnostics studies were performed. The causal relationship between vomiting and GARDASIL 9 was not provided.
NEUROPATHY; CONDITION WORSENED; CRAWLING FEELING UNDER THE SKIN/FELT LIKE BUGS ARE CRAWLING UNDER SKIN; SORES (ON ARMS, CHEST, BACK & LEGS); WEIRDNESS IN TOES AND TOE NAILS; ITCHING; SWELLING OF LEGS; SWELLING OF JOINTS OF HANDS; RASH ALL OVER BODY; TINGLING; NUMBNESS/TOES FELT NUMB; This spontaneous report received from a patient concerned a 62 year old female of unspecified ethnic origin. The patient's weight was 160 pounds, and height was 65 inches. The patient's past medical history included: covid-19, and concurrent conditions included: drug allergy, alcohol consumer, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: C42A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), weirdness in toes and toe nails, itching, swelling of legs, swelling of joints of hands, rash all over body, tingling, and numbness/toes felt numb (dose number in series: 1). Symptoms started before the vaccine was received, and however, these symptoms got worse after the vaccine was received (condition worsened). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy, rash all over body, crawling feeling under the skin/felt like bugs are crawling under skin, sores (on arms, chest, back & legs), numbness/toes felt numb, weirdness in toes and toe nails, tingling, itching, swelling of legs, swelling of joints of hands, and condition worsened. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220124641-COVID-19 VACCCINE AD26.COV2.S-Neuropathy,Condition worsened. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt recvd 3 doses of Engerix-B 4NOV90 & 27NOV90 & 29APR91 & 6SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Chills, severe headache, entire left deltoid was red and swollen, flu-like symptoms: severe fatigue for 2 days and fatigue day 3, nausea.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.  Pt received 1 dose of Janssen for primary series.  Pt reports body aches, chills, tactile fever, for 24-48 hours following vaccine.  Reports a complete resolution of symptoms at this time.
Fever, chills, vomit, dizziness, fever, lathergy  Vaccine 1
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
fatigue; Headache; This is a spontaneous report from a Non-contactable other healthcare professional (HCP). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, NDC 59267-1000-1), intramuscular at right arm on 12Dec2020 14:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue and a headache for 2 days on an unknown date. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
starting on 18th feeling bad no energy, didn't wanna get out of bed arm still sore on 21st upper left arm was swollen and hot had red streaks started moving down the elbow very painful  called doctor on morning of 22 nd spoke to nurse they advised to seek medical attention. CBC done, no cellultitis indicated so gave prednisone 10mg 1 twice a day for 5 days, pepcid ac 20mg 1 tablet twice a day for 7 days, benadryl 25mg as needed for itching.  diagnosed allergy unspecified to initial encounter t78.40xa-uncomplicated