chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling tired; pain [in injection site]; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired) and VACCINATION SITE PAIN (pain [in injection site]) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (feeling tired) and VACCINATION SITE PAIN (pain [in injection site]). At the time of the report, FATIGUE (feeling tired) and VACCINATION SITE PAIN (pain [in injection site]) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-073552 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: This non-significant follow-up was received on 11-MAY-2021 which updated contact details of the reporter.
Information has been received from a Registered Nurse (R.N.) concerning an 11 year old female patient who on 26-MAR-2007 was vaccinated with the first dose of 0.5 mL of Gardasil. The "patients became light headed and fainted after receiving the dose of Gardasil." The nurse reported that the patient had "experienced 2 weeks of injection site soreness." Unspecified medical attention was sought by the patient. Injection site soreness persisted. Additional information has been requested.
48 hours after receiving first dose of VIVOTIF, client reported nausea, could not eat. Later that day felt chills, feverish (no temp taken), slept for several hours. Took second dose at 10 pm that night despite feeling badly. Next day, client could not go to work, slept off and on all day, fever, headache, backache, called clinic for advice. Told to stop VIVOTIF, go to Urgent Care if symptoms worsen, see physician in am. Next morning saw physician, who also said stop VIVOTIF, do not take any antimalarials. Called Clinic to report events.
Client came in on 09/21/2021 and reported no other COVID vaccine had been received by the client. The client was asked by the vaccinator if she had received any other COVID vaccine previously. She reported "no". The client was with her daughter who stated "no", and did not provide any other vaccine record. This was not true. The client received a 2 dose series of Pfizer vaccine. She received a 1st dose of Pfizer vaccine on 01/23/2021 and a 2nd dose Pfizer on 02/13/2021. She also received a 1st dose, of Moderna on 09/21/2021. The client was supposed to be checked in the computer system for record of any previous doses. We cannot confirm if this was in fact completed. Proper completion of this step would have helped identify the client was in fact receiving the wrong vaccine.
dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.84 years.  Concomitant products were not provided.  On 27-Feb-2021, 20 vials were moved to clinic of batch number 014M20A. On 24-Feb-2021, the vaccines of same batch were moved to fridge and proposed beyond use date was 26-Mar-2021 for batch number 014M20A.  For batch number: 014M20A On 28-Feb-2021, at 09:00 A.M. the temperature recorded was 27 Fahrenheit and on same date, at 01:00 P.M. the temperature recorded was 26 Fahrenheit that has been reached by the vial.  The vials were only punctured right before administration and both the doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 Fahrenheit.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
10/7/99 in AM rt arm @ vaccine site w/erythema, inflammation 2" diameter;T100;10/8/99 rt cervical lymph node enlarged;rt ear stuffy;no pain/drainage;
Bell's Palsy; herpes zoster; scarring from herpes zoster; restless leg syndrome; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximate 63-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route not specified) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's Palsy, herpes zoster, scarring from herpes zoster and restless leg syndrome. The outcome of the events was unknown.  Upon internal review, Bell's Palsy was determined to be medically significant.
muscle pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (muscle pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (muscle pain at the injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.   Reporter did not allow further contact
pt recv vax 13JUN97 & pt learned that she was pregnant (LMP MAY97);pt devel a red, hot, & tender inj site rxn w/o an blisters p/each dose;APR97 pt lab test indicated a negative antibody titer;
I got the flu shot on Feb. 1st 2018 at a pharmacy. It hurt at first and then began to swell and get very hot and red. Quite sore for two weeks and more. I went to Dr. (size of baseball). Dear sirs, My arm still hurts and is sore red spot where needle went in. This size very itchy. I am to see my doctor again tomorrow, Tuesday, Feb. 13, 2018. It bleeds when I scratch it. It is very itchy and sore. Most swelling gone down.
The patient was accidentally given the Pfizer 12+ dose of the vaccine instead of the smaller Dose of the Pfizer vaccine.  When I contacted the patient's parent on Monday, December 13, 2021 @ 0834, parent stated she was feeling pretty rough all weekend and literally just laid in bed all weekend wrapped in blankets  with a puke bucket nearby.  She was given a few doses of Tylenol and Ibuprofen and Zofran once for nausea (she never vomited).  She asked for her albuterol inhaler a couple of times for coughing on Sunday (12/12/21).  On Monday morning she seemed better and was bouncing her basketball through the house.
onset of severe chills shaking, then muscle pain, severe fatigue, pain became unbearable as if someone was pouring acid on my bones, entire body ached and unable to move, severe headache, lasted from 5:00pm Friday March 19,2021 until Monday 9:00am March 22nd. Pain lessened enough to get out of bed to use bathroom, fatigue and muscle aches continue as well as severe headache. Slept on and off thru pain, drank ginger-ale and water when I could manage to hold cup, cried when awake, thinking I was dying and slept when too tired to cry any-longer.
Unable to sleep noc a/3FEB92; next day verbalized that lt ear hurt;
The LPN inadvertently gave a bivalent (booster dose) instead of the monovalent (primary) dose. This was supposed to be the second does in the primary series. No adverse effects noted .
Caused my shoulder to droop a little bit; Shoulder pain; The area where I got the vaccine was red, tender; The area where I got the vaccine was red, tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain), VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender) and VACCINATION SITE PAIN (The area where I got the vaccine was red, tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (The area where I got the vaccine was red, tender). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain) and VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain), VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender) and VACCINATION SITE PAIN (The area where I got the vaccine was red, tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.; Sender'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.
No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with an expiration date on 04-JUL-2020 or lot # S005078 with an expiration date on 19-FEB-2021 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of -14 degrees Celsius to -10 degrees Celsius (-9.74 degrees Celsius) (timeframe was not reported). The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Light flu like symptoms), PAIN (Little achy) and ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 5 milliliter. On 13-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose). On 14-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Light flu like symptoms) and PAIN (Little achy). On 13-Nov-2021, ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose) had resolved. On 15-Nov-2021, INFLUENZA LIKE ILLNESS (Light flu like symptoms) and PAIN (Little achy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter.No treatment information was provided.
Within hours felt sleepy and whole body hurt, needed to sleep it off. Missed one day of work. Felt feverish and glands in armpits were swollen for two days.
Patient had low grade fever of 99.1, myalgia and local injection site discomfort 3/10 pain.
Patient mentioned that after dose #1 (administered 3-15-18) he experienced total body soreness and severe lethargy for 2 days post-injection. When I administered his second dose on 5-22-18, he woke up on 5-23-18 with the same extreme symptoms. He described it as soreness like he had mulched or landscaped all day long with no break.
Swelling of eyes, itching, closing of airway, hives.  Was seen at ER, treatment given of IV, steroids, Benadryl, and nebulizer.
Case number PHEH2012US015774 is an initial spontaneous report received from a medical assistant on 07 Aug 2012: This report refers to an adolescent female patient, she was given only the Men-A powder component of MENVEO vaccine (batch number: X11042) reconstituted with sterile water intramuscularly on 07 Aug 2012. No other adverse reaction was reported following this administration error.
Fever 101; Chills; Hot flashes; Terrible headache; Stomach pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00(at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included mental disorder, difficult digestion and allergy to NSAIDS. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 the patient experienced fever 101, chills, hot flashes, terrible headache, stomach pain and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, hot flashes, terrible headache, stomach pain and nausea were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Adult patient was given the undiluted pediatric vaccine.  Dose was still 30 mcg in .03 ml.
Used Vanish point syringe to inject vaccine. After inserting needle into arm and pushing plunger, the plunger stopped or locked midway through injecting. Immediately removed syringe and the syringe proceeded to inject rest of vaccine without touching plunger, resulting in vaccine spraying onto the ground. Patient received unknown, lower than recommended dose. Patient reported no pain or discomfort. Per CDC Interim Revaccination on Guidance (12/14) dose was repeated immediately, 0.3ml IM left arm. Patient was advised to wait 15min after re-administration.
Tired, muscle aches (treated with Tylenol and gone in a day); swollen lymph nodes in left armpit (Over a week so far, treating as needed with Advil)
Fever, chills, sweating greatly, coughing excessively, sore throat.
Rash, heat, and swelling at injection site on left arm. Swelling of lymph nodes, especially in left neck . Throat closure, did not require emergency treatment (treated with antihistamine).  Muscle pain, most severe along left side of body. Severe headache and fatigue. Productive cough (mucous congestion in chest and nasal cavity). Rash disappeared after 2 days, but swollen lymph nodes, throat swelling, muscle pain, and cough lasted 1.5 weeks.
This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 17Aug2021 (at the age of 77-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included underlying mild heart issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. On 16Aug2021, the patient received 3rd dose of COVID vaccine and experienced achey flu like symptoms and arm pain. Stated 3rd dose much worse than dose 1 or 2. Reports lingering tingling all the way down left arm - dose received in left arm. Stated the arm tingling may or may not be vaccine related. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138191
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.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Tested negative after 3 days of treatment ; (Dec2022) Positive, notes: tested positive again 5 days after ending medicine. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 05Dec2022 to 09Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Partial complex seizures lasting 30-60 minutes.  Never had them before 05/05 and has 4 had them since.
Client received 2nd dose of covid vaccine only 20 days after the first dose has been administered
Headache after 2 hours. Woke up next day with continued headache, fever (101), chills, joint pain, muscle pain, pain at injection site, and skin sensitivity
Pain redness and swelling at injection site-not resolved, swollen right axilla-not resolved,  headache-not resolved, muscle pains and severe weakness-not resolved, nause-not resolved, dizziness-not resolved, vomiting-resolved Friday night , high fever-resolved Friday night, chills with violent shaking x 2 hours Thursday morning-resolved, abdominal pains started Friday night- not resolved. Bed rest, water in small amounts, ibuprofen and odansetron per primary
pt recv vax; 2-3 days later, exp lightheadedness, nausea, fatigue, sore throat & devel chicken pox on each thigh; no further details provided;