chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible case of diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that the side effect that she felt was different from what she read in the fact sheet. On 12Feb2021, the patient experienced terrible case of diarrhea. Outcome of the event was unknown.  Information about lot/batch number has been requested.
My mother developed severe muscle aches, severe headaches (worse than prior), generalized malaise. Went to her doctor who ordered several labs including ESR and CRP which were extremely elevated. Saw rheumatology who thought she had polymyalgia rheumatica and later on giant cell arteritis and currently is on high-dose steroids.
Per Mother -  Right arm swelling from shoulder to elbow.  Red, inflamed, pain at injustion site.  Low grade fever.
No adverse event; 7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose; 7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose), UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-May-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 03-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose), UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose).    No concomitant medications were provided. No side effects were reported. No treatment medication was provided.
Red bump at site of vaccination right thigh. Hard. another bump close by. and two more on chest. Localized vaccine associated rash due to vaccine with possibly  secondary bacterial infection. warm compresses and Duracef x 10 days.
SWOLLEN ELBOW WITH REDNESS (LEFT ARM); REDNESS (LEFT ARM); HEADACHE; LIPS NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 26-MAY-2021) dose was not reported, administered on right arm on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced lips numb. On 18-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced swollen elbow with redness (left arm). On 22-MAR-2021, the subject experienced redness (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from lips numb, and the outcome of swollen elbow with redness (left arm) and redness (left arm) was not reported. This report was non-serious.
Patient  developed redness, warmth, and tenderness with itching at the injection site 2 days after the injection was administered. In the office she had 12cm x 15cm area of erythema, warmth and mile tenderness on the left upper arm. Diagnosis: cellulitis versus local allergic reaction. Treatment: Cephalexin 500 mg by mouth TID for 10 days. OTC CLARITIN daily to help with itching fro 3-5 days.
Experienced pain in right arm/at injection site for 3 days that subsided. Experienced a rash at injection site 48 hours (3/7/21) after receiving 1st dose, rash subsided within 24 hours. Rash reappeared at injection site on 3/12/21, covering a larger area than previously experienced along with itching, burning, and mild pain.
Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # no reported).  The patient had developed hives, large raised, hot area and the patient felt achy after receiving the dose of PNEUMOVAX.  No further information was provided.  This is one of several reports received from the same source.  Additional information has been requested.
The needle had a split at the base where it connects to the syringe.  When I went to administer it, the liquid rolled out of the needle and down her arm.  She and I assessed the flaw in the needle and agreed we didn't feel she received her dose.  She asked for me to readminister it so she could get her full dose.  The were no adverse reactions to the shot at the time of administration or by the time she left.
Fever, chills, arm pain and swelling, headache, nausea last more than 24 h
ITCHING; WARM AT INJECTION SITE; RASH; RIGHT LEG IS ACHING FROM KNEE TO HIP AREA; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced warm at injection site. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced right leg is aching from knee to hip area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, right leg is aching from knee to hip area, itching and warm at injection site was not reported. This report was non-serious.
White patches started to appear in my mouth and throat and it begain to get painful to swallow or chew and I've went to doctors and dentist and there not sure what it is.
Pt reported redness, swelling and pain in his left arm for approximately 12 hours the vaccination.  His symptoms slowly went away.  He reported his symptoms to his pcp, Dr. on 6/16/20.
Inflammation and redness at injection site spread to just above elbow and to the inside of bicep and top of deltoid. Visited ER, they recommended Benadryl.
This spontaneous report was received from a healthcare professional concerning an unknown number of patients of unknown age and gender. In November 2015, the patients received improperly stored ROTATEQ lot # reported as L00889, expiration date: 04-DEC-2016 (dose and route were not reported). No adverse effect reported. This is one of two reported received from the same source. Additional information has been requested.
covid vaccine breakthrough  dose 1 7/29/21 EW0164 doe 2 8/19/21 EW0164
I did experience the Covid arm (swelling, redness at injection site) with my first vaccination.  The second vaccine left me feeling lethargic, feverish, aching, chilled, etc.  I tested positive for Covid-19 on January 4, 2022 after having an exposure to a positive patient at work.
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from GlaxoSmithKline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
This spontaneous report as received from a Healthcare Worker regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # K025002, expiration date 20-JUL-2017. There was no information about concomitant medication. No adverse event was reported. No Product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp cellulitis & extreme swelling @ inj site;pt sought medical attention & was treated w/ATB;pt recovered from exp;
fever for 2 days, 38.7... 38.0 Celsius. pain in the muscle around the injection site.
Soreness, muscle aches, chills, headache, tiredness , hot red rash approximately 5?diameter
Information has been received from an RN concerning a 45 year old female pt who on 11/6/99 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. On 11/6/99, the pt experienced local reaction described as raised lump on injection site arm. Pt was seen by a physician and treatment with Keflex was initiated. Follow-up was received which indicated the reporter "had no additional information-we only fill out a short incident report unless the issue goes unresolved. She did not call back so I assume it was resolved". Additional information has been requested.
Extreme muscle pain in arms, shoulders and legs. Received vaccine about 10am, around 9:30 pm the onset hit very quickly and hard.  Pain so bad I have trouble dressing sometimes, and reaching for things triggers awful muscle cramping. I have been treating it using extra strength Tylenol which really doesn?t help at all. Pain is worse in the am and later pm. It is now January 22and I?m still experiencing a lot of pain and cramping. Am unable to take pain meds. Have tried medical marijuana with limited results.
hives all over; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives all over) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over). At the time of the report, URTICARIA (hives all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Patient's details and event verbatim was added.
Headache; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (chills). At the time of the report, HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single  dose covid-19 immunization at a clinic.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid.  The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day.  Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).
This case was reported by a consumer via call center representative and described the occurrence of welts in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included ENBREL for ear disorder. Previously administered products included ENBREL (1st dose received on 31st October 2008). On 13th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th September 2018, the patient started ENBREL (unknown) at an unknown dose and frequency. On 18th September 2018, 5 days after receiving SHINGRIX, the patient experienced welts, itchy legs, extremities hot feeling of and drug interaction. The action taken with ENBREL was unknown. On an unknown date, the outcome of the welts, itchy legs, extremities hot feeling of and drug interaction were unknown. It was unknown if the reporter considered the welts, itchy legs, extremities hot feeling of and drug interaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient received ENBREL in the right leg. The patient experienced a welt, itching, and hot to touch on her right leg. The patient believed it was from the SHINGRIX having an interaction with her ENBREL that caused the injection site reactions on her right leg, which led to drug interaction. It was unknown if the reporter considered the welts, itchy legs, extremities hot feeling of and drug interaction to be related to ENBREL as well. The patient gave consent to be followed up.
Approx. 12 hours after vaccination, patient developed a severe headache, lightheadedness, myalgias and arthralgias. These lasted at least 3 days (so far) and have resulted in at least 2 days off from work. Treatment has been symptomatic - rest, fluids, Tylenol, Motrin.
mild rash (pruritic & macula) over extremities (dorsal surface of arms & legs);
Electric like jolt continuous from shoulder to hand.  Later DX as a injury to the nerve at the site of the vaccination.  Sent to urgent care told to take Tylenol, and ice the area. They referred to physical therapy.
This spontaneous report was received from a physician via a company representative, referring to a 45 year old non-pregnant female patient. The patient's had no drug reactions/allergies, concurrent conditions, nor concomitant medications. On 09-OCT-2017 (reported as "a week and half ago on Monday"), the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly or subcutaneously, for prophylaxis (dose, lot # and expiration date were not reported). In October 2017 (reported as "a few days later"), the patient called her physician and complained that she had pain, swelling and redness at the injection site. It was stated that her physician instructed her to put ice on the injection site and to take some aspirin. On 13-OCT-2017 (reported as " on a Friday"), the patient went to her physician's office and upon be examined, the injection site was "still swollen" and looked as though there was a "knot on their arm" (injection site nodule). The physician also stated that the injection site "was still red and warm to touch". It was reported that the patient was treated with an unspecified steroid and that the patient would have a follow up in the physician's office "in a week" to see if the symptoms had subsided. At the time of reporting, the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between injection site pain, injection site swelling, injection site redness, injection site nodule, and injection site warmth with PNEUMOVAX 23 was not provided.
Initial and follow up information has been received from a physician, the husband of a 69 yr old female pt with no known medical history and no known drug reaction or allergies reported, who on 04Oct05 was vaccinated (route unk) in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). On 05Oct05 the pt developed an injection site, cellulitis like reaction, characterized by erythema, tenderness, swelling and pain. It was also reported that the pt experienced warmth. The pt was treated with conservative treatment; NSAID's and cool compress. On 13Oct05 the pt recovered. No product quality complaint was involved. No further information is available.
Severe headache,  severe muscle aches/pain, joint pain, fever102.9, nausea
Numbness in arm; Numbness in figures; Numbness in  hand; Tingling in figures, arm and hands; Pain in figures; Pain in arm; Pain in hand; This is a spontaneous report from a contactable consumer, the patient. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 24Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to food, medications or other products. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and travoprost (TRAVATAN Z), both for unknown indications form an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENU21) via an unspecified route of administration in the left arm on 03Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 shortly after the second vaccine shot the patient experienced numbness, tingling and excruciating pain at ''figures'', hands, arms when sitting and when sleeping patient was awakened by the pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events numbness, tingling and excruciating pain at ''figures'', hands and arms was not recovered.   No follow-up attempts are needed. No further information is expected.
Headachy most of next day- in evening 9-4 noticed itching and redness at injection site. 9/5 - continuing today 9/6 redness, itching, heat and swelling of injection site- swollen site size of 1/1.5 inches and red.
pt recvd vax; 3cm axillary lymph node on lt side; no oth sxs; 2feb94 recvd returned form; no info avail;
First dose triggered early ovulation with intense sharp pain in right lower abdomen for which I saw my primary doctor who performed ultrasounds with no finding or explanation (lasted for 7 days). Every following month same pain returned with less intensity until 7/21 when pain was extreme and I wasn't even able to walk (felt like ruptured appendix) and required trip to emergency room. CT scan, ultrasounds and blood work was performed with no conclusive diagnosis. The pain went away after 5 days. About 9 months after the first dose these symptoms resolved. Receiving Pfizer booster on 1/21/2022 so far didn't trigger these symptoms but caused vertigo 5 days after administration.
Pt. states 4 hours after vaccine felt fatigued, nausea, vomiting, headaches went to ER. Improved but not back to normal still complaints of fatigue and headache.
raised bump, red, bruise- patient refused benadryl, follow up patient states he is fine, pharmacist reported it with patients doctor
p/vax next day pt exp reddened & sore;to ER swelling & pain;T103, red & ecchymotic @ site;dx as cellulitis;tx w/keflex;