chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in both elbows. R worse. Pain in joints of both feet. L worse; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0182) via an unspecified route of administration, administered in left arm on 05May2021 at 13:00 (age at vaccination 56 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergy. Concomitant medications included ibuprofen, unspecified ground flax seed and stool softener in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On 22May2021 at 13:00, the patient experienced pain in both elbows R worse; pain in joints of both feet L worse. The patient did not receive any treatment for event. Outcome of the event was resolving.   Follow-up attempts are completed. No further information is expected.
Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Pt rec'd 1st vaccine, ambulatory with her partner >40 feet to registration area for 2nd dose appt, completed her appt as pt sat in observation area. She c/o dizziness, feeling like possibly passing out. Took pt to medical bay w/c & placed gurney with legs elevated. Pt immediately stated feeling better. Pt alert oriented, denies difficulty breathing/SOB. Spoke in complete sentences. 0 facial/mandible swelling. 0 strider. Pt states similar symptoms after blood draw 2 years ago, feeling dizzy, states that she's afraid of needle/sight of blood. Pt was able to get out of gurney & no difficulty walking - walked with partner. BP 81/47, HR 83, RR 20 SpO2 100%
Throat swelling, tongue swelling, chest tightness, full body itching. Vomiting Epi-pen given EMS arrived IV Benadryl administered, transported to ED
Injection date: 12/08/2021, 11:30am 12/10/2021 6:30 pm extreme numbness and tingling in all extremities. 12/11/2021 local Medical Center Emergency room visit 9:00 am. Diagnosis: Bilateral upper and lower extremity paresthesias.
pt did not have any adverse event, the syringe failed and some of the vaccine leaked out.
After receiving injection, patient had tingling sensation, severe arm pain and limited ROM lasting x 1 week. Spiked temp of 103 the night of vaccine - resolved with ibuprofen.
My period often is only heavy for 1 day and it lasts for 2 to 3 days. I have had a heavy non stop period for 5 days.
I received the vaccine at 4:30 PM and later that night, I had a headache and I felt very out of it. By the end of the day; however, I was feeling better. The next day, I woke up around 5 AM and my muscles were all tensing very strongly and I could not stop shaking. This went on for about 30 minutes, and then I stopped shaking and tensing  so much, though my muscles still felt a bit tense. I can't really eat in the morning, so I drank two glasses of water over the course of a few hours and took 2 acetaminophen. I stayed in bed until around 10 AM. Then, I took a shower, but while taking it, I felt very lightheaded and my vision had some black spots, and I had to sit down several times. After I got out, I tried to eat something, but then I felt really nauseous and had acid reflux for at least 30 minutes. Afterwards, I drank a bit of water and went back to bed. My muscles started tensing and shaking again, though not quite as intensely as when I first woke up. I felt very cold, so I turned up the heat and put on warm clothes. I fell asleep for about 20 minutes around 12, and when I woke up I felt a little less nauseous and headache-y. I stayed in bed for an hour, and I ate some pudding over the course of an hour or two, but I thinking about eating much else made me feel nauseous. I fell asleep around 5:30 and woke up again around 7:30. I felt better after waking up, but still had a bit of a headache and my muscles were slightly tense. On Sunday and Monday (today) I felt about the same, physically tired but otherwise mostly ok.
Local redness, bump, reddish blister, local itching, headache, itchy all over, fever 101F, muscle aches, swollen lymph nodes, severe chest discomfort across entire chest and into arm and both sides of neck and lower jaws, decreased with Motrin, benadryl and tylenol. Became worse with movement, even worse next night, could not lie down had to sleep sitting up. Pt went to ER that AM. Tx with Vicodin for pain, motrin. Pt was told had Pericarditis, Vicodin helped, decreased sleep. Much better this AM. No short of breath.
Patient screamed inconsolably for 3 1/2 hours starting 2 hours after vaccination.  M.D. rev. - normal exam.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE and IBUPROFEN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: unknown High. On 13-Jan-2021, Weight: unknown High.         Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information  received on 14 Jun 2021 contains patient denied for further follow up.
w/in 24 hrs p/HIB/MMR pt exp urticarial rash but otherwise asymptomatic; mom gave several doses of DPH & pt recovered w/no residual sequelae;
PATIENT NOTICED SIGNIFICANT SWELLING, REDNESS, AND YELLOW/GREEN DISCHARGE AT INJECTION SITE AS WELL AS RASH ON CHEST, BACK, NECK, ARMS, AND RIGHT LEG WHEN HE WOKE ON 21 FEB 2018. HE ADDITIONALLY HAD MILD CONSTITUTIONAL SYMPTOMS OF GENERALIZED FATIGUE AND BODY ACHES. HE PRESENTED TO THE CLINIC FOR EVALUATION AND THE INJECTION SITE WAS NOTED TO HAVE APPEARANCE OF ROBUST TAKE. THE DIFFUSE RASH HAD APPEARANCE OF GENERALIZED VACCINIA. HE HAS NO H/O IMMUNE COMPROMISING CONDITION OR MEDICATION. HE HAD AN OTHERWISE NORMAL EXAM. HE WAS MANAGED SYMPTOMATICALLY WITH DIPHENHYDRAMINE AND IBUPROFEN. HE FOLLOWED UP ON 23 FEB 2018 AND REPORTED THAT THE LESIONS HAD TURNED INTO PUSTULES, RUPTURED, AND SCABBED.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) 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 EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were provided by the reporter.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were provided by the reporter.
TIREDNESS; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included high cholesterol, and spinal cord surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness. This report was non-serious.
redness at injection site; felt ill; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix with an associated reaction of malaise (1st dose received on 24th July 2019, refer linked case US2019AMR176926).   On 25th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and feeling unwell to be related to Shingrix.  Additional information received were as follows: The caller was the patient. The patient felt ill and also developed redness at the injection site. The reporter did not consent to follow-up.  The caller did not provide any additional information.
Itchy hive like rash on right arm, right neck, right chin, and a little on left forearm
Loss of balance, sensory deficits,  fuzzy thinking, confusion, ADHD behavior,  depression,  fever, fatigue
Pt recvd Engerix-B that evening had severe h/a; medical MD was called; pt was hospitalized; tx w/Advil; severe headache persists once a wk since JUN;
Pt. complained of aches all over, wanting to vomit, feeling shaky, heart beating fast, and seeing colors. Pt. was presented at facility for observation.
Vaccine expired on 1/11/2023 and was administered to patient.  Staff instructed to call and inform patient that dose must be repeated due to CDC guidelines.
RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021.  ON 3/14/2021 SHE STARTED TO BECOME DIZZY, CONFUSED AND DEVELOPED MALAISE AND EVENTUALLY BECAME SO WEAK SHE COULD NOT MOVE.  PRIOR TO THIS SHE WAS VERY ACTIVE AND WAS WALKING AROUND FINE AND EVEN CLEANS HORSE STALLS AT HER HORSE BOARDING STABLES.  SHE WAS PHYSICALLY VERY ACTIVE  PRIOR RECEIVING THIS 2ND VACCINATION.  SHE IS CURRENTLY ADMITTED. SHE IS STILL CONFUSED AND AGITATED SHE CONTINUES TO BE WEAK AND CANNOT AMBULATE AT THIS TIME.
CONGESTION; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced congestion. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced fatigue. On 23-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the congestion, chills, fatigue and headache was not reported. This report was non-serious.
Within a few hours I spiked a fever of 103F and it progressively got worse.  I then was overwhelmed with the smell of maple syrup.  It was a very powerful smell, and my hands smelled like maple syrup.  Once that passed,  I began to shake and became delirious for the next 6 hours.  I was unable to eat or drink, and I was bed-ridden.  Almost a day later my fever broke and my sweat stunk like nothing I have ever smelled before.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 11th May 2018, the patient experienced generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, generalized rash, hives, swelling of wrists, ganglion of joint, hair loss, injected limb mobility decreased, heartbeats irregular, thyroid disorder, visual impairment, walking difficulty, psoriasis, shingles, dizziness and increased blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. On 11th May 2018, 7 days after receiving SHINGRIX, the patient experienced, pain at injection site, rash on body, hives on body, swelling on wrist, ganglion cyst on wrist, hair falling out, unable to use right hand, irregular heartbeat, thyroid issues (up and down), difficulty seeing, difficulty walking and psoriasis on back. The patient was planned to follow-up with her physician on an unknown date. The emergency room visit required. The reporter consented to follow up.
Patient received 2 month vaccines and PEDIARIX given on left thigh. Developed bump/lump to area 3 cm x 3.5 cm, no erythema, non tender.
pt request one Prevnar 20 and one Fluad. I accidently gave pt 2 Fluad on the same day (different arm). I informed pt possible muscle pain and followed up with pt on the next day
10JUN93 AM pt was vaxed then 11JUN93 8AM reported rt leg swollen & cranky, didnt sleep all noc;
Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine was placed in refrigerator on 29-Oct-2021 There was no temperature excursion. No adverse event was reported.
Shoulder hurts; got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain) and ARTHRALGIA (Shoulder hurts) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, DD1A2V and 044A217) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain). On an unknown date, the patient experienced ARTHRALGIA (Shoulder hurts). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (got the booster and within 2 hours, the back pain had ease, the soreness in the glutes had eased/ pain was decreasing so patient thought this was a secret to back pain) and ARTHRALGIA (Shoulder hurts) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-373497 (Patient Link).
Getting like dizziness spells; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 22-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0181, Expiry date was unknown) via unspecified route of administration in Arm Left (at the age of 22-years-old) on 07Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (CHATEAL) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021, the patient experienced getting like dizziness spells. Patient got the vaccine, the Pfizer vaccine dose number 2 on Wednesday, this Wednesday and she didn't feel bad the day after but the following Friday, Friday after, patient started getting like dizziness spells and she had read that something she should call someone about. Patient don't have a primary provider at this time, so she did not know where else to call. Therapeutic measures were taken with Advil painkiller today but that was it, it was Advil Liqui-Gels. The outcome of the event was unknown.  Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.
Fatigue Nausea                                                   Symptoms began on March 2nd         Symptoms resolved on March 6th Stomach pain  (burning) Fever
Left arm sore; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter causality for co-suspect Humira for all the events was reported as not related.  No concomitant medication reported. No treatment medication reported.
RN was drawing up Menveo vaccine and got distracted, only drawing up the diluent portion of the Menveo vaccine. RN did not mix the diluent portion with the Lypholized portion of the Menveo vaccine. RN accidently administered only the diluent portion of the Menveo vaccine. After vaccine was administered and patient was going to leave clinic, RN immediately noticed the mistake and informed the patient and patient's parent to come back into the clinic. RN informed the patient and the patient's mother that the patient only received the diluent portion of the vaccine and per recommendations of the unit clinic manager and resources, that the patient should be revaccinated with no minimum interval between the incorrect and the correct vaccine doses. Patient and patient's verbalized understanding of situation and were accepting and agreeable to receiving a corrected Menveo vaccine dose. This was administered the same day, while patient was in the office.