chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the second dose vaccine, severe chills, aches and pains. Progressive chills and rigors with increasing pain. Sent to treatment room for LR IV fluids and Ofermev1 gram IV.
Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.   This case was linked to MOD-2021-310807.
Reddness and warm ot the right thigh, local reaction. Treatment, cool compresses, Benadryl PO.
Red hot and flushed face; Red hot and flushed face; This is a spontaneous report received from a non-contactable consumer (patient). A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 22Mar2021 at 13:45 as a single dose (at the age of 19 year) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient didn't have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 14:30, the patient experienced red hot and flushed face. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the event red hot and flushed face was unknown at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: narrative lead sentence updates, and The patient didn't have known allergies added as allergies: No, event face red added.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Reduction of taste and "salty".; Reduction of taste and "salty".; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number, unknown single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), DYSGEUSIA (non-serious), outcome "unknown" and all described as "Reduction of taste and "salty".  Additional information: Pfizer sponsored program Support.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dramatic decrease in blood sugar levels that lead to loss of consciousness. Roommates brought to the ER for glucose levels to rise. Repeated ER visit two days later with a similar problem. PCP and ER physician deduced COVID vaccine interference. My body is burning through my food faster than I can normally replace it. Recommended frequent meals and rest until symptoms cease. Conducted blood work, urine samples, and EKG to rule out other factors during both ER visits.
Previously seen by Neurology and told she likely had breath holding spells. However, after her vaccines today, pt had a 60-second generalized tonic clonic seizure. Eyes rolled back in head, and upper and lower extremities were jerking in a rhythmic movement. RN retrieved MD from another exam room. I arrived to room to find patient as described above. Placed patient supine on the exam table. CV RRR and Pulm CTA B. Episode subsided on it's own within that 60-second timeline, as described by RN to MD. Patient drowsy afterward, but resting comfortably in mom's arms. Spoke with Dr. in Neurology, who advised this can occur after immunizations. She said that a certain percentage of children will have these episodes after immunization, and that we should "treat it like a febrile seizure or breath holding spell," meaning it was a provoked incident that likely does not signify any underlying pathology.
It started as a bilateral hand rash. I used some topical corticosteroid that had previously been prescribed for eczema. That went on for 2-3 months where it was smoldering and it never went away completely even though I was using those medications. That actually went on for several months. Started in April or May and coincidence with other health event. That same week, it completely exploded and became way worse than it had ever been (Late August). I had a recommendation from another friend to try a higher dose steroid and tried that on my hand and that kept things at a low rumble but it never really went away. At that time I was also having a bilateral lower and upper extremity skin rash and trunk. It was predominantly extensor surfaces. I went to see a dermatologist, a different one at that point and he prescribed a different corticosteroid and used that for another 1-2 months and it improved and never went away on the hands. Went back to see him in follow up and it had been a couple months at that point and he said to keep using it. Around that time, he also put me on high dose on antihistamines. Hydroxyzine at night. Dermatologist is stumped, being sent back to PCP as well as an allergist.
Headaches have been gradual and very intense; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches have been gradual and very intense) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headaches have been gradual and very intense). At the time of the report, HEADACHE (Headaches have been gradual and very intense) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol and Advil as treatment.   Reporter did not allow further contact
complete loss of taste and smell; complete loss of taste and smell; severe aching all over; chills; fever; severe headache; vomiting; nausea; severe fatigue; This is a spontaneous report from a contactable consumer (patient).A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 12Mar2021 at 15:15 (at the age of 51-years) as dose 1, single for covid-19 immunization. The patient received Facility type vaccine at Public Health Clinic/ Administration facility. The patient medical history included degenerative disc disease. The patient had known allergies to Penicillin. The patient was not pregnant at the time of vaccination. The patient's Concomitant medications included clarithromycin (CLARITIN [CLARITHROMYCIN]); ibuprofen (IBUPROFEN); ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY); Iron Supplement. The patient had not received any other vaccine within 4 weeks. One day following vaccination on 13Mar2021 at 17:30, the patient had experienced severe aching all over, chills, fever, severe headache, vomiting, nausea, severe fatigue. Two days following vaccination on 14Mar2021, the patient also had complete loss of taste and smell. Three days following vaccination, headache, loss of taste and smell continued. The patient had not received any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient received vaccine ACT-HIB. The patient's past vaccination(s) included PENTACEL in MAR-2018 with ACTHIB in it. The patient's past medical history and family history were not provided. Concomitant medications included PROQUAD, PREVNAR 13 and VAQTA on unknown dates. On 16-Jan-2019, the patient received a fourth dose in series, 0.5ml of suspect HIB (PRP/T) VACCINE lot UI819AA, expiry date 17-Nov-2018 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that patient was given an expired dose (expiry date 17-Nov-2018) of ACT-HIB vaccine on 16-Jan-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
ITCHINESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Knee surgery NOS (left knee). Concurrent medical conditions included Rheumatoid arthritis (moderate to severe rheumatoid arthritis). Concomitant products included MELOXICAM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE). At the time of the report, VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE) had resolved.            The patient was taking meloxicam in conjunction with/HUMIRA.  Patient had events left knee surgery and non-serious itchiness at site for COVID 19 VACCINE with HUMIRA (ADALIMUMAB).  The reporter's causality for the event(s) of had left knee surgery was not provided. The reporter's causality for the event(s) of itchiness at injection site for covid 19 vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. On unknown date patient had Knee operation and the outcome was Recovered/resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The formulation for Humira was reported as Solution for injection.   No treatment medications information were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Getting weaker; Leg feeling numb; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016BUA and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb). At the time of the report, ASTHENIA (Getting weaker) and HYPOAESTHESIA (Leg feeling numb) outcome was unknown. Not Provided          No concomitant medication information was provided No treatment medication information was provided  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Reporter's E -Mail added
Gastrointestinal distress, vomiting and diarrhea.  Diarrhea lasted over one month without resolution.  Fever, headache, stomachache. Eventually became chronic relapsing and remitting diarrhea and constipation, with periodic fever syndrome, which lasted for almost a year, with 4 or 5 flare ups throughout the next year.  For the next 4 years, she would have 2-3 major episodes of long course stomach viruses each year, with same symptoms, including stomach pain, headache, fever, and diarrhea that lasted 2-3 weeks.
experienced pain in the arm after receiving the GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist, via a company representative and refers to a 16 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced pain in the arm after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine (pain in extremity). It was unknown if the patient received any treatment for the event.       The outcome of pain in extremity was reported as resolved at the reporting time and lasted for 1 week.      the causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was unknown.      This is one of the 2 reports received form the same source.; Sender's Comments:  US-009507513-1905USA010476:
Information has been received from a registered nurse concerning a 14-year-old female with no pertinent medical history and no drug reactions/allergies who in May 2001, was vaccinated with a 0.5ml dose of VARIVAX (Oka/Merck). There was no concomitant medication. In 2001, 7 days after receiving the vaccine, the patient experienced chickenpox. She was noted to have approximately 10 to 20 lesions. The rash cleared up 21 days after the vaccination. The patient was seen by a nurse or physician at the time. Subsequently, the patient recovered from chickenpox. There was no product quality complaint. Additional information has been requested.
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from 7/98 through 2000 and each time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available.
swelling; injection site iching; injection site induration; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date unknown) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Kinrix .5 ml. On 10th July 2019, 2 days after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching and injection site induration were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching and injection site induration to be related to Kinrix.  Additional details were provided as follows: The patient received Kinrix on left arm. The prefilled syringe of Kinrix 1 inch 25 gauge needle was given. The patient's mom noticed swelling on 7 of 10, 4x2 inches swelling, 5x10cm, some induration and itching. The reporter came back to office, no urgent care visit, no fever.
Severe Fever of 103.9 degrees farenheit taken orally. Lethargy.
Expired vaccine used/past expiration administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/past expiration administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/past expiration administration). On 28-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/past expiration administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 05-AUG-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID19 vaccine EUA Woke up at night to go to the bathroom.  Had trouble getting out of bed and walking.  Joints were stiff.  Strangely my right hand was frozen open.  Was unable to make a fist or grasp a water bottle.  When I tried to close my right hand I had a weird sensation in my hand.  It felt like electricity flowing down my hand and into my 4 fingers.  Left hand was not effected.   Had the same effect when I woke up a couple times during the night.  When I got up on Saturday morning the problem with my hand was gone.  Still a bit stiff, was fatigued, headache and body aches.  Sore arm for a few days.
Left side where booster was given: -swollen glands right above clavacle -swelling in my knees front and back -joint pain knees, elbows, wrists, thumbs -pain in legs, back and in my pelvic girdle...difficulty standing for any length of time. Loss of strength in all my limbs. -difficulty standing from a sitting position.  -difficulty doing every day chores, making my bed, doing laundry, etc.
p/2nd capsule-nausea, abdo pain, nausea, vomiting, diarrhea, h/a, chills;
Patient was given vaccine that was was expired on 08/08/2020 Patient was monitored for 15 min, no adverse effect. Dr.  in office was informed,  and Patient parents are going to be contacted in regards, to f/u
On am of 2/21 pt complained of itching from B/L plantar surfaces (mid-arch in midline). Initial presentation was itching macular-papular rash. Progressed to pustule on evening of 2/21. As of submission, L puustule intact, R ruptured. Transient macular rash to B/L palms 2/21 with itch. Afebrile, no other s/s.
COVID PNEUMONIA (SUSPECTED COVID-19 INFECTION); SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age and sex. 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 06-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced covid pneumonia (suspected covid-19 infection) and (suspected clinical vaccination failure). It was reported that "was vaxxed with your vaccine on 06-JUN-2021. was hospitalized with covid pneumonia on 28-NOV-2021 for 5 days after battling it for 8 days at home. Thanks for the failed vaccine and astronomical medical bills".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid pneumonia (suspected covid-19 infection) and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000207499.; Sender's Comments: V0: 20211237564-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. V0: 20211237564-Covid-19 vaccine ad26.cov2.s -Covid pneumonia. 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).
The day after my 2 month old son received the rotavirus vaccine with his other 2 month shots he has had bright green diarhea since, on a daily basis.  He is a breast fed infant and has never had green poop before the vaccine. It has been at least 3 weeks and there has been no change