chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from the literature on 16 Dec 2016. Abstract: A 20-year-old woman presented with a new skin eruption. She described a prodrome of fever and rhinorrhea. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. The physical examination was significant for scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. This case involves a 20-year-old female patient who was vaccinated with a dose of Smallpox vaccine (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date (reported as three weeks earlier in preparation for active duty). Patient's medical history was reported that the patient denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient was presented with a new skin eruption and described a prodrome of fever and rhinorrhea and also had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest two days before presentation and also developed scattered targetoid papules and mucosal erosions. Laboratory examinations including significant physical examination, skin and respiratory viral cultures, as well as mycoplasma testing, were negative. Corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event orbital, lip, and vaginal swelling. List of documents held by sender: none. Sender's Comments: A 20-year-old woman presented with a new skin eruption, fever, rhinorrhea. The physical examination was significant for scattered targetoid papules and mucosal erosions. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. Time to onset is unknown. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time to onset, date of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Within 20 minutes patient began prickly feeling over whole body and itching. A little tightness in lungs
30-year old female who had a reaction to the moderna vaccine s/p 1st dose this past Wednesday 4/7/2021. She developed 2 small itchy blisters on the injection site on the left deltoid  on the following morning Thurs, 4/8/2021. Not painful. Blisters do not come in clusters. No other blisters or rashes on her other body parts.  Denies any fever or flu like sx.
3/13/21-Severe left sided head pain followed by numbness of left side of face, tongue, nose, lips, left ear and left side of neck.  Severe head pain lasted several seconds with the worse numbness lasting 60 minutes.  My left side of  face, lips, ear and head continue to be numb and tingling.
4 days after injection patient had localized redness and itching. The area is slightly warm to the touch and whole arm had mild pain. hard to say if infected or cellular allergic reaction. Advised patient to take an oral OTC antihystamine and if signs/symptoms persisted or get worse, to seek medical attention.
No adverse event; We had an excursion where Moderna product was stored in the fridge and experienced warm excursions; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions) and PRODUCT STORAGE ERROR (Product storage error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. The vaccine was above 46F for a total of 215 hours and 45 minutes. The max temperature reached was 50.68F. Moderna COVID-19 vaccine, bivalent was delivered on 02-Dec-2022 and placed in the freezer upon delivery. Lot was relocated to fridge on 18-Dec-2022 and quarantined on 21-Dec-2022. All impacted product had been damaged. It was possible product might have been used after 18-Dec-2022. Product was not used after 21-Dec-2022.  Treatment information was not provided.
Patient started developing redness at injection site within 24 hours. The site continued to swell and get painful over the next 2 days. Pharmacy contacted on Monday 11/15/21. Patient says the swelling about the size of a "half-dollar".  Pharmacy informed patient to use cold compresses and pain reliever (has allergies to NSAID's). Patient will contact MD later if no improvement.
0n 4/28/04. Mom reports onset of redness late yesterday(4/27/04). This am 4/28/04 at approx 4 am. Reports temperature elevation with swelling to right arm muscle area. Has been applying cool cloth since last night. Advised warm cloth now continue with Tylenol every 4-6 hours as needed temp. If persist for more than 24 hours consult PMD. No answer at home on 4/30/04.
Pain in the entire body on the second day after the shot that lasted 2 days after that the pain went to my back and I needed a walker to move.  The serious back pain last one week.  I still have no energy and sleep more than 8 hours a day.  I also have been fuzzyheaded until recently.
Information has been received from a registered pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck).  It was reported that the patient was supposed to get ZOSTAVAX (Oka/Merck) and was inadvertently given VARIVAX (Oka/Merck) (MSD) due to dispensing error.  No adverse effect reported.  Follow up information was received on 30-JAN-2009:  the pharmacist stated that the error was made in haste.  It was reported that VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) looked similar.  It was reported that the pharmacy was more aware of what product they were dispensing.  The patient was fine at the time of the report.  Additional information is not expected.
Pain at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as adult as per the vaccine indication. The patient had pain at the injection site that began with the injection and lasted 3 days. On 22nd November 2019, the patient received 2nd dose of Shingrix, had no pain with the injection and arm was not at all sore. The patient was concerned that there may had been a medication error and that may had received a flu vaccine by mistake. The reporter wanted to know  were there any cases of patients having no reaction at all after having a reaction to the first shot. The patient did not want to be partially protected from shingles. This case was linked to the case US2019AMR232140.
still dizzy on and off; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for herself that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received second dose last Thursday (25Feb2021) and yesterday (28Feb2021) was still dizzy on and off. Wanting to know if that's normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Low-grade fever, Aches, Chills began approximately 24 hours after vaccination. Onset was fairly quick, within hours.  No treatment.  Slept overnight and felt improved the next morning.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Her arm became painful, red and swollen.  The next day she went swimming a developed a hive rash to her entire upper torso that lasted for a few hours.  She does have a history of developing hives when swimming but mom states it was much worse post her injection. Her pain lasted several days and still has a small lump at the injection site.  The injection site is no longer tender to the touch.  There is also a band-aid "tattoo" at the site of where the bandaid was placed.
Hallucinations.  Covid vaccine  Received 2 doses of Moderna back in March/April.  Based on her age, she was deemed eligible for booster dose of  Moderna last week.   On 10/24 she received her booster dose at pharmacy.  Early AM on 10/25, she was awakened by severe shoulder pain/soreness at injection site.  She also notes that was extremely confused, and hallucinated that home invaders were present in her garage and thought she saw "some shady figures moving around."  She reports being semi-conscious and walking around her house, and getting dressed in slacks and a dress shirt.  She doesn`t remember much past this point, but remembers finding herself in the driveway, wearing a pair of shorts, and it was late afternoon.  Then she reports "someone wanting to move her out of her house and into an old hunting lodge in the mountains."    resolved gradually over next few hours, and is now back to her baseline mental status.
Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly). At the time of the report, DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial and follow-up information has been received from a nurse practitioner concerning a 7 year old female with allergy to OMNICEF (rash) and no previous significant history who on 04-AUG-1998 was vaccinated with the first dose of VARIVAX (Merck). There were no concurrent medications. On 19-DEC-2004 (also reported as 21-DEC-2004) the patient developed shingles (also reported as vesicular rash) and vomiting. There was no rash at the injection site. The lesions were distributed to left lower and upper arm posteriorly left scapula (left side of upper back and neck) over night. On 21-DEC-2004 the patient was seen in office with complaint of fever 102.9- 99.9 for 48 hours. No lab tests or diagnostics were performed. Subsequently, the patient was recovered from shingles and vomiting. Additional information is not expected.
Sepsis due to other etiology. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
her brother who got fully vaccinated in May, now has covid; her brother who got fully vaccinated in May, now has covid.; stated that his D-dimer is tripling; This is a spontaneous report from a contactable consumer (patient sister). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got fully vaccinated in May2021, now had covid. The reporter stated that her brother got the Pfizer vaccine at the beginning of May2021 and was currently in ICU with Covid. Stated that his condition was getting worst. His D-dimer was tripling. Stated that he was fully vaccinated in May 2021 and was fully vaccinated in Sep2021(as reported). Stated that this was not an adverse event due to the vaccine because it was almost four months after the vaccine. Stated that she read that that the Pfizer vaccine should be stored in certain storage conditions. Wanted to know how to ensure get to end user in the correct form. Stated that when it is exposed to higher temperatures for a longer time that it effects the efficacy. Stated that she was in the process of getting the vaccine. Stated that she was not sure that the Pfizer Covid vaccine was effective when he got it. She inquired how Pfizer ensure that the vaccine it reaches its end user are under proper storage temperatures and in its correct form. The patient underwent lab tests and procedures which included fibrin d dimer: d-dimer is tripling, Covid-19 test: positive on unknown date. Outcome of event covid was not recovered, D-dimer was tripling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: ~~~
I have red, itchy rash that resembles hives in these places: under my breasts/ top of stomach, and going down the whole stomach (this is the worst area), armpits, elbow creases,  behind my knees, groin/ thighs, base of neck/ collarbone. A virtual doctor prescribed me prednisone, and it helped for the 6 days but the day I came off of them, it came back and worse. Now I am on a prescribed steroid cream but I have an appointment with an allergist next week
This case was reported by a consumer via call center representative and described the occurrence of vertigo in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The patient received SHINGRIX and developed vertigo after receiving the vaccine. The reporter did not have any additional information regarding this event.
Patient experienced increase Heart rate (117) and increase blood pressure. Patient felt lightheaded and woozy. Contacted 911 and was removed from pharmacy by ambulance.
Developed lymphadenopathy June 2021 and diagnosed with Follicular T Cell Lymphoma 11/2/2021. I am not aware of this being a side effect of COVID vaccines, but wanted to report it to be safe.
Initial unsolicited report received from the literature on 06 September 2016. Abstract: BACKGROUND: Case reports have suggested that vaccines may trigger transverse myelitis (TM) or acute disseminated encephalomyelitis (ADEM), but the evidence for a causal association is inconclusive. We analyzed the association of immunization and subsequent development of TM or ADEM. METHODS: We identified all cases of TM and ADEM in the Vaccine Safety Datalink (VSD) population. Using a case centered method; we compared vaccination of each case to vaccination of all matched persons in the study population, who received the same type of vaccine, with respect to whether or not their vaccination occurred during a pre-determined exposure interval. We calculated a risk difference (excess risk) of TM and ADEM for each vaccine. RESULTS: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. Based on 2 exposed cases, the OR for Tdap exposure 5-28 days prior to ADEM onset was 15.8 (95 % CI 1.2-471.6, p=0.04) and the estimated excess risk was 0.385 (-0.04-1.16) cases per million doses. CONCLUSIONS: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered. This case involve a patient (age and gender was not reported) who was vaccinated with a dose of TDAP Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, 11 days post vaccination, patient developed Acute Disseminated Encephalomyelitis (ADEM). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event Acute Disseminated Encephalomyelitis (ADEM). List of documents held by sender: none. Sender's Comments: Patient was diagnosed with Acute Disseminated Encephalomyelitis(ADEM), following TDAP VACCINE. Time to onset is compatible but additional information regarding patient detail medical history, infectious history which could trigger immune system, family history of any immune disorder, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
one week after getting the vaccination I woke up with a very itchy arm around the site of injection.  It continued to be very itchy and when I looked at it it was red, with hives, and an additional red spot as well as red spot where needle had gone in.  It has continued to be very itchy, and area between the two red spots has appeared bruised (perhaps from scratching).  I have only rubbed it through clothing.  I put on some camomile, and it was a little less itchy for a while.  3 days later, it's still itchy and red area continues.
This medically confirmed health authority report (initial receipt: 21-Sep-2015) concerns a 50 year old female patient. On 20-Sep-2015, the patient received intramuscular AFLURIA (batch number U56606) that had a temperature excursion prior to administration and reached 50 degree F for about an hour. (Medication error). There was no adverse event reported other than the temperature excursion. The outcome was reported as recovered. Reporter's comments: The reporter assessed the event as non-serious.
Fever-around  101.7  had lasted for 36 hours. Chills and extreme muscle pain Weakness
developed stroke (unresponsive, unable to express herself or her needs,  lethargic, unable to swallow)
Client was vaccinated with Moderna vaccines on 1/15 and 2/15/2021 (these are approximate dates give or take a few days per client report).  Symptoms of Covid started 9/9 - nasal congestion, feverish x 1 day, myalgia.  Tested + with PCR on 9/10.  Reported as a case of breakthrough Covid in a previously vaccinated person.
Fetal demise around 10/10/2016, miscairrage 10/28/2016.
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested for COVID-19 and found out that she was positive for the infection, positive COVID-19 test with no symptoms. The patient was supposed to have surgery but she was tested for COVID-19 and found out that she was positive for the infection, she have not had any symptoms, she did not interact with anybody and she wears double mask. The outcome of events was unknown.  Information on the lot/batch number has been requested.